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TABLE OF CONTENTS
ANNUAL CONSOLIDATED FINANCIAL STATEMENTS
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 20-F
(Mark One) | ||
o | REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
OR
OR | ||
ý | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2012 |
For the fiscal year ended December 31, 2011
OR
OR | ||
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
OR
OR | ||
o | SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
Date of event requiring this shell company report. . . . . . . . . . . . . . . . . | ||
For the transition period from to |
Date of event requiring this shell company report . . . . . . . . . . . . . . . . . . .
For the transition period from to
Commission File Number: 001-31368
Sanofi (Exact name of registrant as specified in its charter) |
N/A (Translation of registrant's name into English) |
France (Jurisdiction of incorporation or organization) |
54, Rue La Boétie, 75008 Paris, France (Address of principal executive offices) |
(Exact name of registrant as specified in its charter)
Karen Linehan, Senior Vice President Legal Affairs and General Counsel 54, Rue La Boétie, 75008 Paris, France. Fax: 011 + 33 1 53 77 43 03. Tel: 011 + 33 1 53 77 40 00 (Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person) |
(Translation of registrant’s name into English)
France
(Jurisdiction of incorporation or organization)
54, Rue La Boétie, 75008 Paris, France
(Address of principal executive offices)
Karen Linehan, Senior Vice President Legal Affairs and General Counsel
54, Rue La Boétie, 75008 Paris, France. Fax: 011 + 33 1 53 77 43 03. Tel: 011 + 33 1 53 77 40 00
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
Securities registered or to be registered pursuant to Section 12(b) of the Act:
Title of each class: | Name of each exchange on which registered: | ||||
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American Depositary Shares, each
| New York Stock Exchange | ||||
Ordinary shares, par value €2 per share |
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Contingent Value Rights | NASDAQ Global Market |
Securities registered pursuant to Section 12(g) of the Act:None
The number of outstanding shares of each of the issuer’s classes of capital or
common stock as of December 31, 2011 was:
Ordinary shares: 1,340,918,811
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405
of the Securities Act.
YES x NO ¨.
If this report is an annual or transition report, indicate by check mark if the registrant is not
required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
YES ¨ NO x.
The number of outstanding shares of each of the issuer's classes of capital or common stock as of December 31, 2012 was: Ordinary shares: 1,340,918,811 Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ý NO o. If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. YES o NO ý. |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes xý No ¨o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes xo No ¨ý
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated"accelerated filer and large accelerated filer”filer" in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer | Accelerated filer | Non-accelerated filer |
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
U.S. GAAP ¨o International Financial Reporting Standards as issued by the International Accounting Standards Board xý Other ¨o
If “Other”"Other" has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.
Item 17 ¨o Item 18 ¨o
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
YES ¨o NO xý.
PRESENTATION OF FINANCIAL AND OTHER INFORMATION
The consolidated financial statements contained in this annual report on Form 20-F have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB) and with IFRS as adopted by the European Union, as of December 31, 2011.2012.
Unless the context requires otherwise, the terms “Sanofi,”"Sanofi," the “Company,”"Company," the “Group,” “we,” “our”"Group," "we," "our" or “us”"us" refer to Sanofi and its consolidated subsidiaries.
All references herein to “United States”"United States" or “U.S.”"U.S." are to the United States of America, references to “dollars”"dollars" or “$”"$" are to the currency of the United States, references to “France”"France" are to the Republic of France, and references to “euro”"euro" and “€” "€"are to the currency of the European Union member states (including France) participating in the European Monetary Union.
Brand names appearing in this annual report are trademarks of Sanofi and/or its affiliates, with the exception of:
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Not all trademarks related to investigational agents have been authorized as of the date of this annual report by the relevant health authorities; for instance Lyxumia® and Aubagio™Lyxumia® trade names havename has not been approved by the FDA.
The data relativerelating to market shares and ranking information for pharmaceutical products, in particular as presented in particular in “Item"Item 4. Information on the Company — B. Business Overview — Markets — Marketing and distribution”distribution," are based on sales data from IMS Health MIDAS (IMS), retail and hospital, for calendar year 2011,2012, in constant euros (unless otherwise indicated).
While we believe that the IMS sales data we present below are generally useful comparative indicators for our industry, they may not precisely match the sales figures published by the companies that sell the products (including our company and other pharmaceutical companies). In particular, the rules used by IMS to attribute the sales of a product covered by an alliance or license agreement do not always exactly match the rules of the agreement.
In order to allow a reconciliation with our basis of consolidation as defined in “Item"Item 5. Operating and Financial Review and Prospects — Presentation of Net Sales,”" IMS data shown in the present document have been adjusted and include:
Data relative to market shares and ranking information presented herein for our vaccines business are based on internal estimates unless stated otherwise.
Product indications described in this annual report are composite summaries of the major indications approved in the product’sproduct's principal markets. Not all indications are necessarily available in each of the markets in which the products are approved. The summaries presented herein for the purpose of financial reporting do not substitute for careful consideration of the full labeling approved in each market.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This annual report contains forward-looking statements. We may also make written or oral forward-looking statements in our periodic reports to the Securities and Exchange Commission on Form 6-K, in our annual report to shareholders, in our offering circulars and prospectuses, in press releases and other written materials and in oral statements made by our officers, directors or employees to third parties. Examples of such forward-looking statements include:
This information is based on data, assumptions and estimates considered as reasonable by the Company as at the date of this annual report and undue reliance should not be placed on such statements.
Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “target,” “estimate,” “project,” “predict,” “forecast,” “guideline,” “should”"believe," "anticipate," "plan," "expect," "intend," "target," "estimate," "project," "predict," "forecast," "guideline," "should" and similar expressions are intended to identify forward-looking statements but are not the exclusive means of identifying such statements.
Forward-looking statements involve inherent, known and unknown, risks and uncertainties associated with the regulatory, economic, financial and competitive environment, and other factors that could cause future results and objectives to differ materially from those expressed or implied in the forward-looking statements. The list below indicates some of the risk
Risk factors faced by the Company:
“we rely on our patents and proprietary rights to provide exclusive rights to market certain of our products, and if such patents and other rights were limited or circumvented, our financial results could be materially and adversely affected”;
“product liability claims could adversely affect our business, results of operations and financial condition”;
“changes in the laws or regulations that apply to us could affect the Group’s business, results of operations and financial condition”;
“generic versions of some of our products may be approved for sale in one or more of their major markets”;
“our long-term objectives may not be fully realized”;
“we may fail to adequately renew our product portfolio whether through our own research and development or through acquisitions and strategic alliances”;
“we may lose market share to competing remedies or generic brands if they are perceived to be equivalent or superior products”;
“the diversification of the Group’s business exposes us to additional risks”;
“our products and manufacturing facilities are subject to significant government regulations and approvals, which are often costly and could result in adverse consequences to our business if we fail to comply with the regulations or maintain the approvals”;
“we incurred substantial debt in connection with the acquisition of Genzyme which may limit our business flexibility compared to some of our peers”;
“we face uncertainties over the pricing and reimbursement of pharmaceutical products”;
“the ongoing slowdown of global economic growth and the financial crisis could have negative consequences for our business”;
“the manufacture of our products is technically complex, and supply interruptions, product recalls or inventory losses caused by unforeseen events may reduce sales, adversely affect our operating results and financial condition and delay the launch of new products”; and
risks related to financial markets.
We caution you that the foregoing list of risk factors is not exclusive and a number of important factors, discussed under “Item 3. Key Information — D. Risk Factors” below, could affect the future results and cause actual results to differ materially from those contained in any forward-looking statements.statements are discussed under "Item 3. Key Information — D. Risk Factors". Additional risks, not currently known or considered immaterial by the Group, may have the same unfavorable effect and investors may lose all or part of their investment.
Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments.
Item 1. Identity of Directors, Senior Management and Advisers
N/A
Item 2. Offer Statistics and Expected Timetable
N/A
SUMMARY OF SELECTED FINANCIAL DATA
The tables below set forth selected consolidated financial data for Sanofi. These financial data are derived from the Sanofi consolidated financial statements. The Sanofi consolidated financial statements for the years ended December 31, 2012, 2011 2010 and 20092010 are included in Item 18 of this annual report.
The consolidated financial statements of Sanofi for the years ended December 31, 2012, 2011 2010 and 20092010 have been prepared in compliance with IFRS issued by the International Accounting Standards Board (IASB) and with IFRS adopted by the European Union as of December 31, 2011.2012. The term “IFRS”"IFRS" refers collectively to international accounting and financial reporting standards (IAS and IFRS) and to interpretations of the interpretations committees (SIC and IFRIC) mandatorily applicable as of December 31, 2011.2012.
Sanofi reports its financial results in euros.
SELECTED CONDENSED FINANCIAL INFORMATION
| As of and for the year ended December 31, | |||||||||||||||
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(€ million, except per share data) | 2012 | 2011 | 2010 | 2009 | 2008 | |||||||||||
IFRS Income statement data (a) | ||||||||||||||||
Net sales | 34,947 | 33,389 | 32,367 | 29,785 | 27,568 | |||||||||||
Gross profit | 24,839 | 24,156 | 24,638 | 23,125 | 21,480 | |||||||||||
Operating income | 6,337 | 5,731 | 6,535 | 6,435 | 4,394 | |||||||||||
Net income attributable to equity holders of Sanofi | 4,967 | 5,693 | 5,467 | 5,265 | 3,851 | |||||||||||
Basic earnings per share (€) (a)/(b) : | ||||||||||||||||
Net income attributable to equity holders of Sanofi | 3.76 | 4.31 | 4.19 | 4.03 | 2.94 | |||||||||||
Diluted earnings per share (€) (a)/(c) : | ||||||||||||||||
Net income attributable to equity holders of Sanofi | 3.74 | 4.29 | 4.18 | 4.03 | 2.94 | |||||||||||
IFRS Balance sheet data | ||||||||||||||||
Goodwill and other intangible assets | 58,265 | 62,221 | (g) | 44,411 | 43,480 | 43,423 | ||||||||||
Total assets | 100,407 | 100,668 | (g) | 85,264 | 80,251 | 71,987 | ||||||||||
Outstanding share capital | 2,646 | 2,647 | 2,610 | 2,618 | 2,611 | |||||||||||
Equity attributable to equity holders of Sanofi | 57,338 | 56,203 | (g) | 53,097 | 48,322 | 44,866 | ||||||||||
Long term debt | 10,719 | 12,499 | 6,695 | 5,961 | 4,173 | |||||||||||
Cash dividend paid per share (€) (d) | 2.77 | (e) | 2.65 | 2.50 | 2.40 | 2.20 | ||||||||||
Cash dividend paid per share ($) (d)(f) | 3.65 | (e) | 3.43 | 3.34 | 3.46 | 3.06 | ||||||||||
As of and for the year ended December 31, | ||||||||||||||||||||
(€ million, except per share data) | 2011 | 2010 | 2009 | 2008 | 2007 | |||||||||||||||
IFRS Income statement data(a) | ||||||||||||||||||||
Net sales | 33,389 | 32,367 | 29,785 | 27,568 | 28,052 | |||||||||||||||
Gross profit | 24,156 | 24,638 | 23,125 | 21,480 | 21,636 | |||||||||||||||
Operating income | 5,731 | 6,535 | 6,435 | 4,394 | 5,911 | |||||||||||||||
Net income attributable to equity holders of Sanofi | 5,693 | 5,467 | 5,265 | 3,851 | 5,263 | |||||||||||||||
Basic earnings per share (€)(a)/(b) : | ||||||||||||||||||||
Net income attributable to equity holders of Sanofi | 4.31 | 4.19 | 4.03 | 2.94 | 3.91 | |||||||||||||||
Diluted earnings per share (€)(a)/(c) : | ||||||||||||||||||||
Net income attributable to equity holders of Sanofi | 4.29 | 4.18 | 4.03 | 2.94 | 3.89 | |||||||||||||||
IFRS Balance sheet data | ||||||||||||||||||||
Goodwill and other intangible assets | 61,718 | 44,411 | 43,480 | 43,423 | 46,381 | |||||||||||||||
Total assets | 100,165 | 85,264 | 80,251 | 71,987 | 71,914 | |||||||||||||||
Outstanding share capital | 2,647 | 2,610 | 2,618 | 2,611 | 2,657 | |||||||||||||||
Equity attributable to equity holders of Sanofi | 56,219 | 53,097 | 48,322 | 44,866 | 44,542 | |||||||||||||||
Long term debt | 12,499 | 6,695 | 5,961 | 4,173 | 3,734 | |||||||||||||||
Cash dividend paid per share (€)(d) | 2.65 | (e) | 2.50 | 2.40 | 2.20 | 2.07 | ||||||||||||||
Cash dividend paid per share ($) (d)(f) | 3.43 | (e) | 3.34 | 3.46 | 3.06 | 3.02 |
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SELECTED EXCHANGE RATE INFORMATION
The following table sets forth, for the periods and dates indicated, certain information concerning the exchange rates for the euro from 20072008 through March 20122013 expressed in U.S. dollars per euro. The information concerning the U.S. dollar exchange rate is based on the noon buying rate in New York City for cable transfers in foreign currencies as certified for customs purposes by the Federal Reserve Bank of New York (the “Noon"Noon Buying Rate”Rate"). We provide the exchange rates below solely for your convenience. We do not represent that euros were, could have been, or could be, converted into U.S. dollars at these rates or at any other rate. For information regarding the effect of currency fluctuations on our results of operations, see “Item"Item 5. Operating and Financial Review and Prospects”Prospects" and “Item"Item 11. Quantitative and Qualitative Disclosures about Market Risk.”"
| Period- end Rate | Average Rate (1) | High | Low | |||||||||
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| (U.S. dollar per euro) | ||||||||||||
2008 | 1.39 | 1.47 | 1.60 | 1.24 | |||||||||
2009 | 1.43 | 1.40 | 1.51 | 1.25 | |||||||||
2010 | 1.33 | 1.32 | 1.45 | 1.20 | |||||||||
2011 | 1.30 | 1.40 | 1.49 | 1.29 | |||||||||
2012 | 1.32 | 1.29 | 1.35 | 1.21 | |||||||||
Last 6 months | |||||||||||||
2012 | |||||||||||||
September | 1.29 | 1.29 | 1.31 | 1.26 | |||||||||
October | 1.30 | 1.30 | 1.31 | 1.29 | |||||||||
November | 1.30 | 1.28 | 1.30 | 1.27 | |||||||||
December | 1.32 | 1.31 | 1.33 | 1.29 | |||||||||
2013 | |||||||||||||
January | 1.36 | 1.33 | 1.36 | 1.30 | |||||||||
February | 1.31 | 1.33 | 1.37 | 1.31 | |||||||||
March (2) | 1.30 | 1.30 | 1.30 | 1.30 | |||||||||
Period- end Rate | Average Rate(1) | High | Low | |||||||||||||
(U.S. dollar per euro) | ||||||||||||||||
2007 | 1.46 | 1.38 | 1.49 | 1.29 | ||||||||||||
2008 | 1.39 | 1.47 | 1.60 | 1.24 | ||||||||||||
2009 | 1.43 | 1.40 | 1.51 | 1.25 | ||||||||||||
2010 | 1.33 | 1.32 | 1.45 | 1.20 | ||||||||||||
2011 | 1.30 | 1.40 | 1.49 | 1.29 | ||||||||||||
Last 6 months | ||||||||||||||||
2011 | ||||||||||||||||
September | 1.34 | 1.37 | 1.43 | 1.34 | ||||||||||||
October | 1.39 | 1.37 | 1.42 | 1.33 | ||||||||||||
November | 1.35 | 1.36 | 1.38 | 1.32 | ||||||||||||
December | 1.30 | 1.32 | 1.35 | 1.29 | ||||||||||||
2012 | ||||||||||||||||
January | 1.31 | 1.29 | 1.32 | 1.27 | ||||||||||||
February | 1.34 | 1.32 | 1.35 | 1.31 | ||||||||||||
March (2) | 1.32 | 1.32 | 1.33 | 1.32 |
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On March 5, 20126, 2013 the European Central Bank Rate was 1.32201.3035 per euro.
B. Capitalization and Indebtedness
N/A
C. Reasons for Offer and Use of Proceeds
N/A
Important factors that could cause actual financial, business, research or operating results to differ materially from expectations are disclosed in this annual report, including without limitation the following risk factors and the factors described under “Cautionary Statement Regarding Forward-Looking Statements”.factors. In addition to the risks listed below, we may be subject to other material risks that as of the date of this report are not currently known to us or that we deem immaterial at this time.
Risks Relating to Legal Matters
We rely on our patents and proprietary rights to provide exclusive rights to market certain of our products, and if such patents and other rights were limited or circumvented, our financial results could be materially and adversely affected.
Through patent and other proprietary rights such as supplementary protection certificatecertificates in Europe for instance, we hold exclusivity rights for a number of our research-based products. However, the protection that we are able to obtain varies from product to product and country to country and may not be sufficient to maintain effective product exclusivity because of local variations in the patents, differences in national law or legal systems, development in law or jurisprudence, or inconsistent judgments. Moreover, some countries are becoming more likely to consider granting a compulsory license to patents protecting an innovator's product; India's decision of March 2012 granting a compulsory license to a generic company to a Bayer patent is illustrative of this risk. We are involved in litigation worldwide to enforce certain of these patent rights against generics and proposed generics (see “Item"Item 8. Financial Information — A. Consolidated Financial Statements and Other Financial Information — Information on Legal or Arbitration Proceedings”Proceedings" for additional information). Moreover, patent rights are limited in time and do not always provide effective protection for our products: competitors may successfully avoid patents through design innovation, we may not hold sufficient evidence of infringement to bring suit, ormanufacturers of generic products are also increasingly seeking to challenge patents before they expire, and our infringement claim may not result in a decision that our rights are valid, enforceable or infringed. Moreover, a number of countries are increasingly easing the introduction of generic drugs or biosimilar products through accelerated approval procedures.
Even in cases where we ultimately prevail in our infringement claim, legal remedies available for harm caused to us by infringing products may be inadequate to make us whole. A competitor may launch a generic product “at risk”"at risk" before the initiation or completion of the court proceedings, and the court may decline to grant us a preliminary injunction to halt further “at risk”"at risk" sales and remove the infringing product from the market. Additionally, while we would be entitled to obtain damages in such a case, the amount that we may ultimately be awarded and able to collect may be insufficient to compensate all harm caused to us.
Further, our successful assertion of a given patent against one competing product is not necessarily predictive of our future success or failure in asserting the same patent against a second competing product because of such factors as possible differences in the formulations. Also a successful result in one country may not predict success in another country because of local variations in the patents.patents and patent laws.
To the extent valid third-party patent rights cover our products, we or our partners may be required to obtain licenses from the holders of these patents in order to manufacture, use or sell these products, and payments under these licenses may reduce our profits from these products. We may not be able to obtain these licenses on favorable terms, or at all. If we fail to obtain a required license or are unable to alter the design of our technology to fall outside the scope of a third-party patent, we may be unable to market some of our products, which may limit our profitability.
Product liability claims could adversely affect our business, results of operations and financial condition.
Product liability is a significant business risk for any pharmaceutical company, and the Group’sGroup's ongoing diversification could increase our product liability exposure (see notably “—"— The diversification of the Group’sGroup's business exposes us to additional risks”increased risks." below). Substantial damage awards and/or settlements have been madehanded down — notably in the United States and other common law jurisdictions — against pharmaceutical companies based on claims for injuries allegedly caused by the use of their products. Such claims can also be accompanied by consumer fraud claims by customers or third-party payers seeking reimbursement of the cost of the product.
Often the side effect profile of pharmaceutical drugs cannot be fully established based on preapproval clinical studies involving only several hundred to several thousand patients. Routine review and analysis of the continually growing body of post-marketing safety surveillance and clinical trials provide additional information — for example, potential evidence of rare, population-specific or long-term adverse reactions or of drug
interactions that were not observed in preapproval clinical studies — and may cause product labeling to evolve, including restrictions of therapeutic indications, new contraindications, warnings or precautions, and occasionally even the suspension or withdrawal of a product marketing authorization. Several pharmaceutical companies have withdrawn products from the market because of newly detected or suspected adverse reactions to their products, and as a result of such withdrawal now face significant product liability claims. We are currently defending a number of product liability claims (see(See Note D.22.a) to the consolidated financial statements included at Item 18 of this annual report) and there can be no assurance that the Group will be successful in defending against each of these claims or will not face additional claims in the future. Also our risk exposure also increased due to the fact thatFurthermore, we are now commercializing somecommercialize several devices using new technologies which, in case of malfunction, could cause unexpected damages and triggerlead to our liability (see “—"— We are increasingly dependent on information technologies and networks.”" below).
Although we continue to insure a portion of our product liability with third-party carriers, product liability coverage is increasingly difficult and costly to obtain, particularly in the United States, and in the future it is possible that self-insurance may become the sole commercially reasonable means available for managing the product liability financial risk of our pharmaceutical and vaccines businesses (see “Item"Item 4. Information on the Company — B. Business Overview — Insurance and Risk Coverage”Coverage"). Due to insurance conditions, even when the Group has insurance coverage, recoveries from insurers may not be totally successful. Moreover the insolvency of a carrier could negatively affect our ability to achieve the practical recovery of the coverage for which we have already paid a premium.
Product liability claims, regardless of their merits or the ultimate success of the Group’sGroup's defense, are costly, divert management attention, may harm our reputation and can impact the demand for our products. Substantial product liability claims, if successful, could adversely affect our business, results of operations and financial condition.
Claims and investigations relating to competition law, marketing practices, and pricing, compliance issues, as well as other legal matters, could adversely affect our business, results of operations and financial condition.
The marketing of our products is heavily regulated,regulated. The Group's business covers an extremely wide range of activities worldwide and alleged failuresinvolves numerous partners. Despite our efforts any failure to comply fullydirectly or indirectly (including as a result of a business partners' breach) with applicable regulationslaw could subject uslead to substantial fines, penaltiesliabilities. Governments and injunctive or administrative remedies, potentially leading toregulatory authorities around the imposition of additional regulatory controls or exclusion from government reimbursement programs.world have been strengthening enforcement activities in recent years. Sanofi and certain of its subsidiaries are under investigation by various government entities and are defending a number of lawsuits relating to antitrust and/or pricing and marketing practices, including, for example in the United States, class action lawsuits and whistle blower litigation. See Note D.22.c) to our consolidated financial statements included at Item 18 of this annual report.
Because many of these cases allege substantial unquantified damages, may be subject to treble damages and frequently seek significant punitive damages and penalties, it is possible that any final determination of liability or settlement of these claims or investigations could have a material adverse effect on our business, results of operations or financial condition.
There are other legal matters in which adverse outcomes could have a material adverse effect on our business, results of operations and financial condition.
The Group also faces significant litigation and government investigations or audits, including allegations of securities law violations, corruption, claims related to employment matters, patent and intellectual property disputes, consumer law claims and tax audits. See "Item 8. Financial Information — A. Consolidated Financial Statements and Other Financial Information — Information on Legal or Arbitration Proceedings" and Note D.22. to our consolidated financial statements included at Item 18 of this annual report. Responding to such investigations is costly and distracts management's attention from our business.
Unfavorable outcomes in any of these matters, or in similar matters to be faced in the future, could preclude the commercialization of products, harm our reputation, negatively affect the profitability of existing products and subject us to substantial fines (including treble damages), punitive damages, penalties and injunctive or administrative remedies, potentially leading to the imposition of additional regulatory controls or exclusion from government reimbursement programs. Any such resultprograms and could materially and adversely affecthave a material adverse effect on our business, results of operations or financial condition, or business. See “Item 8. Financial Information — A. Consolidated Financial Statementsconditions. These risks may encourage the company to enter into settlement agreement with governmental authorities including with no admission of wrongdoing. Those settlements may involve large cash payments and Other Financial Information — Information on Legal or Arbitration Proceedings”penalties. Settlement of healthcare fraud cases may require companies to enter into a corporate integrity agreement, which is intended to regulate company behavior for a period of years. For instance in December 2012, Sanofi U.S. entered into a settlement agreement with the U.S. Attorney's Office, District of Massachusetts, the United States Department of Justice and Note D.22.multiple states to our consolidated financial statements included at Item 18resolve all claims arising out of this annual report.an
investigation into sampling of Sanofi's former viscosupplement product, Hyalgan®. As part of the settlement, Sanofi U.S. paid U.S.$109 Million to the settling parties and will enter into a Corporate Integrity Agreement with the Office of the Inspector General of the United States Department of Health and Human Services.
Changes in the laws or regulations that apply to us could affect the Group’sGroup's business, results of operations and financial condition.
Governmental authorities are increasingly looking to facilitate generic and biosimilar competition to existing products through new regulatory proposals intended to, or resulting in, changes to the scope of patent or data exclusivity rights and use of accelerated regulatory pathways for generic and biosimilar drug approvals. Such regulatory proposals, if enacted, could make prosecution of patents for new products more difficult and time consuming or could adversely affect the exclusivity period for our products, thereby materially and adversely affecting our financial results.
This new competitive environment and potential regulatory changes may further limit the exclusivity enjoyed by innovative products on the market and directly impact pricing and reimbursement levels, which may adversely affect our business and future results. See “Item"Item 4. Information on the Company — B. Business Overview — Competition”Competition" and “Item"Item 4. Information on the Company — B. Business Overview — Regulation”Regulatory framework".
In addition, changes in tax laws or in their application with respect to matters such as tax rates, transfer pricing, dividends, controlled companies or a restriction in certain forms of tax relief, could affect our effective tax rate and our future results.
For information regarding risks related to changes in environmental rules and regulations, see “—"— Environmental liabilities and compliance costs may have a significant adverse effect on our results of operations”operations" below.
Risks Relating to Our Business
Generic versions of some of our products may be approved for sale in one or more of their major markets.
Many of our products are subject to aggressive generic competition, and additional products of the Group could become subject to generic competition in the future as product patents and/or exclusivities for several of our products have recently expired, or are about to expire. For example pediatric exclusivity for Aprovel® and Plavix® which contribute significantly to our net income will expire in the United States in March 2012 and May 2012, respectively, and the compound patent of Aprovel® will expire in most of the European Union in August 2012. Also, the U.S. market exclusivity of Eloxatin® will expire in August 2012, pursuant to settlement agreements. We expect this generic competition to continue and to implicate drug products with even relatively modest revenues.
The introduction of a generic version of a branded medicine typically results in a significant and rapid reduction in net sales for the branded product because generic manufacturers typically offer their unbranded versions at sharply lower prices. Accordingly, approval and market entry of a generic product often reduces the price that we receive for these products and/or the volume of the product that we would be able to sell and could materially and adversely affect our business, results of operations and financial condition. The extent of sales erosion also depends on the number of generic versions of our products that are actually marketed. For instance in 2011, there was only one generic product of enoxaparin sodium (Lovenox®) marketed in the United States. The introduction of a second generic on the U.S. market in early 2012 is likely to decrease our sales and revenues on this product.
Our long-termstrategic objectives may not be fully realized.
We have established aOur strategy is focused on three pillars: increased innovationfour pillars in R&D, adaptation oforder to deliver sustainable long-term growth and maximize shareholder returns: grow a global healthcare leader with synergistic platforms, bring innovative products to market, seize value-enhancing growth opportunities, and adapt our structure for future opportunities and challenges and pursuit of external growth opportunities.challenges. We may not be able to fully realize our strategic objectives and, even if we are able to do so, these strategic objectives may not deliver the expected benefits.
For example, our strategy involves concentrating efforts around identified growth platforms and meeting significant growth objectives over 2012-2015. There is no guarantee that we will meet these objectives or that these platforms will grow in line with anticipated growth rates. A failure to continue to expand our business in targeted growth platforms could affect our business, results of operations or financial condition.
As a further example, we are implementingpursuing a Group-wide cost savings program across the Group andwhich we expect, this new initiative, together with the expected synergies from our recent acquisition of Genzyme, to generate additional incremental cost savings by 2015. This also includes an adaptation plan regarding the activities of the Group in France. There is no assurance that the Group will successfully realize this plan. Moreover, the publicity given to this adaptation plan, may prejudice the Group's image and its reputation (see "— The expansion of social media platforms and mobile technologies present new risks and challenges." below). We may fail to realize all the expected cost savings resulting from these initiatives, which could materially and adversely affect our financial results.
We may fail to adequately renew our product portfolio whether through our ownOur research and development or through acquisitions and strategic alliances.efforts may not succeed in adequately renewing our product portfolio.
To be successful in the highly competitive pharmaceutical industry, we must commit substantial resources each year to research and development in order to develop new products to take the place of products facing expiration of patent and regulatory data exclusivity or competition from new products that are perceived as being superior. In 2011,2012, we spent €4,811€4,922 million on research and development, amounting to approximately 14.4%14.1% of our net sales.
Developing a product is a costly, lengthy and uncertain process. Also weWe may not be investing in the right technology platforms, leading therapeutic area, and products classes in order to build a robust pipeline and fulfill unmet medical needs. Fields of discovery and especially biotechnology are highly competitive and characterized by significant and rapid technological changes. Numerous companies are working on the same targets and a product considered as promising at the very beginning may become less attractive if a competitor showingaddressing the same mechanism of actionunmet need reaches earlier the market.market earlier.
Developing a product is a costly, lengthy and uncertain process. The research and development process typically takes from 10 to 15 years from discovery to commercial product launch. This process is conducted in various stages in order to test, along with other features, the effectiveness and safety of a product. There can be no assurance that any of these compounds will be proven safe or effective. See “Item"Item 4. Information on the Company — B. Business Overview — Pharmaceutical Research & Development”Development" and “Item"Item 4. Information on the Company — B. Business Overview — Vaccines Research and Development”Development". Accordingly, there is a substantial risk at each stage of development that we will not achieve our goals of safety and/or effectiveness including during the course of a development trial and that we will have to abandon a product in which we have invested substantial amounts and human resources, including in late stage development (Phase III). There can be no assurance that our research and development strategy will deliver the expected result in the targeted timeframe or at all, which could affect our profitability in the future.
Decisions concerning the studies to be carried out can have a significant impact on the marketing strategy for a given product. Multiple in-depth studies can demonstrate that a product has additional benefits, facilitating the product’sproduct's marketing, but such studies are expensive and time consuming and may delay the product’sproduct's submission to health authorities for approval.
Our ongoing investments in new product launches and research and development for future products could therefore result in increased costs without a proportionate increase in revenues which may negatively affect our operating results. Each regulatory authority may also impose its own requirements in order to grant a license to market the product, including requiring local clinical studies, and may delay or refuse to grant approval, even though a product has already been approved in another country. Finally, obtaining
Obtaining regulatory marketing approval is not a guarantee that the product will achieve commercial success. Following each product marketing approval, the medical need served by the product and the corresponding reimbursement rate are evaluated by other governmental agencies which may in some cases require additional studies, including comparative studies, which may both effectively delay marketing of the new product and add to its development costs.
Also ourThe success of a product also depends on our ability to educate patients and healthcare providers and provide them with innovative data about our productsthe product and theirits uses. If these education efforts are not effective, then we may not be able to increase the sales of our new products to the market.market to realize the full value of our investment in its development.
On the same topic, for the research and development of drugs in rare diseases, we produce relatively small amounts of material at early stages. Even if a product candidate receives all necessary approvals for commercialization, we may not be able to successfully scale-up production of the product material at a reasonable cost or at all and we may not receive additional manufacturing approvals in sufficient time to meet product demand.
Asdemand, which could lead to a complement to our portfolio of products, we pursue a strategy of selective acquisitions, in-licensing and partnerships in order to develop new growth opportunities. The implementation of this strategy depends on our ability to identify business development opportunities at a reasonable cost and under acceptable conditions of
financing. Moreover, entering into these in-licensing or partnership agreements generally requires the payment of significant “milestones” well before the relevant products are placed on the market without any assurance that such investments will ultimately become profitable in the long term.
Because of the active competition among pharmaceutical groups for such business development opportunities, there can be no assurance of our success in completing these transactions when such opportunities are identified.
A substantial share of the revenue and income of the Group continues to depend on the performance of certain flagship products.
We generate a substantial share of our revenues from the sale of certain key products (see “Item 5. Operating and Financial Review and Prospects — Results of Operations — Year ended December 31, 2011 compared with year ended December 31, 2010 — Net Sales by Product — Pharmaceuticals”), which represented 37.6% of the Group’s consolidated revenues in 2011. Among these products is Lantus®, which was the Group’s leading product with revenues of €3,916 million in 2011, representing 11.7% of the Group’s consolidated revenues for the year. Lantus® is a flagship product of the Diabetes division, one of the Group’s growth platforms.
Sales of Cerezyme®, our enzyme-replacement product for patients with Gaucher disease which is also amongst our flagship products, totaled €441 million for the year ended December 31, 2011, below the usual levelloss of sales due to important production disruptions since 2009 (see “— The manufacture of our products is technically complex,that drug and supply interruptions, product recalls or inventory losses caused by unforeseen events may reduce sales, adversely affect our operating results and financial condition and delay the launch of new products.” below). In addition the patient population with Gaucher disease is limited. Furthermore, changes in the methods for treating patients with such disease could limit growth, or result in a decline, in Cerezyme® sales.
In general, a reduction in sales of one or more of our flagship products or in their growth could affect our business, results of operations andor financial condition.
We may lose market share to competing remedies or generic brands if they are perceived to be equivalent or superior products.
We are faced with intense competition from generic products and brand-name drugs. Doctors or patients may choose these products over ours if they perceive them to be safer, more reliable, more effective, easier to administer or less expensive, which could cause our revenues to decline and affect our results of operations.
In 2012, our patented pharmaceutical business faced important patent expirations and generic competition. For example Cerezyme®Avapro®, Plavix®, and Fabrazyme® shortages dueEloxatin® lost their market exclusivity in the U.S in March, May and August 2012, and Aprovel® lost its market exclusivity in the E.U in August 2012.
The introduction of a generic version of a branded medicine typically results in a significant and rapid reduction in net sales for the branded product because generic manufacturers typically offer their unbranded
versions at sharply lower prices. Approval and market entry of a generic product often reduces the price that we receive for these products and/or the volume of the product that we would be able to manufacturing issues atsell and could materially and adversely affect our facility in Allston, Massachusetts (United-States) (see “—business, results of operations and financial condition. The manufactureextent of sales erosion also depends on the number of generic versions of our products is technically complex, and supply interruptions, product recallsthat are actually marketed.
Additionally, in many countries such as the United States or inventory losses caused by unforeseen events mayFrance, applicable legislation encourages the use of generic products to reduce sales, adversely affect our operating results and financial condition and delay the launch of new products.” below) created, and continue to create, opportunities for our competitors and have resulted in a decrease in the number of patients using these products and a loss of our overall market share of Gaucher and Fabry patients, respectively. Even if we are able again to provide a full, sustainable product supply, there is no guarantee these patients will return to using our products.
Additionally,spending on prescription drugs. Therefore, the market for our products could also be affected if a competitor’scompetitor's innovative drug in the same market were to become available as generic because a certain number of patients can be expected to switch to a lower-cost alternative therapy.
The diversificationAdditional products of the Group’s business exposes usGroup could become subject to additional risks.generic competition in the future as we expect this generic competition to continue and to implicate drug products even those with relatively modest revenues.
A substantial share of the revenue and income of the Group continues to depend on the performance of certain flagship products.
We generate a substantial share of our revenues from the sale of certain key products (see "Item 5. Operating and Financial Review and Prospects — Results of Operations — Year ended December 31, 2012 compared with year ended December 31, 2011 — Net Sales by Product — Pharmaceuticals segment"), which represented 42.2% of the Group's consolidated revenues in 2012. Among these products is Lantus®, which was the Group's leading product with revenues of €4,960 million in 2012, representing 14.2% of the Group's consolidated revenues for the year. Lantus® is a flagship product of the Diabetes division, one of the Group's growth platforms.
In general, if the products referred to above were to encounter problems such as loss of patent protection, material product liability litigation, unexpected side effects, regulatory proceedings, publicity affecting doctor or patient confidence, pressure from existing competitive products, changes in labeling, or if a new, more effective treatment were introduced, or if there were a reduction in sales of one or more of our flagship products or in their growth, the impact on our business, results of operations and financial condition could be significant.
We are implementingmay fail to successfully identify external business opportunities or realize the anticipated benefits from our strategic investments.
As a complement to our portfolio of products, we pursue a strategy of selective acquisitions, in-licensing and partnerships in order to develop growth opportunities. The implementation of this strategy depends on our ability to identify business development opportunities and execute them at a reasonable cost and under acceptable conditions of financing. Moreover, entering into in-licensing or partnership agreements generally requires the payment of significant "milestones" well before the relevant products are placed on the market without any assurance that includes pursuing external growthsuch investments will ultimately become profitable in the long term (see Note D.21.1. to the consolidated financial statements included at Item 18 of this annual report).
Because of the active competition among pharmaceutical groups for such business development activities, there can be no assurance of our success in completing these transactions when such opportunities to meetare identified.
Once identified, the challenges that we have identified for the future. The inability to quickly or efficiently integrate newly acquired activities or businesses, such as Genzyme,businesses; a longer integration than expected; the loss of key employeesemployees; or integration costs that are higher than anticipated integration costs, could delay our growth objectives and prevent us from achieving expected synergies. For instance, challenges that we may face in our efforts to integrate Genzyme include, among others:
addressing manufacturing problems and supply constraints that have negatively affected Genzyme’s business in recent years;
ensuring continued compliance with a consent decree that Genzyme entered into with the FDA in May 2010 relating to a manufacturing facility in Allston, Massachusetts (United-States) (see “Item 4. Information on the Company — B. Business Overview — Production and Raw Materials.”);
the outcome of ongoing legal and other proceedings to which Genzyme is a party, including shareholder litigation and patent litigation;
preserving and developing Genzyme’s goodwill in the genetic disease community; and
realizing the potential of the research and development pipeline.
If we fail to effectively integrate Genzyme or the integration takes longer than expected, we may not achieve the expected benefits of the transaction.
Moreover, we may miscalculate the risks associated with newly acquired activities or businesses at the time they are acquired or not have the means to evaluate them properly.properly, including with regards to the potential of research and development pipelines, manufacturing issues, compliance issues, or the outcome of ongoing legal and other proceedings. It may also take a considerable amount of time and be difficult to implement a risk analysis and risk mitigation plan after the acquisition is completed due to lack of historical data. As a result, risk management and the coverage of such risks, particularly through insurance policies, may prove to be insufficient or ill-adapted.
The diversification of the Group's business exposes us to increased risks.
While pursuing our objective to become a global and diversified leader within the health industry, we are exposed to a number of new risks inherent in sectors in which, in the past, we have been either less active or not present at all. As an example:
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the margins of consumer health and generic products are generally lower than those of the traditional branded prescription pharmaceutical business. Moreover, the periodic review of the effectiveness, safety and use of certain over-the-counter drug products by health authorities or lawmakers may result in modifications to the regulations that apply to certain components of such products, which may require them be withdrawn from the market and/or that their formulation be modified.
Moreover, losses that may be sustained or caused by these new businesses may differ, with regards to their nature, scope and level, from the types of product liability claims that we have handled in the past (see “—"— Product liability claims could adversely affect our business, results of operations and financial condition”condition" above), and thus our current risk management and insurance coverage may not be adapted to such losses. These risks could affect our business, results of operations or financial condition.
The globalization of the Group’sGroup's business exposes us to increased risks.
Emerging markets have been identified as one of our growth platforms and are among the pillars of our overall strategy. Any difficultiesDifficulties in adapting to emerging markets and/or a significant decline in the anticipated growth rate in these regions could impair our ability to take advantage of these growth opportunities and could affect our business, results of operations or financial condition.
There is no guarantee that our efforts to expand sales in emerging markets will continue to succeed. The significant expansion of our activities in emerging markets may further expose us to more volatile economic conditions, political instability, competition from companies that are already well established in these markets, the inability to adequately respond to the unique characteristics of these markets, particularly with respect to their regulatory frameworks, difficulties in recruiting qualified personnel, potential exchange controls, weaker intellectual
property protection, higher crime levels (particularly with respect to counterfeit products (see “—"— Counterfeit versions of our products harm our business,”" below)), and compliance issues including corruption and fraud, as we operate in many parts of the world where corruption exists to some degree.
these problems exist. Our existing policies and procedures, which are designed to help ensure that we, our employees, agents, intermediaries, and our agentsother third parties comply with the U.S. Foreign Corrupt Practices Act ( FCPA)(FCPA), the UK Bribery Act, and other anti-bribery laws, may not adequately protect us against liability under these laws for actions taken by our employees, agents and intermediarieswe or they may take with respect to our business.
Failure to comply with domestic or international laws could result in various adverse consequences, including possible delay in the approval or refusal to approve a product, recalls, seizures, withdrawal of an approved product from the market, or the imposition of criminal or civil sanctions, including substantial monetary penalties.
Our products and manufacturing facilities are subject to significant government regulations and approvals, which are often costly and could result in adverse consequences to our business if we fail to comply with the regulations or maintain the approvals.
The industry in which we operate faces a changing regulatory environment and heightened public scrutiny worldwide, which simultaneously require greater assurances than ever as to the safety and efficacy of medications and health products on the one hand, and effectively provide reduced incentives for innovative pharmaceutical research on the other hand.
Each regulatory authority may also impose its own requirements either at the time of the filing of the dossier or later during its review in order to grant a license to market the product, including requiring local clinical studies, and may delay or refuse to grant approval, even though a product has already been approved in another country. For example in August 2012, Genzyme received a Refuse to File letter from the FDA in response to the supplemental Biologics License Application to the FDA seeking approval of Lemtrada™. The FDA did not request additional data or further studies but requested a modified presentation of the data sets to enable agency to better navigate the application. Finally, Genzyme resubmitted at the end of November 2012 the Lemtrada™ file and the FDA accepted on January 28, 2013 the application for review. In December 2012, the CHMP of the European Medicines Agency (EMA) has adopted a negative opinion for the marketing authorization application for Kynamro™, but this product was approved by the FDA in January 2013.
Health authorities are increasingly focusing on product safety and on the risk/benefit profile of pharmaceuticals products. In particular, the FDA and the European Medicines Agency (EMA)EMA have imposed increasingly burdensome requirements on pharmaceutical companies, particularly in terms of the volume of data needed to demonstrate a product’sproduct's efficacy and safety. For the same reasons, the marketed products are subject to continual review, risk evaluations or comparative effectiveness studies even after regulatory approval. These requirements have resulted in increasing the costs associated with maintaining regulatory approvals and achieving reimbursement for our products.
Later discovery of previously undetected problems may result in marketing restrictions or the suspension or withdrawal of the product, as well as an increased risk of litigation for both pharmaceutical and animal health products. These post-regulatory approval reviews and data analyses can lead to the issuance of recommendations by government agencies, health professional and patient organizations or other specialized organizations regarding the use of products, which may result in a reduction in sales volume, such as, for example, a recommendation to limit the patient scope of a drug’sdrug's indication. For instance in September 2011, the EMA defined a more restrictive indication for Multaq®Multaq®, one of our cardiovascular products. Such reviews may result in the discovery of significant problems with respect to a competing product that is similar to one sold by the Group, which may in turn cast suspicion on the entire class to which these products belong and ultimately diminish the sales of the relevant product of the Group. When such issues arise, the contemplative nature of evidence-based health care and restrictions on what pharmaceutical manufacturers may say about their products are not always well suited to rapidly defending the Group or the public’spublic's legitimate interests in the face of the political and market pressures generated by social media and rapid news cycles, and this may result in unnecessary commercial harm, overly restrictive regulatory actions and erratic share price performance.
Government authorities and regulators in the U.S. and in E.U. are considering measures to reduce the risk of supply shortages of live-saving medicine in particular if there are no viable therapeutic alternatives. It cannot be ruled out that these ongoing initiatives may generate additional costs for the Group if they result in a requirement to set-up back up supply channels or to increase the level of the inventories to avoid shortages.
In addition, to the extent that new regulations raise the costs of obtaining and maintaining product authorization, or limit the economic value of a new product to its inventor, the growth prospects of our industry and of the Group are diminished. Also about 50% of our current research and development portfolio is constituted by biological products, that may bring in the future new therapeutic responses to current unmet medical needs but which may also lead to more technical constraints and costly investments from an industrial standpoint.
Moreover, we and certain of our third-party suppliers are also required to comply with applicable regulations, known as good manufacturing practices, which govern the manufacture of pharmaceutical products. To monitor our
compliance with those applicable regulations, the FDA, the EMA and comparable agencies in other jurisdictions routinely conduct inspections of our facilities and may identify potential deficiencies which might be expensive and time consuming to address. For example, in July 2012, Sanofi Pasteur received a Warning Letter from the FDA following regular inspections conducted at manufacturing facilities in Canada and France. If we fail to adequately respond to a warning letter
identifying a deficiency, or otherwise fail to comply with applicable regulatory requirements, we could be subject to enforcement, remedial and/or punitive actions by the FDA, the EMA or other regulatory authorities.
For example, in May In 2010, Genzyme entered into a consent decree with the FDA relating to its Allston facility (see “Item 4. Information on the Company — B. Business Overview — Production and Raw Materials.”). Pursuant to the consent decree, in November 2010, Genzyme paid $175.0U.S.$175.0 million to the U.S. Federal GovernementGovernment as disgorgement of past profits. The consent decree also requiresrequired Genzyme to implement a plan to bring the Allston facility into compliance with applicable laws and regulations. Genzyme submitted a comprehensive remediation plan to FDA in April 2011.2011 and the plan was accepted by FDA. Remediation of the Allston facility in accordance with that plan is underway and is currently expected to continue for fourthree more years, however, there is no guarantee that this timeframe will be respected.
years.
We incurred substantial debt in connection with the acquisition of Genzyme whichOur indebtedness may limit our business flexibility compared to some of our peerspeers.
Our consolidated debt increased substantially in connection with our acquisition of Genzyme because we incurred debt to finance the acquisition price, and because our consolidated debt includes the debt incurred by Genzyme prior to the acquisition.in 2011. Although we already achieved a partial deleverage by the end of 2011continued to reduce our debt in 2012 (as of December 31, 2011,2012, our debt, net of cash and cash equivalents amounted to €10.9€7.7 billion), we still make significant debt service payments to our lenders and this could limit our ability to engage in new transactions which could have been part of our strategy.
We face uncertainties over theincreasing pricing and reimbursement ofpressure on our pharmaceutical products.products that could negatively affect our revenues and/or margins.
The commercial success of our existing products and our products candidates depends in part on the conditions under which our products are reimbursed. Pressure on pricingOur products continue to be subject to increasing price and reimbursement is strongpressure due to:to, amongst others:
In addition to the pricing pressures they exert, governmental and private third-party payers and purchasers of pharmaceutical products may reduce volumes of sales by restricting access to formularies or otherwise discouraging physician prescriptions of our products. In the United States, the new federal health care reform law is increasing the government’sgovernment's role with respect to price, reimbursement and the coverage levels for healthcare-related expenses forhealthcare services and products within the large government health care sector,sector. This law also imposed cost containment measures and imposed drug companies’ rebates to the government.and fees on pharmaceutical companies. Implementation of health care reform has affected and could still affect our revenues and/or margins (for further details concerning this law and a description of certain regulatory pricing systems that affect our Group see “Item"Item 4. Information on the Company — B. Business Overview — Pricing & Reimbursement”Reimbursement"). Some U.S. states are also considering legislation that would controlinfluence the marketing of prices of and access to drugs, and we believe thatU.S. federal and state legislatures and health agenciesofficials will likely continue to focus on healthcare reform implementation in the future.
We encounter similar cost containment issues in countries outside the United States. In certain countries, including countries in the EU and Canada, the coverage of prescription drugs, pricing and levels of reimbursement are subject to governmental control. For example,instance early 2013, in Spain, recent direct price-related measures include price discount to all products launched more than 10 years ago, all genericized products needing to be at a minor (lower) price,China the National Development and no more gradualism in price reductions of originator post generics introduction. Additionally, measures such as INN prescriptions, have been implemented. Another example, in Turkey Government has accelerated enforcement of drugs costs containment measures which include increased institutional discount applied on reimbursement prices and lower referenceReform Commission set new national retail ceiling prices for reimbursement700 formulations of Generics and originals with Generics as well as 20-year old drugs without Generics.400 drugs; among them was Lantus® whose price was cut by 12.9% (effective February 1, 2013).
Due to the ongoing cost containment policies being pursued in many jurisdictionjurisdictions in which we operate, we are unable to predict the availability or amount of reimbursement for our product candidates.
In addition, our operating results may also be affected by parallel imports, particularly within the European Union, whereby distributors engage in arbitrage based on national price differences to buy product on low cost markets for resale on higher cost markets.
The ongoing slowdown of global economic growth and the financial crisis could have negative consequences for our business1.
Over the past several years, growth of the global pharmaceutical market has become increasingly tied to global economic growth. In this context, a substantial and lasting slowdown of the global economy or major national economies could negatively affect growth in the global pharmaceutical market and, as a result, adversely affect our business. This effect may be expected to be particularly strong in markets having significant co-pays or lacking a developed third-party payer system, as individual patients may delay or decrease out-of-pocket healthcare expenditures. Such a slowdown could also reducehas reduced the sources of funding for national social security systems, leading to heightened pressure on drug prices, increased substitution of generic drugs, and the exclusion of certain products from formularies.
Additionally, to the extent the slowing economic environment, as well as ongoing sovereign debt crisis affecting several European countries, may lead to financial difficulties or even the default or failure of major players including wholesalers or public sector buyers financed by insolvent States, the Group could experience disruptions in the distribution of its products as well as the adverse effects described below at “We are subject to the risk of non-payment by our customers”. Moreover, to the extent that the economic and financial crisis is directly affecting business, it may also lead to a disruption or delay in the performance of third parties on which we rely for parts of our business, including collaboration partners and suppliers (for more information see “Item 5. Operating and Financial Review and Prospects — Liquidity.”). Such disruptions or delays could have a material and adverse effect on our business and results of operations. See “— We rely on third parties for the manufacture and supply of a substantial portion of our raw materials, active ingredients and medical devices; supply disruptions and/or quality concerns could adversely affect our operating results and financial condition”, “We rely on third parties for the marketing of some of our products” and “ Fluctuations in currency exchange rates could adversely affect our results of operations and financial condition” below.
Further, we believe our net sales may be negatively impacted by the continuing challenging global economic environment, as high unemployment, levels and increases in co-pays, lack of developed third party payer system, may lead some patients to switch to generic products, delay treatments, skip doses or use less effective treatments to reduce their costs. Moreover, current economic conditions in the United States have resulted in an increase in the number of patients in the Medicaid program, under which sales of pharmaceuticals are subject to substantial rebates and, in many U.S. states, to formulary restrictions limiting access to brand-name drugs, including ours.
Our animal healthThe growth of our OTC and CHC business may also be negatively affected by the current slowdown in global economic growth (for instanceas consumer spending is closely tied to the global economy. Also our animal health business could be impacted. For example, tight credit conditions may limit the borrowing power of livestock producers, causing some to switch to lower-priced products).products.
Although macroeconomic and financial measures have been taken in 2012 by governments and monetary authorities, notably in Europe reducing thus the risk of failure of a State, the slowing economic environment, the default or failure of major players including wholesalers or public sector buyers financed by insolvent States may affect the financial situation of the Group but can also cause the Group to experience disruptions in the distribution of its products as well as the adverse effects described below at "We are subject to the risk of non-payment by our customers". Moreover, to the extent that the economic and financial crisis is directly affecting business, it may also lead to a disruption or delay in the performance of third parties on which we rely for parts of our business, including collaboration partners and suppliers (for more information see "Item 5. Operating and Financial Review and Prospects — Liquidity."). Such disruptions or delays could have a material and adverse effect on our business and results of operations. See "— We rely on third parties for the discovery, manufacture and marketing of some of our products" below.
The manufacture of our products is technically complex, and supply interruptions, product recalls or inventory losses caused by unforeseen events may reduce sales, adversely affect our operating results and financial condition and delay the launch of new products.
Many of our products are manufactured using technically complex processes requiring specialized facilities, highly specific raw materials and other production constraints. We must also be able to produce sufficient quantities of the products to satisfy demand. Our biologic products (including vaccines) in particular are subject to the risk of manufacturing stoppages or the risk of loss of inventory because of the difficulties inherent to the processing of biological materials and the potential unavailability of adequate amounts of raw materials meeting our standards. We may not have redundant manufacturing capacity for certain products particularly biologic products. For instance all of our bulk Cerezyme® products are produced solely at our Allston, Massachusetts facility. Even though we aim to have backup sources of supply whenever possible, including by manufacturing backup supplies of our principal active ingredients at a second or third facility when practicable, we cannot be certain they will be sufficient if our principal sources become unavailable. Switching sources and manufacturing facilities may require significant time.
Additionally, specific conditions must be respected both by the Group and our customers for the storage and distribution of many of our products,e.g., cold storage for certain vaccines and insulin-based products. The complexity of these processes, as well as strict internal and government standards for the manufacture of our products, subject us to risks. The occurrence or suspected occurrence of out-of-specification
production or storage can lead to lost inventories, and in some cases product recalls, with consequential reputational damage and the risk of product liability (see “—"— Product liability claims could adversely affect our business, results of operations and financial condition,”" above). Group products are increasingly reliant on the use of product-specific devices for administration; a technical problem in these devices could jeopardize the approval or the commercialization of the products or require a recall.
Supply shortages are subject to public scrutiny and are subject to even greater public criticism when they occur with respect to life saving medicines with limited therapeutic alternatives. Such shortages can have a negative impact on the image of the Group independent of the level of revenues lost as a result of the shortage of a particular product. The investigation and remediation of any identified manufacturing problems can cause production delays, substantial expense, lost sales and delay the delaylaunch of new product launches and canproducts, which could adversely affect our operating results and financial condition.
Like many of our competitors, we have faced and may face in the future manufacturing issues. For example, Genzyme experienced in the past significant difficulties in manufacturing Cerezyme® and Fabrazyme® for several years. In summer 2011 a technical incident occurred in the filling line used for Apidra 3mL cartridges at our manufacturing site in Frankfurt which caused temporary shortages for Apidra 3mL cartridges. In April 2012 Sanofi Pasteur temporarily imposed supply limitations for Pentacel® and Daptacel® vaccines in the U.S. due to a certain extent continuemanufacturing delay that temporarily reduced the effective capacity to face, significant manufacturing issues, most notablybelow the level needed to fully satisfy market demand in our Genzyme subsidiary for the production of Cerezyme® and Fabrazyme®.U.S. In June 2009, Genzyme announced it had detected a virus that impairs cell growth2012 Sanofi Pasteur voluntarily recalled the Bacille Calmette-Guérin (BCG) vaccine produced in oneits Canadian facility due to manufacturing issues. This withdrawal is expected to last several months while the renovation of the bioreactors used in the Allston, Massachusetts facility to produce Cerezyme®. This contamination has had a material adverse effect on Cerezyme® and Fabrazyme® revenues. We will continue to work with minimal levels of inventory for Cerezyme® and Fabrazyme® until we are able to build inventory. However, therebuilding is completed. There can be no guarantee that we will be able to return to pre-contamination supply levels of such products, nor can there be any guarantee that we will not face similar issues in the future or that we will successfully manage such issues when they arise.
We rely on third parties for the discovery, manufacture and supplymarketing of a substantial portionsome of our raw materials, active ingredients and medical devices; supply disruptions and/or quality concerns could adversely affect our operating results and financial condition.products.
Our industry is highly collaborative, whether in the discovery and development of new products, in-licensing, the marketing and distribution of approved products, or manufacturing activities. We expect that the reliance on third parties for key aspects of our business will continue to characterize our activities.
Third parties supply us with a substantial portion of our raw materials, active ingredients and medical devices, which exposes us to the risk of a supply interruption in the event that these suppliers experience financial difficulties or are unable to manufacture a sufficient supply of our products meeting Group quality standards. It also increases the risk of quality issues, even with the most scrupulously selected suppliers.
Further, some raw materials essential to the manufacture of our products are not widely available from sources we consider reliable; for example, we have approved only a limited number of suppliers of heparins for use in the manufacture of Lovenox®. Heparin purchase prices can also fluctuate. See "Item 4. Information on the Company — B. Business Overview — Production and Raw Materials" for a description of these outsourcing arrangements. Any of these factors could adversely affect our business, operating results or financial condition.
If disruptions or quality concerns were to arise in the third-party supply of raw materials, active ingredients or medical devices, this could adversely affect our ability to sell our products in the quantities demanded by the market and could damage our reputation and relationships with our customers. See also “—"— The manufacture of our products is technically complex, and supply interruptions, product recalls or inventory losses caused by unforeseen events may reduce sales, adversely affect our operating results and financial condition and delay the launch of new products”products" above. We may not have redundant manufacturing capacity for certain products particularly biologic products. For instance in summer 2011 a technical incident occurred in the filling line used for Apidra 3mL cartridges at our manufacturing site in Frankfurt and this has caused temporary shortages for Apidra 3mL cartridges. Also all of our bulk Cerezyme® products are produced solely at our Allston, Massachusetts facility. Even though we aim to have backup sources of supply whenever possible, including by manufacturing backup supplies of our principal active ingredients at a second or third facility when practicable, we cannot be certain they will be sufficient if our principal sources become unavailable. Switching sources and manufacturing facilities may require significant time.
Further, some raw materials essential to the manufacture of our products are not widely available from sources we consider reliable; for example, we have approved onlyWe also conduct a limited number of suppliers of heparins for use in the manufacture of Lovenox®. Heparin purchase prices can also fluctuate. See “Item 4. Information on the Company — B. Business Overview — Productionsignificant research and Raw Materials” for a description of these outsourcing arrangements. Any of these factors could adversely affect our business, operating results or financial condition.
We rely on third parties for the marketing of some of our products.
Wedevelopment programs and market some of our products in collaboration with other biotechnology and pharmaceutical companies. For example, we currently have major collaborative arrangements with Bristol-Myers Squibb (BMS)Regeneron for the marketingdiscovery, development and commercialization of Plavix® and Aprovel® in the United States and several other countries, withtherapies based on monoclonal antibodies, Warner Chilcott for the osteoporosis treatment Actonel®Actonel®, and with
Merck & Co., Inc. for the distribution of vaccines in Europe. See “ItemEurope (See "Item 4. Information on the Company — B. Business Overview — Pharmaceutical Products — Main pharmaceutical products”products" and “Item"Item 4. Information on the Company — B. Business Overview — Vaccine Products”Products" for more information on our major alliances.alliances). We may also rely on partners to design and manufacture medical devices, notably for the administration of our products. When we research and market our products through collaboration arrangements, we are subject to the risk that certain decisions, such as the establishment of budgets, development and promotion strategies and specific tasks, are subject tounder the control of our collaboration partners, and that deadlocks, failures in the development or differing priorities may adversely affect the activities conducted through the collaboration arrangements. For example, our alliances with BMS are subject to the operational management of BMS in some countries, including the United States. Any conflicts that
we may have with our partners during the course of these agreements or at the time of their renewal or renegotiation may affect the marketing of certain of our products and may cause a decline in our revenues and affect our results of operations.
Counterfeit versions of our products harm our business.
The drug supply has been increasingly challenged by the vulnerability of distribution channels to illegal counterfeiting and the presence of counterfeit products in a growing number of markets and over the Internet. Counterfeit products are frequently unsafe or ineffective, and can be potentially life-threatening. To distributors and users, counterfeit products may be visually indistinguishable from the authentic version. Reports of adverse reactions to counterfeit drugs or increased levels of counterfeiting could materially affect patient confidence in the authentic product, and harm the business of companies such as Sanofi. Additionally, it is possible that adverse events caused by unsafe counterfeit products will mistakenly be attributed to the authentic product. If a Group product was the subject of counterfeits, the Group could incur substantial reputational and financial harm. See “Item"Item 4. Information on the Company — B. Business Overview — Competition.”
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We are subject to the risk of non-payment by our customers.customers1.
We run the risk of delayed payments or even non-payment by our customers, which consist principally of wholesalers, distributors, pharmacies, hospitals, clinics and government agencies. This risk is accentuated by the current worldwide financial crisis. The United States poses particular client credit risk issues, because of the concentrated distribution system in which approximately 62%58% of our consolidated U.S. pharmaceutical sales are accounted for by just three wholesalers. In addition, the Group’sGroup's three main customers represent 17.4%17.0% of our gross total revenues. We are also exposed to large wholesalers in other markets, particularly in Europe. An inability of one or more of these wholesalers to honor their debts to us could adversely affect our financial condition (see Note D.34. to our consolidated financial statements included at Item 18 of this annual report).
Since the beginning of 2010, financial difficulties in some countries of southern Europe have increased especially in Greece and Portugal. Part of ourfaced important financial difficulties. Some customers in these countries are public or subsidized health systems. The deteriorating economic and credit conditions in these countries has ledmay lead to longer payment terms. ThisBecause of this trend may continue and we may need to reassess the recoverable amount of our debts in these countries during the coming financial years (for more information see “Item"Item 5. Operating and Financial Review and Prospects — Liquidity.”").
Our pension liabilities are affected by factors such as the performance of plan assets, interest rates, actuarial data and experience and changes in laws and regulations.
Our future funding obligations for our main defined-benefit pension plans depend on changes in the future performance of assets held in trust for these plans, the interest rates used to determine funding levels (or company liabilities), actuarial data and experience, inflation trends, the level of benefits provided for by the plans, as well as changes in laws and regulations. Adverse changes in those factors could increase our unfunded obligations under such plans, which would require more funds to be contributed and hence negatively affect our cash flow and results (see Note D.19.1 to our consolidated financial statements included at Item 18 of this annual report).
Impairment charges or write downs in our books and changes in accounting standards could have a significant adverse effect on the Group’sGroup's results of operations and financial results.
New or revised accounting standards, rules and interpretations issued from time to time by the IASB (International Accounting Standards Board) could result in changes to the recognition of income and expense that may materially and adversely affect the Group’sGroup's financial results.
In addition, substantial value is allocated to intangible assets and goodwill resulting from business combinations, as disclosed at Note D.4. to our consolidated financial statements included in this annual report at Item 18, which could be substantially impaired upon indications of impairment (primarily relating to pharmacovigilance, patent litigation and the launch of competing products), with adverse effects on our financial condition and the value of our assets.
Also if any of our strategic equity investments decline in value and remain below cost for an extended duration, we may be required to write down our investment.
In addition the global financial crisis and in particular the ongoing sovereign debt crisis affecting certain European countries could also negatively affect the value of our assets (see “— Fluctuations in currency exchange rates could adversely affect our results of operations and financial condition” below and “—"— The ongoing slowdown of global economic growth and the financial crisis could have negative consequences for our business” above). For example, given the current levelbusiness" above and "— Fluctuations in currency exchange rates could adversely affect our results of investor confidence in the ability of the Greek State to avoid default, as a result of mark to market accounting standards, we recognized an impairment of €49 million on certain Greek bonds held by us in 2011.
operations and financial condition" below).
We are increasingly dependent on information technologies and networks.
Our business depends on the use of information technologies, which means that certain key areas such as research and development, production and sales are to a large extent dependent on our information technology capabilities. We are commercializing somea number of devices using new technologies which, in case of malfunctions could lead to a misuse causing a risk of damagesharm to patients (see “—"— Product liability claims could adversely affect our business, results of operations and financial condition”condition" above). Our inability or the inabilityunavailability of our products. While we have invested heavily in the protection of data and information technology, there can be no assurance that our efforts or those of our third-party service providers (for instance the accounting of some of our subsidiaries has been externalized) to implement adequate security and quality measures for data processing could leadwould be sufficient to protect against data deterioration or loss in the event of a system malfunction, or allowprevent data to befrom being stolen or corrupted in the event of a security breach, which could have a material adverse effect on our business, operating results and financial condition.
The expansion of social media platforms and mobile technologies presents new risks and challenges.
New technologies are increasingly used to communicate about our products or the diseases they are intended to treat. The use of these media requires specific attention, monitoring programs and moderation of comments. For instance, patients may use these channels to comment on the effectiveness of a product and to report an alleged adverse event. Negative posts or comments about the Company, its business, its directors or officers on any social networking web site could seriously damage our reputation. In addition, our associates may use the social media tools and mobile technologies inappropriately which may give rise to liability, or which could lead to the exposure of sensitive information. In either case, such uses of social media and mobile technologies could have a material adverse effect on our business, financial condition and results of operations.
Natural disasters prevalent in certain regions in which we do business could affect our operationsoperations.
Some of our production sites are located in areas exposed to natural disasters, such as earthquakes (in North Africa, Middle East, Asia, Pacific, Europe, Central and Latin Americas), floods (in Africa, Asia Pacific and Europe) and hurricanes. In the event of a major disaster we could experience severe destruction or interruption of our operations and production capacity. As a result, our operations could suffer serious harm which could have a material adverse effect on our business, financial condition and results of operations.
Environmental Risks of Our Industrial Activities
Risks from the handling of hazardous materials could adversely affect our results of operations.
Manufacturing activities, such as the chemical manufacturing of the active ingredients in our products and the related storage and transportation of raw materials, products and wastes, expose us to various risks, including:
These operating risks can cause personal injury, property damage and environmental contamination, and may result in:
The occurrence of any of these events may significantly reduce the productivity and profitability of a particular manufacturing facility and adversely affect our operating results.
Although we maintain property, business interruption and casualty insurance that we believe is in accordance with customary industry practices, we cannot assure you that this insurance will be adequate to cover fully all potential hazards incidental to our business.
Environmental liabilities and compliance costs may have a significant adverse effect on our results of operations.
The environmental laws of various jurisdictions impose actual and potential obligations on our Group to remediate contaminated sites. These obligations may relate to sites:
These environmental remediation obligations could significantly reduce our operating results. Sanofi accrues provisions for remediation when our management believes the need is probable and that it is reasonably possible to estimate the cost. See “Item"Item 4. Information on the Company — B. Business Overview — Health, Safety and Environment (HSE)”" for additional information regarding our environmental policies. In particular, our provisions for these obligations may be insufficient if the assumptions underlying these provisions prove incorrect or if we are held responsible for additional, currently undiscovered contamination. These judgments and estimates may later prove inaccurate, and any shortfalls could have a material adverse effect on our results of operations and financial condition.
Furthermore, we are or may become involved in claims, lawsuits and administrative proceedings relating to environmental matters. Some current and former Sanofi’sSanofi's subsidiaries have been named as “potentially"potentially responsible parties”parties" or the equivalent under the U.S. Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended (also known as “Superfund”"Superfund"), and similar statutes in France, Germany, Italy, Brazil and elsewhere. As a matter of statutory or contractual obligation, we and/or our subsidiaries may retain responsibility for environmental liabilities at some of the sites of our predecessor companies, or our subsidiaries that we demerged, divested or may divest. We have disputes outstanding regarding certain sites no longer owned by the Group. An adverse outcome in such disputes might have a significant adverse effect on our operating results. See Note D.22.e) to the consolidated financial statements included at Item 18 of this annual report.report and "Item 8. Financial Information — A. Consolidated Financial Statements and Other Financial Information — Information on Legal or Arbitration Proceedings".
Environmental regulations are evolving (i.e., in Europe, REACH, CLP/GHS, SEVESO, IPPC,IPPC/IED, the Waste Framework Directive, the Emission Trading Scheme Directive, the Water Framework Directive and the Directive on Taxation of Energy Products and Electricity and several other regulations aiming at preventing global warming). Stricter environmental, safety and health laws and enforcement policies could result in substantial costs and liabilities to our Group and could subject our handling, manufacture, use, reuse or disposal of substances or pollutants, site restoration and compliance costs to more rigorous scrutiny than is currently the case. Consequently, compliance with these laws could result in significant capital expenditures as well as other costs and liabilities, thereby adversely affecting our business, results of operations or financial condition. For more detailed information on environmental issues, see “Item"Item 4. Information on the Company — B. Business Overview — Health, Safety and Environment (HSE).”"
Risks Related to Financial Markets1
Fluctuations in currency exchange rates could adversely affect our results of operations and financial condition.
Because we sell our products in numerous countries, our results of operations and financial condition could be adversely affected by fluctuations in currency exchange rates. We are particularly sensitive to movements in exchange rates between the euro and the U.S. dollar, the British pound, the Japanese yen, and to currencies in emerging countries. In 2011, 29.8%2012, 31% of our net sales were realized in the United States. While we incur expenses in those currencies, the impact of currency exchange rates on these expenses does not fully offset the impact of currency exchange rates on our revenues. As a result, currency exchange rate movements can have a considerable impact on our earnings. When deemed appropriate and when technically feasible, we enter into transactions to hedge our exposure to foreign exchange risks. These efforts, when undertaken, may fail to offset the effect of
adverse currency exchange rate fluctuations on our results of operations or financial condition. In addition, in the specific context of the sovereign debt crisis affecting certain European countries, the allegedthreatened or actual disruption in the usewithdrawal of the euro as currency in one or more European Monetary Union countries and the associated fluctuations in currency exchange rates could have a material effect on our financial condition and earnings, the magnitude and consequences of which are unpredictable. For more information concerning our exchange rate exposure, see “Item"Item 11. Quantitative and Qualitative Disclosures about Market Risk.”
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In the context of the worldwide financial crisis, our liquidity may be constrained.
As of December 31, 2011,2012, the Group’sGroup's net debt amounted approximately to €10.9 billion, an amount which increased substantially with the acquisition of Genzyme in 2011.€7.7 billion. In addition to debt outstanding, the Group has contracted a number of credit lines and put into place commercial paper and medium term note programs with the aim of providing liquidity. See “Item"Item 11. Quantitative and Qualitative Disclosures about Market Risk.”" In the event of a market-wide liquidity crisis, the Group might be faced with reduced access to sources of financing, including under programs currently in place, or less favorable conditions.
Risks Relating to an Investment in our Shares or ADSs
Foreign exchange fluctuations may adversely affect the U.S. dollar value of our ADSs and dividends (if any).
Holders of ADSs face exchange rate risk. Our ADSs trade in U.S. dollars and our shares trade in euros. The value of the ADSs and our shares could fluctuate as the exchange rates between these currencies fluctuate. If and when we do pay dividends, they would be denominated in euros. Fluctuations in the exchange rate between the euro and the U.S. dollar will affect the U.S. dollar amounts received by owners of ADSs upon conversion by the depositary of cash dividends, if any. Moreover, these fluctuations may affect the U.S. dollar price of the ADSs on the New York Stock Exchange (NYSE), whether or not we pay dividends in addition to the amounts, if any, that a holder would receive upon our liquidation or upon the sale of assets, merger, tender offer or similar transactions denominated in euros or any foreign currency other than U.S. dollars.
Persons holding ADSs rather than shares may have difficulty exercising certain rights as a shareholder.
Holders of ADSs may have more difficulty exercising their rights as a shareholder than if they directly held shares. For example, if we offerissue new shares and theyexisting shareholders have the right to subscribe for a portion of them, the depositary is allowed, at its own discretion, to sell for their benefit that right to subscribe for new shares instead of making it available to them. Also, to exercise their voting rights, as holders of ADSs they must instruct the depositary how to vote their shares. Because of this extra procedural step involving the depositary, the process for exercising voting rights will take longer for holders of ADSs than for holders of shares. ADSs for which the depositary does not receive timely voting instructions will not be voted at any meeting.
Recent French tax legislation applicable to the ADSs may affect their attractiveness.
The implementation of new tax legislation such as the French financial transaction tax of 0.2% (Taxe sur les Transactions Financières — TTF) enacted in 2012 (see "Item 10. — E. Taxation"), which applies by its terms to trading in our shares and ADSs without regard to territoriality could increase the costs linked to the issuance, transfer and cancellation of ADSs. Moreover, uncertainties regarding how such a tax would be assessed and collected from beneficial owners or financial intermediaries outside of France could discourage holding of such instruments.
We cannot foresee the extent to which this tax and uncertainty over its technical and practical aspects may reduce the liquidity and economic value of our ADSs.
Our largest shareholders ownshareholder owns a significant percentage of the share capital and voting rights of Sanofi.
As of December 31, 2011, L’Oré2012, L'Oréal and Total held approximately 8.82% and 3.22%8.91% of our issued share capital, respectively, accounting for approximately 15.69% and approximately 5.52%, respectively,16.13% of the voting rights (excluding treasury shares) of Sanofi. See “Item"Item 7. Major Shareholders and Related Party Transactions — A. Major Shareholders.”" Affiliates of each of these shareholders areL'Oréal currently servingserve on our Board of Directors. To the extent these shareholders continueL'Oréal continues to hold a large percentage of our share capital and voting rights, L’Oréal and Totalit will remain in a position to exert heightened influence in the electionappointment of the directors and officers of Sanofi and in other corporate actions that require shareholders’shareholders' approval.
Sales of our shares may cause the market price of our shares or ADSs to decline.
Neither L’Oréal nor Total is, toTo our knowledge, L'Oréal is not subject to any contractual restrictions on the sale of the shares eachit holds in our Company. Both of these shareholders haveL'Oréal announced that they doit does not consider their stakesits stake in our Company as strategic to them, and Total makes regular sales of its holdings on the financial market.it. Sales of large numbers of our shares, or a perception that such sales may occur, could adversely affect the market price for our shares and ADSs.
Risks Relating to our Contingent Value Rights (CVRs)
In addition to the risks relating to our shares, CVR holders are subject to additional risks.
In connection with our acquisition of Genzyme, we issued CVRs under a CVR agreement entered into by and between us and American Stock Transfer & Trust Company, the trustee.trustee (see also Note D.18. to the consolidated financial statements included at Item 18 of this annual report). A copy of the form of the CVR agreement is attached as exhibit 4.1 to our Registration Statement on Form F-4 (Registration No. 333-172638), as amended. Pursuant to the CVR agreement, each holder of a CVR is entitled to receive cash payments upon the achievement of certain milestones, based on U.S. regulatory approval of Lemtrada™ (alemtuzumab for treatment of multiple sclerosis), and on achievement of certain aggregate net sales thresholds. See “Item"Item 10. Additional Information — C. Material Contracts — The Contingent Value Rights Agreement.”"
CVR holders are subject to additional risks, including:
because a public market for the CVRs has a limited history,
Item 4. Information on the Company
Introduction
We are aan integrated, global pharmaceutical grouphealthcare company focused on patient needs and engaged in the research, development, manufacture and marketing of healthcare products. In 2011,2012, our net sales amounted to €33,389€34,947 million. We are the fifthfourth largest pharmaceutical group in the world and the third largest pharmaceutical group in Europe (source: IMS sales 2011)2012). Sanofi is the parent of a consolidated group of companies. A list of the principal subsidiaries included in this consolidation is shown at Note F. to our consolidated financial statements included at Item 18 of this annual report.
Our business includesThe Sanofi Group is organized around three mainprincipal activities: Pharmaceuticals, Human Vaccines throughvia Sanofi Pasteur, and Animal Health products throughvia Merial Limited (Merial). These activities are operating segments within the meaning of the IFRS 8 accounting standard (see Note D.35. to the consolidated financial statements).
In parallel, the Group operates through seven growth platforms (see "B. Business Overview — Strategy" below): Emerging Markets1, Diabetes, Vaccines, Consumer Health Care, Animal Health, New Genzyme2, and Other Innovative Products3. Unlike the other growth platforms, the Vaccines and Animal Health growth platforms are also operating segments within the meaning of IFRS 8. The Diabetes Solutions, Consumer Health Care, New Genzyme, and Other Innovative Products growth platforms are units whose performance is monitored primarily on the basis of their net sales; the products they sell are part of our Pharmaceuticals segment. The Emerging Markets growth platform is a unit whose performance is monitored primarily on the basis of its net sales; the products it sells are derived from all three of our principal activities: pharmaceuticals, human vaccines and animal health. For an analysis of the net sales of our growth platforms in 2012 and 2011, refer to "Item 5. Results of Operations — Year Ended December 31, 2012 Compared with year Ended December 31, 2011".
In our Pharmaceuticals activity, which generated net sales of €27,890€28,871 million in 2011,2012, our major product categories are:
Rare Diseases and multiple sclerosis are the therapeutic areas of the "New Genzyme" growth platform.
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The global pharmaceutical portfolio of Sanofi also comprisesincludes a wide range of other products in Consumer Health Care (CHC), a category in which we have become the third largest player in terms of global sales, and other prescription drugs including generics.
We are a world leader in the vaccines industry. Our net sales amounted to €3,469€3,897 million in 2011,2012, with leading vaccines in five areas: pediatric combination vaccines, influenza vaccines, adult and adolescent booster vaccines, meningitis vaccines, and travel and endemics vaccines.
Our Animal Health activity is carried out through Merial, one of the world’sworld's leading animal healthcare companies, dedicated to the research, development, manufacture and delivery of innovative pharmaceuticals and vaccines used by veterinarians, farmers and pet owners and providing a comprehensive rangeline of products to enhance the health, well-being and performance of a wide range of animals (productionproduction and companion animals). Ouranimals. The net sales of Merial amounted to €2,030€2,179 million in 2011.2012.
Partnerships are essential to our business, and many of our products on the market or in development have been in-licensed from third parties or rely on third party technologies and rights.
In the description below, the following should be kept in mind:
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A. History and Development of the Company
The current Sanofi corporation was incorporated under the laws of France in 1994 as asociété anonyme, a form of limited liability company, for a term of 99 years. We operateSince May 2011, we have operated under the commercial name “Sanofi”"Sanofi" (formerly known as sanofi-aventis). Our registered office is located at 54, rue La Boétie, 75008 Paris, France, and our main telephone number is +33 1 53 77 40 00. Our principal U.S. subsidiary’ssubsidiary's office is located at 55 Corporate Drive, Bridgewater, NJ 08807; telephone: +1 (908) 981-5000.
We are present in approximately 100 countries on five continents with 113,719111,974 employees at year end 2011. Our legacy companies, Sanofi-Synthélabo (formed by2012. As a global diversified healthcare company our business includes a diversified offering of medicines, consumer healthcare products, generics, animal health and human vaccines.
History of the 1999 merger of Sanofi and Synthélabo into the current holding company) and Aventis (formed by the combination of Rhône-Poulenc and Hoechst also in 1999), bring to theCompany
The Group has more than a century of experience in the pharmaceutical industry.
Sanofi-Synthélabo (formed in 1999 by the merger of Sanofi, was founded in 1973 by Elf Aquitaine, a French oil company, when it took control of the Labaz group, a pharmaceutical company. Its first significant venture into the U.S. market was the acquisition of the prescription pharmaceuticals business of Sterling Winthrop — an affiliate of Eastman Kodak — in 1994.
and Synthélabo, was founded in 1970 through1970) and Aventis (formed in 1999 by the mergercombination of two French pharmaceutical laboratories, Laboratoires Dausse (foundedRhône-Poulenc, formed in 1834)1928 and Laboratoires Robert & Carrière (foundedHoechst, founded in 1899). In 1973, the French cosmetics group L’Oréal acquired the majority of its share capital.
Hoechst traces its origins to the second half of the 19th century, to the time of the German industrial revolution and the emergence of the chemical industry. Traditionally active19th century) were combined in pharmaceuticals, Hoechst strengthened its position in that industry by taking a controlling interest in Roussel-Uclaf in 1974 and the U.S. pharmaceutical company Marion Merrell in 1995.
Rhône-Poulenc was formed in 1928 from the merger of two French companies: a chemical company created by the Poulenc brothers and the Société Chimique des Usines du Rhône, which was founded in 1895. The company’s activities in the first half of the 20th century focused on producing chemicals, textiles and pharmaceuticals. Rhône-Poulenc began to focus its activities on life sciences in the 1990s, which led to the successive purchases of Rorer, a U.S. pharmaceutical company acquired in two stages in 1990 and 1997, the remaining 49% of shares of Pasteur Mérieux Serums & Vaccins S.A. in 1994, and the U.K.-based pharmaceuticals company Fisons in 1995.
Sanofi-Synthélabo took control of Aventis in August 2004 and changed its registered name to “sanofi-aventis”. On December 31, 2004, Aventis merged with and into sanofi-aventis, with sanofi-aventis asare the surviving company.principal legacy companies of our continuously expanding Group.
Important Corporate Developments 2009-2012
In 1994, Pasteur Mérieux Serums & Vaccins, the Group’s vaccines division, together with the vaccines division of Merck & Co., Inc. formed Sanofi Pasteur MSD, creating the only European firm entirely dedicated to vaccines.
Merial was founded in 1997 as a combination of the animal health activities of Rhône-Poulenc and Merck. Merial was a joint venture in which we and Merck each held 50%. On September 17, 2009, we acquired Merck’s entire interest in Merial. Merial became Sanofi’s dedicated animal health division following the joint statement issued by Merck and Sanofi in March 2011 announcing the end of their agreement to create a new animal health joint venture by combining their respective animal health segments. See Note D.2. to our consolidated financial statements included at Item 18 of this annual report.
Starting in 2009, Sanofi madebegan a seriesstrategy of targeted acquisitions to createbecome a diversified healthcare company, and created or strengthen our regionalstrengthened various platforms including CHC and generics platforms including:Generics.
The
On April 27, 2009, Sanofi acquired a 100% equity interest inand Medley, the third largest pharmaceutical company in Brazil and a leading generics company in that country;
Brazil;
company;
this annual report; and
As of the May 2011 General Meeting of Shareholders, the Group changed its name to “Sanofi”.
Strategy
Sanofi is a diversified,an integrated, global healthcare leader offering solutions across areas of core historical strength and multiple growth platforms. Like other groups active in the pharmaceutical companies,industry, we have been facing competition from generics for several of our major products, in an environment subject to cost containment pressures from both third party payers and healthcare authorities. Starting in 2009, we haveWe responded to these major challenges by implementing a new strategy with the objective of repositioning Sanofi for more stable and sustainable revenue and earnings growth. During that timeOver the past years, we have transformed the CompanyGroup by decreasing our reliance on existing “blockbuster”"blockbuster" medicines (medicines with over $1 billion in global sales), optimizing our approach to Research & Development (R&D), increasing our diversification, and investing in 6seven growth platforms (Emerging Markets,(1), Diabetes Solutions, Human Vaccines, Consumer Health Care, Animal Health, New Genzyme, and Innovative Products). Additionally, we became a global leader in rare genetic diseases through our acquisition of Genzyme in 2011.
We regularly review our strategy and its implementation, and are continuing to execute on this strategy along threefour prongs:
• Growing a global healthcare leader with synergistic platforms
Our ambition is to offer an integrated set of businesses within the healthcare space with opportunities to create synergies across activities both upstream and R&D level and downstream in the market place.
Increasing innovation in Research & Development (R&D)• Bringing innovative products to market
We have conducted a completeregularly review of our research and developmentR&D portfolio since 2009, in order to improve the allocation of our resources. This review has led to aAlso, our decision-making processes integrate commercial potential and scope for value creation into our development choices. The result is an ongoing rationalization and optimization of our portfolio focusingallowing us to focus on high-value projects and, reallocatingwhen appropriate, reallocate part of our resources from internal infrastructure to partnerships and collaborations. We also redefined our decision-making processes so that commercial potential and the scope for value creation are better integrated into our development choices. We alsohave redesigned our R&D footprint, including increasing our presence in the Boston, MA area (United States) with its concentration of universities and innovative biotechnology companies. Our R&D is now based on an organizational structure focused on patient needs and encouraging entrepreneurship. This network-based organization, open to external opportunities, enables our R&D portfolio to more effectively capitalize on innovation from a wide range of sources.
In line with this policy, we signed new alliance and licensing agreements in 2011 designed2012 to give us access to new technologies, and/or to broaden or strengthen our existing fields of research (including diabetes, oncology and vaccines). Finally, weresearch. We have also made progress on our objective of offering more products that add value for patients, with five New Molecular Entitiesinnovative products (NMEs) submitted to regulatory agencies in 2011,2012 and 18 potential new product launches possible beforebetween now and the end of 2015.
Adapting our structures to meet the opportunities and the challenges of the future
Since 2009, we have adapted our operating model, from being focused on the best-selling prescription drugs in our traditional markets, to a broader set of products and services reflecting the diversity of our activities and our geographical reach. In particular, we tailored our strategy, structure and offering to each region’s needs, so as to deliver the most appropriate solution to each patient. The result is a dramatic shift in business mix from Top 15 products to key growth platforms. In 2008, 61 % of our sales originated from our top 15 products while in 2011, 65 % of our sales originated from Genzyme and our growth platforms. Moreover, 30 % of our 2011 sales were in emerging markets where we have enhanced our offerings in high growth market segments such as Generics and Consumer Health Care by completing 17 transactions and investing a total of approximately €3.7 billion in acquisitions over the last three years.
We also realigned our industrial capacity to reflect our expectation of changes in volumes and our analyses of growth opportunities. Combined with the streamlining of our R&D structures and keeping a tight control on SG&A expenses, this has helped enable us to successfully navigate through a period where multiple of our leading products faced the loss of patent exclusivity protection, despite an often tougher economic environment with new healthcare cost containment measures in many markets.
Exploring external• Seizing value-enhancing growth opportunities
Business development remains an integral and disciplined pillar of our overall strategy, targeting acquisitions and alliances that create and/or strengthen platforms for long-term growth and create value for our shareholders. Since January 2009, we have invested a total of approximately €23€24 billion in external growth accounting for approximately 20% increase in 2011 consolidated sales.growth. During 2011,2012, we actively pursued this targeted policy, actively, announcing 3026 new transactions, including three8 acquisitions and 2718 major R&D alliances. We successfully completed our acquisition of Genzyme, a global leader in rare genetic diseases and an emerging leader in multiple sclerosis. We also
In 2012, we strengthened our Emerging Markets growth platform with the acquisitionagreement to acquire Genfar S.A. (announced in October 2012), a leading pharmaceuticals manufacturer headquartered in Bogota, Colombia. Also, we acquired the rights to lines of Universal Medicare, advancing our sustainable growth strategygeneric products for Sub Saharan Africa and for Vietnam. With these acquisitions, Sanofi intends to become a market leader in Indiaboth Colombia and facilitating the creationNigeria, and has expanded its portfolio of a Consumer Health Care platformaffordable pharmaceuticals in that country.Latin America, Africa and Southeast Asia.
Our U.S. vaccines operations wereanimal health business was also reinforced within 2012 by the acquisition of Topaz Newport Laboratories, a privately held company based in Worthington, Minnesota (United States), a leader in autogenous vaccines with a focus on swine and bovine production markets, and with the agreement to acquire the Animal Health Division of Dosch
Pharmaceuticals which complements our pediatric offering.in India (announced end of December 2012). When completed, this last acquisition will create a market entry for Merial in that country's strategically important and growing Indian animal health sector.
In the years to come, we expect our sound financial position to provide us the potential to create value viathrough external growth opportunities and to strengthen our diversification and growth platforms through new acquisitions and partnerships. We will remain financially disciplined, withwithin the aimaims of our business development activities, toso that we can execute strategically important transactions and partnerships that securedeliver a return on investment in excess of our cost of capital.
• Adapting our structure for future opportunities and challenges
We have adapted our operating model, previously focused on the best-selling prescription drugs in our traditional markets, to a broader set of products and services that better reflect the diversity of our activities and our geographical reach. In particular, we have tailored our strategy, structure and offering to each region's needs, so as to deliver the most appropriate solution to each patient. The result is a dramatic shift in business mix from our top 15 products to key growth platforms. In 2008, 61% of our sales originated from our top 15 products while in 2012, 67.4% of our sales were generated by our growth platforms. In addition, 31.9% of our 2012 sales were in emerging markets, where we have enhanced our offerings in high growth segments such as Generics and Consumer Health Care by completing 25 transactions and investing a total of approximately €3.9 billion in acquisitions over the last four years.
We have also realigned our industrial capacity to reflect our expectation of changes in volumes and our analyses of growth opportunities. Combined with the streamlining of our R&D structures and tight control over selling, general and administrative expenses, this has helped us successfully navigate a period in which many of our leading products faced the loss of patent exclusivity protection, in a tougher economic environment with new healthcare cost containment measures in many markets.
Pharmaceutical Products
Main Pharmaceutical Products
Within our Pharmaceuticals business, we focus on the following categories:therapeutic areas: diabetes, rare diseases, oncology, and othermultiple sclerosis, oncology. We also have flagship products in such fields as anti-thrombotics, cardiovascular, renal and biosurgery fields.and have developed leading businesses in Consumer Health Care and generics.
The sections that follow provide additional information on the indications and market position of our key products. Our intellectual property rights over our pharmaceutical products are material to our operations and are described at “—"— Patents, Intellectual Property and Other Rights”Rights" below. As disclosed in “Item"Item 8. Financial Information — A. Consolidated Financial Statements and Other Financial Information — Patents”Patents" of this annual report, wereport. We are involved in significant litigation concerning the patent protection of a number of these products.
The following table sets forth the net sales of our best-sellingmain pharmaceutical products for the year ended December 31, 2011. These products are major contributors to public health.2012.
Therapeutic Area / Product Name | Net Sales (€ million) | Drug Category / Main Areas of Use | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Diabetes Solutions | ||||||||||||
| ||||||||||||
| 4,960 | Long-acting analog of human insulin | ||||||||||
• Type 1 and 2 diabetes mellitus | ||||||||||||
| 230 | Rapid-acting analog of human insulin | ||||||||||
• Type 1 and 2 diabetes mellitus | ||||||||||||
| ||||||||||||
| ||||||||||||
| 135 | Human insulin (rapid and intermediate acting) | ||||||||||
• Type 1 and 2 diabetes mellitus | ||||||||||||
| 421 | Sulfonylurea | ||||||||||
• Type 2 diabetes mellitus | ||||||||||||
Rare Diseases | ||||||||||||
| ||||||||||||
| ||||||||||||
| ||||||||||||
| ||||||||||||
| Enzyme replacement therapy | |||||||||||
• | ||||||||||||
| 292 | Enzyme replacement therapy | ||||||||||
• Fabry disease | ||||||||||||
| 462 | Enzyme replacement therapy | ||||||||||
| • Pompe disease | |||||||||||
Multiple Sclerosis | ||||||||||||
Aubagio® (teriflunomide) | 7 | Oral immunomodulating agent | ||||||||||
• Multiple Sclerosis | ||||||||||||
Oncology | ||||||||||||
Taxotere® (docetaxel) | 563 | Cytotoxic agent | ||||||||||
• Breast cancer • Non small cell lung cancer • Prostate cancer • Gastric cancer • Head and neck cancer | ||||||||||||
| 956 | Cytotoxic agent | ||||||||||
• Colorectal cancer | ||||||||||||
| 235 | Cytotoxic agent | ||||||||||
• Prostate cancer | ||||||||||||
Mozobil® (plerixafor) | 96 | Hematopoietic stem cell mobilizer | ||||||||||
• Hematologic maligancies | ||||||||||||
Zaltrap® (aflibercept) | 25 | Recombinant fusion protein | ||||||||||
• Oxaliplatin resistant metastatic colorectal cancer |
| ||||||
Therapeutic Area / Product Name | 2012 Net Sales (€ million) | Drug Category / Main Areas of Use | ||||
---|---|---|---|---|---|---|
Other Prescription Drugs | ||||||
| ||||||
| 1,893 | Low molecular weight heparin | ||||
• Treatment and prevention of deep vein thrombosis • Treatment of acute coronary syndromes | ||||||
| 2,066 | Platelet adenosine disphosphate receptor antagonist | ||||
• Atherothrombosis • Acute coronary syndrome with and without ST segment elevation | ||||||
| 1,151 | Angiotensin II receptor antagonist | ||||
(irbesartan & hydrochlorothiazide) | • Hypertension | |||||
| 255 | Anti-arrhythmic drug | ||||
|
| ||||||||
| Oral phosphate binders | |||||||
Renvala® (sevelamer carbonate) | • High phosphorus levels in patients with chronic kidney disease | |||||||
| 363 | Viscosupplements | ||||||
| ||||||||
• Pain associated with osteoarthritis of the knee | ||||||||
| 497 | Hypnotic | ||||||
| ||||||||
• Sleep disorders | ||||||||
| 553 | Anti-histamine | ||||||
| ||||||||
| ||||||||
| ||||||||
| ||||||||
| ||||||||
| ||||||||
| ||||||||
| ||||||||
| ||||||||
| ||||||||
| ||||||||
| ||||||||
• Allergic rhinitis • Urticaria | ||||||||
Depakine® (sodium valproate) | 410 | Anti-epileptic | ||||||
• |
| |||||
Consumer Health Care | |||||
Total | 3,008 | ||||
Generics | |||||
Total | 1,844 | ||||
The prevalence of diabetes is expected to increase significantly over the next 20 years,by 2030, reflecting multiple socio-economic factors including sedentary lifestyles, excess weight and obesity, unhealthy diet and an aging population. Our principal diabetes products are Lantus®Lantus®, a long-acting analog of human insulin; Apidra®Apidra®, a rapid-acting analog of human insulin; Insuman®Insuman®, a human insulin; and Amaryl®Amaryl®, a sulfonylurea. In 2011, in some European markets, we launched the BGStar® solutionBGStar® range of blood glucose metersmeter solutions for patients with diabetes, whether they are treated with insulin or not. In February 2013, the European Commission granted marketing authorisation in Europe for Lyxumia®, a once-daily prandial GLP-1 receptor agonist.
Lantus®
Lantus®
Lantus®Lantus® (insulin glargine) is a long-acting analog of human insulin, offering improved pharmacokinetic and pharmacodynamic profiles compared to other basal insulins. Lantus®profile. Lantus® is indicated for once-daily subcutaneous administration in the treatment of adult patients with type 2 diabetes mellitus who require basal insulin for the control of hyperglycemia, and for adult and pediatric patients aged sixtwo years (label extension for pediatric use was granted in the EU in 2012) and above with type 1 diabetes mellitus.
Lantus® Lantus® is the most studied basal insulin with over 10 years of clinical evidence in diabetes treatment and a well-established treatment with over 38 million patient-years exposure since 2000. The clinical trial experience with Lantus® covers over 100,000 patients.safety profile.
Lantus®Lantus® can be administered subcutaneously using syringes or specific pens including:
|
|
In September 2009 following four highly publicized but methodologically limited registry analyses, some of which created concern over a potential link betweenin the use of Lantus®European Union and an increased risk of cancer, we announced an action plan to provide methodologically robust research that will contribute to the scientific resolution of the debate over insulin safety, including insulin analogsCanada. It is now available in more than 30 countries worldwide; and Lantus®. The research program encompasses both preclinical and clinical programs involving human insulin and insulin analogues, including insulin glargine; it
|
the U.S. Study will compare the risk of breast, prostate and colon cancer (each considered separately) in glargine users versus human NPH insulin users. Study completion is for the end of the first half of 2012; and
In their 2012 updates, the International Study of Insulin and Cancer, being carried out in the United Kingdom, France and Canada, will assess the association of breast cancer with the use of insulins. The study results are expected by end 2012.
The ADA/ACS (AmericanAmerican Diabetes Association / American Cancer Society) Consensus Report published on June 16, 2010 reasserted the inconclusiveness of any link between insulin and cancer.
In January 2011, the FDA updated its ongoing safety review of Lantus®. In addition to the analysis of the four registry analyses published in 2009, the FDA also reviewed results from a five-year diabetic retinopathy clinical trial in patients with type 2 Diabetes. Based on these data, the FDA has not concluded at this time that Lantus® increases the risk of cancer. FDA review remains ongoing.
In December 2011, results of new meta-analysis were presented at the World Diabetes Congress. This new meta-analysis of all published studies—observational studies derived from databases as well as randomized controlled clinical trials and one case-control study—has demonstrated no increased risk in people using Lantus® when compared to the users of human insulin.
The ADA(ADA) and European Association for the Study of Diabetes (EASD) have maintained their 2008 treatment recommendations for type 2 diabetes. These guidelinesThis consensus statement further established basal insulins such as Lantus®Lantus®, or a sulfonylurea such as Amaryl®Amaryl®, as two preferred second-line treatment options for people with diabetes who are unable to achieve glycemic control targets with lifestyle intervention and metformin alone. These treatment recommendations reinforce the timely use of basal insulin as a core therapy for type 2 diabetes.
Lantus®Lantus® is the world number-one selling insulin brand in terms of both sales and units (source: IMS, 20112012 sales) and is available in over 70120 countries worldwide. The three leading countries for sales of Lantus®Lantus® in 20112012 were the United States, France and Japan.
International epidemiology program
Apidra® The epidemiological program sponsored by Sanofi was aimed at evaluating cancer risk in diabetes and generating comprehensive insulin glargine exposure data from large databases. It is the largest observational program designed for this purpose to date. The program results reinforce the robust safety profile of Lantus®, complementing the existing wealth of data already available from more than 80,000 patients enrolled in clinical trials.
The now completed epidemiological program comprised three major studies. These were designed independently of the company by the lead investigators and endorsed by the European Medicines Agency (EMA) and shared with the Food and Drug Administration (FDA). They used state-of-the-art biostatistical methodology with protocols that were discussed with a senior-level Biostatistics Advisory Group:
ORIGIN
ORIGIN was a seven-year randomized clinical trial designed to assess the effects of treatment with insulin glargine versus standard care on cardiovascular outcomes. This landmark study involved over 12,500 participants worldwide with pre-diabetes or early type 2 diabetes mellitus and high cardiovascular (CV) risk, with 6,264 participants randomized to receive insulin glargine titrated to achieve fasting normoglycemia. The co-primary endpoints were the composite of CV death, or non-fatal myocardial infarction, or nonfatal stroke; and the composite of CV death, or non-fatal myocardial infarction, or non-fatal stroke, or revascularization procedure, or hospitalization for heart failure.
Results showed that Lantus® had no statistically significant positive or negative impact on CV outcomes versus standard care during the study period. Results also showed that insulin glargine delayed progression from pre-diabetes to type 2 diabetes and there was no association between insulin glargine use and increased risk of any cancer. (New England Journal of Medicine, July 2012)
Sanofi is sponsoring a 2-year extension to ORIGIN, called ORIGINALE (Outcome Reduction with an Initial Glargine Intervention and Legacy Effect).
The results of the ORIGIN trial have been filed with the FDA and the EMA to update the Lantus® dossier at the end of 2012.
Apidra®Apidra®
Apidra® (insulin glulisine) is a rapid-acting analog of human insulin. Apidra®Apidra® is indicated for the treatment of adults with type 1 diabetes, or in type 2 diabetes for supplementary glycemic control. Apidra®Apidra® has a more rapid onset and shorter duration of action than fast-acting human insulin and can be associatedin combination with long-acting insulins such as Lantus®Lantus® for supplementary glycemic control at mealtime.
In addition, Apidra®Apidra® is equally effective in adult diabetics ranging from lean to obese and offers patients greater flexibility of administration, either before or just after mealtime.
Apidra®Apidra® can be administered subcutaneously using syringes or specific pens including the Apidra® SoloSTAR®Apidra® SoloSTAR® disposable pen and the ClikSTAR®ClikSTAR® reusable pen.
Apidra®Apidra® is available in over 60100 countries worldwide.
Due to a technical incident on a manufacturing line, Apidra® facedAfter a temporary shortage of Apidra®Apidra® 3mL cartridges (including Apidra® SoloSTAR®Apidra® SoloSTAR®) in 2011 which impacted supplies in some markets. Themarkets, production of Apidra®Apidra® 3mL cartridges is expected to returnreturned to full capacity in the first half of 2012. Apidra
® vials were not impacted.Insuman®
Insuman®
Insuman® Insuman® (human insulin) is a range of insulin solutions and suspensions for injection and is indicated for diabetes patients where treatment with insulin is required. Human insulin is produced by recombinant DNA technology inEscherichia coli strains.strains.
Insuman®Insuman® is supplied in vials, cartridges, pre-filled disposable pens (OptiSet®(OptiSet® and SoloStar®SoloSTAR®) or reusable pens (ClickSTAR®(ClickSTAR®) containing the active substance human insulin. The Insuman®Insuman® range is comprised of rapid-acting insulin solutions (Insuman®(Insuman® Rapid and Insuman®Insuman® Infusat) that contain soluble insulin, an intermediate-acting insulin suspension (Insuman®(Insuman® Basal) that contains isophane insulin, and combinations of fast- and intermediate-acting insulins in various proportions (Insuman®(Insuman® Comb). Insuman®Insuman® is mostlyprincipally sold in Germany.
Amaryl®/Amarel®/Solosa®
Amaryl®/Amarel®/Solosa®
Amaryl®Amaryl® (glimepiride) is a latest-generation, orally administered once-daily sulfonylurea (a glucose-lowering agent) indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Amaryl®Amaryl® reduces the body’sbody's blood sugar level in two ways: by helping the body to produce more insulin both at mealtime and between meals, and by decreasing insulin resistance.
The combination of metformin (which reduces hepatic glucose production and decreases insulin resistance) with a sulfonylurea such as Amaryl®Amaryl® is effective in combating the two causes of type 2 diabetes. It is one of the most prescribed combinations of diabetes drugs worldwide. Amaryl M®M®, a fixed-dose combination of Amaryl®Amaryl® plus metformin in a single presentation, was launched in 2007.
Our leading market for Amaryl® is Japan, where it is the best-selling oral anti-diabetes product by volume (source: IMS 2011 sales). A number of generics have received marketing authorization and have been launched in Europe, and the United States. Generic became available in Japan in November 2010 but the impact on AmarylStates and Japan.
® sales compared to the impact of generic sales generally observed in the U.S. or the EU has been more moderate.BGStar® / iBGStar®
BGStar® / iBGStar™
Sanofi and its partner AgaMatrix are co-developing innovativeintelligent solutions in diabetes care with the aim ofthat demonstrate their commitment to simplifying and innovating the diabetes management experience for patientspeople with diabetes and healthcare providers. The blood glucose monitoring solutions will beare exclusive to Sanofi and are designed to be synergistic with our Diabetes portfolio, with a positive effect on salesthe rest of Lantus®the diabetes portfolio. BGStar® and other products expected.
BGStar®iBGStar® are modern and iBGStar™ areintelligent blood glucose meters that feature Dynamic Electrochemistry®, an innovative technology that extracts a spectrummonitoring solutions which are easy to use, accurate, reliable and fit the lifestyle of information from blood thatpeople with diabetes today:
These monitoring devices are an important step towards ourSanofi's vision of becoming the global leader in diabetes care by integrating innovativeintelligent monitoring technology, therapeutic innovations, personalized services and support solutions. During 2011, the BGStar®
BGStar® and iBGStar™ were made commerciallyiBGStar® are available in France, Germany, France, Switzerland, Spain, Italy, the Netherlands, Switzerland, Belgium, Luxembourg, Canada, Estonia, Australia, the UK and Italy.
In December 2011, the FDA approved the iBGStar™ the first blood glucose meter that connects to the iPhone® allowing patients to view and analyze accurate, reliable information in “real time”.
The main compounds currently in Phase II or III clinical developmentPhilippines. iBGStar® is also available in the Diabetes/Other Metabolic Disorders field are:United States and Saudi Arabia.
Lyxumia®
Lixisenatide (AVE0010 GLP-1: Glucagon-like peptide-1 agonist,Lyxumia® (lixisenatide) is a once-daily prandial GLP-1 receptor agonist. In February 2013, the European Commission granted marketing authorization in Europe for Lyxumia® indicated for the treatment of adults with type 2 diabetes mellitus; Phase IIIb; lixisenatide is in-licensed from Zealand Pharma A/S). The GETGOAL Phase III studiesmellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. On completion of pricing and reimbursement discussions, Sanofi will initiate a phased launch of Lyxumia® throughout the European Union. Applications for regulatory approval were finalized and demonstrated that lixisenatide was effective in lowering blood sugar and decreasing body weight with good safety and tolerability. These results were presented at international conferences (e.g. ADA, EASD, IDF). Lixisenatide wasalso submitted in several other countries around the fourth quarter of 2011 to EMA, Switzerland, Mexico, Brazil, Canada, Ukraine, South Africaworld and Australia.are being reviewed. The FDA accepted the file for review in February 2013.
Additional Phase IIIb studies have been initiated.
initiated and the ELIXA cardiovascular outcomes trial is ongoing.
Phase I studies on combination of lixisenatide and Lantus® have been successfully finalized. A proof-of-concept study to compare insulin glargine/lixisenatide fixed ratio combination versus insulin glargine on glycemic control over 24 weeks has begun.been fully recruited.
GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.
The active ingredient of Lyxumia® is in-licensed from Zealand Pharma.
The main compound currently in Phase III clinical development in the Diabetes field is New Glargine Formulation: A new formulation of insulin glargine with an improved pharmacodynamic profile is now in Phase III clinical testing. In addition to the two Phase III studies started during 2011, in the second half of 2012 the EDITION III and IV Phase III trials were initiated together with two dedicated clinical studies in Japan.
The acquisition of Genzyme in 2011 brought to the Group specific expertise in rare diseases, a sector where there are still many unmet needs, and expanded Sanofi's presence in the biotechnology sector.
Our Rare Disease business is focused on products for the treatment of rare genetic diseases and other chronic debilitating diseases, including lysosomal storage disorders, or LSDs, a group of metabolic disorders caused by enzyme deficiencies. Our principal rare disease products are enzyme replacement therapies: Cerezyme® (imiglucerase for injection) to treat Gaucher disease, Fabrazyme® (agalsidase beta) to treat Fabry disease and Myozyme® / Lumizyme® (alglucosidase alpha) to treat Pompe disease. In January 2013, Kynamro™ (mipomersen), an antisense oligonucleotide that inhibits the synthesis of apolipoprotein B-100, was approved by the FDA for homozygous familial hypercholesterolemia.
Cerezyme®
Cerezyme® (imiglucerase for injection) is an enzyme replacement therapy used to treat Gaucher disease, an inherited, potentially life-threatening LSD. It is estimated that there are approximately 10,000 Gaucher patients worldwide.
Cerezyme® is the only therapy with an 18-year history of reducing, relieving and reversing many of the symptoms and risks of Type 1 and Type 3 (in certain markets) Gaucher disease. Cerezyme® is administered by intravenous infusion over 1-2 hours.
In 2012, significant progress was made in resolving supply challenges encountered starting in 2009, and successfully restoring existing patients in major markets to normal dosing. For more information regarding manufacturing issues related to Cerezyme®, see "Item 4 — Information on the Company — Production and Raw Materials".
The principal markets for Cerezyme® are the United States, Europe and Latin America.
Fabrazyme®
Fabrazyme® (agalsidase beta) is an enzyme replacement therapy used to treat Fabry disease, an inherited, progressive and potentially life-threatening LSD. Fabry disease is estimated to affect between 5,000 and 10,000 people worldwide. Fabrazyme® is administered by intravenous infusion.
Fabrazyme® is available in over 30 countries, including the United States and Europe.
The strong recovery of Fabrazyme®, following manufacturing issues which began in 2009, continued in 2012 with the approval of the new Framingham plant in January 2012, stable production runs, the return of all existing patients in all markets to full dose and the addition of new patients. In the U.S., Fabrazyme® also benefited from Shire's withdrawal of the Replagal® BLA. For more information regarding manufacturing issues related to Fabrazyme®, see "Item 4 — Information on the Company — Production and Raw Materials".
Myozyme® / Lumizyme®
Myozyme® / Lumizyme® (alglucosidase alpha) are enzyme replacement therapies used to treat Pompe disease, an inherited, progressive and often fatal LSD. We estimate that there are approximately 10,000 Pompe patients worldwide.
Myozyme® has been marketed since 2006 in the United States and the EU and is currently available in 48 markets worldwide. Lumizyme® is the first treatment approved in the United States specifically to treat patients
Preliminarywith late-onset Pompe disease: Lumizyme® has been marketed since June 2010. Myozyme® and Lumizyme® are administered by intravenous infusion. Lumizyme® is used to treat Pompe disease in patients over eight years of age without evidence of cardiac hypertrophy.
Both products are a recombinant form of the same human enzyme but are manufactured using different sized bioreactors.
Kynamro™
Kynamro™ (mipomersen) is an antisense oligonucleotide (ASO) that inhibits the synthesis of apoB, a primary protein constituent of atherogenic lipoproteins. Mipomersen is being developed, in collaboration with Isis Pharmaceuticals Inc., for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) and severe heterozygous FH (HeFH). FH is a genetic disorder that causes chronic and lifelong exposure to markedly elevated concentrations and numbers of atherogenic, apoB-containing lipoproteins (LDL, Lp(a)) leading to premature and severe cardiovascular disease. On January 29, 2013, Genzyme and Isis announced the FDA approval of Kynamro™ (Mipomersen sodium) for homozygous familial hypercholesterolemia. On December 14, 2012 Genzyme and Isis announced that the Committee for Medicinal Products for Human Use (CHMP) had adopted a negative opinion for its marketing authorization application submitted in 2011. In January 2013, Genzyme requested a re-examination of the CHMP opinion.
The main compounds currently in Phase II or III clinical development in the Rare Diseases field are:
In ENGAGE, a Phase III trial aimed at evaluating the safety and efficacy of eliglustat in 40 treatment-naive patients with Gaucher disease type 1, improvements were observed across all primary and secondary efficacy endpoints over the nine-month study period.
In ENCORE, a Phase III study assessing eliglustat vs. Cerezyme® in 160 patients with Gaucher disease type 1, the primary composite endpoint of clinical stability was met as well as for the individual components of the composite endpoint which was secondary endpoints.
Multiple Sclerosis (MS)
Our Multiple Sclerosis franchise is focused on the development and commercialization of therapies that treat this chronic autoimmune disease of the central nervous system. More than 2 million people suffer from MS worldwide. Our MS franchise consists of Aubagio® (teriflunomide), a once daily, oral immunomodulator that is approved in the United States and Australia, and Lemtrada™ (alemtuzumab), a monoclonal antibody that has completed two Phase III pivotal studies and has marketing applications under review by regulatory authorities in the U.S. and Europe.
Aubagio®
Aubagio® (teriflunomide), an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. The exact mechanism by which teriflunomide exerts its therapeutic effect in MS is unknown but may involve a reduction in the number of activated lymphocytes in CNS. Aubagio® has shown significant efficacy across key measures of MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI. Results of the first pivotal study (TEMSO), indicating that the product had an effect on disease activity in terms of relapse rate, disability progression and brain lesions with a favorable safety profile, were published in the New England Journal of Medicine in October 2011. Results from the second pivotal study (TOWER) were presented at 28th Congress of the European Committee for Treatment and Research
in Multiple Sclerosis (ECTRIMS) in October 2012. These results ofSAR236553, co-developed with Regeneron (REGN727: anti-PCSK9 mAb), have been obtained. Treatment with SAR236553 leads to mean relative LDL-Cholesterol reductionshowed that Aubagio® significantly reduced the annualized relapse rate and slowed progression of greater than 65% after 8-12 weeks of treatmentdisability in patients with high LDL-C at baseline.
The partnership with Metabolex onrelapsing forms of multiple sclerosis compared to placebo. Aubagio® is the GPR119 receptor agonistSAR260093 has been terminated.
Oncologyfirst and only oral MS therapy to significantly slow the progression of disability in two Phase III trials.
Sanofi is present in the oncology field, primarily in chemotherapy, with three major products: Taxotere®, Eloxatine®, and Jevtana®, which was launched commerciallyAubagio® received FDA approval in the United States in 2010September 2012 for patients with relapsing forms of MS. The product also received regulatory approval in Australia in November 2012. Marketing applications for Aubagio® are currently under review by the European Medicines Agency and other regulatory authorities.
The main compound currently in Phase III clinical development in the multiple sclerosis field is Lemtrada™ (alemtuzumab), a humanized monoclonal antibody targeting CD52 antigen abundant on the surface of B and T lymphocytes leading to changes in the circulating lymphocyte pool. Alemtuzumab has been developed to treat patients with relapsing forms of MS. The two pivotal Phase III studies demonstrating the safety and efficacy of alemtuzumab were completed in 2011 and the results were published in theLancet in November 2012. The first study, CARE-MS I, demonstrated strong and robust treatment effect on the relapse rate co-primary endpoint vs Rebif in treatment-naive MS patients. The co-primary endpoint of disability progression (time to sustained accumulation of disability: SAD) did not meet statistical significance. The second quarterstudy, CARE-MS II, demonstrated that relapse rate and SAD were significantly reduced in MS patients receiving alemtuzumab as compared with Rebif in MS patients who had relapsed on prior therapy. Results from CARE-MS II also showed that patients treated with Lemtrada™ were significantly more likely to experience improvement in disability scores than those treated with Rebif, suggesting a reversal of 2011disability in Europe.some patients. In both pivotal studies, safety results were consistent with previous alemtuzumab use in MS and adverse events continued to be manageable. Marketing applications for Lemtrada™ are currently under review by regulatory authorities.
Sanofi has started to diversify its presence in the oncology field beyond chemotherapy (Eloxatine®, Taxotere® and Jevtana®), and launched an angiogenesis inhibitor, Zaltrap®, in August 2012 in the U.S.
Taxotere®Taxotere®
Taxotere® (docetaxel), a taxoid class derivative, inhibits cancer cell division by essentially “freezing”"freezing" the cell’scell's internal skeleton, which is comprised of microtubules. Microtubules assemble and disassemble during a cell cycle. Taxotere®Taxotere® promotes their assembly and blocks their disassembly, thereby preventing many cancer cells from dividing and resulting in death in many cancer cells.
Taxotere®Taxotere® is available in more than 10090 countries as an injectable solution. The single vial formulation (one vial IV route 20-80mg) was launched in the U.S. and in the European Union in 2010. It has gained approvalbeen approved for use in eleven indications in five different tumor types (breast, prostate, gastric, lung, and head and neck). Taxotere®Taxotere® is indicated for early stage and metastatic breast cancer, first-line and second-line metastatic Non-Small Cell Lung Cancer (NSCLC), androgen-independent (hormone-refractory) metastatic prostate cancer, advanced gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction), and the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
The top four countries contributing to sales of Taxotere®Taxotere® in 20112012 were the United States, Japan, France,China and China.Russia. Generics of docetaxel were launched at the end of 2010 in Europe, and in April 2011 in the U.S. Exclusivity for Taxotere®, and in December 2012 in Japan will be maintained through November 2013 (see “—"— Patents, Intellectual Property and Other Rights”Rights" below).
Eloxatine®
Eloxatin®
Eloxatin®Eloxatine® (oxaliplatin) is a platinum-based cytotoxic agent. Eloxatin® combinedEloxatine®, in combination with infusional (delivered through the bloodstream) administration of two other chemotherapy drugs, 5-fluorouracil/leucovorin (the FOLFOX regimen), is approved by the FDA for adjuvant treatment of people with stage III colon cancer who have had their primary (original) tumors surgically removed. This approval was based on evidence of an improvement in disease-free survival after four years.
Eloxatin®Eloxatine® is in-licensed from Debiopharm and is marketed in more than 70 countries worldwide. The top four countries contributing to sales of Eloxatine® in 2012 were the United States, Canada, China, and South Korea.
Following the end of the Eloxatin®Eloxatine® European regulatory data exclusivity in April 2006, a number of oxaliplatin generics have been launched throughout Europe. With regard to the U.S. market, a number of oxaliplatin generics received final marketing authorization from the FDA and were marketed until June 30, 2010, when their manufacturers were ordered by the U.S. District Court for the District of New Jersey to cease selling their unauthorized Eloxatin® genericMarket exclusivity in the United States. Eloxatin U.S. market exclusivity is expected to be maintained throughStates was lost on August 9, 2012. See “Item 8. Financial Information — A. Consolidated Financial Statements and other Financial Information — Patents”.Several generics of oxaliplatin are available globally, except in Canada where Eloxatine® still has exclusivity.
Jevtana®
Jevtana®
Jevtana®Jevtana® (cabazitaxel) is a new taxane derivative approved in combination with prednisone for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen. Jevtana®Jevtana® was the result of a 14-year research and development program to address the significant unmet medical need after taxane-based treatment progression.
The results of the TROPIC Phase III study demonstrated that cabazitaxel plus prednisone/prednisolone significantly improved overall survival versus the standard regimen of mitoxantrone plus prednisone/prednisolone in patients with metastatic hormone-refractory prostate cancer whose disease progressed following treatment with docetaxel-based chemotherapy. A combination of cabazitaxel and prednisone/prednisolone significantly reduced the risk of death by 28% with an improvement in median overall survival of 15.1 months vs. 12.7 months in the mitoxantrone combination arm.
Jevtana®Jevtana® was launched in the United States in July 2010. Jevtana®Jevtana® therapy is now covered by CMS (Committee for Medicare and Medicaid Services), and by most of the private insurance companies that pay for oncology care. In addition, the safety profile seen in clinical practice has been consistent with that seen in the pivotal TROPIC study.
In March 2011, Jevtana®Jevtana® received marketing authorization from the European Commission andCommission. The product was launched during the second quarter of 2011 in Germany and France. Jevtana®the UK. Jevtana® is now approved in 5378 countries.
Sanofi has initiated a broad development program with Jevtana®Jevtana®. The clinical program is projected to evaluate Jevtana®Jevtana® in first- and second-line treatment of prostate cancer patients, second-line treatment of small-cell lung cancer patients, and pediatric patients with advanced gastricbrain cancer.
The top four countries contributing to sales of Jevtana®Jevtana® in 20112012 were the United States,U.S., Germany, BrazilItaly and France.Brazil.
Mozobil®
Mozobil® (plerixafor injection) is a hematopoietic stem cell mobilizer indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM).
The main countries contributing to Mozobil® sales in 2012 were the U.S., Germany, France, the U.K. and Italy.
Zaltrap®
Zaltrap® (aflibercept) is a recombinant fusion protein which acts as a soluble decoy receptor that binds to Vascular Endothelial Growth Factor-A (VEGF-A), VEGF-B and placental growth factor (PIGF), preventing the bound VEGF from binding to their native receptors. VEGF-A is one of the mediators contributing to angiogenesis. VEGF-B and PlGF, related growth factors in the VEGF family, may contribute to tumor angiogenesis as well. In the U.S., Zaltrap® is a registered trademark of Regeneron Pharmaceuticals, Inc.
In the U.S., Zaltrap® is approved under the U.S. proper name ziv-aflibercept for use in combination with FOLFIRI, in patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. Zaltrap® is marketed in the U.S. in August 2012.
In the European Union, Zaltrap® (aflibercept) was approved in February 2013 by the European Commission to treat metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing regimen.
The marketing of Zaltrap® is organized through our collaboration with Regeneron (see "Item 5 — Alliance Arrangements with Regeneron").
Concerning the development program for the treatment of metastatic prostate cancer, the Phase III VENICE trial (First-line treatment for androgen-independent (hormone-refractory) metastatic prostate cancer in combination
with docetaxel and prednisone) did not meet the pre-specified criterion of improvement in overall survival. The safety profile was generally consistent with previous studies of Zaltrap® in combination with docetaxel.
The oncology R&D pipeline includes a broad spectrum of novel agents with a variety of mechanisms of action for treating cancer, including cytotoxic agents, anti-mitotic agents, anti-angiogenic agents, targeted therapies and monoclonal anti-bodies (unconjugated or conjugated with cytotoxics). Projects are presented from the most advanced to the least advanced stage of development.
The main compounds currently in Phase II or III clinical development in the Oncology field are:
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BSI-201(iniparib SAR240550) (SAR240550; BSI-201) is an agent with novel mechanism of activity that is currently being studied in advanced squamous non-small cell lung cancer (Phase III)III, fully accrued) as well as ovarian and breast cancers (Phase II). While the initial dosing regimen was based on the putative PARP inhibitory activity, current efforts are aimed at elucidating the mechanism of action and exploring the maximal tolerated dose both as a single agent and in combination with chemotherapy.
Ombrabulin(AVE8062; combretastatin derivative, a new anti-vascular agent in-licensed from Ajinomoto; sarcoma; Phase III). Single agent and combination studies with platinums and taxanes alone or in combination have been conducted with ombrabulin. A Phase III study in soft tissue sarcoma in combination with cisplatin was initiated in 2008 and will terminate enrollment in 2012. Ombrabulin is also investigated in a Phase II trial in Non-Small-Cell Lung Cancer in combination with taxanes and platinum salts, which is over 90% enrolled and will report results in 2012, as well as in an ongoing Phase II trial in ovarian cancer.
SAR245408 (XL147) was in-licensed from Exelixis, Inc. and is being developed by Sanofi. This phosphoinositide-3-kinase (PI3K) inhibitor is under evaluation in a Phase II study of monotherapy for
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SAR256212 (MM-121).UnderUnder an exclusive global collaboration and licensing agreement, Merrimack Pharmaceuticals, Inc. and Sanofi are co-developing SAR256212, a fully human monoclonal antibody targeting ErbB3. ErbB3 has been identified as a key node in tumor growth and survival. SAR256212 blocks Heregulin binding to ErbB3, and formation of pErbB3 and pAKT. Given SAR256212’sSAR256212's mode of action, it has the potential to be used in a wide number of tumors and settings. SAR256212 is in Phase II stage of development (Breast,in Breast, Lung and Ovarian cancers), while a numbercancers in order to achieve Proof of combinations withConcept of its activity at reversing resistance to hormones, chemotherapy and targeted agents targeting EGFR. During 2012, over 450 patients were enrolled in this phase II program that will complete by the second half of 2013. Biopsies at study entry are being explored in the Phase I program.performed for all patients to identify biomarkers predictive of response to MM-121. A companion diagnostic tool will be developed during the clinical program.
In addition, a phase 1 combination ofSAR256212 and SAR245408 has been ongoing throughout 2012 in three U.S. sites, based on the rationale that dual blockade of the PI3K pathway prevents feedback loop for reactivating the pathway. The last dose escalation cohort at full dose of both drugs will start in January 2013; so far the safety of the 2 agents together is excellent with no DLTs reported.
Phase I trial of a novel combination with MSC1936369B (under collaboration with Merck Serono, a division of Merck KGaA, Darmstadt, Germany) is ongoing. Combinations with bendamustine and rituximab are also being evaluated. Development in metastatic hormone-receptor-positive breast cancer has been discontinued due to insufficient evidence of activity.
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In 2011, we conducted several additional collaborations with other companies, universitiesThree further projects (semuloparin, ombrabulin and institutes to investigate novel oncology agents (see “— Pharmaceutical Research & Development — Portfolio” below).
Collaborations with Regeneron
We and Regeneron globally collaborate on the development and commercialization of Zaltrap®. Under the terms of our September 2003 collaboration agreement, as amended, we and Regeneron will share co-promotion rights and profits on sales, if any, of Zaltrap® outside of Japan for disease indications included in our collaboration. In Japan, Sanofi will develop and commercialize Zaltrap®, with Regeneron entitled to a royalty payment. Under the terms of the agreement, Sanofi is responsible for funding 100% of the development costs of Zaltrap®. Once Zaltrap® starts to be marketed, Regeneron will repay 50% of the development costs (originally paid by Sanofi) in accordance with a formula based on Regeneron’s share of the profits. Sanofi may also be responsible for making milestone payments upon receipt of specified marketing approvals for Zaltrap® in the United States or the European Unionclofarabine) that were under regulatory review and in Japan.
In November 2007, Sanofi signed additional agreements with Regeneron to discover, develop and commercialize fully-human therapeutic antibodies. These agreements were broadened, and their term extended, on November 10, 2009. UnderPhase III respectively in 2012, have experienced the terms of the discovery agreement, Sanofi committed to fund the costs of Regeneron’s antibody research program until 2017. Sanofi has an option to license for further development those antibodies discovered by Regeneron which advance to IND. Upon exercise of the option, Sanofi is primarily responsible for funding the development and co-developing the antibody with Regeneron. Sanofi and Regeneron would also share co-promotion rights and profits on sales. Once a product begins to be marketed, Regeneron will repay out of its profits (provided they are sufficient) 50% of the development costs borne by Sanofi for all antibodies licensed by Sanofi. Sanofi may also be responsible for making milestone payments based upon aggregate sales of antibodies under the collaboration.following changes:
The acquisition of Genzyme in April 2011 brought to the Group specific expertise in rare diseases, a sector where there are still many unmet needs, and expanded Sanofi’s presence in the biotechnology sector.
Our Rare Disease business is focused on products for the treatment of rare genetic diseases and other chronic debilitating diseases, including lysosomal storage disorders, or LSDs, a group of metabolic disorders caused by enzyme deficiencies. Our principle rare disease products are enzyme replacement therapies: Cerezyme® (imiglucerase for injection) to treat Gaucher disease; Fabrazyme® (agalsidase beta) to treat Fabry disease and Myozyme® / Lumizyme® (alglucosidase alfa) to treat Pompe disease.
Cerezyme®
Cerezyme® (imiglucerase for injection) is an enzyme replacement therapy that is used to treat Gaucher disease, an inherited, potentially life-threatening LSD. It is estimated that there are approximately 10,000 Gaucher patients worldwide.
Cerezyme® is the only therapy with a 17-year history of reducing, relieving and reversing many of the symptoms and risks of Type 1 Gaucher disease. Cerezyme® is administered by intravenous infusion over 1-2 hours.
In June 2009, Genzyme interrupted production of Cerezyme® and Fabrazyme® at its Allston facility after identifying a virus in a bioreactor used for Cerezyme® production. Genzyme resumed Cerezyme® shipments in the fourth quarter of 2009. This interruption was followed by a second one in March 2010 resulting from a municipal electrical power failure that compounded issues with the facility’s water system.
Genzyme communicated at the end of 2011 that, given current productivity and progress in the manufacturing recovery, we expect an improving supply outlook as the year progresses. We have begun communicating with the U.S. Gaucher community to inform them that, beginning in February 2012, current patients in the U.S. can be returned to normal dosing. Genzyme will also begin the process of returning additional regions globally back to normal supply. This process will begin in the second quarter of 2012 and continue gradually through the remainder of the year, to ensure that a ramp-up can be sustained. Regions outside of the U.S. will be maintained at their current allocation of Cerezyme®, as Genzyme assesses the timing of the return of additional regions to full supply. No regional allocation will be decreased to accommodate the U.S. ramp-up. We continue to make Cerezyme® available to patients as it is produced. However, since we have minimal inventory, any change to our manufacturing plans can have an immediate impact on our ability to provide product.
The principal markets for Cerezyme® are the United States, Latin America and Europe.
Fabrazyme®
Fabrazyme® (agalsidase beta) is an enzyme replacement therapy that is used to treat Fabry disease, an inherited, progressive and potentially life-threatening LSD. Fabry disease is estimated to affect between 5,000 and 10,000 people worldwide. Fabrazyme® is administered by intravenous infusion.
Fabrazyme® is available in over 30 countries, including the United States and Europe, and has been used in hundreds of patients.
Due to Following the June 2009 production interruption and low manufacturing productivity upon re-start of production, Fabrazyme® shipments decreased in the fourth quarter of 2009 and Genzyme began shipping Fabrazyme® at a rate equal to 30% of estimated product demand. Throughout 2011, Genzyme has maintained consistent supply of Fabrazyme® to current patients at a reduced dose. To return to normal supply levels of Fabrazyme® for existing and new patients, it will be necessary to utilize the additional capacity from Genzyme’s new manufacturing facility in Framingham, Massachusetts, that was approved in January20, 2012 semuloparin data review by the FDA Oncologic Drugs Advisory Committee, and its vote against the approval of semuloparin for prophylactic prevention of venous thromboembolism (VTE) in cancer patients undergoing chemotherapy, as well as other comments released by some regulatory authorities, Sanofi has decided to withdraw all applications concerning semuloparin.
new patients in the U.S. onto Fabrazyme® at full dosing (1mg/kg) levels. Beginning of March, Genzyme started shipping Fabrazyme® from Framingham. Globally, the return to normal supply levels of Fabrazyme® is expected to begin in the second quarter of 2012 and continue throughout the year as planned, as Genzyme works to obtain all global regulatory approvals throughout the year and to build inventory.
The principal markets for Fabrazyme® are the United States and Europe.
Myozyme® / Lumizyme®
Myozyme®/ Lumizyme® (alglucosidase alfa) are enzyme replacement therapies used to treat Pompe disease, an inherited, progressive and often fatal LSD. We estimate that there are approximately 10,000 Pompe patients worldwide.
Myozyme® has been marketed since 2006 in the United States and the EU and is currently available in 48 markets worldwide. Lumizyme® is the first treatment approved in the United States specifically to treat patients with late-onset Pompe disease: Lumizyme® has been marketed since June 2010. Myozyme®and Lumizyme®are administered by intravenous infusion. Lumizyme® is used to treat Pompe disease in patients over 8 years of age without evidence of cardiac hypertrophy.
Both products are a recombinant formearly termination of the same human enzyme butphase II study in ovarian cancer based on the results of a pre-specified interim analysis. In all these trials there were no substantial safety concerns.
The main compounds currently in Phase II or III clinical development in the Rare Diseases field are:
Eliglustat tartrate— Substrate reduction therapy targeted for the treatment of Gaucher disease type 1. This product candidate is administered orally in capsule form and has the potential to transform the treatment experience of patients by providing a treatment alternative to bi-weekly infusions. The first three years of data from the Phase II trial of eliglustat tartrate showed clinically significant improvements in hematological, visceral and bone disease parameters in the range expected for enzyme replacement therapy. During 2011, the two pivotal Phase III registration studies completed enrollment and the third Phase III study closed screening. Its recruitment should be completed in 2012.
Other FlagshipPrescription Products
Lovenox®/Clexane®
Lovenox®/Clexane®
Lovenox®Lovenox® (enoxaparin sodium) is available in over 100 countries, itcountries. It has been used to treat over 350 million patients since its launch.
Lovenox®Lovenox® has the broadest range of indications amongst low molecular weight heparins (LMWH). A comprehensive clinical development plan has demonstrated the efficacy and safety of Lovenox®Lovenox® in the prevention and treatment of venous thrombo-embolism (VTE) and in the management of the full spectrum of acute coronary syndromes (ACS).
In VTE management, Lovenox®Lovenox® is continuing to grow as a treatment for the prevention of VTE, mainly in acutely ill patients not undergoing surgery.
In 2008, new oral anticoagulants were launched for the prevention of VTE in orthopedic surgery and were approved in 2011 for stroke prevention in patients with atrial fibrillation, with the objective to replace vitamin K antagonists (e.g. warfarin). However, the impact has been limited on Lovenox® usage as prevention of VTE in orthopedic surgery is a small segment of Lovenox® usage and as stroke prevention in atrial fibrillation is not a Lovenox® approved indication.
In VTE prophylaxis in acutely ill medical patients, a major market segment for Lovenox®, two large clinical trials have compared new oral anti-coagulants to Lovenox®: extended prophylaxis using new oral anti-coagulants has not shown added benefit compared to short term prophylaxis using Lovenox®.
CompetingTwo competing generics of enoxaparin were launched respectively in July 2010 and in February 2012are available in the U.S. No biosimilar has been approved in the European Union. An authorized generic is available in the U.S..U.S. See “Item"Item 5. Operating and Financial Review and Prospects — Impacts from generic competition”competition".
In 2011, Lovenox®2012, Lovenox® was the leading anti-thrombotic in Germany, France, Italy, Spain, and the United Kingdom (source: IMS 20112012 sales).
Plavix®/Iscover®
Plavix®/Iscover®
Plavix®Plavix® (clopidogrel bisulfate), a platelet adenosine diphosphate (ADP) receptor antagonist with a rapid onset of action that selectively inhibits platelet aggregation induced by ADP, is indicated for long-term prevention of
atherothrombotic events in patients with a history of recent myocardial infarction, recent ischemic stroke or established peripheral arterial disease. Plavix®Plavix® is indicated for the secondary prevention of atherothrombosis regardless of the location of the arteries initially affected (heart, brain, lower limbs). This indication is supported by the results of the landmark CAPRIE trial, including almost 20,000 patients. CAPRIE demonstrated the superior efficacy of Plavix® over acetylsalicylic acid (ASA, the active ingredient of Aspirin®), with a comparable safety profile.
Following the significant results of several clinical trials, involving a total of almost 62,000 patients, Plavix®Plavix® is now also indicated for the treatment of acute coronary syndrome (ACS) with and without ST segment elevation in combination with ASA.
Plavix®Plavix® is also available in a 300 mg tablet that reinforces early use by simplifying its approved loading dose administration in patients with ACS.
In January 2011, on the basis of the ACTIVE A study results (7,554 patients), the EMA granted marketing authorization for Plavix®Plavix® in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke, in patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA), and have a low bleeding risk.
A Phase III mortality and shunt-related morbidity study in infants palliated with a systemic to pulmonary artery shunt was completed in 2010. Even though results did not support an indication in such infants, the FDA granted Sanofi an additional six month period of exclusivity to market Plavix® (clopidogrel bisulfate). Exclusivity for Plavix® in the U.S. is now scheduled to expire on May 17, 2012.
To further characterize patient responsiveness to Plavix® and provide the best guidance to healthcare professionals, a clinical program designed in close collaboration with the FDA has been completed by Sanofi and Bristol-Myers Squibb (BMS). Based on this program the label was updated worldwide in 2010, including new results on the pharmacological interaction of omeprazole with Plavix® and recent pharmaco-genomics data which have shown genomic variability of the response to Plavix® treatment (diminished effectiveness in poor metabolizers). This has been highlighted in the U.S. label with a boxed warning.
The extensive clinical development program for Plavix®, including all completed, ongoing and planned studies, is among the largest of its kind, involving more than 130,000 patients overall. Plavix® indications are incorporated into major scientific guidelines in North America, Europe and Japan. Over 115 million patients are estimated to have been treated with Plavix® since its launch in 1998, providing significant evidence of real-life efficacy and safety experience with this product.
CoPlavix®CoPlavix® / DuoPlavin®DuoPlavin®, a fixed dose combination of clopidogrel bisulfate and acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome who are already taking both clopidogrel and ASA. The combination has already been launched in several countries (including Australia, Germany, the Netherlands, Ireland, Spain, and Mexico).
The marketing of Plavix®Plavix® / CoPlavix®CoPlavix® / DuoPlavin®DuoPlavin® is organized through our alliance with BMS which was restructured in 2012 with effect on January 1, 2013 (see “—"Item 5 — Alliance Arrangements with BMS” below)Bristol-Myers Squibb"). Sales of Plavix®Plavix® in Japan are consolidated by Sanofi and are outside the scope of our alliance with BMS. Exclusivity for Plavix® in the U.S. expired on May 17, 2012 and a number of generics have been launched. Previously, generics had also been launched in Europe.
Plavix®Plavix® is the leading anti-platelet in the U.S., Chinese and Japanese markets (source: IMS 20112012 sales). In Europe, a number of generics have received marketing authorization and have been launched. Plavix
® marketAprovel®/Avapro® /Karvea®
share(1) by value was 29.1% in Western Europe and 27.2% in Germany (source: IMS 2011 sales). In Canada, generics were launched in December 2011. Plavix® U.S. market exclusivity is expected to be maintained through May 2012.
Aprovel®/Avapro® /Karvea®
Aprovel®Aprovel® (irbesartan) is an anti-hypertensive belonging to the class of angiotensin II receptor antagonists. These highly effective and well tolerated antagonists act by blocking the effect of angiotensin II, the hormone responsible for blood vessel contraction, thereby enabling blood pressure to return to normal. In addition to Aprovel®Aprovel®/Avapro®Avapro®/Karvea®Karvea®, we also market CoAprovel®CoAprovel®/Avalide®Avalide®/Karvezide®Karvezide®, a fixed dose combination of irbesartan and hydrochlorothiazide (HCTZ), a diuretic that increases the excretion of water and sodium by the kidneys and provides an additional blood pressure lowering effect. These products achieve control of blood pressure in over 80% of patients, with a very good safety profile.
Aprovel®Aprovel® and CoAprovel®CoAprovel® tablets are available in a wide range of dosages to fit the needs of patients with different levels of hypertension severity.
Aprovel®Aprovel® is indicated as a first-line treatment for hypertension and for the treatment of nephropathy in hypertensive patients with type 2 diabetes. CoAprovel®CoAprovel® is indicated in patients whose blood pressure is not adequately controlled with a monotherapy, but also as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals (in the United States only).
Aprovel®Aprovel® and CoAprovel®CoAprovel® are marketed in more than 80 countries. The marketing of Aprovel®Aprovel® and CoAprovel®CoAprovel® is organized through an alliance with BMS which was restructured in 2012 (see “—"Item 5 — Alliance Arrangements with BMS”Bristol-Myers Squibb" below). In Japan, the product is licensed/sub-licensed to Shionogi Co. Ltd and Dainippon Sumitomo Pharma Co. Ltd, respectively. Aprovel®Aprovel® U.S. market exclusivity is expected to be maintained throughexpired in March 2012.2012 and a number of generic versions have been launched.
Multaq®
Alliance with Bristol-Myers Squibb (BMS)
Plavix® and Aprovel® are marketed through a series of alliances with BMS. The alliance agreements include marketing and financial arrangements that vary depending on the country in which the products are marketed.
Three principal marketing arrangements are used in the BMS alliance:
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Under the alliance arrangements, there are two territories, one under our operational management and the other under the operational management of BMS. The territory under our operational management consists of Europe and most of Africa and Asia, while the territory under the operational management of BMS consists of the rest of the world excluding Japan. In Japan, Aprovel® has been marketed jointly by Shionogi Pharmaceuticals and Dainippon Sumitomo Pharma Co. Ltd since June 2008. The BMS alliance does not cover rights to Plavix® in Japan; sales of Plavix® in Japan are consolidated by Sanofi.
In the territory under our operational management, the marketing arrangements are as follows:
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In the territory under BMS operational management, the marketing arrangements are as follows:
we use the co-promotion system in the United States and Canada, where the products are sold through the alliances under the operational management of BMS;
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we have the exclusive right to market the products in certain other countries of Latin America.
In countries where the products are marketed by BMS on a co-marketing basis, or through alliances under the operational management of BMS, we often sell the active ingredients for the products to BMS or associated entities.
The financial impact of our principal alliances on our financial position and income is significant, and is described under “Item 5. Operating and Financial Review and Prospects — Financial Presentation of Alliances”; see also “Item 3. Key Information — D. Risk Factors — Risks Relating to Our Business — We rely on third parties for the marketing of some of our products” for more information relating to risks in connection with our alliance agreements.
Multaq®
Multaq®Multaq® (dronedarone) is the most extensively studied anti-arrhythmic drug (AAD) in Atrial Fibrillation (AF) and has demonstrated a unique cardiovascular (CV) outcome benefit in the ATHENA study in addition to effective rhythm control in the EURIDIS and ADONIS studies.
Multaq®Multaq® is a multichannel blocker with both rhythm (prevention of atrial fibrillation recurrences) and rate (decrease of ventricular rate) controlling properties and additional effects (anti-hypertensive, vasodilatory). It is the first and only anti-arrhythmic drug to have shown a significant reduction in cardiovascular hospitalization and death in patients with paroxysmal and persistent Atrial Fibrillation/Atrial Flutter as seen in the ATHENA study..
The landmark ATHENA trial is the only double-blind anti-arrhythmic study in patients with AF to have assessed morbidity-mortality. The study enrolled a total of 4,628 patients. In this trial, the efficacy and safety of Multaq® was evaluated in patients with AF/AFL or a recent history of these conditions. Multaq® 400mg twice a day, in addition to standard therapy, was shown to significantly reduce the risk of first cardiovascular hospitalization or death by 24% (p<0.001) when compared to placebo, meeting the study’s primary endpoint. In a secondary analysis of the ATHENA trial, Multaq® significantly reduced the total number of hospital days versus placebo.
Following reports in January 2011 of hepatocellular liver injury and hepatic failure in patients receiving Multaq®Multaq®, including two post-marketing reports of acute hepatic failure requiring transplantation, Sanofi has collaborated with health authorities agencies to update prescribing information and include liver function monitoring. In Europe, EMA has thenSanofi coordinated a review of all available data concerning the possible risks of liver injury associated with the use of Multaq® and their impact on its benefit-risk balance. The review was extended to include cardiovascular safety of Multaq® following premature terminationimplementation of the PALLAS study (Permanent Atrial fibriLLAtion outcome Study) in July 2011.updated label by disseminating proactively relevant educational materials to prescribers.
The PALLAS study, using dronedarone on top of standard therapy, was a randomized, double-blind, parallel-group, placebo-controlled study comparing the efficacy of dronedarone 400 mg twice-daily to placebo in patients with permanent AF, a population different from the population with non-permanent AF for which Multaq® is currently approved. The study was discontinued in July 2011 following recommendation from the study’s Operations Committee and the Data Monitoring Committee which observed a significant increase in cardiovascular events in the dronedarone arm. The decision to terminate the study was not related to any hepatic adverse event.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed in September 2011 that the benefits of Multaq®Multaq® continue to outweigh the risks with a revised indication for the treatment of a limited, newly defined population of paroxysmal and persistent Atrial Fibrillation patients. Multaq®population: Multaq® is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation. Due to its safety profile, Multaq®Multaq® should only be prescribed after alternative treatment options have been considered and should not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.
The FDA approved a label update in December 2011 to ensure its use in the appropriate patient population, specifically in patients in sinus rhythm with history of paroxysmal or persistent atrial fibrillation (AF), and also reinforcing warnings and precautions for use.
Multaq® hasIn Europe, updated guidelines were issued by the European Society of Cardiology (ESC) confirming Multaq®'s crucial role in the AF treatment armamentarium as a convenient fixed dose regimenfirst line option in a broad range of twice daily 400 mg tabletspatients. Multaq® is the only recommended first line AAD for AF patients with hypertensive heart disease and left ventricular hypertrophy. Multaq® is still the only AAD recommended in non-permanent AF with CV risk factors to be taken with morning and evening meals. Treatment with Multaq® does not require a loading dose and it can be initiated in an outpatient setting.reduce CV hospitalization.
Multaq® has been launchedThe main countries contributing to Multaq® sales in 39 countries. The three leading countries for sales of Multaq® in 20112012 were the United States,U.S., Germany and Spain.Italy.
Renagel® and Renvela®
Renagel® and Renvela®
Renagel®Renagel® (sevelamer hydrochloride) and Renvela®Renvela® (sevelamer carbonate) are oral phosphate binders used by chronic kidney disease (CKD) patients on dialysis as well as late-stage CKD patients in Europe to treat a condition called hyperphosphatemia, or elevated phosphorus levels, which is associated with heart and bone disease. Renvela®Renvela® is a second generation, buffered phosphate binder.
In the United States, there are an estimated 395,000 dialysis patients, approximately 90% of whom receive a phosphate binder. There are an estimated 350,000 dialysis patients in the EU and 65,000 in Brazil. In the EU, Renvela®Renvela® is also approved to treat CKD patients not on dialysis but who have very high blood phosphorus levels.dialysis.
The principal markets for Renagel® are the United States, the EU and Brazil. The principal markets for Renvela®, which was first marketed in 2008, are the United States and the EU (launched in 2010). In 2011, new launches took place in Singapore, Malaysia, Thailand, Israel, Columbia, Panama and Switzerland.
We market Renagel®Renagel® and Renvela®Renvela® directly to nephrologists through Genzyme’sSanofi's employee sales force and distribute these products through wholesalers and distributors. In Japan and several Pacific Rim countries, Renagel®Renagel® is developed and marketed by Chugai Pharmaceutical Co., Ltd and its sublicensee, Kyowa Hakko Kirin Co., Ltd.
In the United States, Genzyme and generic manufacturers have settled pending litigation with regard to the production and sale of generic formulations of Renvela® tablets, Renvela® for oral suspension and Renagel®. According to the terms of the settlements, the first-filer for each product can enter the U.S. market on March 16, 2014 and second-filers can enter the market on September 16, 2014, or earlier under certain circumstances, pending approval of their generic application.
The top five countries contributing to the sales of our Renal portfolioRenagel® and Renvela® in 20112012 were the U.S., Italy, France, the UK, and Brazil.
Synvisc®/Synvisc-One®
Synvisc®/Synvisc-One®
Synvisc®Synvisc® and Synvisc-One®Synvisc-One® (hylan G-F 20) are viscosupplements used to treat pain associated with osteoarthritis of certain joints. Synvisc® is a triple-injection product and Synvisc-One® is our next-generation, single-injection product. The principal viscosupplementation market isindicated for the treatment of pain associated with osteoarthritis of the knee.
The principal marketsknee, hip, ankle, and shoulder joint in countries that have adopted CE marking, and for Synvisc® are the U.S., the EU, and Japan (where launch took placepain due to knee osteoarthritis in December 2010). The principal markets for Synvisc-One® are the United StatesStates. Currently the main viscosupplementation market is for the treatment of pain associated with osteoarthritis of the knee.
Synvisc® is a triple-injection product and Synvisc-One® a single-injection product. Both are administered directly into the EU, markets in which Synvisc-One® was first approved in 2009 and 2007, respectively.intra-articular space of the joint to temporarily restore osteoarthritis synovial fluid.
We market Synvisc®Synvisc® and Synvisc-One®Synvisc-One® are primarily marketed through Genzyme’sSanofi's employee sales force directly to physicians, hospitals, and pharmacies. We distribute thesepharmacies, while in some countries the products directly and throughare still promoted by independent distributors.
In Japan, Synvisc®2012, Sanofi initiated a pivotal clinical trial of Synvisc-One® for treatment of pain associated with mild to moderate primary osteoarthritis of the hip. The trial is marketed and distributed by Teijin Pharma Limited.
The In 2012, the top five countries contributing to Synvisc®Synvisc® and Synvisc-One®Synvisc-One® sales in 2011 were the U.S., Japan, Canada, France, Mexico and Germany.
LeGoo®
At the end of 2012, Sanofi launched LeGoo®, a gel for temporary endovascular occlusion of blood vessels during surgical procedures in the U.S. LeGoo® is an innovative technology that is expected to enhance the Sanofi Biosurgery portfolio.
Other pharmaceutical productsStilnox®/Ambien® /Myslee®
Stilnox®/Ambien® /Myslee®
Stilnox®Stilnox® (zolpidem tartrate) is indicated in the short-term treatment of insomnia. Stilnox®Stilnox® rapidly induces sleep that is qualitatively close to natural sleep and devoid of certain side effects that are characteristic of the benzodiazepine class as a whole. Its action lasts for a minimum of six hours, and it is generally well tolerated, allowing the patient to awaken with a reduced risk of impaired attention, decreased alertness or memory lapses throughout the day.
We have developed a controlled release formulation of zolpidem tartrate, marketed only in the United States under the brand name Ambien® CR.
Stilnox®Stilnox® is marketed in over 100 countries. It was launched in Japanis available under the brand name Myslee®Ambien® / Ambien®CR in December 2000. Myslee® has beenthe United States and Myslee® in Japan, where it is co-promoted jointly with Astellas since 2006. Myslee® is the leading hypnoticAstellas.
Stilnox® and Ambien CR® are subject to generic competition in Japan (source: IMS 2011).
Generic zolpidem tartrate has been available in Europe since 2004. Inmost markets, including the United States and Europe. In Japan, generics of the immediate release formulation of Ambien® have been available since 2007. Ambien® CR genericsMyslee® entered the U.S. market in October 2010. In Japan, competing generics of Myslee® are likely to enter the market in June 2012.
Allegra®/Telfast®
Allegra®/Telfast®
Allegra®Allegra® (fexofenadine hydrochloride) is a long-lasting (12- and 24-hour) non-sedating prescription anti-histamine for the treatment of seasonal allergic rhinitis (hay fever) and for the treatment of uncomplicated hives. It offers patients significant relief from allergy symptoms without causing drowsiness.
We also market Allegra-D®Allegra-D® 12 Hour and Allegra-D®Allegra-D® 24 Hour, anti-histamine/decongestant combination products with an extended-release decongestant for effective non-drowsy relief of seasonal allergy symptoms, including nasal congestion. Generics of most forms of Allegra®Allegra®/Tefast®Tefast® have been approved in our major markets, withmarkets.
In the notable exception of Japan.
In March 2011, inUnited States, the U.S., Allegra®Allegra® family moved to over-the-counter (OTC) use in adults and children two years of age and older in 2011. Allegra® was also launched on the OTC market in Japan in November 2012, though it also remains available on prescription (see “—"— Consumer Health Care”Care" below).
Allegra®Allegra®/Telfast®Telfast® is marketed in approximately 80 countries. The largest market for prescriptions of Allegra®Allegra® is Japan. In Japan, where competing generics of Allegra® may possibly enterentered the market in the second half of 2012 if the generic manufacturers get marketing approvals. Sanofi appealed at the IP High Court to defend two Allegra® use patents following their invalidation by the patent officeearly 2013 (for more information see Item"Item 8 “FinancialFinancial Information — A. Consolidated Financial Statements and Other Financial Information — Information on Legal or Arbitration Proceedings”Proceedings").
Depakine®
Copaxone®
Copaxone® (glatiramer acetate) is a non-interferon immunomodulating agent indicated for reducing the frequency of relapses in patients with relapsing-remitting multiple sclerosis. Copaxone® is available as a self-injectable pre-filled syringe storable at room temperature for up to one month.
This disease-modifying drug is characterized by an original and specific mode of action on multiple sclerosis. Clinical studies have shown that Copaxone® is more effective than placebo at two years, but also that it has a clinical efficacy over 15 years both in reducing relapses and progression of disability. A significant effect on lesions has also been confirmed by nuclear magnetic resonance imaging.
In 2009, the U.K. Medicine and Healthcare Regulatory Agency (MHRA) approved an expanded label for Copaxone® to include the treatment of patients with clinically isolated syndrome suggestive of multiple sclerosis.
We have marketed Copaxone® outside the United States and Canada through our alliance with Teva. As of February 29, 2012 we no longer market or sell Copaxone®: on a country-by-country basis, we instead receive a payment of 6% on sales from Teva for a period of two years from the date of transfer (see “— Alliance with Teva” below).
Alliance with Teva
We in-licensed Copaxone® from Teva and marketed it until 2012 through an agreement with Teva, which was originally entered into in 1995, and has been amended several times, most recently in 2005.
Under the agreement with Teva, marketing and financial arrangements vary depending on the country in which the products are marketed.
Sales and distribution rights were returned to Teva in 2008 for the United States and Canada.
Outside the United States and Canada, there were two principal marketing arrangements:
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Under the terms of our agreement, the Copaxone® business has been transferred to Teva over a period running from the third quarter of 2009 to February 29, 2012 depending on the country. Following the transfer, Sanofi will receive from Teva a royalty of 6% for a period of two years, on a country-by-country basis. In September 2009, the Copaxone® business was transferred to Teva in Switzerland and Lichtenstein. In 2010, the Copaxone® business was transferred to Teva in Poland, in the Czech Republic and in the United Kingdom. In 2011, the Copaxone® business was transferred to Teva in Norway, Germany, Austria, Portugal, and Sweden. In January and February 2012 the Copaxone® business was transferred to Teva in Denmark, the Netherlands, Belgium, France, Greece, Cyprus, Ireland, Italy, Spain, Australia, and New Zealand.
Tritace®/Triatec® /Delix®/Altace®
Tritace® (ramipril) is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, congestive heart failure following or in the absence of acute myocardial infarction, and nephropathy. Tritace® is the only ACE inhibitor approved for the prevention of stroke, myocardial infarction and death in high-risk patients and has the broadest spectrum of indications among ACE inhibitors for the treatment of cardiovascular diseases.
The combinations with diuretics (ramipril + hydrochlorothiazide) and calcium channel blockers (ramipril + felodipine) are available in Europe.
Tritace® is marketed in over 70 countries. A number of generics have received marketing authorization and have been launched since December 2001 in Europe.
Depakine®
Depakine®Depakine® (sodium valproate) is a broad-spectrum anti-epileptic that has been prescribed for more than 40 years. Numerous clinical trials and long years of experience have shown that it is effective for all types of epileptic seizures and epileptic syndromes, and is generally well tolerated. Consequently, Depakine®Depakine® remains a reference treatment for epilepsy worldwide.
Depakine®Depakine® is also a mood stabilizer, registered in the treatment of manic episodes associated with bipolar disorder and, in numerous countries, in the prevention of mood episodes. Depakine® is recommended as a first
line treatment in these indications by international guidelines such as the guidelines of the World Federation of Societies of Biological Psychiatry Guidelines 2009, the Canadian Network for Mood and Anxiety Treatments 2009, and the British Association for Psychopharmacology 2009.
We provide a wide range of formulations of Depakine®Depakine® enabling it to be adapted to most types of patients: syrup, oral solution, injection, enteric-coated tablets, Depakine®Depakine® Chrono (a sustained release formulation in tablets) and Depakine®Depakine® Chronosphere (sustained release formulation of Depakine®Depakine® packaged in stick packs, facilitating its use by children, the elderly and adults with difficulties swallowing).
Depakine®Depakine® is marketed in over 100 countries.
Xatral®/Uroxatral®
Xatral® (alfuzosin hydrochloride) belongs to the class of alpha1-blockers. Capable of acting selectively on the lower urinary tract, it was the first alpha1-blocker indicated and marketed exclusively for the treatment of symptoms of benign prostatic hyperplasia (BPH). It is also the only alpha1-blocker indicated as an adjunctive therapy with catheterization for acute urinary retention, a painful and distressing complication of BPH.
Xatral® OD (extended release formulation) is active from the first dose, provides rapid and lasting symptom relief, and improves patient quality of life. Xatral® is the only alpha1-blocker showing no deleterious effect on ejaculation, as shown by the final results of the international ALF-LIFE trial. The once-daily formulation of Xatral® (branded Uroxatral® in the United States) has been registered in over 90 countries, and is marketed worldwide, withgenerally subject to generic competition.
Auvi-Q™
At the exceptionend of Australia and Japan.
Generic alfuzosin became available in most European countries in 2009. Generics of the extended release formulation of alfuzosin became availableJanuary 2013, Sanofi launched Auvi-Q™ (epinephrine injection, USP) in the U.S. in July 2011.
Actonel®/Optinate® /Acrel®
Actonel® (risedronate sodium) belongs to the bisphosphonate class that helps prevent osteoporotic fractures.
Actonel®Auvi-Q™ is the only osteoporosis treatment that reduces the risk of both vertebralfirst-and-only epinephrine auto-injector with audio and non-vertebral fractures in as little as six months. Actonel® also provides reduced risk of fracture at all key osteoporotic sites: vertebral, hip and non-vertebral sites, studied as a composite endpoint (hip, wrist, humerus, clavicle, leg and pelvis).
Actonel® is available in various dosage strengths and combination forms to better suit patient needs. Depending on dosage form, Actonel® is indicatedvisual cues for the emergency treatment of post-menopausal osteoporosis, osteoporosislife-threatening allergic reactions in men,people who are at risk for or Paget’s disease.have a history of anaphylaxis. Up to six million Americans may be at risk for anaphylaxis, although the precise incidence is unknown and likely underreported.
Actonel® is marketed in more than 75 countries through an alliance with Warner Chilcott “see Note C.2Sanofi US licensed the North American commercialization rights to our consolidated financial statements included at Item 18 of this annual report”.
The contribution of this alliance on our financial position and income is described under “Item 5. Operating and Financial Review and Prospects — Financial Presentation of Alliances”. See “Item 3. Key Information — D. Risk Factors — Risks Relating to Our Business — We rely on third parties for the marketing of some of our products” for more information relating to risk in connection with our alliance agreements.
Nasacort®
Nasacort®AQ Spray (NAQ) (triamcinolone acetonide) is an unscented, water-based metered-dose pump spray formulation unit containing a microcrystalline suspension of triamcinolone acetonide in an aqueous medium. Previously indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children six years of age and older, Nasacort® AQ received an additional approval for the seasonal and annual treatment of pediatric patients between the ages of two and five yearsAuvi-Q™ from the FDA in September 2008. NAQ is an intranasal corticosteroid, which is recommended in treatment guidelines as first-line treatment for moderate to severe allergic rhinitis patients.Intelliject,Inc.
Following a settlement of patent litigation, a competing generic triamcinolone acetonide has been sold in the United States since June 2011.
Main compounds currently in Phase II or III clinical development:
In the Multiple SclerosisMetabolic field:
A large phase III clinical program has been submitted in August 2011 in the U.S.initiated (11 trials, 22,000 patients), and in January 2012 in Europe for the treatment of relapsing forms of multiple sclerosis as a monotherapy agent. Results of the first pivotal study, indicating thatresults are expected during the product had an effect on disease activity in termsthird quarter of relapse rate, disability progression and brain lesions with a favorable safety profile, were published in the NEJM in October 2011. In addition, a Phase III adjunctive therapy study (TERACLES) has been launched to define the additional efficacy and safety profile of teriflunomide, when added to background stable therapy with interferon (IFN-beta). This study follows on from the successful Phase II study which showed teriflunomide had an acceptable tolerability in adjunct to IFN-beta and demonstrated significant improvements of the disease as measured by magnetic resonance imaging (MRI).2013.
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In the context of a business combination prior to the Sanofi takeover, Genzyme acquired in May 2009, from Bayer Schering Pharma A.G (Bayer), development rights and world marketing rights for alemtuzumab. Genzyme also acquired the rights for the products Fludara® and Leukine®. Alemtuzumab is already approved in oncology as the product Campath® (also acquired from Bayer). In exchange, Bayer was granted the right to co-promote Lemtrada™ on a global basis, as well as the right to receive contingent payments (for more information See Note D.1.1. to our consolidated financial statements included in this annual report at Item 18). In connection with the acquisition of Genzyme, Sanofi issued contingent value rights (“CVR”) entitling holders to cash payments upon the achievement of certain milestones, including regulatory approval of alemtuzumab for treatment of multiple sclerosis and on achievements of certain aggregate sales thresholds (see “Item 10. Additional Information — C. Material contracts — The Contingent Value Rights Agreement.”)
In the Ophthalmology field:
Sanofi acquiredstarted establishing its footprint in ophthalmology through the acquisition of Fovea, a French ophthalmology specialist Fovea(in October 2009), the ophthalmology assets of Genzyme (acquired in 2011), and a collaboration agreement with Oxford BioMedica (April 2009) that led to the exercise of two opt-in options in August 2012.
One project in Phase II (FOV2304 — eye-drop formulation of a bradykinin B1 receptor antagonist evaluated in diabetic macular edema) was discontinued in October 2009. Products in2012, and the pipeline include:
Areview of Phase II eye-dropIIb results forFOV-1101 (eye-drop fixed dose combination of prednisolone acetate and cyclosporine A for the treatment of allergic conjunctivitis (FOV1101);conjunctivitis) led to a reassessment of the commercial prospects for this compound and a decision to continue development under a sublicense agreement with an as yet unidentified third party.
A Phase II eye-drop formulation of a bradykinin B1 receptor antagonist for the treatment of diabetic macular edema (FOV2304);
FOV2302 was halted in December 2011 for toxicity reasons.
Oxford BioMedica entered into collaboration with Sanofi in April 2009 to develop novel gene-based medicines, utilizing LentiVector® gene delivery technology, for the treatment of ocular disease. The agreement covers four LentiVector®-based product candidates for different ophthalmologic indications such as wet age-related macular degeneration, Stargardt disease, Usher syndrome, and corneal graft rejection.
In the Thrombosis and Cardiovascular field:
Celivarone (anti-arrhythmic; Phase IIb): project terminated because of lack of efficacy (prevention of shocks and major clinical outcomes) in the Phase II study in patients fitted with an implantable cardioverter/defibrillator.2nd quarter of 2013.
In the Internal Medicine field:
Additional studies in the SARIL-RA phase III clinical program are to be implemented in 2013.
Mipomersen(Genzyme)Antisense oligonucleotide (ASO) that inhibits the synthesis of apoB, a primary protein constituent of atherogenic lipoproteins. In collaboration with Isis Pharmaceuticals Inc. mipomersen is currently being developed forin two indications. Dupilumab modulates signaling of both IL-4 and IL-13 pathways. Asthma will enter Phase IIb in 2Q2013. The asthma PoC study results demonstrated broader efficacy (exacerbations, lung function and symptoms) than the treatmentcompetition. Atopic dermatitis will also enter Phase IIb in 2Q2013. The atopic dermatitis PoC study results demonstrated improvement in signs and symptoms of patientsactive disease, with homozygous familial hypercholesterolemia (HoFH)very effective and severe heterozygous FH (HeFH). FH is a genetic disorder that causes chronic and lifelong exposurerapid onset of action compared to markedly elevated concentrations and numbers of atherogenic, apoB-containing lipoproteins (LDL, Lp(a)) leading to premature and severe cardiovascular disease. The marketing authorization application (MAA) for mipomersen was submittedsystemic therapies currently used in the third quarter of 2011 in Europe.AD.
Consumer Health Care (CHC)
Consumer Health Care is a core growth platform identified in our broader strategy for achieving sustainable growth.strategy. In 2011,2012, we recorded CHC sales of €2,666 million; nearly€3,008 million, an increase of 9.9%. Nearly half of our CHC sales were in emerging markets, 24%22% in Europe, and 21% in the United States.
In March 2011, the Allegra®Allegra® family of allergy medication products was commercially launched in the U.S. for over-the-counter (OTC) use in adults and children two years of age and older. The Allegra®Allegra® family of OTC products is available in drug, grocery, mass merchandiser, and club stores nationwide. This switch constitutes a key stepIn November 2012, Sanofi launched Allegra® OTC in our CHC growth strategy in the U.S. The Allegra® family of OTC products is the number one OTC brandJapan, for Sanofi globally.patients suffering allergic rhinitis (15 years and older).
2011 CHC sales wereare also supported by our legacy CHC brands, which providesprovide us with a strong presence in the fever & pain and digestive health areas.
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Complementary to our legacy CHC business, our other products include:
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Oenobiol’sinclude Gold Bond®, Icy Hot®, ACT®, Cortizone-10®, Selsun Blue® and Unisom®. In January 2013, Chattem completed the acquisition of the worldwide rights to the Rolaids® brand from McNeil Consumer Healthcare Division of McNeil-PPC, Inc. Rolaids® is an over-the-counter antacid that helps relieve heartburn and acid indigestion.
Minsheng products in China, includeincluding 21 Super Vita,Vita®, one of the leading vitamins & mineral supplements.
In August 2011, we entered into a definitive agreement to acquire the Indian domestic branded formulations business of
The top three countries contributing to our CHC sales in 20112012 were the United States, France, and Russia.
Generics
In 2011,2012, sales of the generics business grewreached €1,844 million, an increase of 5.0%. Performance was impacted by 16.2% to €1,746 million led bylower sales of the authorized generic of Lovenox® in Emerging Marketsthe U.S. and less favorable market conditions in Brazil (heightened competition coupled with once-off tax changes in Sao Paulo State which influenced the generics market).
In Latin America, Medley®, Sanofi's Brazilian brand of affordable medicines, was rolled out in Mexico and Venezuela at end of 2011 and in Colombia and Central America during 2012. In October 2012, Sanofi announced that it had signed an agreement to acquire Genfar S.A., a leading pharmaceuticals manufacturer headquartered in
Bogota, Colombia, and a major player in Colombia and the United States. U.S. generic business growth was driven by sales of recent launches of authorized generics of Taxotere®, Ambien® CR and Lovenox®. Authorized generic of Taxotere® launched in March 2011 has captured more than 10% of docetaxel generics (source: IMS December 2011). Sales in Emerging Markets were supported by the roll out of Medley products in additionalother countries in Latin America. The closing of the transaction is subject to certain conditions precedent and is expected to occur in the first quarter of 2013.
In 2011,2012, Sanofi sales of generic products in Emerging Markets exceeded €1 billion. See “Item"Item 5. Operating and Financial Review and Prospects — Results of Operations — Year Ended December 31 2011st, 2012 Compared with Year Ended December 31 2010st, 2011 — Net Sales by Product — Pharmaceuticals”Pharmaceuticals segment".
In March 2009 we created our European Generics Platform, covering generics activities across Western and Eastern Europe, Russia and Turkey. In 2010, we decided to rebrand all our European generics businessesThe rebranding of Sanofi Generics activities under the Zentiva name. This means that the generics businesses of Winthrop and HelvepharmZentiva® brand in France, Germany, Italy, Switzerland, Portugal and the United Kingdom now operate under the Zentiva brand. The roll out will continueWestern Europe, initiated in 2012 in the EU countries where Zentiva operates.2010, is nearly complete.
In Japan in 2011 we established a new joint venture, Sanofi Nichi-Iko K.K., to develop a strong presence in the fast-growing Japanese generics market: we started co-promotion for two molecules (edaravone in August 2011 and donepezil in October 2011). Scope of products to be co-promoted should be expanded in the future.
Vaccine Products
Sanofi Pasteur is a fully integrated vaccines division offering a broad range of vaccines. In 2011,2012, Sanofi Pasteur provided more than 1 billion doses of vaccine, making it possible to immunize more than 500 million people across the globe against 20 serious diseases, and generated net sales of €3,469€3,897 million. Sales were favorably impacted by strong growth in markets outside North America and Europe, including sales of the IPV (inactivated polio vaccine) Imovax® Polio in Japan, continued growth of Pentaxim®Pentaxim® sales and successful seasonal influenza vaccine campaigns in both the Northern and Southern hemispheres. See “Item"Item 5. Operating and Financial Review and Prospects — Results of Operations — Year Ended December 31, 20112012 Compared with Year Ended December 31, 20102011 — Net Sales — Human Vaccines (Vaccines).” segment."
Sanofi Pasteur is a world leader in the vaccine industry in terms of sales. In the United States, Sanofi Pasteur is the market leader in the segments where we compete (source: based on internal estimates).
In Europe, Sanofi Pasteur vaccine products are developed and marketed by Sanofi Pasteur MSD, a joint venture created in 1994 and held equally by Sanofi Pasteur and Merck & Co. Inc., which serves 19 countries. Sanofi Pasteur MSD also distributes such Merck & Co. vaccine products as Gardasil®Gardasil® and Zostavax®, in the joint venture’sventure's geographic scope. In 2011,2012, Sanofi Pasteur MSD net sales, which are accounted for using the equity method, amounted to €791€845 million.
Sanofi Pasteur has been expanding in Asia (China, India and Japan), Latin America (Mexico and Brazil), Africa, the Middle-East and Eastern Europe. Sanofi Pasteur is very active in publicly-funded international markets such as UNICEF and the Global Alliance for Vaccines and Immunization (GAVI).
See "— Vaccines Research and Development" below for a presentation of the Sanofi Pasteur R&D portfolio.
The table below shows net sales of vaccines by product range:
(€ million) | Net Sales | |||||||
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Polio/Pertussis/Hib Vaccines | 1,184 | |||||||
Influenza Vaccines * | ||||||||
Meningitis/Pneumonia Vaccines | ||||||||
Adult Booster Vaccines | ||||||||
Travel and Other Endemics Vaccines | ||||||||
Other Vaccines | ||||||||
Total Human Vaccines |
Pediatric, Combination and Poliomyelitis (Polio) Vaccines
These vaccines vary in composition due to diverse immunization schedules throughout the world.
Sanofi Pasteur is one of the key players in pediatric vaccines in both emerging and mature markets with a broad portfolio of standalone and combination vaccines protecting against up to fivesix diseases in a single injection.
Pentacel® Pentacel®, a vaccine protecting against five diseases (pertussis, diphtheria, tetanus, polio andHaemophilus influenzaetype b), was launched in the United States in 2008.
Pediacel® Pediacel®, a fully liquid acellular pertussis-based pentavalent vaccine, ishas been the standard of care in the United Kingdom since 2004 for protecting against diphtheria, tetanus, pertussis (whooping cough), polio andHaemophilus influenzae type b disease.infections. As of December 31, 2011, Pediacel®® was approved in 29 countries across Europe in a new syringe presentation.
Pentaxim® Pentaxim®, a combination vaccine protecting against diphtheria, tetanus, pertussis, polio andHaemophilus influenzae type b, was first marketed in 1997 and was launched in China in May 2011. To date, more than 100150 million doses of Pentaxim®Pentaxim® have been distributed in over 100 countries, and the vaccine has been included in the national immunization programs in more than 23 countries.
Act-HIB® Act-HIB®, for the prevention ofHaemophilus influenzaetype b (Hib) infections, is also an important growth driver within the pediatric product line. In 2008, Act-HIB®Act-HIB® became the first Hib vaccine to be approved in Japan.
HexaximTM, Hexaxim® is a hexavalentthe only fully liquid, ready to use 6-in-1 (hexavalent) pediatric vaccine providing protection against diphtheria, tetanus, pertussis, poliomyelitis (polio),polio,Haemophilus influenzae type b infections and hepatitis B. TheIn June 2012, Sanofi Pasteur received a positive scientific opinion for Hexaxim® from the European Medicines Agency (EMA) as part of the Article 58 procedure designed to evaluate medicinal products intended for international markets outside the European Union. As a second step, to ensure continuity of supply as well as expanded access to hexavalent vaccines throughout the 27 E.U. member states, the vaccine is currentlywas submitted to the European Medicines Agency for license review in Europe. In February 2013, the EMA recommended market approval for the 6 in 1 pediatric vaccine. This innovative vacine will be commercialized under the registration process (Article 58) at EMA, with an opinion expectedbrand name Hexyon™ in 2012.Western Europe by Sanofi Pasteur MSD, and under the brand name Hexacima™ in Eastern Europe by Sanofi Pasteur.
PR5I is a combination vaccine designed to help protect against six potentially serious diseases: diphtheria, tetanus, whooping cough (pertussis),pertussis, polio (poliovirus type 1, 2 and 3), invasive disease caused byHaemophilus influenzaetype b, and hepatitis B. This product is jointly being developed between Sanofi Pasteur and Merck in the U.S. and Europe. Phase III studies in the U.S. and Europe began in April 2011.
Sanofi Pasteur is one of the world’sworld's leading developers and manufacturers of polio vaccines, in both oral (OPV) and enhanced injectable (eIPV) form. The worldwide polio eradication initiative led by the World Health Organization (WHO) and UNICEF has positioned Sanofi Pasteur as a global preferred partner with both OPV and eIPV vaccines.
In September of 2011, Sanofi Pasteur donated to the WHO a vaccine strain used for polio eradication. The biological material given by Sanofi Pasteur is the original viral seed used to produce large quantities of OPV against type 3 poliovirus. With this donation from Sanofi Pasteur, the WHO will be in full control of the storage of the vaccine strain and its distribution to vaccine producers worldwide.
Sanofi Pasteur is also supporting the introduction of eIPV in the international region.internationally. With recent progress towards polio eradication in countries such as Brazil and Japan in 2012, Sanofi Pasteur expects the use of eIPV to gradually increase. As a result, Sanofi Pasteur is expanding its production capacity to meet the growing demand.
On February 23, 2011, Sanofi Pasteur applied for approval of manufacturing and marketing of standalone inactivated vaccine against polio (acute poliomyelitis) Shantha Biotechnics (Shantha) in Japan.
Shantha BiotechnicsIndia is currently pursuing requalification of Shan5®Shan5®, a combination vaccine protecting against diphtheria, tetanus, pertussis, hepatitis B andHaemophilus influenzae type b, with the WHO. Shantha has worked closely with Sanofi Pasteur to improve key manufacturing steps in the production of the antigen components of the vaccine. The path back to obtaining Prequalificationprequalification status has been discussed extensively with the WHO and local Indian regulators. Based on the successful completion of clinical studies, Shan5®Shan5® is expected to regain WHO prequalification in 2014.
Influenza Vaccines
Sanofi Pasteur is a world leader in the production and marketing of influenza vaccines. Sales of the influenza vaccines Fluzone®Fluzone® and Vaxigrip®Vaxigrip®/Mutagrip®Mutagrip® have more than tripled since 1995 and annual supply reached more than 200 million doses in 20112012 to better meet increasing demand. In recent years, influenza vaccine demand has experienced strong growth in many countries, particularly in the U.S., South Korea, Brazil and Mexico. Sanofi Pasteur expects
the global demand for influenza vaccines to continue to grow within the next decade due to increased disease awareness, growth in emerging markets and wider government immunization recommendations.
Sanofi Pasteur remains focused on maintaining its leadership in the influenza market and on meeting the increasing demand for both pandemic and seasonal influenza vaccines through the launch of innovative vaccines.
In May 2011,2012, Sanofi Pasteur received regulatory approval byexpanded its launch of Fluzone® ID in the U.S. FDA for Fluzone® ID in adults from 18 to 64 years of age.adults. The advantages of this vaccine are particularly its convenience and ease of administration. Fluzone ID®, Intanza®ID® and Intanza®/IDflu® vaccine isIDflu® vaccines are now approved in the United States, European Union, Canada, Australia and other countries for the prevention of seasonal influenza in both adults (agefrom 18 and over) and the elderly (age 60 and over).
In December 2009, the FDA approved Sanofi Pasteur’s supplemental Biologics License Application (sBLA) for licensing of Fluzone® High-Dose influenza virus vaccine. The Fluzone® Fluzone® High-Dose vaccine, launched in the United States in 2010, was specifically designed to generate a more robust immune response against influenza in people 65 years of age or older. This age group, which typically shows a weaker immune response, has proven to respond better to the Fluzone®Fluzone® High-Dose vaccine. This new vaccine was launched in the United States in 2010 andIt continued its strong growth in 2011.2012.
Fluzone®Fluzone® QIV candidate vaccine is a quadrivalent inactivated influenza vaccine containing two antigens of type A (H1N1 and H3N2) and two antigens of type B (one each from Yamagata and Victoria lineage). Selecting the prevailing influenza strains for upcoming seasons is an incredibly difficult task. In the recent past, there have been a number of mismatches of the B strain component in the trivalent vaccine compared with the circulating B lineage. Sanofi Pasteur expects that increasing the number of strains in the vaccine will give increased protection against the most prevalent strains. The targeted population isSanofi Pasteur filed a supplemental Biologics License Application (sBLA) with the same as standard-dose Fluzone® TIV (trivalent vaccine): children 6 months through 17 years, and adults and elderly 18 years and above. A Phase III clinical trial was completed in 2011FDA for FluzoneFluzone® QIV IM and regulatory submission is planned for the first half 2012. Vaxigrip QIV IM, targeting the European market, entered Phase III clinical trials in October 2011.2012. The sBLA file has been accepted by the FDA for full review, and an action date is anticipated in the second quarter of 2013.
Adult and Adolescent Boosters
Pertussis (whooping cough) affects children, adolescents and adults. Resurgence, in particular in the State of California in the U.S. and other parts of the world, in 2010, combined with increased awareness of the dangers of vaccine-preventable diseases in general, has led to higher sales of this product group in recent years. Adacel®
Adacel®, the first trivalent adolescent and adult booster against diphtheria, tetanus and pertussis, was licensed and launched in the United States in 2005. Since 2004, Adacel® has been the standard of care in Canada, where most provinces provide routine adolescent immunization. This vaccine plays an important role in efforts to better control pertussis, by preventing the disease in adolescents and adults, and by breaking the cycle of transmission to infants too young to be immunized or only partially vaccinated. Adacel®Adacel® is now registered in more than 50 countries.
Quadracel®Quadracel®, a quadrivalent booster vaccine (fifth dose) including diphtheria, tetanus, acellular pertussis and IPV, is being developed for the U.S. market. It would allow a child to complete the entire childhood series with the fewest doses possible. AIt is currently in Phase III clinical trial began in April 2011.trials.
Meningitis and pneumonia vaccines
Sanofi Pasteur is at the forefront of the development of vaccines to prevent bacterial meningitis. In 2005, Sanofi Pasteur introduced Menactra®Menactra®, the first conjugate quadrivalent vaccine against meningococcal meningitis, arguablyconsidered by many as the deadliest form of meningitis in the world. In October 2007,By April 2011, the FDA had granted Sanofi Pasteur a license to expand the indication of Menactra®Menactra® to children two years through 10 yearsas young as 9 months of age. Menactra®Menactra® is now indicated for people aged 2-559 months through 55 years in the United States, Canada, Saudi Arabia and numerous other countries in Canada. In 2011, sales of Menactra® continued to grow in the United States following the CDC’s Advisory Committee on Immunization Practices recommendation that a single dose at 11 or 12 years of age be followed-up with a booster dose several years later for protecting adolescents at the time of their highest risk. An Infant/Toddler (age 9/12 months) biological license application for Menactra® was approved by the U.S. FDA in March 2011. Sanofi Pasteur also launched Menactra® inLatin America, the Middle East and Latin America in 2010 and in Asia in 2011.Pacific regions.
Meningitis A, C, Y, W-135 conj. Second Generation is a project that targetstargeting a second generation meningococcal vaccine that uses an alternative conjugation technology. In 2011, interim Phase II clinical trial results were obtained and indicated that the product is sufficiently immunogenic for further development in infants.
For over 30 years, Sanofi Pasteur has supplied vaccines for meningococcal meningitis serogroups A and C used to combat annual epidemics in Sub-Saharan countries (African meningitis belt).
Travel and Endemics Vaccines
Sanofi Pasteur provides a wide range of travelerstravel and endemic vaccines withincluding hepatitis A, typhoid, rabies, yellow fever, cholera measles, mumps, rubella (MMR) vaccines and anti-venoms. These vaccines are used in
endemic settings in the developing
world and are the basis for important partnerships with governments and organizations such as UNICEF. They are also used by the military and travelers to endemic areas. As the global leader in the majority of these vaccine markets, Sanofi Pasteur’sPasteur's Travel/Endemics activity has demonstrated stable growth.
AIMOJEV™, a Japanese encephalitis vaccine, is also in preparation. Japanese encephalitis is endemic in Southeast Asia. Sanofi Pasteur will offer a new vaccine in the market: IMOJEVTM.development. The Australian healthcare authorities granted approval of IMOJEVTMthe latest variations of the IMOJEV™ file on August 16, 2010September 24, 2012 for individuals aged 12 months and over. On October 29, 2010,over, followed by the Thai Food and Drug Administration granted licensureon November 14, 2012. IMOJEV™ has now been launched in the same age indication.these two countries.
TheA new generation Vero serum-free vaccine (VRVg)(VerorabVax™) will provide a worldwide, single rabies vaccine as a replacement to our current rabies vaccine offerings. Results from the 2009 Phase III clinical trial demonstrated non-inferiority of VRVg versus Verorab®. AFSSAPSVerorab® in Francepre-exposure prophylaxis. VRVg was approved VRVgin France as a line extension of VeroRab in January 2011. Clinical2011 and clinical development is continuingfinalized in China and India.
with completion of Phase III confirming non-inferiority vs. Verorab® in simulated post-exposure prophylaxis.
In December 2009, Shantha launched ShanCholTM, India’sIndia's first oral vaccine to protect against cholera in children and adults. In SeptemberShanChol™ was World Health Organization pre-qualified in 2011 Shancholand more than 1 million doses of ShanCholTM was approved for procurement to United Nations Agencies (i.e. WHO Pre-qualified). were sold worldwide in 2012.
Other Products
In October 2011, Sanofi Pasteur acquired Topaz Pharmaceuticals Inc.in October 2011. The integration of Topaz was completed in 2012. The FDA licensed Sklice® (ivermectin) lotion, 0.5%, on February 7, 2012 as a small privately-held U.S. specialty pharmaceutical company focused on developing and commercializing treatments primarilyone-time treatment for pediatric and dermatology markets. Established in June 2005 and based in Horsham PA, Topaz Pharmaceuticals offers a late-stage prescription product for the treatment of head lice. This investigational product, known as Sklice™, Topical Lotion, is a formulation of Ivermectin. It is the sole pipeline product of the company. The regulatory submission for Sklice, topical Lotion, for treatment of head lice in children and adults, was filed with the U.S. FDA in April 2011. In February 2012, the FDA approved Sklice® (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patientspersons aged 6 months of age and older.
older, and commercial launch commenced in July 2012.
Animal Health: Merial
Our animal health activity is carried out through Merial, one of the world’sworld's leading animal healthcare companies (source: Vetnosis), dedicated to the research, development, manufacture and delivery of innovative pharmaceuticals and vaccines used by veterinarians, farmers and pet owners. It provides a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals (productionproduction and companion animals).animals. Its net sales for 20112012 amounted to €2,030€2,179 million.
Merial became Sanofi’sSanofi's dedicated animal health division following the joint statement issued by Merck and Sanofi in March 2011 announcing the end of their agreement to create a new animal health joint venture by combining their respective animal health segments. Consequently all Merial financials are consolidated in Group reports. See Note D.2. to our consolidated financial statements included at Item 18 of this annual report.
The animal health product range comprises four major segments: parasiticides, anti-infectious drugs, other pharmaceutical products (such as anti-inflammatory agents, anti-ulcerous agents, etc.) and vaccines. Merial’sMerial's top-selling products include Frontline®Frontline®, a topical anti-parasitic flea and tick brand for dogs and cats, the highest selling veterinary product in the world (source: Vetnosis 2011)Vetnosis); Heartgard®Heartgard®, a parasiticide for control of heartworm in companion animals; Ivomec®Ivomec®, a parasiticide for the control of internal and external parasites in livestock; Vaxxitek®Vaxxitek®, a high-technology vector vaccine, protects chickens against infectious bursal disease (IBD) and Marek’sMarek's disease; Previcox®Previcox®, a highly selective anti-inflammatory/COX-2 inhibitor for relief of pain and control of inflammation in dogs; Eprinex®Eprinex®, a parasiticide for use in cattle; and Circovac®Circovac® a PCV2 (porcine circovirus type 2) vaccine for swine. Merial plays a key role in the veterinary public health activities of governments around the world. It is the world leader in vaccines for Foot-and-Mouth disease (FMD);, rabies, and bluetongue (BTV) (source: Vetnosis 2011)Vetnosis).
The compound patent protecting fipronil, the active ingredient of Frontline®Frontline®, expired in 2009 in Japan and in some European countries, including France, Germany, Italy, and the United Kingdom, and in August 2010 in the United States. In those markets where the fipronil compound patent has expired, Frontline®Frontline® products are generally still protected through formulation patents (directed to combinations) which expire at the latest in 2017
in Europe (August 2016 in the United States). Frontline®Frontline® is also protected by a method of use patent in the United States and the European Patent area (Germany, France, Italy and the United Kingdom), expiring March 2018. As for human
pharmaceutical products, patent protection for animal pharmaceutical products extends in most cases for 20 years from the filing date of the priority application.
As regards regulatory exclusivity, the position of veterinary medicinal products in Europe is similar to that of human pharmaceutical products: eight-year data exclusivity and ten-year market exclusivity. In the United States, there is ten-year data exclusivity for products approved by the Environmental Protection Agency and an additional five years during which a generic applicant has to compensate the originator if it cites the originator’soriginator's data. For FDA approved veterinary medicinal products, a regulatory exclusivity period of five years is granted for a new chemical entity and three years for a previously-approved active ingredient. No data exclusivity exists at present for veterinary vaccines in the United States.
In April 2012, Merial acquired Newport Laboratories (Newport), a privately held company based in Worthington, Minnesota (United States), a leader in autogenous vaccines with a focus on swine and bovine production markets.
Regarding On December 20, 2012, Merial entered into a binding agreement to acquire the animal health division of the Indian company Dosch Pharmaceuticals Private Limited, creating a market entry for Merial in that country's strategically important and growing animal health sector. The agreement is subject to regulatory approval and is expected to finalize sometime in the first half of 2013.
The 2012 performance of the companion animals and specially the fipronil franchise on June 21, 2011 the U.S. District Court for the Middle District of Georgia ruled in favor of Merial holding that sales of PetArmor™ Plus products infringed Merial’s patent, and it barred Cipla and Velcera from making or selling those products in the United States. A court-ordered seizure of the inventory in the United States still in possession of the generic manufacturers went into effect on August 21, 2011. However, the generic products already sold to retailers were not recalled (see “Item 8. Financial Information — A. Consolidated Financial Statements and Other Financial Information). In July 2011, Merial launched Certifect®, a new fipronil combination parasiticide for tick and flea control for dogs.
Regarding production animals, in the ruminant segment, performance was driven by the launchgrowth of pet vaccines worldwide and by the performance of Heartgard® in the U.S. For production animals, the performance was mainly driven by the avian segment (notably Vaxxitek®) and the swine segment, thanks to Circovac® sales and the acquisition of the antibiotic Zactran® against bovine respiratory disease.Newport.
Merial’sMerial's major stand-alone markets are the United States, France, Brazil, Italy, the United Kingdom, Australia, Germany, Japan, Spain, China, and Canada. The group of “Emerging Markets” countries, withEmerging Markets contributed double digit sales growth in 2011, accounts2012, and now account for 25.0%26.6% of total Merial sales.
Merial operates through a network of 1617 production sites, with major sites located in France, the United States, Brazil and China. The major R&D sites are located in France and in the United States. Merial employs approximately 5,600 employees worldwide.
6,060 people worldwide (see Item 4D "Property, Plant & Equipment").
PharmaceuticalGlobal Research & Development
The mission of Sanofi's Global Research & Development organization is to discover and develop therapies that prevent, treat and cure diseases. Our day-to-day commitment is to respond to patients' real needs and to provide them with adapted therapeutic solutions in order to improve their well-being and extend their life.
To meet these challenges, R&D has evolved towards an integrated organization, encompassing a wide range of therapeutic areas that represent a large and growing burden on populations and healthcare systems, in line with trends and the most pressing health needs.
These include:
To carry out our mission, meet these challenges and maximize our impact we are striving to bring innovation to patients and to build a pipeline of high value projects.
These include:Medical value, scientific quality and operational effectiveness are the three drivers that underpin our strategy. We focus on projects that have the potential to provide the best medical value differential to patients and payers and to reduce healthcare costs for society.
Patent cliffBy using a translational medicine approach, ensuring that research hypotheses are validated in humans as early as possible, we can translate basic research findings into medical practice more quickly and efficiently and improve the scientific quality of our projects. The open innovation and large collaboration processes applied worldwide helped us to deliver the best and most innovative solutions for several products considered as blockbusters, putting revenues under pressurepatients. By implementing new operating models to ensure optimal progress on our projects, especially during clinical development phases, we will improve our operational effectiveness and increasing competitiondeliver the right therapeutic solutions to patients more quickly.
Research & Development Organization
Over recent years, we have moved from a pure pharmaceutical R&D organization to a global and integrated R&D organization where forces are combined to meet a diversity of me-too drugs,health needs.
Decrease in New Molecular Entities approvals by Health Authorities (a 50% drop when compared
Increasing regulatory requirements and payers demands for demonstrated medical and economic value impacting the costs of development
Increased complexity of science leading to a decrease in the success rate for research projects.
To overcome this new situation, Sanofi has revised its overall infrastructure and operations footprint and opened up to external innovation and new fields of opportunity, so as to feed and strengthen its pipeline. We have adopted a network-based organization, open to external opportunities, to enable our R&D to be more creative and make the most of both in-house and external innovation. In December 2011, out of 48 products in clinical development or registration, 34 (or 71%) originate from external R&D. Employee year-end headcount in the researchdiscovery and development functions generally reflects this trend to greater externalization,of human medicines. This is a decentralized organization, consisting of two divisions (Oncology and amounted to 18,823 for 2011 compared to 16,983 for 2010 and 19,132 for 2009 (in each case excluding Merial but including Genzyme in 2011 - 2,006 employees).
We intend to have the most effective R&D organization in the pharmaceutical industry in place by 2013. The new R&D approach aims to foster greater creativity and innovation. Streamlined organizational structures are designed to make R&D more flexible and entrepreneurial and hence better adapted to overcome future challenges.
Organization
During the first phase of transformation (2009-2011) we carried out a rigorous and deep re-evaluation of all current development programs. As a result, we have refocused our efforts on 48 clinical programs (see table below).
In parallel we undertook a profound transformation of our operating model reinforcing our patient centric approach and setting an “open innovation” strategy.
Decentralization with the creation of Oncology, Diabetes and Ophthalmology divisions,Diabetes), five Therapeutic strategic unitstherapeutic Units (TSUs), several Distinct Project Units (DPUs) and five Scientific platforms.
A renewed effort at business development to fillplatforms, responsible for the pipeline by acquiring or in-licensing productsoperational aspects of development.
In line with the Group’s diversification strategy, acquisition of Genzyme in April 2011 leading to a push in biotechnology and bringing the Group’s goal of building a globally integrated R&D organization a step closer.
With each project).
We are constantly adapting our R&D approach, combining global and local action, leveraging local innovative research ecosystems and global high quality development capabilities in order to achieve the greatest possible impact.
We are creating geographically-focused integrated research innovation centers also called "hubs" in four areas: North America, Germany, France and Asia. In the Boston area (United States), which has a high concentration of universities and innovative biotechnology companies, our R&D has been reorganized to support the increasing presence of the Group.
Our R&D is now organized to promote the best leverage each other’s knowledgeuse of our resources within the local ecosystem. Our network-based organization is open to external opportunities, and experience and establishenables us to more effectively capitalize on innovation from a governance model to foster effective collaboration and innovation between all organizations.
Creationwide range of alliances with premier academic programs in the U.S., Europe and a major effort in France with the Aviesan program.sources.
Portfolio
DuringAs in 2011, R&D followed up theagain conducted a rigorous and comprehensive portfolio review already initiated in 2009.review. Projects were assessed using seventwo key criteria which allow management to rapidly understand how the portfolio performs in terms of innovation, unmet medical needs, risk and value. They can be summarized as follows:The two key criteria include:
science: level of innovation, level of safety, quality and reliability
pharmacovigilance: assessment ofunmet need, the benefit/risk ratio for products (i.e.,market dynamics and the clinical benefit versus the potential side effects).
execution: likelihood of development and manufacturing success;
market: existence of a market, positioning within this market, and our place in the market;
reimbursement: likelihood of achieving the desired price and reimbursement based on the health authoritiesauthorities' positioning and Sanofi competencies;
regulatory/legal: dealing with the environment around the project, patent status, regulatory guidelines; and
financial: predicted return on investment for the project.
At the end of 2011, the currentThe clinical portfolio as of the date of filing of this annual report is the result of decisions taken during these reviews, plus compounds entering the portfolio from the discovery phase or from third parties throughvia acquisition, collaboration or alliances.
As described at “Item"Item 3. Key Information — D. Risk Factors — Risks Relating to Our Business — We may fail to adequately renew our product portfolio whether through our own research and development or through acquisitions and strategic alliances.”" our product development efforts are subject to the risks and uncertainties inherent in any new product development program.
The clinical portfolio for new medical entities can be summarized as follows:
Phase I | Phase II | Phase III /registration | |||||||||||
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Cardiovascular diseases |
| SAR236553 | |||||||||||
| mipomersen | ||||||||||||
SAR126119 | otamixaban(XRP0673) | ||||||||||||
SAR127963 | |||||||||||||
Oncology | SAR125844 | SAR245408 | iniparib(BSI-201) | ||||||||||
SAR153192 | SAR245409 | SAR302503 | |||||||||||
SAR260301 | SAR256212 | ||||||||||||
SAR307746 | SAR3419 | ||||||||||||
GZ402674 |
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SAR405838 | |||||||||||||
SAR566658 | |||||||||||||
SAR650984 | |||||||||||||
Immune Mediated diseases | SAR100842 | SAR156597 | alemtuzumab | ||||||||||
(including MS) | SAR113244 | SAR339658 | |||||||||||
SAR252067 | dupilumab | sarilumab(SAR153191) | |||||||||||
Age related degenerative | SAR228810 | SAR110894 | |||||||||||
| SAR113945 | ||||||||||||
SAR399063 | SAR292833 | ||||||||||||
SAR404460 |
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Infectious Diseases | ferroquine | ||||||||||||
SAR97276 | |||||||||||||
SAR279356 | |||||||||||||
Rare Diseases | GZ402665 | eliglustat tartrate | |||||||||||
GZ402671 | |||||||||||||
GZ404477 | |||||||||||||
Ophtalmology | GZ402663 | FOV1101 | |||||||||||
StarGen™ | |||||||||||||
UhsStat™ | |||||||||||||
RetinoStat® | |||||||||||||
Phase I studies are the first studies performed in humans, in healthy volunteers. Their main objective is to assess the tolerability, the pharmacokinetic profile (the way the product is distributed and metabolized in the body and the manner by which it is eliminated) and where possible the pharmacodynamic profiles of the new drug. (howdrug (i.e. how the product may react on some receptors).
Phase II studies are early controlled studies in a limited number of patients under closely monitored conditions to show efficacy and short-term safety and to determine the dose and regimen for Phase III studies.
Phase III studies have the primary objective of demonstrating or confirming the therapeutic benefit and the safety of the new drug, in the intended indication and population. They are made to provide an adequate basis for registration.
TheOur Phase II & III compounds are described in the section “—"— Pharmaceutical Products — Main Pharmaceutical Products”Products" above. A table summarizing selected key facts concerning our late stage experimental pharmaceutical products follows, at the end of this section.
The remainder of this section focuses on compounds entering Phase I compounds entries,or in Phase II and also lists projects that were terminated in 2011.2012.
Diabetes/Other Metabolic Disorders portfolio
The network of R&D collaborations with world leading academic institutions was significantly extended in 2012. A collaboration with the Charité in Berlin that began in 2010 was further extended to include Diabetes as an additional focus. In addition we entered into a research alliance with the Helmholtz Zentrum in Munich, and a new formulationcollaboration with the Joslin Diabetes Center (affiliate of insulin glargine has been tested in Phase I. This new product shows an improved pharmacodynamic profile. Phase III investigatingHarvard Medical School) was formed to promote the efficacy and safety in a broad patients population has been initiated end of 2011.
Lantus: the Lantus Pediatric Investigational plan was finalized as scheduled and results have been submitted in Europe in time.
The development ofSAR101099, an Urotensin II Receptor Antagonist, has been discontinued. new medicines for the treatment of diabetes and related disorders.
Oncology portfolio
Furthermore, SAR307746 (REGN910), a monoclonal antibody directed against Ang2 issued fromIn 2012, we established further collaborations with other companies, universities and institutes to investigate novel oncology agents with partners including the partnership with Regeneron, entered Phase I in oncologyMassachusetts General Hospital (MGH) in the first quarter of 2011.United States and the Institut Gustave-Roussy (IGR) in France.
Finally, the global development of SAR103168, a Phase I multikinase inhibitor being developed in AML,was halted due to pharmacokinetic considerations
Sanofi — Genzyme early stage portfolio
Ophthalmology portfolio
A number of compounds for the treatment of eye disease were added to the portfolio via the acquisition of Fovea, the collaboration agreement with Oxford BioMedica and the acquisition of Genzyme (see “— Pharmaceutical Products — Main Pharmaceutical Products — Other Pharmaceutical Products” above).
In gene therapy, three compounds targeting the treatment of Age-related Macular Degeneration (AMD) and Stargardt Disease entered into Phase I in 2011
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TSU Aging portfolio
Two compounds have progressed into Phase II clinical development:
SAR110894 (H3 receptor antagonist for the treatment of Alzheimer’s dementia)
SAR113945 (IKK-ß kinase inhibitor for the treatment of osteoarthritis by intra-articular administration)
1 compound has completed a Phase I program and should enter Phase II in 2012
SAR292833 — GCR-15300, licensing agreement with Glenmark Pharmaceutical (TRPV3 antagonist for the oral treatment of chronic pain)
1 compound recently completed a Phase I program — results analysis on-going:
SAR114137 (Cathepsin S/K inhibitor for the oral treatment of chronic pain)
1 compound will enter Phase I clinical development in the first quarter of 2012:
SAR228810 (anti-protofibrillar AB mAb for the treatment of Alzheimer’s dementia)
1 compound has been terminated:
SAR152954 (H3 receptor antagonist)
In 2011, two key research agreements were signed with Audion Therapeutics and Aviesan to develop potential treatments in hearing loss and hearing disorders.
For Discovery/development partnerships:
In-license agreement signed in December 2011 with SCIL Technology GMBH, a German biopharmaceutical company to develop CD-RAP products in osteoarthritis indication.
Opt-in agreement signed with Regeneron in December 2011 to develop an anti-GDF8 mAb in the sarcopenia indication
TSU Infectious Diseases portfolio
Ferroquine(4-aminoquinoline; malaria; Phase IIb). Ferroquine is a new 4-amino-quinoline being developed for the treatment of acute uncomplicated malaria. Ferroquine is active against chloroquine sensitive and chloroquine resistant Plasmodium strains, and due to its long half-life has the potential to be part of single dose cure regimens and the unified global treatment of both vivax and falciparum malaria.completed.
SAR97276(in licensed from CNRS)is an antimalarial drug belonging to a new chemical class with an innovative mechanism of action, being developed for the treatment of severe malaria. A Phase IIa study started in the third quarter of 2011.
TSU Immuno-Inflammation portfolio
SAR339658 (also known as GBR500), a monoclonal antibody directed at the VLA-2 (Very Late Antigen 2) integrin receptor was in-licensed from Glenmark Pharmaceuticals in May 2011. The primary target indication is inflammatory bowel disease such as ulcerative colitis or Crohn’sCrohn's disease. The compound successfully completed Phase I in 2010 and entered Phase IIa in 2012.
TSU Aging portfolio
Discovery/development partnerships:
TSU Infectious Diseases portfolio
OZ439 is a synthetic peroxide antimalarial drug candidate from MMV designed to provide a single dose oral cure in humans. An IND was filed with the FDA in November 2012 and a phase I study of combinations of the two compounds is planned to start in February 2013.
The Sanofi Fovea ophthalmology pipelinenow includes four projects in clinical-stage development:
Other Projects portfolio
R&D expenditures for late stage development
Expenditures on research and development amounted to €4,811€4,922 million in 2011,2012, of which €4,101€4,219 million in the pharmaceuticalPharmaceuticals segment, €564€539 million in Human Vaccines and €146€164 million in Animal Health. Research and development expenditures were the equivalent of about 14.4%14.1% of net sales in 2011,2012, compared to about14.4% in 2011, 14.1% in 2010 and 15.5% in 2009. The discontinuationstability of a number of projects contributed to the decrease in suchR&D expenditure in 2009 and 2010 and going forward the level of expenditure can be expected to continue to vary as a reflectionpercentage of sales over the past three years is explained by the management of the numberportfolio and close control over expenditures, despite the increasing proportion of products in late stage development among other factors.development. Preclinical research in the pharmaceuticalPharmaceuticals segment amounted to €1,038 million in 2012, compared to €1,113 million in 2011 compared toand €1,037 million in 2010 and €1,047 million in 2009.2010. Of the remaining €2,988€3,181 million relating to clinical development in the pharmaceutical sector (€2,8482,989 million in 20102011 and €3,043€2,848 million in 2009)2010), the largest portion was generated by Phase III or post-marketing studies, reflecting the cost of monitoring large scale clinical trials.
For each of our current late stage (Phase III) compounds in the Pharmaceutical segment that were in Phase III in 2012, we set out below the date at which this compound entered into Phase III development, information concerning any compound patent in the principal markets for innovative pharmaceutical products (the United States, European Union and Japan) as well as comments regarding significant future milestones that are reasonably determinable at this date. Because the timing of such milestones typically depends on a number of factors outside of our control (such as the time to validate study protocols and recruit subjects, the speed with which endpoints are realized, as well asand the substantial time taken by regulatory review) it is frequently not possible to provide such estimates, and any such estimates as are given should be understood to be indicative only. See also “Item"Item 3. Key Information — D. Risk Factors — Risks Relating to Our Business”Business".
Phase III | Entry into Phase III (1) | Compound Patent Term (2) | Comments | ||||||||||
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| (month/year) | U.S. | E.U. | Japan | | ||||||||
Lyxumia® (lixisenatide) (3) | May 2008 (4) | 2020 | 2020 | 2020 | Dossier approved in Europe in February 2013 and submitted in the U.S. in December 2012. The FDA accepted the file for review on February 19, 2013 | ||||||||
Zaltrap® (aflibercept) | July 2006 | 2020 | 2020 | 2020 | 2nd line colorectal cancer, approved and launched in the U.S. in August 2012, and approved in the E.U. in February 2013 | ||||||||
iniparib (BSI-201) | June 2009 | 2013 | 2014 | N/A | Phase III program ongoing in 1st line squamous Non Small Cell Lung Cancer | ||||||||
Phase II program in 2nd line ovarian cancer ongoing | |||||||||||||
Phase III | Entry into Phase III (1) | Compound Patent Term (2) | Comments | ||||||||||
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otamixaban | April 2010 | 2016 | 2016 | 2016 | Phase III results in Acute Coronay Syndrome (ACS) expected in the second quarter of 2013 | ||||||||
Aubagio® (teriflunomide) (3) | September 2004 | 2014 | expired | expired | In the monotherapy treatment of multiple sclerosis, dossier approved in September 2012 in the U.S., launched in October and submitted in February 2012 in Europe. | ||||||||
SAR236553 (REGN727) (anti PCSK-9 mAb) | July 2012 | 2029 | 2029 | 2029 | Phase III program on going in hypercholesterolemia | ||||||||
SAR302503 (TG101348) | January 2012 | 2026 | 2026 | (3) | 2026 | (3) | Phase III program ongoing in the treatment of myelofibrosis | ||||||
Lemtrada™ (alemtuzumab) | September 2007 (MS) | 2015 | (5) | 2014 | expired | Dossier submitted in Europe and U.S. for the treatment of relapsing forms of Multiple Sclerosis in May and November 2012, respectively | |||||||
New formulation Insulin glargine | December 2011 | 2015 | (6) | 2014 | 2014 | Phase III program ongoing | |||||||
Kynamro™ (mipomersen) (3) | August 2007 | 2025 | pending | 2023 | Dossier submitted in July 2011 in Europe and approved in the U.S. on January 29, 2013 in the treatment of homozygous familial hypercholesterolemia (HoFH) | ||||||||
eliglustat tartrate | September 2009 | 2022 | 2022 | 2022 | Phase III program ongoing in the treatment of Gaucher Disease type 1 | ||||||||
sarilumab | August 2011 | 2028 | 2027 | 2027 | Phase III program in the treatment of Rheumatoid Arthritis ongoing | ||||||||
Phase III | Entry into Phase III 1 | Compound Patent Term 2 | Comments | |||||||||||||
(month/year) | U.S. | E.U. | Japan | |||||||||||||
Lyxumia® (lixisenatide)4 | May 20083 | 2020 | 2020 | 2020 | Dossier submitted in Europe in October 2011; to be submitted in the U.S. in 2012. | |||||||||||
Zaltrap® (aflibercept) | July 2006 | 2020 | 2020 | 2020 | 4 | 2nd line colorectal cancer, dossier submitted in Europe in November 2011 and in the U.S. in February 2012.
1st line prostate cancer Phase III (VENICE) results expected in the second quarter 2012 | ||||||||||
ombrabulin (AVE8062) | June 2008 | 2016 | 2016 | 2016 | Sarcoma Phase III results expected in the third quarter 2012 | |||||||||||
iniparib (BSI-201) | June 2009 | 2013 | 2014 | N/A | Phase III program on going in 1st line squamous Non Small Cell Lung Cancer
Phase II program in 2nd line ovarian cancer to be launched in 2012
Complementary Phase II studies in breast cancer on going |
Visamerin®/Mulsevo® (semuloparin)4 otamixaban Aubagio™ (teriflunomide)4 In the monotherapy treatment of multiple sclerosis, dossier submitted in August 2011 in U.S. and in February 2012 in Europe Adjunct therapy treatment of multiple sclerosis, Phase III program on going Treatment of Clinically Isolated Syndrome, Phase III program on going. Dossier submitted in Europe in July 2011 in the treatment of homozygous familial hypercholesterolemia (HoFH) and severe heterozygous familial hypercholesterolemia (HeFH) Phase III program in severe HeFH on going for a U.S. submissionPhase III Entry into Phase III 1 Compound Patent Term 2 Comments (month/year) U.S. E.U. Japan May 2008 2024 2023 2023 Dossier submitted in Europe and U.S. in September 2011 April 2010 2016 2016 2016 Phase III results in Acute Coronay Syndrome (ACS) expected in the fourth quarter 2012 September 2004 2014 expired expired Clolar® / Evoltra® Life Cycle Management expired expired expired Phase III program on going in the 1st line treatment of Acute Myeloid Leukemia SAR302503 (TG101348) January 2012 2026 2026 4 2026 4 Phase III program on going in the treatment of myelofibrosis Lemtrada™ (alemtuzumab) September 2007 (MS) 2015 2014 expired Dossier to be submitted in Europe and U.S. for the treatment of Relapsing forms of Multiple Sclerosis during the 1st semester of 2012 New formulation Insulin glargine December 2011 2015 5 2014 2014 Phase III program on going Kynamro™ (mipomersen)4 August 2007 2025 pending pending
Phase III Entry into Phase III 1 Compound Patent Term 2 Comments (month/year) U.S. E.U. Japan eliglustat tartrate September 2009 2022 pending pending Phase III program on going in the treatment of Gaucher Disease type 1 results expected the 1st quarter of 2013 sarilumab August 2011 2028 2027 2027 Phase III program in the treatment of Rheumatoid Arthritis on going
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With respect to the compound patent information set out above, investors should bear the following additional factors in mind.
Vaccines Research and Development
Our human vaccine research and development (R&D) remains focused on improving existing vaccines, as well as on the development of new prophylactic vaccines.
Portfolio
The Sanofi Pasteur R&D portfolio includes 1314 vaccines currently in advanced development as shown in the table below. The portfolio includes five vaccines/antibody products for novel targets and eightnine vaccines which are enhancements of existing vaccine products.
Phase I | Phase | Phase III | Submitted | ||||||||||||||
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Tuberculosis *
Rotavirus
Pseudomonas
Prevention of |
2nd generation
Rabies VRVg
ACAM C. diff*
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Dengue *
DTP-HepB-Polio- | Hexaxim®/New hexavalent vaccine DTP-HepB-Polio- Hib vaccine(1) Fluzone® QIV ID Quadrivalent inactivated influenza vaccine intradermal | ||||||||||||||
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Project highlights
This section focuses on Phase I compounds and novel targets. Other vaccines in Phase II or III are described in the section “—"— Vaccine Products”Products" above.
Influenza
To sustain our global leadership in the development of influenza vaccine, our R&D efforts are focused on innovative approaches for assessing new formulations and alternative delivery systems, as well as quadrivalent flu vaccine development (see “—"— Vaccine Products”Products").
Pediatric Combination & Adolescent/Adult Boosters
Several pediatric vaccines are under development. Tailored for specific markets, they are aimed at protecting against five or all six of the following diseases: diphtheria, tetanus, pertussis, poliomyelitis (polio),Haemophilus influenzae type b infections and hepatitis B (see “—"— Vaccine Products”Products").
Meningitis
Neisseria meningitidisbacteria is a leading cause of meningitis in the United States, Europe and elsewhere, affecting infants and children as well as adolescents. The primary focus of several ongoing projects related to Menactra®Menactra® is to decrease the age at which this vaccine can first be administered. (see “—"— Vaccine Products”Products").
Pneumococcal Vaccine
Streptococcus pneumoniae bacteria is the leading etiological agent causing severe infections such as pneumonia, septicemia, meningitis and otitis media, and is responsible for over three million deaths per year worldwide, of which one million are children. Anti-microbial resistance inStreptococcus pneumoniae has complicated the treatment of pneumococcal disease and further emphasized the need for vaccination to prevent large-scale morbidity and mortality.
Sanofi Pasteur is focused on the development of a multi-protein-based pneumococcal vaccine. This approach should result in a vaccine with superior serotype coverage as compared to current polysaccharide or conjugate based vaccines and should not induce nor be sensitive to serotype replacement. Results from the first Phase I clinical trial of a bi-component formulation demonstrated safety and immunogenicity. Results from a second Phase I clinical trial to evaluate a third antigen also demonstrated safety and immunogenicity (ability to induce an immune response). A third Phase I clinical trial of a tri-component formulation began in September 2011 in adults, adolescents, and infants in Bangladesh.
Rabies Vaccine
Rabies mAb Post Exposure Prophylaxis— This product consists of two rabies monoclonal antibodies (MABs)(mAbs) that will be used in association with the rabies vaccine for post-exposure prophylaxis. The last Phase II clinical trial in India was initiated in November 2011. In 2011, Sanofi Pasteur reviewed the rabies mAb project, developed in partnership with Crucell. Crucell, acquired by Johnson & Johnson will takein 2011, has taken over full responsibility for the development of the product and Sanofi Pasteur will market it, when the vaccine is available.
New Vaccine Targets
Dengue— Dengue fever has increasing epidemiological importance due to global socio-climatic changes. It is a major medical and economic burden in the endemic areas of Asia-Pacific, Latin America and Africa. It is also one of the leading causes of fever among travelers. Multiple approaches have been tested to develop a vaccine covering the four viral serotypes of dengue fever in order to prevent this disease and its severe complications (hemorrhagic fever). Results of a Phase II clinical trial in adults in the United States demonstrated proof of concept of the lead quadrivalent vaccine candidate. Sanofi Pasteur’sPasteur's dengue vaccine research program includes ongoing clinical studies (adults and children) in several countries in endemic regions. The first Phase III study was initiated in October 2010 in Australia. This final stagecomplexity of clinical development aims at demonstrating that production of thedengue virus infection has hampered vaccine on an industrial scale will meet the consistency criteria requiredresearch for market authorizations. The study in Australiadecades and it is the first to use ourtime in 50 years of dengue research that a vaccine was seen that protected a large group of children from clinical disease caused by dengue viruses. The results of the world's first efficacy study confirmed the excellent safety profile of Sanofi Pasteur's dengue vaccine doses produced on an industrial scale. Twocandidate. The full analysis of vaccine efficacy against each serotype, reflecting real-life conditions (intent to treat analysis) showed vaccine efficacy to be 61.2% against dengue virus type 1, 81.9% against type 3 and 90% against type 4. One of the
dengue virus types (serotype 2) eluded the vaccine. Analyses are ongoing to understand the lack of protection for serotype 2. Phase III efficacy studies to evaluate efficacy (Latin Americaare ongoing in several Latin American and Asia Pacific) began in June 2011. In February 2011, Sanofi Pasteur announced that it was partnering with the International Vaccine Institute (IVI) to support the recently launched Dengue Vaccine Initiative (DVI) in collaboration with the Sabin Vaccine Institute, the Johns Hopkins University, and the WHO to support development of vaccines to control dengue fever.South East Asian countries.
Tuberculosis— Statens Serum Institute of Denmark (SSI) has granted Sanofi Pasteur a license to its technology with regard to the use of certain fusion proteins in the development of a tuberculosis vaccine. The license from SSI includes access to the Intercell IC31®IC31® adjuvant. The candidate vaccine is made up of recombinant protein units. Results from the 2008 Phase I trial found that the H4/IC31 candidate was safe when administered to healthy adults living in a region of high endemic tuberculosis. Rapid and poly-functional antigen-specific T cell responses were induced following a single dose of the investigational vaccine. A second Phase I trial was initiated in Switzerland in December 2010,2010. A Phase I/II study will be initiated in the Republic of South Africa in infants primed with full enrollment completed in June 2011.BCG.
HIV — A follow-up study to the Phase III clinical trial in Thailand provided new clues in 2011 about the types of immune responses that may have played a role in the protection seen in 2009 with our ALVAC-HIVALVAC®-HIV vaccine. Last year,In 2011, Sanofi Pasteur entered into a public-private partnership with Novartis Vaccines, the Bill & Melinda Gates Foundation, the U.S. National Institutes of Health (NIH), the HIV Vaccine Trial Network, and the Military HIV Research Program to substantiate and extend the vector prime/protein subunit boost regimen used in Thailand. Plans are being made to also study the regimen in the Republic of South Africa. This collaboration is expected to further the field of HIV vaccine development by sharing resources and by providing the manufacturing component of a partnership of funding agencies, research organizations, governments, and experts in the field of HIV vaccine development. Sanofi Pasteur is also looking at its NYVAC-HIV vaccine replicating vectors and a flavivirus-based viral vector, Replivax, by participating in the Pox-T-cellinternational consortium and the IPPOX Foundation inunder the Collaboration for AIDS Vaccine Discovery (CAVD).
ACAM-Cdiff —Clostridium difficile is a major public health concern in North America and Europe. In hospitals, it is the leading cause of infectious diarrhea in adults, particularly the elderly. The epidemiology ofClostridium difficile associated disease (CDAD) has been increasing at an alarminga worrying rate since 2003, driven
primarily by the emergence of a treatment-resistant, highly virulent strain CD027. There is currently no vaccine available and the only vaccine candidate currently in development is ACAM-Cdiff. ACAM-Cdiff is a toxoid-based vaccine. Toxoids have been used as the basis of a number of highly successful licensed vaccines. This vaccine candidate has successfully completed Phase I clinical trials with more than 200 participants in which safety and immunogenicity were evaluated. Sanofi Pasteur received a positive response from the United States. FDA’sStates FDA's Center for Biologics Evaluation & Research (CBER) on the Fast Track Development Program submission in 2010. In November 2010, ourClostridium difficilevaccine started Phase II of clinical study in the U.S. This trial is focused on evaluating prevention of the first episode ofClostridium difficile infection (CDI) in at-risk individuals, which includes adults with imminent hospitalization or current or impending residence in a long-term care or rehabilitation facility. Results from the first stage of this study showed the vaccine was safe and immunogenic and provided important information for dose selection. The ongoing stage 2Phase II study results are under review. A multinational Phase III trial is planned to start in the third quarter of the study is evaluating the dosing schedule.2013.
Pseudomonas aeruginosa— In February 2010, Sanofi Pasteur entered into an agreement with KaloBios Pharmaceuticals, a U.S.-based, privately held biotech company, for the development of a Humaneered™ antibody fragment to both treat and preventPseudomonas aeruginosa (Pa) infections. Most seriousPa infections occur in hospitalized and critically or chronically ill patients — primarily affecting the respiratory system in susceptible individuals — and are a serious clinical problem due to their resistance to antibiotics. The two primary target indications for the antibody are prevention ofPa associated pneumonia in mechanically ventilated patients in hospitals, and prevention of relapses and potential improvement of treatment outcomes in patients with an ongoingPa infection. Under the terms of the agreement, Sanofi Pasteur acquired worldwide rights for all disease indications related toPa infections except cystic fibrosis and bronchiectasis, which Sanofi Pasteur has the option to obtain at a later date. KaloBios has already completed Phase I clinical trials — one in healthy volunteers and one in cystic fibrosis patients — and a small proof of concept Phase II clinical trial in mechanically ventilated patients.patients using anE. coli-derived antibody fragment. A Phase I study in healthy adult volunteers has been initiated in December 2012 with a Chinese hamster ovary cell-derived antibody fragment.
Rotavirus— Rotavirus is the leading cause of severe, dehydrating diarrhea in children aged under five globally. Estimates suggest that rotavirus causes over 25 million outpatient visits, over 2 million hospitalizations and over 500,000 deaths per year. The burden of severe rotavirus illness and deaths falls heavily upon children in the poorer countries of the world, with more than 80% of rotavirus-related deaths estimated to occur in lower income countries of Asia, and in sub-Saharan Africa. Two vaccines (RotaTeq®(RotaTeq® and Rotarix®Rotarix®) are licensed worldwide, but production of local vaccines is necessary to achieve wide coverage. Shantha has a non-exclusive license of rotavirus strains from the U.S. NIH and is developing a live-attenuated human bovine (G1-G4) reassortant vaccine. The license excludes Europe, Canada, United States, China and Brazil. The project is currently in Phase I.I/II (dose finding study).
Patents, Intellectual Property and Other Rights
Patent Protection
We own a broad portfolio of patents, patent applications and patent licenses worldwide. These patents are of various types and may cover:
Patent protection for individual products typically extends for 20 years from the patent filing date in countries where we seek patent protection. A substantial part of the 20-year life span of a patent on a new chemical entity has generally already passed by the time the related product obtains marketing approval. As a
result, the effective period of patent protection for an approved product’sproduct's active ingredient is significantly shorter than 20 years. In some cases, the period of effective protection may be extended by procedures established to compensate significant regulatory delay in Europe (a Supplementary Protection Certificate or SPC), the United States (a Patent Term Extension or PTE) and Japan (also a PTE).
Additionally, the product may benefit from the protection of patents obtained during development or after the product’sproduct's initial marketing approval. The protection a patent affords the related product depends upon the type of patent and its scope of coverage, and may also vary from country to country. In Europe for instance, applications for new patents may be submitted to the European Patent Office (EPO), an intergovernmental organization which centralizes filing and prosecution. As of December 2011,2012, an EPO patent application may cover the 38 European Patent Convention member states, including all 27 member states of the European Union. The granted “European Patent”"European Patent" establishes corresponding national patents with uniform patent claims among the member states. However, some older patents were not approved through this centralized process, resulting in patents having claim terms for the same invention that differ by country. Additionally, a number of patents prosecuted through the EPO may pre-date the European Patent Convention accession of some current European Patent Convention member states, resulting in different treatment in those countries.
We monitor our competitors and vigorously seek to challenge patent infringement when such challenges would negatively impact our business objectives. See “Item"Item 8 -— A. Consolidated Financial Statements and Other Financial Information — Patents”Patents" of this annual report.
The expiration or loss of an active ingredienta compound patent may result in significant competition from generic products and can result in a dramatic reduction in sales of the original branded product. See Item"Item 3. Key Information — D. Risk Factors — “Generic versions of some of our products may be approved for sale in one or more of their major markets”; and “WeWe may lose market share to competing remedies or generic brands if they are perceived to be equivalent or superior products”products". In some cases, it is possible to continue to obtain commercial benefits from product
manufacturing trade secrets or from other types of patents, such as patents on processes, intermediates, structure, formulations, methods of treatment, indications or delivery systems. Certain categories of products, such as traditional vaccines and insulin, have been historically relatively less reliant on patent protection and may in many cases have no patent coverage, although it is increasingly frequent for novel vaccines and insulins to be patent protected. See “—"— Focus on Biologics”Biologics" below. Patent protection is also an important factor in our animal health business, but is of comparatively lesser importance to our Consumer Health Care and generics businesses, which rely principally on trademark protection.
Regulatory Exclusivity
In some markets, including the European Union and the United States, many of our pharmaceutical products may also benefit from multi-year regulatory exclusivity periods, during which a generic competitor may not rely on our clinical trial and safety data in its drug application. Exclusivity is meant to encourage investment in research and development by providing innovators the exclusive use for a limited time of the innovation represented by a newly approved drug product. This exclusivity operates independently of patent protection and may protect the product from generic competition even if there is no patent covering the product.
In the United States, the FDA will not grant final marketing approval to a generic competitor for a New Chemical Entity (NCE) until the expiration of the regulatory exclusivity period (generally five years) that commences upon the first marketing authorization of the reference product. The FDA will accept the filing of an Abbreviated New Drug Application (ANDA) containing a patent challenge one year before the end of this regulatory exclusivity period (see the descriptions of ANDAs in “—"— Product Overview — Challenges to Patented Products”Products" below). In addition to the regulatory exclusivity granted to NCEs, significant line extensions of existing NCEs may qualify for an additional three years of regulatory exclusivity. Also, under certain limited conditions, it is possible to extend unexpired U.S. regulatory and patent-related exclusivities by a pediatric extension. See “—"— Pediatric Extension”Extension", below.
Further, in the United States, a different regulatory exclusivity period applies to biological drugs. The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”("BPCIA"), was enacted on March 23, 2010 as part of the much larger health care reform legislation known as the Patient Protection and Affordable Care Act
(“PPACA” ("PPACA"). The BPCIA introduced an approval pathway for biosimilar products. A biosimilar product is a biologic product that is highly similar to the reference (or innovator) product notwithstanding minor differences in clinically inactive components, and which has no clinically meaningful differences from the reference product in terms of the safety, purity, and potency of the product. The BPCIA provides that an application for a biosimilar product that relies on a reference product may not be submitted to the FDA until four years after the date on which the reference product was first licensed, and that the FDA may not approve a biosimilar application until twelve12 years after the date on which the reference product was first licensed.
In the European Union, regulatory exclusivity is available in two forms: data exclusivity and marketing exclusivity. Generic drug applications will not be accepted for review until eight years after the first marketing authorization (data exclusivity). This eight-year period is followed by a two-year period during which generics cannot be marketed (marketing exclusivity). The marketing exclusivity period can be extended to three years if, during the first eight-year period, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which are deemed to provide a significant clinical benefit over existing therapies. This is known as the “8+"8+2+1”1" rule.
In Japan, the regulatory exclusivity period varies from four years (forfor medicinal products with new indications, formulations, dosages, or compositions with related prescriptions)prescriptions, to six years (forfor new drugs containing a medicinal composition, or requiring a new route of administration)administration, to eight years (forfor drugs containing a new chemical entity)entity, to ten years (forfor orphan drugs or new drugs requiring pharmaco-epidemiological study).study.
Emerging Markets
One of the main limitations on our operations in emerging market countries is the lack of effective intellectual property protection or enforcement for our products. The World Trade Organization (WTO) Agreement on Trade-RelatedTrade-
Related Aspects of Intellectual Property Rights (TRIP) has required developing countries to amend their intellectual property laws to provide patent protection for pharmaceutical products since January 1, 2005, although it provides a limited number of developing countries an extension to 2016. Additionally, these same countries frequently do not provide non-patent exclusivity for innovative products. While the situation has gradually improved, the lack of protection for intellectual property rights or the lack of robust enforcement of intellectual property rights poses difficulties in certain countries. Additionally, in recent years a number of countries facing health crises have waived or threatened to waive intellectual property protection for specific products, for example through compulsory licensing.licensing of generics. See “Item"Item 3. Key Information — D. Risk Factors — Risks Relating to Our Business — The globalization of the Group’sGroup's business exposes us to increased risks.”"
Pediatric Extension
In the United States and Europe, under certain conditions, it is possible to extend a product’sproduct's regulatory exclusivities for an additional period of time by providing data regarding pediatric studies.
In the United States, the FDA may ask a company for pediatric studies if it has determined that information related to the use of the drugs in the pediatric population may produce health benefits. The FDA has invited us by written request to provide additional pediatric data on several of our main products. Under the Hatch-Waxman Act, timely provision of data meeting the FDA’sFDA's requirements (regardless of whether the data supports a pediatric indication) may result in the FDA extending regulatory exclusivity and patent life by six months, to the extent these protections have not already expired (the so-called “pediatric exclusivity”"pediatric exclusivity"). Our main products which have received FDA grants of pediatric exclusivity at some point are Aprovel®Aprovel®, Lantus®Lantus®, Allegra®Allegra®, Ambien®Ambien®/Ambien®Ambien® CR, Plavix® Taxotere®Plavix®, Taxotere®, and Actonel®Actonel®.
In Europe, a regulation on pediatric medicines provides for pediatric research obligations with potential associated rewards including extension of patent protection (for patented medicinal products) and regulatory exclusivity for pediatric marketing authorization (for off-patent medicinal products).
In Japan, for pediatric research there is no extension of patent protection (for patented medicinal products), however, it may result in an extension of marketing exclusivity from 8 to 10 years.
Orphan Drug Exclusivity
Orphan drug exclusivity may be granted in the United States to drugs intended to treat rare diseases or conditions (affecting fewer than 200,000 patients in the U.S. or in some cases more than 200,000 with no expectation of recovering costs).
Obtaining orphan drug exclusivity is a two-step process. An applicant must first seek and obtain orphan drug designation from the FDA for its drug. If the FDA approves the drug for the designated indication, the drug will receive orphan drug exclusivity.
Orphan drug exclusivity runs from the time of approval and bars approval of another application (ANDA, 505(b)(2), New Drug Application (NDA) or Biologic License Application (BLA)) from a different sponsor for the same drug in the same indication for a seven-year period. Whether a subsequent application is for the “same”"same" drug depends upon the chemical and clinical characteristics. The FDA may approve applications for the “same”"same" drug for indications not protected by orphan exclusivity.
Orphan drug exclusivities also exist in the European Union and Japan.
Product Overview
We summarize below the intellectual property coverage in our major markets of the marketed products described above at “—"— Pharmaceutical Products — Main Pharmaceutical Products”Products". Concerning animal health products, Merial’sMerial's intellectual property coverage is described above (see “—"— Animal Health: Merial”Merial"). In the discussion of patents below, we focus on active ingredient patents (compound patents) and any later filed improvement patents listed, as applicable, in the FDA’sFDA's list of Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”
"Orange Book") or on their foreign equivalents. These patents tend to be the most relevant in the event of an application by a competitor to produce a generic version of one of our products or the equivalent of these patents in other countries (see “—"— Challenges to Patented Products”Products" below). In some cases, products may also benefit from pending patent applications or from patents not eligible for Orange Book listing (e.g., patents claiming industrial processes). In each case below, we specify whether the active ingredient is claimed by an unexpired patent. Where patent terms have been extended to compensate for regulatory delay, the extended dates are presented below. U.S. patent expirations presented below reflect U.S. Patent and Trademark Office dates, and therefore do notalso reflect six-month pediatric extensions to the FDA’sFDA's Orange Book dates for the products concerned (Aprovel®, Lantus®, Plavix®,Lantus® and Actonel®)Actonel®.
We do not provide later filed improvement patent information relating to formulations already available as an unlicensed generic. References below to patent protection in Europe indicate the existence of relevant patents in most major markets in the European Union. Specific situations may vary by country, most notably with respect to older patents and to countries having only recently joined the European Union.
We additionally set out any regulatory exclusivity from which these products continue to benefit in the United States, European Union or Japan. Regulatory exclusivities presented below incorporate any pediatric extensions obtained. While EUE.U. regulatory exclusivity is intended to be applied throughout the European Union, in some cases member states have taken positions prejudicial to our exclusivity rights. See “— Regulatory Exclusivity” above.
U.S. | E.U. | Japan | |||||||
Compound: August 2014, protection extended to February 2015 by Pediatric extension | Compound: November 2014 in most of Western Europe requests for pediatric exclusivity until May 2015 are pending | Compound: November 2014 |
U.S. | E.U. | Japan | |||||||
Compound: June 2018 | Compound: September 2019 in most of the EU | Compound: May 2022 | |||||||
Later filed | Later filed
| Later filed | |||||||
Regulatory exclusivity: September 2014 | Regulatory exclusivity: April 2017 |
U.S. | E.U. | Japan | |||||||
Compound: expired | Compound: expired | Compound: | |||||||
expired | |||||||||
Generics on the market | Generics on the market |
U.S. | E.U. | Japan | |||||||
Compound: expired | Compound: expired | Compound: N/A | |||||||
| Generics on the market (2) | Generics on the market |
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U.S. | E.U. | Japan | |||||||
Compound: March 2016 (up to March 2021 if PTE is granted) | Compound: March 2016 | Compound: March 2016 (patent term extension to be determined once product is approved in Japan) | |||||||
Later filed | Later filed | Later filed | |||||||
Regulatory exclusivity: June 2015 | Regulatory exclusivity: March 2021 | Regulatory |
U.S. | E.U. | Japan | |||||||
| Compound: expired | Compound: expired | |||||||
Generics on the market |
Regulatory exclusivity: January 2016 |
U.S. | E.U. | Japan | |||||||
| Generics on the market | Compound: expired | |||||||
Generics on the market | |||||||||
Regulatory exclusivity: January 2014 |
Aprovel® (irbesartan) | ||||||
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U.S. | E.U. | Japan | ||||
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| Compound: March 2016 | ||||
Generics on the market |
Generics on the market | Regulatory exclusivity: April 2016 |
U.S. | E.U. | Japan | |||||||
N/A | Compound: expired | Compound: expired | |||||||
Generics on the market |
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U.S. | E.U. | Japan | |||||||
| Compound: expired | Compound: expired | |||||||
Later filed
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Later filed in most of the countries | ||||||||
Regulatory exclusivity: July 2014 | Regulatory exclusivity: November 2019 |
U.S. | E.U. | Japan | |||||||
| Compound patent: expired | Compound patent: expired | |||||||
Generics on the market |
Generics on the market | ||||||||
Regulatory exclusivity: expired | |||||||||
Later filed |
U.S. | E.U. | Japan | |||||||
Compound: N/A | Compound: N/A (1) | Compound: N/A (1) | |||||||
Depakine® Chronosphere formulation (October 2017) | formulation (October 2017) |
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U.S. | E.U. | Japan | |||||||
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Compound: expired
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Generics on the market | Generics on the market | Generics on the market | ||
Converted to Over-the-Counter | Converted to over-the counter | |||
Later filed patents: coverage ranging through January 2016 |
Nasacort® (triamcinolone acetonide) (1) | ||||
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U.S. | E.U. | Japan | ||
| Compound: expired | Compound: expired | ||
Later filed patents: formulation and method of use July 2016 | ||||
Generics on the market |
U.S. | E.U. | Japan | |||||||
Compound: expired | Compound: expired | Compound: expired | |||||||
Generics on the market | Generics on the market | Generics on the market |
Actonel® (risedronate sodium) (1) | ||||
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U.S. | E.U. | Japan | ||
Compound: December 2013, Extended to June 2014 by Pediatric extension | Compound: expired | Compound: Expired | ||
Later filed | Later filed |
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U.S. | E.U. | Japan | |||||||
Compound: expired | Compound: expired | Compound: expired |
U.S. | E.U. | Japan | |||||||
Compound: N/A | Compound: N/A | Compound: N/A |
U.S. | E.U. | Japan | |||||||
Compound: N/A | Compound: N/A | Compound: N/A | |||||||
Later filed | Later filed patents: November 2013 | ||||||||
Biologics Regulatory Exclusivity: April 2015 |
Orphan regulatory exclusivity: January 2014 |
Cerezyme® (imiglucerase) | ||||
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U.S. | E.U. | Japan | ||
Compound: August 2013 | Compound: N/A | Compound: N/A |
Lumizyme® / Myozyme® (alglucosidase alpha) | |||||||||
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U.S. | E.U. | Japan | |||||||
N/A |
N/A | Compound: N/A Later filed patents: 2021 | |||||||
Orphan Drug Exclusivity: April 2013 |
Orphan Regulatory Exclusivity: March 2016 | Orphan Regulatory Exclusivity: April 2017 | |||||||
Biologics Regulatory Exclusivity: April 2018 |
Biologics Regulatory Exclusivity: March 2016 |
U.S. | E.U. | Japan | |||||||
| Compound: N/A | Compound: N/A | |||||||
Later filed | Later filed | Later filed | |||||||
SPC coverage to January 2015 in certain EU countries | PTE protection to December 2016 |
U.S. | E.U. | Japan | |||||||
Compound: N/A | Compound: N/A | Compound: N/A | |||||||
Later filed | Later filed | Later filed | |||||||
SPC coverage to January 2015 in certain EU countries | |||||||||
SPC coverage to August 2019 in certain countries (Austria, Greece and Luxembourg) |
U.S. | E.U. | Japan | |||||||
Compound: expired | Compound: N/A | Compound: |
U.S. | E.U. | Japan | |||||||
Compound: expired | Compound: N/A | Compound: | |||||||
expired | |||||||||
Later filed |
Lyxumia® (lixisenatide) | ||||
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U.S. | E.U. | Japan | ||
Compound: July 2020 | Compound: July 2020 | Compound: July 2020 |
Zaltrap® (aflibercept) | ||||
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U.S. | E.U. | Japan | ||
Compound: May 2020 (July 2022 if PTE is granted) | Compound: May 2020 (May 2025 if SPC granted) | Compound: May 2020 | ||
Biologics Regulatory Exclusivity: November 2023 | Regulatory Exclusivity: November 2022 |
Aubagio® (teriflunomide) | ||||
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U.S. | E.U. | Japan | ||
Compound: October 2014 (2019 if PTE is granted) | Compound: expired | Compound: expired | ||
Regulatory Exclusivity: September 2017 |
Kynamro™ (mipomersen) | ||||
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U.S. | E.U. | Japan | ||
Compound: December 2025 | Compound: pending | Compound: 2023 |
Patents held or licensed by the Group do not in all cases provide effective protection against a competitor’scompetitor's generic version of our products. For example, notwithstanding the presence of unexpired patents, competitors have launched generic versions of Eloxatin®Eloxatin® in Europe, Allegra®Allegra® in the United States (prior to the product being switched to over-the-counter status) and Plavix®Plavix® in Europe.
We caution the reader that there can be no assurance that we will prevail when we assert a patent in litigation and that there may be instances in which the Group determines that it does not have a sufficient basis to assert one or more of the patents mentioned in this report, for example in cases where a competitor proposes a formulation not appearing to fall within the claims of our formulation patent, a salt or crystalline form not claimed by our composition of matter patent, or an indication not covered by our method of use patent. See “Item"Item 3. Key Information — D. Risk Factors — Risks Relating to Legal Matters — We rely on our patents and proprietary rights to provide exclusive rights to market certain of our products, and if such patents and other rights were limited or circumvented, our financial results could be materially and adversely affected.”"
As disclosed in Item 8 of this annual report, we are involved in significant litigation concerning the patent protection of a number of our products.
Challenges to Patented Products
In the United States, companies have filed Abbreviated New Drug Applications (ANDAs), containing challenges to patents related to a number of our products. An ANDA is an application by a drug manufacturer to receive authority to market a generic version of another company’scompany's approved product, by demonstrating that the purportedly generic version has the same properties as the original approved product. ANDAs may not be filed with respect to drugs licensed as a biological. See “—"— Focus on Biologics”Biologics" below. An ANDA relies on the safety and other technical data of the original approved product, and does not generally require the generic manufacturer to conduct clinical trials (thus the name “abbreviated”"abbreviated" new drug application), presenting a significant benefit in terms of time and cost. As a result of regulatory protection of our safety and other technical data, the ANDA may generally be filed only five years following the initial U.S. marketing authorization of the original product. See “—"— Regulatory Exclusivity”Exclusivity" above. This period can be reduced to four years if the ANDA includes a challenge to a patent listed in the FDA’sFDA's Orange Book. However, in such a case if the patent holder or licensee brings suit in response to the patent challenge within the statutory window, then the FDA is barred from granting final approval to an ANDA during the 30 months following the patent challenge (this bar is referred to in our industry as a “30-month stay”"30-month stay"), unless, before the end of the 30 months, a court decision or settlement has determined either that the ANDA does not infringe the listed patent or that the listed patent is invalid and/or unenforceable.
FDA approval of an ANDA after this 30-month period does not resolve outstanding patent disputes, but it does remove the regulatory impediments to a product launch by a generic manufacturer willing to take the risk of later being ordered to pay damages to the patent holder.
Procedures comparable to the ANDA exist in other major markets.
In the European Union, a generic drug manufacturer may only reference the data of the regulatory file for the original approved product after data exclusivity has expired. However, there is no patent listing system in Europe comparable to the Orange Book, which would allow the patent holder to prevent the competent authorities from granting marketing approval by bringing patent infringement litigation prior to approval. As a result, generic products may be approved for marketing following the expiration of marketing exclusivity without regard to the patent holder’sholder's rights. Nevertheless, in most of these jurisdictions once the competing product is launched and in some jurisdictions, even prior to launch (once launch is imminent), the patent holder may seek an injunction against such marketing if it believes its patents are infringed. See Item 8 of this annual report.
The accelerated ANDA-type procedures are potentially applicable to many, but not all, of the products we manufacture. See “—"— Focus on Biologics”Biologics" and “— Regulation”"— Regulation" below. We seek to defend our patent rights vigorously in these cases. Success or failure in the assertion of a given patent against a competing product is not necessarily predictive of the future success or failure in the assertion of the same patent -— ora fortiori the corresponding foreign patent — against another competing product due to factors such as possible differences in the formulations of the competing products, intervening developments in law or jurisprudence, local variations in the patents and differences in national patent law and legal systems. See “Item"Item 3. Key Information — D. Risk Factors — Risks Relating to Legal Matters — We rely on our patents and proprietary rights to provide exclusive rights to market certain of our products, and if such patents and other rights were limited or circumvented, our financial results could be materially and adversely affected”affected".
Trademarks
Our products are sold around the world under trademarks that we consider to be of material importance in the aggregate. Our trademarks help to identify our products and to protect the sustainability of our growth. Trademarks are particularly important to the commercial success of our CHC, generics and retail animal health business.
It is our policy to protect and register our trademarks with a strategy adapted to each product or service depending on their countries of commercialization:i.e., on a worldwide basis for worldwide products or services, or on a regional or local basis for regional or local products or services.
The process and degree of trademark protection vary country by country, as each country applies its own trademark laws and regulations. In most countries, trademark rights may only be obtained through formal trademark application and registration. In some countries, trademark protection can be based primarily on use. Registrations are granted for a fixed term (in most cases ten years) and are renewable indefinitely, except in some countries where maintenance of the trademarks is subject to their effective use.
When trademark protection is based on use, it covers the products and services for which the trademark is used. When trademark protection is based on registration, it covers only the products and services designated in the registration certificate. Additionally, in certain cases, we may enter into a coexistence agreement with a third-party that owns potentially conflicting rights in order to better protect and defend our trademarks.
Our trademarks are monitored and defended based on this policy and in order to prevent counterfeit, infringement and/or unfair competition.
Production and Raw Materials
For many years, we have chosen to integratekeep the manufacture of our products in-house in order to have better control of quality and distribution. Our manufacturingproduction process consists of three principal stages: the manufacture of active pharmaceutical ingredients, the transformation of these ingredients into products, and packaging.
We have aOur general policy of producingis to produce our main active ingredients and principal products at our own plants in order to minimize our dependence on external manufacturers and ensure theto maintain strict and precise control ofover the product throughout the production cycle. In some cases, however, we rely on third parties for the manufacture and supply of somecertain active ingredients and medical devices. We also have outsourced certainsome of our production, elements, particularly as part ofunder supply framework agreements entered into within the context ofcontracts associated with plant divestitures or in order to adapt locallyestablish a local presence to marketcapitalize on growth in emerging markets. In particular, we outsource a part of the production of the active ingredients used in Stilnox®Stilnox® and Xatral®Xatral®, and certain pharmaceutical product formulations. Our main pharmaceutical subcontractors are Famar, Haupt, Patheon, Catalent and Sofarimex. These subcontractors follow our general quality and logistics policies, as well as meeting other criteria. See section “3.D."Item 3. Key Information — D. Risk factorsFactors — Risks Relating to Our Business”Business".
We also depend on third parties for the manufacture of certain products. Under our partnershipalliance with BMS, a multi-vendor supply and safety stock have been putarrangements are in place for Plavix®Plavix® (clopidogrel bisulfate) and Aprovel®Aprovel® (irbesartan).
Our pharmaceutical production sites are divided into three categories:
global
regional
local
Sanofi Pasteur produces vaccines at sites located in North America, France, Mexico, China, Thailand, Argentina and India. The pharmaceutical sites at Le Trait (France) and Anagni (Italy) pharmaceutical sites form part ofalso contribute to Sanofi Pasteur’sPasteur's industrial operations and carry outby making available their aseptic filling and freeze-drying activities.facilities. A new antigen production unitfacility in Mexico for seasonal and pandemic influenza vaccines is scheduled to commencewas approved by the Mexican authorities early in 2012, and began commercial production in 2012, once the necessary production and marketing approvals have been obtained fromtime for the Mexican authorities.influenza vaccination campaign in September 2012.
In 2011, we diversified our industrial operations diversified into rare diseases with(with the acquisition of GenzymeGenzyme) and via the integration of Merial, Sanofi’sSanofi's dedicated animal health division.
Genzyme’s activities throughout the world cover all biomedicine development stages, from initial research to clinical trials, regulatory matters, manufacture and marketing.
Merial markets pharmaceutical products (Frontline®(Frontline®, Heartgard®Heartgard®, Zactran®Zactran®, Previcox®Previcox®) and a broad range of vaccines for different animal species (dogs, cats, horses, ruminants, pigs and fowl). A number of pharmaceutical products are subcontracted (Heartgard®(Heartgard®, Eprinex®Eprinex®) but almost all veterinary vaccines are manufactured at its own plants. Merial’sMerial's dedicated animal health industrial operations dedicated to animal health cover all activities, from the purchase of raw materials through to the delivery of the finished products, ensuring its customers’product, meeting customer needs can be met through a reliable and flexible offeroffering that meets quality expectations. There are sixteen17 production sites spread across nine countries.
All of our pharmaceutical and vaccine facilities are Good Manufacturing Practices (GMP) compliant, in line with international guidelines. Our principal sites are approved by the U.S. Food & Drug Administration (FDA): this includes.
This applies to our pharmaceutical facilities in AmbarèFrance (Ambarès, Tours, Le Trait, Maisons-Alfort, and Compiègne in France, Dagenham and Holmes ChapelLyon); in the United Kingdom Frankfurt(Haverhill, Holmes Chapel, Dagenham and Fawdon, the last two of which are due to close in 2013 and 2015, respectively); in Ireland (Waterford); in Germany Veresegyhaz(Frankfurt); in Hungary (Veresegyhaz); in Italy (Anagni); and Saint Louis in the United States as well as our vaccine facilities(Saint Louis). Our Vaccines sites with FDA approval are Marcy l'Étoile and Le Trait (Fluzone® ID USA) in Marcy l’EtoileFrance; Swiftwater, Canton and Val de Reuil (our worldwide distribution site) in France, SwiftwaterRockville in the United StatesStates; and Toronto in Canada.
The Genzyme facilities in the United States (Allston, Framingham, Ridgefield, Cambridge) and in Europe (Geel, Lyon, Haverhill and Waterford)Belgium) are all FDA approved.
Our animal health facilities in Athens, Worthington, Gainesville, Berlin and Raleigh in the United States are managed by the U.S. Department of Agriculture (USDA)., while the sites at Paulinia (Brazil) and Toulouse (France) have FDA approval for some of their operations.
Wherever possible, we seek to have multiple plants approved for the production of key active ingredients and our strategic finished products. This is the case of Lovenox®with Lovenox®, for example.
In February 2011, we had received an FDA warning letter concerning our Frankfurt facility following a routine FDA inspection in September 2010. The warning letter cited GMP compliance issues in certain manufacturing processes, without referring to specific products. While believing that the points raised in the letter did not compromise the quality of our marketed products, we acted on this warning and worked towards satisfying the recommendations through a “compliance first” improvement"compliance first" action plan.plan at the Frankfurt facility. In October 2011, we notified the FDA ofthat we had completed this plan. The FDA reinspected the end of this program. We expectsite in April 2012, and issued an unqualified report on Form FDA 483. This was confirmed in the FDA inspection to take place duringEstablishment Inspection Report, received August 14, 2012, which officially closed the second quarter of 2012.warning letter procedure.
On May 24, 2010, Genzyme entered into a consent decree with the FDA relating to the facility at Allston facilityin the United States, following FDA inspections at the Allston facility that resulted in 483 observations and a warning letter raising CGMP
Current Good Manufacturing Practices (CGMP) deficiencies. A consent decree is a court order entered by agreement between a company and the government (in this case the FDA) that requires the company to take certain actions as set out in the decree. Under the terms of Genzyme’s consent decree, Genzyme paid an upfront disgorgement of past profits of $175.0 million. Conditioned upon Genzyme’s compliance with the terms of theGenzyme's consent decree, Genzyme is permitted to continue manufacturing at the site during the remediation process.process, subject to compliance with the terms of the consent decree.
The consent decree requires Genzyme to implement a plan to bring the Allston facility operations into compliance with applicable laws and regulations. The plan must address any deficiencies previously reported to Genzyme or identified as part of a comprehensivean inspection that was completed by a third-party expert in February 2011. This third partyGenzyme has itself retained an expert has been retained by Genzyme and willto monitor and oversee the implementation of the remediation workplan. The required comprehensive remediationThis workplan was submitted to the FDA in April 2011 and accepted by the FDA in January 2012. The workplan2012, and is expected to take approximately four morea further three years to complete. The workplanIt includes a timetable of specified remediation compliance milestones. If the milestones are not met in accordance with the timetable, the FDA can require us to pay $15,000 per day, per affected drug, until these compliance milestones are met. Upon satisfying all compliance requirements in accordance with the terms of the consent decree, Genzyme will be required to retain an auditor to monitor and oversee ongoing compliance at the Allston facility for an additional five years. To date, all requirements of the consent decree, including all requirements of the workplan, have been met by Genzyme.
Genzyme will be meeting with the FDA to proposeIn March 2012, modifications to the workplan as a resultwere submitted to the FDA to take account of planned changes in manufacturing operations regarding Cerezyme®for Fabrazyme® and Fabrazyme® forCerezyme® at the Allston Landing Facility.
The new Genzymefacility. These modifications were accepted by the FDA. In addition, the U.S. facility at Framingham (U.S.) facility was approved by the FDA and the EMA in January 2012 for the production of Fabrazyme® (agalsidase beta)Fabrazyme®.
On July 12, 2012, Sanofi Pasteur received a warning letter from the FDA following routine inspections conducted during 2012 at its facilities in Toronto (Canada) and Marcy l'Étoile (France). The Merial animal health facilities are regulated by different authorities depending onwarning letter contains observations about products intended for the productU.S. market, and the country (EPA,premises in which they are produced. Sanofi Pasteur takes these observations extremely seriously, and is working actively with the FDA USDA, EU GMP, local authorities).to implement a series of immediate and ongoing measures to address the issues raised in the warning letter and to further strengthen its production tools and quality systems.
More details about our manufacturing sites are found below at “—"— Property, Plant and Equipment”Equipment".
Health, Safety and Environment (HSE)
The manufacturing and research operations of Sanofi are subject to increasingly stringent health, safety and environmental (HSE) laws and regulations. These laws and regulations are complex and rapidly changing, and Sanofi invests the necessary sums in order to comply with them. This investment, which aims to respect health, safety and the environment, varies from year to year and totaled approximately €105€100 million in 2011.2012.
The applicable environmental laws and regulations may require Sanofi to eradicate or reduce the effects of chemical substance usage and release at its various sites. The sites in question may belong to the Group, be currently operational, or they may have been owned or operational in the past. Under some of these laws and regulations, a current or previous owner or operator of a property may be held liable for the costs of removal or remediation of hazardous substances on, under or in its property, or transported from its property to third party sites, without regard to whether the owner or operator knew of, or under certain circumstances caused the presence of the contaminants, or at the time site operations occurred, the discharge of those substances was authorized.
Moreover, as is the case for a number of companies involved in the pharmaceutical, chemical and agrochemical industries, soil and groundwater contamination has occurred at some Group sites in the past, and may still occur or be discovered at others. In the Group’sGroup's case, such sites are mainly located in the United States, Germany, France, Hungary, the Czech Republic, Slovakia, Brazil, Italy and the United Kingdom. As part of a program of environmental audits conducted over the last few years, detailed assessments of the risk of soil and groundwater contamination have been carried out at current and former Group sites. In cooperation with national and local authorities, the Group regularly assesses the rehabilitation work required and carries out such work when appropriate. Long-term rehabilitation work is in progress or planed in Rochester, Cincinnati, Mount-Pleasant, East Palo Alto, Ambler and Portland in the United States; Frankfurt in Germany; Beaucaire, Valernes, Limay, Rousset,
Romainville, Neuville, Vitry and Toulouse in France; Dagenham in the United Kingdom; Brindisi and Garessio in Italy; Ujpest in Hungary; Hlohovec in Slovakia; Prague in the Czech Republic; and on a number of sites divested to third parties and covered by contractual environmental guarantees granted by Sanofi. Sanofi may also have potential liability for investigation and cleanup at several other sites.
Provisions have been established for the sites already identified and to cover contractual guarantees for environmental liabilities for sites that have been divested. For example, in 2007 the State of New Jersey initiated a claim against Bayer CropScience seeking compensation for damages caused to natural resources (NRD) at a former Rhône-Poulenc site in the United States, resulting in indemnification claims by Bayer CropScience against the Group under contractual environmental guarantees granted at the time of Bayer’sBayer's acquisition of the CropScience business. Rehabilitation studies and an NRD assessment are underway in a similar project in Portland, Oregon. Potential environmental contingencies arising from certain business divestitures are described in Note D.22.e) to the consolidated financial statements included at Item 18 of this annual report. In 2011,2012, Sanofi spent €41€45 million on rehabilitating sites previously contaminated by soil or groundwater pollution. During the year ended December 31, 2011,2012, a comprehensive review was carried out relating to the legacy of environmental pollution. In light of data collected during this review, the Group adjusted the provisions to approximately €763€728 million as at December 31, 2011;2012; this figure includes the provisions related to Genzyme.
Due to changes in environmental regulations governing site remediation, the Group’sGroup's provisions for remediation obligations may not be adequate due to the multiple factors involved, such as the complexity of operational or previously operational sites, the nature of claims received, the rehabilitation techniques considered, the planned timetable for rehabilitation, and the outcome of discussions with national regulatory authorities or other potentially responsible parties, as in the case of multiparty sites. Given the long industrial history of some of our sites and the legacy obligations of Aventis arising from its past involvement in the chemical and agrochemical industries, it is impossible to quantify the future impact of these laws and regulations with precision. See “Item"Item 3.D. Risk Factors — Environmental Risks of Our Industrial Activities”Activities".
To our knowledge, the Group is not currently subject to liabilities for non-compliance with current HSE laws and regulations that could be expected to significantly jeopardize its activities, financial situation or operating income. We also believe that we are in substantial compliance with current HSE laws and regulations and that all the environmental permits required to operate our facilities have been obtained. Regular HSE audits
(24 (53 in 2011)2012) are carried out by the Group in order to assess compliance with our standards (which implies compliance with regulations) and to initiate corrective measures. Additionally, 17nine specialized audits covering contractors or biosafety were done by our teams. Moreover, 172and 163 loss prevention technical visits were carried out by our teams in 2011.2012.
Sanofi has implemented a worldwide master policy on health, safety and the environment to promote the health and well-being of the employees and contractors working on its sites and respect for the environment. We consider this master policy to be an integral part of our commitment to social responsibility. In order to implement this master policy, 78 rules (policies) have been drawn up in the key fields of HSE management, Good HSE Practices, safety in the workplace, process safety, industrial hygiene, health in the workplace and protection of the environment.
Health
From the development of compounds to the commercial launch of new drugs, Sanofi research scientists continuously assess the effect of products on human health. This expertise is made available to employees through two committees responsible for chemical and biological risk assessment. The Group’sGroup's COVALIS committee classifies all chemical and pharmaceutical products handled within the Group and establishes workplace exposure limits for each of them. The Group’sGroup's TRIBIO Committee is responsible for classifying all biological agents according to their degree of pathogenicity, and applies rules for their containment and the preventive measures to be respected throughout the Group. See “Item"Item 3. Key Information — D. Risk Factors — Environmental Risks of Our Industrial Activities — Risks from the handling of hazardous materials could adversely affect our results of operations”operations".
Appropriate industrial hygiene practices and programs are defined and implemented in each site. These practices consist essentially of containment measures for collective and individual protection against exposure in all workplaces where chemical substances or biological agents are handled. All personnel are monitored with an appropriate initial and routine medical program, focused on the potential occupational health risks linked to their duties.
In addition, a committee has been set up to prepare and support the implementation of the new European Union REACH regulation on Registration, Evaluation, Authorization and Restriction of Chemicals. To fully comply with the new European regulation on the labeling of chemicals (Classification Labeling Packaging), the Group has registered the relevant hazardous chemical substances with the European Chemicals Agency (ECHA).
Safety
Sanofi has rigorous policies to identify and evaluate safety risks and to develop preventive safety measures, and methods for checking their efficacy. Additionally, Sanofi invests in training that is designed to instill in all employees a sense of concern for safety, regardless of their duties. These policies are implemented on a worldwide scale to ensure the safety of all employees and to protect their health. Each project, whether in research, development or manufacturing, is subject to evaluation procedures, incorporating the chemical substance and process data communicated by the COVALIS and TRIBIO committees described above. The preventive measures are designed primarily to reduce the number and seriousness of work accidents and to minimize exposures involving permanent and temporary Sanofi employees as well as our sub-contractors.
The French chemical manufacturing sites in Aramon, Neuville-sur-Saône, Sisteron and Vertolaye, as well as the plants located in the Hoechst Industry Park in Frankfurt, Germany, the Zentiva site in Hlohovec, Slovakia, and the chemical production site in Budapest, Hungary, are listed Seveso II (from the name of the European directive that deals with potentially dangerous sites through a list of activities and substances associated with classification thresholds). In accordance with French law on technological risk prevention, the French sites are also subject to heightened security inspections due to the toxic or flammable materials stored on the sites and used in the operating processes.
Risk assessments of processes and installations are drawn up according to standards and internal guidelines incorporating the best state-of-the-art benchmarks for the industry. These assessments are used to fulfill
regulatory requirements and are regularly updated. Particular attention is paid to any risk-generating changes: process or installation changes, as well as changes in production scale and transfers between industrial or research units.
Our laboratories that specialize in process safety testing, which are fully integrated into our chemical development activities, apply methods to obtain the physico-chemical parameters of manufactured chemical substances (intermediate chemical compounds and active ingredients) and apply models to measure the effect of potentially leachable substances in the event of a major accident. In these laboratories the parameters for qualifying hazardous reactions are also determined to define scale-up process conditions while transferring from development stage to industrial scale. All these data ensure the relevance of thethat our risk assessments.assessments are relevant.
We believe that the safety management systems implemented at each site, the hazard studies carried out and the risk management methods implemented, as well as our third-party property insurance policies covering any third-party physical damage, are consistent with legal requirements and the best practices in the industry.
Environment
The main objectives of our environmental policy are to implement clean manufacturing techniques, minimize the use of natural resources and reduce the environmental impact of our activities. In order to optimize and improve our environmental performance, we have a strategy of continuous improvement practiced at all our sites through the annual implementation of HSE progress plans. In addition, 5560 sites are currently ISO 14001 certified.certified and 15 buildings are LEED certified either in U.S. and Europe. We believe that this strategy clearly expresses the commitment of both management and individuals to health, safety and the environment. In 2011,2012, seven of our European sites were included in the scope of the European CO2 Emissions Credit Trading Scheme aimed at helping to reach the targets set by the Kyoto protocol.
Our recent efforts in terms of environmental protection have mainly targeted reductions in energy consumption, greenhouse gas emissions control, improvements in the performance of water treatment installations, reduction of volatile organic compound emissions, raw material savings and recycling, and reductions in waste materials or increases in the percentage being recycled. In 2011,2012, we reduced carbon dioxide emissions caused by our sales representation car fleet by 10% versus 2010,2011, due to the policy of using energy efficient cars as well as a reduction in the number of cars. Since 2005, in terms ofMeasured against the benchmark year for our activity level per unit produced, ournew targets (2010), direct and indirect carbon dioxide emissions from our production and research facilities (excluding vehicle fleets) have decreasedfallen by 9.5% and 15.6% respectively(1).7.2% overall. We are targeting a 20% reduction in CO2 emissions in 2020 vs. 2010 on a constant structure basis.
An internal committee of experts called ECOVAL assesses the environmental impact of the pharmaceutical agents found in products marketed by Sanofi. It has developed an environmental risk assessment methodology and runs programs to collect the necessary data for such assessments. Additional ecotoxicity assessments are being performed on certain substances which predate current regulations, in order to obtain information that was not gathered when they were launched (as regulatory requirements were different at that time) and evaluate environmental risks resulting from their use by patients.
Markets
A breakdown of revenues by business segment and by geographic region for 2009,2012, 2011 and 2010 and 2011 can be found at Note D.35. to our consolidated financial statements included at Item 18 of this annual report.
The following market shares and ranking information is based on sales data from IMS Health MIDAS, retail and hospital for full year 2011, in constant euros (unless otherwise indicated). For more information on market shares and ranking, see “Presentation"Presentation of Financial and Other Information”Information" at the beginning of this document.
Genzyme’sGenzyme's sales are included from the acquisition date of acquisition.(April 1, 2011).
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Marketing and Distribution
Sanofi has a commercial presence in approximately 100 countries, and our products are available in more than 170. Our main markets in terms of net sales are, respectively:
Emerging Markets (see definition in “B. Business Overview"Item 4. Information on the Company — Strategy”,Introduction" above) represent 30.3%31.9% of our net sales, the largest contribution to net sales of any region. We are the leading healthcare company in emerging markets. In 2011,2012, sales in emerging markets grew by 10.1%8.3% at constant exchange rates. This performance was due to robust organicrates (or +7.2% including the non consolidated sales of Genzyme in the first quarter of 2011). Latin America, Asia and Middle East recorded double-digit sales growth (10.4% excluding Genzyme and A/H1N1 vaccines sales). Brazil salesin 2012. Sales in BRIC countries were up 16.9% (excluding Genzyme and A/H1N1 vaccines sales)12.0%, accounting for 35.0% of Emerging Markets sales. Sales in China, salesBrazil, Russia were up 38.5% (excluding Genzyme)15.0%, 7.7% and Russia13.6% respectively. In 2012, sales were up 7.4% (excluding Genzyme). In 2011, Asiain Africa and Latin America continued to deliver strong double digit sales growth of 15.7% and 18.1% respectively (excluding Genzyme and A/H1N1 vaccines sales). Sales in Eastern Europe and Turkey were slightly down (-0.4% excluding Genzyme and A/H1N1 vaccines sales), which were particularly impacted by price cuts and generic competitionthe Middle East each exceeded €1 billion for Taxotere® in Turkey.the first time.
The United States represent 29.8%31.1% of our net sales; we rank thirteenthtwelfth with a market share of 3.1%3.7% (3.1% in 2010)2011). Sales in the U.S. were up 6.8%0.7% at constant exchange rates in 2011 (down 5.7% excluding2012 (or -2.8% including the non consolidated sales of Genzyme in the first quarter of 2011), driven by strong performances for Diabetes and A/H1N1 vaccines sales) reflectingGenerics but impacted by the impactloss of genericsexclusivity of Lovenox®, Taxotere®, Ambien® CR, Allegra®Eloxatine® and Xyzal®; partially off-set by Lantus® growth, Eloxatin® return to market exclusivity and the launch of Allegra® OTC.generic competition for Lovenox®.
Western Europe represents 27.3%23.8% of our net sales; we are the leading pharmaceutical company in France where our market share is 9.9% (10.1%9.3% (9.9% in 2010)2011), and we rank fifthfourth in Germany with a 4.6%4.7% market share (after Copaxone®the Copaxone® transfer and without taking into account parallel trade). In 2011,2012, sales in Western Europe were down 4.0%9.3% at constant exchange rate (down 10.5%rates (or -7.5% including the non consolidated sales of Genzyme in the first quarter of 2011 and excluding Genzyme and A/H1N1 vaccines sales) dueCopaxone®), impacted by the transfer of the Copaxone® business to the impact ofTeva, generic competition for Plavix®Plavix®, Aprovel® and Taxotere® as well asTaxotere® and the impact of austerity measures.
Japan represents 8.6%Other countries represent 13.1% of our net sales; our market share in Japan is 3.4% (3.1%3.5% (3.4% in 2010)2011). Full-year 20112012 sales in Japan were up 20.2%6.6% at constant exchange rate, or up 12.0% excludingrates (or +4.7% with Genzyme and were supported by Plavix® (up 22.9%), Allegra® (up 22.2%) and Hib vaccine sales.on a full-year basis in 2011).
A breakdown of our sales by geographic market is presented in “Item"Item 5. Operating and Financial Review and Prospects — Results of Operations — Year Ended December 31, 20112012 Compared with Year Ended December 31, 2010.”2011."
Although specific distribution patterns vary by country, we sell prescription drugs primarily to wholesale drug distributors, independent and chain retail drug outlets, hospitals, clinics, managed care organizations and government institutions. With regard to rareRare disease, renal, and biosurgery products we sell these productsare also sold directly to physicians as well.physicians. With the exception of Consumer Health Care products, these drugs are ordinarily dispensed to patients by pharmacies upon presentation of a doctor’sdoctor's prescription.
We use a selection of channels to disseminate information about and promote our products among healthcare professionals and patients, ensuring that the channels not only cover our latest therapeutic advances but also our mature products, as they provide the foundation for satisfying major therapeutic needs. We regularly advertise in medical journals and exhibit at major medical congresses. In some countries, products are also marketed directly to patients by way of television, radio, newspapers and magazines, and we sometimes use new media channels (such as the internet) to market our products. National education and prevention campaigns can be used to improve patients’patients' knowledge of conditions.
Our medical representatives, who work closely with healthcare professionals, use their expertise to promote and provide information on our drugs. They represent our values on a day-to-day basis and are required to adhere to a code of ethics. As of December 31, 2011,2012, we had a global sales force of 32,874 representatives: 9,866 in Europe, 4,866 in the United States, and 18,142 in the rest of the world.
Although we market most of our products through our own sales forces, we have entered into and continue to form partnerships to co-promote/co-market certain products in specific geographic areas. Our major alliances are detailed at “— Pharmaceutical Products"Item 5. Operating and Financial Review and Prospects — Main pharmaceutical products” above.Financial Presentation of Alliances." See also “Item"Item 3. Key Information — D. Risk Factors — We rely on third parties for the marketing of some of our products.”
Our vaccines are sold and distributed through multiple channels, including physicians, pharmacies, hospitals, private companies and distributors in the private sector, and governmental entities and non-governmental organizations in the public and international donor markets, respectively.
Our animal health products are sold and distributed through various channels, depending on the countrieseach country's legislation for veterinary products. Merial takes into account each country’scountry's specific characteristics and sells either to veterinaries, chemists, or via wholesalers. In the case of epizootics, Merial delivers directly to governments.
Competition
The pharmaceutical industry continues to experience significant changes in its competitive environment. Innovative drugs, a broad product range, and a presence in all geographical markets are key factors in maintaining a strong competitive position.
There are four types of competition in the prescription pharmaceutical market:
We compete with other pharmaceutical companies in all major markets to develop innovative new products. We may develop new technologies and new patented products wholly in-house, but we also enter into collaborative
R&D agreements in order to access new technologies. See Note D.21. to our consolidated financial statements included at Item 18 of this annual report.
Our prescription drugs compete in all major markets against patented drugs from major pharmaceutical companies like; AstraZenecalike: Novo Nordisk in cardiovascular disease, hypertension and oncology; Bayer-Schering in thrombosis prevention; Boehringer-Ingelheim in atherothrombosis; Bristol-Myers Squibb in oncology;diabetes; Eli Lilly in diabetes and oncology; Bristol-Myers Squibb in diabetes and oncology; Merck & Co in diabetes and hypertension; GlaxoSmithKline in diabetes, oncology allergies, diabetes and thrombosis; Merck in hypertension, osteoporosis, diabetes and benign prostatic hyperplasia; Novartis in hypertensiondiabetes, multiple sclerosis, oncology and oncology; Novo Nordisk in diabetes; Pfizer in oncology, thrombosis and allergies;hypertension; Shire plc in rare diseases and renal; Pfizer in renal;rare diseases and oncology; Biogen Idec, Teva and Merck Serono in multiple sclerosis; Bayer in multiple sclerosis and thrombosis prevention; Roche in oncology; Johnson & Johnson in oncology and thrombosis prevention; AstraZeneca in cardiovascular diseases, hypertension and oncology; Boehringer-Ingelheim in diabetes; Fresenius Medical Care in renal and Roche in oncology and osteoporosis.diseases.
Our Consumer Health Care business competes with multinational corporations such as Johnson & Johnson, Bayer, Novartis, Pfizer and GlaxoSmithKline and local players, especially in emerging markets.
Our generics business competes with multinational corporations such as Teva, Sandoz (a division of Novartis), Mylan and Actavis and local players, especially in emerging markets.
In our Vaccines business, we compete primarily with multinational players backed by large healthcare groups, including Merck (outside Europe), GlaxoSmithKline, Pfizer (Wyeth), Novartis and Johnson & Johnson (Crucell).
In selected market segments, Sanofi Pasteur competes with mid-size international players (such as CSL of Australia in the influenza market for the Southern Hemisphere). Sanofi Pasteur also competes with an increasing number of manufacturers, entrenched in densely populated and economically emerging regions, which are leveraging their cost/volume advantage and raising their level of technical capability and quality standards to compete on more sophisticated antigens in their domestic markets and alsoincreasingly in international donor markets. Multinational players are increasingly seeking alliances with manufacturers from emerging economies to secure positions in their markets of origin. Finally, there are emerging vaccine manufacturers in middle income countries, where privately owned companies in various industry sectors are investing in me-too vaccine production. Overall, there is increasingly intense competition on existing vaccines across the middle to low income segments.
In our Animal Health business, we compete primarily with international companies like Pfizer in both production and companion animals; with Merck and Boehringer Ingelheim in production animals; with Boehringer Ingelheim mainly in the vaccines segment; with Novartis and Bayer for pets and particularly for pets parasiticides; and with Virbac, Ceva and Vetoquinol, French companies with global presence, for pharmaceuticals and vaccines except(except for Vetoquinol, operatingwhich operates only in the pharmaceutical segment segment).
We also face competition from generic drugs that enter the market when our patent protection or regulatory exclusivity expires, or when we lose a patent infringement lawsuit (see “—"— Patents, Intellectual Property and
Other Rights”Rights" above). Similarly, when a competing patented drug from another pharmaceutical company faces generic competition, these generic products can also affect the competitive environment of our own patented product. See “Item"Item 3. Key Information — D. Risk factors — Risks related to our business”business".
Competition from producers of generics has increased sharply in response to healthcare cost containment measures and to the increased number of products for which patents or regulatory exclusivity have expired.
Generics manufacturers who have received all necessary regulatory approvals for a product may decide to launch a generic version before the patent expiry date. Such launch may occur notwithstanding the fact that the owner of the original product may already have commenced patent infringement litigation against the generics manufacturer. Such launches are said to be “at risk”"at risk" for the promoter of the generic product because it may be required to pay damages to the owner of the original product in the context of patent infringement litigation; however, these launches may also significantly impair the profitability of the pharmaceutical company whose product is challenged.
Drug manufacturers also face competition through parallel trading, also known as reimportation. This takes place when drugs sold abroad under the same brand name as in a domestic market are imported into that domestic market by parallel traders, who may repackage or resize the original product or sell it through alternative channels such as mail order or the Internet. This situation is of particular relevance to the European Union, where these practices have been encouraged by the current regulatory framework. Parallel traders take advantage of the price differentials between markets arising from factors including sales costs, market conditions (such as intermediate trading stages), tax rates, or national regulation of prices.
Finally, pharmaceutical companies face illegal competition from counterfeit drugs. The WHO estimates that counterfeit products account for 10% of the market worldwide, rising to more than 30% in some countries. However, in markets where powerful regulatory controls are in place, counterfeit drugs are estimated to represent less than 1% of market value.
The WHO also estimates that 50% of drugs sold on illegal websites have been found to be counterfeit.
A counterfeit medicine is deliberately and fraudulently mislabeled with respect to its identity and/or its source. Counterfeiting can apply to both branded and generic products, and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients, or with fake packaging.
Sanofi is committedacts ethically and responsibly to being part ofprotect patient health worldwide. We become involved in any efforts made to overcome drug counterfeiting and hashave implemented the following actions:
Intensification of close
to deliver information and educational programs to raise awareness about the risk related to falsified medicines;
RegulationRegulatory Framework
The pharmaceutical and health-related biotechnology sectors are highly regulated. National and supranational health authorities administer a vast array of legal and regulatory requirements that dictate pre-approval testing and quality standards to maximize the safety and efficacy of a new medical product. These authorities also regulate product labeling, manufacturing, importation/exportation and marketing, as well as mandatory post-approval commitments that may include pediatric development.
The submission of an application to a regulatory authority does not guarantee that a license to market will be granted. Furthermore, each regulatory authority may impose its own requirements during the course of the product development and application review. It may refuse to grant approval and require additional data before granting approval, even though the same product has already been approved in other countries. Regulatory authorities also have the authority to request product recalls, product withdrawals and penalties for violations of regulations based on data that are made available to them.
Product approval can vary from six months or less to several years from the date of application depending upon the country. Factors such as the quality of data submitted, the degree of control exercised by the regulatory authority, the review procedures, the nature of the product and the condition to be treated, play a major role in the length of time a product is under review.
In recent years, efforts have been made by the ICH (International Conference on Harmonization) participants to harmonize product development and regulatory submission requirements. The ICH consists of the regulatory agencies of the three founding members (European Union, Japan, United States), plus Health Canada and
Swissmedic as observers. An example of these efforts is the Common Technical Document (CTD), which can be used in different ICH regions for a product application review, with only local or regional adaptation. Electronic CTD is becoming the standard for worldwide product submission. Interestingly, emergentemerging countries are starting to participate in ICH standardization discussions, and could be more involved in the near future.
International collaboration between regulatory authorities continues to develop with implementation of confidentiality arrangements between ICH regulatory authorities, and with non-ICH regulatory authorities. Examples include work-sharing on Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) inspections and regular interactions identified as “clusters”in the form of "clusters" (i.e. pediatrics, oncology, advanced therapy medicinal products, vaccines, pharmacogenomics, orphans, biosimilars, blood products) between the United States and the European Union, as well as creatingUnion. Other initiatives include the presence of permanent representatives from the FDA and the Japanese Pharmaceutical and Medical Devices Agency (PMDA) now based in London, and a corresponding permanent representative from EMA at the FDA.
The requirement of many countries, including Japan and several member states of the European Union, to negotiate selling prices or reimbursement rates for pharmaceutical products with government regulators meaningfully extendsignificantly extends the time for market entry beyond the initial marketing approval. While marketing authorizationsapprovals for new pharmaceutical products in the European Union have been substantiallylargely centralized with the EMA, pricing and reimbursement remain a matter of national competence.
In the European Union, there are three main procedures by which to apply for marketing authorization:
Generic products are subject to the same marketing authorization procedures. A generic product must contain the same active medicinal substance as an approveda reference product approved in the European Union.E.U. Generic applications are abridged: generic manufacturers only need to submit quality data and demonstrate that the generic drug is “bioequivalent”"bioequivalent" to the originator product (i.e., works in the same way in the patient’spatient's body), but do not need to submit safety or efficacy data since regulatory authorities can refer to the reference product’sproduct's dossier. Generic product applications can be filed and approved in the European Union only after the originator product eight year data exclusivity period has expired. Further, generic manufacturers can only market their generic products after a 10- or 11-year period has elapsed from the date of approval of the originator product has elapsed.
Another relevant aspect in the EUE.U. regulatory framework is the “sunset clause”"sunset clause": a provision leading to the cessation of the validity of any marketing authorization whichif it is not followed by marketing within three years or, not remaining on the marketif marketing is interrupted for a period of three consecutive three year period.years.
Post-authorization safety monitoring of pharmaceutical products is carefully regulated in Europe. The EUE.U. pharmaceutical legislation for medicinal products describes the respective obligations of the marketing authorization holder and of the regulatory authorities to set up a system for pharmacovigilance in order to collect, collate and evaluate information about suspected adverse reactions.
It is possible for the regulatory authorities to withdraw products from the market for safety reasons. The responsibilitiesResponsibilities for pharmacovigilance rest with the regulatory authorities of all the EUE.U. member states in which the marketing authorizations are held. In accordance with applicable legislation, each EUE.U. member state has a pharmacovigilance system for the collection and evaluation of information relevant to the benefit to risk balance of medicinal products. The regulatory authority regularly monitors the safety profile of the products available on its territory and takes appropriate action where necessary and monitors the compliance of marketing authorisationauthorization holders with their obligations with respect to pharmacovigilance. All relevant information is shared between the regulatory authorities and the marketing authorization holder, in order to allow all parties involved in pharmacovigilance activities to assumefulfill their obligations and responsibilities.
In 2010, new legislation aimed at improving patient protection by strengthening and rationalizing the EUE.U. system for the safety monitoring of medicines was approved. In July 2012, Pharmacovigilance System was approved, which will be enforced in July 2012.legislation came into force, with significant impacts on the regulatory environment. Changes include the creation of a strengthenednew scientific advisory committee, the Pharmacovigilance Risk Assessment Committee (PRAC) at EMA level, with a key role in recommendation/advice on product safety issues. This committee, which includes a patient representative, can hold public hearings. Since its introduction in the second quarter of 2012 the PRAC has initiated reviews of products with subsequent regulatory actions leading to harmonization of the labeling. For instance several Sanofi products including zolpidem, clopidogrel, and insulin glargine are currently under review.
The Pharmacovigilance legislation also strengthens the legal basis for regulators to require post-authorization safety and efficacy studies throughout the life cycle of a medicinal product, with regulatory supervision of protocols and results. Such studies are aimed at collecting data to enable the safety or efficacy of medicinal products to be assessed in everyday medical practice. The granting of marketing authorization will be conditional on such studies being performed. Consequently, the pharmaceutical industry will have to build the need for post-authorization safety studies (PASS) and post-authorization efficacy studies (PAES) into development and life cycle management plans. As of today, no PASS or PAES has been requested to Sanofi.
The Pharmacovigilance legislation also introduces a new periodic safety report prepared by the companies. This is no longer limited to safety data, but instead presents a critical analysis of the risk-benefit balance of the medicinal product. An additional scientific committee called the Pharmacovigilance Risk Assessment Committee, with a key role in pharmacovigilance assessments (scope: all marketed drugsproduct, taking into account new or emerging information in the EU), is being established at the levelcontext of the EMA. This committee, which includes a patient representative, can hold public hearings. As a result, the Periodic Safety Update Report work-sharing procedure, as well as the new Urgent Union procedure should improve the harmonization of regulatory outcomes of safety evaluation for nationally authorized products.
Implementation of this pharmacovigilance legislation will be a particular priority in light of the highly-publicized Mediator affair in France. Given AFSSAPS’ stature as a leading regulatory agency, as well as the way the European regulatory network is organized, (with national agencies that are closely entwined with the EMA through their experts’ membership of EMA’s scientific committeescumulative information on risks and groups), it is possible the affair will have EU repercussions. Indeed member states may bring additional tighter national requirements. For example, the recently French law of December 29, 2011 that aims at reinforcing the oversight of safety of medical products allows the French regulator to ask for clinical trials to be conducted against both an active comparator and placebo for marketing authorisation purposes.
In addition the EU regulatory framework for medical devices will undergo to an in-depth revision in 2012, that will aim to improve coordination, evaluation and certification of medical devices, as well as reinforcing efficient vigilance and post-market surveillance systems with greater harmonization of EU member states’ market surveillance activities.
benefits.
In theUnited States, applications for drug and biological approval are submitted for review to the FDA, for review which has broad regulatory powers over all pharmaceutical and biological products that are intended for U.S. sale and marketing.marketing in the U.S. To commercialize a product in the U.S., a New Drug Application (NDA) under the Food, Drug and Cosmetic (FD&C) Act or Biological License Application (BLA) under the Public Health Service (PHS) Act is submitted to the FDA with data for filing and pre-market review. Specifically, the FDA must decide whether the product is safe and effective for its proposed use, if the benefits of the drug’sdrug's use outweigh its risks, whether the drug’sdrug's labeling is adequate, and if the manufacturing of the drug and the controls used for maintaining quality are adequate to preserve the drug’sdrug's identity, strength, quality and purity. Based upon this review, the FDA can require post-approval commitments and requirements. Approval for a new indication of a previously approved product requires the submission of a supplemental NDA (sNDA) for a drug or supplemental BLA (sBLA) for a biological product.
The FD&C Act provides another abbreviated option for NDA approved products, called the 505(b)(2) pathway. This pre-market application may rely on the FDA finding that the reference product has been found to be safe and effective by the FDA based upon the innovator’sinnovator's preclinical and clinical data.
Sponsors wishing to market a generic drug can file an Abbreviated NDA (ANDA) under 505(j) of the FD&C Act. These applications are “abbreviated”"abbreviated" because they are generally not required to include data to establish safety and effectiveness, but need only demonstrate that their product is bioequivalent (i.e., performs in humans in the same manner as the originator’soriginator's product). Consequently, the length of time and cost required for development of generics can be considerably less than for the originator’soriginator's drug. AnWith effect from October 1, 2012 (FDASIA — GDUFA), an application for a generic drug product does not currently requirerequires a user fee payment; however this will likely change under GDUFA (Generic Drug User Fee Act) which is expected to be introduced as an Omnibus Bill in 2012.payment. User fees for generic drug applications are
necessary to help alleviate the backlog of applications at the Office of Generics Drugs (OGD). The
current review time for an ANDA exceeds 30 months. The ANDA pathway in the United States can only be used for copiesgenerics of drugs approved under the FD&C Act.
The Patient Protection and Affordable Care Act, signed into law by President Obama on March 23, 2010, amends the Public Health Service Act to create an abbreviated licensure pathway (351k) for biological products that are demonstrated to be "biosimilar" to or "interchangeable" with an FDA-licensed biological product. As of January 1, 2013, no sponsor has submitted a 351k application to the FDA for review.
On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA), which primarily amends the Federal Food, Drug, and Cosmetic Act and notPublic Health Service Act. In addition to reauthorizing and amending several drug and medical device provisions that were scheduled to expire, the new law establishes new user fee statutes for BLA approved biological products undergeneric drugs and biosimilars. FDASIA also provides the FDA with tools intended to expedite the development and review of innovative new medicines that address certain unmet medical needs, and with new authority concerning drug shortages, among other things. The law significantly changes the FDC Act and the PHS Act.Act in several respects that will have considerable short- and long-term effects on the regulated industry.
FDASIA includes 11 titles, the first five of which concern drug and medical device user fee and pediatric-related programs. FDASIA § 501 makes permanent both the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act by eliminating the "sunset" provision of the BPCA and a related PREA provision. Title VI includes changes to the law styled as medical device regulatory improvements. Title VII makes significant changes to enhance the FDA's inspection authority and the drug supply chain. Title VIII creates incentives to encourage the development of products for antibiotic-resistant infections. Title IX expands the scope of products that qualify for accelerated approval and creates a new "breakthrough therapy" program, among other things. Title X is intended to legislatively address the current drug shortage crisis. Finally, Title XI reauthorizes certain provisions created by the FDA Amendments Act of 2007, provides for the regulation of medical gases, and includes several miscellaneous provisions, such as provisions on prescription drug abuse, 180-day generic drug marketing exclusivity, citizen petitions, controlled substances, and nanotechnology to name a few.
In Japan, regulatory authorities can require local development studies, though they also accept multi-national studies. They can also request bridging studies to verify that foreign clinical data are applicable to Japanese patients and require data to determine the appropriateness of the dosages for Japanese patients. These additional procedures have created a significant delay in the registration of some innovative products in Japan compared to the European Union and the United States. In order to solve this drug-lag problem, the MHLW (Ministry of Health, LabourLabor and Welfare) introduced the new NHI (National Health Insurance) pricing system on a trial basis. Reductions in NHI prices of new drugs every two years isare compensated by a “Premium”"Premium" for a maximum of 15 years. “Premium” areA "Premium" is granted in exchange for the development of unproved drugs/off-label indications with high medical needs. Pharmaceutical manufacturers are required to conduct literatures-based submission within 6six months or start a clinical trial for registration within one year after the official request. Otherwise, NHI prices of all products of the manufacturer would be reduced dramatically. In addition, the regulatory authorities have begun to promote multinational studies.
For new drugs and biosimilar products with approval applications submitted on or after April 2013, Japan will begin implementing a "Risk management plan", similar to the E.U. Pharmacogivilance system.
For generic products, the data necessary for filing isare similar to that which is required in EUE.U. and U.S. requirements. Pharmaceutical companies only need to submit quality data, and data demonstrating bioequivalence to the originator product, unless the drug is administered intravenously.
Focus on Biologics
Products can be referred to as “biologics”"biologics" when they are derived from plant or animal tissues, including blood products or products manufactured within living cells (e.g., antibodies). Most biologics are complex molecules or mixtures of molecules which are difficult to characterize and require physico-chemical-biological testing, and an understanding of and control over the manufacturing process.
The concept of “generics”"generics" is not scientifically appropriate for biologics due to their high level of complexity and therefore the concept of “biosimilar”"biosimilar" products is more appropriate. A full comparison of the purity, safety and efficacy of the biosimilar product against the reference biological product should be undertaken, including assessment of physical/chemical, biological, non-clinical and clinical similarity.
In the European Union, a regulatory framework for developing and evaluating biosimilar products has been in place since November 2005. The CHMP has issued several product/disease specific guidelines for biosimilar products. In March 2009, the CHMP adopted a guidelineproducts including guidance on preclinical and clinical development of biosimilars of low molecular weight heparins (LMWH). Currently in Europe a potential product candidate claiming to be biologically similar to Lovenox® must show therapeutic equivalence in terms of efficacy and safety in at least one adequately powered, randomized, double-blind, parallel group clinical trial. However, starting in 2011 and continuing in 2012, the EMA has initiated thea revision of severalthe majority of the existing biosimilar guidelines (general guidelines, as well as immunogenicity and product-related guidelines for recombinant insulinsinsulin and LMWH). Two new guidelines on monoclonal antibodies and immunogenicity of monoclonal antibodies have also been issued; other product-related guidelines (follitropina andb interferon) are under preparation.
In response to the European Commission's wish to stimulate the global development of biosimilars, biosimilar reference medicines sourced outside the European Economic Area will be allowed (the basis will always be a locally licensed product, but 'Bridging studies' to another product licensed in another part of the world will be allowed). Currently in the E.U., the reference product for a biosimilar has to be licensed in the E.U. and therefore clinical trials have to be repeated in all three major markets (Japan, E.U. and U.S.). This important change will enter into force after the revision of the EU so-called "over-arching" biosimilar guideline, already under review and expected for early 2013.
While the EMA has adopted so far a balanced approach for all biosimilars, which allows evaluation on a case-by-case basis in accordance with relevant biosimilar guidelines, it seems that there is some willingness to simplify the pathway in very specific circumstances. For a very simple biological fully characterized on the quality level, a biosimilar could be authorized based on a bioequivalence study combined only combined with an extensive quality package. With respect to vaccines, the CHMP position is that it is at present it is unlikely that these products may be characterized at the molecular level, and that each vaccine product must be evaluated on a case-by-case basis.
In Japan, guidelines defining the regulatory approval pathway for follow-on biologics were finalized in March 2009. These guidelines set out the requirements on CMC (Chemistry, Manufacturing and Control), preclinical and clinical data to be considered for the development of the new application category of biosimilars. Different fromUnlike the CHMP guidelines, the main scope of the guidelineJapanese guidelines includes recombinant proteins and polypeptides, but not polysaccharides such as LMWH.
In the United States, several complex protein-based drugs have been approved as NDAs under the Federal Food Drug and Cosmetic Act (FD&C Act). It is currently possible to submit an abbreviated application (ANDA) with respect to those particular products (e.g., Lovenox®, Lantus®). Since an ANDA is not required to contain
clinical trial data other than from bioequivalence studies, the appropriateness of an ANDA with respect to these NDA approved biological products raises significant scientific issues for the FDA. Lovenox® (enoxaparin) was approved as a drug by the FDA on March 29, 1993 under Section 505(b)(1) of the FD&C Act and not as a biologic under Section 351 of the Public Health Service Act; therefore it was not possible to submit a biosimilar of the product. An abbreviated NDA (ANDA/generic) application was submitted to FDA August 2005 by Momenta/Sandoz under section 505(j) of the FD&C Act. This application was approved in July 2010; the generic product was approved as therapeutically equivalent to Lovenox®. The FDA approved a second enoxaparin ANDA on September 19, 2011. The sponsor, Amphastar, had submitted the application in 2003. A third ANDA from TEVA, also submitted in 2003, is still pending.
U.S. law now provides for a pathway for “biosimilar” versions of a reference product licensed as a biological under the PHS Act. Healthcare reform legislation entitled the “PatientPatient Protection and Affordable Care Act,” in particular Title VII, Subtitle A "Biologics Price Competition and Innovation Act," was signed into law by the President Obama on March 2010. Title VII, Subtitle A “Biologics Price Competition and Innovation”, allows for the creation of a regulatory approval pathway for biosimilars and a litigation procedure for patent infringement lawsuits brought against biosimilar applicants.
Under the new law, the definition of “biological product” in section 351(i) is revised to include proteins, except any chemically synthesized polypeptide. In addition, the law describes how a “biosimilar” product may be “highly similar” to the reference product “notwithstanding minor differences in clinically inactive components”, and for which there are “no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency of the product”.
23, 2010, This law also statedamends the Public Health Service Act to create an abbreviated licensure pathway (351k) for biological products that approval ofare demonstrated to be "biosimilar" to or "interchangeable" with an application under section 351(k) may not be made effective until 12 years after the date on which the reference product was first licensed under section 351(a). The date on which the reference product was first licensed does not include the date of approval of: (1) a supplement for theFDA-licensed biological product that is the reference product; (2) a subsequent application by the reference product sponsor or manufacturer for a change (other than a structural modification) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength for the previously licensed reference product; or (3) a subsequent application by the reference product sponsor or manufacturer for a modification to the structure of the reference product that does not result in a change in safety, purity, or potency.product.
Other provisions of this new U.S. law state that ten years after enactment, certain “biological products” approved under section 505 of the FD&C Act will be deemed licensed under section 351 of the PHS Act. Prior to that time, the current legal interpretation is that they cannot be “reference products” for applications submitted under section 351(k) of the PHS Act. The new law also describes how a biological product that is shown to meet the new interchangeability standards, “may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product”.
On February 15, 2012, the FDA published for consultation three draft guidancesguidance documents for biosimilar development: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009. These guidance documents remain in draft format. A fourth document on clinical pharmacology has yet to be published.
The Agency hasFederal Food, Drug, and Cosmetic Act, as amended by the Biosimilar User Fee Act of 2012 (Title IV of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144, which was signed by the President on July 9, 2012), authorizes the FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, for certain applications and supplements for approval of biosimilar biological products, on establishments where approved biosimilar biological product products are made, and on biosimilar biological products after approval.
At the December 2012 FDA-CMS meeting, the agency stated at publicly attended meetings that they are conducting “resource-intensive” pre-INDhad received 50 requests for initial meetings with potential biosimilar sponsors on a range ofto talk about development plans and conducted 34. The agency has now
received 12 biosimilar INDs and has many other active programs with no IND submitted. Proposals have involved 12 reference products.
Focus on Medical Devices
In the E.U., the European Commission released its legislative proposal on medical devices on September 26, 2012. The new revised framework could enter into force by 2015, if approved at first reading.
The main change of this proposal is the replacement of the current three directives by two regulations (one for medical devices and one forin-vitro medical devices).
The objectives of the legislation are to simplify and strengthen the current E.U. legal framework by implementing a robust and transparent regulatory framework. The revision impacts the pre-market assessment of devices by strengthening the oversight of Notified Bodies (NBs), post-market safety and continuous assessment of NB compliance, and the management of the regulatory system (better coordination, transparency and communication). A "scrutiny procedure" (via a European decentralized approach) would be used for high-risk Class III devices (novel technologies or specific public health threats). The new revised framework also formally introduces the concept of "companion diagnostic", which is expected to deliver a more accurate definition of the patient population that will benefit from a given product.
In addition, enhanced vigilance and post-market surveillance systems for medical devices, with greater harmonization of E.U. member states' market surveillance activities, are expected.
In the U.S., in January 2011, the FDA announced a Plan of Action, which includes 36 specific actions, to modernize and improve the FDA's premarket review of medical devices. In the two years since the FDA began implementing the plan, the speed and predictability of device review have improved for the first time in almost a decade, including significant reductions in the time it takes the FDA to review applications and the size of application backlogs. These results have been achieved even though the Plan of Action has not yet been fully implemented.
The FDA has met almost all of its early implementation timelines. As implementation continues and the impact of the Plan grows over the next several years, the FDA expects performance on review times and reductions in backlogs to continue to improve. The new process improvements and resources made available by this year's reauthorization of the Medical Device User Fee Act (MDUFA III) will accelerate the FDA's ability to make premarket review of devices predictable, consistent, transparent, efficient, and timely.
Recent biomedical breakthroughs are pushing medicine toward tailored therapeutics, or personalized medicine. This means an increase in the development of companion diagnostics. To address this issue, the FDA issued the draft guidance In Vitro Companion Diagnostic Devices on July 12, 2011, to communicate to industry how the FDA defines these devices and what the Agency's regulatory requirements are for them. The finalization of this guidance has been delayed.
Focus on transparency and public access to documents
Over the last two to three years the pharmaceutical industry ishas been subject to growing pressure for greater transparency about clinical trials (conduct and results). Regulatory authorities are also being pushed for more openness and transparency, to makefor example by making more comprehensive disclosure about the rationale and basis of regulatory decisions on medicinal products, for enhancedso as to enhance the credibility of the regulatory process. This is a meaningfulsignificant driver of the transparency initiatives undertaken in several countries.
Pharmaceutical manufacturers have committed to publishing protocols and results of clinical studies performed with their products in publicly accessible registries. In addition, both ICH and non-ICH countries often impose mandatory disclosure of clinical trials information.
From a regulatory perspective, ambitious initiatives have been undertaken by the major regulatory authorities.
EUE.U. pharmaceutical legislation for medicinal products requires national regulatory authorities and the EMA to actively publish information concerning authorisationauthorization and supervision of medicinal products. The EMA has introduced a series of initiatives aimed at improving the transparency of its activities, such as improving the format of the European Public Assessment Report, web-published product approvals, withdrawals and rejections. In addition, there is an increased focus on comparative efficacy and effectiveness. With the new EUE.U. pharmacovigilance legislation, there will be an increased level ofgreater transparency, especially with regard to communication of safety issues (e.g. public hearings, specific European web-portals with information on medicinal products). Finally, patients and consumers are increasingly involved in the work of the EMA’sEMA's scientific committees.
The European regulators recently took a major step towards more openness and transparency by giving a considerablymuch wider access to documents originated by pharmaceutical companies and submitted to the regulatory authorities for scientific evaluation after a regulatory decision is taken. Whilst it is anticipated that these documents shouldwould be redacted before disclosure in order to protect information contained therein that cannot be disclosed (commercial confidential information or personal data), the identification of commercially confidential information (CCI) and protection of personal data (PPD) within the structure of the marketing-authorization dossier has been restricted according to the draft document released in June 2011 for public consultation by the EMA and the Head of Medicines Agencies (HMA). Therefore, gives a narrower definition of commercially confidential information and personal data within the context of the marketing authorization dossier. Consequently, the scope of the information accessible to the public ishas been considerably widened (e.g., clinical study reports in a marketing authorization dossier, but also major partsa significant portion of non-clinical test data).
During the second half of 2012 the EMA informed stakeholders about its intention to implement by January 2014 the previously announced proactive policy for public disclosure of raw data from clinical trials that are included in marketing authorization dossiers of approved medicinal products.
Protection of patients' personal data, data format definition and document redaction, rules of engagement for third parties willing to conduct new analyses on data files, legal aspects about risk of infringement of commercially confidential information are among the main ethical and technical issues to be overcome before the new transparency policy is enforced, and are to be discussed between the EMA and its stakeholders over the first part of 2013.
The EMA does not routinely require raw data files as part of the submitted dossier, implying that this new policy will apply in particular to prospective submissions.
In the highly competitive field of medicinal products, thereit is the needstill necessary to reinforce the principle that non-innovators cannot obtain marketing authorization based solely based on the originator’soriginator's data released in the EU and whileE.U. for as long as the data protection period runs.is in force.
As of the end of 2012, the E.U. disclosure policy appears more advanced than that in other major markets.
In the U.S., the FDA has initiated a transparency initiativeCommissioner, Dr. Margaret A. Hamburg, launched FDA's Transparency Initiative in June 2009, in response to President Obama’sObama's January 2009 “Open"Open Government Initiative”Initiative". The objective of the initiative was to render the FDA much more transparent and open to the American public by providing the public with useful, user-friendly information about agency activities and decision-making.
The FDA Transparency Initiative has three phases: Phase I — Improving the understanding of FDA basics (completed)(completed with ongoing updates); Phase II — Improving FDA’sFDA's disclosure of information to the public (ongoing); and Phase III — Improving FDA’sFDA's transparency to regulated industry (ongoing). Proposals to improve transparency and access to information were released for consultation for both Phase II (May 19, 2010) and Phase III (January 6, 2011). Some of the less controversial proposals have been implemented; others, such as proactive release of information that the Agency has in its possession, may require revisions to U.S. federal regulations.
Other new legislation proposed or pending implementation
Clinical trials applications: a proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, repealing Directive 2001/20/EC, was released in July 2012 with the following objectives:
Discussions have begun on this proposal (2012/2013) and the final regulation is expected to come into force by 2016.
Overall, the replacement of Directive 2001/20/EC by a Regulation is expected to introduce a harmonized review pathway and timelines without interfering with Member States' competences in terms of ethical aspects. A single E.U. submission portal is expected to significantly streamline the review process and will also allow increased transparency over the conduct and results of clinical trials.
Falsified medicines: implementation of Directive 2011/62/EU: The European Union (E.U.) has reformed the rules for importing into the E.U. active substances for medicinal products for human use. As of January 2, 2013, all imported active substances must have been manufactured in compliance with standards of good manufacturing practices (GMP) at least equivalent to the GMP of the E.U. The manufacturing standards in the EU for active substances are those of the "International Conference for Harmonisation" — ICH Q7. As of July 2, 2013, this compliance must be confirmed in writing by the competent authority of the exporting country. This document must also confirm that the plant where the active substance was manufactured is subject to control and enforcement of good manufacturing practices at least equivalent to that in the E.U.
In practice, the full implementation of Directive 2011/62/EU by July 2013 could generate temporary drug shortages in the E.U. in those cases where manufacturers will be unable to supply the required documentation.
Pricing & Reimbursement
Rising overall healthcare costs are leading to efforts to curb drug expenditures in most markets in which Sanofi operates. Increasingly these efforts result in pricing and market access controls for pharmaceuticals. The nature and impact of these controls vary from country to country, but some common themes are reference pricing, systematic price reductions, formularies, volume limitations, patient co-pay requirements, and generic substitution. In addition, governments and third-party payers are increasingly demanding comparative / relative effectiveness data to support their decision making process. They are also increasing their utilization of emerging healthcare information technologies such as electronic prescribing and health records to enforce transparency and tight compliance with these regulations and controls. As a result, the environment in which pharmaceutical companies must operate in order to make their products available to patients and providers who need them continues to grow more complex each year.
Significant changes in the Pharmaceutical/Healthcare environment emerged since 2010:
state programs or mandatory enrollment in private plans. Cost-containment pressures affecting pharmaceuticals are also persisting in the public and private health care sectors.
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In Asia, while the Chinese market continues to grow, the National Development and Reform Commission continues to bring controls on drug prices through severe price cuts. As with China, in India, there is a strong move towards a universal minimum health coverage, with the National Pharmaceutical Pricing Authority also pushing for price control of an essential drug list (EDL).
In Russia, healthcare provision guarantees were signed into law with as yet undefined treatment standards to control usage. However, the 2012 EDL has been established but prices have not been changed considerably.
Regardless of the exact method, we believe that third-party payers will continue to act to curb the cost of pharmaceutical products. While the impact of these measures cannot be predicted with certainty, we are taking the necessary steps to defend the accessibility and price of our products in order to reflect the value of our innovative product offerings:
Keeping in mind the importance of recognizing the value of our products and the high cost of research and development, we continue to analyze innovative pricing and access strategies that balance patient accessibility with appropriate rewards for innovation. Specifically, we are involved in risk sharing agreements with payers, whereby part of the financial risk related to a treatment's success is carried by the marketing company. Those agreements usually foresee that the clinical efficacy of a drug is followed after its commercialization, for a specified period of time and patient population. The price and reimbursement level of the drug is then either confirmed or revised based on these post-marketing results.
Insurance and Risk Coverage
We are protected by four key insurance programs, relying not only on the traditional corporate insurance and reinsurance market but also on our captive insurance company, Carraig Insurance Ltd (Carraig).
These four key programs cover Property & Business Interruption, General & Product Liability, Stock and Transit, and Directors & Officers Liability.
Our captive insurance company, Carraig, participates in our coverage for various lines of insurance mainly including but not only, excess property, stock and transit and general & product liability. Carraig is run under the supervision of the Irish regulatory authorities, is wholly-owned by Sanofi, and has sufficient resources to meet those portions of our risks that it has agreed to cover. It sets premiums for Group entities at market rates. Claims are assessed using the traditional models applied by insurance and reinsurance companies, and the company’scompany's reserves are regularly verified and confirmed by independent actuaries.
Our Property & Business Interruption program covers all Group entities worldwide, wherever it is possible to use a centralized program operated by our captive insurance company. This approach shares risk between Group entities, enabling us to set deductibles and guarantees that are appropriate to the needs of local entities. It also incorporates a prevention program, including a comprehensive site visit program covering our production, storage, research and distribution facilities and standardized repair and maintenance procedures across all sites. Specialist
site visits are conducted every year to address specific needs, such as testing of sprinkler systems or emergency plans to deal with flooding risks.
The Stock and Transit program protects goods of all kindkinds owned by the Group that are in transit nationally or internationally, whatever the means of transport, and all our inventories wherever they are located. Sharing risk between Group entities means that we can set deductibles at appropriate levels, for instance differentiating between goods that require temperature controlled distribution and those that do not. We have developed a prevention program with our insurers,assistance from experts, implementing best practices in this area at our distribution sites. This program, which is led by our captive insurance company, has substantial capacity, largely to deal with the growth in sea freight which can lead to a concentration of value in a single ship.
Our General Liability & Product Liability program has been renewed for all our subsidiaries worldwide wherever it was possible to do so, despite the increasing reluctance in the insurance and reinsurance market to cover product liability risks for large pharmaceutical groups. For several years, insurers have been reducing product liability cover because of the difficulty of insuring some products that have been subject to numerous claims. These products are excluded from the cover provided by insurers, and hence from the cover obtained by us on the insurance market. This applies to a few of our products, principally those described in Note D.22.a) to our consolidated financial statements included at Item 18 in this annual report. Because of these market conditions we have increased, year by year, the extent to which we self-insure.
The principal risk exposure for our pharmaceutical products is covered with low deductibles at the country level, the greatest level of risk being retained by our captive insurance company. The level of risk self-insured by the Group –— including our captive reinsurance company –— enables us to retain control over the management and prevention of risk. Our negotiations with third-party insurers and reinsurers are tailored to our specific risks. In particular, they allow for differential treatment of products in the development phase, for the discrepancies in risk exposure between European countries and the United States, and for specific issues arising in certain jurisdictions. Coverage is adjusted every year in order to take into account the relative weight of new product liability risks, such as those emerging fromrelating to rare diseases with very low exposure or to healthcare products which aredo not subject to marketrequire marketing approval.
Our cover for risks that are not specific to the pharmaceutical industry (general liability) is designed to address the potential impacts of our operations.
In respect ofFor all lines of business of Carraig, outstanding claims are covered by provisions for the estimated cost of settling all claims incurred up to, but not paid at the balance sheet date, whether reported or not, together with all related claims handling expenses. Where there is sufficient data history from the company or from the market offor claims made and settlements,settled, management — with assistance from independent actuaries — prepares an incurred but not reported (IBNR) actuarial technique is developed by management with the assistance of expert external actuaries to determine a reasonable estimate of the captive’scompany's exposure to unassertedunreported claims for those risks.the risks covered. The actuaries perform an actuarial valuation of the company's IBNR loss(incurred but not reported) and ALAE (allocated loss adjustment expense) liabilities of the Company as ofat year end. Two ultimate loss projections (based upon reported losses and paid losses respectively) are computed each year using the Bornhuetter-Ferguson method are computed each year. Provisions are recorded on that basis.method; these projections form the basis for the provisions set.
The Directors & Officers Liability program protects allthe legal entities under our legal entitiescontrol, and their directors and officers. Our captive insurance company is not involved in this program.
The Group also operates other insurance programs, but these are of much lesser importance than those described above.
These All the insurance programs are backed by best-in-class insurers and reinsurers and are designed in such a way that we can integrate most newly-acquired businesses on a continuous basis. Our cover has been designed to reflect our risk profile and the capacity available in the insurance market. This is now also the case for Genzyme and Merial which are integrated in the Group cover at each inception date. By centralizing our major programs, not only do we reduce costs, but we also provide world-class coverage for the entire Group.
Significant subsidiaries
Sanofi is the holding company of a consolidated group of subsidiaries. The table below sets forth our significant subsidiaries and affiliates as of December 31, 2011.2012. For a complete list of the principal companies in our main consolidated subsidiaries,group, see Note F. to our consolidated financial statements, included in this annual report at Item 18.
Significant Subsidiary or Affiliate | Date of Incorporation | Country of | Principal Activity | and Voting Interest | ||||||||||
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Aventis Inc. | 07/01/1998 | United States | Pharmaceuticals | 100% | ||||||||||
Aventis Pharma S.A. | 09/24/1974 | France | Pharmaceuticals | 100% | ||||||||||
Genzyme Corporation | 11/21/1991 | United States | Pharmaceuticals | 100% | ||||||||||
Hoechst GmbH | 07/08/1974 | Germany | Pharmaceuticals | 100% | ||||||||||
Merial Ltd | 08/01/1997 | United Kingdom | Animal Health | 100% | ||||||||||
Merial S.A.S. | 02/25/1941 | France | Animal Health | 100% | ||||||||||
Sanofi-Aventis Amérique du Nord S.A.S. | 09/20/1985 | France | Pharmaceuticals | 100% | ||||||||||
Sanofi-Aventis Deutschland GmbH | 06/30/1997 | Germany | Pharmaceuticals | 100% | ||||||||||
Sanofi-Aventis Europe S.A.S. | 07/15/1996 | France | ||||||||||||
Pharmaceuticals | 100% | |||||||||||||
Sanofi-Aventis U.S. LLC | ||||||||||||||
United States | Pharmaceuticals | 100% | ||||||||||||
Sanofi Pasteur | 02/08/1989 | France | Vaccines | 100% | ||||||||||
01/18/1977 | United States | |||||||||||||
Vaccines | 100% | |||||||||||||
Sanofi Winthrop Industrie | 12/11/1972 | France | Pharmaceuticals | 100% | ||||||||||
Since 2009, we have transformed our Group through numerous acquisitions (see Item 4A "History and Development of the Company"), in particular those of Genzyme in April 2011 and Merial in September 2009. The financial effects of the Genzyme acquisition are presented in Note D.1.2. to our consolidated financial statements, included in this annual report at Item 18. The financial effects of the Merial acquisition are presented in Note D.1.3. to our consolidated financial statements for the year ended December 31, 2010, included in our annual report on Form 20-F for that year.
In certain countries, we carry on some of our business operations through joint ventures with local partners. We have also entered into worldwide marketing arrangements. Two of our major products (Plavix® and Aprovel®) are marketed through an alliance with BMS, Actonel® is marketed through an alliance with Warner Chilcott, and Zaltrap® is marketed through an alliance with Regeneron. See "Item 5 — Financial Presentation of Alliances".
Internal organization of activities
Sanofi and its subsidiaries form a group, organized around three activities: Pharmaceutical products,Pharmaceuticals, Human Vaccines (Vaccines) and Animal Health products.Health.
The patentsWithin the Group, responsibility for research and trademarks of the pharmaceutical activity are primarily owned by thedevelopment (R&D) in their respective fields rests with Sanofi parent company, Aventis Pharma S.A. (France), Hoechst GmbH (Germany), Sanofi-Aventis Deutschland GmbH (Germany) and Genzyme Corporation (United States). The main patents and trademarks of the Human Vaccines and Animal Health activities are owned by(Pharmaceuticals), Sanofi Pasteur S.A.and Sanofi Pasteur, Inc. (Vaccines), and Merial Ltd respectively.
Within the Group, the holding company oversees research and development activities by definingMerial S.A.S. (Animal Health); these entities define strategic priorities coordinating work, and taking out industrial property rights under its own name and at its own expense. In order tocoordinate R&D efforts. To fulfill this role, Sanofi subcontracts research and developmentthese entities subcontract R&D work to its specialized French and foreign subsidiaries in many cases licensing itsthat have the necessary resources. They also license patents, manufacturing know-how and trademarks.trademarks to certain French and foreign subsidiaries. In these cases, the licensee subsidiaries manufacture and distribute the Group’sGroup's products, either directly or via local distribution entities.
Our industrial property rights, patents and trademarks are mainly held by the following companies:
For a description of our principal items of property, plant and equipment, see Item 4.D. "Property, Plant and Equipment". These assets are mainly held by Sanofi Pasteur, Genzyme Corporation, Sanofi Chimie, Sanofi-Aventis Deutschland GmbH, Sanofi Pasteur Inc. and Sanofi Winthrop Industrie.
In certain countries, Sanofi carries out part of its business operations through ventures with local partners. In addition, the Group has signed worldwide alliances by which two of its products (Plavix® and Aprovel®) are marketed through an alliance with BMS and Actonel® is marketed through an alliance with Warner Chilcott. See “— Pharmaceutical Products — Main Pharmaceutical Products” above.
For most Group subsidiaries, Sanofi provides financing and centrally manages their cash surpluses. Under the alliance arrangement with BMS, cash surpluses and cash needs arising within alliance entities give rise to symmetrical monthly transfers between the two groups. The holding company also operates a centralized foreign exchange risk management system, which enters into positions to manage the operational risks of its main subsidiaries.
D. Property, Plant and Equipment
D.1. Overview
Our headquarters are located in Paris, France. See “—"— Office Space”Space" below.
We operate our business through officesoffice premises and research, production and logistics facilities in approximately 100 countries. Allcountries around the world. Our office premises house of all our support functions, operate out ofplus operational representatives from our office premises.subsidiaries and the Group.
A breakdown of these sites by use and by ownership/leaseholdownership status (owned versus leasehold) is provided below. Breakdowns are based on surface area. All surface area figures are unaudited.
Breakdown of sites by use*
Industrial | 63% | |||
Research | ||||
| 13% | |||
| 12% | |||
| 7% | |||
Breakdown of the Group’s sites between owned and leasedby ownership status
| Leasehold | 32% | ||
Owned | 68% |
We own most of our research and development and production facilities, either freehold or under finance leases with a purchase option exercisable at expiration.
expiration of the lease.
Research and Development Sites: Pharmaceuticals segmentD.2. Description of our sites
Sanofi industrial sites
Research and Development activities are housedWe carry out our industrial production at 21 sites:
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seven112 sites in the United States, the largest beingnearly 40 countries (including 40 sites in Cambridge and Framingham;emerging markets):
one site in China, a Clinical Research Unit in Beijing.
The Group has 116 production82 sites for pharmaceuticals (including rare diseases),our Pharmaceuticals activity, including Genzyme;
In 2012, we produced the following quantities:
Sanofi believes itsWe believe that our production plants and research centersfacilities are in compliance with all regulatory requirements, are properly maintained and are generally suitable for future needs. Nonetheless, the Groupwe regularly inspectsinspect and evaluates its productionevaluate these facilities with regard to environmental, health, safety and security matters, quality compliance and capacity utilization. For more information about the Group’sour property, plant and equipment, see Note D.3 to the consolidated financial statements.
Industrial Sites: Pharmaceuticals Segment
Production of chemical and pharmaceutical products is the responsibility of our Industrial Affairs function, which is also in charge of most of our logistics facilities (distribution and storage centers).
The sites where theour major Sanofi drugs, active ingredients, specialties and medical devices are manufactured are:
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In the field ofThe rare diseases specialist Genzyme became a Sanofi subsidiary in April 2011. This acquisition expands the Group’sexpanded our presence in biotechnologies, especially rare diseases. Genzyme manages 11 production sites and collaboratesworks with overmore than 20 subcontractors to manufacture 22 commercial products over an entirea broad range of technological platformsplatforms.
GenzymeGenzyme's sites are as follows:
Industrial Sites: Vaccines (Sanofi Pasteur)
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Sanofi Pasteur Industrial Sites
The headquarters of the Group’sour Vaccines division, Sanofi Pasteur, are located in Lyon, France. Sanofi Pasteur’sPasteur has production and/or Research and DevelopmentR&D sites are located inat Swiftwater, Cambridge, Rockville, Canton and Orlando United States,(United States); Toronto, Canada,(Canada); Marcy l’Etoile,l'Étoile, Neuville and Val de Reuil France,(France); Shenzhen China,(China); Pilar Argentina,(Argentina); Chachoengsao Thailand,(Thailand); Hyderabad India,(India); and Ocoyoacac Mexico.(Mexico.)
In May 2009, Sanofi launched thewe began construction of a new vaccine manufacturing center inat our Neuville-sur-Saône site in France. This €300 million site investment, is the largest ever made by Sanofi. The objectiveSanofi, is intended to progressivelygradually transition the existing chemical activity to vaccine production beginning in 2013.from 2013 onwards.
In 2010, Sanofi Pasteur acquired VaxDesign, a U.S. company located in Orlando, Florida. VaxDesign’sVaxDesign's Modular IMmune In-vitro Construct (MIMIC®(MIMIC®) System is designed to capture genetic and environmental diversity and predict human immune responses. The MIMIC®MIMIC® platform is expected to accelerate vaccine development, reducedreduce time to market and increased probability ofincrease success rates in the pre-clinical and clinical stages.
Sanofi Pasteur owns its Research and Development and production sites, either freehold or under finance leases with a purchase option exercisable at expiration.expiration of the lease.
Industrial Sites: Animal Health Industrial Sites (Merial)
Since the announcement of Merck and Sanofi announced in March 2011 that they will maintainwere maintaining separate activities in the field of animal health, Merial has become a dedicated Sanofi division. Merial has 1617 industrial sites distributed throughoutin nine countries; nine research and developmentdifferent countries, 9 R&D sites, and numerous administrative offices withincluding its principal headquarters located at Lyon, France.
Merial industrial sites are as follows:
Italy: Noventa (inactivated avian vaccines);
autogenous bovine and swine vaccines at Worthington (Minnesota);
Research & Development sites: Pharmaceuticals
Research and Development activities are conducted at 15 sites:
D.3. Acquisitions, Capital Expenditures and Divestitures
The carrying amount of our property, plant and equipment at December 31, 20112012 was €10,750€10,578 million. In 2011,During 2012, we invested €1,440€1,351 million (see Note D.3. to theour consolidated financial statements)statements, included at Item 18 of this annual report) in increasing capacity and improving productivity at our various production and R&D sites.
The Group’sOur principal capital expenditures and divestments for, 2009,divestitures in 2010, 2011 and 20112012 are set outdescribed in this annual report at “Item 5. OperatingNotes D.1. ("Impact of changes in the scope of consolidation"), D.2. ("Merial"), D.3. ("Property, plant and Financial Reviewequipment") and Prospects — Divestments”, “— Acquisitions”D.4. ("Goodwill and “— Liquidity and Capital Resources” and in Note D.1., Note D.2., Note D.3. and Note D.4.other intangible assets") to our consolidated financial statements, included at Item 18 of this annual report.
As of December 31, 2012, our firm commitments in respect of future capital expenditures amounted to €323 million. The principal sites involved were (for the Pharmaceuticals activity) the industrial facilities at Frankfurt (Germany), Framingham and Allston (United States), Vertolaye (France), and in Hungary; and for the Vaccines activity, the facility at Swiftwater (United States).
In the medium term and assuming no changes in the scope of consolidation, we expect to invest on average €1.4 billion a year in property, plant and equipment. We believe that our own cash resources and the undrawn portion of our existing credit facilities will be sufficient to fund these expenditures.
Our principal ongoing investments are described below. During 2012, our industrial network actively contributed to the development of our seven growth platforms: Emerging Markets, Diabetes Solutions, Consumer Health Care, New Genzyme and Other Innovative Products (all of which are part of our Pharmaceuticals activity), Vaccines, and Animal Health.
Pharmaceuticals
East, 2012 saw Sanofi lay the foundation stone for a facility in Saudi Arabia that will produce solid pharmaceutical formulations, which will be marketed from 2015. In Latin America, where we already have a large industrial footprint, we are building a dedicated hormonal products facility in Brasilia. Also during 2012, the Ankleshwar Pharma site in Gujarat State (India) handled packaging and quality control through to release of the first commercial batches ofAllSTAR™, the first high-quality affordable insulin pen specifically intended for the local market. The Goa site (India) invested to extend its solid formulation production capacity to around 2.5 billion pills a year. And in Algeria, Sanofi signed an agreement with the local authorities for a major industrial investment that will lead to the construction of our biggest industrial complex in the Africa-Middle East region.
Vaccines (Sanofi Pasteur)
Sanofi Pasteur is undergoing a major investment phase, particularly the new dedicated dengue fever vaccine facility at Neuville (France), which will produce its first batches in 2014. Two new dedicated influenza vaccine facilities are in the start-up phase: Shenzhen (China) is currently testing its production processes, while Ocoyoacac (Mexico) was approved by the Mexican authorities at the start of 2012 and began production in time for the Mexican influenza vaccination program in September 2012. In response to observations made by the FDA during routine inspections conducted in 2012 in Toronto (Canada) and Marcy l'Etoile (France), Sanofi Pasteur initiated a compliance program to address the quality issues identified.
Pharmaceuticals SegmentAnimal Health (Merial)
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We have also begun the Biolaunch project, designed to convert our chemical facilities to biotechnologies, with a project to create a monoclonal antibodygrowing animal health market. In 2012, Merial acquired Newport Laboratories, which has an autogenous vaccine production facility at our Vitry-sur-SeineWorthington, Minnesota (United States). In China, Merial is investing in a new site in France from 2012, plus investments in the creation of a new innovative biosynthetic process at the Saint-Aubin-Lès-Elbeuf and Vertolaye industrial sites, in order to improve our corticosteroid production competitiveness at a global level.
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Vaccines Segment (Sanofi Pasteur)
Our Vaccines business has invested significantly in recent years, with the construction of a state-of-the-art research facility in Toronto (Canada); the creation of a new vaccines campus in Neuville (France); the construction of bulk and filling facilities in Val de Reuil (France) and a bacteriological bulk facility in Marcy l’Étoile (France); the creation of two new influenza vaccine facilities in Shenzhen (China) and Ocoyoacac (Mexico); and the completion of bulk and filling facilities in Swiftwater (United States), mainly dedicated to influenza and meningitis vaccines.
Animal Health Segment (Merial)
A significant proportion of the investment in Europe over the last several years has been allocated to transferring Lyon Gerland’s vaccine production operations to the new Saint Priest site. In Toulouse, Merial adapted its production capacity to the arrival of new products. Merial invested in a packaging line for Certifect® production (managed according to the Good Manufacturing Practices applicable in the European Union, and approved by the Environmental Protection Agency in the United States) and an injectible facility for Zactran® production. In 2009, Merial acquired a site to produce vaccines against foot-and-mouth disease in Lelystad, Netherlands, which thereby granted Merial two foot-and-mouth vaccine production licenses of the three in existence in Europe.
In the United States, Merial has invested significantly in Athens, Georgia in a pharmaceutical form unit in an effort to increase its capacity to meet the growing number of products.
In Emerging Markets, Merial invested in China to transfer an existing site to a new production site located in Nanchang’sNanchang high-tech development zone, in order to supportservice future growth ofin vaccines for avian and other species vaccines.in the local market. In addition,Europe, a substantial portion of the investment in recent years has been directed at the transfer of vaccine production from Lyon Gerland (France) to a new site nearby at Saint Priest (Lyon Porte des Alpes). At the Toulouse site (France), Merial investedis adapting its production capacity to new products by investing in a R&D laboratorypackaging line for use in Shanghaithe manufacturing ofCertifect® (compliant with European Union Good Manufacturing Practices (GMP), and approved by the U.S. Environmental Protection Agency) and in order to facilitate local vaccine developmenta building for the production of the injectable form of Zactran®.
Industrial innovation was a key theme in China.
As of December 31, 2011,2012. The fourth "Innovation Trophy" awards again illustrated the striking progress being made in this area, which we regard as a top priority in our firm orders related to future capital expenditure amounted to €292 million. They were mainly relatedindustrial strategy. The2012 Pierre Potier Prize was awarded to the followingChemicals and Biotechnology teams, who developed an innovative industrial sites: Frankfurt (Germany) and Elbeuf (France)process for the Pharmaceuticals segment, Swiftwater (United States) and Neuville (France)production of artemisinin, the basis for the Vaccines segment, and the La Boétie site (the Group’s corporate headquarters in France).
In the medium term and on a constant structure basis, we expect our yearly average capital expenditure to beantimalarial drugs. Investment is ongoing in the rangeinstallation of €1.7 billion. We believe thatan innovative biosynthesis process at two French sites, Saint-Aubin-lès-Elbeuf (Seine Maritime) and Vertolaye (Puy de Dôme), with the aim of improving the international competitiveness of our existing cash resources and unused credit facilities will be sufficient to finance these investments.corticosteroid production.
D.4. Office Space
As part of the rationalization of our office sites in the Paris region of France, we have since mid-2009 been reviewingcarrying out a medium-term review of our medium-term office space master plan for the Greater Paris area.
This review is expected towill result in all our Group support functions and operating divisions being housed on a smaller number of sites (five(5 in 2012 whenon completion of phase 1, is implemented)and 3 by 2015). All of these sites will meet environmental certification standards, and offer cost-effective space solutions.
Closing of the property located in Gentilly, Val de Bièvre marked the 2011 step in this Master Plan.
Preparing our new global corporate headquarters in first quarter 2012 on the Rue La Boétie, in the 8tharrondissement of Paris, at the heart of the city’s business district will bring all our Group support functions together within a single site, symbolizing the transformation of the Group.
Finally, our former corporate headquarters at 174 avenue de France in the 13tharrondissement of Paris will be closed in 2012, along with the adjacent site at 182 avenue de France.
The second phase of the Greater Paris office space master plan is currently under consideration, the aim being to reduce the overall area in use and the overall cost of operation.
A second Master Plan was initiated in late 2011 to outline the Group’s medium-term office space needs for the greater Lyon area.
A project was launched to integrate office sites from the property portfolio of Genzyme and Merial, and represents a presence in 50 countries and 540,000 m2.
Item 4A. Unresolved Staff Comments
N/A
Item 5. Operating and Financial Review and Prospects
You should read the following discussion in conjunction with our consolidated financial statements and the notes thereto included in this annual report at Item 18.
Our consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB) and with IFRS adopted by the European Union as of December 31, 2011.2012.
The following discussion contains forward-looking statements that involve inherent risks and uncertainties. Actual results may differ materially from those contained in such forward-looking statements. See “Cautionary"Cautionary Statement Regarding Forward-Looking Statements”Statements" at the beginning of this document.
Unless otherwise stated, all change figures in this item are given on a reported basis.
20112012 Overview
In 2011, the Group, which changed its name to “Sanofi” following the May 2011 General Meeting of Shareholders,During 2012, we continued to implement its transformingfollow the strategic direction established in 2008 and sustainableto pursue the objectives for 2012-2015 announced in September 2011 and reiterated in February 2013. The thrust of these objectives is fourfold: grow a global healthcare leader with synergistic platforms, bring innovative products to market, seize value-enhancing growth strategy throughopportunities, and adapt our structure for future challenges and opportunities.
Our 2012 full-year results were affected by the year. Sanofi acquired Genzyme Corporation (Genzyme), a leading American biotechnology company specializing in rare diseases with operationsloss of exclusivity for Plavix® and Avapro® in the areas of renal diseases, endocrinology, oncology, biosurgery,United States in the first half, and multiple sclerosis. Despiteby ongoing generic competition for our former flagship products. However, the erosion in our net sales and profitability was cushioned by our growth platforms, the contribution from genericsGenzyme, and their impact on thetight cost control.
Our 2012 net sales of some of our flagship products, as well as the absence of sales of pandemic Influenza A/H1N1 vaccinesreached €34,947 million, 4.7% higher than in 2011 our continuing efforts to establish growth platforms have helped(0.5% at constant exchange rates, see definition at "— Presentation of Net Sales" below), driven mainly by the Group to improve its position inperformance of the Emerging Markets, Diabetes, Vaccines, Consumer Health Care, Animal Health and Animal Health. Sanofi has shown resilience in terms ofOther Innovative Products growth platforms, by advances for the Generics business, and by the contribution from Genzyme (whose net sales and profitability.
The Group’s nethave only been consolidated since April 2011). This performance was achieved in spite of the significant impact of competition from generics, which cost us €1.2 billion in lost sales for the year totaled €33,389 million, up 3.2% compared to 2010 (5.3%(€1.3 billion at constant exchange rates, (see definition at “— Presentation of Net Sales” below), buoyed by the solid performance of its growth platforms, Emerging Markets, Diabetes, Vaccines, Consumer Health Care, and Animal Health, as well as the consolidation of Genzyme (€2,395 million in net sales from early April 2011), and this is despite significant competition from generics, which based on 2010 sales at constant exchange rates represented a €2.2 billion loss in net sales (see “—see "— Impacts from generic competition”competition" below), and the ending of the co-promotion agreement with Teva on Copaxone®. In terms of organic growth developments, 2011 was especially marked byMilestones for our research efforts during 2012 included the launch of the cancer drug Jevtana® in the European Union, the approval of Allegra® for over-the-counter useZaltrap® (metastatic colorectal cancer) and Aubagio® (multiple sclerosis) in the United States, FDA approvalStates.
The ongoing realignment of our resources cut research and development expenses by 0.4% and limited the influenza vaccine Fluzone® IDrise in selling and general expenses to 1.8%, after including Genzyme's costs over the full year. Business net income was €8,179 million, 7.0% lower than in 2011 on a reported basis, mainly due to the loss of exclusivity for Plavix® and Avapro® in the United States and launch of Certifect® for animal health in the United States.
By continuing to adapt its resources, the Group has managed to reduce its R&D costs and its selling and general expenses by 2.4% and 2.6%, respectively (at constant exchange rates, excluding Genzyme). Business net income totaled €8,795 million, down 4.6% compared to 2010 on a reported basis, caused by the competition from generics and the absence of pandemic influenza A/H1N1 vaccine sales.generics. Business earnings per share was €6.65, down 5.8% compared with 2010.€6.20, 6.8% lower than in 2011. Business net income and business earnings per share are non-GAAP financial measures which our management uses to monitor our operational performance, and which are defined at “—"— Business Net Income”Income" below.
Net income attributable to equity holders of Sanofi totaled €5,693came to €4,967 million, 4.1% higher than in 2010.down 12.8% on 2011. Basic earnings per share for 2011 were €4.31, 2.9% higheramounted to €3.76, also 12.8% lower than in 2010;2011; diluted earnings per share for 20112012 were €4.29 (2.6% higher)€3.74 (12.8% lower).
SanofiDuring 2012, we continued to pursue its strategywith our policy of targeted acquisitions and R&D partnerships. Theof alliances in research and development. In Generics, we announced in October 2012 that we had signed an agreement to acquire Genfar S.A., a Colombian pharmaceutical company which is a key generics player not only in Colombia, but also in other Latin American countries. Closing of this acquisition is subject to certain conditions, and is expected to take place during the first half of 2013. In biosurgery, we acquired the U.S. medical devices company Pluromed, Inc. in April 2012. We strengthened our Animal Health division with the April 2012 acquisition of Genzyme in April 2011 has been described above. In Consumer Health Care,Newport Laboratories (a U.S. American producer of autogenous vaccines for the Group successfully completed its acquisition of BMP Sunstone in China. In Animal Health, Merial became Sanofi’s dedicatedbovine and swine markets), and by entering into an agreement to acquire the animal health division of Dosch Pharmaceuticals Pvt Ltd that will give Merial an entry point into the
Indian market. We also entered into various alliances and licensing deals to extend or strengthen our existing research fields.
In October 2012, Sanofi and Bristol-Myers Squibb announced that they were restructuring their alliance following the joint statement issued by Merckloss of exclusivity for Plavix® and Avapro®/Avalide® in many major markets. The new agreement, which took effect on January 1, 2013, returns the rights for Plavix® and Avapro®/Avalide® to Sanofi in March 2011 announcing the end of their agreement to create a new animal health joint venture by combining their respective animal health activities. In addition, partnership and licensing agreements have enabled the Group to expand and to further develop its existing areas of research.
In September 2011, the Group announced new objectivesworldwide (except for the 2012-2015 period basedUnited States and Puerto Rico for Plavix®), thereby giving Sanofi exclusive control over these products and their commercialization.
In August 2012, we sold our interest in Société Financière des Laboratoires de Cosmétologie Yves Rocher, in line with our desire to focus on three initiatives: improvementstrategic activities.
As of growth platforms, maintenanceDecember 31, 2012, we had reduced our debt, net of tight cost-control,cash and advancescash equivalents to €7.7 billion, compared with €10.9 billion as of December 31, 2011. The Annual General Meeting of shareholders, to be held on May 3, 2013, will be asked to approve a dividend of €2.77 per share in transforming R&D.respect of the 2012 fiscal year, representing a payout equivalent to 45% of our business net income.
While we remain focused on theseour objectives for 2012-2015 announced in September 2011, we expect erosion from generic competition to continue, with a negative impact on net income in 20122013 (see “—"— Impacts from generic competition”competition" below).
Our operations generate significant cash flow. We recorded €9,319€8,171 million of net cash provided by operating activities in 20112012 compared to €9,859€9,319 million in 2010.2011. During the course of 2011,2012, we paid out €1.4€3.5 billion in dividends and contracted new debtrepaid part of $18.0 billion to finance the Genzyme acquisition.our debt. With respect to our financial position, we ended 20112012 with our debt, net of cash and cash equivalents (meaning the sum of short-term(see definition at "— Liquidity and long-term debt plus related interest rate and currency derivatives, minus cash and cash equivalents)Capital Resources" below) at €10,859€7,719 million (2010: €1,577(2011: €10,859 million). Debt, net of cash and cash equivalents, is a non-GAAP financial measureindicator that is used by management and investors to measure the Company’sCompany's overall net indebtedness and to manage the Group's equity capital. In order to assess the Company’sCompany's financing risk, we also use a "gearing ratio", a non-GAAP financial measure, that we define as measured by its gearingthe ratio (debt,of debt, net of cash and cash equivalents, to total equity).equity. Our gearing ratio was 13.4% at the end of 2012 versus 19.3% at the end of 2011 versus 3.0% at the end of 2010.2011. See “—"— Liquidity and Capital Resources — Consolidated Balance Sheet and Debt” below and Note D.17. to our consolidated financial statements included at Item 18 of this annual report.Resources" below.
Impacts from generic competition
OurSome of our flagship products experiencedcontinued to experience sales erosion in 20112012 due to generic competition. While we do not believe it is not possible to state with certainty what level of net sales levels would have been achieved in the absence of generic competition, it is possiblewe are able to estimate the sales impact of generic competition for each product.
By comparing 2011 and 2010A comparison of our net sales figures included at “—for the years ended December 31, 2012 and 2011 (see "— Results of Operations — Year Ended December 31, 20112012 Compared with Year Ended December 31, 2010”,2011") shows that competition from generics representedwas associated with a €2.2decline of €1.2 billion loss in net sales in 2011 (at2012 (or €1.3 billion at constant exchange rates). The table below shows the impact by product.
(€ million) Product | 2012 Reported | 2011 Reported | Change on a reported basis | Change on a reported basis (%) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Plavix® Western Europe | 285 | (1) | 406 | (1) | (121 | ) | -29.8% | ||||||
Aprovel® Western Europe | 542 | (1) | 718 | (1) | (176 | ) | -24.5% | ||||||
Taxotere® Western Europe | 53 | 189 | (136 | ) | -72.0% | ||||||||
Eloxatine® U.S. | 718 | 806 | (88 | ) | -10.9% | ||||||||
Lovenox® U.S. | 319 | 633 | (314 | ) | -49.6% | ||||||||
Plavix® U.S. | 76 | (2) | 196 | (120 | ) | -61.2% | |||||||
Aprovel® U.S. | 45 | (2) | 49 | (4 | ) | -8.2% | |||||||
Taxotere® U.S. | 53 | 243 | (190 | ) | -78.2% | ||||||||
Ambien® U.S. | 85 | 82 | +3 | +3.7% | |||||||||
Xatral® U.S. | 20 | 75 | (55 | ) | -73.3% | ||||||||
Nasacort® U.S. | 21 | 54 | (33 | ) | -61.1% | ||||||||
Xyzal® U.S. | 6 | 13 | (7 | ) | -53.8% | ||||||||
Allegra® U.S. | (1 | ) | 3 | (4 | ) | -133.3% | |||||||
Total | 2,222 | 3,467 | (1,245 | ) | -35.9% | ||||||||
Despite the introduction of generics in the second half of 2012, Myslee® in Japan posted a 2.8% rise in net sales in 2012 (or a fall of 4.9% at constant exchange rates), or €2.3 billion on a reported basis. The table below presents the detailed impact by product.to €292 million.
(€ million) Product | 2011 Reported | 2010 Reported | Change on a reported basis | Change on a reported basis (%) | ||||||||||||
Plavix® Western Europe | 414 | 641 | (227 | ) | -35.4 | % | ||||||||||
Aprovel® Western Europe | 753 | 825 | (72 | ) | -8.7 | % | ||||||||||
Taxotere® Western Europe | 189 | 709 | (520 | ) | -73.3 | % | ||||||||||
Allegra® U.S. | 3 | 147 | (144 | ) | -98.0 | % | ||||||||||
Eloxatin® U.S. | 806 | 172 | +634 | +368.6 | % | |||||||||||
Lovenox® U.S. | 633 | 1,439 | (806 | ) | -56.0 | % | ||||||||||
Xyzal® U.S. | 13 | 127 | (114 | ) | -89.8 | % | ||||||||||
Ambien® U.S. | 82 | 443 | (361 | ) | -81.5 | % | ||||||||||
Xatral® U.S. | 75 | 155 | (80 | ) | -51.6 | % | ||||||||||
Nasacort® U.S. | 54 | 130 | (76 | ) | -58.5 | % | ||||||||||
Taxotere® U.S. | 243 | 786 | (543 | ) | -69.1 | % | ||||||||||
Total | 3,265 | 5,574 | (2,309 | ) | -41.4 | % |
We expect erosion from generic competition to continue in 2012,2013, with a negative impact on net income. The following products are expected to be impacted by generics in 2012:2013:
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A special case is Eloxatin®expected to continue in 2013: Plavix®, Avapro® and Eloxatine® in the United States (net sales of Plavix® and Avapro® in the U.S. are not included in our consolidated net sales), Co-Aprovel® in Europe, and Myslee® and Taxotere® in Japan;
Eloxatine® in the U.S. is a special case. This product was subject to generic competition for part of 2010 until a court ruling prevented further sales of unauthorized generics from June 2010 tilluntil August 9, 2012. Wholesalers worked down their inventories of generic products in the second half of 2010 and in the first half of 2011.
Aggregate 2011In 2012, aggregate consolidated net sales generated by all the products in the specific countries where generic competition currently exists or is expected in 2012, excluding Plavix®2013 (excluding Plavix® and Avapro®Avapro® in the U.S., totaled €4,014and industrial sales of these two products worldwide) were €2,996 million, including €1,909€1,221 million in the U.S., €1,356€880 million in Europe and €749€
895 million (Allegra®in Japan (Allegra®, Myslee® and Myslee®Taxotere®) in Japan.. The negative impact on our 20122013 net sales could be estimatedis liable to potentially represent a substantial partportion of these salesthis amount, but the actual impact will depend on a number of factors such as the actual launch dates of genericsgeneric products in 2012, selling2013, the prices of such products,at which they are sold, and potential litigation outcomes.
In addition, the loss of Plavix®Plavix® and Avapro®Avapro® exclusivity in the U.S. in the first half of 2012 is anticipatedexpected to negatively impact our 2012 net income by around €1.4€0.8 billion comparedin 2013 relative to 2011. Net2012. Although sales for Plavix®of Plavix® and Avapro®Avapro® in the U.S. are not included in our consolidated by Sanofi, however theynet sales, these products nonetheless have an impact Sanofi’son our net income (see “—"— Financial Presentation of Alliances — Alliance Arrangements with Bristol-Myers Squibb” below)Squibb" below for further explanations).
Purchase Accounting Effects
Our results of operations and financial condition for the years ended December 31, 2011,2012, December 31, 20102011 and December 31, 20092010 have been significantly affected by our August 2004 acquisition of Aventis and certain subsequent transactions, mainly our acquisition of Genzyme on April 4, 2011.
The Aventis acquisition has given rise to significant amortization (€1,7881,489 million in 2012, €1,788 million in 2011, and €3,070 million in 2010, and €3,175 million in 2009)2010) and impairment of intangible assets (reversal(reversals of €12 million in 2012 and of €34 million in 2011, and charges of €127 million in 2010 and €344 million in 2009)2010). The Genzyme acquisition has also given rise to new amortization of intangible assets (€981 million in 20112012 and €709 million in 2011) and impairment of intangible assets (€709 million)25 million in 2012 and €119 million in 2011).
In order to isolate the impactpurchase accounting effects of theseall acquisitions and certain other items, we use as an evaluation tool a non-GAAP financial measure that we refer to as “business"business net income”income". For a further discussion and definition of “business"business net income”income", see “—"— Business Net Income”Income" below. For consistency of application of this principle, business net income also takes into account the impact of our subsequent acquisitions.
Business net income for the years ended December 31, 2012, 2011 2010 and 20092010 is presented in “—"— Business Net Income”Income" below.
Sources of Revenues and Expenses
Revenue Revenue.. Revenue arising from the sale of goods is presented in the income statement under “Net sales.”"Net sales". Net sales comprise revenue from sales of pharmaceutical products, human vaccines, animal health products and active ingredients, net of sales returns, of customer incentives and discounts, and of certain sales-based payments paid or payable to the healthcare authorities. Returns, discounts, incentives and rebates described above are recognized in the period in which the underlying sales are recognized, as a reduction of sales revenue. See Note B.14. to our consolidated financial statements included at Item 18 of this annual report. We sell pharmaceutical products and human vaccines directly, through alliances, and through licensees throughout the world. When we sell products directly, we record sales revenues as part of our consolidated net sales. When we sell products through alliances, the revenues reflected in our consolidated financial statements are based on the overall level of sales of the products and on the arrangements governing those alliances. For more information about our alliances, see “—"— Financial Presentation of Alliances”Alliances" below. When we sell products through licensees, we receive royalty income that we record in “Other revenues.”"Other revenues". See Note C. to the consolidated financial statements included at Item 18 of this annual report.
Cost of SalesSales.. Our cost of sales consists primarily of the cost of purchasing active ingredients and raw materials, labor and other costs relating to our manufacturing activities, packaging materials, payments made under licensing agreements and distribution costs. We have license agreements under which we distribute products that are patented by other companies and license agreements under which other companies distribute products that we have patented. When we pay royalties, we record them in cost of sales, and when we receive royalties, we record them in “Other revenues”"Other revenues" as discussed above.
Operating IncomeIncome.. Our operating income reflects our revenues, our cost of sales and the remainder of our operating expenses, the most significant of which are research and development expenses and selling and general expenses. For our business segments, we also measure our results of operations through an indicator referred to as “Business"Business Operating Income,”" which we describe below under “—"— Segment Information — Business Operating Income of Segments.”"
Segment Information
Operating Segments
In accordance with IFRS 8 “Operating"Operating Segments,”" we have defined our segments as “Pharmaceuticals”"Pharmaceuticals", “Human Vaccines”"Human Vaccines" (Vaccines) and “Animal Health”"Animal Health". Our other identified segments are categorized as “Other”"Other".
The Pharmaceuticals segment covers research, development, production and marketing activities relating to pharmaceutical products,of medicines, including activities acquired with Genzyme. Sanofi’sSanofi's pharmaceuticals portfolio consists of flagship products, plus a broad range of prescription medicines, generic medicines, and consumer health products. This segment also includes all associates and joint ventures with pharmaceutical businesswhose activities are related to pharmaceuticals, in particular the entities majority owned by BMS. See “—"— Financial Presentation of Alliances”Alliances" below.
The Vaccines segment is wholly dedicated to vaccines, including research, development, production and marketing. This segment includes our Sanofi Pasteur MSD joint venture with Merck & Co., Inc. in Europe.
The Animal Health segment comprises the research, development, production and marketing activities of Merial, which offers a complete range of medicines and vaccines for a wide variety of animal species.
The Other segment includes all activities that do not qualify as reportable segments under IFRS 8 “Operating Segments”"Operating Segments". In particular, this segment includesincluded our interest in the Yves Rocher group until the date of loss of significant influence (November 2011) (see note D.6. to our consolidated financial statements included at Item 18 of this annual report), and; it also includes the effects of retained commitments in respect of divested businesses.
Inter-segment transactions are not material.
Business Operating Income of Segments
We report segment results on the basis of “Business"Business Operating Income”Income". This indicator, adopted in accordancecompliance with IFRS 8, is used internally to measure operational performance and to allocate resources.
“Business"Business Operating Income”Income" is derived from “Operating income”"Operating income", adjusted as follows:
The following table presents our Business Operating Income for the year ended December 31, 2012.
(€ million) | Pharmaceuticals | Vaccines | Animal Health | Other | Total | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Net sales | 28,871 | 3,897 | 2,179 | — | 34,947 | |||||||||||
Other revenues | 933 | 44 | 33 | — | 1,010 | |||||||||||
Cost of sales | (8,759 | ) | (1,635 | ) | (701 | ) | — | (11,095 | ) | |||||||
Research and development expenses | (4,219 | ) | (539 | ) | (164 | ) | — | (4,922 | ) | |||||||
Selling and general expenses | (7,666 | ) | (611 | ) | (669 | ) | (1 | ) | (8,947 | ) | ||||||
Other operating income and expenses | 98 | (7 | ) | 3 | 14 | 108 | ||||||||||
Share of profit/(loss) of associates and joint ventures | 432 | (1 | ) | (7 | ) | — | 424 | |||||||||
Net income attributable to non-controlling interests | (171 | ) | — | (1 | ) | — | (172 | ) | ||||||||
Business operating income | 9,519 | 1,148 | 673 | 13 | 11,353 | |||||||||||
The following table presents our Business Operating Income for the year ended December 31, 2011.
(€ million) | Pharmaceuticals | Vaccines | Animal Health | Other | Total | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Net sales | 27,890 | 3,469 | 2,030 | — | 33,389 | |||||||||||
Other revenues | 1,622 | 25 | 22 | — | 1,669 | |||||||||||
Cost of sales | (8,368 | ) | (1,404 | ) | (654 | ) | — | (10,426 | ) | |||||||
Research and development expenses | (4,101 | ) | (564 | ) | (146 | ) | — | (4,811 | ) | |||||||
Selling and general expenses | (7,376 | ) | (542 | ) | (617 | ) | (1 | ) | (8,536 | ) | ||||||
Other operating income and expenses | (13 | ) | — | (7 | ) | 24 | 4 | |||||||||
Share of profit/(loss) of associates and joint ventures | 1,088 | 1 | — | 13 | 1,102 | |||||||||||
Net income attributable to non-controlling interests | (246 | ) | — | (1 | ) | — | (247 | ) | ||||||||
Business operating income | 10,496 | 985 | 627 | 36 | 12,144 | |||||||||||
(€ million) | Pharmaceuticals | Vaccines | Animal Health | Other | Total | |||||||||||||||
Net sales | 27,890 | 3,469 | 2,030 | — | 33,389 | |||||||||||||||
Other revenues | 1,622 | 25 | 22 | — | 1,669 | |||||||||||||||
Cost of sales | (8,368 | ) | (1,404 | ) | (654 | ) | — | (10,426 | ) | |||||||||||
Research and development expenses | (4,101 | ) | (564 | ) | (146 | ) | — | (4,811 | ) | |||||||||||
Selling and general expenses | (7,376 | ) | (542 | ) | (617 | ) | 1 | (8,536 | ) | |||||||||||
Other operating income and expenses | (13 | ) | — | (7 | ) | 24 | 4 | |||||||||||||
Share of profit/(loss) of associates and joint ventures | 1,088 | 1 | — | 13 | 1,102 | |||||||||||||||
Net income attributable to non-controlling interests | (246 | ) | — | (1 | ) | — | (247 | ) | ||||||||||||
Business operating income | 10,496 | 985 | 627 | 36 | 12,144 |
The following table presents our Business Operating Income for the year ended December 31, 2010.
(€ million) | Pharmaceuticals | Vaccines | Animal Health | Other | Total | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Net sales | 26,576 | 3,808 | 1,983 | — | 32,367 | |||||||||||
Other revenues | 1,623 | 28 | 18 | — | 1,669 | |||||||||||
Cost of sales | (7,316 | ) | (1,371 | ) | (615 | ) | — | (9,302 | ) | |||||||
Research and development expenses | (3,884 | ) | (517 | ) | (155 | ) | — | (4,556 | ) | |||||||
Selling and general expenses | (6,962 | ) | (603 | ) | (604 | ) | (2 | ) | (8,171 | ) | ||||||
Other operating income and expenses | 177 | 14 | (6 | ) | (108 | ) | 77 | |||||||||
Share of profit/(loss) of associates and joint ventures | 1,009 | 19 | — | 8 | 1,036 | |||||||||||
Net income attributable to non-controlling interests | (258 | ) | 1 | — | — | (257 | ) | |||||||||
Business operating income | 10,965 | 1,379 | 621 | (102 | ) | 12,863 | ||||||||||
(€ million) | Pharmaceuticals | Vaccines | Animal Health (1) | Other | Total | |||||||||||||||
Net sales | 26,576 | 3,808 | 1,983 | — | 32,367 | |||||||||||||||
Other revenues | 1,623 | 28 | 18 | — | 1,669 | |||||||||||||||
Cost of sales | (7,316 | ) | (1,371 | ) | (615 | ) | — | (9,302 | ) | |||||||||||
Research and development expenses | (3,884 | ) | (517 | ) | (155 | ) | — | (4,556 | ) | |||||||||||
Selling and general expenses | (6,962 | ) | (603 | ) | (604 | ) | (2 | ) | (8,171 | ) | ||||||||||
Other operating income and expenses | 177 | 14 | (6 | ) | (108 | ) | 77 | |||||||||||||
Share of profit/(loss) of associates and joint ventures | 1,009 | 19 | — | 8 | 1,036 | |||||||||||||||
Net income attributable to non-controlling interests | (258 | ) | 1 | — | — | (257 | ) | |||||||||||||
Business operating income | 10,965 | 1,379 | 621 | (102 | ) | 12,863 |
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The following table presents(in accordance with paragraph 28 of IFRS 8) reconciles our Business Operating Income to our Income before tax and associates and joint ventures for the yearyears ended December 31, 2009.2012, 2011 and 2010:
(€ million) | Pharmaceuticals | Vaccines | Animal Health (1) | Other | Total | |||||||||||||||
Net sales | 25,823 | 3,483 | 479 | — | 29,785 | |||||||||||||||
Other revenues | 1,412 | 31 | 4 | — | 1,447 | |||||||||||||||
Cost of sales | (6,527 | ) | (1,326 | ) | (176 | ) | — | (8,029 | ) | |||||||||||
Research and development expenses | (4,091 | ) | (491 | ) | (46 | ) | — | (4,628 | ) | |||||||||||
Selling and general expenses | (6,762 | ) | (561 | ) | (146 | ) | (2 | ) | (7,471 | ) | ||||||||||
Other operating income and expenses | 387 | (3 | ) | (5 | ) | 1 | 380 | |||||||||||||
Share of profit/(loss) of associates and joint ventures | 792 | 41 | 178 | (2) | 8 | 1,019 | ||||||||||||||
Net income attributable to non-controlling interests | (426 | ) | (1 | ) | — | — | (427 | ) | ||||||||||||
Business operating income | 10,608 | 1,173 | 288 | 7 | 12,076 |
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(€ million) | Year Ended December 31, 2012 | Year Ended December 31, 2011 | Year Ended December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Business Operating Income | 11,353 | 12,144 | 12,863 | |||||||
Share of profit/(loss) of associates and joint ventures (1) | (424 | ) | (1,102 | ) | (1,036 | ) | ||||
Net income attributable to non-controlling interests (2) | 172 | 247 | 257 | |||||||
Amortization of intangible assets | (3,291 | ) | (3,314 | ) | (3,529 | ) | ||||
Impairment of intangible assets | (117 | ) | (142 | ) | (433 | ) | ||||
Fair value remeasurement of contingent consideration liabilities | (192 | ) | 15 | — | ||||||
Expenses arising from the impact of acquisitions on inventories (3) | (23 | ) | (476 | ) | (142 | ) | ||||
Restructuring costs | (1,141 | ) | (1,314 | ) | (1,384 | ) | ||||
Other gains and losses and litigation (4) | — | (327 | ) | (138 | ) | |||||
Impact of the non-depreciation of property, plant and equipment of Merial (in accordance with IFRS 5) | — | — | 77 | |||||||
Operating Income | 6,337 | 5,731 | 6,535 | |||||||
Financial expense | (553 | ) | (552 | ) | (468 | ) | ||||
Financial income | 93 | 140 | 106 | |||||||
Income before tax and associates and joint ventures | 5,877 | 5,319 | 6,173 | |||||||
Business Net Income
In addition to net income, we use a non-GAAP financial measure that we refer to as “business"business net income”income" to evaluate our Group’sGroup's performance. Business net income, which is defined below, represents the aggregate business operating income of all of our operating segments, less net financial expenses and the relevant income tax charges.effects. We believe that this non-GAAP financial measure allows investors to understand the performance of our Group because it segregates the results of operations of our current business activities, as opposed to reflecting the impact of past transactions such as acquisitions.
Our management uses business net income to manage and to evaluate our performance, and we believe it is appropriate to disclose this non-GAAP financial measure, as a supplement to our IFRS reporting, in order to assist investors in analyzing the factors and trends affecting our business performance. Our management also intends to use business net income as the basis for proposing the dividend policy for the Group. Accordingly, management believes that an investor’sinvestor's understanding of trends in our dividend policy is enhanced by disclosing business net income.
We have also decided to report “business"business earnings per share”share". Business earnings per share is a specific non-GAAP financial measure, which we define as business net income divided by the weighted average number of shares outstanding. Our management intends to give earnings guidance based on business earnings per share. We also present business earnings per share on a diluted basis.
Business net income is defined as “Net"Net income attributable to equity holders of Sanofi”Sanofi", determined under IFRS, excluding (i) amortization of intangible assets; (ii) impairment of intangible assets; (iii) fair value
remeasurement of contingent consideration liabilities; (iv) other impacts associated with acquisitions (including impacts of acquisitions on associates and joint ventures); (v) restructuring costs (including restructuring costs relating to associates and joint ventures),; (vi) other gains and losses, and litigation; (vii) the impact of the non-depreciation of the property, plant and equipment of Merial in 2010 and starting September 18, 2009 and continuing through 2010 (in accordance with IFRS 5); (viii) the tax effect related to the items listed in (i) through (vii); as well as (ix) the effects of major tax disputes and, as an exception for 2011, the retroactive effect (2006-2010) on the tax liability resulting from the agreement signed on December 22, 2011 by France and the United States on transfer prices (APA-Advance Pricing Agreement), for which the amount is deemed to be significant, and (x) the share of non-controlling interests in items (i) through (ix). Items (i), (ii), (iii), (v) and (vi) correspond to those reported in the income statement line items “Restructuring costs”"Amortization of intangible assets", “Fair"Impairment of intangible assets", "Fair value remeasurement of contingent consideration liabilities”liabilities", "Restructuring costs" and “Other"Other gains and losses, and litigation”litigation", as defined in Notes B.19. and B.20. to our consolidated financial statements.
The following table reconciles our business net income to our Net income attributable to equity holders of Sanofi for the years ended December 31, 2012, 2011 2010 and 2009:2010:
(€ million) | | 2012 | 2011 | 2010 | ||||||||
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Business net income | 8,179 | 8,795 | 9,215 | |||||||||
(i) | Amortization of intangible assets | (3,291 | ) | (3,314 | ) | (3,529 | ) | |||||
(ii) | Impairment of intangible assets | (117 | ) | (142 | ) | (433 | ) | |||||
(iii) | Fair value remeasurement of contingent consideration liabilities | (192 | ) | 15 | — | |||||||
(iv) | Expenses arising from the impact of acquisitions on inventories (1) | (23 | ) | (476 | ) | (142 | ) | |||||
(v) | Restructuring costs | (1,141 | ) | (1,314 | ) | (1,384 | ) | |||||
(vi) | Other gains and losses, and litigation (2) | — | (327 | ) | (138 | ) | ||||||
(vii) | Impact of the non-depreciation of the property, plant and equipment of Merial (IFRS 5) | — | — | 77 | ||||||||
(viii) | Tax effects on the items listed above, comprising: | 1,580 | 1,905 | 1,856 | ||||||||
— amortization of intangible assets | 1,159 | 1,178 | 1,183 | |||||||||
— impairment of intangible assets | 42 | 37 | 143 | |||||||||
— fair value remeasurement of contingent consideration liabilities | 2 | 34 | — | |||||||||
— expenses arising from the impact of acquisitions on inventories | 7 | 143 | 44 | |||||||||
— restructuring costs | 370 | 399 | 466 | |||||||||
— other gains and losses, and litigation | — | 114 | 46 | |||||||||
— non-depreciation of property, plant and equipment of Merial (IFRS 5) | — | — | (26 | ) | ||||||||
(iv)/(ix) | Other tax items (3) | — | 577 | — | ||||||||
(x) | Share of items listed above attributable to non-controlling interests | 3 | 6 | 3 | ||||||||
(iv)/(v) | Restructuring costs and expenses arising from the impact of acquisitions on associates and joint ventures (4) | (31 | ) | (32 | ) | (58 | ) | |||||
Net income attributable to equity holders of Sanofi | 4,967 | 5,693 | 5,467 | |||||||||
The following table sets forth the calculation of our business net income for the years ended December 31, 2012, 2011 and 2010:
(€ million) | 2011 | 2010 (1) | 2009 (1) | |||||||||||
Business net income | 8,795 | 9,215 | 8,629 | |||||||||||
(i) | Amortization of intangible assets | (3,314 | ) | (3,529 | ) | (3,528 | ) | |||||||
(ii) | Impairment of intangible assets | (142 | ) | (433 | ) | (372 | ) | |||||||
(iii) | Fair value remeasurement of contingent consideration liabilities | 15 | — | — | ||||||||||
(iv) | Expenses arising from the impact of acquisitions on inventories (2) | (476 | ) | (142 | ) | (90 | ) | |||||||
(v) | Restructuring costs | (1,314 | ) | (1,384 | ) | (1,080 | ) | |||||||
(vi) | Other gains and losses, and litigation (3) | (327 | ) | (138 | ) | — | ||||||||
(vii) | Impact of the non-depreciation of the property, plant and equipment of Merial (IFRS 5) | — | 77 | 21 | ||||||||||
(viii) | Tax effects on the items listed above, comprising: | 1,905 | 1,856 | 1,644 | ||||||||||
– amortization of intangible assets | 1,178 | 1,183 | 1,130 | |||||||||||
– impairment of intangible assets | 37 | 143 | 136 | |||||||||||
– fair value remeasurement of contingent consideration liabilities | 34 | — | — | |||||||||||
– expenses arising from the impact of acquisitions on inventories | 143 | 44 | 24 | |||||||||||
– restructuring costs | 399 | 466 | 360 | |||||||||||
– other gains and losses, and litigation | 114 | 46 | — | |||||||||||
– non-depreciation of property, plant and equipment of Merial (IFRS 5) | — | (26 | ) | (6 | ) | |||||||||
(iv)/(ix) | Other tax items (4) | 577 | — | 106 | ||||||||||
(x) | Share of items listed above attributable to non-controlling interests | 6 | 3 | 1 | ||||||||||
(iv)/(v) | Restructuring costs and expenses arising from the impact of acquisitions on associates and joint ventures (5) | (32 | ) | (58 | ) | (66 | ) | |||||||
Net income attributable to equity holders of Sanofi | 5,693 | 5,467 | 5,265 |
(€ million) | 2012 | 2011 | 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Business operating income | 11,353 | 12,144 | 12,863 | |||||||
Financial income and expenses | (460 | ) | (412 | ) | (362 | ) | ||||
Income tax expense | (2,714 | ) | (2,937 | ) | (3,286 | ) | ||||
Business net income | 8,179 | 8,795 | 9,215 | |||||||
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The most significant reconciliation items in the table above relate to the purchase accounting effect of our acquisitions, particularly the amortization and impairment of intangible assets. We believe that excluding these non-cash charges enhances an investor’sinvestor's understanding of our underlying economic performance because we do not consider that the excluded charges reflect the combined entity’sentity's ongoing operating performance. Rather, we believe that each of the excluded charges reflects the decision to acquire the businesses concerned.
The purchase-accounting effects on net income primarily relate to:
We believe (subject to the limitations described below) that disclosing business net income enhances the comparability of our operating performance, for the following reasons:
We remind investors, however, that business net income should not be considered in isolation from, or as a substitute for, net income attributable to equity holders of Sanofi reported in accordance with IFRS. In addition, we strongly encourage investors and potential investors not to rely on any single financial measure but to review our financial statements, including the notes thereto, and our other publicly filed reports, carefully and in their entirety.
There are material limitations associated with the use of business net income as compared to the use of IFRS net income attributable to equity holders of Sanofi in evaluating our performance, as described below:
paid for certain intangible assets that we have acquired through acquisitions. For example, in connection with our acquisition of Aventis in 2004, we paid an aggregate of €31,279 million for these amortizable intangible assets (which, in general, were to be amortized over their useful lives, representing an average amortization period of eight years) and €5,007 million for in-progress research & development. More recently, in connection with our acquisition of Genzyme in April 2011, we paid an aggregate of €7,877 million for amortizable intangible assets (average amortization period of eight and a half years) and €2,148 million for in-progress research & development. A large part of our revenues could not be generated without owning acquired intangible assets.
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We compensate for the above-described material limitations by using business net income only to supplement our IFRS financial reporting and by ensuring that our disclosures provide sufficient information for a full understanding of all adjustments included in business net income. In addition, subject to applicable law, we may in the future decide to report additional non-GAAP financial measures which, in combination with business net income, may compensate further for some of the material limitations described above.
In determining the level of future dividend payments, and in analyzing dividend policy on the basis of business net income, our management intends to take into account the fact that many of the adjustments reflected in business net income have no effect on the underlying amount of cash available to pay dividends. However, although the adjustments relating to the elimination of the effect of the purchase accounting treatment of the Aventis acquisition and other acquisitions represent non-cash charges, the adjustments relating to restructuring costs represent significant cash charges in the periods following the closing of the acquisition.
This Item 5 contains a discussion and analysis of business net income on the basis of consolidated financial data. Because our business net income is not a standardized measure, it may not be comparable with the non-GAAP financial measures of other companies using the same or a similar non-GAAP financial measure.
Presentation of Net Sales
In the discussion below, we present our consolidated net sales for 2012, 2011 2010 and 2009.2010. We break down our net sales among various categories, including by business segment, product and geographic region. We refer to our consolidated net sales as “reported”"reported" sales.
In addition to reported sales, we analyze non-GAAP financial measures designed to isolate the impact on our net sales of currency exchange rates and changes in group structure.
When we refer to changes in our net sales “at"at constant exchange rates”rates", we exclude the effect of exchange rates by recalculating net sales for the relevant period using the exchange rates that were used for the previous period. See Note B.2 to our consolidated financial statements for further information relating to the manner in which we translate into euros transactions recorded in other currencies.
When we refer to our net sales on a “constant"constant structure basis”basis", we eliminate the effect of changes in structure by restating the net sales for the previous period as follows:
A reconciliation of our reported net sales to our net sales at constant exchange rates is provided at “—"— Results of Operations — Year Ended December 31, 2012 Compared with Year Ended December 31, 2011 — Net Sales" and at "— Results of Operations — Year Ended December 31, 2011 Compared with Year Ended December 31, 2010 — Net Sales” and at “— Results of Operations — Year Ended December 31, 2010 Compared with Year Ended December 31, 2009 — Net Sales”Sales" below.
Financial Presentation of Alliances
We have entered into a number of alliances for the development, co-promotion and/or co-marketing of our products. We believe that a presentation of our two principal alliances is useful to an understanding of our financial statements.
The financial impact of the alliances on the Company’sCompany's income statement is described in “—"— Results of Operations — Year Ended December 31, 2012 Compared with Year Ended December 31, 2011" and "— Year Ended December 31, 2011 Compared with Year Ended December 31, 2010” and “— Year Ended December 31, 2010 Compared with Year Ended December 31, 2009”2010", in particular in “—"— Net sales”sales", “—"— Other Revenues”Revenues", “—"— Share of Profit/Loss of Associates and Joint Ventures”Ventures" and “—"— Net Income Attributable to Non-Controlling Interests”Interests".
Alliance Arrangements with Bristol-Myers Squibb
Our revenues, expenses and operating income are affected significantly by the presentation of our alliance with Bristol-Myers Squibb (BMS) in our consolidated financial statements.
On September 27, 2012 Sanofi and BMS restructured their alliance following the loss of exclusivity of Plavix® and Avapro®/Avalide® in many major markets. Under the terms of the revised agreement, which came into effect on January 1, 2013, BMS has returned to Sanofi its rights to Plavix® and Avapro®/Avalide® in all markets worldwide with the exception of Plavix® in the U.S. and Puerto Rico, giving Sanofi sole control and freedom to operate commercially. In exchange, starting January 1, 2013 BMS will receive royalty payments on Sanofi's sales of branded and unbranded Plavix® worldwide, excluding the U.S. and Puerto Rico, and on sales of branded and unbranded Avapro®/Avalide® worldwide, in each case through 2018; BMS will also receive a terminal payment of $200 million from Sanofi in December 2018. Plavix® rights in the U.S. and Puerto Rico will continue unchanged under the terms of the existing agreement through December 2019.
There In addition, under the terms of this new agreement ongoing disputes between the companies related to the alliance have been resolved. The resolution of these disputes includes various commitments by both companies, including a one-time payment of $80 million by BMS to Sanofi in relation to the Avalide® supply disruption in the U.S. in 2011.
As of December 31, 2012, there are three principal marketing arrangements that are used:
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The alliance arrangements as of December 31, 2012 include two royalty streams that are applied on a worldwide basis (excluding Japan and other opt out countries), regardless of the marketing system and regardless of which company has majority ownership and operational management:
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Under the alliance arrangements as of December 31, 2012, there are two territories, one under our operational management and the other under the operational management of BMS. The territory under our operational management consists of Europe and most of Africa and Asia, while the territory under the operational management of BMS consists of the rest of the world (excluding Japan). In Japan, Aprovel®Aprovel® has been marketed jointly by Shionogi Pharmaceuticals and Dainippon Sumitomo Pharma Co. Ltd since June 2008. Our alliance with BMS does not cover distribution rights to Plavix®Plavix® in Japan, which is marketed by Sanofi.
Territory under our operational managementmanagement.. In the territory under our operational management, the marketing arrangements and recognition of operations by the Group are as follows:
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Territory under BMS operational managementmanagement.. In the territory under BMS operational management, the marketing arrangements and recognition of operations by the Group are as follows:
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In countries where the products are marketed by BMS on a co-marketing basis, or through alliances under the operational management of BMS, we also earn revenues from the sale of the active ingredients for the products to BMS or such entities, which we record as “Net sales”"Net sales" in our consolidated income statement.
Alliance Arrangements with Regeneron
Our relationship with Regeneron began in 2003 with an agreement for the co-development of the anti-angiogenic agent Zaltrap®. We expanded our relationship in 2007 and created a strategic R&D collaboration on fully human monoclonal antibodies.
Collaboration agreement on Zaltrap® (aflibercept)
Zaltrap® (aflibercept) is a solution administered by intravenous perfusion, used in association with 5-fluorouracil, leucovorin and irinotecan (FOLFIRI) as a treatment for metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen.
In September 2003, Sanofi and Regeneron signed an agreement to collaborate on the development and commercialization of Zaltrap®. Under the terms of this agreement (as amended in 2005), Sanofi is responsible for funding 100% of the development costs, co-promotion rights are shared between Sanofi and Regeneron, and the profits generated from sales of Zaltrap® worldwide (except Japan) are shared equally. Sales of Zaltrap® made by subsidiaries under the control of Sanofi are recognized in consolidated net sales, and the associated costs incurred by those subsidiaries are recognized as operating expenses in the consolidated income statement. Regeneron's share of the profits is recognized in the line item "Other operating expenses", a component of operating income.
Under the terms of the same agreement, Regeneron agreed to repay 50% of the development costs initially funded by Sanofi. Contractually, this amount represents 5% of the residual repayment obligation per quarter, but may not exceed Regeneron's profit share for the quarter unless Regeneron voluntarily decides to make a larger payment in a given quarter.
The agreement also stipulates milestone payments to be made by Sanofi on receipt of specified marketing approvals for Zaltrap® in the United States, within the European Union and in Japan.
In the United States, Zaltrap® is a registered trademark of Regeneron Pharmaceuticals, Inc. The product was approved by the U.S. Food and Drug Administration ("FDA") in August 2012, and has been marketed in the United States since that date. On February 5, 2013, the European Commission granted marketing authorization in the European Union for Zaltrap®. Regeneron has not elected to co-promote Zaltrap® at launch in the major market countries defined as United States, France, Italy, Spain, United Kingdom, Germany and Canada.
In Japan, Sanofi will develop and commercialize Zaltrap®, with Regeneron entitled to receive a royalty.
Collaboration agreement on the discovery, development and commercialization of human therapeutic antibodies
In November 2007, Sanofi and Regeneron signed additional agreements under which Sanofi committed to funding the development costs of Regeneron's human monoclonal antibody research program until 2017, up to a maximum of $160 million a year (see Note D.21. to our consolidated financial statements included at Item 18 of this annual report). Sanofi has an option to license for further development any antibodies discovered by Regeneron that attain Investigational New Drug (IND) status.
If such an option is exercised, Sanofi is primarily responsible for funding, and co-develops the antibody with Regeneron. Sanofi and Regeneron would share co-promotion rights and profits on sales of the co-developed antibodies. Development costs for the drug candidate are shared between the companies, with Sanofi generally funding these costs up front, except that following receipt of the first positive Phase III trial results for a co-developed drug candidate, subsequent Phase III trial-related costs for that drug candidate are shared 80% by Sanofi and 20% by Regeneron. Once a product begins to be marketed, Regeneron will progressively repay out of its profits 50% of the development costs borne by Sanofi for all antibodies licensed by Sanofi. However, Regeneron are not required to apply more than 10% of its share of the profits from collaboration products in any calendar quarter towards reimbursing Sanofi for these development costs. Under the terms of the collaboration agreement, Sanofi may also be required to make milestone payments based on aggregate sales of antibodies. In 2012, six antibodies were in clinical development; two of which were in Phase III.
If Sanofi does not exercise its licensing option for an antibody under development, Sanofi will be entitled to receive a royalty once the antibody begins to be marketed.
Alliance arrangements with Warner Chilcott (previously with Procter & Gamble Pharmaceuticals)
Our agreement with Warner Chilcott (“("the Alliance Partner”Partner") covers the worldwide development and marketing arrangements of Actonel®Actonel®, except Japan for which we hold no rights. Until October 30, 2009, this agreement was between Sanofi and Procter & Gamble Pharmaceuticals (P&G). Since the sale by P&G of its pharmaceutical business to Warner Chilcott on October 30, 2009, Actonel®Actonel® has been marketed in collaboration with Warner Chilcott. The local marketing arrangements may take various forms.
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In 2010, Sanofi and Warner Chilcott began negotiations on the future of their alliance arrangements. In an arbitration proceeding, an arbitration panel decided on July 14, 2011 that the termination by Warner Chilcott of an ancillary agreement did not lead to the termination of the Actonel®Actonel® Alliance. Pursuant to this decision, the alliance will remain in effect until January 1, 2015.
Impact of Exchange Rates
We report our consolidated financial statements in euros. Because we earn a significant portion of our revenues in countries where the euro is not the local currency, our results of operations can be significantly affected by exchange rate movements between the euro and other currencies, primarily the U.S. dollar and, to a lesser extent, the Japanese yen, and currencies in emerging countries. We experience these effects even though certain of these countries do not account for a large portion of our net sales. In 2011,2012, we earned 29.8%31.1% of our net sales in the United States. A decrease in the value of the U.S. dollar against the euro has a negative impact on our revenues, which is not offset by an equal reduction in our costs and therefore negatively affects our operating income. A decrease in the value of the U.S. dollar has a particularly significant impact on our operating income, which is higher in the United States than elsewhere, and on the contribution to net income of our alliance with BMS in the United States, which is
under the operational management of BMS, as described at “—"— Financial Presentation of Alliances — Alliance arrangements with Bristol-Myers Squibb”Squibb" above.
For a description of positions entered into to manage operational foreign exchange risks as well as our hedging policy, see “Item"Item 11. Quantitative and Qualitative Disclosures about Market Risk”Risk", and “Item"Item 3. Key Information — D. Risk Factors — Risks Related to Financial Markets — Fluctuations in currency exchange rates could adversely affect our results of operations and financial condition”condition".
Divestments
In August 2012, Sanofi sold its 39.1% interest in Société Financière des Laboratoires de Cosmétologie Yves Rocher, in line with the Group's desire to focus on strategic activities.
On In December 19, 2011 Sanofi sold the Dermik dermatology business to Valeant Pharmaceuticals International Inc., for €321 million (see Note D.1.3. to our consolidated financial statements included at Item 18 of this annual report).
There were no material divestments in 2010 or 2009.
2010.
Acquisitions
In April 2012, Sanofi strengthened its presence in biosurgery by acquiring a 100% equity interest in Pluromed, Inc. (Pluromed), an American medical devices company. Pluromed has developed a proprietary polymer technology — Rapid Transition Polymers (RTP™) — pioneering the use of plugs that can be injected into blood vessels to improve the safety, efficacy and economics of medical interventions.
In March 2012, Merial (Sanofi's Animal Health division) completed the acquisition of Newport Laboratories, a privately held company based in Worthington, Minnesota (United States), which is a leader in autogenous vaccines for the bovine and swine markets.
The impact of these two acquisitions on our consolidated financial statements is not material.
In October 2012, Sanofi signed an agreement to acquire Genfar S.A. (Genfar), a Colombian pharmaceutical company that is a major player in Colombia and other countries in Latin America. Genfar is the second-largest generics manufacturer in Colombia by sales, and the leader by volumes sold. Closing of the deal is subject to certain conditions, and is expected to take place in the first quarter of 2013.
In December 2012, Sanofi announced that an agreement had been reached to acquire the animal health division of Dosch Pharmaceuticals Pvt Ltd, an Indian company, allowing Merial to enter this strategic animal health market. Closing of the deal is subject to regulatory approval, and is expected to take place during the first half of 2013.
In February 2011, Sanofi completed the acquisition of 100% of the share capital of BMP Sunstone Corporation (BMP Sunstone), a pharmaceutical company that develops a portfolio of branded pharmaceutical and healthcare products in China. See Note D.1.2. to our consolidated financial statements included at Item 18 of this annual report.
In April 2011, Sanofi acquired Genzyme Corporation (Genzyme), a major biotechnology company headquartered in Cambridge, Massachussets (United States), with primary areas of focus in rare diseases, renal endocrinology, oncology and biosurgery. In 2011, Genzyme generated full-year net sales of €3.1 billion, out of which €2.4 billion were consolidated by Sanofi as from the acquisition date. The transaction was completed in accordance with the terms of the public exchange offer at a price of $74 in cash plus the issuance to Genzyme shareholders of one contingent value right (CVR) per share. TotalThe total purchase price amounted to €14.8 billion. The provisional purchase price allocation is disclosed in Note D.1.1.D.1.2. to our consolidated financial statements included at Item 18 of this annual report.
In October 2011, Sanofi acquired Topaz Pharmaceuticals Inc. (Topaz), a U.S. pharmaceutical research company that developed an innovative anti-parasitic product for treating head lice. An upfront payment of $35 million was made on completion of the transaction. According to the agreement, future milestone payments may be made upon market approval and depending on the achievement of sales targets. See Note D.1.2. to our consolidated financial statements included at Item 18 of this annual report. The total amount of payments (including the upfront payment) could reach $207.5 million.
In November 2011, Sanofi acquired the business of Universal Medicare Private Limited (Universal), a major producer of neutraceuticalsnutraceuticals in India. An upfront payment of €83 million was made on completion of the transaction. See Note D.1.2. to our consolidated financial statements included at Item 18 of this annual report.
In December 2011, Sanofi co-invested in Warp Drive Bio, an innovative start-up biotechnology company, along with two venture capital firms, Third Rock Ventures (TRV) and Greylock Partners. Warp Drive Bio is an
innovative biotechnology company, focusing on proprietary genomic technology to discover drugs of natural origin. Under the terms of the agreement, Sanofi and TRV / Greylock will investhave invested in Warp Drive Bio at parity. Total program funding over the first five years could amount to up to $125 million, including an equity investment of up to $75 million.
In February 2010, Sanofi acquired the U.S.-based company Chattem, Inc. (Chattem) by successfully completing a cash tender offer leading to the acquisition of 100% of the share capital. Chattem is a major consumer health player in the United States, producing and distributing branded consumer health products, toiletries and dietary supplements across various market segments. Chattem manages the Allegra®Allegra® brand, and acts as the platform for Sanofi over-the-counter and consumer healthcare products in the United States. See Note D.1.D.1.4. to our consolidated financial statements included at Item 18 of this annual report.
In April 2010, Sanofi acquired a controlling interest in the capital of Bioton Vostok, a Russian insulin manufacturer. Under the terms of the agreement, put options were granted to non-controlling interests. See Note D.18. to our consolidated financial statements included at Item 18 of this annual report.
In May 2010, Sanofi formed a new joint venture with Nichi-Iko Pharmaceuticals Co., Ltd (Nichi-Iko), a leading generics company in Japan, to expand generics activities in the country. In addition to forming this joint venture, Sanofi took a 4.66% equity interest in the capital of Nichi-Iko.
In June 2010, Sanofi acquired 100% of the share capital of Canderm Pharma Inc. (Canderm), a privately-held leading Canadian skincare company distributing cosmeceuticals and dermatological products. Canderm generated net sales of 24 million Canadian dollars in 2009.
In July 2010, Sanofi acquired 100% of the share capital of TargeGen, Inc. (TargeGen), a U.S. biopharmaceutical company developing small molecule kinase inhibitors for the treatment of certain forms of leukemia, lymphoma and other hematological malignancies and blood disorders. An upfront payment of $75 million was made on completion of the transaction. Future milestone payments may be made at various stages in the development of TG 101348, TargeGen’sTargeGen's principal product candidate. The total amount of payments (including the upfront payment) could reach $560 million. See Note D.1.D.1.4. and Note D.18. to our consolidated financial statements included at Item 18 of this annual report.
In August 2010, Sanofi acquired 100% of the share capital of Nepentes S.A. (Nepentes), a Polish manufacturer of pharmaceuticals and dermocosmetics, for a consideration of PLN 425 million (€106 million).
In October 2010, Sanofi Pasteur acquired 100% of the share capital of VaxDesign Corporation (VaxDesign), a privately-held U.S. biotechnology company which has developed a technology reproducing in vitro models of the human immune system, that can be used to select the best candidate vaccines at the pre-clinical stage. Under the terms of the agreement, an upfront payment of $55 million was made upon closing of the transaction, and a further $5 million will be payable upon completion of a specified development milestone.
In October 2010, Sanofi acquired a 60% equity interest in the Chinese consumer healthcare company Hangzhou Sanofi Minsheng Consumer Healthcare Co. Ltd, in partnership with Minsheng Pharmaceutical Co., Ltd (“Minsheng”("Minsheng"). Minsheng was also granted a put option over the remaining shares not held by Sanofi. See Note D.18. to our consolidated financial statements included at Item 18 of this annual report.
The principal acquisitions during 2009 are described below:
On September 17, 2009, and further to the agreement signed on July 29, 2009, Sanofi completed the acquisition of the interest held by Merck & Co., Inc. (Merck) in Merial Limited (Merial) for consideration of $4 billion in cash. Founded in 1997, Merial was previously held jointly (50/50) by Merck and Sanofi. Merial is one of the world’s leading animal health companies, with annual sales of $2.6 billion in 2009 and 2010. With effect from September 17, 2009, Sanofi has held 100% of the shares of Merial and has exercised exclusive control over the company.
In connection with the agreement signed on July 29, 2009, Sanofi had also signed an option contract giving it the possibility, once the Merck/Schering-Plough merger would be complete, to combine the Merck-owned Intervet/Schering-Plough Animal Health business with Merial in a joint venture to be held 50/50 by Merck and Sanofi. Because of the high probability of the option being exercised as of year-end 2009 and 2010, Merial was treated as an asset held for sale or exchange pursuant to IFRS 5 as of December 31, 2009 and December 31, 2010. On March 8, 2010, Sanofi exercised its contractual right to combine the Intervet/Schering-Plough Animal Health business with Merial. However, on March 22, 2011, Merck and Sanofi announced that they had mutually terminated their agreement to form a new animal health joint venture and decided to maintain Merial and Intervet/Schering-Plough as two separate entities, operating independently. This decision was mainly due to the increasing complexity of implementing the proposed transaction. Starting from January 1, 2011, Merial is no longer accounted for separately on the consolidated balance sheet and income statements of Sanofi. Detailed information about the impact of Merial on the consolidated financial statements of Sanofi as of December 31, 2011 is provided in Note D.2. and Note D.8.1. to our consolidated financial statements included at Item 18 of this annual report.
In March 2009, Sanofi successfully closed its offer for Zentiva N.V. (Zentiva). As of December 31, 2009, Sanofi held about 99.1% of Zentiva’s share capital. Following the buyout of the remaining non-controlling interests, Sanofi held 100% of Zentiva’s share capital as of December 31, 2010. The purchase price was €1,200 million, including acquisition-related costs.
In March 2009, Sanofi acquired Laboratorios Kendrick, one of Mexico’s leading manufacturers of generics, with sales of approximately €26 million in 2008.
In April 2009, Sanofi acquired a 100% equity interest in Medley, the third largest pharmaceutical company in Brazil and a leading generics company in that country. The purchase price was €348 million inclusive of acquisition-related costs.
In April 2009 Sanofi acquired 100% of BiPar Sciences, Inc. (BiPar), a U.S. biopharmaceutical company developing novel tumor-selective approaches for the treatment of different types of cancers. The purchase price was in large part contingent on the achievement (regarded as probable) of milestones related to the development of BSI-201, and could reach $500 million. See Note D.18. to our consolidated financial statements included at Item 18 of this annual report.
In July 2009, Sanofi completed the acquisition of 100% of the share capital of Helvepharm, a Swiss generics company.
In August 2009, Sanofi took control of Shantha Biotechnics (Shantha), a vaccines company based in Hyderabad (India). As of December 31, 2010, Sanofi held approximately 96.4% of Shantha. The purchase price allocation led to the recognition of intangible assets (excluding goodwill) worth €374 million. This amount includes the acquisitions-date value of the Shan5® pentavalent vaccine, which was partially written down in 2010 (see Note D.5. to our consolidated financial statements included at Item 18 of this annual report).
In October 2009, Sanofi acquired 100% of the share capital of Fovea Pharmaceuticals SA, a privately-held French biopharmaceutical research and development company specializing in ophthalmology. The purchase consideration included contingent milestone payments of up to €280 million linked to the development of three products. See Notes D.1. and D.18. to our consolidated financial statements included at Item 18 of this annual report.
In November 2009, Sanofi completed the acquisition of 100% of the share capital of Laboratoire Oenobiol, one of France’s leading players in health and beauty dietary supplements.
Results of Operations
Year Ended December 31, 2012 Compared with Year Ended December 31, 2011
The consolidated income statements for the years ended December 31, 2012 and December 31, 2011 break down as follows:
(under IFRS) (€ million) | 2012 | as % of net sales | 2011 | as % of net sales | |||||||||
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Net sales | 34,947 | 100.0% | 33,389 | 100.0% | |||||||||
Other revenues | 1,010 | 2.9% | 1,669 | 5.0% | |||||||||
Cost of sales | (11,118 | ) | (31.8% | ) | (10,902 | ) | (32.7% | ) | |||||
Gross profit | 24,839 | 71.1% | 24,156 | 72.3% | |||||||||
Research & development expenses | (4,922 | ) | (14.1% | ) | (4,811 | ) | (14.4% | ) | |||||
Selling & general expenses | (8,947 | ) | (25.6% | ) | (8,536 | ) | (25.6% | ) | |||||
Other operating income | 562 | 319 | |||||||||||
Other operating expenses | (454 | ) | (315 | ) | |||||||||
Amortization of intangible assets | (3,291 | ) | (3,314 | ) | |||||||||
Impairment of intangible assets | (117 | ) | (142 | ) | |||||||||
Fair value remeasurement of contingent consideration liabilities | (192 | ) | 15 | ||||||||||
Restructuring costs | (1,141 | ) | (1,314 | ) | |||||||||
Other gains and losses, and litigation (1) | — | (327 | ) | ||||||||||
Operating income | 6,337 | 18.1% | 5,731 | 17.2% | |||||||||
Financial expenses | (553 | ) | (552 | ) | |||||||||
Financial income | 93 | 140 | |||||||||||
Income before tax and associates and joint ventures | 5,877 | 16.8% | 5,319 | 15.9% | |||||||||
Income tax expense | (1,134 | ) | (455 | ) | |||||||||
Share of profit/(loss) of associates and joint ventures | 393 | 1,070 | |||||||||||
Net income | 5,136 | 14.7% | 5,934 | 17.8% | |||||||||
Net income attributable to non-controlling interests | 169 | 241 | |||||||||||
Net income attributable to equity holders of Sanofi | 4,967 | 14.2% | 5,693 | 17.1% | |||||||||
Average number of shares outstanding (million) | 1,319.5 | 1,321.7 | |||||||||||
Average number of shares outstanding after dilution (million) | 1,329.6 | 1,326.7 | |||||||||||
Basic earnings per share (in euros) | 3.76 | 4.31 | |||||||||||
Diluted earnings per share (in euros) | 3.74 | 4.29 | |||||||||||
Our consolidated income statements include the results of the operations of Genzyme from April 2011. In order to help investors gain a better understanding of our performances, in the narrative discussion of certain income statement line items ("net sales", "research & development expenses", and "selling & general expenses"), we include non-consolidated 2011 first-quarter data for Genzyme in additional analyses.
Net Sales
Net sales for the year ended December 31, 2012 amounted to €34,947 million, up 4.7% on 2011. Exchange rate movements had a favorable effect of 4.2 points, mainly reflecting the appreciation of the U.S. dollar against the euro, and to a lesser extent the appreciation of the yen and the yuan. At constant exchange rates and after taking account of changes in structure (mainly the consolidation of Genzyme from April 2011), net sales rose by 0.5% year-on-year.
The following table sets forth a reconciliation of our reported net sales for the years ended December 31, 2012 and December 31, 2011 to our net sales at constant exchange rates:
(€ million) | 2012 | 2011 | Change (%) | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Net sales | 34,947 | 33,389 | +4.7% | |||||||
Effect of exchange rates | (1,400 | ) | ||||||||
Net sales at constant exchange rates | 33,547 | 33,389 | +0.5% | |||||||
Our net sales comprise the net sales generated by our Pharmaceuticals, Human Vaccines (Vaccines) and Animal Health segments.
The following table breaks down our 2012 and 2011 net sales by business segment:
(€ million) | 2012 Reported | 2011 Reported | Change on a reported basis (%) | Change at constant exchange rates (%) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pharmaceuticals | 28,871 | 27,890 | +3.5% | -0.4% | |||||||||
Vaccines | 3,897 | 3,469 | +12.3% | +5.7% | |||||||||
Animal Health | 2,179 | 2,030 | +7.3% | +3.1% | |||||||||
Total | 34,947 | 33,389 | +4.7% | +0.5% | |||||||||
Net Sales by Product — Pharmaceuticals segment
Net sales generated by our Pharmaceuticals segment were €28,871 million in 2012, up 3.5% on a reported basis but down 0.4% at constant exchange rates. The year-on-year change reflects the positive impact of consolidating Genzyme from April 2011 and the performance of growth platforms, but also the negative effects of generic competition (mainly on sales of Lovenox®, Taxotere® and Eloxatine® in the United States, and of Taxotere®, Plavix® and Aprovel® in Western Europe), the ending of the co-promotion agreement with Teva on Copaxone®, the divestiture of the Dermik business in July 2011, and austerity measures in the European Union.
On a constant structure basis and at constant exchange rates (which primarily means including the non-consolidated sales of Genzyme for the first quarter of 2011 and excluding sales of Copaxone® for the whole of 2011), net sales for the Pharmaceuticals segment fell by 0.6% in 2012.
Our flagship products (Lantus® and Apidra®, Lovenox®, Plavix®, Aprovel®/CoAprovel®, Taxotere®, Eloxatine®, Cerezyme®, Myozyme®/Lumizyme®, Fabrazyme®, Renagel®/Renvela®, Synvisc®/Synvisc-One®, Multaq®, Jevtana®, Aubagio® and Zaltrap®) are discussed below. Sales of Plavix® and Aprovel® are discussed further below under "— Worldwide Presence of Plavix® and Aprovel®".
The following table breaks down our 2012 and 2011 net sales for the Pharmaceuticals segment by product:
(€ million) Product | Indication | 2012 Reported | 2011 Reported | Change on a reported basis (%) | Change at constant exchange rates (%) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lantus® | Diabetes | 4,960 | 3,916 | +26.7% | +19.3% | ||||||||||
Apidra® | Diabetes | 230 | 190 | +21.1% | +16.8% | ||||||||||
Amaryl® | Diabetes | 421 | 436 | -3.4% | -8.0% | ||||||||||
Insuman® | Diabetes | 135 | 132 | +2.3% | +3.0% | ||||||||||
Other diabetes products | Diabetes | 36 | 10 | +260.0% | +250.0% | ||||||||||
Total: Diabetes | Diabetes | 5,782 | 4,684 | +23.4% | +16.7% | ||||||||||
Eloxatin® | Colorectal cancer | 956 | 1,071 | -10.7% | -17.3% | ||||||||||
Taxotere® | Breast, lung, prostate, stomach, and head & neck cancer | 563 | 922 | -38.9% | -41.9% | ||||||||||
Jevtana® | Prostate cancer | 235 | 188 | +25.0% | +20.2% | ||||||||||
Zaltrap® | Colorectal cancer | 25 | — | — | — | ||||||||||
Mozobil® (1) | Hematologic malignancies | 96 | 59 | — | — | ||||||||||
Other oncology products (1) | 519 | 389 | — | — | |||||||||||
Total: Oncology | 2,394 | 2,629 | -8.9% | -14.3% | |||||||||||
Lovenox® | Thrombosis | 1,893 | 2,111 | -10.3% | -12.0% | ||||||||||
Plavix® | Atherothrombosis | 2,066 | 2,040 | +1.3% | -4.6% | ||||||||||
Aprovel®/CoAprovel® | Hypertension | 1,151 | 1,291 | -10.8% | -13.3% | ||||||||||
Allegra® | Allergic rhinitis, urticaria | 553 | 580 | -4.7% | -9.5% | ||||||||||
Stilnox®/Ambien®/Myslee® | Sleep disorders | 497 | 490 | +1.4% | -4.5% | ||||||||||
Copaxone® | Multiple sclerosis | 24 | 436 | -94.5% | -94.7% | ||||||||||
Depakine® | Epilepsy | 410 | 388 | +5.7% | +3.1% | ||||||||||
Tritace® | Hypertension | 345 | 375 | -8.0% | -8.3% | ||||||||||
Multaq® | Atrial fibrillation | 255 | 261 | -2.3% | -8.0% | ||||||||||
Xatral® | Benign prostatic hypertrophy | 130 | 200 | -35.0% | -37.0% | ||||||||||
Actonel® | Osteoporosis, Paget's disease | 134 | 167 | -19.8% | -21.6% | ||||||||||
Nasacort® | Allergic rhinitis | 71 | 106 | -33.0% | -35.8% | ||||||||||
Renagel®/Renvela® (1) | Hyperphosphatemia | 653 | 415 | — | — | ||||||||||
Synvisc®/Synvisc-One® (1) | Arthritis | 363 | 256 | — | — | ||||||||||
Aubagio® | Multiple sclerosis | 7 | — | — | — | ||||||||||
Sub-total Multiple sclerosis | 7 | — | — | — | |||||||||||
Cerezyme® (1) | Gaucher disease | 633 | 441 | — | — | ||||||||||
Myozyme®/Lumizyme® (1) | Pompe disease | 462 | 308 | — | — | ||||||||||
Fabrazyme® (1) | Fabry disease | 292 | 109 | — | — | ||||||||||
Other rare disease products (1) | 391 | 264 | — | — | |||||||||||
Sub-total Rare diseases (1) | 1,778 | 1,122 | — | — | |||||||||||
Total: New Genzyme (1) | 1,785 | 1,122 | — | — | |||||||||||
Other prescription products | 5,513 | 5,927 | -7.0% | -9.1% | |||||||||||
Consumer Health Care | 3,008 | 2,666 | +12.8% | +9.9% | |||||||||||
Generics | 1,844 | 1,746 | +5.6% | +5.0% | |||||||||||
Total Pharmaceuticals | 28,871 | 27,890 | +3.5% | -0.4% | |||||||||||
Diabetes
Net sales for theDiabetes business amounted to €5,782 million, up 16.7% at constant exchange rates, driven by strong growth for Lantus®.
Lantus® posted a 19.3% increase in net sales at constant exchange rates in 2012 to €4,960 million, driven by very strong growth in the United States (up 22.0% at €3,087 million); in Emerging Markets (up 25.4% at €793 million), especially in China (up 35.9%) and Latin America (up 32.3%); and in Japan (up 22.0%). In Western Europe, growth was a more modest 5.3% at constant exchange rates.
Net sales of the rapid-acting insulin analogApidra® advanced by 16.8% (at constant exchange rates) to €230 million in 2012, buoyed by the product's performance in Emerging Markets (up 37.8%).
Amaryl® saw net sales fall by 8.0% at constant exchange rates to €421 million, mainly as a result of competition from generics in Japan (down 31.7%, at €125 million), and in spite of 11.4% growth in Emerging Markets to €263 million.
Oncology
Net sales for theOncology business were €2,394 million, down 14.3% at constant exchange rates.
Net sales ofEloxatine® fell by 17.3% at constant exchange rates to 956 million in 2012, reflecting the loss of exclusivity in the United States on August 9, 2012, which had been expected.
Taxotere® reported a fall in net sales of 41.9% at constant exchange rates, to €563 million. The product is facing competition from generics in Western Europe (down 72.5%) and the United States (down 80.2%). Emerging Markets sales amounted to €270 million, down 11.2% at constant exchange rates.
Jevtana® posted net sales of €235 million in 2012, up 20.2% at constant exchange rates, boosted by product launches in various countries in Western Europe (€91 million, up 104.5% at constant exchange rates) and in Emerging Markets.
Zaltrap® , launched in the United States and Puerto Rico at the end of August 2012, generated net sales of €25 million for the year.
Mozobil® reported net sales of €96 million, up 19.7% on a constant structure basis and at constant exchange rates (i.e., including non-consolidated sales generated by Genzyme in the first quarter of 2011).
Jevtana®, Zaltrap® and Mozobil®, along with Multaq® (see "— Other pharmaceutical products" below), form the "Other Innovative Products" growth platform. This platform generated net sales of €611 million in 2012.
Other pharmaceutical products
Lovenox® recorded a fall in net sales of 12.0% at constant exchange rates to €1,893 million in 2012, as a result of competition from generics in the United States, where sales slipped by 53.1% (at constant exchange rates) to €319 million. Sales generated outside the United States accounted for 83.1% of worldwide net sales and rose by 5.5% at constant exchange rates to €1,574 million, driven by Emerging Markets (up 11.6% at constant exchange rates at €615 million). Sanofi also launched its own generic version of Lovenox® in the United States, sales of which are recognized in the Generics business.
Net sales ofRenagel®/Renvela® rose by 13.0% on a constant structure basis and at constant exchange rates (i.e. including non-consolidated sales generated by Genzyme in the first quarter of 2011) to €653 million, on a fine performance in the United States (up 19.2% on a constant structure basis and at constant exchange rates).
Synvisc®/Synvisc-One® reported sales growth of 4.0% on a constant structure basis and at constant exchange rates (including non-consolidated sales generated by Genzyme in the first quarter of 2011) to €363 million, driven mainly by the Synvisc-One® franchise in the United Sates (€302 million, up 5.7% on a constant structure basis and at constant exchange rates).
Net sales of theAmbien® range fell by 4.5% at constant exchange rates to €497 million, reflecting competition from generics of Ambien® CR in the United States and Western Europe and the introduction of generic versions of Myslee® in Japan during the second half of 2012.
Allegra® reported a decline in net sales as a prescription medicine (down 9.5% at constant exchange rates) to €553 million, reflecting lower prices in Japan (down 15.2% at constant exchange rates, at €423 million). This product is sold over the counter in the United States, and has also been available over the counter in Japan since November 2012. Sales over the counter are recognized in the Consumer Health Care business. In August 2012 three generic versions of Allegra® were approved by the regulatory authorities in Japan; since February 2013, Allegra® as a prescription medicine has been subject to generic competition in this country.
Net sales ofMultaq® fell by 8.0% at constant exchange rates to €255 million, due to the effect of restrictions placed on the product's indication during the second half of 2011.
Net sales ofCopaxone® amounted to €24 million, versus €436 million in 2011, down 94.7% (at constant exchange rates), reflecting the ending of the co-promotion agreement with Teva in all territories in the first quarter of 2012. Since the transfer of Copaxone® to Teva, we no longer recognize net sales of the product. Instead, for the two years following the transfer we are entitled to receive a payment representing 6% of net sales, which we recognize under the income statement line item "Other revenues".
New Genzyme business
Thenew Genzyme business consists of products used to treat rare diseases, and products for the treatment of multiple sclerosis (Aubagio® and the experimental agent Lemtrada™).
Because Genzyme's net sales have been consolidated from the acquisition date (i.e. the start of April 2011), the 2011 consolidated net sales of the new Genzyme business do not include sales for the first quarter of 2011. On a constant structure basis and at constant exchange rates, i.e. after including non-consolidated net sales for the first quarter of 2011, the net sales of the new Genzyme business rose by 16.9% in 2012 to €1,785 million.
The following table breaks down our 2012 and 2011 net sales for the new Genzyme business by product:
(€ million) Product | Indication | 2012 Reported | 2011 Reported | Change on a constant structure basis and at constant exchange rates (%) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Aubagio® | Multiple sclerosis | 7 | — | — | ||||||||
Sub-total Multiple sclerosis | 7 | — | — | |||||||||
Cerezyme® (1) | Gaucher disease | 633 | 441 | +6.0% | ||||||||
Myozyme®/Lumizyme® (1) | Pompe disease | 462 | 308 | +11.4% | ||||||||
Fabrazyme® (1) | Fabry disease | 292 | 109 | +96.4% | ||||||||
Other rare disease products (1) | 391 | 264 | +7.5% | |||||||||
Sub-total Rare diseases (1) | 1,778 | 1,122 | +16.4% | |||||||||
Total: New Genzyme (1) | 1,785 | 1,122 | +16.9% | |||||||||
Cerezyme® recorded net sales growth of 6.0% on a constant structure basis and at constant exchange rates, to €633 million (+0.9% in Western Europe, at €215 million; +6.3% in the United States, at €166 million). Production continued to improve during the year, enabling normal doses to be delivered to patients in the product's principal markets
Net sales ofMyozyme®/Lumizyme® were up 11.4% on a constant structure basis and at constant exchange rates at €462 million (+10,4% in Western Europe, at €257 million; +6.9% in the United States, at €117 million).
Fabrazyme® reported a 96.4% surge in net sales on a constant structure basis and at constant exchange rates, to €292 million. This increase was due mainly to the resumption of production at the new facility at Framingham (United States) in March 2012, enabling full doses to be supplied in all markets where the product is approved for sale.
For more information regarding the manufacturing issues related to Cerezyme® and Fabrazyme® see "Item 4 — Information on the Company — Production and Raw Materials."
In multiple sclerosis,Aubagio® was launched in the United States in October 2012, and recorded fourth-quarter net sales of €7 million.
Consumer Health Care business
Net sales for theConsumer Health Care business rose by 9.9% at constant exchange rates in 2012, to €3,008 million. This figure includes revenues generated from the acquisitions made in 2011 (primarily BMP Sunstone in China, and the nutraceuticals business of Universal Medicare in India).
In Emerging Markets, net sales advanced by 19.9% at constant exchange rates to €1,478 million. In the United States, sales growth was modest (up 2.2% at constant exchange rates, at €606 million) compared with 2011; this reflects the fact that in the early part of 2011, distributors were building up inventories of the over-the-counter (OTC) version of Allegra®, launched in March 2011. Excluding Allegra® OTC, growth in the United States reached 6.2% at constant exchange rates. Allegra® OTC was also launched in Japan in November 2012.
Generics business
TheGenerics business reported net sales of €1,844 million in 2012, a rise of 5.0% at constant exchange rates. The business was boosted by sales growth in the United States (up 42.4% at constant exchange rates, at €272 million), where we launched our own authorized generic versions of Lovenox® and Aprovel®. In Emerging Markets, net sales fell slightly (down 2.7% at constant exchange rates) to €1,045 million, due to the impact of tougher competition and disruptions in the Brazilian market.
Net sales of theother prescription products in the portfolio were down 9.1% at constant exchange rates, to €5,513 million. For a description of our other pharmaceutical products, see "Item 4. Information on the Company — B. Business Overview — Pharmaceutical Products."
The following table breaks down net sales of our Pharmaceutical segment products by geographical region in 2012:
(€ million) Product | Western Europe (1) | Change at constant exchange rates | United States | Change at constant exchange rates | Emerging Markets (2) | Change at constant exchange rates | Other countries (3) | Change at constant exchange rates | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lantus® | 778 | +5.3% | 3,087 | +22.0% | 793 | +25.4% | 302 | +20.6% | |||||||||||||||||
Apidra® | 78 | +14.7% | 73 | +3.1% | 51 | +37.8% | 28 | +30.0% | |||||||||||||||||
Amaryl® | 28 | -12.5% | 3 | -25.0% | 263 | +11.4% | 127 | -32.6% | |||||||||||||||||
Insuman® | 98 | -4.9% | 1 | — | 37 | +27.6% | (1 | ) | — | ||||||||||||||||
Other diabetes products | 30 | +190.0% | 3 | — | — | — | 3 | — | |||||||||||||||||
Total: Diabetes | 1,012 | +4.3% | 3,167 | +21.5% | 1,144 | +22.5% | 459 | +0.2% | |||||||||||||||||
Eloxatine® | 13 | -65.8% | 718 | -18.0% | 153 | -10.5% | 72 | +3.1% | |||||||||||||||||
Taxotere® | 53 | -72.5% | 53 | -80.2% | 270 | -11.2% | 187 | -10.7% | |||||||||||||||||
Jevtana® | 91 | +104.5% | 109 | -23.7% | 33 | +153.8% | 2 | — | |||||||||||||||||
Zaltrap® | — | — | 24 | — | — | — | 1 | — | |||||||||||||||||
Mozobil® (4) | 30 | — | 56 | — | 7 | — | 3 | — | |||||||||||||||||
Other oncology products (4) | 104 | — | 281 | — | 95 | — | 39 | — | |||||||||||||||||
Total: Oncology | 291 | -23.7% | 1,241 | -19.8% | 558 | 0.0% | 304 | -1.7% | |||||||||||||||||
Lovenox® | 854 | +1.9% | 319 | -53.1% | 615 | +11.6% | 105 | +2.1% | |||||||||||||||||
Plavix® | 307 | -25.8% | 76 | * | -62.2% | 799 | +5.5% | 884 | +13.4% | ||||||||||||||||
Aprovel®/CoAprovel® | 557 | -26.4% | 45 | * | -8.2% | 395 | +2.5% | 154 | +17.5% | ||||||||||||||||
Allegra® | 11 | -15.4% | (1 | ) | -133.3% | 120 | +21.2% | 423 | -15.1% | ||||||||||||||||
Stilnox®/Ambien®/Myslee® | 46 | -13.2% | 85 | -4.9% | 70 | +7.7% | 296 | -5.5% | |||||||||||||||||
Copaxone® | 19 | -95.4% | — | — | — | — | 5 | -81.0% | |||||||||||||||||
Depakine® | 143 | -3.4% | — | — | 251 | +7.9% | 16 | -6.3% | |||||||||||||||||
Tritace® | 150 | -11.8% | — | — | 180 | -1.1% | 15 | -37.5% | |||||||||||||||||
Multaq® | 46 | -31.8% | 200 | +0.5% | 8 | 0.0% | 1 | -25.0% | |||||||||||||||||
Xatral® | 45 | -24.1% | 20 | -74.7% | 62 | -6.3% | 3 | 0.0% | |||||||||||||||||
Actonel® | 33 | -38.9% | — | — | 66 | -16.7% | 35 | -5.7% | |||||||||||||||||
Nasacort® | 20 | -20.0% | 21 | -63.0% | 26 | +8.7% | 4 | -25.0% | |||||||||||||||||
Renagel®/Renvela® (4) | 128 | — | 451 | — | 53 | — | 21 | — | |||||||||||||||||
Synvisc®/Synvisc-One® (4) | 20 | — | 302 | — | 24 | — | 17 | — | |||||||||||||||||
Aubagio® | — | — | 7 | — | — | — | — | — | |||||||||||||||||
Sub-total Multiple sclerosis | — | — | 7 | — | — | — | — | — | |||||||||||||||||
Cerezyme® (4) | 215 | — | 166 | — | 190 | — | 62 | — | |||||||||||||||||
Myozyme®/Lumizyme® (4) | 257 | — | 117 | — | 55 | — | 33 | — | |||||||||||||||||
Fabrazyme® (4) | 52 | — | 152 | — | 41 | — | 47 | — | |||||||||||||||||
Other rare disease products (4) | 92 | — | 122 | — | 83 | — | 94 | — | |||||||||||||||||
Sub-total Rare diseases (4) | 616 | — | 557 | — | 369 | — | 236 | — | |||||||||||||||||
Total: New Genzyme (4) | 616 | — | 564 | — | 369 | — | 236 | — | |||||||||||||||||
Other prescription products | 2,105 | -12.9% | 567 | -16.7% | 2,062 | -2.8% | 779 | -8.4% | |||||||||||||||||
Consumer Health Care | 666 | +2.2% | 606 | +2.2% | 1,478 | +19.9% | 258 | -2.1% | |||||||||||||||||
Generics | 500 | +11.5% | 272 | +42.4% | 1,045 | -2.7% | 27 | -29.4% | |||||||||||||||||
Total pharmaceuticals | 7,569 | -9.9% | 7,935 | +0.9% | 9,325 | +7.8% | 4,042 | -0.3% | |||||||||||||||||
Net Sales — Human Vaccines (Vaccines) segment
Net sales for the Vaccines segment amounted to €3,897 million in 2012, up 12.3% on a reported basis and 5.7% at constant exchange rates.
The following table presents the 2012 and 2011 sales of our Vaccines segment by range of products:
(€ million) | 2012 Reported | 2011 Reported | Change on a reported basis (%) | Change at constant exchange rates (%) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Polio/Pertussis/Hib Vaccines (including Pentacel® and Pentaxim®) | 1,184 | 1,075 | +10.1% | +5.0% | |||||||||
Influenza Vaccines (including Vaxigrip® and Fluzone®) | 884 | 826 | +7.0% | -0.2% | |||||||||
– of which seasonal influenza vaccines | 882 | 826 | +6.8% | -0.6% | |||||||||
– of which pandemic influenza vaccines | 2 | — | — | — | |||||||||
Meningitis/Pneumonia Vaccines (including Menactra®) | 650 | 510 | +27.5% | +18.0% | |||||||||
Adult Booster Vaccines (including Adacel®) | 496 | 465 | +6.7% | 0.0% | |||||||||
Travel and Other Endemics Vaccines | 364 | 370 | -1.6% | -4.9% | |||||||||
Other Vaccines | 319 | 223 | +43.0% | +31.8% | |||||||||
Total Vaccines | 3,897 | 3,469 | +12.3% | +5.7% | |||||||||
Polio/Pertussis/Hib vaccines saw net sales increase by 5.0% at constant exchange rates to €1,184 million. This rise reflects a strong performance in Japan (€239 million, up 140.9% at constant exchange rates, mainly due to the successful launch of Imovax® in September 2012) and a good performance in Emerging Markets (€495 million, up 5.7% at constant exchange rates), but also a drop in net sales in the United States (down 25.1% at constant exchange rates, at €374 million) due to order restrictions on Pentacel® following a temporary shutdown in production at Sanofi Pasteur.
Net sales ofinfluenza vaccines were flat (down 0.2% at constant exchange rates), at €884 million. In the United States, net sales fell by 5.5% at constant exchange rates, to €466 million; in Emerging Markets, net sales rose by 5.1% at constant exchange rates, to €317 million.
Meningitis/Pneumonia vaccines posted net sales of €650 million, up 18.0% at constant exchange rates, driven by a strong performance from Menactra® (€564 million, up 21.8% at constant exchange rates). Growth was especially strong in Emerging Markets (up 52.9% at constant exchange rates, at €165 million) and in the United States (up 10.5% at constant exchange rates, at €473 million).
Net sales ofadult booster vaccines were unchanged year-on-year (at constant exchange rates), at €496 million.
Net sales oftravel and other endemics vaccines fell by 4.9% (at constant exchange rates) to €364 million, hit by a temporary shutdown in production of the Theracys®/Immucyst® and BCG vaccines.
The following table presents the 2012 sales of our Vaccines segment by range of products and by region:
(€ million) | Western Europe (1) Reported | Change at constant exchange rates | United States Reported | Change at constant exchange rates | Emerging Markets (2) Reported | Change at constant exchange rates | Other countries (3) Reported | Change at constant exchange rates | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Polio/Pertussis/Hib Vaccines (inc. Pentacel® and Pentaxim®) | 55 | +52.8% | 374 | -25.1% | 495 | +5.7% | 260 | +105.0% | |||||||||||||||||
Influenza Vaccines (4) (inc. Vaxigrip® and Fluzone®) | 79 | +2.6% | 466 | -5.1% | 317 | +5.1% | 22 | +16.7% | |||||||||||||||||
Meningitis/Pneumonia Vaccines (inc. Menactra®) | 4 | +33.3% | 473 | +10.5% | 165 | +52.9% | 8 | -38.5% | |||||||||||||||||
Adult Booster Vaccines (inc. Adacel®) | 59 | -22.4% | 372 | +0.9% | 45 | +50.0% | 20 | -5.0% | |||||||||||||||||
Travel and Other Endemics Vaccines | 21 | -12.5% | 96 | -1.1% | 201 | -4.8% | 46 | -8.5% | |||||||||||||||||
Other Vaccines | 9 | -46.7% | 277 | +46.6% | 18 | 0.0% | 15 | -25.0% | |||||||||||||||||
Total Vaccines | 227 | -2.2% | 2,058 | -0.7% | 1,241 | +9.1% | 371 | +48.9% | |||||||||||||||||
In Western Europe and the United States, net sales fell slightly (by 2.2% and 0.7% at constant exchange rates, respectively). In Emerging Markets, most of the rise in sales (9.1% at constant exchange rates) was generated in Latin America and China. The Other Countries region reported strong growth (48.9% at constant exchange rates), due mainly to the performance of Imovax® in Japan.
In addition to the Vaccines activity reflected in our consolidated net sales, sales of Sanofi Pasteur MSD, our joint venture with Merck & Co., Inc. in Europe, amounted to €845 million in 2012, up 6.8% on a reported basis. Sales generated by Sanofi Pasteur MSD are not included in our consolidated net sales. The main growth drivers were the performance of Gardasil® (up 13.6% on a reported basis, at €206 million) and sales of the travel and endemics vaccines franchise.
Net Sales — Animal Health segment
The Animal Health segment achieved net sales of €2,179 million in 2012, up 3.1% at constant exchange rates (7.3% on a reported basis), driven by the performance in Emerging Markets and the first-time consolidation of the net sales of Newport Laboratories ("Newport").
The following table presents the 2012 and 2011 sales of our Animal Health segment by range of products:
(€ million) | 2012 Reported | 2011 Reported | Change on a reported basis | Change at constant exchange rates | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Frontline® and other fipronil-based products | 775 | 764 | +1.4% | -3.4% | |||||||||
Vaccines | 730 | 662 | +10.3% | +7.6% | |||||||||
Avermectin | 423 | 372 | +13.7% | +7.8% | |||||||||
Other products | 251 | 232 | +8.2% | +3.9% | |||||||||
Total Animal Health | 2,179 | 2,030 | +7.3% | +3.1% | |||||||||
Net sales for thecompanion animals franchise rose by 1.8% at constant exchange rates to €1,372 million. Erosion in sales of theFrontline®/fipronil range of products was limited to 3.4% at constant exchange rates
(€775 million) despite competitive pressure in the United States (down 7.8% at constant exchange rates, at €411 million), thanks to good performances in Emerging Markets (up 10.5%, at €93 million).
Net sales for theproduction animals franchise were 5.1% higher at constant exchange rates, at €807 million. These figures include the contribution from Newport from April 2012 onwards.
The following table breaks down net sales of our Animal Health segment by product and by geographical region in 2012:
(€ million) Product | Western Europe (1) | Change at constant exchange rates | United States | Change at constant exchange rates | Emerging Markets (2) | Change at constant exchange rates | Other countries (3) | Change at constant exchange rates | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Frontline® and other fipronil-based products | 208 | -0.5% | 411 | -7.8% | 93 | +10.5% | 63 | -3.3% | |||||||||||||||||
Vaccines | 181 | -7.7% | 152 | +11.1% | 375 | +14.2% | 22 | +31.3% | |||||||||||||||||
Avermectin | 62 | -4.7% | 223 | +15.8% | 65 | +10.0% | 73 | -2.8% | |||||||||||||||||
Other products | 88 | -2.2% | 94 | +1.1% | 46 | +27.8% | 23 | 0.0% | |||||||||||||||||
Total Animal Health | 539 | -3.8% | 880 | +1.4% | 579 | +14.0% | 181 | +0.6% | |||||||||||||||||
Net Sales by Geographical Region
We divide our sales geographically into four regions: Western Europe, the United States, Emerging Markets and other countries. The following table breaks down our 2012 and 2011 net sales by region:
(€ million) | 2012 Reported | 2011 Reported | Change on a reported basis | Change at constant exchange rates | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Western Europe (1) | 8,335 | 9,130 | -8.7% | -9.3% | |||||||||
United States | 10,873 | 9,957 | +9.2% | +0.7% | |||||||||
Emerging Markets (2) | 11,145 | 10,133 | +10.0% | +8.3% | |||||||||
Of which Eastern Europe and Turkey | 2,721 | 2,666 | +2.1% | +2.1% | |||||||||
Of which Asia (excl. Pacific region (3)) | 2,841 | 2,416 | +17.6% | +10.1% | |||||||||
Of which Latin America | 3,435 | 3,111 | +10.4% | +11.3% | |||||||||
Of which Africa | 1,018 | 949 | +7.3% | +8.3% | |||||||||
Of which Middle East | 1,001 | 872 | +14.8% | +12.2% | |||||||||
Other Countries (4) | 4,594 | 4,169 | +10.2% | +2.5% | |||||||||
Of which Japan | 3,274 | 2,865 | +14.3% | +6.6% | |||||||||
Total | 34,947 | 33,389 | +4.7% | +0.5% | |||||||||
Net sales in Western Europe fell by 9.3% at constant exchange rates to €8,335 million, hampered by the transfer of the Copaxone® business to Teva; by competition from generics of Taxotere® (down 72.5% at constant exchange rates), Aprovel® (down 26.4% at constant exchange rates) and Plavix® (down 25.8% at constant exchange
rates); and by the impact of austerity measures implemented by European governments. After including Genzyme for the first quarter of 2011 and excluding Copaxone®, net sales fell by 7.5% at constant exchange rates.
In the United States, net sales were up 0.7% at constant exchange rates (but fell by 2.8% after including Genzyme in the first quarter of 2011) to €10,873 million. The year-on-year change reflected strong performances from Lantus® and from the new Genzyme and Generics businesses (including our own generic version of Lovenox®), but also the impact of generics of Taxotere®, Lovenox® and Eloxatine®.
In Emerging Markets, net sales reached €11,145 million, up 8.3% at constant exchange rates (or 7.2% after including Genzyme for the first quarter of 2011). In China, net sales were €1,249 million, up 15,0% at constant exchange rates, on a strong performance from Plavix® and Lantus®. In Brazil, net sales increased by 7.7% at constant exchange rates to €1,530 million, boosted by the Consumer Health Care business and the contribution from Genzyme, although growth was hampered by a slowdown in sales of generics. The Africa and Middle East zones topped the billion-euro mark for the first time (€1,018 million and €1,001 million, respectively). Sales in Russia reached €851 million, up 13.6% at constant exchange rates, driven by the Consumer Health Care and Generics businesses and also by Lantus®, Plavix® and Lovenox®.
In the Other Countries region, net sales totaled €4,594 million, up 2.5% at constant exchange rates (or 0.8% after including Genzyme sales for the first quarter of 2011). In Japan, net sales were €3,274 million (up 6.6% at constant exchange rates, or 4.7% after including Genzyme sales for the first quarter of 2011); positive factors included strong performances from Plavix® (up 16.0% at constant exchange rates, at €837 million) and from the Polio/Pertussis/Hib vaccines franchise (up 140.9% at constant exchange rates at €239 million, driven by the successful launch of Imovax®), while negative factors included erosion in sales of Allegra® (down 15.2% at constant exchange rates, at €423 million) and the impact of bi-annual price cuts.
Worldwide Presence of Plavix® and Aprovel®
Two of our leading products — Plavix® and Aprovel® — were discovered by Sanofi and jointly developed with Bristol-Myers Squibb ("BMS") under an alliance agreement. In all territories except Japan, these products are sold either by Sanofi or by BMS in accordance with the terms of this alliance agreement applicable in 2012 and 2011 (see "— Financial Presentation of Alliances — Alliance arrangements with Bristol-Myers Squibb" above).
Worldwide sales of these two products are an important indicator because they facilitate a financial statement user's understanding and analysis of our consolidated income statement, particularly in terms of understanding our overall profitability in relation to consolidated revenues, and also facilitate a user's ability to understand and assess the effectiveness of our research and development efforts.
Also, disclosing sales made by BMS of these two products enables the users to have a clearer understanding of trends in different lines of our income statement, in particular the lines "Other revenues", where we record royalties received on those sales (see "— Other Revenues"); "Share of profit/loss of associates and joint ventures" (see "— Share of Profit/Loss of Associates and Joint Ventures"), where we record our share of the profit/loss of entities included in the BMS Alliance and under BMS operational management; and "Net income attributable to non-controlling interests" (see "— Net Income Attributable to Non-Controlling Interests"), where we record the BMS share of the profit/loss of entities included in the BMS Alliance and under our operational management.
On October 3, 2012, Sanofi and BMS announced the restructuring of their alliance with effect from January 1, 2013 (see "— Financial Presentation of Alliances — Alliance arrangements with Bristol-Myers Squibb" above).
The table below sets forth the worldwide sales of Plavix® and Aprovel® in 2012 and 2011, by geographic region:
(€ million) | 2012 | 2011 | Change on a reported basis | Change at constant exchange rates | |||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi (2) | BMS (3) | Total | Sanofi (2) | BMS (3) | Total | |||||||||||||||||||
Plavix®/Iscover® (1) | |||||||||||||||||||||||||
Europe | 424 | 29 | 453 | 530 | 44 | 574 | -21.1% | -21.2% | |||||||||||||||||
United States | — | 1,829 | 1,829 | — | 4,759 | 4,759 | -61.6% | -63.7% | |||||||||||||||||
Other countries | 1,613 | 89 | 1,702 | 1,370 | 286 | 1,656 | +2.8% | -4.6% | |||||||||||||||||
Total | 2,037 | 1,947 | 3,984 | 1,900 | 5,089 | 6,989 | -43.0% | -46.2% | |||||||||||||||||
Aprovel®/Avapro® /Karvea®/Avalide® (4) | |||||||||||||||||||||||||
Europe | 527 | 99 | 626 | 694 | 130 | 824 | -24.0% | -24.3% | |||||||||||||||||
United States | 24 | 110 | 134 | — | 374 | 374 | -64.2% | -66.5% | |||||||||||||||||
Other countries | 521 | 91 | 612 | 451 | 156 | 607 | +0.8% | -5.1% | |||||||||||||||||
Total | 1,072 | 300 | 1,372 | 1,145 | 660 | 1,805 | -24.0% | -26.6% | |||||||||||||||||
Worldwide sales of Plavix®/Iscover® fell by 46.2% at constant exchange rates in 2012 to €3,984 million, under the impact of competition from generics in the United States and Europe. In the United Sates, where the product lost exclusivity on May 17, 2012, sales (consolidated by BMS) were down 63.7% at constant exchange rates, at €1,829 million. In Europe, net sales of Plavix® fell by 21.2% at constant exchange rates, to €453 million. In the Other Countries region, net sales were down 4.6% at constant exchange rates; this reflected the entry of generics into the Canadian market (where sales, consolidated by BMS, dipped by 76.1% at constant exchange rates to €50 million), but also the continuing success of the product in Japan and China where net sales (consolidated by Sanofi) reached €837 million (up 16.0% at constant exchange rates) and €371 million (up 20.6% at constant exchange rates), respectively.
Worldwide sales of Aprovel®/Avapro®/Karvea®/Avalide® in 2012 amounted to €1,372 million, a decline of 26.6% at constant exchange rates, reflecting loss of exclusivity in the United States on March 30, 2012 and competition from generics in most Western European countries. In Japan and China, net sales (consolidated by Sanofi) came to €101 million (up 47.0% at constant exchange rates) and €138 million (up 17.3% at constant exchange rates), respectively.
Other Revenues
Other revenues, which mainly comprise royalty income under licensing agreements contracted in connection with ongoing operations, fell by 39.5% to €1,010 million (versus €1,669 million in 2011).
The decrease was mainly due to lower licensing revenue under the worldwide alliance with BMS on Plavix® and Aprovel®, which totaled €532 million in 2012 versus €1,275 million in 2011 (down 58.1% on a reported basis), due largely to the loss of exclusivity in the United States for Aprovel® (on March 30, 2012) and Plavix® (on May 17, 2012). However, the appreciation of the U.S. dollar against the euro had a favorable impact on other revenues, as did the recognition in 2012 of a €45 million payment from BMS relating to the Avalide® supply disruption in the United States during 2011.
This line also includes royalty income of €171 million from Amgen relating to a worldwide license contracted on the product Enbrel®. Royalties received on U.S. sales represented a significant portion of this income in 2012 and will contractually end in February 2013.
Gross Profit
Gross profit amounted to €24,839 million in 2012 (71.1% of net sales), versus €24,156 million in 2011 (72.3% of net sales). This represents an increase of 2.8% in gross profit, but a fall of 1.2 points in the gross margin ratio.
The gross margin ratio for the Pharmaceuticals segment slipped by 2.9 points to 72.9%, reflecting a lower level of royalty income (-2.6 points) and a deterioration in the ratio of cost of sales to net sales (-0.3 of a point); this latter trend was mainly attributable to the adverse impact of generics (mainly of Taxotere® in the United States), partially offset by productivity gains and lower raw materials prices for heparins.
The gross margin ratio for the Vaccines segment fell by 1.0 point to 59.2%.
The gross margin ratio for the Animal Health segment improved by 0.4 of a point to 69.3%.
In addition, consolidated gross profit for 2012 was adversely affected by a €23 million expense (0.1 of a point) arising from the workdown of acquired inventories remeasured at fair value in connection with the acquisition of Genzyme. In 2011, this expense was €476 million (1.4 points), out of which €473 million were related to the acquisition of Genzyme.
Research and Development Expenses
Research and development (R&D) expenses totaled €4,922 million (versus €4,811 million in 2011), representing 14.1% of net sales (versus 14.4% in 2011). Overall, R&D expenses rose by €111 million, or 2.3% on a reported basis. After including Genzyme's costs for the first quarter of 2011, R&D expenses fell by 0.4% year-on-year. In addition, the amount of R&D expenses reported for 2012 was adversely affected by the appreciation of the U.S. dollar against the euro.
R&D expenses for the Pharmaceuticals segment increased by €118 million, up 2.9% on a reported basis. After including Genzyme's costs for the first quarter of 2011, R&D expenses fell by €15 million (or 0.4%) year-on-year, reflecting our ongoing transformation initiatives and the rationalization of the project portfolio.
R&D expenses for the Vaccines segment fell by €25 million to €539 million (down 4.4% on a reported basis), due mainly to trends in the cost of clinical trials on the dengue fever vaccine and various influenza-related projects.
In the Animal Health segment, R&D expenses rose by €18 million (up 12.3% on a reported basis) versus 2011.
Selling and General Expenses
Selling and general expenses amounted to €8,947 million, compared with €8,536 million in 2011, an increase of €411 million or 4.8% on a reported basis. The ratio of selling and general expenses to net sales was unchanged year-on-year at 25.6%. After including Genzyme's costs for the first quarter of 2011, selling and general expenses were up 1.8% year-on-year. In addition, the amount reported for 2012 was adversely affected by the appreciation of the U.S. dollar against the euro.
In the Pharmaceuticals segment, selling and general expenses increased by €290 million, or 3.9% on a reported basis. After including Genzyme's costs for the first quarter of 2011, selling and general expenses for the segment fell by €37 million (or 0.5%) year-on-year. This trend reflects tight cost control (especially in mature regions) and the effect of synergies unlocked by the integration of Genzyme, and was achieved in spite of ongoing investment in our growth platforms and the launch costs incurred on Zaltrap® and Aubagio®.
Selling and general expenses for the Vaccines segment rose by €69 million (up 12.7% on a reported basis), due partly to adverse trends in the U.S. dollar/euro exchange rate and partly to increased promotional investments.
In the Animal Health segment, selling and general expenses increased by €52 million (up 8.4% on a reported basis), reflecting adverse trends in the U.S. dollar/euro exchange rate and higher promotional costs on the companion animals franchise.
Other Operating Income and Expenses
In 2012, other operating income amounted to €562 million (versus €319 million in 2011), and other operating expenses to €454 million (versus €315 million in 2011).
Overall, other operating income and expenses represented net income of €108 million in 2012, compared with €4 million in 2011. This increase was mainly due to the favorable outcome of litigation relating to a license.
This line item also includes a net operational foreign exchange loss of €41 million, against €5 million in 2011.
Amortization of Intangible Assets
Amortization charged against intangible assets amounted to €3,291 million in 2012, versus €3,314 million in 2011. The year-on-year reduction of €23 million was mainly due to:
Impairment of Intangible Assets
This line showed impairment losses of €117 million against intangible assets in 2012, compared with €142 million in 2011. The impairment losses recognized in 2012 relate mainly to the discontinuation of R&D projects in the Pharmaceuticals segment, in particular some development programs in oncology.
In 2011, the impairment losses related mainly to (i) the discontinuation of a Genzyme research project; (ii) certain Zentiva generics, following a downward revision of sales projections; and (iii) the discontinuation of a joint project with Metabolex in diabetes. This line also included a reversal of impairment losses on Actonel®, recognized following confirmation of the terms of the collaboration agreement with Warner Chilcott (see Note C.3. to our consolidated financial statements included at Item 18 of this annual report).
Fair Value Remeasurement of Contingent Consideration Liabilities
Fair value remeasurements of contingent consideration liabilities recognized on acquisitions in accordance with the revised IFRS 3 represented an expense of €192 million in 2012, compared with a net gain of €15 million in 2011. This item mainly relates to the contingent value rights (CVRs) issued in connection with the Genzyme acquisition, and to contingent consideration payable to Bayer as a result of an acquisition made by Genzyme prior to the latter's acquisition by Sanofi (see Note D.18. to our consolidated financial statements included at Item 18 of this annual report).
Restructuring Costs
Restructuring costs amounted to €1,141 million in 2012, versus €1,314 million in 2011, and relate primarily to measures announced in connection with the major transformation program that we initiated in 2009 to adapt our structures to the challenges of the future.
In 2012, these costs mainly related to measures taken to adapt our resources in France, transform our industrial facilities in Europe and make adjustments to our sales forces worldwide, along with the integration of Genzyme and impairment losses against property, plant and equipment in France.
In 2011, these costs reflected the transformation and reorganization of our R&D operations, measures taken to adapt our industrial facilities in Europe, adjustments to our sales forces in the United States and Europe, the implementation of multi-country organizations in Europe, and the integration of Genzyme entities worldwide.
Other Gains and Losses, and Litigation
Nothing was recognized on this line in 2012.
In 2011, this line item included a net expense of €327 million, mainly comprising (i) a €519 million backlog of depreciation and amortization expense that was not charged against the property, plant and equipment and intangible assets of Merial from September 18, 2009 through December 31, 2010 because these assets were classified as held for sale or exchange during that period in accordance with IFRS 5 (see Note D.8.2. to the consolidated financial statements included at Item 18 of this annual report), (ii) a gain of €210 million arising from damages received in connection with a Plavix® patent; and (iii) the impact of the divestiture of the Dermik dermatology business (see Note D.28. to our consolidated financial statements).
Operating Income
Operating income totaled €6,337 million for 2012, versus €5,731 million for 2011, an increase of 10.6%.
Financial Income and Expenses
Net financial expense for 2012 was €460 million, compared with €412 million for 2011, an increase of €48 million.
Financial expenses directly related to our debt, net of cash and cash equivalents (see definition at "— Liquidity and Capital Resources" below) were €349 million in 2012 compared to €325 million in 2011. This increase was due to a reduction in financial income resulting from a lower average rate of return on cash.
Because the average level of debt and the average rate of interest on debt were relatively stable year-on-year, financial expenses were virtually unchanged in 2012.
Impairment losses on investments and financial assets amounted to €30 million in 2012 (versus €58 million in 2011). In 2012, these losses related primarily to available-for-sale financial assets; in 2011, they related mainly to Greek government bonds (€49 million, versus €6 million in 2012).
Gains on disposals of non-current financial assets amounted to €37 million in 2012, compared with €25 million in 2011. The 2011 figure included the effect of the change in consolidation method for the investment in the Société Financière des Laboratoires de Cosmétologie Yves Rocher following loss of significant influence (see Note D.6. to our consolidated financial statements). In August 2012, Sanofi sold this investment.
The effect of the unwinding of discount on provisions was €87 million in 2012 (versus €83 million in 2011), and the net financial foreign exchange loss was €17 million in 2012 (versus a net gain of €10 million in 2011).
Income before Tax and Associates and Joint Ventures
Income before tax and associates and joint ventures for 2012 was €5,877 million in 2011, versus €5,319 million in 2011, an increase of 10.5%.
Income Tax Expense
Income tax expense amounted to €1,134 million in 2012, versus €455 million in 2011 and €1,430 million in 2010.
The fall in income tax expense in 2011 relative to 2010 was mainly attributable to a reduction in the deferred tax liability relating to the remeasurement of the intangible assets of Merial in response to changes in tax rates and
legislation (primarily in the United Kingdom) and the effect of the Franco-American Advance Pricing Agreement (APA) for the period from 2006 through 2011 (see Note D.30. to our consolidated financial statements).
These effects did not impact income tax expense for 2012. However, the rise in income tax expense during the year was limited by the favorable effects of differential income tax rates applicable to our foreign subsidiaries (including the impact of an Advance Pricing Agreement (APA) with the Japanese authorities covering the period from 2012 through 2014), and also by the settlement of tax inspections and the effects of time-barring.
This item includes tax gains arising from (i) the amortization of intangible assets, totaling €1,159 million in 2012 (versus €1,178 million in 2011, including the impact of the Merial backlog, see "— Other Gains and Losses, and Litigation" above) and (ii) restructuring costs (€370 million in 2012, versus €399 million in 2011).
The effective tax rate is calculated on the basis of business operating income minus net financial expenses and before the share of profit/loss of associates and joint ventures and net income attributable to non-controlling interests. The effective tax rate was 25.5% in 2012, versus 27.0% in 2011. The difference relative to the standard corporate income tax rate applicable in France (34.4%) was mainly due to royalty income being taxed at a reduced rate in France, and to the differential in tax rates applied to profits of our foreign subsidiaries.
Share of Profit/Loss of Associates and Joint Ventures
The share of profit/loss of associates and joint ventures in 2012 was €393 million, versus €1,070 million in 2011. This line mainly includes our share of after-tax profits from territories managed by BMS under the Plavix® and Avapro® alliance, which fell by 60.7% to €420 million (versus €1,070 million in 2011). The decline in our share was mainly attributable to a 61.6% drop in sales of Plavix® in the United States due to the loss of exclusivity and competition from generics.
Net Income
Net income amounted to €5,136 million in 2012, compared with €5,934 million in 2011.
Net Income Attributable to Non-Controlling Interests
Net income attributable to non-controlling interests totaled €169 million in 2012, against €241 million in 2011. This line mainly comprises the share of pre-tax profits paid to BMS from territories managed by Sanofi (€149 million, versus €225 million in 2011); this year-on-year fall was directly related to increased competition from generics of clopidogrel (Plavix®) in Europe.
Net Income Attributable to Equity Holders of Sanofi
Net income attributable to equity holders of Sanofi was €4,967 million in 2012, versus €5,693 million in 2011.
Basic earnings per share for 2012 was €3.76, 12.8% lower than the 2011 figure of €4.31, based on an average number of shares outstanding of 1,319.5 million in 2012 (1,321.7 million in 2011). Diluted earnings per share for 2012 was €3.74, compared to €4.29 for 2011, based on an average number of shares outstanding after dilution of 1,329.6 million in 2012 and 1,326.7 million in 2011.
Business Operating Income
Sanofi reports segment results on the basis of "Business Operating Income". This indicator, adopted in compliance with IFRS 8, is used internally to measure operational performance and to allocate resources. See "Item 5. Operating and Financial Review and Prospects — Segment information" above for the definition of business operating income and reconciliation to our Income before tax and associates and joint ventures.
Business operating income for 2012 was €11,353 million, compared to €12,144 million in 2011 (down 6.5%). The table below shows trends in business operating income by business segment for 2012 and 2011:
(€ million) | 2012 | 2011 | Change | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Pharmaceuticals | 9,519 | 10,496 | -9.3% | |||||||
Vaccines | 1,148 | 985 | +16,5% | |||||||
Animal Health | 673 | 627 | +7.3% | |||||||
Other | 13 | 36 | -63.9% | |||||||
Business operating income | 11,353 | 12,144 | -6.5% | |||||||
Business Net Income
Business net income is a non-GAAP financial measure that we use to evaluate our Group's performance. See "Item 5. Operating and Financial Review and Prospects — Business Net Income" above for the definition of business net income and reconciliation to our Net income attributable to equity holders of Sanofi.
Business net income totaled €8,179 million in 2012 versus €8,795 million in 2011 (down 7.0%), and represented 23.4% of net sales compared with 26.3% in 2011.
Business Earnings Per Share
We also report business earnings per share, a non-GAAP financial measure which we define as business net income divided by the weighted average number of shares outstanding (see "— Business Net Income" above).
Business earnings per share for 2012 were €6.20 versus €6.65 in 2011, down 6.8%, based on an average number of shares outstanding of 1,319.5 million in 2012 (1,321.7 million in 2011). Diluted business earnings per share for 2012 were €6.15 versus €6.63 in 2011, down 7.2%, based on an average number of shares outstanding of 1,329.6 million in 2012 and 1,326.7 million in 2011.
Year Ended December 31, 2011 Compared with Year Ended December 31, 2010
TheOur consolidated income statements for the years ended December 31, 2011 and December 31, 2010 break down as follows:
(under IFRS) (€ million) | 2011 | as % of net sales | 2010 | as % of net sales | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Net sales | 33,389 | 100.0% | 32,367 | 100.0% | ||||||||
Other revenues | 1,669 | 5.0% | 1,669 | 5.2% | ||||||||
Cost of sales | (10,902 | ) | (32.7%) | (9,398 | ) | (29.0%) | ||||||
Gross profit | 24,156 | 72.3% | 24,638 | 76.1% | ||||||||
Research & development expenses | (4,811 | ) | (14.4%) | (4,547 | ) | (14.0%) | ||||||
Selling & general expenses | (8,536 | ) | (25.6%) | (8,149 | ) | (25.2%) | ||||||
Other operating income | 319 | 369 | ||||||||||
Other operating expenses | (315 | ) | (292 | ) | ||||||||
Amortization of intangible assets | (3,314 | ) | (3,529 | ) | ||||||||
Impairment of intangible assets | (142 | ) | (433 | ) | ||||||||
Fair value remeasurement of contingent consideration liabilities | 15 | — | ||||||||||
Restructuring costs | (1,314 | ) | (1,384 | ) | ||||||||
Other gains and losses, and litigation (1) | (327 | ) | (138 | ) | ||||||||
Operating income | 5,731 | 17.2% | 6,535 | 20.2% | ||||||||
Financial expenses | (552 | ) | (468 | ) | ||||||||
Financial income | 140 | 106 | ||||||||||
Income before tax and associates and joint ventures | 5,319 | 15.9% | 6,173 | 19.1% | ||||||||
Income tax expense | (455 | ) | (1,430 | ) | ||||||||
Share of profit/(loss) of associates and joint ventures | 1,070 | 978 | ||||||||||
Net income | 5,934 | 17.8% | 5,721 | 17.7% | ||||||||
Net income attributable to non-controlling interests | 241 | 254 | ||||||||||
Net income attributable to equity holders of Sanofi | 5,693 | 17.1% | 5,467 | 16.9% | ||||||||
Average number of shares outstanding (million) | 1,321.7 | 1,305.3 | ||||||||||
Average number of shares outstanding after dilution (million) | 1,326.7 | 1,308.2 | ||||||||||
Basic earnings per share (in euros) | 4.31 | 4.19 | ||||||||||
Diluted earnings per share (in euros) | 4.29 | 4.18 | ||||||||||
(under IFRS) (€ million) | 2011 | as % of net sales | 2010 (1) | as % of net sales | ||||||||||||
Net sales | 33,389 | 100.0% | 32,367 | 100.0% | ||||||||||||
Other revenues | 1,669 | 5.0% | 1,669 | 5.2% | ||||||||||||
Cost of sales | (10,902 | ) | (32.7%) | (9,398 | ) | (29.0%) | ||||||||||
Gross profit | 24,156 | 72.3% | 24,638 | 76.1% | ||||||||||||
Research & development expenses | (4,811 | ) | (14.4%) | (4,547 | ) | (14.0%) | ||||||||||
Selling & general expenses | (8,536 | ) | (25.6%) | (8,149 | ) | (25.2%) | ||||||||||
Other operating income | 319 | 369 | ||||||||||||||
Other operating expenses | (315 | ) | (292 | ) | ||||||||||||
Amortization of intangible assets | (3,314 | ) | (3,529 | ) | ||||||||||||
Impairment of intangible assets | (142 | ) | (433 | ) | ||||||||||||
Fair value remeasurement of contingent consideration liabilities | 15 | — | ||||||||||||||
Restructuring costs | (1,314 | ) | (1,384 | ) | ||||||||||||
Other gains and losses, and litigation (2) | (327 | ) | (138 | ) | ||||||||||||
Operating income | 5,731 | 17.2% | 6,535 | 20.2% | ||||||||||||
Financial expenses | (552 | ) | (468 | ) | ||||||||||||
Financial income | 140 | 106 | ||||||||||||||
Income before tax and associates and joint ventures | 5,319 | 15.9% | 6,173 | 19.1% | ||||||||||||
Income tax expense | (455 | ) | (1,430 | ) | ||||||||||||
Share of profit/(loss) of associates and joint ventures | 1 070 | 978 | ||||||||||||||
Net income | 5,934 | 17.8% | 5,721 | 17.7% | ||||||||||||
Net income attributable to non-controlling interests | 241 | 254 | ||||||||||||||
Net income attributable to equity holders of Sanofi | 5,693 | 17.1% | 5,467 | 16.9% | ||||||||||||
Average number of shares outstanding (million) | 1,321.7 | 1,305.3 | ||||||||||||||
Average number of shares outstanding after dilution (million) | 1,326.7 | 1,308.2 | ||||||||||||||
Basic earnings per share (in euros) | 4.31 | 4.19 | ||||||||||||||
Diluted earnings per share (in euros) | 4.29 | 4.18 |
|
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Our consolidated income statements include the results of the operations of Genzyme from April 2011. In order to help investors gain a better understanding of our performance, in the narrative discussion of certain income statement line items ("research & development expenses", and "selling & general expenses") we exclude 2011 data for Genzyme in the analyses. In the narrative discussion of Genzyme's products net sales, we used non-consolidated 2010 net sales in additional analyses.
Net Sales
Net sales for the year ended December 31, 2011 totaled €33,389 million, up 3.2% on 2010. TheExchange rate fluctuations had an unfavorable currency fluctuationeffect of 2.1 points, was primarily theas a result of the depreciation of the U.S. dollar’s depreciationdollar against the euro. At constant exchange rates, and after taking account of changes in structure (mainly the consolidation of Genzyme from April 2011), net sales were up 5.3% year-on-year.
Excluding Genzyme, the Group’s net sales were down 2.6% in 2011 at constant exchange rates, a reflection ofreflecting the loss in sales associated with competition from generics and the impacts of austerity measures in the European Union. Excluding both Genzyme and sales of A/H1N1 vaccines, the Group’s net sales were down 1.2% at constant exchange rates.
The following table sets forth a reconciliation of our reported net sales for the years ended December 31, 2011 and December 31, 2010 to our net sales at constant exchange rates:
(€ million) | 2011 | 2010 | Change (%) | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Net sales | 33,389 | 32,367 | +3.2% | |||||||
Effect of exchange rates | 704 | |||||||||
Net sales at constant exchange rates | 34,093 | 32,367 | +5.3% | |||||||
(€ million) | 2011 | 2010(1) | Change (%) | |||||||||
Net sales | 33,389 | 32,367 | +3.2% | |||||||||
Effect of exchange rates | 704 | |||||||||||
Net sales at constant exchange rates | 34,093 | 32,367 | +5.3% |
|
Our net sales comprise the net sales generated by our Pharmaceuticals, Human Vaccines (Vaccines) and Animal Health businesses.segments.
The following table breaks down our 2011 and 2010 net sales by business segment:
(€ million) | 2011 Reported | 2010 Reported | Change on a reported basis (%) | Change at constant exchange rates (%) | ||||||||||||
Pharmaceuticals | 27,890 | 26,576 | +4.9% | +6.7% | ||||||||||||
Vaccines | 3,469 | 3,808 | -8.9% | -5.5% | ||||||||||||
Animal Health | 2,030 | 1,983 | +2.4% | +4.3% | ||||||||||||
Total | 33,389 | 32,367 | +3.2% | +5.3% |
(€ million) | 2011 Reported | 2010 Reported | Change on a reported basis (%) | Change at constant exchange rates (%) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Pharmaceuticals | 27,890 | 26,576 | +4.9% | +6.7% | ||||||||
Vaccines | 3,469 | 3,808 | -8.9% | -5.5% | ||||||||
Animal Health | 2,030 | 1,983 | +2.4% | +4.3% | ||||||||
Total | 33,389 | 32,367 | +3.2% | +5.3% | ||||||||
Net Sales by Product — Pharmaceuticals segment
Net sales generated by our Pharmaceuticals segment were €27,890 million in 2011, up 4.9% on a reported basis and 6.7% at constant exchange rates. This change reflects the positive impact fromof the Genzymefirst-time consolidation of Genzyme; the negative impactimpacts of competition from the competition of generics on sales of Lovenox®Lovenox®, Ambien®Ambien® CR and Taxotere®Taxotere® in the United States Plavix®and Taxotere®Plavix® and Taxotere® in the European Union, as well asUnion; and the effects of healthcare reform in the U.S.United States and austerity measures in Europe. Excluding Genzyme, our Pharmaceuticals segment posted net sales of €25,495 million, a drop ofdown 4.1% on a reported basis and 2.7% at constant exchange rates.
The following table breaks down our 2011 and 2010 net sales for the Pharmaceuticals segment by product:
(€ million) Product | Indication | 2011 Reported | 2010 Reported | Change on a reported basis (%) | Change at constant exchange rates (%) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lantus® | Diabetes | 3,916 | 3,510 | +11.6% | +15.0% | |||||||||
Apidra® | Diabetes | 190 | 177 | +7.3% | +9.6% | |||||||||
Insuman® | Diabetes | 132 | 133 | -0.8% | -0.8% | |||||||||
Amaryl® | Diabetes | 436 | 478 | -8.8% | -7.9% | |||||||||
Other diabetes products | Diabetes | 10 | — | — | — | |||||||||
Total: Diabetes | Diabetes | 4,684 | 4,298 | +9.0% | +12.0% | |||||||||
Taxotere® | Breast, lung, prostate, stomach, and head & neck cancer | 922 | 2,122 | -56.6% | -57.0% | |||||||||
Eloxatine® | Colorectal cancer | 1,071 | 427 | +150.8% | +160.9% | |||||||||
Jevtana® | Prostate cancer | 188 | 82 | +129.3% | +135.4% | |||||||||
Mozobil® | Hematologic malignancies | 59 | — | — | — | |||||||||
Other oncology products (1) | 389 | 59 | +559.3% | — | ||||||||||
Total: Oncology | 2,629 | 2,690 | -2.3% | — | ||||||||||
Lovenox® | Thrombosis | 2,111 | 2,806 | -24.8% | -23.4% | |||||||||
Plavix® | Atherothrombosis | 2,040 | 2,083 | -2.1% | -2.9% | |||||||||
Aprovel®/CoAprovel® | Hypertension | 1,291 | 1,327 | -2.7% | -2.4% | |||||||||
Allegra® | Allergic rhinitis, urticaria | 580 | 607 | -4.4% | -8.6% | |||||||||
Stilnox®/Ambien®/Myslee® | Sleep disorders | 490 | 819 | -40.2% | -41.4% | |||||||||
Copaxone® | Multiple sclerosis | 436 | 513 | -15.0% | -15.4% | |||||||||
Tritace® | Hypertension | 375 | 410 | -8.5% | -6.3% | |||||||||
Depakine® | Epilepsy | 388 | 372 | +4.3% | +5.4% | |||||||||
Multaq® | Atrial fibrillation | 261 | 172 | +51.7% | +56.4% | |||||||||
Xatral® | Benign prostatic hypertrophy | 200 | 296 | -32.4% | -30.7% | |||||||||
Actonel® | Osteoporosis, Paget's disease | 167 | 238 | -29.8% | -29.8% | |||||||||
Nasacort® | Allergic rhinitis | 106 | 189 | -43.9% | -41.8% | |||||||||
Renagel®/Renvela® (1) | Hyperphosphatemia | 415 | — | — | — | |||||||||
Synvisc®/Synvisc-One® (1) | Arthritis | 256 | — | — | — | |||||||||
Cerezyme® (1) | Gaucher disease | 441 | — | — | — | |||||||||
Myozyme®/Lumizyme® (1) | Pompe disease | 308 | — | — | — | |||||||||
Fabrazyme® (1) | Fabry disease | 109 | — | — | — | |||||||||
Other rare disease products (1) | 264 | — | — | — | ||||||||||
Total: New Genzyme (1) | 1,122 | — | — | — | ||||||||||
Other prescription products | 5,927 | 6,005 | -1.3% | -0.9% | ||||||||||
Consumer Health Care | 2,666 | 2,217 | +20.3% | +22.8% | ||||||||||
Generics | 1,746 | 1,534 | +13.8% | +16.2% | ||||||||||
Total pharmaceuticals | 27,890 | 26,576 | +4.9% | +6.7% | ||||||||||
Flagship Products Diabetes
Our flagship products (Lantus® and other products in the Diabetes business, Lovenox®, Plavix®, Taxotere®, Aprovel®/CoAprovel®, Eloxatin®, Multaq® and Jevtana®) are discussed below. Sales of Plavix® and Aprovel® are discussed further below under “— Worldwide Presence of Plavix® and Aprovel®”.
Net sales infor the Diabetes business were €4,684 million, up 12.0% at constant exchange rates, bolstereddriven by the growth of Lantus®Lantus®.
LantusLantus®®, the world’s leading diabetes brand (source: IMS 2011 sales), posted a 15.0% increase in net sales at constant exchange rates in 2011 to €3,916 million. This change is a result of thereflected sharp growth in Emerging Markets (26.0% at constant exchange rates), especially in China (61.7%) and Brazil (29%), as well as solid performanceperformances in the United States (14.6%) and Japan (19.5%). In Western Europe, growth was more moderate (6.4%), which reflected thereflecting pricing pressures specifically(especially in Germany.Germany).
Net sales of the rapid-acting insulin analogApidra®Apidra®advanced by 9.6% at constant exchange rates in 2011 to €190 million, led by solid performances in Japan (87.9% growth) and the United States (11.3% growth). At year-end, sales were impacted negatively by a temporary shortage of Apidra® Apidra® 3ml cartridges.
AmarylAmaryl®® saw net sales decrease by 7.9% at constant exchange rates in 2011 to €436 million, due principally to competition from generics in Japan, and despite an 8.6% increase (at constant exchange rates) in Emerging Markets.
Oncology
Taxotere® reported net sales of €922 million, down 57.0% at constant exchange rates. This product faced competition from generics in Western Europe (down 73.6%) and the United States (down 69.2%), although the decline was much less pronounced in Emerging Markets (down 24.6%).
Eloxatine® net sales rebounded sharply in 2011 by 160.9% at constant exchange rates to €1,071 million, as sales recovered in the United States (€806 million in 2011, versus €172 million in 2010) following a court ruling barring manufacturers of generics in the United States from selling their unapproved generic versions of oxaliplatin from June 30, 2010.
Jevtana®, which has been available in the U.S. market since July 2010 and has become gradually available throughout most of the countries of Western Europe since April 2011, registered net sales of €188 million in 2011, €131 million of which were generated in the United Sates.
Other oncology products (net sales of €448 million in 2011) are essentially new products acquired with Genzyme; net sales for these Genzyme products have been consolidated since the acquisition date (April 2011).
Lovenox Other pharmaceutical products
®Lovenox® saw net sales decrease by 23.4% at constant exchange rates in 2011 to €2,111 million, as a result of competition from generics in the United States where net sales declined by 54.3% to €633 million. Outside the United States, net sales were up 9.0% at constant exchange rates toat €1,478 million (representing 70.0% of worldwide 2011 sales of Lovenox®Lovenox®), postingwith good performances in Western Europe (up 6.4%) and Emerging Markets (up 14.0%).
Taxotere® reported net sales of €922 million, down 57.0% at constant exchange rates. This product has faced competition from generics in Western Europe (down 73.6%) and the United States (down 69.2%), although the decline was much less pronounced in Emerging Markets (down 24.6%).
Eloxatin® net sales rebounded sharply in 2011 by 160.9% at constant exchange rates to €1,071 million, which reflects recovering sales in the United States (€806 million in 2011, versus €172 million in 2010), following a court ruling barring manufacturers of generics in the U.S. from selling their unapproved generic versions of oxaliplatin from June 30, 2010.
Multaq® posted a 56.4% growth in net sales to €261 million at constant exchange rates, achieved primarily in the United States (€184 million) and Western Europe (€66 million).
Jevtana®, which has been available in the U.S. market since July 2010, and has become gradually available throughout most of the countries of Western Europe since April 2011, registered €188 million in sales in 2011, €131 million of which was in the United Sates.
Our other major products are described below.
Net sales of the hypnoticStilnox®Stilnox®/Ambien®/Myslee®/Ambien®/Myslee® fell by 41.4% at constant exchange rates to €490 million, reflecting competition from Ambien®Ambien® CR generics in the United States. In Japan, Myslee®Myslee® continued to post a solid performance with net sales up 9.2% at constant exchange rates at €284 million.
AllegraAllegra®® prescription sales were down 8.6% (at constant exchange rates) toat €580 million. In Japan, which represents 80.2% of Allegra®’s worldwide sales of Allegra®, net sales totaled €465 million (up 22.1% at constant exchange rates) with thedue to a sharp increase in seasonal allergies. A generic has been approved but not yet distributed in Japan. The dropslump in prescription sales in the United States (98.6%(down 98.6% at constant exchange rates) is relatedwas mainly due to the approval of Allegra®Allegra® as an over-the-counter (OTC) product starting in March 2011 on the U.S. market. Followingmarket effective March 2011. Since this approval, we account for U.S. sales of AllegraAllegra® have been recognized in our Consumer Health Care business.
® under CHC and not prescription sales.Table of Contents
CopaxoneCopaxone®® net sales, achievedgenerated primarily in Western Europe, fell by 15.4% at constant exchange rates to €436 million, a reflection ofmillion. This reflected the endending of the co-promotion agreement with Teva forin certain countries, specifically sincein particular the United Kingdom (from the end of 2010 in the UK2010) and Germany (from the end of 2011 in Germany.2010).
Multaq® posted 56.4% growth in net sales to €261 million at constant exchange rates, primarily in the United States (€184 million) and Western Europe (€66 million).
Renagel®/Renvela® posted net sales of €415 million, up 10.2% on a constant structure basis and at constant exchange rates, due to increased market share in the United States. Net sales for this product are recognized as from the Genzyme acquisition date (April 2011) and comparisons are with the net sales reported by Genzyme in 2010 for the same period.
Net sales ofSynvisc® totaled €256 million (up 14.7% on a constant structure basis and at constant exchange rates), supported by the solid performance ofSynvisc-One® in the U.S. and Japan. Net sales for this product are recognized as from the Genzyme acquisition date and comparisons are with the net sales reported by Genzyme in 2010 for the same period.
New Genzyme
The "new Genzyme" business consists of products used to treat rare diseases and products for the treatment of multiple sclerosis. The latter did not generate any sales in 2011 and 2010, since Aubagio® was only launched in 2012 and Copaxone® is not included in the new Genzyme business. Net sales of Genzyme's rare diseases products are recognized as from the Genzyme acquisition date and comparisons are with the net sales reported by Genzyme in 2010 for the same period.
Net sales ofCerezyme® were up 11.1% (on a constant structure basis and at constant exchange rates) at €441 million, reflecting higher production volumes in 2011 following a reduction in availability of the product in 2010 due to manufacturing issues.Myozyme®/Lumizyme® posted strong growth (27.4% on a constant structure basis and at constant exchange rates, to €308 million), driven mainly by the performance of Lumizyme® in the United States and volume growth worldwide. Growth inFabrazyme® sales (9.4% on a constant structure basis and at constant exchange rates, to €109 million) was sparked by the increase in the product's availability following partial resolution of manufacturing issues. For more information regarding the manufacturing issues related to Cerezyme® and Fabrazyme® see "Item 4 — Information on the Company — Production and Raw Materials."
Consumer Health Care
TheConsumer Health Carebusiness posted year-on-year growth of 22.8% at constant exchange rates to €2,666 million, supported by the successful launch of Allegra®Allegra® as an over-the-counter product in the U.S. in the first quarter of 2011 generating(which generated €211 million in net sales for the year (outout of a worldwide total of €245 million), and by the performance of Emerging Markets in whichwhere net sales have increased by 20.8% at constant exchange rates to €1,225 million. These figures consolidatedinclude the effect of the first-time consolidation of the consumer health products of Chattem in the United States as offrom February 2010, and of BMP Sunstone in China as offrom February 2011.
Generics
TheGenericsbusiness reported net sales of €1,746 million in 2011, up 16.2% at constant exchange rates. This growth was underpinned by sales in Emerging Markets (€1,092 million, up 14.0% at constant exchange rates), especially in Latin America (up 21.4% at constant exchange rates), and in the United States (up 79.4% at constant exchange rates) where Sanofi launched its own approved generics of Ambien®Ambien® CR, Taxotere®Taxotere® and Lovenox®Lovenox®.
Net sales ofGenzyme Other prescription products in 2011 (since the acquisition date beginning of April) were up 7.7% on a constant structure basis and at constant exchange rates, to €2,395 million. Net sales are recognized as from the acquisition date and comparisons are with the net sales reported by Genzyme in 2010 for the same period.
Net sales ofCerezyme® were up 11.1% (on a constant structure basis and at constant exchange rates) to €441 million, which reflects the higher production in 2011 following a reduction in availability of the product in 2010 due to manufacturing issues.Myozyme®/Lumizyme® posted sharp growth (27.4% on a constant structure basis and at constant exchange rates, to €308 million), bolstered mainly by the performance of Lumizyme® in the United States and volume growth worldwide. Growth inFabrazyme® sales (9.4% on a constant structure basis and at constant exchange rates, to €109 million) was sparked by the increase in the product’s availability following on-going resolution of manufacturing issues. For more information regarding the manufacturing issues related to Cerezyme® and Fabrazyme® see “Item 4 — Information on the Company — Production and Raw Materials.”
Renagel®/Renvela® posted net sales of €415 million, up 10.2% on a constant structure basis and at constant exchange rates, associated with growth in the market share in the U.S.
Net sales ofSynvisc® totaled €256 million (up 14.7% on a constant structure basis and at constant exchange rates), supported by the solid performance ofSynvisc One® in the U.S. and Japan.
Net sales of the other prescription products in the portfolio were down 3.4%0.9% at constant exchange rates, to €5,773at €5,928 million. For a description of our other pharmaceutical products, see “Item"Item 4. Information on the Company — B. Business Overview — Pharmaceutical Products.”
The following table breaks down our 2011 and 2010 net sales for the Pharmaceuticals business by product:"
(€ million) Product | Indication | 2011 Reported | 2010 Reported | Change on a reported basis (%) | Change at constant exchange rates (%) | |||||||||||||
Lantus® | Diabetes | 3,916 | 3,510 | +11.6% | +15.0% | |||||||||||||
Apidra® | Diabetes | 190 | 177 | +7.3% | +9.6% | |||||||||||||
Insuman® | Diabetes | 132 | 133 | -0.8% | -0.8% | |||||||||||||
Amaryl® | Diabetes | 436 | 478 | -8.8% | -7.9% | |||||||||||||
Other products | Diabetes | 10 | — | — | — | |||||||||||||
Sub-total: Diabetes | 4,684 | 4,298 | +9.0% | +12.0% | ||||||||||||||
Lovenox® | Thrombosis | 2,111 | 2,806 | -24.8% | -23.4% | |||||||||||||
Plavix® | Atherothrombosis | 2,040 | 2,083 | -2.1% | -2.9% | |||||||||||||
Taxotere® | Breast, lung, prostate, stomach, and head & neck cancer | 922 | 2,122 | -56.6% | -57.0% | |||||||||||||
Aprovel®/CoAprovel® | Hypertension | 1,291 | 1,327 | -2.7% | -2.4% | |||||||||||||
Eloxatin® | Colorectal cancer | 1,071 | 427 | +150.8% | +160.9% | |||||||||||||
Multaq® | Atrial fibrillation | 261 | 172 | +51.7% | +56.4% | |||||||||||||
Jevtana® | Prostate cancer | 188 | 82 | +129.3% | +135.4% | |||||||||||||
Stilnox®/Ambien® / Myslee® | Sleep disorders | 490 | 819 | -40.2% | -41.4% | |||||||||||||
Allegra® | Allergic rhinitis, urticaria | 580 | 607 | -4.4% | -8.6% | |||||||||||||
Copaxone® | Multiple sclerosis | 436 | 513 | -15.0% | -15.4% | |||||||||||||
Tritace® | Hypertension | 375 | 410 | -8.5% | -6.3% | |||||||||||||
Depakine® | Epilepsy | 388 | 372 | +4.3% | +5.4% | |||||||||||||
Xatral® | Benign prostatic hypertrophy | 200 | 296 | -32.4% | -30.7% | |||||||||||||
Actonel® | Osteoporosis, Paget’s disease | 167 | 238 | -29.8% | -29.8% | |||||||||||||
Nasacort® | Allergic rhinitis | 106 | 189 | -43.9% | -41.8% | |||||||||||||
Other products | 5,773 | 6,064 | -4.8% | -3.4% | ||||||||||||||
Consumer Health Care | 2,666 | 2,217 | +20.3% | +22.8% | ||||||||||||||
Generics | 1,746 | 1,534 | +13.8% | +16.2% | ||||||||||||||
Genzyme | 2,395 | — | — | — | ||||||||||||||
Total pharmaceuticals | 27,890 | 26,576 | +4.9% | +6.7% |
The following table breaks down our 2011Sales of Plavix® and 2010 net sales for the products acquired with Genzyme:Aprovel® are discussed further below under "— Worldwide Presence of Plavix® and Aprovel®".
(€ million) Product | Indication | 2011 Reported | 2010 Reported | Change on a constant structure basis and at constant | ||||||||||
Cerezyme® | Gaucher disease | 441 | — | +11.1% | ||||||||||
Myozyme®/Lumizyme® | Pompe disease | 308 | — | +27.4% | ||||||||||
Fabrazyme® | Fabry disease | 109 | — | +9.4% | ||||||||||
Renagel®/Renvela® | Hyperphosphatembosis | 415 | — | +10.2% | ||||||||||
Synvisc® | Atherothrombosis | 256 | — | +14.7% | ||||||||||
Other Genzyme products | 866 | — | -2.2% | |||||||||||
Total Genzyme | 2,395 | — | +7.7% |
The following table breaks down net sales of our Pharmaceutical business productsPharmaceuticals segment by product and by geographical region in 2011:
(€ million) Product | Western Europe (1) | Change at constant exchange rates | United States | Change at constant exchange rates | Emerging Markets (2) | Change at constant exchange rates | Other countries (3) | Change at constant exchange rates | ||||||||||||||||||||||||
Lantus® | 730 | +6.4% | 2,336 | +14.6% | 617 | +26.0% | 233 | +22.3% | ||||||||||||||||||||||||
Apidra® | 68 | 0.0% | 65 | +11.3% | 37 | +8.6% | 20 | +58.3% | ||||||||||||||||||||||||
Insuman® | 103 | -4.6% | — | — | 29 | +20.0% | — | — | ||||||||||||||||||||||||
Amaryl® | 32 | -23.8% | 4 | -33.3% | 228 | +8.6% | 172 | -21.6% | ||||||||||||||||||||||||
Other products | 10 | — | — | — | — | — | — | — | ||||||||||||||||||||||||
Sub-total: Diabetes | 943 | +4.3% | 2,405 | +14.4% | 911 | +20.1% | 425 | +0.5% | ||||||||||||||||||||||||
Lovenox® | 833 | +6.4% | 633 | -54.3% | 551 | +14.0% | 94 | +3.5% | ||||||||||||||||||||||||
Plavix® | 414 | -35.6% | 196* | -8.0% | 706 | +11.9% | 724 | +18.6% | ||||||||||||||||||||||||
Taxotere® | 189 | -73.6% | 243 | -69.2% | 294 | -24.6% | 196 | -20.2 | ||||||||||||||||||||||||
Aprovel®/CoAprovel® | 753 | -9.1% | 49* | +25.6% | 363 | +6.7% | 126 | +8.6% | ||||||||||||||||||||||||
Eloxatin® | 38 | -19.6% | 806 | +393.0% | 162 | +9.3% | 65 | +10.2% | ||||||||||||||||||||||||
Multaq® | 66 | +66.7% | 184 | +50.8% | 7 | +250.0% | 4 | +33.3% | ||||||||||||||||||||||||
Jevtana® | 44 | — | 131 | +65.9% | 13 | — | — | — | ||||||||||||||||||||||||
Stilnox®/Ambien® /Myslee® | 53 | -3.6% | 82 | -80.6% | 65 | -1.5% | 290 | +8.3% | ||||||||||||||||||||||||
Allegra® | 13 | -18.8% | 3 | -98.6% | 99 | +19.3% | 465 | +22.2% | ||||||||||||||||||||||||
Copaxone® | 415 | -14.1% | — | — | — | -100.0% | 21 | +11.1% | ||||||||||||||||||||||||
Tritace® | 170 | -10.1% | — | — | 181 | 0.0% | 24 | -23.3% | ||||||||||||||||||||||||
Depakine® | 145 | -2.0% | — | — | 227 | +11.5% | 16 | -6.7% | ||||||||||||||||||||||||
Xatral® | 58 | -12.1% | 75 | -49.7% | 63 | -7.1% | 4 | -20.0% | ||||||||||||||||||||||||
Actonel® | 54 | -48.1% | — | — | 78 | -12.9% | 35 | -22.0% | ||||||||||||||||||||||||
Nasacort® | 25 | -10.7% | 54 | -57.7% | 23 | 0.0% | 4 | -20.0% | ||||||||||||||||||||||||
Other products | 2,417 | -8.9% | 497 | -19.9% | 2,106 | +7.4% | 753 | +1.4% | ||||||||||||||||||||||||
Consumer Health Care | 651 | +3.2% | 549 | +80.0% | 1,225 | +20.8% | 241 | +5.1% | ||||||||||||||||||||||||
Generics | 443 | +9.4% | 177 | +79.4% | 1,092 | +14.0% | 34 | -20.0% | ||||||||||||||||||||||||
Genzyme | 621 | — | 1,180 | — | 347 | — | 247 | — | ||||||||||||||||||||||||
Total pharmaceuticals | 8,345 | -3.9% | 7,264 | +8.5% | 8,513 | +15.0% | 3,768 | +14.0% |
(€ million) Product | Western Europe (1) | Change at constant exchange rates | United States | Change at constant exchange rates | Emerging Markets (2) | Change at constant exchange rates | Other countries (3) | Change at constant exchange rates | ||||||||||||||||
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Lantus® | 730 | +6.4% | 2,336 | +14.6% | 617 | +26.0% | 233 | +22.3% | ||||||||||||||||
Apidra® | 68 | 0.0% | 65 | +11.3% | 37 | +8.6% | 20 | +58.3% | ||||||||||||||||
Insuman® | 103 | -4.6% | — | — | 29 | +20.0% | — | — | ||||||||||||||||
Amaryl® | 32 | -23.8% | 4 | -33.3% | 228 | +8.6% | 172 | -21.6% | ||||||||||||||||
Other diabetes products | 10 | — | — | — | — | — | — | — | ||||||||||||||||
Total: Diabetes | 943 | +4.3% | 2,405 | +14.4% | 911 | +20.1% | 425 | +0.5% | ||||||||||||||||
Taxotere® | 189 | -73.6% | 243 | -69.2% | 294 | -24.6% | 196 | -20.2% | ||||||||||||||||
Eloxatine® | 38 | -19.6% | 806 | +393.0% | 162 | +9.3% | 65 | +10.2% | ||||||||||||||||
Jevtana® | 44 | — | 131 | +65.9% | 13 | — | — | — | ||||||||||||||||
Other oncology products (4) | 108 | — | 245 | — | 69 | — | 26 | — | ||||||||||||||||
Total: Oncology | 379 | ��� | 1,425 | — | 538 | — | 287 | — | ||||||||||||||||
Lovenox® | 833 | +6.4% | 633 | -54.3% | 551 | +14.0% | 94 | +3.5% | ||||||||||||||||
Plavix® | 414 | -35.6% | 196 | * | -8.0% | 706 | +11.9% | 724 | +18.6% | |||||||||||||||
Aprovel®/CoAprovel® | 753 | -9.1% | 49 | * | +25.6% | 363 | +6.7% | 126 | +8.6% | |||||||||||||||
Allegra® | 13 | -18.8% | 3 | -98.6% | 99 | +19.3% | 465 | +22.2% | ||||||||||||||||
Stilnox®/Ambien®/Myslee® | 53 | -3.6% | 82 | -80.6% | 65 | -1.5% | 290 | +8.3% | ||||||||||||||||
Copaxone® | 415 | -14.1% | — | — | — | -100.0% | 21 | +11.1% | ||||||||||||||||
Tritace® | 170 | -10.1% | — | — | 181 | 0.0% | 24 | -23.3% | ||||||||||||||||
Depakine® | 145 | -2.0% | — | — | 227 | +11.5% | 16 | -6.7% | ||||||||||||||||
Multaq® | 66 | +66.7% | 184 | +50.8% | 7 | +250.0% | 4 | +33.3% | ||||||||||||||||
Xatral® | 58 | -12.1% | 75 | -49.7% | 63 | -7.1% | 4 | -20.0% | ||||||||||||||||
Actonel® | 54 | -48.1% | — | — | 78 | -12.9% | 35 | -22.0% | ||||||||||||||||
Nasacort® | 25 | -10.7% | 54 | -57.7% | 23 | 0.0% | 4 | -20.0% | ||||||||||||||||
Renagel®/Renvela® (4) | 98 | — | 266 | — | 30 | — | 21 | — | ||||||||||||||||
Synvisc®/Synvisc-One® (4) | 15 | — | 211 | — | 12 | — | 17 | — | ||||||||||||||||
Cerezyme® (4) | 155 | — | 108 | — | 135 | — | 43 | — | ||||||||||||||||
Myozyme®/Lumizyme® (4) | 175 | — | 79 | — | 33 | — | 21 | — | ||||||||||||||||
Fabrazyme® (4) | 24 | — | 48 | — | 14 | — | 23 | — | ||||||||||||||||
Other rare disease products (4) | 59 | — | 93 | — | 53 | — | 59 | — | ||||||||||||||||
Total: New Genzyme (4) | 413 | — | 328 | — | 235 | — | 146 | — | ||||||||||||||||
Other prescription products | 2,404 | -8.7% | 627 | +7.1% | 2,107 | +7.6% | 790 | +7.1% | ||||||||||||||||
Consumer Health Care | 651 | +3.2% | 549 | +80.0% | 1,225 | +20.8% | 241 | +5.1% | ||||||||||||||||
Generics | 443 | +9.4% | 177 | +79.4% | 1,092 | +14.0% | 34 | -20.0% | ||||||||||||||||
Total pharmaceuticals | 8,345 | -3.9% | 7,264 | +8.5% | 8,513 | +15.0% | 3,768 | +14.0% | ||||||||||||||||
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Net Sales — Human Vaccines (Vaccines) segment
In 2011, the Vaccines segment reported net sales of €3,469 million, andown 8.9% drop on a reported basis, and 5.5% at constant exchange rates. The business suffered in 2011 from the absence of sales of A/H1N1 pandemic influenza vaccines (€452 million in 2010). If we exclude these sales, growth for the Vaccines business reached 7.2% at constant exchange rates, driven primarily by Emerging Markets (up 10.7%).
The following table presents the 2011 and 2010 sales of our Vaccines segment by range of products:
(€ million) | 2011 Reported | 2010 Reported | Change on a reported basis (%) | Change at constant exchange rates (%) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Polio/Pertussis/Hib Vaccines (including Pentacel® and Pentaxim®) | 1,075 | 984 | +9.3% | +12.0% | |||||||||
Influenza Vaccines (including Vaxigrip® and Fluzone®) | 826 | 1,297 | -36.3% | -33.2% | |||||||||
-of which seasonal influenza vaccines | 826 | 845 | -2.2% | +2.5% | |||||||||
-of which pandemic influenza vaccines | — | 452 | -100.0% | -100.0% | |||||||||
Meningitis/Pneumonia Vaccines (including Menactra®) | 510 | 527 | -3.2% | +2.3% | |||||||||
Adult Booster Vaccines (including Adacel®) | 465 | 449 | +3.6% | +7.3% | |||||||||
Travel and Other Endemics Vaccines | 370 | 382 | -3.1% | -1.6% | |||||||||
Other Vaccines | 223 | 169 | +32.0% | +37.8% | |||||||||
Total Vaccines | 3,469 | 3,808 | -8.9% | -5.5% | |||||||||
The drop in vaccines sales in 2011 in Western Europe (down 18.4% at constant exchange rates) and in Emerging Markets (down 18.1% at constant exchange rates) was primarily due to the lack of sales of pandemic influenza vaccines. Strong growth in the Other Countries region (up 24.2% at constant exchange rates) was driven by sales of Polio/Pertussis/Hib Vaccines in Japan.
Polio/Pertussis/Hibvaccines net sales were up 12.0% (at constant exchange rates) to €1,075 million, based on the solid performance of Pentaxim®Pentaxim® (up 30.2% at constant exchange rates, toat €238 million) related to product launches in Russia, India and China, and ofHaemophilus influenzae type b(Hib) vaccines (up 20.7% at €178 million) primarily in Emerging Markets and Japan.
Net sales ofinfluenza vaccines in 2011 were down 33.2% at constant exchange rates toat €826 million, tied toreflecting the non-recurrence in 2011 lack of sales ofthe pandemic influenza vaccines achievedvaccine sales generated in 2010, primarily in Latin America and Western Europe. Sales of seasonal influenza vaccines were up 2.5% at constant exchange rates, supporteddriven by the performance of Latin America.
Meningitis/Pneumoniavaccines generated net sales of €510 million, up 2.3% at constant exchange rates. The increaseGrowth was limited by the temporary reduction in catch-up immunization programs for the Menactra®Menactra® quadrivalent vaccine against meningococcal meningitis in the United States during the first half of 2011, however supported bybut booster vaccinations at the end of the year.year had a positive impact.
Net sales ofAdultadult boostervaccines reached €465 million (up 7.3% at constant exchange rates), driven by Adacel®Adacel® (€314 million, up 9.2% at constant exchange rates).
Net sales ofTraveltravel and other endemics Vaccines vaccines fell by 1.6% at constant exchange rates to €370 million.
The following table presents the 2011 and 2010 sales of our Vaccines business by range of products:
(€ million) | 2011 Reported | 2010 Reported | Change on a reported basis (%) | Change at constant exchange rates (%) | ||||||||||||
Polio/Pertussis/Hib Vaccines (including Pentacel® and Pentaxim®) | 1,075 | 984 | +9.3 % | +12.0 % | ||||||||||||
Influenza Vaccines (including Vaxigrip® and Fluzone®) | 826 | 1,297 | -36.3 % | -33.2 % | ||||||||||||
– of which seasonal influenza vaccines | 826 | 845 | -2.2 % | +2.5 % | ||||||||||||
– of which pandemic influenza vaccines | — | 452 | -100.0 % | -100.0 % | ||||||||||||
Meningitis/Pneumonia Vaccines (including Menactra®) | 510 | 527 | -3.2 % | +2.3 % | ||||||||||||
Adult Booster Vaccines (including Adacel®) | 465 | 449 | +3.6 % | +7.3 % | ||||||||||||
Travel and Other Endemics Vaccines | 370 | 382 | -3.1 % | -1.6 % | ||||||||||||
Other Vaccines | 223 | 169 | +32.0 % | +37.8 % | ||||||||||||
Total Vaccines | 3,469 | 3,808 | -8.9% | -5.5% |
The following table presents the 2011 sales of our Vaccines businesssegment by range of products and by region:
(€ million) | Western Europe (1) Reported | Change at constant exchange rates | United States Reported | Change at constant exchange rates | Emerging Markets (2) Reported | Change at constant exchange rates | Other countries (3) Reported | Change at constant exchange rates | ||||||||||||||||||||||||
Polio/Pertussis.Hib Vaccines (inc.Pentacel® and Pentaxim®) | 36 | -41.0 % | 463 | +2.8% | 457 | +21.9% | 119 | +66.7% | ||||||||||||||||||||||||
Influenza Vaccines(4) (inc. Vaxigrip® and Fluzone®) | 77 | -39.8 % | 435 | -11.2% | 296 | -51.1% | 18 | -21.7% | ||||||||||||||||||||||||
Meningitis/Pneumonia Vaccines (inc. Menactra®) | 3 | -40.0 % | 390 | +2.7% | 104 | +4.0% | 13 | -6.6% | ||||||||||||||||||||||||
Adult Booster Vaccines (inc. Adacel®) | 76 | +40.7 % | 339 | +3.5% | 30 | -9.1% | 20 | +11.8% | ||||||||||||||||||||||||
Travel and Other Endemics Vaccines | 24 | +33.3 % | 89 | +17.5% | 210 | -9.4% | 47 | -8.2% | ||||||||||||||||||||||||
Other Vaccines | 15 | -12.5 % | 176 | +45.3% | 16 | +13.3% | 16 | +58.7% | ||||||||||||||||||||||||
Total Vaccines | 231 | -18.4 % | 1,892 | +2.5% | 1,113 | -18.1% | 233 | +24.2% |
| France, Germany, United Kingdom, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Netherlands, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark. Net sales in Europe generated by Sanofi Pasteur MSD (the joint venture between Sanofi and Merck & Co., Inc.) are not consolidated. Sales generated by |
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In addition to the Vaccines activity reflected in our consolidated net sales, sales of Sanofi Pasteur MSD, our joint venture with Merck & Co., Inc. in Europe (not included in our consolidated net sales), amounted to €791 million in 2011, down 13.8% on a reported basis. Sales generated by Sanofi Pasteur MSD are not included in our consolidated net sales. The decrease in 2011 reflects the drop inlower sales of Gardasil®, a vaccine that prevents papillomavirus infections known to cause cervical cancerGardasil® (down 31.1% on a reported basis, to €181 million), and a decline in sales of influenza vaccines (down 23.7% on a reported basis, to €129 millions)million), primarily of seasonal influenza vaccines.
Net Sales — Animal Health segment
The Animal Health business is carried outon by Merial, which has been a wholly-owned subsidiary of Sanofi since September 18, 2009. On March 22, 2011 Merck and Sanofi announced that they had mutually terminated their agreement to form a new animal health joint venture and had decided to maintain Merial and Intervet/Schering-Plough as two separate entities, operating independently. This decision was mainly due to the increasing complexity of implementing the proposed transaction. Since January 1, 2011 Merial ishas no longer been presented separately on thein our consolidated balance sheet and the income statement, since January 1, 2011 and net income from Merial has been reclassified and included in the income from continuing operations for all periods reported. Detailed information about the impact of Merial on theour consolidated financial statements of Sanofi as of December 31, 2011 is provided in Note D.2. and Note D.8.1.D.8.2. to our consolidated financial statements included at Item 18 of this annual report.
Merial generated net sales of €2,030 million in 2011, up 4.3% at constant exchange rates and 2.4% on a reported basis, led by the performance in Emerging Markets.
The following table presents the 2011 and 2010 sales of our Animal Health segment by range of products:
(€ million) | 2011 Reported | 2010 Reported | Change on a reported basis | Change at constant exchange rates | |||||||||
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Frontline® and other fipronil-based products | 764 | 774 | -1.3% | +0.9% | |||||||||
Vaccines | 662 | 627 | +5.6% | +7.2% | |||||||||
Avermectin | 372 | 355 | +4.8% | +6.5% | |||||||||
Other products | 232 | 227 | +2.2% | +4.4% | |||||||||
Total Animal Health | 2,030 | 1,983 | +2.4% | +4.3% | |||||||||
Net sales for the companion animals franchise were marked by moderate growth in sales of the Frontline®Frontline® product range (up 0.9% at constant exchange rates, to €764 million), reflecting the temporary impact from generic Frontline®Frontline® Plus competitors in the United States and the arrival of competitor products in the United States and Western Europe. Sales of vaccines showed sustained growth (7.2% at constant exchange rates), especially in Emerging Markets (up 14.2%) with the success of the Vaxxitex®Vaxxitex® vaccine.
The following table presents the 2011 and 2010 sales of our Animal Health business by range of products:
(€ million) | 2011 Reported | 2010 Reported | Change on a reported basis | Change at exchange | ||||||||||||
Frontline® and other fipronil-based products | 764 | 774 | -1.3% | +0.9% | ||||||||||||
Vaccines | 662 | 627 | +5.6% | +7.2% | ||||||||||||
Avermectin | 372 | 355 | +4.8% | +6.5% | ||||||||||||
Other products | 232 | 227 | +2.2% | +4.4% | ||||||||||||
Total Animal Health | 2,030 | 1,983 | +2.4% | +4.3% |
The following table breaks down net sales of our Animal Health business productssegment by product and by geographical region in 2011:
(€ million) Product | Western Europe (1) | Change at constant exchange rates | United States | Change at constant exchange rates | Emerging Markets (2) | Change at constant exchange rates | Other countries (3) | Change at constant exchange rates | ||||||||||||||||||||||||
Frontline® and other fipronil-based products | 206 | +4.5% | 411 | -2.1% | 86 | +8.8% | 61 | 0.0% | ||||||||||||||||||||||||
Vaccines | 195 | +2.6% | 126 | +2.3% | 325 | +14.2% | 16 | -21.1% | ||||||||||||||||||||||||
Avermectin | 64 | +8.5% | 177 | +2.8% | 60 | +8.9% | 71 | +13.6% | ||||||||||||||||||||||||
Other products | 89 | -6.4% | 87 | +24.3% | 36 | +11.8% | 20 | -24.0% | ||||||||||||||||||||||||
Total Animal Health | 554 | +2.4% | 801 | +2.1% | 507 | +12.4% | 168 | -1.2% |
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(€ million) Product | Western Europe (1) | Change at constant exchange rates | United States | Change at constant exchange rates | Emerging Markets (2) | Change at constant exchange rates | Other countries (3) | Change at constant exchange rates | |||||||||||||||||
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Frontline® and other fipronil-based products | 206 | +4.5% | 411 | -2.1% | 86 | +8.8% | 61 | 0.0% | |||||||||||||||||
Vaccines | 195 | +2.6% | 126 | +2.3% | 325 | +14.2% | 16 | -21.1% | |||||||||||||||||
Avermectin | 64 | +8.5% | 177 | +2.8% | 60 | +8.9% | 71 | +13.6% | |||||||||||||||||
Other products | 89 | -6.4% | 87 | +24.3% | 36 | +11.8% | 20 | -24.0% | |||||||||||||||||
Total Animal Health | 554 | +2.4% | 801 | +2.1% | 507 | +12.4% | 168 | -1.2% | |||||||||||||||||
Net Sales by Geographical Region
We divide our sales geographically into four regions: Western Europe, the United States, Emerging Markets and other countries. The following table breaks down our 2011 and 2010 net sales by region:
(€ million) | 2011 Reported | 2010 Reported | Change on a reported basis | Change at constant exchange rates | |||||||||
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Western Europe (1) | 9,130 | 9,539 | -4.3% | -4.0% | |||||||||
United States | 9,957 | 9,790 | +1.7% | +6.8% | |||||||||
Emerging Markets (2) | 10,133 | 9,533 | +6.3% | +10.1% | |||||||||
Of which Eastern Europe and Turkey | 2,666 | 2,659 | +0.3% | +3.7% | |||||||||
Of which Asia (excl. Pacific region) (3) | 2,416 | 2,095 | +15.3% | +16.5% | |||||||||
Of which Latin America | 3,111 | 2,963 | +5.0% | +11.8% | |||||||||
Of which Africa | 949 | 880 | +7.8% | +9.7% | |||||||||
Of which Middle East | 872 | 825 | +5.7% | +8.6% | |||||||||
Other Countries (4) | 4,169 | 3,505 | +18.9% | +13.8% | |||||||||
Of which Japan | 2,865 | 2,275 | +25.9% | +20.2% | |||||||||
Total | 33,389 | 32,367 | +3.2% | +5.3% | |||||||||
(€ million) | 2011 Reported | 2010 Reported | Change on a reported basis | Change at exchange | ||||||||||||
Western Europe (1) | 9,130 | 9,539 | -4.3 | % | -4.0% | |||||||||||
United States | 9,957 | 9,790 | +1.7 | % | +6.8% | |||||||||||
Emerging Markets (2) | 10,133 | 9,533 | +6.3 | % | +10.1% | |||||||||||
Of which Eastern Europe and Turkey | 2,666 | 2,659 | +0.3 | % | +3.7% | |||||||||||
Of which Asia (excl. Pacific region (3)) | 2,416 | 2,095 | +15.3 | % | +16.5% | |||||||||||
Of which Latin America | 3,111 | 2,963 | +5.0 | % | +11.8% | |||||||||||
Of which Africa | 949 | 880 | +7.8 | % | +9.7% | |||||||||||
Of which Middle East | 872 | 825 | +5.7 | % | +8.6% | |||||||||||
Other Countries (4) | 4,169 | 3,505 | +18.9 | % | +13.8% | |||||||||||
Of which Japan | 2,865 | 2,275 | +25.9 | % | +20.2% | |||||||||||
Total | 33,389 | 32,366 | +3.2 | % | +5.3% |
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Western Europe posted a 4% decrease in net sales at constant exchange rates to €9,130 million, hit by competition from generics of Taxotere®Taxotere® (down 73.6% at constant exchange rates) and Plavix®Plavix® (down 35.6% at constant exchange rates), by the transfer of the Copaxone®Copaxone® business to Teva in certain countries, as well asand by the impact of austerity measures. Excluding A/H1N1 vaccines and Genzyme, the decline was 10.5% at constant exchange rates.
The United States posted a 6.8% increase in net sales at constant exchange rates to €9,957 million, but a 5.7% decline after excluding A/H1N1 vaccines and Genzyme, showed a 5.7% decline.Genzyme. Sales were affected by competition from generic versions of Lovenox®Lovenox®, Taxotere®Taxotere® and Ambien®Ambien® CR, which werethough the impact was partially offset by the performance of Lantus®Lantus® and Eloxatin® as well asEloxatine® and by the successful launch of Allegra®Allegra® as an over-the-counter product.
In Emerging Markets, net sales totaled €10,133 million, up 10.1% at constant exchange rates. Growth at constant exchange rates reached 10.4% excludingExcluding sales of A/H1N1 vaccines postedreported in 2010 (€361 million, primarily in Latin America) and Genzyme.Genzyme, growth at constant exchange rates reached 10.4%. In Brazil, net sales hit €1,522 million, up 4.9% at constant exchange rates or 21.9% if we exclude(21.9% after excluding A/H1N1 vaccines, therebyvaccines), reflecting the solid performance of generics and the contribution made by Genzyme. In China, net sales totaled €981 million (up 40.4% at constant exchange rates), supported by the performance of Plavix®Plavix® and Lantus®Lantus®. In Eastern Europe and Turkey, growth (3.7% at constant exchange rates) suffered from lower prices and competition from Taxotere®Taxotere® generics in Turkey; Russia posted sales of €732 million, a growth ofup 11.2% at constant exchange rates.
In the Other Countries region, net sales totaled €4,169 million, up 13.8% at constant exchange rates. Excluding A/H1N1 vaccines and Genzyme, net sales increased by 6.2%. Japan recorded net sales of €2,865 million (up 20.2% at constant exchange rates), buoyed by the solid performance of Plavix®performances from Plavix® (up 22.9% to €671 million), Allegra®Allegra® (up 22.2% to 465 million) and Hib vaccines, as well as by the contribution from Genzyme.
Worldwide Presence of Plavix®Plavix® and Aprovel®Aprovel®
Two of our leading products — Plavix®Plavix® and Aprovel®Aprovel® — were discovered by Sanofi and jointly developed with Bristol-Myers Squibb (“BMS”("BMS") under an alliance agreement. In all territories except Japan, these products are sold either by Sanofi or by BMS in accordance with the terms of this alliance agreement which is describedapplicable in “—2010 and 2011 (see "— Financial Presentation of Alliances — Alliance arrangements with Bristol-Myers Squibb” above.Squibb" above).
Worldwide sales of these two products are an important indicator because they facilitate a financial statement user’suser's understanding and analysis of our consolidated income statement, particularly in terms of understanding our overall profitability in relation to consolidated revenues, and also facilitate a user’suser's ability to understand and assess the effectiveness of our research and development efforts.
Also, disclosing sales made by BMS of these two products enables the users to have a clearer understanding of trends in different lines of our income statement, in particular the lines “Other revenues”line items "Other revenues", where we record royalties received on those sales (see “—"— Other Revenues”Revenues"); “Share"Share of profit/loss of associates and joint ventures”ventures" (see “—"— Share of Profit/Loss of Associates and Joint Ventures”Ventures"), where we record our share of profit/loss of entities included in the BMS Alliance and under BMS operational management; and “Net"Net income attributable to non-controlling interests”interests" (see “—"— Net Income Attributable to Non-Controlling Interests”Interests"), where we record the BMS share of profit/loss of entities included in the BMS Alliance and under our operational management.
The table below sets forth the worldwide sales of Plavix®Plavix® and Aprovel®Aprovel® in 2011 and 2010, by geographic region:
| 2011 | 2010 | Change on a reported basis | Change at constant exchange rates | |||||||||||||||||||||
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(€ million) | Sanofi (2) | BMS (3) | Total | Sanofi (2) | BMS (3) | Total | |||||||||||||||||||
Plavix®/Iscover® (1) | |||||||||||||||||||||||||
Europe | 530 | 44 | 574 | 724 | 98 | 822 | -30.2% | -29.8% | |||||||||||||||||
United States | — | 4,759 | 4,759 | — | 4,626 | 4,626 | +2.9% | +7.8% | |||||||||||||||||
Other countries | 1,370 | 286 | 1,656 | 1,165 | 282 | 1,447 | +14.4% | +13.8% | |||||||||||||||||
Total | 1,900 | 5,089 | 6,989 | 1,889 | 5,006 | 6,895 | +1.4% | +4.5% | |||||||||||||||||
Aprovel®/Avapro®/ Karvea®/Avalide® (4) | |||||||||||||||||||||||||
Europe | 694 | 130 | 824 | 789 | 158 | 947 | -13.0% | -13.0% | |||||||||||||||||
United States | — | 374 | 374 | — | 482 | 482 | -22.4% | -18.8% | |||||||||||||||||
Other countries | 451 | 156 | 607 | 411 | 216 | 627 | -3.2% | -2.1% | |||||||||||||||||
Total | 1,145 | 660 | 1,805 | 1,200 | 856 | 2,056 | -12.2% | -11.0% | |||||||||||||||||
(€ million) | 2011 | 2010 | Change on a reported | Change at constant exchange rates | ||||||||||||||||||||||||||||
Sanofi (2) | BMS (3) | Total | Sanofi (2) | BMS (3) | Total | |||||||||||||||||||||||||||
Plavix®/Iscover®(1) | ||||||||||||||||||||||||||||||||
Europe | 530 | 44 | 574 | 724 | 98 | 822 | -30.2% | -29.8% | ||||||||||||||||||||||||
United States | — | 4,759 | 4,759 | — | 4,626 | 4,626 | +2.9% | +7.8% | ||||||||||||||||||||||||
Other countries | 1,370 | 286 | 1,656 | 1,165 | 282 | 1,447 | +14.4% | +13.8% | ||||||||||||||||||||||||
Total | 1,900 | 5,089 | 6,989 | 1,889 | 5,006 | 6,895 | +1.4% | +4.5% | ||||||||||||||||||||||||
Aprovel®/Avapro® /Karvea®/Avalide®(4) | ||||||||||||||||||||||||||||||||
Europe | 694 | 130 | 824 | 789 | 158 | 947 | -13.0% | -13.0% | ||||||||||||||||||||||||
United States | — | 374 | 374 | — | 482 | 482 | -22.4% | -18.8% | ||||||||||||||||||||||||
Other countries | 451 | 156 | 607 | 411 | 216 | 627 | -3.2% | -2.1% | ||||||||||||||||||||||||
Total | 1,145 | 660 | 1,805 | 1,200 | 856 | 2,056 | -12.2% | -11.0% |
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Worldwide sales of Plavix®Plavix®/Iscover®Iscover® totaled €6,989 million in 2011, up 4.5 %4.5% at constant exchange rates. Sales in the U.S. (consolidated by BMS) were uprose by a sustainedrobust 7.8% at constant exchange rates, to €4,759 million. In Japan and China, Plavix® realizedPlavix® continued their success with sales of €671 million (+22.9% at constant exchange rates) and €277 million (+27.7% at constant exchange rates), respectively. These results sharplymore than offset the decline in sales of Plavix®Plavix® in Europe caused by competition from generics (down 29.8% at constant exchange rates, toat €574 million).
Worldwide sales of Aprovel®Aprovel®/Avapro®Avapro®/Karvea®Karvea®/Avalide®Avalide® totaled €1,805 million in 2011, down 11.0% at constant exchange rates, withreflecting the impact of increasing penetration of generic losartan on the market for anti-hypertensives.
Other Revenues
Other revenues, made up primarily of royalty income under licensing agreements contracted in connection with ongoing operations, remained stable at €1,669 million in 2011 and 2010.
Revenues from licensing under the worldwide alliance with BMS on Plavix®Plavix® and Aprovel®Aprovel® represented €1,275 million in 2011 versus €1,303 million in 2010 (down 2.1% on a reported basis). These licensing revenues sufferedwere adversely affected by the effectdepreciation of the U.S. dollar depreciation against the euro, despite thean increase in Plavix®sales of Plavix® in the United States (up 7.8% at constant exchange rates).
Gross Profit
Gross profit for the year ended December 31, 2011 came to €24,156 million (72.3% of net sales), 2.0% down on the 2010 figure ofversus €24,638 million (76.1% of net sales), in 2012. This represents a year-on-year fall of 2.0% in gross profit, and a declinedeterioration of 3.8 points in the gross profit reported under sales.
The gross margin ratio of the Pharmaceuticals segment was down 2.8 points toat 75.8%, reflecting both thea decrease in royalty income (-0.3 of a point) and the unfavorablean adverse trend in the ratio of cost of sales to net sales ratio (-2.5 points). The latter was primarily due to the unfavorable impact of new generics (especially Lovenox®Lovenox®, Ambien®Ambien® CR and Taxotere®Taxotere® in the United States, and Plavix®Plavix® and Taxotere®Taxotere® in Europe).
The gross margin ratio of the Vaccines segment was down 4.5 points toat 60.2%. This change was principally due to the absence in 2011 of 2011 profits fromthe margin on pandemic influenza vaccines, which had trended favorablya favorable impact in 2010.
The gross margin ratio of the Animal Health segment was down 1.0 point toat 68.9%.
The Group’sOur consolidated gross profit was also impacted in 2011 by aan expense of €476 million expense (or 1.4 points) arising from the workdown of inventories remeasured at fair value in connection with acquisitions, principally Genzyme (€473 million). In 2010, this expense represented €142 million (0.4 of a point) and for the most part affectedrelated mainly to the workdown of Merial’sMerial inventories.
Research and Development Expenses
Research and development (R&D) expenses totaled €4,811 million in 2011 (14.4% of net sales), up 5.8% on the 2010 figure of €4,547 million (14.0% of net sales).
In the Pharmaceuticals segment, R&D expenses rose by €217 million or an increase of(up 5.6%). Excluding Genzyme, R&D expenses decreased by 4.3% at constant exchange ratesshowed a single-digit decrease as a result of reorganizations initiated in 2009, and of the streamlining of the project portfolio.
In the Vaccines segment, R&D expenses rose by €47 million year-on-year (toto €564 million) or an increase ofmillion (up 9.1%), due mainly to the clinical trials ofon vaccines against dengue fever and Clostridium difficile.
In the Animal Health segment, R&D expenses declinedfell by €9 million year-on-year or a decrease of 5.8%.(5.8%) year-on-year.
Selling and General Expenses
Selling and general expenses amounted to €8,536 million (25.6% of net sales), an increase of 4.7% on the prior-year figure of €8,149 million (25.2% of net sales).
The Pharmaceuticals segment generated a €414 million increase or (+5.9%), due primarily fromto the first-time consolidation of Genzyme. Excluding Genzyme, selling and general expenses dropped by 2.9% at constant exchange rates, due both to reducedshowed a single-digit decrease, reflecting lower costs for genericized products in Europe and the United States and tight control ofover general expenses.
In the Vaccines segment, selling and general expenses were down €61 million or 10.1% due to the decline inlower selling expenses for pandemic influenza vaccines.
In the Animal Health business,segment, selling and general expenses were up €13 million (+2.2%), in line with the increase in net sales.
Other Operating Income and Expenses
Other operating income totaled €319 million in 2011 (versus €369 million in 2010), and other operating expenses accounted foramounted to €315 million (compared with €292 million in 2010).
The balance of otherOther operating income and expenses represented a net profit of €4 million in 2011, compared with €77 million in 2010. The year-on-year decrease of €73 million was essentially due to the discontinuation of royalty payments from Teva on North American sales of Copaxone®Copaxone® from the second quarter of 2010.
This line item also includes expenses forincurred in connection with the 2011 acquisition of Genzyme (€65 million), as well as a net operational foreign exchange loss of €5 million compared to(versus €138 million in 2010: the latter occurred2010, a year of high volatility in the middle of a highly volatileforeign exchange environment.markets).
Amortization of Intangible Assets
Amortization charged against intangible assets in the year ended December 31, 2011 amounted to €3,314 million, compared with €3,529 million in the previous year. The declinereduction of €215 million was mainly due to a dropdecrease in amortization charged against intangible assets recognized on the acquisition of Aventis (€1,788 million in 2011, versus €3,070 million in 2010, as some products have reached the end of their life cycles and facedin the face of competition from generics), that. This positive impact was partly compensatedpartially offset by new amortization charges in 2011 generated by intangible assets recognized on the acquisition of Genzyme in the second quarter of 2011 and on the first-time consolidation of Merial in the first quarter of 2011 (€709 million and €353 million, respectively).
Impairment of Intangible Assets
This line recorded net impairment losses against intangible assets of €142 million in 2011, compared with €433 million in 2010. Impairment losses booked in 2011 were mainly associated with (i) discontinuing a Genzyme research project,project; (ii) certain Zentiva generics for which the sales outlook was adjusted downward,downward; and (iii) discontinuing a joint development project developed jointly with Metabolex in the field of diabetes. It also includesincluded an impairment reversal in connection with Actonel®Actonel®, pursuant to confirmation of the terms of the collaboration agreement with Warner Chilcott (see Note C.2.C.3. to theour consolidated financial statements included at Item 18 of this annual report).
In 2010, impairments wereimpairment losses related primarily related to (i) Actonel®Actonel®, due to plannedproposed changes to the terms of the collaboration agreement with Warner Chilcott; (ii) the pentavalent vaccine Shan5®Shan5®, for which sales projections had beenwere revised to factor in the need for another WHO pre-qualification following a flocculation problem encountered in some batches; (iii) the BSI-201 project, in whichfollowing a revision to the development plan was revised followingin response to the announcement of the initial Phase III trial results in metastatic triple negative breast cancer; and (iv) certain generics and Zentiva consumer health products for which sales projections in Eastern Europe were revised downwards.
Fair Value Remeasurement of Contingent Consideration Liabilities
This line item records fair value remeasurements of liabilities related to business combinations accounted for in accordance with the revised IFRS 3R. Such3. These remeasurements generated a new profitgain of €15 million in 2011, and were mainly related to a contingent purchase consideration on the acquisition of TargeGen, to the contingent value rights (CVRs) issued as part of the Genzyme acquisition, and theto contingent consideration to be paidpayable to Bayer on certain Genzyme products (see Note D.18. to the consolidated financial statements included at Item 18 of this annual report).
Restructuring Costs
Restructuring costs accounted for aamounted to €1,314 million expense in 2011, compared with €1,384 million in 2010.
In 2011, these were mainly employee-related expenses incurred under plans to adjust headcount in support functions and sales forces in Europe and in Research & DevelopmentR&D in Europe and the United States, and measures to adapt the Group’sour manufacturing facilities in Europe.
In 2010, these costs related mainly to measures taken to adapt our industrial operations in France, and our sales and R&D functions in the United States and some European countries.
Other Gains and Losses, and Litigation
This line item includedshowed a net expense of €327 million, which mainly representedcomprising (i) athe €519 million backlog of depreciation and amortization expense against Merial’sthe tangible and intangible assets in the amount of €519 million, that hadMerial, which was not been recognized from September 18, 2009 through December 31, 2010 because these assets had beenwere classified as held for sale or exchange during that period in accordance with IFRS 5 (see Note D.8.1.D.8.2. to theour consolidated financial statements included at Item 18 of this annual report), (ii) proceeds of €210 million in damages with regard to a Plavix®Plavix® patent and (iii) the impact of the disposaldivestiture of the Dermik dermatology business (see Note D.28. to theour consolidated financial statements).
In 2010, this line item reportedshowed a net expense of €138 million expense forarising from an adjustment of warrantyto vendor's guarantee provisions associatedin connection with prior disposals of operations.past business divestitures.
Operating Income
Operating income totaled €5,731 million for 2011, versus €6,535 million for 2010 down(down 12.3%); the year-on-year fall mainly as a result ofreflected the competition from generics and the absence of A/H1N1 pandemic influenza vaccine sales in 2011.
Financial Income and Expenses
Net financial expenses came to €412 million in 2011 versus €362 million in 2010, an increase of €50 million.
Financial expenses directly related to our debt, net debt (defined as short-term and long-term debt, plus related interest rate and currency derivatives, minusof cash and cash equivalents)equivalents (see definition at "— Liquidity and Capital Resources" below) were €325 million in 2011, versusvirtually unchanged from the 2010 figure of €324 million, in 2010. This stabilization wasas a result of:of contrasting factors:
debt;
Provisions against securitiesinvestments and receivablesfinancial assets totaled €58 million in 2011 (versus €6 million in 2010); in 2011, these provisions were primarily related to the impairment of Greek government bonds.
Gains on disposals of non-current financial assets came to €25 million versus €61 million in 2010. These were essentially related toIn 2011, the 2011main item was the impact of the change in the consolidation method for the investment in Société Financière des Laboratoires de Cosmétologie Yves Rocher securities associated with thefollowing loss of significant influence (see Note D.6. to theour consolidated financial statements), and; in 2010, the Group’s 2010 salemain item was the disposal of itsthe equity interest in Novexel.
Lastly,This item also included net financial foreign exchange gains totaledof €10 million in 2011 (versus a net loss of €20 million in 2010).
Income before Tax and Associates and Joint Ventures
Income before tax and associates and joint ventures was €5,319 million in 2011, versus €6,173 million in 2010, a decrease of 13.9%.
Income Tax Expense
Income tax expense totaled €455 million in 2011, compared with €1,430 million in 2010. The decrease was mainly due to the changea reduction in deferred taxes followingtax liabilities as a result of changes in both the ratetax rates and the lawstax legislation (mainly in the UK)United Kingdom), and to the effect of the Franco-American Advance Pricing AgreementsAgreement (APA) for the 2006-2011 period from 2006 through 2011 (see Note D.30. to theour consolidated financial statements).
This line item also includes the tax effects of the amortization of intangible assets (€1,178 million in 2011 versus €1,183 million in 2010) and of restructuring costs (€399 million in 2011 versus €466 million in 2010).
The effective tax rate is calculated on the basis of business operating income minus net financial expenses, and before (i) the share of profit/loss of associates and joint ventures and (ii) net income attributable to non-controlling interests. The effective tax rate was 27.0% in 2011, versus 27.8% in 2010. The difference relative to the standard corporate income tax rate applicable in France (34.4%) was mainly due to lower taxes on patent royalties in France.
Share of Profit/Loss of Associates and Joint Ventures
OurThe share of profits and losses fromprofit/loss of associates and joint ventures totaled €1,070 million in 2011, compared with €978 million in 2010. This line mainly includes our share of after-tax profits generated in territories managed by BMS under the Plavix®Plavix® and Avapro®Avapro® alliance, which advanced by 9.2% to €1,070 million compared with €980 million in 2010. The increase in 2011this share in this share2011 was partly related to growth in Plavix®Plavix® sales in the United States (up 2.9%).
Net Income
Net income for the year was €5,934 million in 2011, compared with €5,721 million in 2010.
Net Income Attributable to Non-Controlling Interests
Net income attributable to non-controlling interests amounted to €241 million in 2011, compared with €254 million in 2010. This line mainly includes the share of pre-tax profits paid to BMS generated in territories managed by Sanofi (€225 million, versus €238 million in 2010); this declinethe year-on-year fall is directly related to increased competition from clopidogrel (Plavix®(Plavix®) generics in Europe.
Net Income Attributable to Equity Holders of Sanofi
Net income attributable to equity holders of Sanofi totaled €5,693 million in 2011, against €5,467 million in 2010.
Basic earnings per share for 2011 was €4.31, 2.9% higher than the 2010 figure of €4.19, based on an average number of shares outstanding of 1,321.7 million in 2011 compared withand 1,305.3 million in 2010. Diluted earnings per share was €4.29 in 2011, compared withversus €4.18 in 2010, based on an average number of shares outstanding after dilution of 1,326.7 million in 2011 and 1,308.2 million in 2010.
Business Operating Income
Sanofi reports segment results on the basis of "Business Operating Income". This indicator, adopted in compliance with IFRS 8, is used internally to measure operational performance and to allocate resources. See "Item 5. Operating and Financial Review and Prospects — Segment information" above for the definition of business operating income and reconciliation to Income before tax and associates and joint ventures.
Business operating income for 2011 was €12,144 million, compared to €12,863 million in 2010. The table below shows trends in business operating income by business segment for 2011 and 2010:
(€ million) | 2011 | 2010 | |||||
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Pharmaceuticals | 10,496 | 10,965 | |||||
Vaccines | 985 | 1,379 | |||||
Animal Health | 627 | 621 | |||||
Other | 36 | (102 | ) | ||||
Business operating income | 12,144 | 12,863 | |||||
Business Net Income
Business net income is a non-GAAP financial measure that we use to evaluate our Group’s performance (see “Item"Item 5. Operating and Financial Review and Prospects — Business Net Income” above).
Business net income totaled €8,795 million in 2011 versus €9,215 million in 2010, a drop of 4.6%. It represented 26.3% of net sales compared with 28.5% in 2010.
(€ million) | 2011 | 2010 (1) | ||||||||
Business net income | 8,795 | 9,215 | ||||||||
(i) | Amortization of intangible assets | (3,314 | ) | (3,529 | ) | |||||
(ii) | Impairment of intangible assets | (142 | ) | (433 | ) | |||||
(iii) | Fair value remeasurement of contingent consideration liabilities | 15 | — | |||||||
(iv) | Expenses arising from the impact of acquisitions on inventories (2) | (476 | ) | (142 | ) | |||||
(v) | Restructuring costs | (1,314 | ) | (1,384 | ) | |||||
(vi) | Other gains and losses, and litigation (3) | (327 | ) | (138 | ) | |||||
(vii) | Impact of the non-depreciation of the property, plant and equipment of Merial (IFRS 5) | — | 77 | |||||||
(viii) | Tax effects on the items listed above, comprising: | 1,905 | 1,856 | |||||||
– amortization of intangible assets | 1,178 | 1,183 | ||||||||
– impairment of intangible assets | 37 | 143 | ||||||||
– fair value remeasurement of contingent consideration liabilities | 34 | — | ||||||||
– expenses arising from the impact of acquisitions on inventories | 143 | 44 | ||||||||
– restructuring costs | 399 | 466 | ||||||||
– other gains and losses, and litigation | 114 | 46 | ||||||||
– non-depreciation of property, plant and equipment of Merial (IFRS 5) | — | (26 | ) | |||||||
(iv)/(ix) | Other tax items (4) | 577 | — | |||||||
(x) | Share of items listed above attributable to non-controlling interests | 6 | 3 | |||||||
(iv)/(v) | Restructuring costs and expenses arising from the impact of acquisitions on associates and joint ventures (5) | (32 | ) | (58 | ) | |||||
Net income attributable to equity holders of Sanofi | 5,693 | 5,467 |
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Business Earnings Per Share
We also report business earnings per share, a non-GAAP financial measure which we define as business net income divided by the weighted average number of shares outstanding (see “—"— Business Net Income”Income" above).
Business earnings per share for 2011 were €6.65, versus5.8% lower than the 2010 figure of €7.06, in 2010, down 5.8% based on a weighted average number of shares outstanding of 1,321.7 million in 2011 compared withand 1,305.3 million in 2010. Diluted business earnings per share for 2011 were €6.63, versus5.8% lower than the 2010 figure of €7.04, in 2010, down 5.8% based on a weighted average number of shares outstanding of 1,326.7 million in 2011 and 1,308.2 million in 2010.
Year Ended December 31, 2010 Compared with Year Ended December 31, 2009
The consolidated income statements for the years ended December 31, 2010 and December 31, 2009 break down as follows:
(under IFRS) (€ million) | 2010 (1) | as % of net sales | 2009 | as % of net sales | ||||||||||||
Net sales | 32,367 | 100.0% | 29,785 | 100.0% | ||||||||||||
Other revenues | 1,669 | 5.2% | 1,447 | 4.9% | ||||||||||||
Cost of sales | (9,398 | ) | (29.0%) | (8,107 | ) | (27.2%) | ||||||||||
Gross profit | 24,638 | 76.1% | 23,125 | 77.6% | ||||||||||||
Research & development expenses | (4,547 | ) | (14.0%) | (4,626 | ) | (15.5%) | ||||||||||
Selling & general expenses | (8,149 | ) | (25.2%) | (7,464 | ) | (25.1%) | ||||||||||
Other operating income | 369 | 861 | ||||||||||||||
Other operating expenses | (292 | ) | (481 | ) | ||||||||||||
Amortization of intangible assets | (3,529 | ) | (3,528 | ) | ||||||||||||
Impairment of intangible assets | (433 | ) | (372 | ) | ||||||||||||
Fair value remeasurement of contingent consideration liabilities | — | |||||||||||||||
Restructuring costs | (1,384 | ) | (1,080 | ) | ||||||||||||
Other gains and losses, and litigation (2) | (138 | ) | — | |||||||||||||
Operating income | 6,535 | 20.2% | 6,435 | 21.6% | ||||||||||||
Financial expenses | (468 | ) | (325 | ) | ||||||||||||
Financial income | 106 | 27 | ||||||||||||||
Income before tax and associates and joint ventures | 6,173 | 19.1% | 6,137 | 20.6% | ||||||||||||
Income tax expense | (1,430 | ) | (1,399 | ) | ||||||||||||
Share of profit/(loss) of associates and joint ventures | 978 | 953 | ||||||||||||||
Net income | 5,721 | 17.7% | 5,691 | 19.1% | ||||||||||||
Net income attributable to non-controlling interests | 254 | 426 | ||||||||||||||
Net income attributable to equity holders of Sanofi | 5,467 | 16.9% | 5,265 | 17.7% | ||||||||||||
Average number of shares outstanding (million) | 1,305.3 | 1,305.9 | ||||||||||||||
Average number of shares outstanding after dilution (million) | 1,308.2 | 1,307.4 | ||||||||||||||
Basic earnings per share (in euros) | 4.19 | 4.03 | ||||||||||||||
Diluted earnings per share (in euros) | 4.18 | 4.03 |
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Net Sales
Net sales for the year ended December 31, 2010 were €32,367 million, up 8.7% on 2009. Growth was sustained by both the appreciation of the U.S. dollar and the yen against the euro, and changes in structure (mainly the consolidation of Zentiva from the second quarter of 2009, of Merial from September 18, 2009, and of Chattem from the first quarter of 2010).
Our net sales comprise the net sales generated by our Pharmaceuticals, Human Vaccines (Vaccines) and Animal Health businesses.
The following table breaks down our 2010 and 2009 net sales by business segment:
(€ million) | 2010 Reported | 2009 Reported | Change on a reported basis (%) | |||||||||
Pharmaceuticals | 26,576 | 25,823 | +2.9% | |||||||||
Vaccines | 3,808 | 3,483 | +9.3% | |||||||||
Animal Health | 1,983 | 479 | +314.0% | |||||||||
Total | 32,367 | 29,785 | +8.7% |
Net Sales by Product — Pharmaceuticals
Net sales generated by our Pharmaceuticals segment were €26,576 million in 2010, up 2.9% on a reported basis but down 1.6% at constant exchange rates.
Flagship Products
Our flagship products (Lantus® and other Diabetes business products, Lovenox®, Plavix®, Taxotere®, Aprovel®/CoAprovel®, Eloxatin®, Multaq® and Jevtana®) are discussed below. Sales of Plavix® and Aprovel® are discussed further below under “— Worldwide Presence of Plavix® and Aprovel®”.
Net sales for the Diabetes business came to €4,298 million, up 9.2% at constant exchange rates, driven by growth for Lantus®, Apidra® and Amaryl®.
Lantus®, the world’s leading diabetes brand (source: IMS 2011 sales), posted a 9.1% rise in net sales at constant exchange rates in 2010 to €3,510 million. Growth was strong in Emerging Markets (18.2% at constant exchange rates), but slowed in the United States (7.4% at constant exchange rates) due to healthcare reforms, despite higher sales of the SoloSTAR® injection pen. Lantus® achieved particularly strong growth at constant exchange rates in Japan (32.3%), Russia (25.9%), and Brazil (30.6%).
Net sales of the rapid-acting insulin analogApidra®advanced by 24.1% at constant exchange rates in 2010 to €177 million, buoyed by solid performances in Western Europe (21.8% growth) and Emerging Markets (37.5% growth).
Lovenox® saw net sales decrease by 10.5% at constant exchange rates in 2010 to €2,806 million. In the United States, sales fell by 22.7% to €1,439 million following the introduction of a generic version of enoxaparin at the end of July 2010. Excluding the United States, net sales were up 7.8% at constant exchange rates at €1,367 million (representing 48.7% of worldwide 2010 sales of Lovenox®), with good performances in Western Europe (up 7.3%) and Eastern Europe (up 14.0%).
Taxotere® reported net sales of €2,122 million, down 6.4% at constant exchange rates. The drop in sales came in the United States and Western Europe, where the patents expired in November 2010. Generic docetaxel became available throughout Western Europe by November 2010. In the United States, distributors commenced a work down of Taxotere® inventories in late 2010 in anticipation of the expected arrival of generic docetaxel in 2011. However, the product saw modest growth in Emerging Markets and in the Other Countries region (1.4% and 2.5% respectively).
Net sales ofEloxatin® fell by 58.8% at constant exchange rates in 2010 to €427 million, hit by competition from generics. Following a court ruling, generics manufacturers have been under order to stop selling their unauthorized Eloxatin® generics in the U.S. market since June 30, 2010. The workdown of existing inventories of generics impaired our Eloxatin® sales performance in the second half of 2010.
Multaq®, which began to be marketed at the end of 2009, reported net sales of €172 million, mainly in the United States. The product is now available in over 20 countries, and further launches are ongoing.
Jevtana®, which has been available in the U.S. market since July 2010, registered net sales of €82 million in 2010.
Our other major products are described below.
Net sales of the hypnoticStilnox®/Ambien®/Myslee® fell by 10.9% at constant exchange rates to €819 million. In the United States, net sales were €443 million (including €375 million for Ambien® CR), down 21.6% at constant exchange rates, following FDA approval of a generic version of Ambien® CR in October 2010; we responded by launching our own generic version in the United States. In Japan, Myslee® again performed well, with net sales up 14.5% at constant exchange rates at €247 million.
Allegra® reported a 22.4% drop in net sales (at constant exchange rates) to €607 million, due to the effect of generics of Allegra® D-12, which have been available on the U.S. market since the end of 2009. Sales in Japan were down 2.0% at constant exchange rates, at €356 million.
Net sales ofCopaxone®, generated mainly in Western Europe, grew by 8.4% at constant exchange rates to €513 million.
TheConsumer Health Carebusiness posted year-on-year growth of 45.7% at constant exchange rates to €2,217 million, driven by Emerging Markets where net sales rose by 44.4% at constant exchange rates to €1,050 million. These figures consolidate the consumer health products of Zentiva from April 2009, Oenobiol from December 2009, Chattem from February 2010, and Nepentes from August 2010.
TheGenericsbusiness reported 2010 net sales of €1,534 million, up 41.5% at constant exchange rates. Growth was driven by Emerging Markets, due to the acquisition and consolidation of Zentiva and Kendrick (from April 2009) and Medley (from May 2009), and by the United States, following the launch of our generic version of Ambien®CR.
Net sales of the other products in the portfolio were down 1.9% (at constant exchange rates) year-on-year at €6,064 million. For a description of our other pharmaceutical products, see “Item 4. Information on the Company — B. Business Overview — Pharmaceutical Products.”
The following table breaks down our 2010 and 2009 net sales for the Pharmaceuticals business by product:
(€ million) Product | Indication | 2010 Reported | 2009 Reported | Change on a reported basis (%) | Change at constant exchange rates (%) | |||||||||||||||
Lantus® | Diabetes | 3,510 | 3,080 | +14.0% | +9.1% | |||||||||||||||
Apidra® | Diabetes | 177 | 137 | +29.2% | +24.1% | |||||||||||||||
Amaryl® | Diabetes | 478 | 416 | +14.9% | +7.7% | |||||||||||||||
Insuman® | Diabetes | 133 | 131 | +1.5% | +1.5% | |||||||||||||||
Sub-total: Diabetes | 4,298 | 3,764 | +14.2% | +9.2% | ||||||||||||||||
Lovenox® | Thrombosis | 2,806 | 3,043 | -7.8% | -10.5% | |||||||||||||||
Plavix® | Atherothrombosis | 2,083 | 2,623 | -20.6% | -24.6% | |||||||||||||||
Taxotere® | | Breast, lung, prostate, stomach, and head & neck cancer | | 2,122 | 2,177 | -2.5% | -6.4% | |||||||||||||
Aprovel®/CoAprovel® | Hypertension | 1,327 | 1,236 | +7.4% | +4.2% | |||||||||||||||
Eloxatin® | Colorectal cancer | 427 | 957 | -55.4% | -58.8% | |||||||||||||||
Multaq® | Atrial fibrillation | 172 | 25 | +588.0% | +560.0% | |||||||||||||||
Jevtana® | Prostate cancer | 82 | — | — | — | |||||||||||||||
Stilnox® / Ambien®/Myslee® | Sleep disorders | 819 | 873 | -6.2% | -10.9% | |||||||||||||||
Allegra® | | Allergic rhinitis, urticarial | | 607 | 731 | -17.0% | -22.4% | |||||||||||||
Copaxone® | Multiple sclerosis | 513 | 467 | +9.9% | +8.4% | |||||||||||||||
Tritace® | Hypertension | 410 | 429 | -4.4% | -7.2% | |||||||||||||||
Depakine® | Epilepsy | 372 | 329 | +13.1% | +7.6% | |||||||||||||||
Xatral® | | Benign prostatic hypertrophy | | 296 | 296 | 0.0% | -3.4% | |||||||||||||
Actonel® | | Osteoporosis, Paget’s disease | | 238 | 264 | -9.8% | -16.3% | |||||||||||||
Nasacort® | Allergic rhinitis | 189 | 220 | -14.1% | -16.8% | |||||||||||||||
Other products | 6,064 | 5,947 | +2.0% | -1.9% | ||||||||||||||||
Consumer Health Care | 2,217 | 1,430 | +55.0% | +45.7% | ||||||||||||||||
Generics | 1,534 | 1,012 | +51.6% | +41.5% | ||||||||||||||||
Total pharmaceuticals | 26,576 | 25,823 | +2.9% | -1.6% |
The following table breaks down net sales of our Pharmaceutical business products by geographical region in 2010:
(€ million) Product | Western Europe (1) | Change at constant exchange rates | United States | Change at constant exchange rates | Emerging Markets (2) | Change at constant exchange rates | Other Countries (3) | Change at constant exchange rates | ||||||||||||||||||||||||
Lantus® | 684 | +5.3% | 2,134 | +7.4% | 508 | +18.2% | 184 | +25.2% | ||||||||||||||||||||||||
Apidra® | 68 | +21.8% | 62 | +11.1% | 35 | +37.5% | 12 | +150.0% | ||||||||||||||||||||||||
Amaryl® | 42 | -17.6% | 6 | -33.3% | 222 | +21.7% | 208 | +3.3% | ||||||||||||||||||||||||
Insuman® | 108 | -0.9% | — | — | 25 | +19.0% | — | -100.0% | ||||||||||||||||||||||||
Sub-total: Diabetes | 902 | +4.2% | 2,202 | +7.4% | 790 | +20.0% | 404 | +13.7% | ||||||||||||||||||||||||
Lovenox® | 782 | +7.3% | 1,439 | -22.7% | 499 | +6.9% | 86 | +19.4% | ||||||||||||||||||||||||
Plavix® | 641 | -53.9% | 213 | * | -4.1% | 648 | +0.7% | 581 | +25.4% | |||||||||||||||||||||||
Taxotere® | 709 | -10.6% | 786 | -8.0% | 394 | +1.4% | 233 | +2.5% | ||||||||||||||||||||||||
Aprovel®/CoAprovel® | 825 | -5.0% | 39 | * | +457.1% | 358 | +8.3% | 105 | +67.3% | |||||||||||||||||||||||
Eloxatin® | 46 | -42.9% | 172 | -76.4% | 150 | -9.8% | 59 | +4.0% | ||||||||||||||||||||||||
Multaq® | 39 | — | 128 | — | 2 | — | 3 | — | ||||||||||||||||||||||||
Jevtana® | — | — | 82 | — | — | — | — | — | ||||||||||||||||||||||||
Stilnox®/Ambien® /Myslee® | 55 | -8.3% | 443 | -21.6% | 68 | +5.0% | 253 | +13.6% | ||||||||||||||||||||||||
Allegra® | 16 | -5.9% | 147 | -53.6% | 88 | +17.4% | 356 | -3.2% | ||||||||||||||||||||||||
Copaxone® | 482 | +9.1% | — | — | 13 | -13.3% | 18 | +7.7% | ||||||||||||||||||||||||
Tritace® | 189 | -4.1% | — | — | 191 | -2.6% | 30 | -41.9% | ||||||||||||||||||||||||
Depakine® | 148 | +2.1% | — | — | 209 | +12.0% | 15 | +9.1% | ||||||||||||||||||||||||
Xatral® | 66 | -14.3% | 155 | +2.7% | 70 | +0.0% | 5 | -50.0% | ||||||||||||||||||||||||
Actonel® | 104 | -23.5% | — | — | 93 | -12.4% | 41 | +3.2% | ||||||||||||||||||||||||
Nasacort® | 28 | -3.4% | 130 | -20.3% | 26 | -10.7% | 5 | -20.0% | ||||||||||||||||||||||||
Other products | 2,649 | -2.3% | 652 | +3,3% | 2,052 | +0.4% | 711 | -10.9% | ||||||||||||||||||||||||
Consumer Health Care | 630 | +1.1% | 320 | — | 1,050 | +44.4% | 217 | +31.3% | ||||||||||||||||||||||||
Generics | 404 | +11.1% | 102 | — | 988 | +42.8% | 40 | +61.9% | ||||||||||||||||||||||||
Total pharmaceuticals | 8,715 | -8.5% | 7,010 | -7,5% | 7,689 | +11.9% | 3,162 | +6.9% |
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Net Sales — Human Vaccines (Vaccines)
In 2010, the Vaccines segment reported net sales of €3,808 million, up 4.8% at constant exchange rates and 9.3% on a reported basis. Growth was driven by sales of seasonal influenza vaccines (€845 million, versus €597 million in 2009). Sales of pandemic influenza vaccines (mainly against the A/H1N1 virus) were flat; excluding their impact, growth for the Vaccines segment reached 5.5% at constant exchange rates.
Although the Vaccines segment saw net sales decrease in Western Europe and the United States (by 15.6% and 11.5% at constant exchange rates, respectively), the effect was amply offset by strong growth in Emerging Markets and in the Other Countries region (of 46.2% and 23.0% at constant exchange rates, respectively).
Net sales ofinfluenza vaccines rose by 18.7% at constant exchange rates to €1,297 million in 2010, boosted by the performance of the Fluzone® seasonal influenza vaccine in the U.S. market. Excluding pandemic influenza vaccines (net sales of €452 million, flat year-on-year), growth reached 33.3% at constant exchange rates.
Polio/Pertussis/Hibvaccines net sales fell by 2.9% (at constant exchange rates) to €984 million, reflecting a decline in sales of Pentacel® (down 11.4% at €317 million at constant exchange rates) but also the performance of Pentaxim® (up 43.9% at €190 million at constant exchange rates).
Meningitis/Pneumoniavaccines generated net sales of €527 million, down 6.7% at constant exchange rates, mainly due to a reduction in catch-up vaccination programs with the Menactra® quadrivalent meningococcal meningitis vaccine in the United States.
Net sales ofAdult boostervaccines reached €449 million (up 4.7% at constant exchange rates), driven by Adacel® (€301 million, up 6.1% at constant exchange rates).
Net sales ofTravel and other endemics Vaccines rose by 15.7% at constant exchange rates to €382 million, mainly due to growth in anti-rabies vaccines.
The following table presents the 2010 and 2009 sales of our Vaccines business by range of products:
(€ million) | 2010 Reported | 2009 Reported | Change on a reported basis (%) | Change at constant exchange rates (%) | ||||||||||||
Influenza Vaccines (including Vaxigrip® and Fluzone®) | 1,297 | 1,062 | +22.1% | +18.7% | ||||||||||||
– of which seasonal influenza vaccines | 845 | 597 | +41.5% | +33.3% | ||||||||||||
– of which pandemic influenza vaccines | 452 | 465 | -2.8% | 0.0% | ||||||||||||
Polio/Pertussis/Hib Vaccines (including Pentacel® and Pentaxim®) | 984 | 968 | +1.7% | -2.9% | ||||||||||||
Meningitis/Pneumonia Vaccines (including Menactra®) | 527 | 538 | -2.0% | -6.7% | ||||||||||||
Adult Booster Vaccines (including Adacel®) | 449 | 406 | +10.6% | +4.7% | ||||||||||||
Travel and Other Endemics Vaccines | 382 | 313 | +22.0% | +15.7% | ||||||||||||
Other Vaccines | 169 | 196 | +13.8% | -18.4% | ||||||||||||
Total Vaccines | 3,808 | 3,483 | +9.3% | +4.8% |
The following table presents the 2010 sales of our Vaccines business by range of products and by region:
(€ million) | Western Europe (1) Reported | Change at constant exchange rates | United States Reported | Change at constant exchange rates | Emerging Markets (2) Reported | Change at constant exchange rates | Other Countries (3) Reported | Change at constant exchange rates | ||||||||||||||||||||||||
Influenza Vaccines (4) (inc. Vaxigrip® and Fluzone®) | 128 | -7.9% | 528 | -20.2% | 618 | +116.4% | 23 | +5.6% | ||||||||||||||||||||||||
Polio/Pertussis.Hib Vaccines (inc.Pentacel® and Pentaxim®) | 61 | -16.2% | 470 | -14.6% | 384 | +11.4% | 69 | +56.4% | ||||||||||||||||||||||||
Meningitis/Pneumonia Vaccines (inc. Menactra®) | 5 | -54.5% | 407 | -11.4% | 101 | +25.6% | 14 | 0.0% | ||||||||||||||||||||||||
Adult Booster Vaccines (inc. Adacel®) | 54 | -3.6% | 345 | +5.2% | 33 | +32.0% | 17 | -20.0% | ||||||||||||||||||||||||
Travel and Other Endemics Vaccines | 18 | +20.0% | 80 | +11.6% | 235 | +15.8% | 49 | +21.2% | ||||||||||||||||||||||||
Other Vaccines | 16 | -63.2% | 128 | -10.4% | 15 | +0.0% | 10 | +22.2% | ||||||||||||||||||||||||
Total Vaccines | 282 | -15.6% | 1,958 | -11.5% | 1,386 | +46.2% | 182 | +23.0% |
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In addition to the Vaccines activity reflected in our consolidated net sales, sales at Sanofi Pasteur MSD, our joint venture with Merck & Co., Inc. in Europe, amounted to €918 million, down 18.9% on a reported basis. Sales generated by Sanofi Pasteur MSD are not included in our consolidated net sales. Sales of Gardasil®, a vaccine that prevents papillomavirus infections (a cause of cervical cancer), totaled €263 million in 2010, compared with €395 million in 2009. This decrease of 33.5% was mainly due to a reduction in catch-up vaccination programs.
Net Sales — Animal Health
The Animal Health business is carried out by Merial, which has been a wholly-owned subsidiary of Sanofi since September 18, 2009. Following the mutual termination by Sanofi and Merck of their agreement to create a new animal health joint venture, Merial’s results have since been included in the results from continuing operations for all periods reported (see note D.2. to our consolidated financial statements included at Item 18 of this annual report).
Merial generated net sales of €1,983 million in 2010, up 314.0% on a reported basis. 2009 net sales were consolidated from September 18, 2009. The following table presents the 2010 and 2009 sales of our Animal Health business by range of products:
(€ million) | 2010 Reported | 2009 Reported | Change on a Reported basis | |||||||||
Frontline® and other fipronil-based products | 774 | 195 | +296.9% | |||||||||
Vaccines | 627 | 131 | +378.6% | |||||||||
Avermectin | 355 | 90 | +294.4% | |||||||||
Other products | 227 | 63 | +260.3% | |||||||||
Total Animal Health | 1,983 | 479 | +314.0% |
The following table breaks down net sales of our Animal Health business products by geographical region in 2010:
(€ million) Product | 2010 Net sales | Western Europe (1) | United States | Emerging Markets (2) | Other countries (3) | |||||||||||||||
Frontline® and other fipronil-based products | 774 | 198 | 438 | 80 | 58 | |||||||||||||||
Vaccines | 627 | 191 | 129 | 288 | 19 | |||||||||||||||
Avermectin | 355 | 59 | 181 | 56 | 59 | |||||||||||||||
Other products | 227 | 94 | 74 | 34 | 25 | |||||||||||||||
Total Animal Health | 1,983 | 542 | 822 | 458 | 161 |
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Net Sales by Geographical Region
We divide our sales geographically into four regions: Western Europe, the United States, Emerging Markets and other countries. The following table breaks down our 2010 and 2009 net sales by region:
(€ million) | 2010 Reported | 2009 Reported | Change on a Reported basis | |||||||||
Western Europe (1) | 9,539 | 9,938 | -4.0% | |||||||||
United States | 9,790 | 9,573 | +2.3% | |||||||||
Emerging Markets (2) | 9,533 | 7,493 | +27.2% | |||||||||
Of which Eastern Europe and Turkey | 2,659 | 2,279 | +16.7% | |||||||||
Of which Asia (excl. Pacific region (3)) | 2,095 | 1,638 | +27.9% | |||||||||
Of which Latin America | 2,963 | 1,991 | +48.8% | |||||||||
Of which Africa | 880 | 782 | +12.5% | |||||||||
Of which Middle East | 825 | 658 | +25.4% | |||||||||
Other Countries (4) | 3,505 | 2,781 | +26.0% | |||||||||
Of which Japan | 2,275 | 1,871 | +21.6% | |||||||||
Total | 32,367 | 29,785 | +8.7% |
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Western Europe saw net sales decrease by 4.0% in 2010 to €9,539 million, hit by competition from generics of Plavix® and Taxotere®, and by price pressure from the healthcare authorities.
In the United States, net sales grew by 2.3% at €9,790 million, despite the arrival of generic competition for Lovenox® and Ambien® CR, the workdown of inventories of generic versions of Eloxatin® during the second half of 2010 and the effects of healthcare reform. These figures include net sales generated by Chattem from February 2010 and by Merial from September 18, 2009.
Emerging Markets net sales were €9,533 million, representing robust growth of 27.2%. This performance reflected solid organic growth and the impact of acquisitions (primarily Merial, Zentiva in Eastern Europe and Medley in Brazil). Emerging Markets accounted for 29.5% of total consolidated net sales in 2010. The main growth drivers were Latin America, Russia and China. In Latin America (primarily Brazil and Mexico), growth was fueled by sales of influenza vaccines, which virtually trebled (189% growth).
In the Other Countries region, net sales rose by 26.0% to €3,505 million. Net sales in Japan reached €2,275 million, up 21.6%, thanks largely to the success of Plavix®, the performance of the Vaccines business and the integration of Merial.
Worldwide Presence of Plavix® and Aprovel®
Two of our leading products — Plavix® and Aprovel® — were discovered by Sanofi and jointly developed with Bristol-Myers Squibb (“BMS”) under an alliance agreement. In all territories except Japan, these products are sold either by Sanofi or by BMS in accordance with the terms of this alliance agreement which is described in “— Financial Presentation of Alliances — Alliance arrangements with Bristol-Myers Squibb” above.
Worldwide sales of these two products are an important indicator because they facilitate a financial statement user’s understanding and analysis of our consolidated income statement, particularly in terms of understanding our overall profitability in relation to consolidated revenues, and also facilitate a user’s ability to understand and assess the effectiveness of our research and development efforts.
Also, disclosing sales made by BMS of these two products enables the users to have a clearer understanding of trends in different lines of our income statement, in particular the lines “Other revenues”, where we record royalties received on those sales (see “— Other Revenues”); “Share of profit/loss of associates and joint ventures” (see “— Share of Profit/Loss of Associates and Joint Ventures”), where we record our share of profit/loss of entities included in the BMS Alliance and under BMS operational management; and “Net income attributable to non-controlling interests” (see “— Net Income Attributable to Non-Controlling Interests”), where we record the BMS share of profit/loss of entities included in the BMS Alliance and under our operational management.
The table below sets forth the worldwide sales of Plavix® and Aprovel® in 2010 and 2009, by geographic region:
(€ million) | 2010 | 2009 | Change on a reported basis | Change at constant exchange rates | ||||||||||||||||||||||||||||
Sanofi (2) | BMS (3) | Total | Sanofi (2) | BMS (3) | Total | |||||||||||||||||||||||||||
Plavix®/Iscover®(1) | ||||||||||||||||||||||||||||||||
Europe | 724 | 98 | 822 | 1,443 | 161 | 1,604 | -48.8% | -49.2% | ||||||||||||||||||||||||
United States | — | 4,626 | 4,626 | — | 4,026 | 4,026 | +14.9% | +10.8% | ||||||||||||||||||||||||
Other countries | 1,165 | 282 | 1,447 | 897 | 255 | 1,152 | +25.6% | +13.7% | ||||||||||||||||||||||||
Total | 1,889 | 5,006 | 6,895 | 2,340 | 4,442 | 6,782 | +1.7% | -2.9% | ||||||||||||||||||||||||
Aprovel®/Avapro® /Karvea®/Avalide®(4) | ||||||||||||||||||||||||||||||||
Europe | 789 | 158 | 947 | 810 | 172 | 982 | -3.6% | -4.4% | ||||||||||||||||||||||||
United States | — | 482 | 482 | — | 524 | 524 | -8.0% | -10.4% | ||||||||||||||||||||||||
Other countries | 411 | 216 | 627 | 314 | 192 | 506 | +23.9% | +13.5% | ||||||||||||||||||||||||
Total | 1,200 | 856 | 2,056 | 1,124 | 888 | 2,012 | +2.2% | -1.5% |
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In the United States, sales of Plavix®/Iscover® (consolidated by BMS) grew by a robust 10.8% in 2010 to €4,626 million. Plavix® continued to perform well in Japan and China, where sales grew respectively by 37.1% (to €520 million) and by 36.6% (to €216 million) at constant exchange rates. These performances to some extent cushioned the effect of the decline in European sales of Plavix® (down 49.2% at constant exchange rates) caused by competition from generics.
Worldwide sales of Aprovel®/Avapro®/Karvea®/Avalide® were €2,056 million in 2010, down 1.5% at constant exchange rates. The performance in the Other Countries region, lifted by sales of active ingredient to our alliance partners in Japan, partially offset the drop in sales in the United States and Europe, where net sales fell by 10.4% and 4.4% respectively at constant exchange rates. At the end of 2010, sales were impacted by a voluntary recall of certain lots of Avalide® (irbesartan-hydrochlorothiazide) by Bristol-Myers Squibb and Sanofi from the U.S., Puerto Rican, Canadian, Mexican and Argentinean markets.
Other Revenues
Other revenues, which mainly comprise royalty income under licensing agreements contracted in connection with ongoing operations, totaled €1,669 million in 2010, 15.3% higher than the 2009 figure of €1,447 million.
This increase was mainly due to license revenues under the worldwide alliance with BMS on Plavix® and Aprovel®, which totaled €1,303 million in 2010 versus €1,155 million in 2009 (a 12.8% rise on a reported basis). These revenues were boosted by stronger sales of Plavix® in the United States (up 10.8% at constant exchange rates), and by favorable trends in the exchange rate of the U.S. dollar against the euro.
Gross Profit
Gross profit for the year ended December 31, 2010 came to €24,638 million (76.1% of net sales), 6.5% up on the 2009 figure of €23,125 million (77.6% of net sales).
The gross margin ratio of the Pharmaceuticals segment fell by 1.6 points, reflecting the net effect of increased royalty income (+0.6 of a point) and erosion in the ratio of cost of sales to net sales (-2.2 points). This erosion was mainly due to genericization (primarily Plavix® in Europe and Lovenox® in the United States) and higher raw material prices for heparins. Nevertheless, the 2010 gross margin ratio for the Pharmaceuticals segment remained healthy at 78.6%.
The gross margin ratio of the Vaccines segment rose by 1.9 points to 64.7%, driven by a 2.1-point improvement in the ratio of cost of sales to net sales, thanks mainly to cost efficiencies in the production of pandemic influenza vaccines.
The Animal Health segment recorded a gross margin ratio of €1 386 million in 2010, up 5.8 points to 69.9% due to product mix.
Consolidated gross profit was also dented by a €142 million charge in 2010 (0.4 of a point) arising from the workdown during 2010 of inventories remeasured at fair value in connection with acquisitions (principally Merial and Chattem), against €90 million in 2009 (0.3 of a point, principally Merial).
Research and Development Expenses
Research and development expenses amounted to €4,547 million in 2010 (14.0% of net sales), compared with €4,626 million in 2009 (15.5% of net sales). This represents a year-on-year reduction of 1.7% on a reported basis.
The Pharmaceuticals segment generated savings of 5.1% as a result of the reorganization initiated in 2009, which has helped reorient some in-house resources towards third-party collaborations. These savings also reflect a rationalization of R&D projects following a full, objective review of the portfolio. Research and development expenses in the Vaccines segment rose by €26 million year-on-year, an increase of 5.3%. Research and development expenses in the Animal Health segment amounted to €155 million in 2010, compared to €46 million in 2009 (for the period starting September 18, 2009).
Selling and General Expenses
Selling and general expenses amounted to €8,149 million (25.2% of net sales), an increase of 9.2% on the prior-year figure of €7,464 million (25.1% of net sales), reflecting the first-time consolidation of companies acquired in 2010 (primarily Chattem) and the impact of the Jevtana® and Multaq® launches. Excluding these impacts, selling and general expenses show a decrease, which reflects the transformation program initiated in 2009, and was mainly driven by savings in marketing costs in the United States and Europe, and in general expenses.
Other Operating Income and Expenses
Other operating income amounted to €369 million in 2010 (2009: €861 million), and other operating expenses totaled €292 million (2009: €481 million). Overall, other operating income and expenses represented net income of €77 million in 2010, compared with €380 million in 2009. The year-on-year decrease of €303 million was mainly due to the discontinuation of royalty payments from Teva on North American sales of Copaxone® from the second quarter of 2010.
In addition, Sanofi recorded a net operational foreign exchange loss of €141 million due to highly volatile currency markets; this compares with a net gain of €40 million in 2009.
Amortization of Intangible Assets
Amortization charged against intangible assets in the year ended December 31, 2010 amounted to €3,529 million, compared with €3,528 million in the previous year. An increase in amortization expense in North America, related to trends in the U.S. dollar/euro exchange rate and the Chattem acquisition, was offset by a reduction in Europe as some intangible assets reached the end of their useful lives.
This line item mainly comprises amortization charged against intangible assets remeasured at fair value on the acquisitions of Aventis (€3,070 million in 2010, versus €3,175 million in 2009) and of Zentiva (€130 million in 2010, versus €98 million in 2009).
Impairment of Intangible Assets
This line recorded impairment losses of €433 million in 2010, compared with €372 million in 2009. The losses booked in 2010 related mainly to (i) Actonel®, due to contemplated amendments to the terms of the collaboration agreement with Warner Chilcott; (ii) the pentavalent vaccine Shan5®, for which sales projections were revised to take account of the need to file a new application for WHO pre-qualification following a flocculation problem in some batches; (iii) the BSI-201 project, for which the development plan was revised following the announcement of the initial results from a Phase III trial in triple-negative metastatic breast cancer; and (iv) some of Zentiva’s generics and consumer health products, whose sales projections in Eastern Europe were adjusted downwards.
The net impairment loss of €372 million recognized in 2009 related mainly to Actonel®, Benzaclin® and Nasacort®, and reflected the changing competitive environment and the approval dates of generics.
Restructuring Costs
Restructuring costs amounted to €1,384 million in 2010, compared with €1,080 million in 2009.
In 2010, these costs mainly related to measures taken to adapt our industrial operations in France, and our sales and R&D functions in the United States and some European countries.
In 2009, restructuring costs mainly related to measures aimed at transforming R&D operations to encourage innovation, and adapting central support functions to streamline the organizational structure. They mainly comprised employee-related expenses, in the form of early retirement benefits and termination benefits under voluntary redundancy plans. To a lesser extent, they reflected ongoing measures to adapt our industrial facilities in Europe and adjust our sales forces.
Other Gains and Losses, and Litigation
In 2010, this line item reported an expense of €138 million, relating to an adjustment to vendor’s guarantee provisions in connection with past divestments.
We made no material divestments in 2010 or 2009.
Operating Income
Operating income for 2010 was €6,535 million, versus €6,435 million for 2009, an increase of 1.6%.
Financial Income and Expenses
Net financial expenses were €362 million in 2010, compared with €298 million in 2009, an increase of 21.5%.
Financial expenses directly related to net debt (defined as short-term and long-term debt, plus related interest rate and currency derivatives, minus cash and cash equivalents) were €325 million in 2010, versus €230 million in 2009. This year-on-year rise reflected the following factors:
an increase in the average interest rate (due to a longer average maturity), charged on a higher level of average consolidated debt;
a reduction in interest income, reflecting a lower average rate of return; and
the €34 million of financial expenses incurred on the acquisition credit facilities contracted in October 2010 in connection with the launch of the public tender offer for Genzyme (see “Item 8.B. Significant changes”).
Gains on disposals amounted to €61 million, mainly on the sale of the equity interest in Novexel.
Net foreign exchange losses on financial items totaled €20 million in 2010 (2009: €67 million).
Income before Tax and Associates and Joint Ventures
Income before tax and associates and joint ventures was €6,173 million in 2010, versus €6,137 million in 2009, an increase of 0.6%.
Income Tax Expense
Income tax expense totaled €1,430 million in 2010, compared with €1,399 million in 2009.
The effective tax rate is calculated on the basis of business operating income minus net financial expenses and before the share of profit/loss of associates and joint ventures and net income attributable to non-controlling interests. The effective tax rate was 27.8% in 2010, versus 28.2% in 2009. The difference relative to the standard income tax rate applicable in France in 2010 and 2009 (34.4%) was mainly due to royalty income being taxed at a reduced rate in France.
This line item also includes tax effects of amortization of intangible assets (€1,183 million in 2010, €1,130 million in 2009) and of restructuring costs (€466 million in 2010, €360 million in 2009).
Share of Profit/Loss of Associates and Joint Ventures
Our share of profits and losses from associates and joint ventures was €978 million in 2010, compared with €953 million in 2009. This line mainly includes our share of after-tax profits from territories managed by BMS under the Plavix® and Avapro® alliance, which rose by 24.8% from €785 million in 2009 to €980 million in 2010. This year-on-year increase was mainly related to stronger sales of Plavix® in the United States (up 10.8% at constant exchange rates) and to the appreciation of the U.S. dollar against the euro (positive impact of 3.7%).
Net Income
Net income for the year was €5,721 million in 2010, compared with €5,691 million in 2009.
Net Income Attributable to Non-Controlling Interests
Net income attributable to non-controlling interests amounted to €254 million in 2010, compared with €426 million in 2009. This line mainly comprises the share of pre-tax profits paid to BMS from territories managed by Sanofi (€238 million, versus €405 million in 2009). The decrease in net income attributable to non-controlling interests in 2010 was directly related to increased competition from generics of clopidogrel (Plavix®) in Europe.
Net Income Attributable to Equity Holders of Sanofi
Net income attributable to equity holders of Sanofi totaled €5,467 million in 2010, against €5,265 million in 2009.
Basic earnings per share for 2010 was €4.19, 4.0% higher than the 2009 figure of €4.03, based on an average number of shares outstanding of 1,305.3 million in 2010 and 1,305.9 million in 2009. Diluted earnings per share was €4.18 in 2010 compared with €4.03 in 2009, based on an average number of shares outstanding after dilution of 1,308.2 million in 2010 and 1,307.4 million in 2009.
Business Operating Income
Business operating income for 2010 was €12,863 million, compared to €12,076 million in 2009. The table below shows trends in business operating income by business segment for 2010 and 2009:
(€ million) | 2010 | 2009 | ||||||
Pharmaceuticals | 10,965 | 10,608 | ||||||
Vaccines | 1,379 | 1,173 | ||||||
Animal Health | 621 | 288 | ||||||
Other | (102 | ) | 7 | |||||
Business operating income | 12,863 | 12,076 |
Business Net Income
Business net income is a non-GAAP financial measure that we use to evaluate our Group’s performance (see “Item 5. Operating and Financial Review and Prospects — Business Net Income” above).
Business net income for 2010 was €9,215 million, an improvement of 6.8% on the 2009 figure of €8,629 million, and represented 28.5% of net sales compared with 29.0% in 2009. The increase was mainly due to our good operating performance, reflected in the increase in gross profit (€24,638 million in 2010 versus €23,125 million in 2009).
(€ million) | 2010 (1) | 2009 (1) | ||||||
Business net income | 9,215 | 8,629 | ||||||
(i) Amortization of intangible assets | (3,529 | ) | (3,528 | ) | ||||
(ii) Impairment of intangible assets | (433 | ) | (372 | ) | ||||
(iii) Fair value remeasurement of contingent consideration liabilities | — | — | ||||||
(iv) Expenses arising from the impact of acquisitions on inventories (2) | (142 | ) | (90 | ) | ||||
(v) Restructuring costs | (1,384 | ) | (1,080 | ) | ||||
(vi) Other gains and losses, and litigation (3) | (138 | ) | — | |||||
(vii) Impact of the non-depreciation of the property, plant & equipment of Merial (IFRS 5) | 77 | 21 | ||||||
(viii) Tax effects on the items listed above, comprising: | 1,856 | 1,644 | ||||||
- amortization of intangible assets | 1,183 | 1,130 | ||||||
- impairment of intangible assets | 143 | 136 | ||||||
- expenses arising from the impact of acquisitions on inventories | 44 | 24 | ||||||
- restructuring costs | 466 | 360 | ||||||
- other gains and losses, and litigation | 46 | — | ||||||
- non-depreciation of property, plant and equipment of Merial (IFRS 5) | (26 | ) | (6 | ) | ||||
(iv)/(ix) Other tax items (4) | — | 106 | ||||||
(x) Share of items listed above attributable to non-controlling interests | 3 | 1 | ||||||
(iv)/(v) Restructuring costs and expenses arising from the impact of acquisitions on associates and joint ventures (5) | (58 | ) | (66 | ) | ||||
Net income attributable to equity holders of Sanofi | 5,467 | 5,265 |
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Business Earnings Per Share
We also report business earnings per share, a non-GAAP financial measure which we define as business net income divided by the weighted average number of shares outstanding (see “— Business Net Income” above).
Business earnings per share for 2010 were €7.06, up 6.8% on the 2009 business earnings per share figure of €6.61. The weighted average number of shares outstanding was 1,305.3 million in 2010 and 1,305.9 million in 2009. Diluted business earnings per share for 2010 were €7.04, up 6.7% on the 2009 diluted business earnings per share figure of €6.60. On a diluted basis, the weighted average number of shares outstanding was 1,308.2 million in 2010 and 1,307.4 million in 2009.
Liquidity and Capital Resources
Our operations generate significant positive cash flows. We fund our day-to-day investments (with the exception of significant acquisitions) primarily with operating cash flow, and pay regular dividends on our shares. During the course ofIn addition, we reduced our net debt during 2012, whereas in 2011 our debt increased significantly increased to finance the acquisition of Genzyme.
We define "debt, net of cash and cash equivalents" as (i) the sum total of short-term debt, long-term debt and interest rate and currency derivatives used to hedge debt, minus (ii) the sum total of cash and cash equivalents and interest rate and currency derivatives used to hedge cash and cash equivalents. As of December 31, 2011,2012, our debt, net of cash and cash equivalents stood at €7,719 million versus €10,859 million (19.3%as of our net equity) versusDecember 31, 2011 and €1,577 million as of December 31, 2010 (3.0% of our net equity) and €4,128 million as of December 31, 2009 (8.5% of our net equity).2010. See Note D.17. to our consolidated financial statements included at Item 18 of this annual report.
In order to assess the Company's financing risk, we also use the "gearing ratio", a non-GAAP financial measure. The gearing ratio is defined as the ratio of debt, net of cash and cash equivalents, to total equity. As of December 31, 2012, our gearing ratio stood at 13.4% of our net equity versus 19.3% as of December 31, 2011 and 3.0% as of December 31, 2010.
Consolidated Statement of Cash Flows
The table below shows our summarized cash flows for the years ended December 31, 2012, 2011 2010 and 2009:2010:
(€ million) | 2012 | 2011 | 2010 | |||||||
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Net cash provided by / (used in) operating activities | 8,171 | 9,319 | 9,859 | |||||||
Net cash provided by / (used in) investing activities | (1,587 | ) | (14,701 | ) | (3,475 | ) | ||||
Net cash provided by / (used in) financing activities | (4,351 | ) | 2,893 | (4,646 | ) | |||||
Impact of exchange rates on cash and cash equivalents | 24 | 1 | 55 | |||||||
Impact of the cash and cash equivalents of Merial (1) | — | 147 | — | |||||||
Net change in cash and cash equivalents — (decrease) / increase | 2,257 | (2,341 | ) | 1,793 | ||||||
(€ million) | 2011 | 2010 | 2009 | |||||||||
Net cash provided by / (used in) operating activities | 9,319 | 9,859 | 8,602 | |||||||||
Net cash provided by / (used in) investing activities | (14,701 | ) | (3,475 | ) | (7,327 | ) | ||||||
Net cash provided by / (used in) financing activities | 2,893 | (4,646 | ) | (788 | ) | |||||||
Impact of exchange rates on cash and cash equivalents | 1 | 55 | 27 | |||||||||
Impact of the cash and cash equivalents of Merial (1) | 147 | — | — | |||||||||
Net change in cash and cash equivalents — (decrease) / increase | (2,341 | ) | 1,793 | 514 |
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Generally, factors that affect our earnings — for example, pricing, volume, costs and exchange rates — flow through to cash from operations. The most significant source of cash from operations is sales of our branded pharmaceutical products and human vaccines. Receipts of royalty payments also contribute to cash from operations.
Year Ended December 31, 20112012 Compared with Year Ended December 31, 20102011
Net cash provided by operating activities totaled amounted to €8,171 million in 2012, compared with €9,319 million in 2011, compared with €9,859 million in 2010. In 2011, operating2011. Operating cash flow before changes in working capital was €8,503 million, versus €9,834 million in 2011. This decrease was largely attributable to erosion in revenues from the territories managed by BMS under the alliance on Plavix® and Avapro®, due to competition from generics in the United States. This revenue erosion was reflected in a reduced share of after-tax profits from these territories (€420 million, versus €10,024€1,070 million in 2010.2011) and lower license revenue from the worldwide alliance with BMS on Plavix® and Aprovel®/Avapro® (€532 million in 2012, versus €1,275 million in 2011).
Our operating cash flow before changes in working capital is generally affected by the same factors that affect “Operating income”"Operating income", which is discussed in detail above under “Results"Results of Operations — Year Ended December 31, 20112012 Compared with Year Ended December 31, 2010” and “Results of Operations — Year Ended December 31, 2010 Compared with Year Ended December 31, 2009”. The principal difference is that operating cash flow before changes in working capital reflects our share of the profits and losses of associates and joint ventures, net of dividend and similar income received.
Working capital requirements rose by €515 million in 2011, compared with an €165 million increase in 2010. The 2011 increase was related to increased inventories (€232 million) and trade receivables (€257 million), following the consolidation of Genzyme and Merial.
Net cash used in investing activities totaled €14,701 million in 2011, versus €3,475 million in 2010.
Acquisitions of property, plant and equipment and intangible assets amounted to €1,782 million (compared with €1,662 million in 2010) and included Genzyme investments from April 2011. These mainly corresponded to investments in industrial and research facilities (1,394 million compared with €1,261 million in 2010) as well as contractual payments for intangible rights under licensing or collaboration agreements (€182 million versus €312 million in 2010).
Financial investments for 2011 totaled €13,616 million, net of cash from acquired companies. Including assumed liabilities and commitments, these were valued at €14,079 million and regarded mainly the acquisition of Genzyme (€13,602 million) and BMP Sunstone (€374 million). In 2010, financial investments were €1,733 million net of acquired cash; they were valued, after including assumed liabilities and commitments, at €2,130 million, primarily covering the acquisition of equity interests in Chattem (€1,640 million) and Nepentes (€104 million).
After-tax proceeds from disposals amounted to €359 million, coming mainly from the sale of the Dermik dermatology business (€321 million). In 2010, proceeds from disposals accounted for €136 million net of taxes, mainly from the sale divestment of the equity interest in Novexel (€48 million) and on the disposal of various tangible assets (€55 million).
Net cash used in financing activities yielded a positive balance in 2011 of €2,893 million, compared with a negative balance in 2010 of €4,646 million. In 2011, these specifically included €5,283 million in outside funding (net change in short-term and long-term debt) compared with €1,165 million in debt repayments in 2010, our dividend payout of €1,372 million to Sanofi shareholders (versus €3,131 million in 2010), and the acquisition of 21.7 million of our own shares for €1,074 million.
After the impact of exchange rates and the impact of the cash and cash equivalents of Merial, the net change in cash and cash equivalents during 2011 was a decline of €2,341 million, versus a €1,793 million increase in 2010.
Year Ended December 31, 2010 Compared with Year Ended December 31, 2009
Net cash provided by operating activities amounted to €9,859 million in 2010, compared with €8,602 million in 2009. Operating cash flow before changes in working capital was €10,024 million, versus €9,384 million in 2009, reflecting our operating performance.
Our operating cash flow before changes in working capital is generally affected by the same factors that affect “Operating income”, which is discussed in detail above under “Results of Operations — Year Ended December 31, 2010 Compared with Year Ended December 31, 2009” and “Results of Operations — Year Ended December 31, 2009 Compared with Year Ended December 31, 2008”2011". The principal difference is that operating cash flow before changes in working capital reflects our share of the profits and losses of associates and joint ventures, net of dividend and similar income received.
Working capital requirements rose by €165€332 million in 2010, compared with2012, after an €782increase of €515 million in 2011. The increase during 2012 was mainly attributable to an increase in 2009. The main factor in 2010 was a €386inventories (€445 million, rise inincluding €315 million for reconstituting inventories partly offset byat the discontinuation of royalty payments from Teva on North American sales of Copaxone® (impact: €126 million) and the integration of Merial’s net current liabilities.Genzyme business).
Net cash used in investing activities amounted to €1,587 million in 2012, versus €14,701 million in 2011.
Acquisitions of property, plant and equipment and intangible assets totaled €1,612 million (2011: €1,782 million). The main items were investments in industrial and research facilities (€1,324 million, versus €1,394 million in 2011) and contractual payments for intangible rights under license and collaboration agreements (€293 million, versus €245 million in 2011).
Acquisitions of investments in the period amounted to €328 million, net of cash acquired and after including assumed liabilities and commitments. The main items were a payment of contingent consideration to Bayer arising from the acquisition of Genzyme, the repurchase of some of the CVRs issued in connection with that acquisition, the acquisitions of Pluromed and Newport, and the purchase of an equity interest in Merrimack. In 2011, acquisitions of investments amounted to €13,616 million; after including assumed liabilities and commitments, they totaled €14,079 million, and mainly comprised the acquisitions of Genzyme (€13,602 million) and BMP Sunstone (€374 million).
After-tax proceeds from disposals (€358 million) related to divestitures of financial assets (in particular, our equity interests in Société Financière des Laboratoires de Cosmétologie Yves Rocher and Handok), and to disposals of various items of property, plant and equipment and intangible assets. In 2011, proceeds from disposals came to €359 million, mainly generated by the divestiture of the Dermik dermatology business (€321 million).
Financing activities generated a net cash outflow of €4,351 million in 2012, compared with a net cash inflow of €2,893 million in 2011. The 2012 figure includes €615 million of debt repayments (net change in short-term and long-term debt), as compared with net external debt raised of €5,283 million in 2011; it also includes the Sanofi dividend payout of €3,487 million (versus €1,372 million in 2011).
After the impact of exchange rates and of the cash and cash equivalents of Merial, the net change in cash and cash equivalents in 2012 was an increase of €2,257 million, compared with a decrease of €2,341 million in 2011.
Year Ended December 31, 2011 Compared with Year Ended December 31, 2010
Net cash provided by operating activities totaled €9,319 million in 2011, compared with €9,859 million in 2010. In 2011, operating cash flow before changes in working capital was €9,834 million, versus €10,024 million in 2010.
Our operating cash flow before changes in working capital is generally affected by the same factors that affect "Operating income", which is discussed in detail above under "Results of Operations — Year Ended December 31, 2011 Compared with Year Ended December 31, 2010". The principal difference is that operating cash flow before changes in working capital reflects our share of the profits and losses of associates and joint ventures, net of dividend and similar income received.
Working capital requirements rose by €515 million in 2011, compared with a €165 million increase in 2010. The 2011 increase was related to increased inventories (€232 million) and trade receivables (€257 million), following the first-time consolidation of Genzyme and Merial.
Net cash used in investing activities totaled €14,701 million in 2011, versus €3,475 million in 2010, versus €7,327 million in 2009.2010.
Acquisitions of property, plant and equipment and intangible assets amounted to €1,782 million (compared with €1,662 million (2009: €1,826 million), comprising €1,350 million ofin 2010) and included Genzyme investments from April 2011. The main items were investments in industrial and research facilities and €312(€1,394 million, ofcompared with €1,261 million in 2010) and contractual payments for intangible rights under licensing or collaboration agreements.
Financial Acquisitions of investments duringfor 2011 totaled €13,616 million, net of cash from acquired companies. After including assumed liabilities and commitments, they amounted to €14,079 million. The main items were the acquisitions of Genzyme (€13,602 million) and BMP Sunstone (€374 million). In 2010, totaledfinancial investments were €1,733 million, net of acquired cash; after including assumed liabilities and commitments, these acquisitions were valued atthey amounted to €2,130 million. Our main investment during 2010 wasmillion, and mainly comprised the acquisition of equity interestinterests in Chattem (€1,640 million). In 2009, acquisitions of investments were €5,568 million, net of acquired cash; after including assumed liabilities and commitments, these acquisitions were valued at €6,334 million. Our main investments in 2009 were the equity interests in MerialNepentes (€2,829104 million), Zentiva (€1,752 million), Shantha, Medley, and BiPar..
After-tax proceeds from disposals amounted to €359 million, mainly from the divestiture of the Dermik dermatology business (€321 million). In 2010, after-tax proceeds from disposals were €136 million, arising mainly onfrom the divestment of the equity interest in Novexel (€48 million) and on the disposal of various items of property, plant and equipment (€55 million). In 2009, after-tax proceeds from disposals were €87
Financing activities generated a net cash inflow of €2,893 million mainly on disposalsin 2011, versus a net cash outflow of intangible assets, some of which were required as conditions for clearance of our acquisition of Zentiva.
Net cash used in financing activities amounted to €4,646 million in 2010, versus €7882010. In 2011, financing cash inflows included €5,283 million in 2009.
The 2010 figure includes our dividend payout of €3,131 million (2009: €2,872 million), plus net repayments of debtexternal funding raised (net change in short-term and long-term debt), as opposed to 2010 which saw net debt repayments of €1,165 million. Cash outflows included the dividend payout of €1,372 million to Sanofi shareholders (versus a net €1,922€3,131 million of new debt contracted in 2009). It also includes2010), and the acquisition of 5.921.7 million of our own shares for €321€1,074 million.
After the impact of exchange rates and the impact of the cash and cash equivalents of Merial, the net change in cash and cash equivalents during 20102011 was an increasea decline of €2,341 million, versus a €1,793 million compared with an increase of €514 million in 2009.2010.
Consolidated Balance Sheet and Debt
Total assets stood at €100,165€100,407 million as of December 31, 2012, versus €100,668 million as of December 31, 2011, compared with €85,264 million asa decrease of December 31, 2010, an increase of €14,901€261 million.
Ourdebt, net of cash and cash equivalents was €10,859 million as of December 31, 2011, versus €1,577 million as of December 31, 2010. We define “debt, net of cash and cash equivalents” as short-term and long-term debt, plus related interest rate and currency derivatives, minus cash and cash equivalents. Debt, net of cash and cash equivalents is a non-GAAP financial measure that is used by management and investors(see definition above) amounted to measure the Company’s overall net indebtedness and to assess the Company’s financing risk€7,719 million as measured by its gearing ratio (debt, net of cash and cash equivalents, to total equity). See Note D.17. to our consolidated financial statements included at Item 18December 31, 2012, compared with €10,859 million as of this annual report.
December 31, 2011. The table below shows our financial position for the years ended December 31, 2012, 2011 2010 and 2009:2010:
(€ million) | 2012 | 2011 | 2010 | |||||||
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Long-term debt | 10,719 | 12,499 | 6,695 | |||||||
Short-term debt and current portion of long-term debt | 3,812 | 2,940 | 1,565 | |||||||
Cash and cash equivalents | (6,381 | ) | (4,124 | ) | (6,465 | ) | ||||
Related interest rate and currency derivatives | (431 | ) | (456 | ) | (218 | ) | ||||
Debt, net of cash and cash equivalents | 7,719 | 10,859 | 1,577 | |||||||
(€ million) | 2011 | 2010 | 2009 | |||||||||
Long-term debt | 12,499 | 6,695 | 5,961 | |||||||||
Short-term debt and current portion of long-term debt | 2,940 | 1,565 | 2,866 | |||||||||
Cash and cash equivalents | (4,124 | ) | (6,465 | ) | (4,692 | ) | ||||||
Related interest rate and currency derivatives | (456 | ) | (218 | ) | (7 | ) | ||||||
Debt, net of cash and cash equivalents | 10,859 | 1,577 | 4,128 |
TheOur gearing ratio (debt, net of cash and cash equivalents as a proportion of total equity) rosefell from 3.0% on19.3% in 2011 to 13.4% in 2012. Analyses of debt as of December 31, 2010 to 19.3% on2012 and December 31, 2011; this change was due to financing arrangement for the Genzyme acquisition in the first half of 2011. For an analysis of our debt2011, by type, maturity, interest rate and currency, as of December 31, 2011 and December 31, 2010, refer toare provided in Note D.17. to our consolidated financial statements.
The financing arrangements in place as of December 31, 20112012 at the Sanofi parent company level are not subject to covenants regarding financial ratios and do not contain any clauses linking credit spreads or fees to our credit rating. Under the Bridge Facility, the margin above Libor and mandatory costs may vary under Facility B as a function of our credit rating (see Item 10.C. hereof for further information).
Other key movements in balance sheet items are described below.
Total equity stood at €56,389€57,472 million as of December 31, 2011, compared with €53,2882012, versus €56,373 million a year earlier.as of December 31, 2011. The main factors underlying this net year-on-year increase were as follows:in equity was attributable primarily to:
reductions: dividend payments to our shareholders (payment of dividends for fiscal year 2010 of €3,262 million).
As of December 31, 2011, Sanofi2012, we held 17.23.1 million of itsour own shares, recorded as a deduction from equity and representing 1.3%0.2% of the share capital.
Goodwill and other intangible assets (€61,718 million) increased58,265 million in total) decreased by €17,307€3,956 million, compared to a year earlier, mainlylargely as a result of amortization and impairment losses recognized in the following factors:
increases:period (€3,516��million) and a decline in the impact of company acquisitions (€4,361 million of goodwill, and €10,446 million of other intangible assets), mainly Genzyme, the reclassification of Merial’s assets previously reported as held for sale or exchange (€1,210 million of goodwill and €3,979 million of other intangible assets), and the euro revaluationequivalent value in euros of assets denominated in other currencies (€1,276611 million, primarily onmainly relating to the U.S. dollar);.
reductions: amortization and impairment losses for the period (€3,976 million).
Provisions and other non-current liabilities (€10,34611,036 million) were €1,020rose by €690 million, higher than at the previous year-end,due mainly due to thea net increase in actuarial gains and losses associated with provisions for pensions and other benefits (€677 million), the impact of the recent consolidation€874 million, primarily as a result of new companies (Genzyme and BMP Sunstone) and the reclassification of Merial’s provisions previously reported as assets held for sale or exchange.actuarial losses on defined-benefit plans.
Net deferred tax liabilities (€2,3781,555 million) were up €1,621fell by €1,342 million in 2011; they increased on the one handyear-on-year, primarily due to the consolidation of new companies, mainly Genzyme and Merial, and decreased on the other hand from the reversal of deferred tax liabilities associated withrelating to the amortization and impairmentremeasurement of acquired intangible assets (€1,5295,641 million in 2012 versus €6,815 million in 2011, a difference of €1,174 million).
LiabilitiesCurrent and non-current liabilities related to business combinations and to non-controlling interests both current and non-current, (€1,5561,450 million) increased by €1,070were €106 million duelower. The main factors were the reversal of the contingent consideration relating to the 2011 recognition of a price considerationFovea acquisition, payments to Bayer (relating to contingent consideration arising from our acquisition of Genzyme), and the repurchase (for $70 million) of some of the contingent value rights (CVR) resulting from(CVRs) issued in connection with the acquisitionGenzyme acquisition. These factors were partly offset by the effect of Genzymefair value remeasurements (see Note D.18. to our consolidated financial statements).
The change in net assets held for sale or exchange (€47 million versus €5,364 million as of December 31, 2010) was related to the reclassification of Merial’s net assets (€5,347 million) to each line item on the balance sheet based on its type (see Note D.8.1. to our consolidated financial statements).
We expect that our existing cash resources and cash from operations will be sufficient to finance our foreseeable working capital requirements. At year-end 2011,2012, we held cash and cash equivalents amounting to €4,124€6,381 million, substantially all of which were held in euros (see Note D.13. to our consolidated financial statements). As at December 31, 2011, €4602012, €507 million of our cash and cash equivalents were held by our captive insurance and reinsurance companies in accordance with insurance regulations.
Since the beginning of 2010, certainsome countries in Southern European countriesEurope have encountered increasingfaced severe financial difficulties, particularly Greece and Portugal, where part of our customers are government-owned or supported healthcare facilities.difficulties. Deteriorating credit and economic conditions and other factors in these countries have resulted in, and may continue to result in an increase in the average length of time taken to collect theseour accounts receivable in these countries and may require us to re-evaluate the collectability of these receivables in future periods. We carefully monitor sovereign debt issues and economic conditions and evaluate accounts receivable in these countries for potential collection risks. We are conducting an active recovery policy, adapted to each country and including intense communication with customers, negotiations of payments plans, charging of interest for late payments, and legal action. See
“Item "Item 3.D. RisksRisk Factors — Risks Relating to Our Business — We are subject to the risk of non-payment by our customers”customers" and “—"— Impairment charges or write downs in our books and changes in accounting standards could have a significant adverse effect on the Group’sGroup's results of operations and financial results”results". During 2012, the amount of our trade receivables in Europe decreased, primarily as a result of a reduction in the sums owed to us by public-sector customers in Spain due to payments received. The total consolidated amount of trade receivables overdue by more than 12 months — which primarily consists of amounts due from public-sector customers — fell from €276 million as of December 31, 2011 to €161 million as of December 31, 2012 due to payments received (see Note D.10. to our consolidated financial statements included at Item 18 of this annual report).
In November 2011, Sanofi obtained the necessary corporate authorizations to purchase any or all of the outstanding Contingent Value Rights ("CVR") and subsequently purchased CVRs in 2011. In 2012 following a tender offer initiated in September 2012 on the basis of the same corporate authorization, Sanofi purchased an additional 40,025,805 CVRs (for a total consideration of approximately $70 million). As of December 31, 2012, 249,196,371 CVRs were outstanding out of 291,313,510 issued at the time of the Genzyme acquisition.
At year-end 2011,2012, we had no commitments for capital expenditures that we consider to be material to our consolidated financial position. Undrawn confirmed credit facilities amounted to a total of €10.0 billion at December 31, 2011.2012. For a discussion of our treasury policies, see “Item"Item 11. Quantitative and Qualitative Disclosures about Market Risk.”"
In November 2011, Sanofi obtained the necessary corporate authorizations to purchase any or all of the outstanding Contingent Value Rights (“CVR”). As of December 31, 2011, Sanofi had purchased 2,120,897 CVRs (for a total consideration of $2.6 million) out of 291,313,510 issued at the time of the Genzyme acquisition.
We expect that cash from our operations will be sufficient to repay our debt. For a discussion of our liquidity risks, see “Item"Item 11. Quantitative and Qualitative Disclosures about Market Risk.”
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Off-Balance Sheet Arrangements / Contractual Obligations and Other Commercial Commitments
We have various contractual obligations and other commercial commitments arising from our operations. Our contractual obligations and our other commercial commitments as of December 31, 20112012 are shown in Notes D.3., D.17., D.18. and D.21. to our consolidated financial statements included at Item 18 of this annual report. Note D.21. to our consolidated financial statements included at Item 18 discloses details of commitments under our principal research and development collaboration agreements. For a description of the principal contingencies arising from certain business divestitures, refer to Note D.22.e) to our 20112012 consolidated financial statements.
The Group’sGroup's contractual obligations and other commercial commitments are set forth in the table below:
December 31, 2012 | Payments due by period | |||||||||||||||
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(€ million) | Total | Under 1 year | From 1 to 3 years | From 3 to 5 years | Over 5 years | |||||||||||
• Future contractual cash-flows relating to debt and debt hedging instruments (1) | 15,283 | 3,959 | 4,165 | 4,106 | 3,053 | |||||||||||
• Operating lease obligations | 1,296 | 250 | 367 | 220 | 459 | |||||||||||
• Finance lease obligations (2) | 100 | 20 | 36 | 31 | 13 | |||||||||||
• Irrevocable purchase commitments (3) | ||||||||||||||||
- given | 2,913 | 1,513 | 651 | 368 | 381 | |||||||||||
- received | (209 | ) | (106 | ) | (67 | ) | (14 | ) | (22 | ) | ||||||
• Research & development license agreements | ||||||||||||||||
- Future service commitments (4) | 767 | 181 | 286 | 276 | 24 | |||||||||||
- Potential milestone payments (5) | 2,201 | 149 | 267 | 295 | 1,490 | |||||||||||
• Obligations relating to business combinations (6) | 4,993 | 341 | 1,135 | 560 | 2,957 | |||||||||||
• Firm commitment related to the BMS agreement (7) | 82 | — | — | — | 82 | |||||||||||
• Estimated benefit payments on unfunded pensions and post employment benefits (8) | 1,741 | 60 | 115 | 133 | 1,433 | |||||||||||
Total contractual obligations and other commitments | 29,167 | 6,367 | 6,955 | 5,975 | 9,870 | |||||||||||
Undrawn general-purpose credit facilities | 10,021 | 3,020 | 225 | 6,775 | 1 | |||||||||||
December 31, 2011 | Payments due by period | |||||||||||||||||||
(€ million) | Total | Under 1 year | From 1 to 3 years | From 3 to 5 years | Over 5 years | |||||||||||||||
• Future contractual cash-flows relating to debt and debt hedging instruments (1) | 16,495 | 3,121 | 6,496 | 3,680 | 3,198 | |||||||||||||||
• Operating lease obligations | 1,456 | 284 | 406 | 245 | 521 | |||||||||||||||
• Finance lease obligations (2) | 123 | 19 | 40 | 35 | 29 | |||||||||||||||
• Irrevocable purchase commitments (3) | ||||||||||||||||||||
- given | 3,041 | 1,672 | 608 | 325 | 436 | |||||||||||||||
- received | (247 | ) | (105 | ) | (76 | ) | (42 | ) | (24 | ) | ||||||||||
• Research & development license agreements | ||||||||||||||||||||
- Future service commitments (4) | 944 | 196 | 307 | 416 | 25 | |||||||||||||||
- Potential milestone payments (5) | 2,822 | 175 | 297 | 444 | 1,906 | |||||||||||||||
• Obligations relating to business combinations(6) | 5,578 | 496 | 1,144 | 718 | 3,220 | |||||||||||||||
Ÿ Estimated benefit payments on unfunded pensions and post employment benefits(7) | 1,453 | 64 | 121 | 140 | 1,128 | |||||||||||||||
Total contractual obligations and other commitments | 31,665 | 5,922 | 9,343 | 5,961 | 10,439 | |||||||||||||||
Undrawn general-purpose credit facilities | 10,046 | 3,046 | — | 7,000 | — |
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We may have payments due to our current or former research and development partners under collaborative agreements. These agreements typically cover multiple products, and give us the option to participate in development on a product-by-product basis. When we exercise our option with respect to a product, we pay our collaboration partner a fee and receive intellectual property rights to the product in exchange. We are also generally required to fund some or all of the development costs for the products that we select, and to make payments to our partners when those products reach development milestones.
We have entered into collaboration agreements under which we have rights to acquire products or technology from third parties through the acquisition of shares, loans, license agreements, joint development, co-marketing and other contractual arrangements. In addition to upfront payments on signature of the agreement, our contracts frequently require us to make payments contingent upon the completion of development milestones by our alliance partner or upon the granting of approvals or licenses.
Because of the uncertain nature of development work, it is impossible to predict (i) whether Sanofi will exercise further options for products, or (ii) whether the expected milestones will be achieved, or (iii) the number of compounds that will reach the relevant milestones. It is therefore impossible to estimate the maximum aggregate amount that Sanofi will actually pay in the future under existing collaboration agreements.
Given the nature of its business, it is highly unlikely that Sanofi will exercise all options for all products or that all milestones will be achieved.
The main collaboration agreements relating to development projects in the Pharmaceuticals segment are described below. Milestone payments relating to development projects under these agreements amounted to €2.1€2.0 billion in 2011.2012. These exclude projects in the research phase (€4.25.0 billion in 2012, €4.2 billion in 2011) and payments contingent upon the attainment of sales targets once a product is on the market ((€4.7 billion in 2012, €4.4 billion in 2011).
Following the
Sanofi has also entered into the following major agreements, which are currently in a less advanced research phase:
In
December 2010: an exclusive global licensing option with Oxford BioTherapeutics for three existing antibodies, plus a research and collaboration agreement to discover and validate new targets in oncology.
|
In the Vaccines segment, Sanofi Pasteur has entered into a number of collaboration agreements. Milestone payments relating to development projects under those agreements amounted to €0.3€0.2 billion in 2011.
In December 2009, Sanofi Pasteur signed a donation letter to the World Health Organization (WHO). The terms of the agreement committed Sanofi Pasteur to donate 10% of its future output of vaccines against A(H1N1), A(H5N1) or any other influenza strain with pandemic potential, up to a maximum of 100 million doses. Since this agreement was put in place, Sanofi Pasteur has already donated to the WHO some of the doses covered by the commitment.
Critical accounting and reporting policies
Our consolidated financial statements are affected by the accounting and reporting policies that we use. Certain of our accounting and reporting policies are critical to an understanding of our results of operations and financial condition, and in some cases the application of these critical policies can be significantly affected by the estimates, judgments and assumptions made by management during the preparation of our consolidated financial
statements. The accounting and reporting policies that we have identified as fundamental to a full understanding of our results of operations and financial condition are the following:
We offer various types of price reductions on our products. In particular, products sold in the United States are covered by various programs (such as Medicare and Medicaid) under which products are sold at a discount. Rebates are granted to healthcare authorities, and under contractual arrangements with certain customers. Some wholesalers are entitled to charge backchargeback incentives based on the selling price to the end customer, under specific contractual arrangements. Cash discounts may also be granted for prompt payment. The discounts, incentives and rebates described above are estimated on the basis of specific contractual arrangements with our customers or of specific terms of the relevant regulations and/or agreements applicable for transactions with healthcare authorities, and of assumptions ofabout the attainment of sales targets. They are recognized in the period in which the underlying sales are recognized, as a reduction of sales revenue. We also estimate the amount of product returns, on the basis of contractual sales terms and reliable historical data; the same recognition principles apply to sales returns. For additional details regarding the financial impact of discounts, rebates and sales returns, see Note D.23. to our consolidated financial statements included at Item 18 of this annual report.
Non-product revenues, mainly comprising royalty income from license arrangements that constitute ongoing operations of the Group, are presented in “Other revenues”"Other revenues".
of intangible assets and property, plant and equipment" to our consolidated financial statements included at Item 18 of this annual report.
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Depending on the discount rate used, the pension and post-retirement benefit expense could vary within a range of outcomes and have a material effect on equity because in applying IAS 19 (Employee Benefits), we have elected to recognize all actuarial gains and losses (including the impact of a change in discount rate) immediately through equity. A sensitivity analysis to discount rate is performedset forth in Note D.19.1. “Provisions"Provisions for pensions and other benefits”benefits" to our consolidated financial statements included at Item 18 of this annual report.
Depending on the expected long term rate of return on plan assets used, the pension and post-retirement benefit expense could vary within a range of outcomes and have a material effect on reported earnings. A sensitivity analysis to expected long term rate of return is performedset forth in Note D.19.1. “Provisions"Provisions for pensions and other benefits”benefits" to our consolidated financial statements included at Item 18 of this annual report. As indicated in Note B.28.1. to our consolidated financial statements, the amended IAS 19 issued by the IASB in June 2011 will be applicable as from January 1, 2013 to our consolidated financial statements. The comparative periods presented in the 2013 financial statements will require retrospective application of the new standard. The application of this change would have reduced business net income by €47 million in 2011 and by €78 million in 2012. The impact of this change on shareholders' equity would have been negligible.
Provisions are estimated on the basis of events and circumstances related to present obligations at the balance sheet date, of past experience, and to the best of management’smanagement's knowledge at the date of preparation of the financial statements. The assessment of provisions can involve a series of complex judgments about future events and can rely heavily on estimates and assumptions. Given the inherent uncertainties related to these estimates and assumptions, the actual outflows resulting from the realization of those risks could differ from our estimates.
Item 6. Directors, Senior Management and Employees
A. Directors and Senior Management
The offices of Chairman and Chief Executive Officer have been separated since January 1, 2007. While this decision was initially adopted out of a desire to ensure an orderly succession in light of the scheduled departure of Jean-François Dehecq, who was nearing the mandatory age limit set in the Company’s Articles of Association, theThe annual evaluations conducted since have indicated that this governance structure is suitableappropriate to the Group’sGroup's current configuration. This arrangement was thustherefore continued with the appointment of Serge Weinberg to the office of Chairman on May 17, 2010 and again with his reappointment on May 6, 2011. The Board of Directors considers that this governance structure is appropriate in the Group’sGroup's current context.
TheChairman represents the Board of Directors. The ChairmanDirectors, organizes and directs the work of the Board, and is responsible for ensuring the proper functioning of the corporate decision-making bodies in compliance with good governance practices. The Chairman coordinates the work of the Board of Directors with its Committees. The Chairman is accountable to the Shareholders’Shareholders' General Meeting, which he presides.chairs.
When the offices of Chairman and Chief Executive Officer are separated, the Chairman may remain in office until the Ordinary Shareholders’Shareholders' General Meeting called to approve the financial statements held during the calendar year in which he reaches the age of 70.
The Board of Directors has not deemed it necessary to appoint a lead independent director, since suchthis role has been broadly assumed by Serge Weinberg. No elementfactor other than his chairmanshiprole as Chairman is of a nature which puts into questionliable to undermine his independence, in particularespecially given that prior to joining the Board Serge Weinberg did not have any tieshe had no links to Sanofi.
TheChief Executive Officer is responsible for the management of the Company, and represents the Company in dealings with third parties within the limit of the corporate purpose. The Chief Executive Officer has the broadest powers to act in all circumstances in the name of the Company, subject to the powers that are attributed by law to the Board of Directors and the Shareholders’Shareholders' General Meeting and within the limits set by the Board of Directors.
The Chief Executive Officer must be no more than 65 years old.
Limitations toon the powers of the Chief Executive Officer set by the Board
The Board of Directors Meeting of July 28, 2009 set limits on the powers of the Chief Executive Officer. The prior authorization of the Board of Directors is required to commit Sanofi to investments, acquisitions and divestments in the following cases:
When the consideration payable to the contracting parties for such undertakings includes potential installment payments subject tocontingent upon the achievement of future results or objectives, such as the registration of one or more products, the caps are calculated by addingaggregating the various payments due from signature of the contract until (and including) filing of the first application for marketing authorization in the United States or in Europe.
The Company is administered by a Board of Directors, comprised currently ofcomprising fifteen members.
Since May 14, 2008, the terms of office of the directors have been staggered, in order to ensure that the directors are progressively re-elected between 2010 and 2012.re-elected.
Each year, the Board of Directors conducts a review to ensure that there is an appropriate balance in its composition and the composition of its Committees, inCommittees. In particular, the Board seeks to ensure a balanced
representation of men and women and diversity of background and country of origin, since the business of the Group is both diversified and global. The Board also investigates and evaluates the potential candidates as well as each timewhenever individual directors are up for election. Above all, the Board seeks talented directors, who show independence of mind and who are competent, presentdedicated and involved.committed.
Under the terms of the AFEP-MEDEF corporate governance code (hereafter referred to as the "AFEP-MEDEF Code"), a director is deemed to be independent when the director has no relationship of any nature whatsoever with the Company, the group it belongs to or its senior management which could compromise the exercise of the director’sdirector's freedom of decision. More specifically, independent directors are required:
The influence of other factors such as length of service on the Board, the ability to understand challenges and risks, and the courage to express ideas and form a judgment, is also evaluated before a director qualifies as independent.
In conformitycompliance with theour Board Charter and pursuant to the AFEP-MEDEF corporate governance code,Code, a discussion as to the independence of the current directors took place during the meeting of the Board of Directors of December 13, 2011.March 5, 2013. Of the fifteen directors, eightnine were deemed to be independent directors having regardwith reference to the independence criteria set forth inused by the Board of Directors pursuant to the AFEP-MEDEF corporate governance code:Code: Uwe Bicker, Robert Castaigne, Lord Douro, Jean-René Fourtou, Claudie Haigneré, Suet-Fern Lee, Carole Piwnica, Klaus Pohle, and Gérard Van Kemmel.
In particular, it was determined that the situation of Robert Castaigne had changed. Until 2012, Robert Castaigne was not considered as an independent director due to his past links with the Total Group. Since April 2008, when the independence criteria of the AFEP-MEDEF Code were adopted, his situation has changed in two ways:
Consequently, the Board of Directors considered that the links with Total no longer created a presumption of non-independence.
Moreover, contrary to the independence criteria set by the AFEP-MEDEF Code, the Board of Directors has decided that belonging to the Board for more than 12 years would not of itself disqualify a director from being independent.
The length of service criterion is intended to address the concern that the passage of time may deprive a director of his ability to challenge senior management. This is a legitimate concern, which Sanofi takes very seriously.
However, it is not always appropriate to apply this criterion rigidly, since it does not take full account of the variety of situations that may exist. Robert Castaigne has always demonstrated a questioning approach, which is fundamentally what the APEF-MEDEF criteria are seeking to check.
Finally, there was no other reason to determine that Robert Castaigne is not independent.
Consequently, the Board determined on this basis, at its meeting of May 4, 2012, that Robert Castaigne qualified as an independent director.
In addition, the Total group has since that date effectively ceased to have any equity interest in the Company.
In its examination of the independence of each Director, the Board of Directors took into account the various relationships that could exist between Directors and the Group and concluded that no such relationships were of a nature that could put into questionmight undermine their independence. The Board of Directors noted that the Company and its subsidiaries had, in the normal course of business, over the last three years, sold products and provided services with,to, and/or purchased products and received services from, companies in which certain of the Company’sCompany's directors who
are classified as independent or members of their close family were senior managers or employees during the financial year 2011. Each time,2012. On each occasion, the amounts paid to or received from such companies over the past three years were determined in accordance with normal course of businesson an arm's length basis and did not represent amounts that the Board considered to be of such natureregarded as to bring into questionundermining the independence of the directorsDirectors in question. In the same manner,Similarly, the Board of Directors did not find the office of trustee held by Uwe Bicker and Klaus Pohle with the Aventis Foundation (Germany) was of such a nature as to bring into questionundermine their independence with respect toas members of the Sanofi Board of Directors.
No more than one-third of the serving members of our Board of Directors may be over 70 years of age.
Subject to the powers expressly attributed to the Shareholders’Shareholders' General Meeting and within the scope of the Company’sCompany's corporate purpose, the Board of Directors’Directors' powers cover all issues relating to the proper management of the Company, and through its decisions the Board determines all matters falling within its authority.
Composition of the Board of Directors as of December 31, 20112012
Positions held in listed companies are flagged by an asterisk.
Serge Weinberg | Date of birth: | February 10, 1951 | ||
1,636 shares | Nationality: | French | ||
First elected: | December 2009 | |||
Last reappointment: | May 2011 | |||
Term expires: | 2015 |
Directorships and appointments of Serge Weinberg
Within the Sanofi Group | Outside the Sanofi Group | |||
Current directorships and appointments | ||||
In French companies | ||||
• Chairman of the Board |
|
| ||
|
| ||
– Chairman of the Strategy Committee of | ||
• Member of the Supervisory Board of Schneider Electric* • Chairman of Weinberg Capital Partners – Chairman of Financière Piasa and Piasa Holding | ||
Director of VL Holding | ||
Manager of Alret and Maremma | ||
Member of the Supervisory Board of Financière BFSA | ||
Vice Chairman and Director of Financière Poinsétia and Financière Sasa | ||
| ||
| ||
In foreign companies | ||
None | • Chairman of Corum (Switzerland) |
Table of Corum (Suisse)Contents
Past directorships since 2008 | ||
In French companies | ||
None | • Chairman of the Board of Accor* (until 2009) • Director of Rasec (until 2010), of Fnac (until 2010), of Rothschild Concordia (until 2010) and of Team Partners Group (until 2011) • Member of the Supervisory Board of Rothschild & Cie (until 2010) • Member of the Board of Pharma Omnium International (until 2010) • Vice Chairman of the Supervisory Board of Schneider Electric* (until 2010) • Member of the Supervisory Board of Amplitude Group and of Alfina (until 2011) | |
In foreign companies | ||
None | • Member of the Supervisory Board of Gucci Group (Netherlands, until 2010) |
Education and business experience
1976-1982 |
1982-1987 | Deputy General Manager of FR3 |
1987-1990 | Chief Executive Officer of Pallas Finance |
1990-2005 | Various positions at PPR* group including Chairman of the Management Board for 10 years | |
Since 2005 | Chairman of Weinberg Capital Partners |
Past directorships held since 2007
Christopher Viehbacher
| Date of
| March 26, 1960
| ||
95,442 shares | Nationality: | German and Canadian | ||
First elected: | December 2008 | |||
Last reappointment: | May 2010 | |||
Term expires: | 2014 |
Other current directorshipsDirectorships and appointments of Christopher Viehbacher
Within the Sanofi Group | Outside the Sanofi Group | |
Current directorships and appointments | ||
In French companies | ||
• Director and Chief Executive Officer of Sanofi* – Chairman of the Executive Committee and Head of Global Leadership Team of Sanofi – Member of the Strategy Committee of Sanofi | None |
Table of the Executive Committee and Head of Global Leadership Team of Sanofi*Contents
In foreign companies | ||
• Chairman of Genzyme (United States) | • Vice Chairman of European Federation of Pharmaceutical Industries and Associations (EFPIA, Belgium) • Member of Visitors of Fuqua School of Business, Duke University (United States) • Member of the Board of Business Roundtable (United States) • Member of the International Business Council, World Economic Forum (Switzerland) • Chairman of the CEO Roundtable on Cancer (United States) • Member of PhRMA | |
Past directorships since 2008 | ||
In French companies | ||
None | None | |
In foreign companies | ||
• Chairman and Chief Executive Officer of Genzyme (United States, until 2011) | • Member of Advisory Council of Center for Healthcare Transformation (United States, until 2010) • Chairman and member of the Board of Directors of Research America and Burroughs Wellcome Fund (United States, until 2011) • Chairman of the Board of Directors of PhRMA (United States, until 2012) |
Education and business experience
1988-2008 | Various positions at the GSK group, including President Pharmaceutical Operations for North America | |
2004-2008 | Member of the Cardinal Club (United States) |
Past directorships held since 2007
Laurent Attal | Date of birth: | February 11, 1958 | ||
500 shares | Nationality: | French | ||
First elected: | May 2012 | |||
Term expires: | 2016 |
Directorships and appointments of Laurent Attal
Within the Sanofi Group | Outside the Sanofi Group | |
Current directorships and appointments | ||
In French companies | ||
•
Member of the Strategy Committee of Sanofi | • Director ofFondation d'Entreprise L'Oréal | |
In foreign companies | ||
None | None | |
Past directorships held since 2008 | ||
In French Companies | ||
None | None |
In foreign companies | ||
None | • President and Chief Executive Officer of L'Oréal USA (United States, until 2009) |
Education and business experience
Since 1986 | Various positions within the L'Oréal* Group notably within the active cosmetics division | |
Since 2002 | Member of L'Oréal* Executive Committee | |
Since 2010 | Executive Vice-President Research and Innovation at L'Oréal* |
Uwe Bicker | Date of | June 14, 1945 | ||
600 shares | Nationality: | German | ||
First elected: | May 2008 | |||
Last reappointment: | May 2012 | |||
Term expires: | 2016 |
Directorships and appointments of Uwe Bicker
Within the Sanofi Group | Outside the Sanofi Group | |
Current directorships and appointments | ||
In French companies | ||
•
|
| |
In foreign companies | ||
None | • Trustee of the Aventis Foundation (1) (not-for-profit, Germany) •
•
•
| |
Past directorships since 2008 | ||
In French companies | ||
None | None | |
In foreign companies | ||
None | • Member of the Board of Trustees of Bertelsmann Stiftung (Bertelsmann Foundation, Germany, until 2011) • Chairman of the Supervisory Board of Siemens Healthcare Diagnostics Holding GmbH (Germany, until 2012) • Vice-Chairman of the Supervisory Board of Epigenomics AG (Germany) and of Definiens AG (Germany, until 2012) |
600 shares
Contents
Education and business experience
Since 1983 | Professor at the Medical Faculty of Heidelberg (Germany) | |
Since 2011 | Dean at the Medical Faculty, Heidelberg University (Germany) Managing Director at the University Clinic of Mannheim (Germany) | |
1975-1994 | Various positions at Boehringer Mannheim GmbH (later Roche AG) (Germany) |
1994-2004 | Various positions at Hoechst group (Germany) |
1997-2007 |
Past directorships held since 2007
Robert Castaigne | Date of birth: | April 27, 1946 | ||
1,000 shares | Nationality: | French | ||
First elected: | February 2000 | |||
Last reappointment: | May 2010 | |||
Term expires: | 2014 |
Directorships and appointments of Robert Castaigne
Within the Sanofi Group | Outside the Sanofi Group | |
Current directorships and appointments | ||
In French companies | ||
•
– Member of the Audit Committee of Sanofi |
Société Générale*: – Director – Member of
– Member of the Audit Committee – Member of the Remuneration Committee | |
In foreign companies | ||
None | None | |
Past directorships since 2008 | ||
In French companies | ||
None |
| |
In foreign companies | ||
None | •
|
517 shares
Other current directorships and appointments
Education and business experience
1972-2008 | Various positions at the Total* group, including Chief Financial Officer and member of the Executive Committee | |
1995-2008 | Director of Hutchinson | |
1996-2008 | Director of Omnium Insurance & Reinsurance Company Ltd (Bermuda) |
Past directorships held since 2007Table of Contents
Thierry Desmarest | Date of birth: | December 18, 1945 | ||
1,017 shares | Nationality: | French | ||
First elected: | February 2000 | |||
Last reappointment: | May 2011 | |||
Term expires: | 2015 |
Directorships and appointments of Thierry Desmarest
Within the Sanofi Group | Outside the Sanofi Group | |
Current directorships and appointments | ||
In French companies | ||
• Director of Sanofi* – Member of the Compensation Committee of Sanofi – Member of the Appointments and Governance Committee of Sanofi – Member of the Strategy Committee of Sanofi |
Total SA*: – Director and Honorary President – Chairman of
– Chairman ofFondation Total • L'Air Liquide*: – Director – Member of the Appointments and Governance Committee – Member of the Compensation Committee | |
• Renault group: – Director of Renault SA* – Director of Renault SAS – Chairman of the International Strategy Committee of Renault SA – Member of the Remuneration Committee of Renault SA – Member of the Industrial Strategy Committee of Renault SA • Member of the Board of Directors of l'Ecole Polytechnique and Chairman ofFondation de l'Ecole Polytechnique • Director ofMusée du Louvre | ||
In foreign companies | ||
None | •
–
–
|
517 shares
Other current directorships and appointments
Past directorships since 2008 | |||
In French companies | |||
None | • | Chairman of • Member of the Supervisory Board of Areva* (until 2010) | |
In foreign companies | |||
None | None |
Contents
Education and business experience
2000-2007 |
Since 1981 | Various positions at the Total* group including Chairman and Chief Executive Officer (1995-2007) |
Past directorships held since 2007
Lord Douro
| Date of | August 19, 1945 | ||
2,000 shares | Nationality: | British | ||
First elected: | May 2002 | |||
Last reappointment: | May 2010 | |||
Term expires: | 2014 |
Directorships and appointments of Lord Douro
Within the Sanofi Group | Outside the Sanofi Group | |
Current directorships and appointments | ||
In French companies | ||
•
Member of the Strategy Committee of Sanofi |
|
2,000 shares
Other current directorships and appointments
In foreign companies | |||
None | • | Chairman of Richemont Holdings UK Ltd (United Kingdom) and Kings College London (United Kingdom) • Compagnie Financière Richemont AG* (Switzerland): – Director – Member of the Appointments Committee and of the Compensation Committee • Director of GAM Worldwide (United Kingdom) • Member of the International Advisory Board of Abengoa SA* (Spain) • RIT Capital* (United Kingdom): – Director – Chairman of the Remuneration Committee and the Conflicts Committee – Member of the Nominations Committee | |
Past directorships since 2008 | |||
In French companies | |||
None | • Pernod Ricard*: – Director (until 2011) – Member of the Compensation Committee and of the Appointments Committee (until 2010) | ||
In foreign companies | |||
None | • Director of Abengoa Bioenergy (Spain, •
|
Education and business experience
1979-1989 | Member of the European Parliament |
1995-2000 | Chairman of Sun Life & Provincial Holdings Plc* (United Kingdom) |
1993-2005 | Chairman of Framlington | |
2003-2007 | Commissioner of English Heritage (United Kingdom) |
Past directorships held since 2007
Jean-René Fourtou | Date of birth: | June 20, 1939 | ||
4,457 shares | Nationality: | French | ||
First elected: | August 2004 | |||
Last reappointment: | May 2012 | |||
Term expires: | 2016 |
Directorships and appointments of Jean-René Fourtou
Within the Sanofi Group | Outside the Sanofi Group | |
Current directorships and appointments | ||
In French companies | ||
• Independent – Member of the Compensation Committee of Sanofi – Member of the Appointments and Governance Committee of Sanofi – Member of the Strategy Committee of Sanofi |
Chairman of | |
In foreign companies | ||
| •
| |
Past directorships since 2008 | ||
In French companies | ||
None | • Chairman of the Supervisory Board of Group Canal+* (until 2011) •
–
–
–
• Director of Cap Gemini SA* (until 2009) | |
In foreign companies | ||
None | • Director of NBC Universal Inc. (United States, until 2010) • Director and member of the Compensation Committee of Nestlé* (Switzerland, until 2012) |
4,457 shares
Other current directorships and appointments
Contents
Education and business experience
1963-1986 | Various positions at the Bossard group, including Chairman and Chief Executive Officer (1977-1986) |
1986-1999 | Chairman and Chief Executive Officer of Rhône-Poulenc* |
1999-2004 | Vice Chairman of the Management Board, then Vice Chairman of the Supervisory Board and member of the Strategy Committee of Aventis* |
2002-2005 | Chairman and Chief Executive Officer of Vivendi* | |
2002-2008 | Vice Chairman, Chairman then Honorary Chairman of the International Chamber of Commerce |
Past directorships held since 2007
Claudie Haigneré | Date of birth: | May 13, 1957 | ||
500 shares | Nationality: | French | ||
First elected: | May 2008 | |||
Last reappointment: | May 2012 | |||
Term expires: | 2016 |
Directorships and appointments of Claudie Haigneré
Within the Sanofi Group | Outside the Sanofi Group | |||
Current directorships and appointments | ||||
In French companies | ||||
• Independent – Member of the Appointments and Governance Committee of Sanofi – Member of the Compensation Committee of Sanofi |
France Telecom*: – Director – Member of
| Chairman of the Board of Directors of
|
500 shares
Other current directorships and appointments
Chairman of Universcience (Cité des Sciences et de |
• | Director of • Director ofFondation CGénial • Director ofFondation • Director ofFondation Lacoste |
• | Member ofAcadémie des Technologies, ofAcadémie des Sports • Director ofEcole Normale Supérieure (ENS), Campus Condorcet, and PRES HESAM(Pôle de Recherche et d'Enseignement Supérieur Hautes-Etudes-Sorbonne-Arts-et-Métiers) | |
In foreign companies | ||
None | None | |
Past directorships since 2008 | ||
In French companies | ||
None | • Counselor at the European Space Agency (until 2009) • Director and Chairman of theCité des Sciences et de l'Industrie (until 2009) • Chairman ofPalais de la Découverte (until 2009) • Director of the Aéro Club de France (until 2011) • Vice President of the IAA (International Academy of Astronautics, until 2011) | |
In foreign companies | ||
None | None |
Contents
Education and business experience
1984-1992 | Rheumatologist, Cochin Hospital (Paris) |
1996 | Scientific space mission to the MIR space station (Cassiopée, Franco-Russian mission) |
2001 |
2002-2004 | Deputy Minister for Research and New Technologies in French government |
2004-2005 | Deputy Minister for European Affairs | |
2005-2009 | Counselor to at the European Space Agency (ESA) |
Past directorships held since 2007
Igor Landau | Date of birth: | July 13, 1944 | ||
500 shares | Nationality: | French | ||
First elected: | August 2004 | |||
Last reappointment: | May 2011 | |||
Term expires: | 2015 |
Directorships and appointments of Igor Landau
Within the Sanofi Group | Outside the Sanofi Group | |
Current directorships and appointments | ||
In French companies | ||
• Director of Sanofi* |
Director of | |
In foreign companies | ||
| •
•
–
–
| |
Past directorships since 2008 | ||
In French companies | ||
None | • Director of HSBC France (until 2012) | |
In foreign companies | ||
None | • Allianz AG* (Germany, until 2012): –
– Member of the General Committee – Member of the Mediation Committee – Member of the Nomination Committee |
12,116 shares
Other current directorships and appointments
Education and business experience
1968-1970 | | Chief Executive Officer of the German subsidiary of La Compagnie du Roneo (Germany) |
1971-1975 | | Management consultant at McKinsey (France) |
1975-2004 | | Various positions at the Rhône-Poulenc group, including member of the Management Board of Aventis (1999-2002) and Chairman of the Management Board of Aventis (2002-2004) |
2001-2005 | | Director of Essilor* |
2002-2005 | | Director of Thomson* |
2003-2006 | | Member of the Supervisory Board of Dresdner Bank (Germany) |
Past directorships held since 2007Table of Contents
N/A
Suet-Fern Lee | Date of birth: | May 16, 1958 | ||
500 shares | Nationality: | Singaporean | ||
First elected: | May 2011 | |||
Term expires: | 2015 |
Directorships and appointments of Suet-Fern Lee
Within the Sanofi Group | Outside the Sanofi Group | |
Current directorships and appointments | ||
In French companies | ||
•
|
Axa*: – Director – Member of | |
In foreign companies | ||
| •
•
•
•
• Chairman of the Board of directors of the Asian Civilizations Museum (Singapore) | |
Past directorships since 2008 | ||
In French companies | ||
None | None | |
In foreign companies | ||
None | • Director of Richina Pacific Limited* (Bermuda, until 2009) • Director of Transcu Group Limited* (Singapore, until 2010) • Director of Sembcorp Industries Ltd* (Singapore, until 2011) |
500 shares
Other current directorships and appointments
Education and business experience
Since 2006 | Member of the Board of | |
Member of the | ||
Since 2007 | Member of the Advisory Committee of the Singapore Management University School of Law | |
2000-2007 | Director of ECS Holdings Limited* (Singapore) | |
2004-2007 | Director of International Capital Investment Limited (Singapore) Director of Media Asia Entertainment Group Limited (Hong Kong) Director of Transpac Industrial Holdings Limited* (Singapore) | |
2005-2008 | Director of China Aviation Oil* (Singapore) | |
2006-2008 | Director of Sincere Watch* (Hong Kong) | |
2010-2011 | President of the Inter-Pacific Bar Association |
Past directorships held since 2007Table of Contents
Christian Mulliez | Date of birth: | November 10, 1960 | ||
1,423 shares | Nationality: | French | ||
First elected: | June 2004 | |||
Last reappointment: | May 2010 | |||
Term expires: | 2014 |
Directorships and appointments of Christian Mulliez
Within the Sanofi Group | Outside the Sanofi Group | |
Current directorships and appointments | ||
In French companies | ||
• Director of Sanofi* – Member of the Audit Committee of Sanofi – Member of the Compensation Committee of Sanofi |
Vice President, General Manager Administration and Finance of
| |
In foreign companies | ||
None | •
•
| |
Past directorships since 2008 | ||
In French companies | ||
None | None | |
In foreign companies | ||
None | None |
1,391 shares
Other current directorships and appointments
Education and business experience
Since 2003 | Executive Vice President Administration and Finance at L'Oréal* | |
1984-2002 | Various positions at Synthélabo and then at Sanofi-Synthélabo, including Vice President Finance | |
|
Past directorships held since 2007
N/A
Carole Piwnica | Date of birth: | February 12, 1958 | ||
500 shares | Nationality: | Belgian | ||
First elected: | December 2010 | |||
Last reappointment: | May 2012 | |||
Term expires: | 2016 |
Directorships and appointments of Carole Piwnica
Within the Sanofi Group | Outside the Sanofi Group | |
Current directorships and appointments | ||
In French companies | ||
•
Member of the Audit Committee of Sanofi |
Eutelsat Communications*: – Director – Chairman of |
In foreign companies | ||
| •
–
–
•
•
| |
Past directorships since 2008 | ||
In French companies | ||
None | None | |
In foreign companies | ||
None | • Director of Toepfer GmbH (Germany, until 2010) • Director of Dairy Crest Plc.* (United Kingdom, until 2010) • Member of the Ethical Committee of Monsanto* (United States, until 2009) • Aviva Plc.* (United Kingdom, until 2011): – Director – Chairman of the Corporate Responsibility Committee – Member of the Compensation Committee |
15,000 shares
Other current directorships and appointments
Member of the Compensation Committee, of the Appointments and Governance Committee and of the Strategy Committee of Sanofi*
Chairman of the Board of Directors of Fondation d’Entreprise L’Oréal (Foundation)
Chairman of Alba Plus
Director of L’Oréal* (France) and Ferrari S.p.A. (Italy)
Education and business experience
Bachelor of Arts (Hons) from Oxford University and degree from INSEAD
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Vice-Chairman of the Board of Directors of L’Air Liquide* (2006-2009)
Chairman of the Board of Directors and Chairman of the Strategy and Implementation Committee of L’Oréal* (France, until 2011)
Chairman & Director of L’Oréal USA Inc. (United States, until 2011) and L’Oréal UK Ltd (United Kingdom, until 2011)
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500 shares
Other current directorships and appointments
Director of Naxos UK Ltd (United Kingdom)
Director and Chairman of the Committee of Governance, Compensation and Appointment of Eutelsat Communications*
Director of Louis Delhaize* (Belgium), Big Red (United States), Elevance (United States) and Amyris Inc.* (United States)
Education and business experience
Degree in law,Université Libre de Bruxelles
1985-1991 | Attorney at Proskauer, Rose (New York) and Shearman & Sterling (Paris) with practice in mergers and acquisitions | |
1991-1994 | General Counsel of Gardini & Associés | |
1994-2000 | Chief Executive Officer of Amylum France, then Chairman of Amylum Group | |
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1998-2004 | Director of Spadel (Belgium) | |
1996-2006 | Director of Tate & Lyle Plc. (United Kingdom) | |
2000-2006 | Director and Vice-Chairman of Tate & Lyle Plc. for Governmental Affairs (United Kingdom) | |
1996-2006 | Chairman of the Liaison Committee and director of the | |
| Chairman of the Export Commission and director of theAssociation Nationale des Industries Alimentaires (ANIA) |
Past directorships held since 2007Table of Contents
Klaus Pohle
| Date of Birth: | November 3, 1937 | ||
2,500 shares | Nationality: | German | ||
First appointment: | August 2004 | |||
Last reappointment: | May 2012 | |||
Term expires: | 2016 |
Directorships and appointments of Klaus Pohle
Within the Sanofi Group | Outside the Sanofi Group | |
Current directorships and appointments | ||
In French companies | ||
• Independent director of Sanofi* – Chairman of the Audit Committee of Sanofi |
| |
In foreign companies | ||
| •
| |
Past directorships since 2008 | ||
In French companies | ||
None | None | |
In foreign companies | ||
None | • DWS Investment GmbH, Frankfurt (Germany, until 2009): –
–
•
• Coty Inc.* New York (United States, until 2011): – Director – Chairman of the Audit Committee |
Other current directorships and appointments
Education and business experience
1966-1980 | Various positions at the BASF group (Germany) | |
1981-2003 | Deputy Chief Executive Officer and Chief Financial Officer of Schering AG (Germany) | |
2003-2005 | Chairman of the German Accounting Standards Board (Germany) | |
2004-2008 | Various positions at Hypo Real Estate Holding AG*, Munich, including Chairman of the Supervisory Board (Germany) |
Past directorships held since 2007
Gérard Van Kemmel | Date of birth: | August 8, 1939 | ||
1,005 shares | Nationality: | French | ||
First elected: | May 2003 | |||
Last reappointment: | May 2011 | |||
Term expires: | 2015 |
Directorships and appointments of Gérard Van Kemmel
Within the Sanofi Group | Outside the Sanofi Group | |||
Current directorships and appointments | ||||
In French companies | ||||
• Independent – Chairman of the Compensation Committee of Sanofi – Member of the Audit Committee of Sanofi – Member of the Appointments and Governance Committee of Sanofi |
Europacorp*: – Director – Member of | |||
In foreign companies | ||||
None | None | |||
Past directorships since 2008 | ||||
In French companies | ||||
|
| |||
In foreign companies | ||||
| • Director of Eurotunnel NRS Holders Company Limited (United Kingdom, until 2010) |
Other current directorships and appointments
Education and business experience
1966-1995 | Various positions including President of Arthur Andersen and Andersen Consulting in France (1976-1995) and Chairman of the Board of Arthur Andersen Worldwide (1989-1994) | |
1996-1997 | Senior advisor to French Finance Minister | |
1997-2006 | Various positions at Cambridge Technology Partners | |
2004-2006 | Various positions at Novell* including President EMEA then Europe Chairman |
Past directorships held since 2007
Several changes in theThe composition of the Board of Directors occurredchanged in 2011.2012. The co-optationterm of Carole Piwnica on December 15, 2010, was ratifiedoffice of Lindsay Owen-Jones expired at the Shareholders’close of the Shareholders' General Meeting held on May 6, 2011. Likewise, Suet-Fern Lee4, 2012. Laurent Attal was appointed directoras a Director of our Company at the Company during the Shareholders’Shareholders' General Meeting held on May 6, 2011.4, 2012.
The Executive Committee is chaired by the Chief Executive Officer.
The Committee meets once a month, and has the following permanent members:
The name, business address, present principal occupation or employment and material occupations, positions, offices or employment for the past five years of each of the executive officers of Sanofi are set forth below. The business address and phone number of each such executive officer is c/o Sanofi, 54 rue La Boétie, 75008 Paris, France, +33 1 53 77 40 00. Unless otherwise indicated, each executive officer is a citizen of France.
Christopher Viehbacher
Chief Executive Officer
Chairman of the Executive Committee
Date of birth: March 26, 1960
Christopher Viehbacher was appointed as Chief Executive Officer on December 1, 2008, and is also a member of the Strategy Committee.
For additional information regarding his professional education and business experience see “Composition"Composition of the Board of Directors as of December 31, 2011”2012" in “A."A. Directors and Senior Management”Management" on this Item 6.
Christopher Viehbacher is a citizen of Germany and Canada.
Olivier Charmeil
Senior Vice President Vaccines since January 1, 2011
Date of birth: February 19, 1963
Olivier Charmeil is a graduate of HEC (Ecole des Hautes Etudes Commerciales) and of theInstitut d’Etudesd'Etudes Politiques in Paris. From 1989 to 1994, he worked in the Mergers & Acquisitions department of Banque de l’Unionl'Union Européenne. He joined Sanofi Pharma in 1994 as head of Business Development. Subsequently, he held various posts within the Group, including Chief Financial Officer (Asia) for Sanofi-Synthélabo in 1999 andAttaché to the Chairman, Jean-François Dehecq, in 2000, before being appointed as Vice President, Development within the Sanofi-Synthélabo International Operations Directorate, where he was responsible for China and support functions. In 2003, Olivier Charmeil was appointed Chairman and Chief Executive Officer of Sanofi-Synthélabo France, before taking the post of Senior Vice President, Business Management and Support within the Pharmaceutical Operations Directorate. In this role, he piloted the operational integration of Sanofi-Synthélabo and Aventis. He was appointed Senior Vice President Asia/Pacific, Pharmaceutical Operations in February 2006 and since January 1, 2008, Operations Japan have reported to him as well as Asia/Pacific and Japan Vaccines since February 2009. Since January 1, 2011, Olivier Charmeil has served as Senior Vice President Vaccines and a member of the Executive Committee.
Jérôme Contamine
Executive Vice President Chief Financial Officer
Date of birth: November 23, 1957
Jérôme Contamine is a Graduate ofÉcole Polytechnique(X),ENSAE, andENSAE, the national statistics and economics engineering school, affiliated with the Ministry of Finance (1982). He also graduated from theENA(Ecole Nationale d’Administrationd'Administration). After four years at the“"Cour des Comptes”Comptes", as a Senior State General Auditor, he joined Elf Aquitaine in 1988, as advisor to the Chief Financial Officer, and became Group Finance and Treasury Director & Treasurer in 1991. He became the General Manager of Elf Petroleum Norway in 1995, after being named Deputy Vice President of Elf Upstream Division for Europe and the U.S. In 1999, he was appointed as a member of the taskforce for integration with Total, in charge of the reorganization of the merged entity, TotalFinaElf, and in 2000 became Vice President Europe and Central Asia, Upstream Division of Total. The same year, he joined Veolia Environnement as CFO and Deputy General Manager. In 2003, he was appointed Vice-President Senior Executive, Deputy Chief
Executive Officer, Financial Director of Veolia Environnement. Jérôme Contamine joined Sanofi as Executive Vice President, Chief Financial Officer (CFO) of Sanofi in March 2009.
David-Alexandre Gros
Chief Strategy Officersince September 2011
Date of birth: July 23, 1972
David-Alexandre Gros has a B.A. from Darmouth College (1995), an M.D. from Johns Hopkins University School of Medicine (1999), and an M.B.A. from Harvard Business School (2002). He began his career in clinical research at the Department of Urology of the Johns Hopkins Hospital, from 1996 to 1999, and acquiring clinical experience as a Resident Physician at the University of Pennsylvania Health System from 1999 to 2000. He started his advisory career in 2002 at McKinsey & Company as an Associate, was promoted to Engagement Manager in 2004 and to Associate Principal in 2006. In late 2006, he was appointed Vice President at Merrill Lynch, serving healthcare clients on a wide range of strategic, corporate finance and merger & acquisition issues. In 2009, he joined Centerview Partners, in San Franciso, California, as a keyan advisor to pharmaceutical, biotechnology and diagnostichealthcare companies as a Principal and founding member of the Healthcare Investment Banking practice. David-Alexandre Gros joined Sanofi as Chief Strategy Officer in September 2011.
Karen Linehan
Senior Vice President Legal Affairs and General Counsel
Date of birth: January 21, 1959
Karen Linehan graduated from Georgetown University with Bachelor of Arts and Juris Doctorate degrees. Prior to practicing law, Ms. Linehan served on the congressional staff of the Speaker of the U.S. House of Representatives from September 1977 to August 1986. Until December 1990, she was an Associate in a mid-size law firm in New York. In January 1991, she joined Sanofi as Assistant General Counsel of its U.S. subsidiary. In July 1996, Ms. Linehan moved to Paris to work on international matters within the Group and she has held a number of positions within the Legal Department, most recently as Vice President — Deputy Head of Legal Operations. She was appointed to her current position in March 2007.
Karen Linehan is a citizen of the United States of America and Ireland.
Philippe Luscan
Senior Vice President Industrial Affairs
Date of birth: April 3, 1962
Philippe Luscan is a graduate of theÉcole Polytechnique and theÉcole des Minesin Biotechnology in Paris. He began his career in 1987 as a Production Manager at Danone. In 1990, he joined the Group as Director of the Sanofi Chimie plant at Sisteron, France, and subsequently served as Industrial Director of Sanofi in the United States, as Vice President Supply Chain and as Vice President Chemistry in September 2006. He was appointed to his present position in September 2008.
Roberto Pucci
Senior Vice President Human Resources
Date of birth: December 19, 1963
Roberto Pucci has a Lawlaw degree from the University of Lausanne, Switzerland. He started his career in 1985 at Coopers & Lybrand in Geneva, Switzerland as an external auditor. He then joined Hewlett-Packard (HP) in 1987, where he held various positions in Human Resources in Switzerland and Italy including HR Manager for the European Headquarters and Human Resources Director in Italy. In 1999, he became Director, Compensation & Benefits for Agilent Technologies, a spin off from HP, and was appointed Vice President Human Resources Europe in 2003. In 2005 he moved to the United States to join Case New Holland, a subsidiary of the Fiat Group, as Senior Vice President, Human Resources, and was appointed, in 2007, Executive Vice President, Human Resources for the Fiat Group in Torino, Italy. Roberto Pucci joined Sanofi as Senior Vice President Human Resources in October 2009.
Roberto Pucci is a citizen of Italy and Switzerland.
Hanspeter Spek
President Global Operations
Date of birth: November 5, 1949
Hanspeter Spek graduated from business school in Germany. In 1974, he completed a management training program at Pfizer International, and then joined Pfizer RFA as a junior product manager. He served in various positions at Pfizer RFA, including as manager of the marketing division. Mr. Spek joined Sanofi Pharma GmbH, a German subsidiary of Sanofi, in 1985 as Marketing Director, and served in various positions in Germany and then at Sanofi in France, before being named Senior Vice President Europe following the merger with Synthélabo in 1999. He served as Executive Vice President, International Operations from October 2000, to January 2003, when he was named in charge of worldwide operations of Sanofi-Synthélabo. He was appointed Executive Vice President, Pharmaceutical Operations in August 2004. Since November 2009, he has been President, Global Operations.
Hanspeter Spek has announced his intention to retire by mid-2013.
Hanspeter Spek is a citizen of Germany.
Elias Zerhouni
President, Global Research and Development
Date of birth: April 12, 1951
After completingBorn in Algeria where he completed his initial medical training, in Algeria, Dr. Zerhouni continued his academic career at the Johns Hopkins University and Hospital (United States) in 1975 where he is currentlyrose to the rank of professor of Radiology and Biomedical engineering and senior adviser for Johns Hopkins Medicine.engineering. He served as Chair of the Russell H. Morgan Department of Radiology and Radiological Sciences, Vice Dean for Research and Executive Vice Dean of the School of Medicine from 1996 to 2002 before his appointment as Director of the National Institutes of Health of the United States of America from 2002 to 2008. Dr. Zerhouni was received as member of the U.S. National Academy of Sciences’Sciences' Institute of Medicine in 2000. He was recently appointed as Chair of Innovation at the College de France, elected member of the French Academy of Medicine in 2010 and received the Transatlantic Innovation Leadership award in December 2011. He is the author of over 200 scientific publications and 8 patents. In February 2009, Sanofi named Dr. Zerhouni Scientific Advisor to the Chief Executive Officer and to the Senior Vice-President Research & Development. He was appointed President Global Research & Development and has served on the Executive Committee of Sanofi, since January 2011. He has just been received as member of the U.S. National Academy of Engineering.
Dr. Zerhouni is a citizen of the United States of America.
As of December 31, 2011,2012, none of the members of the Executive Committee had their principal business activities outside of Sanofi.
The Executive Committee is assisted by the Global Leadership Team, which represents the principal servicesfunctions of the Group. The Global Leadership Team is made up of the members of the Executive Committee and 3538 additional senior managers.
Compensation and pension arrangements for corporate officers
Christopher Viehbacher has held the office of Chief Executive Officer of Sanofi since December 1, 2008. He was an outside appointment and has never had an employment contract with Sanofi distinct from his current office. The compensation of the Chief Executive Officer is determined by the Board of Directors upon the recommendation of the Compensation Committee with reference to compensation paid to the chief executive officers of major global pharmaceutical companies and of major companies in the CAC 40 stock market index. The Chief Executive Officer receives fixed compensation, benefits in kind, and variable compensation. In addition, he may be granted stock options and performance shares. Since 2009, in accordance with the AFEP-MEDEF
corporate governance code, stock options and, when applicable, performance shares granted to the Chief Executive Officer arehave been subject to performance conditions.
Serge Weinberg has held the office of Chairman of the Board of Directors since May 17, 2010. He was an outside appointment and has never had an employment contract with Sanofi distinct from his current office. The Chairman of the Board also chairs the Strategy Committee and the Appointments and Governance Committee. In accordance with theour Board Charter and in close collaboration with the Senior Management, he represents the Company in high-level dealings with governmental bodies and with the Group’sGroup's key partners, both nationally and internationally, and participates in the defining of the major strategic choices of the Group especially as regards mergers, acquisitions and alliances. The Chairman and the Chief Executive Officer keep each other fully informed of their actions. The compensation of the Chairman of the Board of Directors consists solely of fixed compensation and benefits in kind and excludes any variable compensation, any awards of stock options and performance shares and any directors’directors' attendance fees.
The compensation policy for the corporate officers is established by the Board of Directors upon the recommendation of the Compensation Committee.
The corporate officers do not receive directors’directors' attendance fees in their capacity as directors. Thus,Consequently, Christopher Viehbacher does not receive directors’directors' attendance fees in his capacity ofas a member of the Strategy Committee. Similarly, Serge Weinberg does not receive directors’directors' attendance fees in his capacity ofas chairman of the Appointments and Governance Committee or ofas chairman of the Strategy Committee.
The AFEP-MEDEF corporate governance code (hereafter referred to as the "AFEP-MEDEF Code") and the recommendations of theAutorité des marchés financiers (the French market regulator, hereafter referred to as "AMF"), require precise disclosures about the implementation of the recommendations and, if applicable, explanations of the reasons why any of them may not have been implemented. Currently, as reported "— C. Board practices —", there is no divergence from the AFEP-MEDEF Code related to compensation.
Serge Weinberg
Compensation awarded to Serge Weinberg
(in euros) | 2011 | 2010 | 2009 | |||||||||
Compensation payable for the year (details provided in the table below) | 709,463 | 480,158 | 6,215 | |||||||||
Value of stock subscription options awarded during the year | N/A | N/A | N/A | |||||||||
Value of performance shares awarded during the year | N/A | N/A | N/A | |||||||||
Total | 709,463 | 480,158 | 6,215 |
(in euros) | 2012 | 2011 | 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Compensation payable for the year (details provided in the table below) | 708,115 | 709,463 | 480,158 | |||||||
Value of stock subscription options awarded during the year | N/A | N/A | N/A | |||||||
Value of performance shares awarded during the year | N/A | N/A | N/A | |||||||
Total | 708,115 | 709,463 | 480,158 | |||||||
Compensation payable and paid to Serge Weinberg
2011 | 2010 | 2009 | ||||||||||||||||||||||
(in euros) | Payable | Paid | Payable | Paid | Payable | Paid | ||||||||||||||||||
Fixed compensation(1) | 700,000 | 700,000 | 439,748 | 439,748 | N/A | N/A | ||||||||||||||||||
Variable compensation | N/A | N/A | N/A | N/A | N/A | N/A | ||||||||||||||||||
Exceptional compensation | N/A | N/A | N/A | N/A | N/A | N/A | ||||||||||||||||||
Attendance fees | N/A | 35,625 | 35,625 | 6,215 | 6,215 | N/A | ||||||||||||||||||
Benefits in kind | 9,463 | 9,463 | 4,785 | 4,785 | N/A | N/A | ||||||||||||||||||
Total | 709,463 | 745,088 | 480,158 | 450,748 | 6,215 | N/A |
| 2012 | 2011 | 2010 | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(in euros) | Payable | Paid | Payable | Paid | Payable | Paid | |||||||||||||
Fixed compensation (1) | 700,000 | 700,000 | 700,000 | 700,000 | 439,748 | 439,748 | |||||||||||||
Variable compensation | N/A | N/A | N/A | N/A | N/A | N/A | |||||||||||||
Exceptional compensation | N/A | N/A | N/A | N/A | N/A | N/A | |||||||||||||
Attendance fees (2) | N/A | N/A | N/A | 35,625 | 35,625 | 6,125 | |||||||||||||
Benefits in kind | 8,115 | 8,115 | 9,463 | 9,463 | 4,785 | 4,785 | |||||||||||||
Total | 708,115 | 708,115 | 709,463 | 745,088 | 480,158 | 450,748 | |||||||||||||
The amounts reported are gross amounts before taxes.
|
On
For 2010, his fixed compensation was set at an annual rate of €700,000 and was paid on apro rata basis of his chairmanship. Serge Weinberg did not receive any variable compensation, stock options, or performance shares.
Attendance fees relateBoard. Pursuant to the period starting December 15, 2009 and ending May 17, 2010 prior to Serge Weinberg becoming Chairman. Consequently, in line with the Company’s compensation policy applicable to the Chairman and the Chief Executive Officer, Serge Weinberg no longer receives anycorporate officers, he has not received directors' attendance fees as a Director since his appointment as Chairman of the Board.Board of our Company.
On March 9, 2011, upon the recommendationSerge Weinberg took office as Chairman of the Compensation Committee, the Board of Directors set the terms of the compensation of Serge Weinberg.on May 17, 2010.
For 2011, his fixed compensation was maintained at an annual rate of €700,000.
He did not receive any variable compensation, stock options, or performance shares. He did not receive attendance fees.
The amount reported for benefits in kind related principally to a company car.
Serge Weinberg does not benefit from the sanofi-aventis top-up pension plan which covers Christopher Viehbacher.
On March 5, 2012, upon the recommendation of the Compensation Committee, the Board of Directors set the terms of the compensation of Serge Weinberg.
For 2012, his fixed compensation was maintained at an annual rate of €700,000.
He did not receive any variable compensation, stock options, or performance shares. He did not receive attendance fees.
The amount reported for benefits in kind relates principally to a company car.
Serge Weinberg does not benefit from the Sanofi top-up pension plan.
On March 5, 2013, upon the recommendation of the Compensation Committee, the Board of Directors set the terms of the compensation of Serge Weinberg. For 2013, his fixed compensation is maintained at an annual rate of €700,000. He will not receive any variable compensation, stock options, or performance shares. He will not receive attendance fees.
Christopher Viehbacher
Christopher Viehbacher took office as Chief Executive Officer on December 1, 2008.
Compensation, options and shares awarded to Christopher Viehbacher
(in euros) | 2011 | 2010 | 2009 | |||||||||
Compensation payable for the year (details provided in the table below) | 3,488,287 | 3,605,729 | 3,669,973 | |||||||||
Value of stock subscription options awarded during the year(1) | 2,364,000 | 2,499,750 | 1,237,500 | |||||||||
Value of performance shares awarded during the year (2) | 1,282,500 | 887 | 2,221,700 | |||||||||
Total | 7,134,787 | 6,106,366 | 7,129,173 |
|
|
(in euros) | 2012 | 2011 | 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Compensation payable for the year (details provided in the table below) | 3,522,051 | 3,488,287 | 3,605,729 | |||||||
Value of stock subscription options awarded during the year (1) | 2,020,800 | 2,364,000 | 2,499,750 | |||||||
Value of performance shares awarded during the year (2) | 1,938,300 | 1,282,500 | 887 | |||||||
Total | 7,481,151 | 7,134,787 | 6,106,366 | |||||||
Compensation payable and paid to Christopher Viehbacher
2011 | 2010 | 2009 | ||||||||||||||||||||||
(in euros) | Payable | Paid | Payable | Paid | Payable | Paid | ||||||||||||||||||
Fixed compensation(1) | 1,200,000 | 1,200,000 | 1,200,000 | 1,200,000 | 1,200,000 | 1,200,000 | ||||||||||||||||||
Variable compensation(2) | 2,280,000 | 2,400,000 | 2,400,000 | 2,400,000 | 2,400,000 | 0 | ||||||||||||||||||
Exceptional compensation (3) | 0 | 0 | 0 | 0 | 0 | 2,200,000 | ||||||||||||||||||
Attendance fees | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||||||
Benefits in kind | 8,287 | 8,287 | 5,729 | 5,729 | 69,973 | 69,973 | ||||||||||||||||||
Total | 3,488,287 | 3,608,287 | 3,605,729 | 3,605,729 | 3,669,973 | 3,469,973 |
| 2012 | 2011 | 2010 | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(in euros) | Payable | Paid | Payable | Paid | Payable | Paid | |||||||||||||
Fixed compensation (1) | 1,250,000 | 1,250,000 | 1,200,000 | 1,200,000 | 1,200,000 | 1,200,000 | |||||||||||||
Variable compensation (2) | 2,268,000 | 2,280,000 | 2,280,000 | 2,400,000 | 2,400,000 | 2,400,000 | |||||||||||||
Exceptional compensation (3) | 0 | 0 | 0 | 0 | 0 | 0 | |||||||||||||
Attendance fees | 0 | 0 | 0 | 0 | 0 | 0 | |||||||||||||
Benefits in kind | 4,051 | 4,051 | 8,287 | 8,287 | 5,729 | 5,729 | |||||||||||||
Total | 3,522,051 | 3,534,051 | 3,488,287 | 3,608,287 | 3,605,729 | 3,605,729 | |||||||||||||
The amounts reported are gross amounts before taxes.
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Variable compensation in respect of a given year is determined and paid at the start |
|
At its meeting on March 1, 2010, upon the recommendation of the Compensation Committee, the Board of Directors established the terms of thefollowing year
His variable compensation with respect to 2010 was based half on the basis of quantitative criteria and half on the basis of qualitative criteria. The quantitative criteria included:
For reasons of confidentiality, the precise targets set for the quantitative criteria cannot be publicly disclosed. Such criteria were evaluated taking account of the performance of the major global pharmaceutical companies.
The qualitative criteria, based on the strategy determined in 2008, related to leadership and strategic choices, adaptation of our structures to the industry’s environment, reconfiguration of our research efforts, commitment in terms of organic and external growth, and the quality of investor communications.
The variable compensation of Christopher Viehbacher could have represented between 0% and 200% of his fixed compensation. In the event of exceptional performance, it could have exceeded 200% of the fixed compensation.
The Board of Directors, pursuant to the above mentioned criteria and taking into account the performance of the Company and the contribution of Christopher Viehbacher during 2010, fixed his variable compensation for 2010 at €2,400,000, i.e., 200% of the fixed portion of his compensation.
At its meeting on March 9, 2011, upon the recommendation of the Compensation Committee, the Board of Directors established the terms of the compensation package for Christopher Viehbacher for the financial year 2011. His fixed compensation remained unchanged at 1,200,000 euros.
His variable compensation with respect to 2011 was established on the basis of quantitative and qualitative criteria. The criteria have changed and include:
the achievement of financial targets compared to our budget excluding Genzyme;
the development of the growth platforms and the launch of products by research and development;
the integration of Genzyme;
the organizational and employment policies of the Group.
For reasons of confidentiality, the precise targets set for the quantitative criteria cannot be publicly disclosed. Such criteria were evaluated taking account of the performance of the major global pharmaceutical companies.
The variable compensation structure acts as incentive for the achievement of the financial targets while taking into account sustainable growth centered on continuing operations and increasingly on developing countries and encouraging the human element with an emphasis on the proper integration of Genzyme and a specific focus on employment policies.
In general, the performance criteria apply not only to the variable compensation but also to the vesting of the stock options and performance shares in compliance with our targets, which are ambitious.
The variable compensation of Christopher Viehbacher could have represented between 0% and 200% of his fixed compensation. In the event of exceptional performance, it could have exceeded 200% of the fixed compensation.
The Board of Directors, pursuant to the above mentioned criteria and taking into account the performance of the Company and the contribution of Christopher Viehbacher during 2011, fixed his variable compensation for 2011 at 2,280,000 euros, i.e., 190% of the fixed portion of his compensation. Christopher Viehbacher’s 2011 variable compensation is to be paid in 2012.
The amount reported for benefits in kind relatedcorresponds to a company car.
At its meeting on March 5, 2012, upon the recommendation of the Compensation Committee, the Board of Directors established the terms of the compensation package for Christopher Viehbacher for the financial year 2012. His fixed annual compensation was set at €1,260,000 as from March 5, 2012 i.e. the total fixed compensation
for 2012 is fixed at 1,260,000 euros, whichamounted to €1,250,000. This represents an increase of 5% compared to the level of fixed compensation set by the Board in 2008 at the time Christopher Viehbacher was recruited.
The variable compensation of Christopher Viehbacher could have represented between 0% and 200% of his fixed compensation. In the event of exceptional performance, it could have exceeded 200% of his fixed compensation.
His variable compensation with respect to 2012 has been established on the basis of quantitative and qualitative criteria. Such criteria include:
the
the
The variable compensation structure acts as an incentive for the attainment of financial targets, while also taking into account sustainable growth centered on continuing operations and increasingly on developing countries, and at the same time fostering human capital and encouraging a specific focus on employment policies.
In general, the performance criteria apply not only to variable compensation but also to the vesting of stock options and performance shares in compliance with our targets, which are ambitious.
For reasons of confidentiality, the precise targets set for the quantitative and qualitative criteria, even though they have been properly established in a precise manner, cannot be publicly disclosed. In evaluating these criteria, the performance of the major global pharmaceutical companies was taken into account.
The Board of Directors, pursuant to the above mentioned criteria and taking into account the performance of the Company and the contribution of Christopher Viehbacher during 2012, fixed his variable compensation for 2012 at 2,268,000 euros, i.e., 180% of the fixed portion of his compensation. Christopher Viehbacher's 2012 variable compensation is to be paid in 2013.
The amount reported for benefits in kind relates to a company car.
At its meeting on March 5, 2013, upon the recommendation of the Compensation Committee, the Board of Directors established the terms of the compensation package for Christopher Viehbacher for 2013. His fixed compensation for 2013 is maintained at €1,260,000.
His variable compensation with respect to 2013 has been established on the basis of quantitative and qualitative criteria. These criteria include:
Stock options awarded to Christopher Viehbacher in 20112012
Origin | Date of Board grant | Nature of options | Value (in €) | Number of options awarded in 2012 | Exercise price (in €) | Exercise period | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sanofi | 03/05/2012 | Subscription options | 2,020,800 | 240,000 | 56,44 | 03/06/2016 03/05/2022 | |||||||||||
Origin | Date of Board grant | Nature of the options | Value (in €) | Number of options awarded in 2010 | Exercise (in €) | Exercise period | ||||||||||||||||||
sanofi-aventis | 03/09/11 | | Subscription options | | 2,364,000 | 300,000 | 50.48 | | 03/10/2015 03/09/2021 | |
On March 9, 2011, 300,0005, 2012, 240,000 share subscription options were awarded to Christopher Viehbacher. In conformitycompliance with the AFEP-MEDEF corporate governance code,Code, the entire award is subjectcontingent upon both to internal criteria based upon Business Net Income and Return on Assets (“ROA”("ROA"), and to external criteria based uponon Total Shareholder Return (“TSR”("TSR") in comparison to a reference set of pharmaceutical companies. These criteria were selected because they align the share-basedmedium-term equity-based compensation on the medium-term with the strategy adopted by the Company.
This award is broken down as follows:
WhileAlthough for reasons of confidentiality the quantitative measures for the internal criteria cannot be publicly disclosed, even though they have been properly established in a precise manner, the quanta for the internal criteria cannot be publicly disclosed, the targets and the level of achievement offor the internal criteria will be publicly disclosed publicly at the end of the performance measurement period.
Using the Black & Scholes method, each option awarded on March 9, 20115, 2012 was valued at €7.88,€8.42, valuing the total benefit at €2,364,000.€2,020,800.
The number of options awarded to Christopher Viehbacher in 2011 represents 0.92% of the global envelope voted by the Shareholders’ General Meeting held on April 17, 2009 (2.5% of our share capital) and 34.31% of the total award to all beneficiaries on March 9, 2011. The Board of Directors has decided to limit the number of options that could be awarded to Christopher Viehbacher to 10% of the global envelope votedtotal limit approved by the Shareholders’Shareholders' General Meeting held on May 6, 2011 (1% of our share capital). The number of options awarded to Christopher Viehbacher in 2012 represents 1.81% of the total limit approved by the Shareholders' General Meeting held on May 6, 2011 (1% of our share capital) and 29.48% of the total award to all beneficiaries on March 5, 2012.
Stock options held by Christopher Viehbacher
Origin | Date of Board grant | Nature of options | Value (in €) | Number of options awarded | Exercise price (in €) | Exercise period | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
sanofi-aventis | 03/02/09 | Subscription options | 1,237,500 | 250,000 | 45.09 | 03/04/2013 03/01/2019 | ||||||||||
sanofi-aventis | 03/01/10 | Subscription options | 2,499,750 | 275,000 | 54.12 | 03/03/2014 02/28/2020 | ||||||||||
sanofi-aventis | 03/09/11 | Subscription options | 2,364,000 | 300,000 | 50.48 | 03/10/2015 03/09/2021 | ||||||||||
Sanofi | 03/05/12 | Subscription options | 2,020,800 | 240,000 | 56.44 | 03/06/2016 03/05/2022 | ||||||||||
In 2011, as part of its commitment to transparency, Sanofi undertook to publish in its annual report the level of attainment determined by the Board of Directors for performance conditions applicable to future equity-based compensation plans awarded to Christopher Viehbacher and the other members of the Executive Committee. The Board considers that disclosing the level of attainment allows our shareholders to better understand the demanding nature of the performance conditions. The 2011 stock option plan and the 2011 performance share plan are the first plans for which the Board of Directors determined the level of fulfillment of the performance conditions.
Origin | Date of Board grant | Nature of the options | Value (in €) | Number of options awarded | Exercise price (in €) | Exercise period | ||||||||||||||||||
sanofi-aventis | 03/02/09 | | Subscription options | | 1,237,500 | 250,000 | 45.09 | | 03/04/2013 03/01/2019 | | ||||||||||||||
sanofi-aventis | 03/01/10 | | Subscription options | | 2,499,750 | 275,000 | 54.12 |
| 03/03/2014 02/28/2020 |
| ||||||||||||||
sanofi-aventis | 03/09/11 | | Subscription options | | 2,364,000 | 300,000 | 50.48 |
| 03/10/2015 03/09/2021 |
|
On March 2, 2009, in accordance with what had been intended on the announcement of his joining the Group, 250,000 subscription options were awarded to Christopher Viehbacher. All of these options were subject to a performance condition. The performance condition, which had to be fulfilled each financial year preceding the vesting of the shares (i.e. 2009, 2010, 2011 and 2012), was based on a ratio of adjusted net income excluding selected items (which was a non-GAAP financial measure used until the end of 2009) to net sales of at least 18%.
On February 6, 2013, the Board of Directors determined that the conditions had been met and that the 250,000 options would be exercisable subject to meeting the condition of continuing employment.
On March 9, 2011, 300,000 subscription options were awarded to Christopher Viehbacher. In compliance with the AFEP-MEDEF Code, the entire award is contingent upon both internal criteria based on Business Net Income and Return on Assets ("ROA"), and external criteria based on Total Shareholder Return ("TSR") in comparison to a reference set of twelve pharmaceutical companies.
For the first period (consisting of fiscal years 2011 and 2012) which related to 50% of the March 9, 2011 grant, the performance was as follows:
The Board of Directors, in its meeting of February 6, 2013, determined that the global performance rate for the first period was greater than 100% and therefore, since the performance condition had been fulfilled, 50% of the stock subscription options granted would be exercisable at the end of the four-year vesting period subject to meeting the condition of continuing employment.
On March 5, 2012,2013, 240,000 share subscription options were awarded to Christopher Viehbacher. In conformitycompliance with the AFEP-MEDEF corporate governance code,Code, the entire award is subject tocontingent upon both internal criteria based uponon Business Net Income and Return on Assets (“ROA”("ROA"), and to external criteria based uponon Total Shareholder Return (“TSR”("TSR") in comparison to a reference set of eleven pharmaceutical companies. These criteria were selectedmaintained because they align the share-basedmedium-term equity-based compensation on the medium-term with the strategy adopted by the Company.
This award is broken down as follows:
The targets and the level of achievement offor the internal criteria will be disclosed publicly at the end of the performance measurement period.
Christopher Viehbacher did not exercise any stock options in 2010 or 2011. None of his stock option awards is currently exercisable.2012.
As of the date of publication of this document, the total number of unexercised options held by Christopher Viehbacher represented 0.08%0.098% of the share capital as at December 31, 2011.2012.
Performance shares awarded to Christopher Viehbacher in 20112012
Origin | Date of Board award | Value (in €) | Number of performance shares awarded in 2012 | Acquisition date | Availability date | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Sanofi | 03/05/12 | 1,938,300 | 42,000 | 03/06/2015 | 03/06/2017 | |||||||
Origin | Date of Board award | Number of performance shares awarded in 2010 | Value (in €) | Acquisition date | Availability date | |||||||||||||||
sanofi-aventis | 03/09/11 | 30,000 | 1,282,500 | 03/10/2013 | 03/10/2015 |
On March 9, 2011, 30,0005, 2012, 42,000 performance shares were awarded to Christopher Viehbacher. In conformitycompliance with the AFEP-MEDEF corporate governance code,Code, the entire award is subjectcontingent upon both to internal criteria based uponon Business Net Income and Return on Assets (“ROA”("ROA"), and to external criteria based upon Total Shareholder Return (“TSR”("TSR") in comparison to a reference set of pharmaceutical companies. These criteria were selected because they align the share-basedmedium-term equity-based compensation on the medium-term with the strategy adopted by the Company. Each performance share awarded on March 5, 2012, was valued at €46.15, valuing the total benefit at € €1,938,300.
This award is broken down as follows:
WhileAlthough for reasons of confidentiality, the quantitative measures for the internal criteria cannot be publicly disclosed, even though they have been properly established in a precise manner, the quanta for the internal criteria cannot be publicly disclosed, the targets and the level of achievement offor the internal criteria will be publicly disclosed publicly at the end of the performance measurement period.
The number of shares awarded to Christopher Viehbacher in 20112012 represents 0.23%0.31% of the global envelope votedtotal limit approved by the Shareholders’Shareholders' General Meeting held on April 17, 2009 (1% of our share capital) and 0.9%0.89% of the total award to all beneficiaries on March 9, 2011.5, 2012. The Board of Directors proposeshas decided to limit the number of performance shares that could be awarded to Christopher Viehbacher to 5% of the global envelope submitted to the shareholders at the Shareholders’total limit approved by Shareholders' General Meeting to be held on May 4, 2012 (1.2% of our share capital).
Performance shares awarded to Christopher Viehbacher
Origin | Date of Board award | Value (in €) | Number of performance shares awarded | Acquisition date | Availability date | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|
sanofi-aventis | 03/02/09 | 2,221,700 | 65,000 | 03/03/2011 | 03/04/2013 | ||||||
sanofi-aventis | 03/09/11 | 1,282,500 | 30,000 | 03/10/2013 | 03/10/2015 | ||||||
Sanofi | 03/05/12 | 1,938,300 | 42,000 | 03/06/2015 | 03/06/2017 | ||||||
Origin | Date of Board award | Number of performance shares awarded | Value (in €) | Acquisition date | Availability date | |||||||||||||||
sanofi-aventis | 03/02/09 | 65,000 | 2,221,700 | 03/03/2011 | 03/04/2013 | |||||||||||||||
sanofi-aventis | 03/09/11 | 30,000 | 1,282,500 | 03/10/2013 | 03/10/2015 |
On March 2, 2009, in accordance with what had been contemplated on the announcement of his appointment in September 2008, 65,0009, 2011, 30,000 performance shares were awarded to Christopher Viehbacher. All of his performance shares were subjectIn compliance with the AFEP-MEDEF Code, the entire award is contingent upon both internal criteria based on Business Net Income and Return on Assets ("ROA"), and external criteria based on Total Shareholder Return ("TSR") in comparison to a performance condition.reference set of twelve pharmaceutical companies.
The performance condition, which had to be fulfilled each financial year precedingmeasure covered fiscal years 2011 and 2012, and the vestingperformance was as follows:
The Board of Directors, acting on the recommendationin its meeting of the Compensation Committee,February 6, 2013, determined that the conditions toglobal performance rate was greater than 100% and therefore, since the March 2, 2009 grantperformance condition had been met for eachfulfilled, 100% of the financial years.performance shares granted would vest subject to meeting the condition of continuing employment.
Taking into account the number of shares acquired at the outset of his mandate as well as the lock-up obligations applicable to shares obtained on exercise of stock options, or disposition of performance shares, the Board of Directors has decided not to imposerequire Christopher Viehbacher to acquire any further acquisition of shares out ofat his own pocket.expense.
Within the context ofUnder Share 2010, the Group’sGroup's global restricted share plan benefiting to each Group employee with at least three months’months' service, 20 restricted shares were awarded to Christopher Viehbacher on October 27, 2010. This award is not included in the schedule above as Christopher Viehbacher subsequently renounced to this award.
On March 5, 2012, 42,0002013, 45,000 performance shares were awarded to Christopher Viehbacher. In conformitycompliance with the AFEP-MEDEF corporate governance code,Code, the entire award is subject tocontingent upon both internal criteria based uponon Business Net Income and Return on Assets (“ROA”("ROA"), and to external criteria based uponon Total Shareholder Return (“TSR”("TSR") in comparison to a reference set of eleven pharmaceutical companies. These criteria were selectedmaintained because they align the share-basedmedium-term equity-based compensation on the medium-term with the strategy adopted by the Company.
This award is broken down as follows:
The targets and the level of achievement of the internal criteria will be disclosed publicly at the end of the performance measurement period.
Concommitantly withIn making the making of the 20122013 award, the Board of Directors determinedhad to determine whether to conditionmake these awards oncontingent upon future share purchases. Taking into account the number of shares acquired at the outset of his mandate as welland the lock-up obligations applicable to shares obtained on exercise of stock options or disposition of performance shares as well as spontaneous share purchases made spontaneously by Christopher Viehbacher, the Board of Directors has decided not to imposerequire him to acquire any further acquisition of shares out ofat his own pocket.
As of the date of this annual report, the total number of performance shares awarded to Christopher Viehbacher represents 0.01%0.009% of our share capital as of December 31, 2011.2012.
Performance shares awarded to Christopher Viehbacher which became available in 20112012
No performance shares awarded to Christopher Viehbacher became available in 2011.2012.
Pension arrangements for Christopher Viehbacher
Christopher Viehbacher is covered by the sanofi-aventisSanofi top-up defined benefit pension plan.plan (which has been called the Sanofi plan since the Company changed its name). The plan is offered to all employees of Sanofi and its French subsidiaries who meet the eligibility criteria specified in the plan rules, extended to corporate officers, including currently Christopher Viehbacher.rules. This plan was set up on October 1, 2008 as the final stage in the process of harmonizing the status of personnel across the French subsidiaries.
The rules of this plan were reviewed on January 1, 2012 in order to apply the 2010 French pension reforms and the French Social Security Financing Act for 2012 (whichinter aliareflected the increase in the statutory retirement age for a full pension). This plan also includes the Merial SAS, Genzyme SAS and Gensyme Polyclonals SAS subsidiaries, for which the eligibility criteria and pension rights calculation take into account length of service from January 1, 2012 at the earliest.
This top-up defined-benefit pension plan is offered to executives (within the meaning of the AGIRC regime —Association Générale des Institutions de Retraite des Cadres, a confederation of executive pension funds) of Sanofi and its French subsidiaries who meet the eligibility criteria specified in the plan rules; the benefit is contingent upon the plan member ending his or her career within the Group. The plan is reserved for executives with at least ten years’years' service whose annual base compensation has for ten years exceeded four times the French social security ceiling, and is wholly funded by the Company.
Based on the assumptions used in the actuarial valuation of this plan, approximately 480550 executives are potentially eligible for this plan, almost all of them active employees.
The top-up pension, which may not exceed 37.50% of final salary, is in the form of a life annuity, and is transferable as a survivor’ssurvivor's pension. The annuity is based on the arithmetical average of the three highest years’years' average annual gross compensation (fixed plus variable) paid during the five years (not necessarily consecutive) preceding final cessation of employment. This reference compensation is capped at 60 times the French social security ceiling (“PASS”("PASS") applicable in the year in which the rights vest. The annuity varies according to length of service (capped at 25 years) and supplements the compulsory industry schemes, subject to a cap on the total pension from all sources equal to 52% of the final level of compensation.
The admission of Christopher Viehbacher to this plan was approved by the Shareholders’Shareholders' General Meeting of April 17, 2009.
The decision to admit Christopher Viehbacher to the top-up defined benefit pension plan and to award him ten years' service at the outset of his mandate, must be seen within the historical context. These commitments were part of the conditions for the hiring of Christopher Viehbacher negotiated before he accepted the position of Chief Executive Officer of Sanofi, and hence before there could be any conflict of interest. These commitments were intended to replace the pension plan which he had to renounce in order to join the Group. Having conducted his career in different countries, Christopher Viehbacher was unable to meet the requirements of the compulsory industry schemes that exist in France.
Commitments in favor of the Chairman and the Chief Executive Officer in office as of December 31, 20112012
Executive director | Contract of employment | Top-up pension plan | Compensation or benefits payable or potentially payable on termination of office | Compensation payable under non-competition clause | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Serge Weinberg | No | No | No | No | ||||||||||||||||||
Christopher Viehbacher | No | Yes | Yes | No | ||||||||||||||||||
In the event of his removal from office as Chief Executive Officer, Christopher Viehbacher would receive a termination benefit equivalent to 24 months of total compensation on the basis of his fixed compensation effective on the date he ceases to hold office and the last variable compensation received prior to that date, subject to the performance criteria described below.
In accordance with article L. 225-42-1 of the French Commercial Code, payment of the termination benefit would be contingent upon fulfillment of two of the three performance criteria, assessed over the three financial years preceding his ceasing to hold office.
The three criteria are:
The terms for the termination benefit entitlement of Christopher Viehbacher were approved by the Shareholders’Shareholders' Annual General Meeting of April 17, 2009.
Any activation of this termination benefit will be carried out in compliance with the AFEP-MEDEF corporate governance code,Code,i.e. only if the departure is non-voluntary and linked to a change in control or strategy.
This termination benefit was negotiated at the time of the recruitment of Christopher Viehbacher, and hence at a time when there was no conflict of interest. Moreover, the terms and conditions of this termination benefit comply with the AFEP-MEDEF Code.
Lock-up periodobligation for shares obtained on exercise of stock options or disposition of performance shares by the Chief Executive Officer
Until he ceases to hold office, the Chief Executive Officer will be required to retain, in the form of Sanofi shares, 50% of any capital gains (net of taxes and social contributions) obtained by the exercise of stock options or upon disposition of performance shares awarded by Sanofi. He must hold these shares in registered.registered form.
In conformitycompliance with the AFEP-MEDEF corporate governance code, theCode and our Board Charter, forbids the Chief Executive OfficerChristopher Viehbacher has undertaken to refrain from contracting anyentering into speculative or hedging instruments in respect of his own interests,transactions, and, inso far as Sanofi is aware, no such instruments have been contracted.
Compensation and pension payments for Directors other than the Chairman and the Chief Executive Officer
Attendance fees
The table below shows amounts paid to each member of the Sanofi Board of Directors in respect of 20102011 and 2011,2012, including those whose term of office ended during these years.
Attendance fees in respect of 2010, the amount of which was set by the Board meeting of February 24, 2011, were be paid in 2011.
Attendance fees in respect of 2011, the amount of which was set by the Board meeting of March 5, 2012, were paid in 2012.
Attendance fees in respect of 2012, the amount of which was set by the Board meeting of March 5, 2013, will be paid in 2012.2013.
For 2011,2012, the basic annual attendance fee was set at €15,000, apportioned on a time basis for Directors who assumed or left office during the year.
The variable portion of the fee is linked to actual attendance by Directors in accordance with the principles described below:
The attendance fee payable to a Director who participates by conference call or by videoconference is equivalent to half of the attendance fee received by a French Director who attends in person.
As an exception, some dual meetings give entitlement to a single attendance fee:
both;
For 2010, as for 2009, a reduction coefficient was applied to this scale in order to keep attendance fees within the total attendance fee entitlement of €1,200,000. The Shareholders’Shareholders' Annual General Meeting of May 6, 2011 approved a proposal to increase the maximum amount of annual attendance fees to € 1,500,000.€1,500,000.
(in euro) | 2011 | 2010 | ||||||||||||||||||||||||||||||||||
Name | Attendance fees in respect of 2011 to be paid in 2012 | Pensions paid in 2011 | Total compensation | Attendance fees in respect of 2010 to be paid in 2011 | Pensions 2010 | Total theoretical compensation (6) | Total effective compensation (7) | |||||||||||||||||||||||||||||
fixed | variable | fixed | Variable | |||||||||||||||||||||||||||||||||
Uwe Bicker | 15,000 | 71 000 | 86,000 | 15,000 | 98,500 | 113,500 | 105,548 | |||||||||||||||||||||||||||||
Jean-Marc Bruel (1) | 0 | 0 | 0 | 5,625 | 47,500 | 141,380 | 194,505 | 190,923 | ||||||||||||||||||||||||||||
Robert Castaigne | 15,000 | 103,750 | 118,750 | 15,000 | 107,500 | 122,500 | 114,241 | |||||||||||||||||||||||||||||
Patrick de La Chevardière (2) | 0 | 0 | 0 | 7,500 | 15,000 | 22,500 | 20,983 | |||||||||||||||||||||||||||||
Thierry Desmarest | 15,000 | 75,500 | 90,000 | 15,000 | 92,500 | 107,500 | 100,253 | |||||||||||||||||||||||||||||
Lord Douro | 15,000 | 86,500 | 101,500 | 15,000 | 116,000 | 131,000 | 122,168 | |||||||||||||||||||||||||||||
Jean-René Fourtou | 15,000 | 75,000 | 1,640,304 | 1,730,304 | 15,000 | 97,500 | 1,618,818 | 1,731,318 | 1,723,733 | |||||||||||||||||||||||||||
Claudie Haigneré | 15,000 | 65,000 | 80,000 | 15,000 | 65,000 | 80,000 | 74,607 | |||||||||||||||||||||||||||||
Igor Landau | 15,000 | 37,500 | 2,245,724 | 2,298,224 | 15,000 | 42,500 | 2,216,308 | 2,273,808 | 2,269,931 | |||||||||||||||||||||||||||
Suet-Fern Lee (3) | 10,000 | 35,500 | 45,500 | 0 | 0 | 0 | 0 | |||||||||||||||||||||||||||||
Christian Mulliez | 15,000 | 55,000 | 70,000 | 15,000 | 42,500 | 57,500 | 53,623 | |||||||||||||||||||||||||||||
Lindsay Owen-Jones | 15,000 | 42,500 | 57,500 | 15,000 | 62,500 | 77,500 | 72,275 | |||||||||||||||||||||||||||||
Carole Piwnica (4) | 15,000 | 55,000 | 70,000 | 0 | 0 | 0 | 0 | |||||||||||||||||||||||||||||
Klaus Pohle | 15,000 | 135,250 | 150,250 | 15,000 | 143,500 | 158,500 | 147,814 | |||||||||||||||||||||||||||||
Gérard Van Kemmel | 15,000 | 138,750 | 153,750 | 15,000 | 142,500 | 157,500 | 146,882 | |||||||||||||||||||||||||||||
Serge Weinberg (5) | 0 | 0 | 0 | 5,625 | 30,000 | 35,625 | 33,223 | |||||||||||||||||||||||||||||
Total | 190,000 | 975,750 | 3,886,028 | 5,051,778 | 183,750 | 1,103,000 | 3,976,506 | 5,263,256 | 5,176,504 | |||||||||||||||||||||||||||
Total attendance fees (theoretical) | 1,165,750 | 1,286,750 | ||||||||||||||||||||||||||||||||||
Total attendance fees (effective) | 1,165,750 | 1,199,997 |
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(in euro) | 2012 | 2011 | |||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Name | Attendance fees in respect of 2012 to be paid in 2013 | Pensions paid in 2012 | Total compensation | Attendance fees in respect of 2011 to be paid in 2012 | Pensions paid in 2011 | Total compensation | |||||||||||||||||||
| fixed | variable | | | fixed | variable | | | |||||||||||||||||
Laurent Attal (1) | 10,000 | 40,000 | 50,000 | 0 | 0 | 0 | |||||||||||||||||||
Uwe Bicker | 15,000 | 89,000 | 104,000 | 15,000 | 71,000 | 86,000 | |||||||||||||||||||
Robert Castaigne | 15,000 | 90,000 | 105,000 | 15,000 | 103,750 | 118,750 | |||||||||||||||||||
Thierry Desmarest | 15,000 | 75,000 | 90,000 | 15,000 | 75,000 | 90,000 | |||||||||||||||||||
Lord Douro | 15,000 | 104,000 | 119,000 | 15,000 | 86,500 | 101,500 | |||||||||||||||||||
Jean-René Fourtou | 15,000 | 85,000 | 1,676,787 | 1,776,787 | 15,000 | 75,000 | 1,640,304 | 1,730,304 | |||||||||||||||||
Claudie Haigneré | 15,000 | 65,000 | 80,000 | 15,000 | 65,000 | 80,000 | |||||||||||||||||||
Igor Landau | 15,000 | 35,000 | 2,295,672 | 2,345,672 | 15,000 | 37,500 | 2,245,724 | 2,298,224 | |||||||||||||||||
Suet-Fern Lee (2) | 15,000 | 64,000 | 79,000 | 10,000 | 35,500 | 45,500 | |||||||||||||||||||
Christian Mulliez | 15,000 | 77,500 | 92,500 | 15,000 | 55,000 | 70,000 | |||||||||||||||||||
Lindsay Owen-Jones (3) | 6,250 | 20,000 | 26,250 | 15,000 | 42,500 | 57,500 | |||||||||||||||||||
Carole Piwnica | 15,000 | 93,750 | 108,750 | 15,000 | 55,000 | 70,000 | |||||||||||||||||||
Klaus Pohle | 15,000 | 131,500 | 146,500 | 15,000 | 135,250 | 150,250 | |||||||||||||||||||
Gérard Van Kemmel | 15,000 | 125,000 | 140,000 | 15,000 | 138,750 | 153,750 | |||||||||||||||||||
Total | 196,250 | 1,094,750 | 3,972,459 | 5,263,459 | 190,000 | 975,750 | 3,886,028 | 5,051,778 | |||||||||||||||||
Total attendance fees | 1,291,000 | 1,165,750 | |||||||||||||||||||||||
|
Pensions
The amount recognized in 20112012 in respect of corporate pension plans for Directorsdirectors with current or past executive responsibilities at Sanofi (or companies whose obligations have been assumed by Sanofi) was €4.7€4.3 million.
As retirees, Jean-René Fourtou and Igor Landau are covered by the “GRCD”"GRCD" top-up pension plan instituted in 1977 for senior executives of Rhône-Poulenc. This plan was amended in 1994, 1996, 1999 and 2003, and currently applies to 1 active executive, 43 early retirees and 2628 retired executives.executives (including one survivor's pension). At its meeting of February 11, 2008, the Board of Directors decided to close this plan to new entrants. Christopher Viehbacher does not benefit from this top-up pension plan.
Compensation of Senior Management
The compensation of the other Executive Committee members is established upon the recommendation of the Compensation Committee taking into consideration the practices of major global pharmaceutical companies.
In addition to fixed compensation, they receive variable compensation, which is determined as a function of the trends in the business areas for which the senior managers in questionthey are responsible. Variable compensation generally represents 60% to 110% of their fixed compensation.
In addition to cash compensation, Executive Committee members may be awarded share subscription or purchase options and/or performance shares (see “Item"Item 6. Directors, Senior Management and Employees — E. Share Ownership”Ownership" for details of the related plans).
With respect to 2011,2012, the total gross compensation paid and provisioned withaccrued in respect toof members of the Executive Committee (including the Chief Executive Officer) amounted to 13.9€14.9 million, euros, including 5.7€6.3 million euros in fixed compensation.
In 2011, the Board of Directors made significant changes to its share-basedequity compensation policy. In order to limit the dilutive effect on shareholders, the Board of Directors determined to primarily award performance shares, except with respect tofor a limited group of senior managers who may continue to receive options. The members of the Executive Committee are included in this limited group. Furthermore, whoever the beneficiary is, any award of options or performance shares will henceforth be fully subject to the condition ofcontingent upon the performance targets being achieved over several financial years, as well as a presence condition at the time of the exercise ofstill being an employee when the option is exercised or at delivery of the performance share.share is delivered.
On March 9, 2011, 577,5005, 2012, 445,500 share subscription options were awarded to members of the Executive Committee (including 300,000240,000 options awarded to Christopher Viehbacher). The entire award was subject to twocontingent upon the same internal criteria based on Business Net Income and Return on Assets (ROA).
This award as Christopher Viehbacher, but excluding the TSR-based criterion. Consequently, the weighting of the two criteria is broken down as follows:
The performance criterion based upon Business Net Income coversdifferent, with each representing 50% of the award. It relates togrant.
The quantitative measures of performance are the ratio, at constant exchange rate, between actual Business Net Income achieved andsame as for the Business Net Income specified in the budget. If this ratio is less than 90%, the corresponding options will lapse.
The ROA-based criterion covers 50%award of the award. If the target is achieved, all of the corresponding options may be exercised; otherwise such options will all lapse.
In addition to the two conditions set forth above, an implicit condition exists: the exercise price.
The performance will be measured over two periods of two financial years.
WhileChristopher Viehbacher. Although for reasons of confidentiality, the quantitative measures for the internal criteria cannot be publicly disclosed, even though they have been properly established in a precise manner, the quanta for the internal criteria cannot be publicly disclosed, the targets and the level of achievement offor the internal criteria will be publicly disclosed publicly at the end of the performance measurement period.
As of December 31, 20112012 a total of 2,552,5002,998,000 options had been awarded to members of the Executive Committee (existing plans or plans ending in 2011)2012). As of the same date, members of the Executive Committee held 2,452,5002,898,000 unexercised options. These figures include the unexercised options awarded to Christopher Viehbacher, who is also a member of the Executive Committee.
The table below summarizes the options awarded to individuals who were members of the Executive Committee at the time of the award. For more information on the characteristics of such options see the table “—"— E. Share Ownership — Existing Options Plans as of December 31, 2011”2012" below.
Origin | Date of shareholder authorization | Date of Board grant | Grant to Executive Committee Members (1) | Start date of exercise period | Expiration date | Exercise price (in €) | Number exercised as of 12/31/2012 | Number canceled as of 12/31/2012 | Number outstanding | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
sanofi-aventis | 05/31/07 | 12/13/07 | 520,000 | 12/14/11 | 12/13/17 | 62.33 | 0 | 0 | 520,000 | |||||||||||||||||||
sanofi-aventis | 05/31/07 | 03/02/09 | 650,000 | 03/04/13 | 03/01/19 | 45.09 | 0 | 50,000 | 600,000 | |||||||||||||||||||
sanofi-aventis | 04/17/09 | 03/01/10 | 805,000 | 03/03/14 | 02/28/20 | 54.12 | 0 | 50,000 | 755,000 | |||||||||||||||||||
sanofi-aventis | 04/17/09 | 03/09/11 | 577,500 | 03/10/15 | 03/09/21 | 50.48 | 0 | 0 | 577,500 | |||||||||||||||||||
Sanofi | 05/06/11 | 03/05/12 | 445,500 | 03/06/16 | 03/05/22 | 56.44 | 0 | 0 | 445,500 | |||||||||||||||||||
|
Origin | Date of shareholder authorization | Date of Board grant | Grant to Executive Committee Members (1) | Start date of exercise period | Expiration date | Purchase price (in €) | Number exercised as of 12/31/2011 | Number canceled as of 12/31/2011 | Number outstanding | |||||||||||||||||||||||||||
sanofi-aventis | 05/31/07 | 12/13/07 | 520,000 | 12/14/11 | 12/13/17 | 62.33 | 0 | 0 | 520,000 | |||||||||||||||||||||||||||
sanofi-aventis | 05/31/07 | 03/02/09 | 650,000 | 03/04/13 | 03/01/19 | 45.09 | 0 | 50,000 | 600,000 | |||||||||||||||||||||||||||
sanofi-aventis | 04/17/09 | 03/01/10 | 805,000 | 03/03/14 | 02/28/20 | 54.12 | 0 | 50,000 | 755,000 | |||||||||||||||||||||||||||
sanofi-aventis | 04/17/09 | 03/09/11 | 577,500 | 03/10/15 | 03/09/21 | 50.48 | 0 | 0 | 577,500 |
|
During the financial year 2011, no option was2012, 70,000 share subscription options were exercised by the members of the Executive Committee.Committee (Sanofi-Synthélabo subscription option plan of December 10, 2003, i.e. before the creation of the Executive Committee, with an exercise price of €55.74).
On March 9, 2011, 85,5005, 2012, 137,900 performance shares (including 30,00042,000 performance shares awarded to Christopher Viehbacher) were awarded to members of the Executive Committee. The entire award was subject to twocontingent upon the same internal criteria based on Business Net Income and Return on Assets (ROA). as Christopher Viehbacher, but
This awardexcluding the TSR-based criterion. Consequently, the weighting of each criterion is broken down as follows:
The performancedifferent, with each criterion based upon Business Net Income coversrepresenting 50% of the award. It relates togrant.
The quantitative measures of performance are the ratio, at constant exchange rate, between actual Business Net Income achieved andsame as for the Business Net Income specified in the budget. If this ratio is less than 90%, the corresponding performance shares will lapse.
The ROA-based criterion covers 50%award of the award. If the target is achieved, all of the corresponding performance shares vest, otherwise such performance shares will all lapse.
The performance will be measured over two financial years.
WhileChristopher Viehbacher. Although for reasons of confidentiality, the quantitative measures for the internal criteria cannot be publicly disclosed, even though they have been properly established in a precise manner, the quanta for the internal criteria cannot be publicly disclosed, the targets and the level of achievement offor the internal criteria will be publicly disclosed publicly at the end of the performance measurement period.
As of December 31, 2011, the2012, a total of 150,500287,900 performance shares had been awarded to members of the Executive Committee (existing plans or plans ending in 2011)2012). As of the same date, 85,500223,400 performance shares were in the process of acquisition.vesting. These figures include the performance shares awarded to Christopher Viehbacher, who is also a member of the Executive Committee.
The table below summarizes the performance shares awarded to individuals who were members of the Executive Committee at the time of the award. For more information on the characteristics of such performance shares see the table “—"— E. Share Ownership — Existing Restricted Shares Plans as of December 31, 2011”2012" below.
Origin | Date of shareholder authorization | Date of Board Decision | Grant to Executive Committee Members (1) | Date of award | Vesting date | Availability date | Number transferred as of 12/31/2012 | Number of rights canceled as of 12/31/2012 | Number outstanding | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
sanofi-aventis | 5/31/07 | 03/02/09 | 65,000 | 03/02/09 | 03/03/11 | 03/04/13 | 65,000 | 0 | 0 | |||||||||||||||||||
sanofi-aventis | 4/17/09 | 03/09/11 | 85,500 | 03/09/11 | 03/10/13 | 03/10/15 | 0 | 0 | 85,500 | |||||||||||||||||||
Sanofi | 4/17/09 | 03/05/12 | 137,900 | 03/05/12 | 03/06/15 | 03/06/17 | 0 | 0 | 137,900 | |||||||||||||||||||
|
On March 5, 2013, 402,000 share subscription options and 120,600 performance shares were awarded to members of the Executive Committee (including 240,000 options and 45,000 performance shares awarded to Christopher Viehbacher). The entire award is contingent upon the same internal criteria based on Business Net Income and Return on Assets (ROA) as Christopher Viehbacher, but excluding the TSR-based criterion. Consequently, the weighting of the two criteria is different, with each representing 50% of the grant.
Origin | Date of shareholder authorization | Date of Board Decision | Grant to Executive Committee Members (1) | Date of award | Vesting date | Availability date | Number transferred as of 12/31/2011 | Number of rights canceled as of 12/31/2011 | Number outstanding | |||||||||||||||||||||||||||
sanofi-aventis | 5/31/07 | 03/02/09 | 65,000 | 03/02/09 | 03/03/11 | 03/04/13 | 65,000 | 0 | 0 | |||||||||||||||||||||||||||
sanofi-aventis | 4/17/09 | 03/09/11 | 85,500 | 03/09/11 | 03/10/13 | 03/10/15 | 0 | 0 | 85,500 |
|
As part of its commitment to transparency, Sanofi has undertaken to publish in its annual report the level of attainment determined by the Board of Directors for performance conditions applicable to future equity-based compensation plans awarded to Christopher Viehbacher and the other members of the Executive Committee. The Board considers that disclosing the level of attainment allows our shareholders to better understand the demanding nature of the performance conditions. For disclosures about the level of attainment of the various equity-based compensation plans, see "— B. Compensation — Compensation and pension arrangements for corporate officers — Christopher Viehbacher", bearing in mind that the TSR-based criterion only applies to the Chief Executive Officer and that the criteria based on Business Net Income and the ROA each apply to 50% of the grant.
Under French law, Directors may not receive options solely as compensation for service on our Board, and thus our Company may grant options only to those Directors who are also our officers.
Because some of our non-executive Directors were formerly officers or executive officers of our Company or its predecessor companies, some of our non-executive Directors hold Sanofi stock options.
We do not have separate profit-sharing plans for key executives. As employees, they are able to participate in our voluntary and statutory profit-sharing schemes on the same terms as our other employees. These plans are described below under “—"— Employees — Profit-sharing schemes.”"
The total amount accrued as of December 31, 20112012 in respect of corporate pension plans for (i) Directorsdirectors with current or past executive responsibilities at Sanofi or at companies whose obligations have been assumed by Sanofi and (ii) members of the Executive Committee was €121.2€162.0 million, including €9.6€9.1 million recognized in the income statement for the year ended December 31, 2011.2012.
This total amount accrued as of December 31, 20112012 included €56.2€83.5 million for members of the Executive Committee collectively of which €5.9€6.0 million were recognized in the income statement for the year ended December 31, 2011.
2012.
Neither we nor our subsidiaries have entered into service contracts with members of our Board of Directors providing for benefits upon termination of employment. With respect to Christopher Viehbacher, see also “—"— B. Compensation — Christopher Viehbacher”Viehbacher" above.
The AFEP-MEDEF corporate governance codeCode requires us to specifically report on the application of its recommendations and, as the case may be,if applicable, explain the reason why a company wouldany of them have not have applied some of them.been applied. Sanofi follows the guidelines contained in the AFEP-MEDEF corporate governance codeCode as amended. Currently our only two departures from this code are:Code are as follows:
During 2011,2012, the Board of Directors met teneight times, with an overall attendance rate among Board members of over 91%95%. This attendance rate includes participation by conference call. The attendance rate is particularly high, given that several extraordinary meetings were convened on short notice, largely as a result of the projected acquisition of Genzyme. Nevertheless, participation in Board meetings by conference call, remained limited to the extraordinary meetings of the Board, andthough only affected a limited number of directors.Directors participated in this way. The individual attendance rates varied between 71% and 100%.
The following persons attended meetings of the Board of Directors in 2011:2012:
The agenda for each meeting of the Board is prepared by the Secretary after consultation with the Chairman, taking account of the agendas for the meetings of the specialist Committees and the suggestions of the directors.
AroundApproximately one week prior to each meeting of the Board of Directors, the Directors each receive a file containing the agenda, the minutes for the prior meeting, as well as theand documentation with respectrelating to the agenda.
The minutes for each meeting are expressly approved at the next meeting of the Board of Directors.
In conformitycompliance with theour Board Charter, certain subjects, depending upon their area,issues, are examined in advance by the various Committees whichaccording to their areas of competence; these issues are then presentedsubmitted for a decision by the Board of Directors.
In 2011,2012, the main activities of the Board of Directors related to the following questions:issues:
the projected acquisition of Genzyme, regular updates as to the acquisition and then as to the integration of Genzyme, an update as to Merial and its strategy, a presentation on the Latin America region, an update on the Vaccines strategy,
Genzyme;
both unregulated and 2013;
agreements;
program;
auditors;
Association;
Chief Executive Officer still absent;
2011;
the risk panorama with respect to pharmacovigilance,
of 2012;
updating the renewal of the Board Charter,
chairmanship of the Audit Committee following the renewal of his mandate as a Director, and the review of the composition of the Committees in view of the new composition of the Board;
opportunities;
the draft resolutions, the report of the Board of Directors on the resolutions, and the special reports on the share subscription options and on the restricted shares awarded,awarded;
the transfer of the registered office,
Board Committees
Since 1999, our Board of Directors has been assisted in its deliberations and decisions by specialist committees. Members of these committees are chosen by the Board from among its members, based on their experience.
The members of these Committees are selected from among the Directors as a function ofbased on their experience and are appointed by the Board of Directors.
The Committees are responsible for the preparation of certain items on the agenda of the Board of Directors. The decisions of the Committees are adopted by a simple majority with the chairman of the Committee having a casting vote. Minutes are established and approved by the Committee members.
The Committee chairmen forof the Audit Committee, the Compensation Committee and the Appointments and Governance Committee are appointed by the Board of Directors.
The chairman of each of such specialist Committee reports to the Board as to the work of the Committee in question, so that the Board is fully informed whenever it adopts a decision.
The Board of Directors thus works in close collaboration with the specialist Committees. Its work is prepared and organizedCommittees, with a continuing concernview to ensureensuring that it is both transparentcarries on its work with maximum transparency and efficient.
efficiency at all times.
Audit Committee
At December 31, 2011,2012, this Committee was composed of:
Carole PiwnicaChristian Mulliez was appointed as a member of the Audit Committee by the Board of Directors during its meeting of December 13, 2011.May 4, 2012, following the Shareholders' General Meeting held on the same day.
During Before this appointment, during its meeting of December 12, 2011,March 5, 2012, the Audit Committee examined the experience of Carole Piwnica in her roleChristian Mulliez as a memberVice President, General Manager Administration and Finance of various supervisory boards as well as her performance within the Sanofi BoardL'Oréal and on the occasions she was invited to attend meetingsgraduate of the Audit Committee.Ecole Supérieure des Sciences Economiques et Commerciales (ESSEC). The Audit Committee concluded that Carole PiwnicaChristian Mulliez has the necessary knowledge and experience in finance and accounting, in particular with respect to IFRS standards and internal controls.controls, to be a financial expert. On November 2, 2011,February 23, 2012 the AppointmentAppointments and Governance Committee examined the independence of its members and concluded that Carole PiwnicaChristian Mulliez was asnot an independent Director under the AFEP-MEDEF corporate governance code.Code.
ThreeFour members of the Audit Committee are classified as independent pursuant to the criteria adopted by the Board of Directors, i.e. Robert Castaigne, Carole Piwnica, Klaus Pohle and Gérard Van Kemmel. In addition, all of the members, including Robert Castaigne,Christian Mulliez, fulfill the conditions required to be classified as independent under the Sarbanes-Oxley Act.
All fourfive members of the Committee have financial or accounting expertise as a consequence of their education and professional experience. Furthermore, Robert Castaigne, Christian Mulliez, Klaus Pohle and Gérard Van
Kemmel are deemed to be financial experts pursuant to the definition in the Sarbanes-Oxley Act and the definition in Article L. 823-19 of the French Commercial Code. See “Item"Item 16A. Audit Committee Financial Expert.”Expert".
��
The Audit Committee met seveneight times in 2011,2012, including prior to the meetings of the Board of Directors during which the financial statements were approved. In addition to the statutory auditors, the principal financial officers, the Senior Vice President Audit and Evaluation of Internal Controls as well asControl and other members of senior management of the Group attended meetings of the Audit Committee.
The meetings of the Audit Committee take place at least two days prior to any meetings of the Board of Directors during which the annual or interim financial statements are to be examined.
The members of the Audit Committee have a very good attendance record for meetings, with an overall attendance rate among members of 94%. Individual attendance rates varied between 75% and 100%.
The statutory auditors attended all of the meetings of the Audit Committee; they presented their views as to the annual and half yearly financial statements at the Committee meetings of February 4,3, and July 25, 2011,23, 2012, respectively.
In 2011,2012, the main activities of the Audit Committee related to:
statements;
liquidity;
20-F;
13, 2012); |
the acquisitionconclusions of GenzymeGroup management as to internal control procedures, the 2011 Board of Directors' Management Report and its financial implications, particularlyChairman's Report, including the description of risk factors contained in termsthe FrenchDocument de Référence;
Genzyme;
deputy;
its functioning as of the end of the year.
The Committee did not have recourse to external consultants in 2011.2012.
Compensation Committee
At December 31, 2011,2012, this Committee was composed of:
Lindsay Owen-Jones.Owen-Jones, whose mandate as Director expired at the close of the May 4, 2012 Shareholders' General Meeting, also left the Compensation Committee. At the end of the Board meeting which followed the Shareholders' General Meeting, Christian Mulliez joined the Compensation Committee.
Of the five members of the Compensation Committee, three are deemed to be independent.
The Compensation Committee met fourthree times in 2011.2012.
The members of the Compensation Committee have a goodan excellent attendance record for meetings, with an overall attendance rate among members of 90 %.100%.
In 2011,2012, the main activities of the Compensation Committee related to:
fees; |
the policy for share-basedequity-based compensation, comprised ofincluding both share subscription options and performance shares, which was discussed at several meetings,
meetings;
its functioning as of the end of the year.
The Committee did not have recourse to external consultants in 2011.2012.
When the Committee discusses the compensation policy for members of senior management who are not corporate officers, i.e. the members of the Executive Committee, the Committee invites the members of senior management who are corporate officers to attend.
Appointments and Governance Committee
At December 31, 2011,2012, this Committee was composed of:
Lindsay Owen-Jones;
Lindsay Owen-Jones, whose mandate as Director expired at the close of the May 4, 2012 Shareholders' General Meeting, also left the Appointments and Governance Committee.
Of the sevensix members of the Appointments and Governance Committee, four are deemed to be independent.
The Appointments and Governance Committee met twice in 2011.
The members of the Appointments and Governance Committee have a goodan excellent attendance record for meetings, with an overall attendance rate among members of 75 %.100%.
In 2011,2012, the main activities of the Appointments and Governance Committee related to:
Chairman's Report, and the chapter of the 2011Document de Référence containing disclosures about governance;
Directors;
the proposal for an update to the Board Charter and in particular an increase in the minimum number of shares that each Director is required to hold from 500 to 1,000 shares,
the review of the results of the evaluation of the Board of Directors and its Committees,
The Committee did not have recourse to external consultants in 2011.
2012.
Strategy Committee
At December 31, 2011,2012, this Committee was composed of:
Lindsay Owen-Jones,. whose mandate as Director expired at the close of the May 4, 2012 Shareholders' General Meeting, also left the Strategy Committee. At the end of the Board meeting which followed the Shareholders' General Meeting, Laurent Attal joined the Strategy Committee.
Of the seven members of the Strategy Committee, three are deemed to be independent.
TheIn 2012, the Strategy Committee met twicesix times, four times in 2011,restrictive sessions and twice in expanded sessions.
The members of the Strategy Committee have a goodan excellent attendance record for meetings, with an overall attendance rate among members of 90 %.100%.
TheAs in 2011, the work of the Committee covered, in particular, research and development and proposed acquisitions. Several meetings also covered the projected acquisitiondevelopment of Genzyme.a strategic plan for 2015-2020, analysis of the risk from generics, macro trends in the market, and the outlook for each of the growth platforms.
The Committee did not have recourse to external consultants in 2011.
2012.
Number of Employees
In 2011,2012, Sanofi employed 113,719111,974 people worldwide, increasing by 12,956 people compared to 2010. This increase is due to the integration of the workforce of various companies acquired by us, mainly Genzyme and Merial.1,745 fewer than in 2011. The tables below give a breakdown of employees by geographic area and function as of December 31, 2011.2012.
Employees by geographic area
As of December 31, | ||||||||||||||||||||||||
2011 | % | 2010 | % | 2009 | % | |||||||||||||||||||
Europe | 58,339 | 51.3% | 54,815 | 54% | 57,896 | 55.2% | ||||||||||||||||||
United States | 18,334 | 16.1% | 12,954 | 12.7% | 14,517 | 13.8% | ||||||||||||||||||
Other countries | 37,046 | 32.6% | 33,806 | 33.3% | 32,454 | 31% | ||||||||||||||||||
Total | 113,719 | 100% | 101,575 | 100% | 104,867 | 100% |
| As of December 31, | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2012 | % | 2011 | % | 2010 | % | |||||||||
Europe | 56,265 | 50.2% | 58,339 | 51.3% | 54,815 | 54.0% | |||||||||
North America | 18,994 | 17.0% | 20,233 | 17.8% | 15,106 | 14.9% | |||||||||
Other countries | 36,715 | 32.8% | 35,147 | 30.9% | 31,654 | 31.1% | |||||||||
Total | 111,974 | 100% | 113,719 | 100% | 101,575 | 100% | |||||||||
|
Employees by function
As of December 31, | ||||||||||||||||||||||||
2011 | % | 2010 | % | 2009 | % | |||||||||||||||||||
Sales | 32,874 | 28.9% | 32,686 | 32.2% | 34,292 | 32.7% | ||||||||||||||||||
Research and Development | 18,823 | 16.6% | 16,983 | 16.7% | 19,132 | 18.3% | ||||||||||||||||||
Production | 44,415 | 39% | 37,504 | 36.9% | 36,849 | 35.1% | ||||||||||||||||||
Marketing and Support Functions | 17,607 | 15.5% | 14,402 | 14.2% | 14,594 | 13.9% | ||||||||||||||||||
Total | 113,719 | 100% | 101,575 | 100% | 104,867 | 100% |
| As of December 31, | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2012 | % | 2011 | % | 2010 | % | |||||||||
Sales | 32,270 | 28.8% | 32,874 | 28.9% | 32,686 | 32.2% | |||||||||
Research and Development | 17,066 | 15.2% | 18,823 | 16.6% | 16,983 | 16.7% | |||||||||
Production | 45,035 | 40.2% | 44,415 | 39.0% | 37,504 | 36.9% | |||||||||
Marketing and Support Functions | 17,603 | 15.7% | 17,607 | 15.5% | 14,402 | 14.2% | |||||||||
Total | 111,974 | 100% | 113,719 | 100% | 101,575 | 100% | |||||||||
|
Industrial Relations
In all countries where Sanofi operates, we strive to combine economic and social performance — which we believe are inseparable.
Sanofi’s Sanofi's social responsibility is based on the basic principles of respect for people. The Sanofithe Group's Social Charter, which outlines the rights and duties of eachall Group employee. Thisemployees. The Social Charter addresses the major issues to which Sanofi is committed such asSanofi's key commitments towards its workforce: equal opportunity for all people without discrimination, the right to health and safety, for all, respect for privacy, the right to information and professional training, social protection for employees and their families, as well asfreedom of association and the right to collective bargaining, and respect for the principles contained in the Global Compact on labor relations and ILO treaties governing the physical and emotional wellbeingwell-being and safety of children.
The Group’sGroup's social relations are based on respect and dialog.dialogue. In this spirit, the Company’sCompany's management and employee representatives meet regularly to exchange views, negotiate, sign agreements and ensure that agreements are being implemented. In 2011,
Social dialogue takes place in different ways from one country to the forums fornext, as necessitated by specific local circumstances. Depending on the case, social dialogue with ourrelating to information, consultation and negotiation processes may take place at the national, regional or company level. It may be organized on an interprofessional or sectorial basis, or both. Social dialogue may be informal or it may be implemented through a specific formal body, or a combination of both methods. Whatever the situation, Sanofi encourages employees that existto voice their opinions, help create a stimulating work environment and take part in mostdecisions aiming to improve the way we work. These efforts reflect one of the countries where we operate were kept regularly informed about the Group’s operations, various organizational changes and updates on recent acquisitions like Genzyme and Merial.
In Europe, Sanofi’s European Works Council (EWC) is made up of 40 members and 40 alternates, representing employees from 27 European Union countries in which we operate. In 2011, EWC members received training about organizational changes.
The EWC met in February, April, May and November 2011 to give the employee representatives regular updates on reorganizations in the Group’s various entities (R&D, Industrial Affairs, Commercial Operations, and Support Functions). These developments reflect the adaptation needed for us to adjust and stay competitive internationally, make our research and industrial facilities evolve toward biotechnologies, and also adjust our sales forces based on local regulatory constraints (such as exclusion from reimbursement or price regulation, etc.) and to generic competition for some of our flagship drugs.
In addition, intermediate meetings with the EWC officers provided more regular and timely information of this body based on Group updates. In 2011, a joint working group on employment in Europe was set up and met three times to study threatened and emerging professions in an effort to anticipate trends and communicate about the necessary means required to support employees (training, reconversion, etc.).
In each European country concerned, negotiations with employee representative bodies were also conducted over the year 2011 to present the changes (sales and support operations with the creation of a multi-country organization in Europe; saleprinciples of the Alcorcón site in Spain, etc.) and outlineSocial Charter whereby the employee support measures that are the best suited to local situations (internal reconversion, outplacement, voluntary layoff, early retirement, etc.). The objective is to inform employee representatives as early as possible in order to take into account their opinions and proposals.
In November 2011, Sanofi announced a plan to reorganize R&D at a global level by proposing to create integrated research centers in order to develop highly innovative collaborative facilities that are more in line with the current reality in science, medicine and patients’ unmet needs.
In Europe, the employee representatives’ consultation process has already begun in Germany, Hungary, Italy, in the United Kingdomimprovement of working conditions and the Netherlands.
In the United States, the Boston R&D center will allow usGroup's necessary adaptation to consolidate discovery and early development activities, while a newly created development center in Bridgewater, NJ, will house clinical development, regulatory affairs and other development platforms.
The France Group Committee Council, made up of 25 members and 25 alternates in addition to labor union representatives, was renewed in 2011 for two years and now includes representatives from newly consolidated companies (Merial, Genzyme). It met in May, June, September and December of 2011. During those meetings, the committee was kept abreast of the operations, financial situation and labor changes in the Group in France, as well as the terms and conditions of the Merial and Genzyme consolidation. A presentation was also offered about changes in the economicits environment and the medication reform project.go hand-in-hand.
In 2011, 8 agreements and 5 amendments agreements were discussed with the employee representative bodies. The agreements notably addressed touched on workplace arduousness (agreement on methodology to approach it and agreement on measures to promote prevention and compensation), gender equity, Group-wide implementation of job and skill management planning (GPEC), methods for calculating Group voluntary profit-sharing as well as Sanofi’s contribution through matching funds to PEG and PERCO.
Negotiations were also initiated at the end of the year on home working, special leave and time off to care for dependent relatives. These are expected to be finalized in 2012.
Lastly, special agreements were entered into with certain premises of the Group’s companies (Sanofi-aventis Research & Development, Sanofi Winthrop Industry, Sanofi Chimie, Sanofi-aventis France, Sanofi Pasteur and the sanofi-aventis group).
In order to further our policy to employ the over-fifties and to prevent psychosocial risks, a number of initiatives were instituted throughout France in 2011:
Profit-sharing Schemes, Employee Savings Schemes and Employee Share Ownership
Profit-sharing Schemes
All employees of our French companies belong to voluntary and statutory profit-sharing schemes.
Voluntary Scheme (Intéressement des salariés)
These are collective schemes that are optional for the employer and contingent upon performance. The aim is to give employees an interest in the growth of the business and improvements in its performance.
The amount distributed by our French companies during 20112012 in respect of voluntary profit-sharing for the year ended December 31, 20102011 represented 4.6%5.2% of total payroll.
In June 2011, Sanofi entered into a three-year Group-wide agreement, effective from the 2011 financial year, and applicable to all French companies more than 50% owned by Sanofi. Under the agreement, payments under the Group voluntary profit-sharing scheme depend on the most favorable criterion between growth of growth platforms turnover compared to the previous year’syear's turnover (with constant exchange rate and perimeter) and the level of business net income. For each criterion, a schedule allows to determine the percentage of total payroll to be distributed.
Statutory Scheme (Participation des salariés aux résultats de l’entreprisel'entreprise)
The scheme is a French legal obligation for companies with more than 50 employees that made a profit in the previous financial year.
The amount distributed by our French companies during 20112012 in respect of the statutory scheme for the year ended December 31, 20102011 represented 6.9%5.7% of total payroll.
In November 2007, Sanofi entered into a new Group-wide agreement for an indefinite period, covering all the employees of our French companies.
An amendment to this agreement was signed in April 2009, primarily to align the agreement on a change in French legislation (Law 2008-1258 of December 3, 2008) in order to protect against erosion in purchasing power, under which each qualifying employee can elect to receive some or all of his or her profit-sharing bonus without regard to the normally applicable mandatory lock-up period.
Distribution Formula
In order to favor lower-paid employees, the voluntary and statutory profit-sharing agreements entered into since 2005 split the benefit between those entitled as follows:
Employee Savings Schemes and Collective Retirement Savings Plan
The employee savings arrangements operated by Sanofi are based on a Group savings scheme (Plan Epargne Groupe) and a collective retirement savings plan (Plan Epargne pour la Retraite Collectif). These schemes reinvest the sums derived from the statutory and voluntary profit-sharing schemes (compulsory investments), and voluntary contributions by employees.
SinceIn June 1, 2008, 75.9%2012, 77% of the employees who benefited from the profit-sharing schemes havehad opted to invest in the collective retirement savings plan.
In 2011, €117.52012, €122.9 million and €56.9€57.6 million were invested in the Group savings scheme and the collective retirement savings plan respectively through the voluntary and statutory schemes for 2010, and through top-up contributions.
Employee Share Ownership
At December 31, 2011,2012, shares held by employees of Sanofi and of related companies as well asand by former employees under Group employee savings schemes amounted to 1.38%1.31% of the share capital.
Senior Management
Members of the Executive Committee hold shares of our Company amounting in the aggregate to less than 1% of our share capital.
At December 31, 2011, a total of 2,552,5002,998,000 options had been granted to the members of the Executive Committee (plans existing or closed in 2011)2012) and 2,452,5002,898,000 unexercised options to subscribe for or to purchase Sanofi shares were held by the members of the Executive Committee.
In 2011, no stock option was2012, 70,000 options were exercised by members of the Executive Committee.Committee (December 10, 2003 Sanofi-Synthélabo subscription option plan, i.e. before the creation of the Executive Committee, with an exercise price of €55.74).
At December 31, 2011,2012, a total of 150,500287,900 performance shares had been awarded to the members of the Executive Committee (plans existing or closed in 2011)2012) and 85,500223,400 unvested performance shares not yet vested were held by the members of the Executive Committee.
These figures include the options granted to Christopher Viehbacher, who is a member of the Executive Committee. The terms of these options and performance shares are summarized in the tables below.
Existing Option Plans as of December 31, 20112012
As of December 31, 2011,2012, a total of 67,732,06451,022,011 options were outstanding, including 3,204,077291,537 options to purchase Sanofi shares and 64,527,98750,730,474 options to subscribe for Sanofi shares. Out of this total, 40,872,33934,622,756 were immediately exercisable, including 3,204,077291,537 options to purchase shares and 37,668,26234,331,219 options to subscribe for shares.
The share-basedEquity-based compensation, which is composedconsisting of share subscription option plans and performance share plans, and which aims to align the employees’employees' objectives on those of the shareholders and to reinforce the link between employees and the Group,Group. Under French law, this falls within the powers of the Board of Directors under French law.Directors. Stock options (which may be options to subscribe for shares or options to purchase shares) are granted to employees and the Chief Executive Officer by the Board of Directors on the basis of recommendations from the Compensation Committee.
Granting options is a way of recognizing the beneficiary’sbeneficiary's contribution to the Group’sGroup's development, and also of securing his or her future commitment to the Group.
For each plan, the Compensation Committee and the Board of Directors assess whether it should take the form of options to subscribe for shares or options to purchase shares, based on criteria that are primarily financial.
A list of beneficiaries is proposed by the Senior Management to the Compensation Committee, which reviews the list and then submits it to the Board of Directors, which grants the options. The Board of Directors also sets the terms for the exercise of the options (including the exercise price) and the lock-up period. The exercise price never incorporates a discount, and must be at least equal to the average of the quoted market prices on the 20 trading days preceding the date of grant by the Board. Stock option plans generally specify a vesting period of four years and a total duration of ten years.
In 2011, the Board of Directors made significant changes to its share-basedequity-based compensation policy. In order to limit the dilutive effect on shareholders, the Board of Directors determined to primarily award performance shares, except with respect tofor a limited group of senior managers who may continue to receive options. Furthermore, whoever the beneficiary is, any award of options or performance shares will henceforth be fully subject to the condition ofcontingent upon the performance targets being achievedmet over several financial years.
On March 9, 2011, 574,5005, 2012, 574,050 share subscription options were awarded to 2755 beneficiaries (excluding 300,000240,000 options awarded to Christopher Viehbacher). Each option entitles the grantee to the subscription of one share, in the aggregate representing 0.04% of our share capital before dilution.
This The entire award is broken down as follows:
The performance criterionwas contingent upon two of the same internal criteria based uponon Business Net Income coversand Return on Assets (ROA) as Christopher Viehbacher, but excluding the TSR-based criterion. Consequently, the weighting of each criterion is different, each representing 50% of the award. It relates togrant. The quantitative measures of performance are the ratio, at constant exchange rate, between actual Business Net Income achieved and the Business Net Income specified in the budget. If this ratio is less than 90%, the corresponding options will lapse.
The ROA-based criterion covers 50% of the award. If the target is achieved, all of the corresponding options may be exercised; otherwise such options will all lapse.
In addition to the two conditions set forth above, an implicit condition exists: the exercise price.
The performance will be measured over two periods of two financial years.
While for reasons of confidentiality, even though they have been properly established in a precise manner, the quantasame as for the internal criteria cannot be publicly disclosed, the targets and the levelaward of achievement of the internal criteria will be disclosed publicly at the end of the performance measurement period.Christopher Viehbacher.
The percentage of options awarded to Christopher Viehbacher in 2011 represent 0.92%2012 represents 1.81% of the global envelope votedtotal limit approved by the Shareholders’Shareholders' General Meeting held on April 17, 2009 (2.5%May 6, 2011 (1% of our share capital) and 34.31%29.48% of the total award to all beneficiaries on March 9, 2011.
5, 2012.
Not all of the employees are able to benefit from the awards of performance shares, but a new agreement on the voluntary scheme (intéressement des salariés) was concluded in June 2011 to ensure that all employees have an interest in the performance of the business.
In addition, pursuant to the French Law of July 28, 2011, all of the employees in France of the French subsidiaries of the Group benefited from a profit-sharing bonus amounting to 600 euros€620 gross in November 2011.July 2012. In total, Sanofi paid out 17.9€18.3 million euros in this regard.regard (including social contributions).
On March 5, 2012,2013, the Board of Directors awarded 574,050548,725 share subscription options to 5557 beneficiaries (excluding 240,000 options awarded to Christopher Viehbacher). Each option entitles the grantee to the subscription of one share, in the aggregate representing 0.04% of our share capital before dilution.
ThisThe entire award is broken down as follows:
The performance criterionwas contingent upon two of the same internal criteria based uponon Business Net Income coversand Return on Assets (ROA) as Christopher Viehbacher, but excluding the TSR-based criterion. Consequently, the weighting of each criterion is different, each representing 50% of the award. It relatesgrant.
As part of its commitment to transparency, Sanofi has undertaken to publish in its annual report the level of attainment determined by the Board of Directors for the performance conditions applicable to future equity-based compensation plans awarded to Christopher Viehbacher and the other members of the Executive Committee. The Board considers that disclosing the level of attainment allows our shareholders to better understand the demanding nature of the performance conditions. For disclosures about the level of attainment of the various equity-based compensation plans, see "— B. Compensation — Compensation and pension arrangements for corporate officers — Christopher Viehbacher", bearing in mind that the TSR-based criterion only applies to the ratio, at constant exchange rate, between actualChief Executive Officer and that the criteria based on Business Net Income achieved and the Business Net Income specified in the budget. The targets have been revised upwards and if the ratio is less than 95%, the corresponding options will lapse.
The ROA-based criterion coversROA each apply to 50% of the award. The schedule includes a target ROA, performance below which will be penalized by the lapsinggrant.
In addition to the two conditions set forth above, an implicit condition exists: the exercise price.
In order to reinforce the medium-term aspects of the share-based compensation, performance will henceforth be measured over three financial years, whatever the form of the share-based compensation.
While for reasons of confidentiality, even though they have been properly established in a precise manner, the quanta for the internal criteria cannot be publicly disclosed, the targets and the level of achievement of the internal criteria will be disclosed publicly at the end of the performance measurement period.
Share Purchase Option Plans
Origin | Date of shareholder authorization | Date of Board grant | Number of options initially granted | - to corporate officers (1) | - to the 10 employees granted the most options (2) | Start date of exercise period | Expiration date | Purchase price (in €) | Number exercised as of 12/31/2011 | Number canceled as of 12/31/2011 | Number outstanding | |||||||||||||||||||||||||||||||||
Synthélabo | 6/28/1990 | 12/15/1993 | 364,000 | 130,000 | 104,000 | 12/15/1998 | 12/15/2013 | 6.36 | 358,800 | 5,200 | 0 | |||||||||||||||||||||||||||||||||
Synthélabo | 6/28/1990 | 10/18/1994 | 330,200 | 0 | 200,200 | 10/18/1999 | 10/18/2014 | 6.01 | 324,500 | 0 | 5,700 | |||||||||||||||||||||||||||||||||
Synthélabo | 6/28/1990 | 1/12/1996 | 208,000 | 0 | 52,000 | 1/12/2001 | 1/12/2016 | 8.56 | 193,930 | 0 | 14,070 | |||||||||||||||||||||||||||||||||
Synthélabo | 6/28/1990 | 4/05/1996 | 228,800 | 0 | 67,600 | 4/05/2001 | 4/05/2016 | 10.85 | 199,330 | 0 | 29,470 | |||||||||||||||||||||||||||||||||
Synthélabo | 6/28/1990 | 10/14/1997 | 262,080 | 0 | 165,360 | 10/14/2002 | 10/14/2017 | 19.73 | 228,638 | 5,200 | 28,242 | |||||||||||||||||||||||||||||||||
Synthélabo | 6/28/1990 | 6/25/1998 | 296,400 | 148,200 | 117,000 | 6/26/2003 | 6/25/2018 | 28.38 | 292,300 | 0 | 4,100 | |||||||||||||||||||||||||||||||||
Synthélabo | 6/23/1998 | 3/30/1999 | 716,040 | 0 | 176,800 | 3/31/2004 | 3/30/2019 | 38.08 | 446,575 | 5,720 | 263,745 | |||||||||||||||||||||||||||||||||
Sanofi-Synthélabo | 5/18/1999 | 5/10/2001 | 2,936,500 | 145,000 | 286,000 | 5/11/2005 | 5/10/2011 | 64.50 | 275,061 | 2,661,439 | 0 | |||||||||||||||||||||||||||||||||
Sanofi-Synthélabo | 5/18/1999 | 5/22/2002 | 3,111,850 | 145,000 | 268,000 | 5/23/2006 | 5/22/2012 | 69.94 | 61,000 | 192,100 | 2,858,750 |
|
|
Origin | Date of shareholder authorization | Date of Board grant | Number of options initially granted | - to corporate officers (1) | - to the 10 employees granted the most options (2) | Start date of exercise period | Expiration date | Purchase price (in €) | Number exercised as of 12/31/2012 | Number canceled as of 12/31/2012 | Number outstanding | |||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Synthélabo | 6/28/1990 | 10/18/1994 | 330,200 | 0 | 200,200 | 10/18/1999 | 10/18/2014 | 6.01 | 325,000 | 0 | 5,200 | |||||||||||||||||||||||
Synthélabo | 6/28/1990 | 1/12/1996 | 208,000 | 0 | 52,000 | 1/12/2001 | 1/12/2016 | 8.56 | 199,130 | 0 | 8,870 | |||||||||||||||||||||||
Synthélabo | 6/28/1990 | 4/05/1996 | 228,800 | 0 | 67,600 | 4/05/2001 | 4/05/2016 | 10.85 | 210,300 | 0 | 18,500 | |||||||||||||||||||||||
Synthélabo | 6/28/1990 | 10/14/1997 | 262,080 | 0 | 165,360 | 10/14/2002 | 10/14/2017 | 19.73 | 233,438 | 5,200 | 23,442 | |||||||||||||||||||||||
Synthélabo | 6/28/1990 | 6/25/1998 | 296,400 | 148,200 | 117,000 | 6/26/2003 | 6/25/2018 | 28.38 | 292,900 | 0 | 3,500 | |||||||||||||||||||||||
Synthélabo | 6/23/1998 | 3/30/1999 | 716,040 | 0 | 176,800 | 3/31/2004 | 3/30/2019 | 38.08 | 478,295 | 5,720 | 232,025 | |||||||||||||||||||||||
Sanofi-Synthélabo | 5/18/1999 | 5/22/2002 | 3,111,850 | 145,000 | 268,000 | 5/23/2006 | 5/22/2012 | 69.94 | 61,000 | 3,050,850 | 0 | |||||||||||||||||||||||
Share Subscription Option Plans
Origin | Date of shareholder authorization | Date of grant | Number of options initially granted | - to corporate officers (1) | - to the 10 employees granted the most options (2) | Start date of exercise period | Expiration date | Subscription price (in €) | Number exercised as of 12/31/2012 | Number canceled as of 12/31/2012 | Number outstanding | |||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aventis | 5/24/2000 | 3/06/2002 | 1,173,913 | 1,173,913 | 0 | 3/07/2005 | 3/06/2012 | 69.82 | 0 | 1,173,913 | 0 | |||||||||||||||||||||||
Aventis | 5/14/2002 | 11/12/2002 | 11,775,414 | 352,174 | 741,100 | 11/13/2005 | 11/12/2012 | 51.34 | 8,844,395 | 2,931,019 | 0 | |||||||||||||||||||||||
Aventis | 5/14/2002 | 12/02/2003 | 12,012,414 | 352,174 | 715,000 | 12/03/2006 | 12/02/2013 | 40.48 | 8,379,556 | 1,782,670 | 1,850,188 | |||||||||||||||||||||||
Sanofi-Synthélabo | 5/18/1999 | 12/10/2003 | 4,217,700 | 240,000 | 393,000 | 12/11/2007 | 12/10/2013 | 55.74 | 2,630,340 | 227,500 | 1,359,860 | |||||||||||||||||||||||
sanofi-aventis | 5/31/2005 | 5/31/2005 | 15,228,505 | 400,000 | 550,000 | 6/01/2009 | 5/31/2015 | 70.38 | 201,864 | 2,129,105 | 12,897,536 | |||||||||||||||||||||||
sanofi-aventis | 5/31/2005 | 12/14/2006 | 11,772,050 | 450,000 | 585,000 | 12/15/2010 | 12/14/2016 | 66.91 | 1,031,435 | 1,149,310 | 9,591,305 | |||||||||||||||||||||||
sanofi-aventis | 5/31/2007 | 12/13/2007 | 11,988,975 | 325,000 | 625,000 | 12/14/2011 | 12/13/2017 | 62.33 | 2,318,000 | 1,038,645 | 8,632,330 | |||||||||||||||||||||||
sanofi-aventis | 5/31/2007 | 3/02/2009 | 7,736,480 | 250,000 | 655,000 | 03/04/2013 | 3/01/2019 | 45.09 | 18,755 | 574,265 | 7,143,460 | |||||||||||||||||||||||
sanofi-aventis | 4/17/2009 | 3/01/2010 | 7,316,355 | 0 | 665,000 | 3/03/2014 | 02/28/2020 | 54.12 | 440 | 473,670 | 6,842,245 | |||||||||||||||||||||||
sanofi-aventis | 4/17/2009 | 3/01/2010 | 805,000 | 275,000 | 805,000 | 3/03/2014 | 02/28/2020 | 54.12 | 0 | 50,000 | 755,000 | |||||||||||||||||||||||
sanofi-aventis | 4/17/2009 | 3/09/2011 | 574,500 | 0 | 395,000 | 3/10/2015 | 3/09/2021 | 50.48 | 0 | 30,000 | 544,500 | |||||||||||||||||||||||
sanofi-aventis | 4/17/2009 | 3/09/2011 | 300,000 | 300,000 | 0 | 3/10/2015 | 3/09/2021 | 50.48 | 0 | 0 | 300,000 | |||||||||||||||||||||||
Sanofi | 5/06/2011 | 3/05/2012 | 574,050 | 0 | 274,500 | 3/06/2016 | 3/05/2022 | 56,44 | 0 | 0 | 574,050 | |||||||||||||||||||||||
Sanofi | 5/06/2011 | 3/05/2012 | 240,000 | 240,000 | 0 | 3/06/2016 | 3/05/2022 | 56,44 | 0 | 0 | 240,000 | |||||||||||||||||||||||
Origin | Date of shareholder authorization | Date of grant | Number of options initially granted | - to corporate officers (1) | - to the 10 employees granted the most options (2) | Start date of exercise period | Expiration date | Subscription price (in €) | Number exercised as of 12/31/2010 | Number canceled as of 12/31/2010 | Number outstanding | |||||||||||||||||||||||||||||||||
Aventis | 5/24/2000 | 3/29/2001 | 612,196 | 0 | 206,000 | 3/30/2004 | 3/29/2011 | 68.94 | 28,476 | 583,720 | 0 | |||||||||||||||||||||||||||||||||
Aventis | 5/24/2000 | 11/07/2001 | 13,374,051 | 1,068,261 | 875,200 | 11/08/2004 | 11/07/2011 | 71.39 | 880,241 | 12,493,810 | 0 | |||||||||||||||||||||||||||||||||
Aventis | 5/24/2000 | 3/06/2002 | 1,173,913 | 1,173,913 | 0 | 3/07/2005 | 3/06/2012 | 69.82 | 0 | 7 | 1,173,906 | |||||||||||||||||||||||||||||||||
Aventis | 5/14/2002 | 11/12/2002 | 11,775,414 | 352,174 | 741,100 | 11/13/2005 | 11/12/2012 | 51.34 | 5,133,836 | 1,970,035 | 4,671,543 | |||||||||||||||||||||||||||||||||
Aventis | 5/14/2002 | 12/02/2003 | 12,012,414 | 352,174 | 715,000 | 12/03/2006 | 12/02/2013 | 40.48 | 6,146,520 | 1,751,651 | 4,114,243 | |||||||||||||||||||||||||||||||||
Sanofi-Synthélabo | 5/18/1999 | 12/10/2003 | 4,217,700 | 240,000 | 393,000 | 12/11/2007 | 12/10/2013 | 55.74 | 191,480 | 224,750 | 3,801,470 | |||||||||||||||||||||||||||||||||
sanofi-aventis | 5/31/2005 | 5/31/2005 | 15,228,505 | 400,000 | 550,000 | 6/01/2009 | 5/31/2015 | 70.38 | 6,500 | 2,025,045 | 13,196,960 | |||||||||||||||||||||||||||||||||
sanofi-aventis | 5/31/2005 | 12/14/2006 | 11,772,050 | 450,000 | 585,000 | 12/15/2010 | 12/14/2016 | 66.91 | 0 | 1,061,910 | 10,710,140 | |||||||||||||||||||||||||||||||||
sanofi-aventis | 5/31/2007 | 12/13/2007 | 11,988,975 | 325,000 | 625,000 | 12/14/2011 | 12/13/2017 | 62.33 | 0 | 944,545 | 11,044,430 | |||||||||||||||||||||||||||||||||
sanofi-aventis | 5/31/2007 | 03/02/2009 | 7,736,480 | 250,000 | 655,000 | 03/04/2013 | 03/01/2019 | 45.09 | 995 | 490,775 | 7,244,710 | |||||||||||||||||||||||||||||||||
sanofi-aventis | 4/17/2009 | 03/01/2010 | 7,316,355 | 0 | 665,000 | 03/03/2014 | 28/02/2020 | 54.12 | 0 | 345,270 | 6,971,085 | |||||||||||||||||||||||||||||||||
sanofi-aventis | 4/17/2009 | 03/01/2010 | 805,000 | 275,000 | 805,000 | 03/03/2014 | 28/02/2020 | 54.12 | 0 | 50,000 | 755,000 | |||||||||||||||||||||||||||||||||
sanofi-aventis | 4/17/2009 | 03/09/2011 | 574,500 | 0 | �� | 395,000 | 03/10/2015 | 03/09/2021 | 50.48 | 0 | 30,000 | 544,500 | ||||||||||||||||||||||||||||||||
sanofi-aventis | 4/17/2009 | 03/09/2011 | 300,000 | 300,000 | 0 | 03/10/2015 | 03/09/2021 | 50.48 | 0 | 0 | 300,000 |
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The main characteristics of our stock options are also described in Note D.15.8 to our consolidated financial statements, included in Item 18 of this annual report.
Existing Restricted Share Plans as of December 31, 20112012
Since 2009, the Board of Directors has awarded restricted shares to certain employees in order to give them a direct stake in the Company’sCompany's future and performances via trends in the share price, as a partial substitute for the granting of stock options.
Restricted shares are awarded to employees on the basis of a list submitted to the Compensation Committee. Then thisThis Committee then submits this list to the Board of Directors, which awards the shares. The Board of Directors sets the vesting conditions for the award, and any lock-up conditions for the shares.
In 2011, the Board of Directors made significant changes to its share-basedequity-based compensation policy. In order to limit the dilutive effect on shareholders, the Board of Directors determined to primarily award performance shares, except with respect tofor a limited group of senior managers who may continue to receive options. Furthermore, whoever the beneficiary is, any award of options or performance shares will henceforth be fully subject to the condition ofcontingent upon the performance targets being achieved over several financial years.
On March 9, 2011,5, 2012, the Board of Directors set up two plans:plans in addition to the award made to the Chief Executive Officer:
These plans are broken down as follows:
The performance criterionentire award was contingent upon two of the same internal criteria based uponon Business Net Income coversand Return on Assets (ROA) as Christopher Viehbacher, but excluding the TSR-based criterion. Consequently, the weighting of each criterion is different, each representing 50% of the award. It relates togrant. The quantatitive measures of performance are the ratio, at constant exchange rate, between actual Business Net Income achieved and the Business Net Income specified in the budget. If this ratio is less than 90%, the corresponding performance shares will lapse.
The ROA-based criterion covers 50% of the award. If the target is achieved, all of the corresponding performance shares vest, otherwise such performance shares will all lapse.
The performance will be measured over two periods of two financial years.
While for reasons of confidentiality, even though they have been properly established in a precise manner, the figuressame as for the internal criteria cannot be publicly disclosed, the targets and the levelaward of achievement of the internal criteria will be disclosed publicly at the end of the performance measurement period.Christopher Viehbacher.
The 20112012 awards represent a dilution of 0.25%0.35% of our share capital before dilution as of December 31, 2011.
2012.
Not all of the employees are able to benefit from the awards of performance shares, but a new agreement on the voluntary scheme (intéressement des salariés) was concluded in June 2011 to ensure that all employees have an interest in the performance of the business.
In addition, pursuant to the French Act of July 28, 2011, all of the employees in France of the French subsidiaries of the Group benefited from a profit-sharing bonus amounting to €600€620 gross in November 2011.July 2012. In total, Sanofi paid out 17.9€18.3 million euros in this regard.regard (including social contributions).
On March 5, 2012,2013, the Board of Directors set up two plans:
These plans are broken down as follows:
The performance criterionentire award was subject to two of the same internal criteria based uponon Business Net Income coversand Return on Assets (ROA) as Christopher Viehbacher, but excluding the TSR-based criterion. Consequently, the weighting of each criterion is different, each representing 50% of the award. It relatesgrant.
As part of its commitment to transparency, Sanofi has undertaken to publish in its annual report the level of attainment determined by the Board of Directors for the performance conditions applicable to future equity-based compensation plans awarded to Christopher Viehbacher and the other members of the Executive Committee. The Board considers that disclosing the level of attainment allows our shareholders to better understand the demanding nature of the performance conditions. For disclosures about the level of attainment of the various equity-based compensation plans, see "— B. Compensation — Compensation and pension arrangements for corporate officers — Christopher Viehbacher", bearing in mind that the TSR-based criterion only applies to the ratio, at constant exchange rate, between actualChief Executive Officer and that the criteria based on Business Net Income achieved and the Business Net Income specified in the budget. The targets have been revised upwards and if the ratio is less than 95%, the corresponding performance shares will lapse.
The ROA-based criterion coversROA apply to 50% of the award. The schedule includes a target ROA, performance below which will be penalized by the lapsinggrant each.
In order to reinforce the medium-term aspects of the share-based compensation, performance will henceforth be measured over three financial years.
While for reasons of confidentiality, even though they have been properly established in a precise manner, the quanta for the internal criteria cannot be publicly disclosed, the targets and the level of achievement of the internal criteria will be disclosed publicly at the end of the performance measurement period.
Restricted Share Plans
Origin | Date of shareholder authorization | Date of award | Number of shares initially awarded | - to corporate officers (1) | - to the 10 employees awarded the most shares (2) | Date of award (3) | Vesting date | Availability date | Number transferred as of 12/31/2012 | Number of rights canceled as of 12/31/2012 | Number outstanding | |||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
sanofi-aventis | 5/31/07 | 3/02/09 | 590,060 | 65,000 | 13,900 | 3/02/09 | 3/03/11 | 3/04/13 | 585,782 | 4,278 | 0 | |||||||||||||||||||||||
sanofi-aventis | 5/31/07 | 3/02/09 | 604,004 | 0 | 13,200 | 3/02/09 | 3/04/13 | 3/04/13 | 2,564 | 59,071 | 542,369 | |||||||||||||||||||||||
sanofi-aventis | 4/17/09 | 3/01/10 | 531,725 | 0 | 12,600 | 3/01/10 | 3/02/12 | 3/03/14 | 523,767 | 7,958 | 0 | |||||||||||||||||||||||
sanofi-aventis | 4/17/09 | 3/01/10 | 699,524 | 0 | 16,530 | 3/01/10 | 3/02/14 | 3/03/14 | 2,686 | 65,294 | 631,544 | |||||||||||||||||||||||
sanofi-aventis | 4/17/09 | 10/27/10 | 556,480 | 20 | 200 | 10/27/10 | 10/27/12 | 10/28/14 | 533,200 | 23,280 | 0 | |||||||||||||||||||||||
sanofi-aventis | 4/17/09 | 10/27/10 | 1,544,860 | 0 | 200 | 10/27/10 | 10/27/14 | 10/28/14 | 1,080 | 72,800 | 1,470,980 | |||||||||||||||||||||||
sanofi-aventis | 4/17/09 | 3/09/11 | 1,366,040 | 0 | 71,000 | 3/09/11 | 3/10/13 | 3/10/15 | 200 | 18,050 | 1,347,790 | |||||||||||||||||||||||
sanofi-aventis | 4/17/09 | 3/09/11 | 1,934,610 | 0 | 103,300 | 3/09/11 | 3/10/15 | 3/10/15 | 12,000 | 116,160 | 1,806,450 | |||||||||||||||||||||||
sanofi-aventis | 4/17/09 | 3/09/11 | 30,000 | 30,000 | 0 | 3/09/11 | 3/10/13 | 3/10/15 | 0 | 0 | 30,000 | |||||||||||||||||||||||
Sanofi | 4/17/09 | 3/05/12 | 1,525,100 | 0 | 126,700 | 3/05/2012 | 3/06/15 | 3/06/17 | 100 | 4,980 | 1,520,020 | |||||||||||||||||||||||
Sanofi | 4/17/09 | 3/05/12 | 3,127,160 | 0 | 96,300 | 3/05/2012 | 3/06/16 | 3/06/16 | 0 | 104,260 | 3,022,900 | |||||||||||||||||||||||
Sanofi | 4/17/09 | 3/05/12 | 42,000 | 42,000 | 0 | 3/05/2012 | 3/06/15 | 3/06/17 | 0 | 0 | 42,000 | |||||||||||||||||||||||
Origin | Date of shareholder authorization | Date of award | Number of shares initially awarded | - to corporate officers (1) | - to the 10 employees awarded the most shares (2) | Date of award (3) | Vesting date | Availability date | Number transferred as of 12/31/2011 | Number of rights canceled as of 12/31/2011 | Number outstanding | |||||||||||||||||||||||||||||||||
sanofi-aventis | 5/31/07 | 03/02/09 | 590,060 | 65,000 | 13,900 | 03/02/09 | 03/03/11 | 03/04/13 | 585,782 | 4,278 | 0 | |||||||||||||||||||||||||||||||||
sanofi-aventis | 5/31/07 | 03/02/09 | 604,004 | 0 | 13,200 | 03/02/09 | 03/04/13 | 03/04/13 | 356 | 47,642 | 556,006 | |||||||||||||||||||||||||||||||||
sanofi-aventis | 4/17/09 | 3/01/10 | 531,725 | 0 | 12,600 | 3/01/10 | 03/02/12 | 03/03/14 | 290 | 7,280 | 524,155 | |||||||||||||||||||||||||||||||||
sanofi-aventis | 4/17/09 | 3/01/10 | 699,524 | 0 | 16,530 | 3/01/10 | 03/02/14 | 03/03/14 | 148 | 47,493 | 651,883 | |||||||||||||||||||||||||||||||||
sanofi-aventis | 4/17/09 | 10/27/10 | 556,480 | 20 | 200 | 10/27/10 | 10/27/12 | 10/28/14 | 160 | 15,240 | 541,080 | |||||||||||||||||||||||||||||||||
sanofi-aventis | 4/17/09 | 10/27/10 | 1,544,860 | 0 | 200 | 10/27/10 | 10/27/14 | 10/28/14 | 320 | 22,180 | 1,522,360 | |||||||||||||||||||||||||||||||||
sanofi-aventis | 4/17/09 | 03/09/11 | 1,366,040 | 0 | 71,000 | 03/09/11 | 03/10/13 | 03/10/15 | 200 | 7,850 | 1,357,990 | |||||||||||||||||||||||||||||||||
sanofi-aventis | 4/17/09 | 03/09/11 | 1,934,610 | 0 | 103,300 | 03/09/11 | 03/10/15 | 03/10/15 | 0 | 55,760 | 1,878,850 | |||||||||||||||||||||||||||||||||
sanofi-aventis | 4/17/09 | 03/09/11 | 30,000 | 30,000 | 0 | 03/09/11 | 03/10/13 | 03/10/15 | 0 | 0 | 30,000 |
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As of December 31, 2010,2012, a total of 7,062,32410,414,053 restricted shares were outstanding, as the vesting period of each planthe plans had not yet expired.
Shares Owned by Members of the Board of Directors
As of December 31, 2011,2012, members of our Board of Directors held in the aggregate 137,106113,080 shares, or under 1% of the share capital and of the voting rights, excluding the beneficial ownership of 43,196,815 shares held by Total as of such date which may be attributed to Thierry Desmarest (who disclaims beneficial ownership of such shares) and excluding the beneficial ownership of 118,227,307 shares held by L’OréL'Oréal as of such date which may be attributed to Lindsay Owen-JonesLaurent Attal or Christian Mulliez (who disclaim beneficial ownership of such shares).
Transactions in Shares by Members of the Board of Directors and comparable persons in 20112012
Item 7. Major Shareholders and Related Party Transactions
The table below shows the ownership of our shares as of January 31, 2012,2013, indicating the beneficial owners of our shares. To the best of our knowledge and on the basis of the notifications received as disclosed below, except for L’OréL'Oréal, no other shareholder currently holds more than 5% of our share capital or voting rights.
Total number of issued shares | Number of actual (excluding own shares) (3) | Theoretical number of voting rights | ||||||||||||||||||||||
Number | % | Number | % | Number | % | |||||||||||||||||||
L’Oréal | 118,227,307 | 8.82 | 236,454,614 | 15.71 | 236,454,614 | 15.53 | ||||||||||||||||||
Total | 39,225,808 | 2.93 | 77,434,821 | 5.14 | 77,434,821 | 5.09 | ||||||||||||||||||
Treasury shares(1) | 17,252,363 | 1.29 | - | - | 17,252,363 | 1.13 | ||||||||||||||||||
Employees(2) | 18,209,756 | 1.36 | 35,492,367 | 2.36 | 35,492,367 | 2.33 | ||||||||||||||||||
Public | 1,148,084,236 | 85.61 | 1,155,698,845 | 76.79 | 1,155,698,845 | 75.92 | ||||||||||||||||||
Total | 1,340,999,470 | 100 | 1,505,080,647 | 100 | 1,522,333,010 | 100 |
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|
| Total number of issued shares | Number of actual voting rights (excluding own shares) (3) | Theoretical number of voting rights (including own shares) (4) | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number | % | Number | % | Number | % | |||||||||||||
L'Oréal | 118,227,307 | 8.91 | 236,454,614 | 16.13 | 236,454,614 | 16.10 | |||||||||||||
Treasury shares (1) | 3,193,787 | 0.24 | — | — | 3,193,787 | 0.22 | |||||||||||||
Employees (2) | 17,191,116 | 1.30 | 34,062,116 | 2.32 | 34,062,116 | 2.32 | |||||||||||||
Public | 1,187,958,233 | 89.55 | 1,195,268,262 | 81.55 | 1,195,268,262 | 81.36 | |||||||||||||
Total | 1,326,570,443 | 100 | 1,465,784,992 | 100 | 1,468,978,779 | 100 | |||||||||||||
Ourstatuts(Articles (Articles of Association) provide for double voting rights for shares held in registered form for at least two years. All of our shareholders may benefit from double voting rights if these conditions are met, and no shareholder benefits from specific voting rights. For more information relating to our shares, see “Item"Item 10. Additional Information — B. Memorandum and Articles of Association.”"
L’OréL'Oréal is the only entity known to hold more than 5% of the outstanding Sanofi ordinary shares. This entityL'Oréal reduced its holding from 2007 to 2011 after no significant changes in 2006 and 2005. At year endyear-end 2007, its holding was 8.66% of our share capital compared to 8.82%8.91% on December 31, 2011.2012.
On April 28, 2011,February 16, 2012, Total declared, following a loss of double voting rights resulting from the conversion of its shares into bearer shares, that it had passed below the legal threshold of 5% of our voting rights.
Total also declared that, following sales of shares on the stock market and conversion of shares into bearer shares with a view to selling them, it had passed below the thresholds of 3%, 2%, 1% of our share capital (declarations of January 19, 2012, May 10, 2012, and July 30, 2012), and of 5%, 3%, 2% and 1% of our voting rights (declarations of February 16, 2012, June 11, 2012, July 2, 2012, and August 7, 2012) and as a result of its share sales, andlast declaration held as of the declaration date shares representing 4.99%0.56% of our share capital and 8.59%0.5% of our voting rights.
rights (declaration of August 7, 2012). Total subsequently announced that it had sold the remainder of its shareholding in Sanofi during September 2012.
In accordance with ourstatuts, shareholders are required to notify us once they have passed the threshold of 1% of our share capital or our voting rights and each time they cross an incremental 1% threshold (see “Item"Item 10. Additional Information — B. Memorandum and Articles of Association — Requirements for Holdings Exceeding Certain Percentages”Percentages").
For the year ended December 31, 2011,2012, we were informed that the following share ownership declaration thresholds had been passed:
Amundi declared that, as a result of holdings through its mutual funds, (fonds communs de placement), it had passed successively above on January 5, 2011 and below on January 6, 2011, the threshold of 3% of ourthe share capital (declaration of February 8, 2012), then passed successively above (declaration of July 19, 2012) and successively below on May 23, 2011 and above on June 7, 2011, the threshold of 2%3% of our voting rights, and as of its last declarationsdeclaration held 2.98%3.16% of our share capital (declaration of January 6, 2011) and 2%2.98% of our voting rights (declaration of June 7, 2011)December 21, 2012).
Crédit Suisse BNP Paribas declared that, the Crédit Suisse Groupthrough its mutual funds, it had successively passed successively above (declaration of April 27, 2012) and below (declaration of May 22, 2012) the threshold of 1% of our share capital (declaration of January 28, 2011), and successively above and below the thresholds of 1%, 2% and 3% of our share capital and as of its last declaration held 0.996% of our share capital (declaration of December 19, 2011).
Dodge & Cox declared that it had passed above the threshold of 3%0.95% of our share capital and as of its last declaration held 3.39% of our share capital and 2.97% of our voting rights (declarations of June 21, 2011 and of December 14, 2011).
Franklin Resources declared that it had passed below on September 15, 2011 and above on September 27, 2011, the threshold of 2% of our share capital, and as of its last declaration held 2% of our share capital and 1.75% of our voting rights (declaration of September 27, 2011).
L’Oréal declared that it had passively passed above the threshold of 9% of our share capital, and as of its last declaration held 8.76% of our share capital and 15.23%0.80% of our voting rights (declaration of May 31, 2011)22, 2012).
Natixis Asset Management declared that it had passed above the threshold of 2% of our share capital, and as of its last declaration held 2.07% of our share capital (declaration of September 16, 2011).
Total declared that as a result of share sales, it had passed successively below the thresholds of 5% and 4% of our share capital (declarations of April 28, 2011 and September 29, 2011) and the thresholds of 9%, 8%, 7% and 6% of our voting rights (declarations of January 14, 2011, May 26, 2011, September 8, 2011 and December 1, 2011), and as of its last declaration held 3.5% of our share capital and 5.99% of our voting rights (declaration of December 1, 2011).
Since January 1, 2012, we have been informed that one legal threshold had been passed.
On February 16, 2012, TotalThe Caisse des dépôts et consignations declared that it had passed below the legal threshold of 5% of our voting rights as a result of its share sales, and as of its last declaration held 2.83% of our share capital and 4,69% of our voting rights. On February 10, 2012, Total confirmed its intent to sell the remainder of its shareholding in Sanofi by the end of 2012.
Moreover since January 1, 2012 we have been informed that the following share ownership declaration thresholds have been passed:
Amundi declared that, as a result of share acquisitions through its mutual funds (fonds communs de placement), it had passed above the threshold of 3% of our share capital and as of its last declarations held 3.16% of our share capital (declaration of February 8, 2012).
Caisse des Dépôts et Consignations declared that it had passed below the thresholds of 2% of our share capital and as of its last declaration held 1.99% of our share capital and 1.74% of our voting rights (declaration of January 20, 2012).
Crédit Suisse declared that the Crédit Suisse Group had passed above the threshold of 1% of our share capital (declaration of January 5, 2012), then successively above and below the thresholdthresholds of 2% and 1% of our share capital and as of its last declaration held 0.99%1.34% of our capital (declaration of July 24, 2012).
Franklin Resources, Inc. declared that it had successively passed below (declaration of January 6, 2012), above (declaration of April 24, 2012) and again below (declaration of November 13, 2012) the threshold of 2% of our share capital, then above (declaration of February 17,May 9, 2012) and below (declaration of August 24, 2012) the threshold of 2% of our voting rights and as of its last declaration held 1.98% of our share capital and 1.79% of our voting rights (declaration of November 13, 2012).
Franklin ResourcesL'Oréal declared that, due to the reduction of the number of our voting rights, it had passively passed above the threshold of 16% of our voting rights and as of its last declaration held 16.01% of our voting rights (declaration of July 16, 2012).
Natixis Asset Management declared that on several occasions it had passed below the threshold of 2% of our share capital (declaration of February 21, 2012) and as of its last declaration held 1.99%1.98% of our share capital and 1.75% of our voting rights (declaration of February 6,December 4, 2012).
Total declared that as a result of share sales, it had passed below the thresholds of 3% and as of its last declaration held 2.98% of our share capital and 5.11% of our voting rights (declaration of January 19, 2012).
Individual shareholders (including employees of Sanofi and its subsidiaries, as well as retired employees holding shares via the sanofi-aventis Group Employee Savings Plan), hold approximately 5.4%8.7% of our share capital. Institutional shareholders (excluding L’Oréal and Total)L'Oréal) hold approximately 78.5%78.3% of our share capital. Such shareholders are primarily American (28.4%(27.9%), French (18.3%(16.3%) and British (12.9%(14.1%). German institutions
hold 3.4%3.0% of our share capital, Swiss institutions hold 2.2%, institutions from other European countries hold 8%8.5% and Canadian institutions hold 1.3%1.4% of our share capital. Other international institutional investors (excluding those from Europe and the United States) hold approximately 4.2%4.9% of our share capital. In France, our home country, we have 10,71114,887 identified holdersshareholders of record. In the United States, our host country, we have 5762 identified shareholders of record and 12,02611,322 identified ADS holders of record.
(source:(source: a survey conducted by Euroclear France as of December 31, 2011,2012, and internal information).
Shareholders’Shareholders' Agreement
We are unaware of any shareholders’shareholders' agreement currently in force.
In the ordinary course of business, we purchase or provide materials, supplies and services from or to numerous companies throughout the world. Members of our Board of Directors are affiliated with some of these companies. We conduct our transactions with such companies on an arm’s-lengtharm's-length basis and do not consider the amounts involved in such transactions to be material.
On September 17, 2009, Sanofi acquired the interest held by Merck & Co., Inc. (Merck) in Merial Limited (Merial) and Merial has been a wholly-owned subsidiary of Sanofi since that date. As per the terms of the agreement signed on July 29, 2009, Sanofi also had an option, following the closing of the Merck/Schering-Plough merger, to combine the Intervet/Schering-Plough Animal Health business with Merial to form an animal health joint venture that would be equally owned by the new Merck and Sanofi. On March 8, 2010, Sanofi exercised its contractual right to combine the Intervet/Schering-Plough Animal Health business with Merial. On March 22, 2011, Merck and Sanofi jointly announced the mutual termination of their agreement to form a new animal health joint venture. As a result, Merial and Intervet/Schering-Plough continue to operate as separate businesses.
Consequently, the assets and liabilities of Merial, which previously were classified in Sanofi’sSanofi's balance sheet as assets or liabilities held for sale or exchange, have been reclassified to the relevant balance sheet line items with no restatement of comparative periods. At the same time, results from the Merial business were included in continuing operations for all the periods reported (for more information on these and other impacts of the termination of the agreement on Sanofi’sSanofi's financial statements, see Notes D.2 and D.8.1D.8.2 to our consolidated financial statements included at Item 18 of this annual report).
On October 2, 2010, in order to fund a significant part of its proposed acquisition of Genzyme Corporation, Sanofi executed a Facilities Agreement (the “Facilities Agreement”"Facilities Agreement", described at “Item"Item 10. Additional Information — C. Material Contracts”Contracts" herein) with J.P. Morgan plc, Société Générale Corporate & Investment Banking and BNP Paribas for unsecured term loan facilities of up to U.S.$15,000,000,000.$15,000,000,000. Because Robert Castaigne serves on the boards of both Société Générale and Sanofi, Sanofi submitted the Facilities Agreement and certain non-material ancillary agreements, as well as a subsequent amendment, to the prior approval of its Board of Directors with Robert Castaigne abstaining from the vote. In April 2011, U.S.$4,000,000,000$4,000,000,000 were borrowed by Sanofi under the Facilities Agreement to partially fund partly the acquisition of Genzyme andGenzyme; these amounts were fully reimbursed during the course of 2011. The Facilities Agreement expired as a consequence of such reimbursement.
On February 21, 2012, Sanofi European Treasury Center (SETC), a 100% subsidiary of the Sanofi Group, was incorporated under the laws of Belgium, with the purpose of providing financing and some financial services to Group subsidiaries. In addition, cash management agreements exist between Sanofi and certain of its subsidiaries.
Other than these agreements, duringThe Sanofi parent company transferred the Genzyme Corporation shares acquired in April 2011 to Aventis, Inc. on June 28, 2012. This transfer consisted of two principal operations:
enterprises that, directly or indirectly, control or are controlled by or are under common control with us;
enterprises or associates in which we have significant influence or that have significant influence over us;
shareholders beneficially owning a 10.0% or greater interest in our voting power;
any member of our Executive Committee or Board of Directors or close members of such individuals’ families; or
enterprises in which persons described above own, directly or indirectly, a substantial interest in the voting power or over which persons described above are able to exert significant influence.
C. Interests of Experts and Counsel
N/A
A. Consolidated Financial Statements and Other Financial Information
Our consolidated financial statements as of and for the years ended December 31, 2012, 2011, 2010, and 20092010 are included in this annual report at “Item"Item 18. Financial Statements.”"
Dividends on Ordinary Shares
We paid annual dividends for the years ended December 31, 2006, 2007, 2008, 2009, 2010 and 20102011 and our shareholders will be asked to approve the payment of an annual dividend of €2.65€2.77 per share for the 20112012 fiscal year at our next annual shareholders’shareholders' meeting. If approved, this dividend will be paid on May 15, 2012.14, 2013.
We expect that we will continue to pay regular dividends based on our financial condition and results of operations. The proposed 20112012 dividend equates to a distribution of 39.8%45% of our business earnings per share. For information on the non-GAAP financial measure, “business"business earnings per share”share", see “Item"Item 5. Operating and Financial Review and Prospects — Business Net Income.”" The proposed dividend distribution will subject Sanofi to a 3% additional corporate tax charge on the amount distributed.
The following table sets forth information with respect to the dividends paid by our Company in respect of the 2007, 2008, 2009, 2010 and 20102011 fiscal years and the dividend that will be proposed for approval by our shareholders in respect of the 20112012 fiscal year at our May 4, 2012 shareholders’3, 2013 shareholders' meeting.
| 2012 (1) | 2011 | 2010 | 2009 | 2008 | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Net Dividend per Share (in €) | 2.77 | 2.65 | 2.50 | 2.40 | 2.20 | |||||||||||
Net Dividend per Share (in $) (2) | 3.65 | 3.43 | 3.34 | 3.46 | 3.06 | |||||||||||
2011 (1) | 2010 | 2009 | 2008 | 2007 | ||||||||||||||||
Net Dividend per Share (in €) | 2.65 | 2.50 | 2.40 | 2.20 | 2.07 | |||||||||||||||
Net Dividend per Share (in $)(2) | 3.43 | 3.34 | 3.46 | 3.06 | 3.02 |
The declaration, amount and payment of any future dividends will be determined by majority vote of the holders of our shares at an ordinary general meeting, following the recommendation of our Board of Directors. Any declaration will depend on our results of operations, financial condition, cash requirements, future prospects and other factors deemed relevant by our shareholders. Accordingly, we cannot assure you that we will pay dividends in the future on a continuous and regular basis. Under French law, we are required to pay dividends approved by an ordinary general meeting of shareholders within nine months following the meeting at which they are approved.
Annual Payments on Participating Share Series A (“PSSA”)Disclosure pursuant to Section 219 of the Iran Threat Reduction & Syria Human Rights Act (ITRA)
The table below sets forth, forSanofi conducts limited business relating to human and animal health products with Iran contributing well under 1% of the years indicated,Group's consolidated net sales in 2012. Although these activities are compliant with applicable law and not financially material to the amountGroup, the Iran Threat Reduction and Syria Human Rights Act of dividends paid per PSSA (see “Item 9. The Offer2012 (the "Act") requires us to include the following disclosures in this report. Sales consisted of bulk and Listing” for further detail). Inbranded pharmaceuticals, vaccines, and animal health supplies. U.S. affiliates, or foreign affiliates controlled by U.S. affiliates, are either not involved in these activities or operate under humanitarian licenses issued by the United States,U.S. Treasury Department's Office of Foreign Assets Control, and the PSSAs existGroup has not knowingly conducted a transaction or dealing with a person or entity designated in U.S. Executive Orders No. 13224 and 13382. Limited business not exceeding €10.2 million in gross revenues has been conducted by foreign subsidiaries not requiring an OFAC license with entities such as public hospitals or distributors tied to the Ministry of Health or Ministry of Agriculture. It is estimated that this activity contributed no more than €3.7 million to net profits. A representative office in Tehran incurs incidental expenses from state-owned utilities. Otherwise, no business has been transacted with the Government of Iran as defined in the formAct. The Group does not believe any of American Depositary Shares issued by The Bankits activities to be sanctionable under the Iran Sanctions Act or the Comprehensive Iran Sanctions, Accountability, and Divestment Act of New York Mellon, formerly known as The Bank of New York, as depositary, each representing one-quarter of a PSSA (“PSSA-ADSs”). The PSSAs are generally entitled to receive an annual payment determined according to a specific formula and subject to certain conditions.
The annual payments on the PSSAs are equal to the sum of a fixed portion (€1.14 per PPSA) and a variable portion equal to the greater of 704%2010. In light of the dividend per ordinary share or 150%nature of an amount calculated pursuantthe products concerned, Sanofi does not currently intend to a formula which takes into account changescease its commercial operations in consolidated sales and consolidated net income.Iran.
Such amounts have been translated in each case into U.S. dollars and adjusted for the one-to-four ratioTable of PSSAs to PSSA-ADSs. Annual payments paid to holders of PSSA-ADSs will generally be exempt from French withholding tax.Contents
In 2011, the annual payment per PSSA in respect of 2010 was equal to €18.7521.
2010 | 2009 | 2008 | 2007 | 2006 | ||||||||||||||||
Annual payment per PSSA | € | 18.7521 | € | 18.0477 | € | 16.6390 | € | 15.7234 | € | 13.4695 | ||||||||||
Annual payment per PSSA-ADS | $ | 6.6303 | $ | 5.7708 | $ | 6.0204 | $ | 5.8550 | $ | 4.5877 |
Information on Legal or Arbitration Proceedings
This Item 8 incorporates by reference the disclosures found at Note D.22 to the consolidated financial statements found at Item 18 of this annual report; material updates thereto as of the date of this annual report are found below under the heading “—"— Updates to Note D.22”D.22".
Sanofi and its affiliates are involved in litigation, arbitration and other legal proceedings. These proceedings typically are related to product liability claims, intellectual property rights (particularly claims against generic companies seeking to limit the patent protection of Sanofi products), competition law and trade practices, commercial claims, employment and wrongful discharge claims, tax assessment claims, waste disposal and pollution claims, and claims under warranties or indemnification arrangements relating to business divestitures. As a result, the Group may become subject to substantial liabilities that may not be covered by insurance and could affect our business and reputation. While we do not currently believe that any of these legal proceedings will have a material adverse effect on our financial position, litigation is inherently unpredictable. As a consequence, we may in the future incur judgments or enter into settlements of claims that could have a material adverse effect on results of operations, cash flows and/or our reputation.
• Plavix®Plavix® Patent Litigation
United States.Sanofi and Bristol-Myers Squibb sought damages from Apotex, in reparation of harm caused by that company’s “at risk”company's "at risk" marketing and sale of an infringing generic version of Plavix®Plavix® in 2006. In October 2010, the U.S. District Court awarded Sanofi and Bristol-Myers Squibb damages in the amount of U.S.$442,209,362, plus U.S.$107,930,857 in pre-judgment interest, as well as costs and post-judgment interestinterests as set by statute. Apotex secured the amount of the award by cash deposit and filed a notice of appeal. On October 18, 2011, the U.S. Court of Appeals for the Federal Circuit upheld the U.S. District Court ruling regarding the amount of damages but did not uphold the District Court decision regarding the pre-judgment interest. Sanofi’sSanofi's and Bristol-Myers Squibb’sSquibb's petition for rehearing en banc with respect to the Court of Appeals decision concerning pre-judgment interest was denied on January 13, 2012. The order of payment of the damages was issued in February 2012. On February 7, 2012 Sanofi collected its share of the Plavix® patent infringement damage award, post-judgment interest and awarded litigation costs (totaling U.S.$272,828,073.10).
Australia Canada.. On August 17, 2007, GenRX, a subsidiary of Apotex obtained registration of a generic clopidogrel bisulfate product on the Australian Register of Therapeutic Goods and sent notice to Sanofi that it had in parallel applied to the Federal Court of Australia for an order revoking the Australian enantiomer patent claiming clopidogrel salts. On September 21, 2007, Sanofi obtained a preliminary injunction from the Federal Court preventing commercial launch of this generic clopidogrel bisulfate product until judgment on the substantive issues of patent validity and infringement. In February 2008, Spirit Pharmaceuticals Pty. Ltd. also introduced a nullity action against the Australian enantiomer patent. The Spirit proceeding was consolidated with the Apotex proceeding.
On August 12, 2008, the Australian Federal Court confirmed that the claim directed to clopidogrel bisulfate was valid and infringed. Claims covering the hydrochloride, hydrobromide and taurocholate salts also were found valid. However claim 1 of the patent directed to clopidogrel and its pharmaceutical salts was found to be invalid. All parties appealed. In September 2009, the Full Federal Court of Australia held the Australian patent covering clopidogrel to be invalid. Sanofi filed an appeal with the Supreme Court in November 2009. The security bond posted by Sanofi in connection with the preliminary injunction obtained in 2007 was subsequently increased from Australian $40 million to Australian $204 million (€160 million as of December 31, 2011). In March 2010, the Supreme Court refused special leave to appeal. Apotex is now seeking damages for having been subject to an injunction. The case is in the early stages.
Canada. On April 22, 2009, Apotex filed an impeachment action against Sanofi in the Federal Court of Canada alleging the invalidity of Sanofi’sSanofi's Canadian Patent No. 1,336,777 (the ‘777'777 Patent) claiming clopidogrel bisulfate. On June 8, 2009, Sanofi filed its defense to the impeachment action and filed a suit against Apotex for infringement of the ‘777'777 Patent. The actions were combined and the trial was completed in June 2011. In December 2011, the Federal Court issued a decision that the ‘777'777 Patent is invalid, and subsequently generic companies entered the market with generic clopidogrel products. Sanofi is appealing this decision tofiled an appeal with the Federal Court of Appeal.Appeal in 2012, which is still pending.
• Apotex Settlement Claim
On November 13, 2008, Apotex filed a complaint before a state court in New Jersey against Sanofi and Bristol-Myers Squibb claiming the payment of a U.S.$60 million break-up fee, pursuant to the terms of the initial settlement agreement of March 2006 relating to the U.S. Plavix®Plavix® patent litigation. On April 8, 2011, the New Jersey state court granted Sanofi and Bristol-Myers Squibb’sSquibb a motion for summary judgment. Apotex filed an appeal to the Superior Court of New Jersey, Appellate Division. Oral argument is expectedjudgment that was reversed in the second quarter ofNovember 2012.
In January 2011, Apotex filed a lawsuit in Florida State Court, Broward County, alleging breach of contract relating to the parties’ Mayparties' March 2006 proposed settlement agreement. Discovery is ongoing.Sanofi was granted a motion for summary judgment in 2012, removing Sanofi from the case. BMS's summary judgment motion was denied. Apotex appealed the summary judgment as to Sanofi in December 2012.
• Allegra®Allegra® Patent Litigation
Japan. On November 8, In late 2010, TakadaTakata Seiyaku Co. Ltd. ("Takata") and Sawai Pharmaceutical Co. Ltd. ("Sawai") filed a patent invalidation actionactions at the Japan patent office (JPO)Patent Office ("JPO") against Japan patent nos. 3041954 and 3037697. Subsequently, on January 11, 2011, Sawai Pharmaceutical Co., Ltd filed a patent invalidation at the Japan patent office against the sametwo fexofenadine hydrochloride (the active ingredient in Allegra®) method of treatment patents. Sanofi is the exclusive licensee of these patents, which are set to expire in March 2014, but have obtained a patent term extension for use in treating dermatitis until September 2015. OnIn December 9, 2011, the JPO found theall claims in both patents invalid and Sanofi subsequently appealed on December 15, 2011appealed. In July 2012, during the appeal process, Sanofi entered into settlement agreements with Takata and Sawai. As a result of the settlement agreements, Takata and Sawai withdrew their legal challenges to the Intellectual Property High Court. The appeal is currently pending. On January 17,validity of the '954 and '697 patents. This caused the validity of these two patents to be reinstated by the JPO.
In August 2012, SawaiElmed Eisai Co., Ltd. ("Eisai"), Kobayashi Kako Co., Ltd. ("Kobayashi"), and Taisho Pharm. Ind., Ltd. ("Taisho") obtained approvals to manufacture and market generic fexofenadine hydrochloride products in Japan, despite the existence and validity of the two fexofenadine hydrochloride patents. In August and September 2012, patent invalidation actions against those two patents were filed at the JPO by Eisai, Daiko Pharmaceutical Co. Ltd., Kyorin Rimedio Co. Ltd., Nihon Generic Co., Ltd., Nihon Pharmaceutical Industry Co. Ltd., Nippon Chemiphar Co., Ltd., Nissin Pharmaceutical Co., LtdLtd., Shiono Chemical Co. Ltd., Teva Pharma Japan Inc., and Yoshindo Inc. The invalidation actions are in preliminary stages.
In October 2012, Sanofi filed patent infringement lawsuits against Eisai, Taisho and Kobayashi. Those lawsuits are in an early stage. In December 2012, the previously approved generic fexofenadine hydrochloride products of Eisai and Kobayashi were added to Japan's National Health Insurance (NHI) price list. Since February 2013, Allegra® as a declaratory judgment action at the Tokyo District Court seeking the Courtprescription medicine has been subject to find Japan Patent Nos. 3041954 and 3037697 invalid. This declaratory judgment action is currently pending.
generic competition in this country.
• Eloxatin®Eloxatin® (oxaliplatin) Patent Litigation
United States. Starting in February 2007, over a dozen ANDA certifications relating to Eloxatin® (oxaliplatin) solution and/or lyophilized products were filed contesting part or all of the Orange Book patents under Paragraph IV. Each of the generic manufacturers was sued for infringement of one or more of the Orange-Book listed patents before the U.S. District Court for the District of New Jersey. U.S. regulatory data exclusivity expired in February 2008.
In June 2009, the U.S. District Court for the District of New Jersey granted a summary judgment motion in favor of certain generic manufacturers. The District Court held that the generic oxaliplatin products that would be introduced by these generic challengers would not infringe the U.S. Patent No. 5,338,874 (the ‘874 Patent). While Sanofi obtained appellate reversal of the District Court’s judgment, a number of generic oxaliplatin products were launched “at risk” in the United States over the second half of 2009. Sanofi had been unsuccessful in obtaining injunctive relief. On December 2, 2009, the court asked all the parties to consider settlement.
By April 2010, Sanofi and Debiopharm, licensor of the patents rights concerned, signed settlement agreements with all but one of the generic manufacturers, Sun Pharmaceuticals, thus resolving the litigation over certain formulations of Eloxatin® (oxaliplatin) in the U.S. District Court for the District of New Jersey and the U.S. District Court for the District of Columbia.
Under the terms of the settlement agreements, the generic manufacturers would cease selling their unauthorized generic oxaliplatin products in the U.S. starting from June 30, 2010, to August 9, 2012, at which time the generic manufacturers would be authorized to sell generic oxaliplatin products under a license, before expiry of the patents at issue. The settlement provisions, including the market exit and re-entry dates noted above, are subject to contingencies. The settlement agreements are subject to review by the Federal Trade Commission, the U.S. Department of Justice and the Attorney General for the State of Michigan.
In addition, the court decided that the above-described obligation to cease selling unauthorized generic oxaliplatin in the U.S. market also applied to Sun Pharmaceuticals and issued an injunction against Sun Pharmaceuticals. Sun Pharmaceuticals appealed that decision. On December 22, 2010, the Court of Appeals for the Federal Circuit ruled in favor of Sun Pharmaceuticals, by vacating the U.S. District Court of New Jersey decision and entering an injunction which required Sun Pharmaceuticals to cease selling its “at risk” generic product on June 30, 2010. The Federal Circuit then remanded the case to the District Court.
In February 2011, the U.S. District Court for the District of New Jersey granted Sanofi’sSanofi's request for a preliminary injunction prohibiting Sun Pharmaceuticals from launching an unauthorized generic product.product of oxaliplatin. On September 15,16, 2011, the U.S. District Court for the District of New Jersey ruled in favor of Sanofi, requiring that Sun’sSun's unauthorized generic oxaliplatin remain off the U.S. market until August 9, 2012, pursuant to the April 2010 consent judgment. On October 12, 2011, Sun filed a Notice2012. Sun's appeal of Appeal to the Federal Circuit seeking to overturn the District Court’s judgment. That appeal is pending.
In a related matter, on June 17, 2011, Sanofi filed suit against Sun PharmaceuticalsCourt's ruling was dismissed in the U.S. District Court for the District of New Jersey in response to Sun’s application filed with the FDA seeking marketing approval for a new solution formulation of a generic oxaliplatin product. On December 5, 2011, Sanofi and Sun stipulated that Sun’s proposed generic solution product would be governed by the settlement and license agreements governing Sun’s other proposed generic oxaliplatin product, which enjoin Sun from marketing either product before August 9,September 2012.
• Synvisc One®Synvisc-One® Patent Litigation
In April 2011, Genzyme filed suit in the U.S. District Court for the District of Massachusetts against generic manufacturers Seikagaku Corporation (Seikagaku), Zimmer Holdings, Inc., Zimmer, Inc. and Zimmer U.S., Inc. (collectively, “Zimmer”"Zimmer") for the infringement of U.S. Patent No. 5,399,351 (the ‘351'351 patent) and U.S. Patent No. 7,931,030 (the ‘030'030 patent), upon Seikagaku’sSeikagaku's and Zimmer’sZimmer's launch of generic versions of Synvisc-One®Synvisc-One® in the United States.
On October 3, 2011, the U.S. District Court granted Genzyme’s motion for a temporary restraining order preventing Seikagaku and Zimmer from marketing their generic versions of Synvisc-One® for the remainder of the year 2011.
On December 30, 2011, the U.S. District Court further granted, in part, Genzyme’sGenzyme's Motion for a preliminary injunction, enjoining Seikagaku and Zimmer from selling generic versions of Synvisc-One®Synvisc-One®, pending a decision in the infringement action, except on limited and specific pricing conditions. Full trial on the merits is scheduled to beginIn August 2012, a federal jury in Massachusetts found that Seikagaku Corp's recently approved product Gel-One®, distributed in the second quarter of 2012.
Glossary of Patent Terminology
A number of technical terms which may be used above in Item 8 are defined below forUS by Zimmer, did not infringe the convenience of the reader.
ANDA or Abbreviated New Drug Application (United States): An application by a drug manufacturer to receive authority from the U.S. FDA to market a generic version of another company’s approved product, by demonstrating'030 patent. The jury also found that the purportedly generic version has the same properties (bioequivalence) as the original approved product. As a result of data exclusivity, the ANDA may be filed only several years after the initial market authorization of the original product.
Paragraph III and Paragraph IV Certifications: ANDAs relating'030 patent claims were invalid due to approved productsobviousness. A motion for which a patent has been listed in the FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the “Orange Book”, must specify whether final FDA approval of the ANDA is sought onlyafter expiration of the listed patent(s) (this is known as a Paragraph III certification under the Hatch-Waxman Act) or whether final FDA approval is soughtprior to expiration of one or more listed patents (a Paragraph IV certification). ANDAs including a Paragraph IV certification may be subject to the 30-Month Stay defined below.
Section 505(b)(2) application: A section 505(b)(2) application may be used to seek FDA approval for, among other things, combination products, different salts of listed drugs, products that do not demonstrate bioequivalence to a listed drug and over-the-counter versions of prescription drugs.
Summary judgment: A judgment granted on a claim or defense about which there is no genuine issue of material fact and upon which the movant is entitled to prevail as a matter of law. This procedural device allows the speedy dispositionlaw and a motion for new trial were filed in September 2012.
• Co-Aprovel® Patent Infringement Actions in Europe
Sanofi has been involved since early 2012 in a number of a controversy without the needlegal proceedings involving generic companies that attempted to launch or launched generic versions of Sanofi's Co-Aprovel® in several European countries including, United Kingdom, Belgium, France, Germany, Netherlands, Italy and Norway. Sanofi filed for trial.
30-Month Stay (United States): If patent claims cover a product listedand was granted preliminary injunctions (PI) against several generic companies based on Sanofi's Supplemental Protection Certificate (SPC) covering Co-Aprovel®. However, Sanofi was not granted PIs against three generic companies, Sandoz, Mylan and Arrow, in the FDA’s list of Approved Drug ProductsFrance. Sanofi appealed this decision in August 2012. Sanofi followed its PI actions with Therapeutic Equivalence Evaluations, also known as the “Orange Book”, and are owned by or licensed to the manufacturermain infringement suits against some of the original version,generic companies. A few of the FDA is barred from granting a final approvalgeneric companies have filed revocation actions seeking to an ANDA duringrevoke Sanofi's Co-Aprovel® SPC. Some of these revocation actions were denied
(Italy), others have been suspended (United Kingdom, Belgium), in France, the 30 months followingTribunal de Grande Instance of Paris held the SPC and the patent challenge, unless, beforeinvalid at the end of the 30 months, a court decision or settlement has determined eitherFebruary 2013. Sanofi and BMS have appealed that the ANDA does not infringe the listed patent or that the listed patent is invalid and/or unenforceable. FDA approval of an ANDA after this 30-month period does not resolve outstanding patent disputes, which may continue to be litigated in the courts.decision.
• Lovenox®Lovenox® Regulatory Litigation
In July 2010, Sanofi learned that the Food and Drug Administration (FDA) had approved a generic enoxaparin ANDA filed by Sandoz. Sanofi subsequently filed suit against the FDA in the U.S. District Court for the District of Columbia and requested preliminary injunctive relief against the FDA. In August 2010, the U.S. District Court denied this request. As a result of this ruling, the generic version of enoxaparin can continue to be marketed in the United States. On February 7, 2012, the Court ruled in favor of the FDA regarding the approval of the Sandoz enoxaparin ANDA.
Government Investigations — Pricing and Marketing Practices
SubsidiariesFrom time to time, subsidiaries of Sanofi are subject from time to time to governmental investigations and information requests from regulatory authorities inquiring as to the practices of Sanofi with respect to the sales, marketing, and promotion of its products.
For example, Sanofi is cooperating with the U.S. Department of Justice in its respective investigations into the promotion of Sculptra®, Seprafilm®Seprafilm® and Sculptra®, and Hyalgansettled in December 2012 all claims arising out of an investigation into sampling of its former product Hyalgan®. In that respect, Sanofi U.S. paid U.S.$109 million to the settling parties and expects to enter into a Corporate Integrity Agreement with the Office of the Inspector General of the United States Department of Health and Human Services.
In June 2012, Sanofi U.S. became aware that the U.S. Department of Justice is investigating disclosures to the FDA regarding the variability of response to Plavix®. Sanofi U.S. is cooperating with the U.S. Department of Justice in this matter.
®. In France, Sanofi is involved in an investigation bya claim before the French Antitrust Authority (Autorité de la Concurrence) concerning allegations brought by Teva Santé that Sanofi’sSanofi's communications and promotional practices foreclosedinhibited the entry on the market of Plavix®Plavix® generics. generics.
In Germany, following a criminal complaint filed by Sanofi against one of its distributors, a criminal investigation was initiated against fourthree current and two retired Sanofi employees in connection with the alleged sale in Germany of medications originally destined for humanitarian aid outside of the European Union. The criminal proceedings are ongoing.
Sanofi has received information that improper payments may have been made in connection with the sale of pharmaceutical products in two small markets within the Emerging Markets region. Sanofi currently is assessing whether these payments were made and, if so, whether they fall within the U.S. Foreign Corrupt Practices Act. In connection with its review, Sanofi has provided information to the U.S. Department of Justice and the U.S. Securities and Exchange Commission and is cooperating with these agencies.
A number of technical terms which may be used above in Item 8 are defined below for the convenience of the reader.
ANDA or Abbreviated New Drug Application (United States): An application by a drug manufacturer to receive authority from the U.S. FDA to market a generic version of another company's approved product, by demonstrating that the purportedly generic version has the same properties (bioequivalence) as the original approved product. As a result of data exclusivity, the ANDA may be filed only several years after the initial market authorization of the original product.
Summary judgment: A judgment granted on a claim or defense about which there is no genuine issue of material fact and upon which the movant is entitled to prevail as a matter of law. This procedural device allows the speedy disposition of a controversy without the need for trial.
N/A
• Rhodia Retained Liabilities
On February 5, 2013, Rhodia's motion for reconsideration of the Sao Paolo's Court of Appeal's decision (of September 2011) was rejected by anen banc decision of the same Court. Rhodia may still initiate some recourse against this decision to the Brazilian Supreme Court.
N/A
We have one class of shares. Each American Depositary Share, or ADS, represents one-half of one share. The ADSs are evidenced by American Depositary Receipts, or ADRs, which are issued by JPMorgan Chase Bank, N.A..
Our shares trade on Compartment A of NYSE Euronext Paris, or Euronext Paris, and our ADSs trade on the New York Stock Exchange, or NYSE.
In April 2011, in connection with our acquisition of Genzyme, we issued contingent value rights (“CVRs”("CVRs") under a CVR agreement entered into by and between us and the American Stock Transfer & Trust Company, LLC, as trustee (see Item 10.C. Material Contracts — The Contingent Value Rights Agreement). Our CVRs trade on the NASDAQ Global Market.
Trading History
The table below sets forth, for the periods indicated, the reported high and low market prices of our shares on Euronext Paris and our ADSs on the NYSE (source: Bloomberg).
| Shares, as traded on Euronext Paris | ADSs, as traded on the NYSE | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Calendar period | High | Low | High | Low | |||||||||
| (price per share in €) | (price per ADS in $) | |||||||||||
Monthly | |||||||||||||
February 2013 | 74.20 | 65.91 | 49.70 | 44.50 | |||||||||
January 2013 | 74.29 | 71.50 | 49.56 | 47.43 | |||||||||
December 2012 | 72.38 | 68.43 | 47.97 | 44.82 | |||||||||
November 2012 | 69.95 | 66.46 | 45.26 | 42.20 | |||||||||
October 2012 | 69.86 | 65.63 | 45.72 | 42.52 | |||||||||
September 2012 | 69.46 | 64.52 | 44.97 | 40.52 | |||||||||
2012 | |||||||||||||
First quarter | 59.56 | 54.86 | 39.19 | 34.92 | |||||||||
Second quarter | 59.74 | 53.20 | 39.33 | 33.03 | |||||||||
Third quarter | 69.46 | 59.45 | 44.97 | 36.53 | |||||||||
Fourth quarter | 72.38 | 65.63 | 47.97 | 42.20 | |||||||||
Full Year | 72.38 | 53.20 | 47.97 | 33.03 | |||||||||
2011 | |||||||||||||
First quarter | 52.23 | 46.04 | 36.29 | 31.45 | |||||||||
Second quarter | 56.50 | 49.64 | 40.75 | 35.34 | |||||||||
Third quarter | 56.82 | 42.85 | 40.58 | 30.98 | |||||||||
Fourth quarter | 56.75 | 47.00 | 37.66 | 31.61 | |||||||||
Full Year | 56.82 | 42.85 | 40.75 | 30.98 |
| Shares, as traded on Euronext Paris | ADSs, as traded on the NYSE | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Calendar period | High | Low | High | Low | |||||||||
| (price per share in €) | (price per ADS in $) | |||||||||||
2010 | |||||||||||||
Full Year | 58.90 | 44.01 | 41.59 | 28.01 | |||||||||
2009 | |||||||||||||
Full Year | 56.78 | 38.43 | 40.80 | 24.59 | |||||||||
2008 | |||||||||||||
Full Year | 66.90 | 36.055 | 49.04 | 23.95 | |||||||||
Shares, as traded on Euronext Paris | ADSs, as traded on the NYSE | |||||||||||||||||
Calendar period | High | Low | High | Low | ||||||||||||||
(price per share in €) | (price per ADS in $) | |||||||||||||||||
Monthly | ||||||||||||||||||
February 2012 | 56.91 | 54.86 | 38.04 | 36.31 | ||||||||||||||
January 2012 | 57.42 | 54.89 | 37.58 | 34.92 | ||||||||||||||
December 2011 | 56.75 | 51.14 | 36.85 | 33.64 | ||||||||||||||
November 2011 | 52.51 | 47.00 | 35.40 | 31.61 | ||||||||||||||
October 2011 | 53.53 | 47.95 | 37.66 | 31.63 | ||||||||||||||
September 2011 | 51.90 | 45.52 | 37.07 | 31.00 | ||||||||||||||
August 2011 | 54.75 | 42.85 | 39.04 | 30.98 | ||||||||||||||
2011 | ||||||||||||||||||
First quarter | 52.23 | 46.04 | 36.29 | 31.45 | ||||||||||||||
Second quarter | 56.50 | 49.64 | 40.75 | 35.34 | ||||||||||||||
Third quarter | 56.82 | 42.85 | 40.58 | 30.98 | ||||||||||||||
Fourth quarter | 56.75 | 47.00 | 37.66 | 31.61 | ||||||||||||||
Full Year | 56.82 | 42.85 | 40.75 | 30.98 | ||||||||||||||
2010 | ||||||||||||||||||
First quarter | 58.90 | 51.68 | 41.59 | 34.90 | ||||||||||||||
Second quarter | 55.85 | 45.21 | 37.72 | 28.01 | ||||||||||||||
Third quarter | 50.90 | 44.01 | 34.10 | 28.03 | ||||||||||||||
Fourth quarter | 51.41 | 46.23 | 36.31 | 30.05 | ||||||||||||||
Full Year | 58.90 | 44.01 | 41.59 | 28.01 | ||||||||||||||
2009 | ||||||||||||||||||
Full Year | 56.78 | 38.43 | 40.80 | 24.59 | ||||||||||||||
2008 | ||||||||||||||||||
Full Year | 66.90 | 36.055 | 49.04 | 23.95 | ||||||||||||||
2007 | ||||||||||||||||||
Full Year | 71.95 | 56.20 | 48.30 | 37.90 |
Fluctuations in the exchange rate between the euro and the U.S. dollar will affect any comparisons of euro share prices and U.S. ADS prices.
N/A
Shares and ADSs
Our shares are listed on Euronext Paris under the symbol “SAN”"SAN" and our ADSs are listed on the NYSE under the symbol “SNY”"SNY".
As of the date of this annual report, our shares are included in a large number of indices, including the “CAC"CAC 40 Index,”Index", the principal French index published by Euronext Paris. This index contains 40 stocks selected among the top 100 companies based on free-float capitalization and the most active stocks listed on the Euronext Paris market. The CAC 40 Index indicates trends in the French stock market as a whole and is one of the most widely followed stock price indices in France. Our shares are also included in the S&P Global 100 Index, the Dow Jones EuroSTOXX 50, the Dow Jones STOXX 50, the FTS Eurofirst 100, the FTS Eurofirst 80 and the MSCI Pan-Euro Index, among other indices.
CVRs
Our CVRs trade on the NASDAQ Global Market under the symbol “GCVRZ”"GCVRZ".
Participating Shares Series A
In accordance with its prior intentions and in the view of the limited number of registered holders of Participating Shares Series A which was reported to Sanofi to amount to 7, as of December 13, 2011, the Company filed on December 16, 2011 a Form 15 to terminate the registration of the Participating Shares Series A. Upon such filing, the Company’s duty to file reports with the SEC with respect to such Participating Shares Series A ceased.
Trading by Sanofi in our own Shares
Under French law, a company may not issue shares to itself, but it may purchase its own shares in the limited cases described at “Item"Item 10. Additional Information — B. Memorandum and Articles of Association — Trading in Our Own Shares.”
"
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N/A
N/A
Item 10. Additional Information
N/A
B. Memorandum and Articles of Association
General
Our Company is asociété anonyme, a form of limited liability company, organized under the laws of France.
In this section, we summarize material information concerning our share capital, together with material provisions of applicable French law and ourstatuts, an English translation of which has been filed as an exhibit to this annual report. For a description of certain provisions of ourstatutsrelating to our Board of Directors and statutory auditors, see “Item"Item 6. Directors, Senior Management and Employees.”" You may obtain copies of ourstatutsin French from thegreffe(Clerk) of theRegistre du Commerce et des Sociétés de Paris(Registry (Registry of Commerce and Companies of Paris, France, registration number: 395 030 844). Please refer to that full document for additional details.
Ourstatutsspecify that our corporate affairs are governed by:
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Article 3 of ourstatuts specifies that the Company’sCompany's corporate purpose, in France and abroad, is:
in the following areas:
and, more generally:
Directors
Transactions in Which Directors Are Materially Interested
Under French law, any agreement entered into (directly or through an intermediary) between our Company and any one of the members of the Board of Directors that is not entered into (i) in the ordinary course of our
business and (ii) under normal conditions is subject to the prior authorization of the disinterested members of the Board of Directors. The same provision applies to agreements between our Company and another company if one of the members of the Board of Directors is the owner, general partner, manager, director, general manager or member of the executive or supervisory board of the other company, as well as to agreements in which one of the members of the Board of Directors has an indirect interest.
The Board of Directors must also authorize any undertaking taken by our Company for the benefit of our Chairman, Chief Executive Officer (directeur général) or his delegates (directeurs généraux délégués) pursuant to which such persons will or may be granted compensation, benefit or any other advantage as a result of the termination of or a change in their offices or following such termination or change.
In addition, except with respect to any non-compete indemnity or certain pension benefits, any such termination package,:package: (i) must be authorized by our shareholders through the adoption of a separate general shareholders meeting resolution for each such beneficiary, which authorization must be renewed at each renewal of such beneficiary’sbeneficiary's mandate, and (ii) cannot be paid to such beneficiary unless (a) the Board of Directors decides that such beneficiary has satisfied certain conditions, linked to such beneficiary’sbeneficiary's performance measured by our Company’sCompany's performance, that must have been defined by the Board of Directors when granting such package, and (b) such decision is publicly disclosed.
Directors’Directors' Compensation
The aggregate amount of attendance fees (jetons de présence) of the Board of Directors is determined at the Shareholders’Shareholders' Ordinary General Meeting. The Board of Directors then divides this aggregate amount among its members by a simple majority vote. In addition, the Board of Directors may grant exceptional compensation (rémunérations exceptionnelles) to individual directors on a case-by-case basis for special assignments following the procedures described above at “—"— Transactions in Which Directors Are Materially Interested.”" The Board of Directors may also authorize the reimbursement of travel and accommodation expenses, as well as other expenses incurred by Directors in the corporate interest. See also “Item"Item 6. Directors, Senior Management and Employees.”"
Board of Directors’Directors' Borrowing Powers
All loans or borrowings on behalf of the Company may be decided by the Board of Directors within the limits, if any, imposed by the Shareholders’Shareholders' General Meeting. There are currently no limits imposed on the amounts of loans or borrowings that the Board of Directors may approve.
Directors’Directors' Age Limits
For a description of the provisions of ourstatutsrelating to age limits applicable to our Directors, see “Item"Item 6. Directors, Senior Management and Employees.”"
Directors’Directors' Share Ownership Requirements
Pursuant to the Board Charter, our Directors are required to hold at least 1,000 shares during the term of their appointment.
Share Capital
As of December 31, 2011,2012, our share capital amounted to €2,681,837,622,€2,652,685,918, divided into 1,340,918,8111,326,342,959 outstanding shares with a par value of €2 per share. All of our outstanding shares are of the same class and are fully paid. Of these shares, we or entities controlled by us held 17,225,8033,150,287 shares (or 1.28%0.24% of our outstanding share
capital), as treasury shares as of such date. As of December 31, 2011,2012, the carrying amount of such shares was €933€207 million.
At an extraordinary general meeting held on May 6, 2011, our shareholders authorized our Board of Directors to increase our share capital, through the issuance of shares or other securities giving access to the share capital with or without preemptive rights, by an aggregate maximum nominal amount of €1.3 billion. See “—"— Changes in Share Capital — Increases in Share Capital,”" below.
The maximum total amountnumber of authorized but unissued shares as of December 31, 20112012 was 231.6321 million, reflecting the unused part of the April 17, 2009May 6, 2011 and May 6, 20114, 2012 shareholder authorizations to issue shares without preemptive rights, outstanding options to subscribe for shares, and awards of shares.
Stock Options
We have two types of stock options outstanding: options to subscribe for shares (options de souscription d’actionsd'actions) and options to purchase shares (options d’achat d’actionsd'achat d'actions). Upon exercise of an option to subscribe for shares, we issue new shares, whereas upon exercise of an option to purchase shares, the option holder receives existing shares. We purchase our shares on the market prior to the grantvesting of the options to purchase in order to provide the option holder with shares upon exercise. Following the merger of Aventis with and into sanofi-aventis (which became Sanofi on May 2011), all previously granted options for the shares of Aventis were converted into options for our shares.
Because the exercise of options to purchase shares will be satisfied with existing shares repurchased on the market or held in treasury, the exercise of options to purchase shares has no impact on the amount of our equity share capital.
Our combined general meeting held on May 6, 2011 authorized our Board of Directors for a period of 26 months to grant, on one or more occasions, options to subscribe for shares and options to purchase shares in favor of persons to be chosen by the Board of Directors from among the salaried employees and corporate officers of our Company or of companies or groupings of economic interest of the Group in accordance with Article L. 225-180 of the French Commercial Code.
The aggregate number of options to subscribe for shares and options to purchase shares that may be granted under this authorization may not give entitlement to a total number of shares exceeding 1% of the share capital as of the date of the decision by the Board of Directors to grant such options.
The Board of Directors sets the exercise price of options to subscribe for shares and options to purchase shares. However, the exercise price never incorporates a discount and must be at least equal to the average of the quoted market prices on the 20 trading sessions preceding the date of grant by the Board of Directors.
Stock option plans generally provide for a lock-up period of four years and have a duration of ten years.
Under such authorization the shareholders expressly waive, in favor of the grantees of options to subscribe for shares, of their preemptive rights in respect of shares that are to be issued as and when options are exercised.
The Board of Directors is granted full power to implement this authorization and to set the terms and conditions on which options are granted and the arrangements with respect to the dividend entitlement of the shares.
See “Item"Item 6. Directors, Senior Management and Employees — E. Share Ownership”Ownership" for a description of our option plans currently in force.
Awards of Shares
Our combined general meeting held on April 17, 2009May 4, 2012 authorized our Board of Directors for a period of 38 months to allot, on one or more occasions, existing or new restricted shares in favor of persons to be chosen by the Board of Directors from among the salaried employees and corporate officers of our Company or of companies or groupings of economic interest groupings of the Group in accordance with Articles L. 225-197-1et seq. of the French Commercial Code.
The existing or new shares allotted under this authorization may not represent more than 1%1.2% of the share capital as of the date of the decision by the Board of Directors to allot such shares.
The authorization provides that allotment of shares to the allottees will become irrevocable either (i) at the end of a minimum vesting period of twothree years, in which case the allottees will also be required to retain their shares for a minimum period of two years from the irrevocable allotment thereof, or (ii) after a minimum vesting period of four years, in which case allottees may not be subject to any minimum retention period.
In the case of newly issued shares, the authorization entails the express waiver by the shareholders, in favor of the allottees of restricted shares, of their preemptive rights in respect of shares that are to be issued as and when restricted shares vest.
The Board of Directors sets the terms on which restricted shares are granted and the arrangements with respect to the dividend entitlement of the shares.
See “Item"Item 6. Directors, Senior Management and Employees — E. Share Ownership”Ownership" for a description of our restricted shares plans currently in force.
Changes in Share Capital in 20112012
See Note D.15.1. to our consolidated financial statements included at Item 18 of this annual report.
Voting Rights
In general, each shareholder is entitled to one vote per share at any shareholders’shareholders' general meeting. Ourstatuts do not provide for cumulative voting rights. However, ourstatutsprovide that any fully paid-up shares that have been held in registered form under the name of the same shareholder for at least two years acquire double voting rights. The double voting rights cease automatically for any share converted into bearer form or transferred from one owner to another, subject to certain exceptions permitted by law.
As of December 31, 2011,2012, there were 183,197,929142,585,235 shares that were entitled to double voting rights, representing 13.66%10.75% of our total share capital, approximately 24.31%9.73% of our voting rights held by holders other than us and our subsidiaries, and 24.04%9.71% of our total voting rights.
Double voting rights are not taken into account in determining whether a quorum exists.
Under the French Commercial Code, treasury shares or shares held by entities controlled by that company are not entitled to voting rights and do not count for quorum purposes.
Ourstatuts allow us to obtain from Euroclear France the name, nationality, address and number of shares held by holders of our securities that have, or may in the future have, voting rights. If we have reason to believe that a person on any list provided by Euroclear France holds securities on behalf of another person, ourstatuts allow us to request information regarding beneficial ownership directly from such person. See “—"— B. Memorandum and Articles of Association — Form, Holding and Transfer of Shares,”" below.
Ourstatutsprovide that Board members are elected on a rolling basis for a maximum tenure of four years.
Shareholders’Shareholders' Agreement
We are not aware of any shareholder’sshareholder's agreement currently in force concerning our shares.
Shareholders’Shareholders' Meetings
In accordance with the provisions of the French Commercial Code, there are three types of shareholders’shareholders' meetings: ordinary, extraordinary and special.
Ordinary general meetings of shareholders are required for matters such as:
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Extraordinary general meetings of shareholders are required for approval of matters such as amendments to ourstatuts, including any amendment required in connection with extraordinary corporate actions. Extraordinary corporate actions include:
Special meetings of shareholders of a certain category of shares or shares with certain specific rights (such as shares with double voting rights) are required for any modification of the rights derived from that category of shares. The resolutions of the shareholders’shareholders' general meeting affecting these rights are effective only after approval by the relevant special meeting.
The French Commercial Code requires the Board of Directors to convene an annual ordinary general shareholders’shareholders' meeting to approve the annual financial statements. This meeting must be held within six months of the end of each fiscal year. This period may be extended by an order of the President of the Commercial Court. The Board of Directors may also convene an ordinary or extraordinary general shareholders’shareholders' meeting upon proper notice at any time during the year. If the Board of Directors fails to convene a shareholders’shareholders' meeting, our independent auditors may call the meeting. In case of bankruptcy, the liquidator or court-appointed agent may also call a shareholders’shareholders' meeting in some instances. In addition, any of the following may request the court to appoint an agent for the purpose of calling a shareholders’shareholders' meeting:
Notice of Shareholders’Shareholders' Meetings
All prior notice periods provided for below are minimum periods required by French law and cannot be shortened, except in case of a public offer for our shares.
We must announce general meetings at least thirty-five days in advance by means of a preliminary notice (avis de réunion), which is published in theBulletin des Annonces Légales Obligatoires, orBALO. The preliminary notice must first be sent to the French Financial markets authority (Autorité des marchesmarchés financiers, the “AMF”"AMF"), with an indication of the date on which it will be published in the BALO. It must be published on our website at least twenty-one days prior to the general meeting. The preliminary notice must contain, among other things, the agenda, a draft of the resolutions to be submitted to the shareholders for consideration at the
general meeting and a detailed description of the voting procedures (proxy voting, electronic voting or voting by mail), the procedures permitting shareholders to submit additional resolutions or items to the agenda and to ask written questions to the Board of Directors. The AMF also recommends that, prior to or simultaneously with the publication of the preliminary notice, we publish a summary of the notice indicating the date, time and place of the meeting in a newspaper of national circulation in France and on our website.
At least fifteen days prior to the date set for a first convening, and at least ten days prior to any second convening, we must send a final notice (avis de convocation) containing the final agenda, the date, time and place of the meeting and other information related to the meeting. Such final notice must be sent by mail to all registered shareholders who have held shares in registered form for more than one month prior to the date of the final notice and by registered mail, if shareholders have asked for it and paid the corresponding charges. The final notice must also be published in a newspaper authorized to publish legal announcements in the local administrative department (département) in which our Company is registered as well as in theBALO, with prior notice having been given to the AMF for informational purposes. Even if there are no proposals for new resolutions or items to be submitted to the shareholders at the meeting, we must publish a final notice in a newspaper authorized to publish legal announcements in the local administrative department (départment) in with our Company is registered as well as in theBALO.
In general, shareholders can only take action at shareholders’shareholders' meetings on matters listed on the agenda. As an exception to this rule, shareholders may take action with respect to the appointment and dismissal of directors even if this action has not been included on the agenda.
Additional resolutions to be submitted for approval by the shareholders at the shareholders’shareholders' meeting may be proposed to the Board of Directors, for recommendation to the shareholders at any time from the publication of the preliminary notice in theBALO until twenty-five days prior to the general meeting and in any case no later than twenty days following the publication of the preliminary notice in theBALOby:
Within the same period, the shareholders may also propose additional items (points) to be submitted and discussed during the shareholders’shareholders' meeting, without a shareholders’shareholders' vote. The shareholders must substantiate the reasons for proposing their proposals of additional items.
The resolutions and the list of items added to the agenda of the shareholders’shareholders' meeting must be promptly published on our website.
The Board of Directors must submit the resolutions to a vote of the shareholders after having made a recommendation thereon. The Board of Directors may also comment on the items that are submitted to the shareholders’shareholders' meeting.
Following the date on which documents must be made available to the shareholders (including documents to be submitted to the shareholders’shareholders' meeting and resolutions proposed by the Board of Directors, which must be published on our website at least twenty-one days prior to the general meeting), shareholders may submit written questions to the Board of Directors relating to the agenda for the meeting until the fourth business day prior to the general meeting. The Board of Directors must respond to these questions during the meeting or may refer to a Q&A section located on our website in which the question submitted by a shareholder has already been answered.
Attendance at Shareholders’Shareholders' Meetings; Proxies and Votes by Mail
In general, all shareholders may participate in general meetings either in person or by proxy. Shareholders may vote in person, by proxy or by mail.
The right of shareholders to participate in general meetings is subject to the recording (enregistrement comptable) of their shares on the third business day, zero hour (Paris time), preceding the general meeting:
Attendance in Person
��Any shareholder may attend ordinary general meetings and extraordinary general meetings and exercise its voting rights subject to the conditions specified in the French Commercial Code and ourstatuts.
Proxies are sent to any shareholder upon a request received between the publication of the final notice of meeting and six days before the general meeting and must be made available on our website at least twenty-one days before the general meeting. In order to be counted, such proxies must be received at our registered office, or at any other address indicated on the notice of the meeting or by any electronic mail indicated on the notice of the meeting, prior to the date of the meeting (in practice, we request that shareholders return proxies at least three business days prior to the meeting; electronic proxies must be returned before 3 p.m. Paris time, on the day prior to the general meeting). A shareholder may grant proxies to any natural person or legal entity. The agent may be required to disclose certain information to the shareholder or to the public.
Alternatively, the shareholder may send us a blank proxy without nominating any representative. In this case, the chairman of the meeting will vote the blank proxies in favor of all resolutions proposed or approved by the Board of Directors and against all others.
With respect to votes by mail, we must send to shareholders a voting form upon request or must make available a voting form on our website at least twenty-one days before the general meeting. The completed form must be returned to us at least three days prior to the date of the shareholders’shareholders' meeting. For holders of registered shares, in addition to traditional voting by mail, instructions may also be given via the internet.
Quorum
The French Commercial Code requires that shareholders holding in the aggregate at least 20% of the shares entitled to vote must be present in person, or vote by mail or by proxy, in order to fulfill the quorum requirement for:
of free share warrants in the event of a public offer for our shares (article L. 233-32 of the French Commercial Code).
For any other extraordinary general meeting the quorum requirement is at least 25% of the shares entitled to vote, held by shareholders present in person, voting by mail or by proxy.
For a special meeting of holders of a certain category of shares, the quorum requirement is one third of the shares entitled to vote in that category, held by shareholders present in person, voting by mail or by proxy.
If a quorum is not present at a meeting, the meeting is adjourned. However, only questions that were on the agenda of the adjourned meeting may be discussed and voted upon once the meeting resumes.
When an adjourned meeting is resumed, there is no quorum requirement for meetings cited in the first paragraph of this “"Quorum”" section. In the case of any other reconvened extraordinary general meeting or special meeting, the quorum requirement is 20% of the shares entitled to vote (or voting shares belonging to the relevant category for special meetings of holders of shares of such specific category), held by shareholders present in person or voting by mail or by proxy. If a quorum is not met, the reconvened meeting may be adjourned for a maximum of two months with the same quorum requirement. No deliberation or action by the shareholders may take place without a quorum.
Votes Required for Shareholder Action
The affirmative vote of a simple majority of the votes cast may pass a resolution at either an ordinary general meeting or an extraordinary general meeting where the only resolution(s) pertain to either (a) a proposed increase in our share capital through incorporation of reserves, profits or share premium, or (b) the potential issuance of free share warrants in the event of a public offer for our shares (article L. 233-32 of the French Commercial Code). At any other extraordinary general shareholders’shareholders' meeting and at any special meeting of holders of a specific category of shares, the affirmative vote of two-thirds of the votes cast is required.
Abstention from voting by those present or those represented by proxy or voting by mail is counted as a vote against the resolution submitted to a shareholder vote.
Changes to Shareholders’Shareholders' Rights
Under French law, the affirmative vote of two-thirds of the votes cast at an extraordinary shareholders’shareholders' meeting is required to change ourstatuts, which set out the rights attached to our shares, except for capital increases through incorporation of reserves, profits or share premium, or through the issuance of free share warrants in the event of a public offer for our shares (article L. 233-32 of the French Commercial Code).
The rights of a class of shareholders can be amended only after a special meeting of the class of shareholders affected has taken place. The voting requirements applicable to this type of special meeting are the same as those applicable to an extraordinary general shareholders’shareholders' meeting. The quorum requirements for a special meeting are one-third of the voting shares, or 20% upon resumption of an adjourned meeting.
A unanimous shareholders’shareholders' vote is required to increase the liabilities of shareholders.
Financial Statements and Other Communications with Shareholders
In connection with any shareholders’shareholders' meeting, we must provide a set of documents including our annual report and a summary of the financial results of the five previous fiscal years to any shareholder who so requests.
We must also provide on our website at least twenty-one days before a shareholders’shareholders' meeting certain information and a set of documents that includes the preliminary notice, the proxies and voting forms, the resolutions proposed by the Board of Directors, and the documents to be submitted to the shareholders’shareholders' meeting pursuant to articles L.225-15L. 225-15 and R.225-83R. 225-83 of the French Commercial Code, etc. The resolutions and the list of items added to the agenda of the shareholders’shareholders' meeting must be promptly published on our website.
Dividends
We may only distribute dividends out of our “distributable"distributable profits,”" plus any amounts held in our reserves that the shareholders decide to make available for distribution, other than those reserves that are specifically required by law or ourstatuts. “Distributable profits”"Distributable profits" consist of our unconsolidated net profit in each fiscal year, as increased or reduced by any profit or loss carried forward from prior years, less any contributions to the reserve accounts pursuant to law or ourstatuts.
The French Commercial Code requires us to allocate 5% of our unconsolidated net profit for each year to our legal reserve fund before dividends may be paid with respect to that year. Funds must be allocated until the
amount in the legal reserve is equal to 10% of the aggregate par value of the issued and outstanding share capital. This restriction on the payment of dividends also applies to each of our French subsidiaries on an unconsolidated basis. At December 31, 2011,2012, our legal reserve amounted to €282,280,863, representing 10.53%10.64% of the aggregate par value of our issued and outstanding share capital as of that date. The legal reserve of any company subject to this requirement may serve to allocate losses that may not be allocated to other reserves, or may be distributed to shareholders upon liquidation of the company.
According to the French Commercial Code, our Board of Directors may propose a dividend for approval by shareholders at the annual general shareholders’shareholders' meeting. If we have earned distributable profits since the end of the preceding fiscal year, as reflected in an interim income statement certified by our independent auditors, our Board of Directors may distribute interim dividends to the extent of the distributable profits for the period covered by the interim income statement. Our Board of Directors exercises this authority subject to French law and regulations and may do so without obtaining shareholder approval.
Dividends are distributed to shareholderspro rata according to their respective holdings of shares. In the case of interim dividends, distributions are made to shareholders on the date set by our Board of Directors during the meeting in which the distribution of interim dividends is approved. The actual dividend payment date is decided by the shareholders at an ordinary general shareholders’shareholders' meeting or by our Board of Directors in the absence of such a decision by the shareholders. Shareholders that own shares on the actual payment date are entitled to the dividend.
Dividends may be paid in cash or, if the shareholders’shareholders' meeting so decides, in kind, provided that all shareholders receive a whole number of assets of the same nature paid in lieu of cash. Ourstatutsprovide that, subject to a decision of the shareholders’shareholders' meeting taken by ordinary resolution, each shareholder may be given the choice to receive his dividend in cash or in shares.
According to the French Commercial Code, we must pay any existing dividends within nine months of the end of our fiscal year, unless otherwise authorized by court order. Dividends on shares that are not claimed within five years of the date of declared payment revert to the French State.
Changes in Share Capital
As provided for by the French Commercial Code, our share capital may be increased only with shareholders’shareholders' approval at an extraordinary general shareholders’shareholders' meeting following the recommendation of our Board of Directors. The shareholders may delegate to our Board of Directors either the authority(délégation de compétence) or the power(délégation de pouvoir) to carry out any increase in share capital. Our Board of Directors may further delegate this power to our Chief Executive Officer or, subject to our Chief Executive Officer’sOfficer's approval, to his delegates(directeurs généraux délégués).
Increases in our share capital may be effected by:
Increases in share capital by issuing additional securities may be effected through one or a combination of the following:
Decisions to increase the share capital through the capitalization of reserves, profits and/or share premium or through the issuance of free share warrants in the event of a public offer for our shares (article L. 233-32 of the French Commercial Code) require shareholders’shareholders' approval at an extraordinary general shareholders’shareholders' meeting, acting under the quorum and majority requirements applicable to ordinary shareholders’shareholders' meetings. Increases effected by an increase in the par value of shares require unanimous approval of the shareholders, unless effected by capitalization of reserves, profits or share premium. All other capital increases require shareholders’shareholders' approval at an extraordinary general shareholders’shareholders' meeting acting under the regular quorum and majority requirements for such meetings. See “— Quorum”"— Quorum" and “—"— Votes Required for Shareholder Action”Action" above.
On May 6, 2011, our shareholders approved various resolutions delegating to the Board of Directors the authority to increase our share capital through the issuance of shares or securities giving access to the share capital, subject to an overall cap set at €1.3 billion. This cap applies to all the resolutions whereby the extraordinary shareholders’shareholders' meeting delegated to the Board of Directors the authority to increase the share capital, it being also specified that:
On May 6, 2011, our shareholders also approved resolutions delegating to the Board of Directors the authority to increase the share capital by granting options to our employees and/or corporate officers, subject to the overall cap mentioned above and under the following terms and conditions:
On April 17, 2009,May 4, 2012, our shareholders also approved resolutions delegating to the Board of Directors the authority to increase the share capital by granting existing or new restricted shares to our employees and/or corporate officers, subject to the overall cap mentioned above and under the following terms and conditions:
See also “Item"Item 6. Directors, Senior Management and Employees — E. Share Ownership”Ownership".
In accordance with the provisions of the French Commercial Code, any decrease in our share capital requires approval by the shareholders entitled to vote at an extraordinary general meeting. The share capital may be reduced either by decreasing the par value of the outstanding shares or by reducing the number of outstanding shares. The number of outstanding shares may be reduced either by an exchange of shares or by the repurchase and cancellation of shares. Holders of each class of shares must be treated equally unless each affected shareholder agrees otherwise.
In addition, specific rules exist to permit the cancellation of treasury shares, by which the shareholders’shareholders' meeting may authorize the cancellation of up to a maximum of 10% of a company’scompany's share capital within any 24-month period. On May 6, 2011, our shareholders delegated to our Board of Directors for 26 months the right to reduce our share capital by canceling our own shares.
Preemptive Rights
According to the French Commercial Code, if we issue additional securities to be paid in cash, current shareholders will have preemptive rights to these securities on apro rata basis. These preemptive rights require us to give priority treatment to current shareholders. The rights entitle the individual or entity that holds them to subscribe to the issuance of any securities that may increase the share capital of our Company by means of a cash payment or a set-off of cash debts. Preemptive rights are transferable during the subscription period relating to a particular offering. These rights may also be listed on Euronext Paris Stock Exchange.
Preemptive rights with respect to any particular offering may be waived by the affirmative vote of shareholders holding two-thirds of the shares entitled to vote at an extraordinary general meeting. Our Board of Directors and our independent auditors are required by French law to present reports that specifically address any proposal to waive preemptive rights. In the event of a waiver, the issue of securities must be completed within the period prescribed by law. Shareholders may also notify us that they wish to waive their own preemptive rights with respect to any particular offering if they so choose.
The shareholders may decide at extraordinary general meetings to give the existing shareholders a non-transferable priority right to subscribe to the new securities, for a limited period of time.
In the event of a capital increase without preemptive rights to existing shareholders, French law requires that the capital increase be made at a price equal to or exceeding the weighted average market prices of the shares for the last three trading days on Euronext Paris Stock Exchange prior to the determination of the subscription price of the capital increase less 5%.
Form, Holding and Transfer of Shares
Ourstatutsprovide that the shares may be held in either bearer form or registered form at the option of the holder.
In accordance with French law relating to the dematerialization of securities, shareholders’shareholders' ownership rights are represented by book entries instead of share certificates. We maintain a share account with Euroclear France (a French clearing system, which holds securities for its participants) for all shares in registered form, which is administered by BNP Paribas Securities Services. In addition, we maintain separate accounts in the name of each shareholder either directly or, at a shareholder’sshareholder's request, through the shareholder’sshareholder's accredited intermediary. Each shareholder account shows the name of the holder and the number of shares held. BNP Paribas Securities Services issues confirmations (attestations d’inscriptiond'inscription en compte) to each registered shareholder as to shares registered in the shareholder’sshareholder's account, but these confirmations are not documents of title.
Shares of a listed company may also be issued in bearer form. Shares held in bearer form are held and registered on the shareholder’sshareholder's behalf in an account maintained by an accredited financial intermediary and are
credited to an account at Euroclear France maintained by such intermediary. Each accredited financial intermediary maintains a record of shares held through it and provides the account holder with a securities account statement. Transfers of shares held in bearer form may only be made through accredited financial intermediaries and Euroclear France.
Shares held by persons who are not domiciled in France may be registered in the name of intermediaries who act on behalf of one or more investors. When shares are so held, we are entitled to request from such intermediaries the names of the investors. Also, we may request any legal entity (personne morale) which holds more than 2.5% of our shares or voting rights to disclose the name of any person who owns, directly or indirectly, more than one-third of its share capital or of its voting rights. A person not providing the complete requested information in time, or who provides incomplete or false information, will be deprived of its voting rights at shareholders’shareholders' meetings and will have its payment of dividends withheld until it has provided the requested information in strict compliance with French law. If such person acted willfully, the person may be deprived by a French court of either its voting rights or its dividends or both for a period of up to five years.
Ourstatutsdo not contain any restrictions relating to the transfer of shares.
Registered shares must be converted into bearer form before being transferred on the Euronext Paris Stock Exchange on the shareholders’shareholders' behalf and, accordingly, must be registered in an account maintained by an accredited financial intermediary on the shareholders’shareholders' behalf. A shareholder may initiate a transfer by giving instructions to the relevant accredited financial intermediary.
A fee or commission is payable to the broker involved in the transaction, regardless of whether the transaction occurs within or outside France. Registration duty is currently payable in France if a written deed of sale and purchase (acte) is executed in France or outside France with respect to the shares of the Company.
Redemption of Shares
Under French law, our Board of Directors is entitled to redeem a set number of shares as authorized by the extraordinary shareholders’shareholders' meeting. In the case of such an authorization, the shares redeemed must be cancelled within one month after the end of the offer to purchase such shares from shareholders. However, shares redeemed on the open market do not need to be cancelled if the company redeeming the shares grants options on or awards those shares to its employees within one year following the acquisition. See also “—"— Trading in Our Own Shares”Shares" below.
Sinking Fund Provisions
Ourstatuts do not provide for any sinking fund provisions.
Liability to Further Capital Calls
Shareholders are liable for corporate liabilities only up to the par value of the shares they hold; they are not liable to further capital calls.
Liquidation Rights
If we are liquidated, any assets remaining after payment of our debts, liquidation expenses and all of our remaining obligations will first be distributed to repay in full the par value of our shares. Any surplus will be distributedpro rataamong shareholders in proportion to the par value of their shareholdings.
Requirements for Holdings Exceeding Certain Percentages
The French Commercial Code provides that any individual or entity, acting alone or in concert with others, that becomes the owner, directly or indirectly, of more than 5%, 10%, 15%, 20%, 25%, 30%, 331/3%3%, 50%, 662/3%3%, 90% or 95% of the outstanding shares or voting rights of a listed company in France, such as our Company, or that increases or decreases its shareholding or voting rights above or below any of those
percentages, must notify the company, before the end of the fourth trading day following the date it crosses the threshold, of the number of shares it holds and their voting rights. The individual or entity must also notify the AMF before the end of the fourth trading day following the date it crosses any such threshold. The AMF makes the notice public.
ThePursuant to the French Commercial Code and the AMF also requires disclosureGeneral Regulation, the participation thresholds shall be calculated on the basis of certain information relatingthe shares and voting rights owned, and shall take into account the shares and voting rights which are deemed to other financial instruments (e.g., convertible or exchangeable securities, warrants, equity swaps, etc.) that could increase the shareholding ofbe shares and voting rights owned, even if the individual or entity.entity does not itself hold shares or voting rights. In accordance with this deemed ownership principle, the individual or entity must take into account specific situations where shares and voting rights are deemed to be shares and voting rights owned when calculating the number of shares owned to be disclosed in the notifications to the Company and to the AMF. It includes among others situations where an individual or entity is entitled to acquire issued shares at its own initiative, immediately or at the end of a maturity period, under an agreement or a financial instrument, without set-off against the number of shares that this individual or entity is entitled to sell under another agreement or financial instrument. The individual or entity required to make such notification shall also take into account issued shares covered by an agreement or cash-settled financial instrument and having an economic effect for said individual or entity that is equivalent to owning such shares. In the cases of deemed ownership described above, the notification shall mention the type of deemed ownership and include a description of the main characteristics of the financial instrument or agreement with specific details required by the AMF General Regulation.
The AMF General Regulation provides that shares and voting rights subject to multiple cases of deemed ownership shall only be counted once.
When an individual or entity modifies the allocation between the shares it owns and its financial instruments or agreements deemed to be owned shares, it must disclose that change in a new notification. However, the change must only be disclosed if the acquisition of owned shares due to the settlement of the financial instruments or agreements causes the investor to cross a threshold.
Subject to certain limited exceptions, French law and AMF regulations impose additional reporting requirements on persons who acquire more than 10%, 15%, 20% or 25% of the outstanding shares or voting rights of a company listed company in France. These persons must file a report with the company and the AMF before the end of the fifth trading day following the date they cross any such threshold.
In the report, the acquirer will have to specify its intentions for the following six months including:
The AMF makes the report public. Upon any change of intention within the six-month period following the filing of the report, it will have to file a new report for the following six-month period.
In order to enable shareholders to give the required notice, we must each month publish on our website and send the AMF a written notice setting forth the total number of our shares and voting rights (including treasury shares) whenever they vary from the figures previously published.
If any shareholder fails to comply with an applicable legal notification requirement, the shares in excess of the relevant threshold will be deprived of voting rights for all shareholders’shareholders' meetings until the end of a two-year period following the date on which the owner complies with the notification requirements. In addition, any shareholder who fails to comply with these requirements may have all or part of its voting rights suspended for up to five years by the Commercial Court at the request of our Chairman, any shareholder or the AMF, and may be subject to criminal fines.
Under AMF regulations, and subject to limited exemptions granted by the AMF, any person or entity, acting alone or in concert, that crosses the threshold of 30% of the share capital or voting rights of a French listed company must initiate a public tender offer for the balance of the shares and securities giving access to the share capital or voting rights of such company.
Cash-settled derivative instruments or agreements mentioned in Article L. 233-9, 4° bis of the French Commercial Code are not included in the calculation of the number of shares related to the mandatory public tender offer.
In addition, ourstatutsprovide that any person or entity, acting alone or in concert with others, who becomes the owner of 1%, or any multiple of 1% of our share capital or our voting rights, even beyond the minimum declaration limits permitted by the legal and regulatory provisions, must notify us by
certified mail, return receipt requested, within five trading days, of the total number of shares and securities giving access to our share capital and voting rights that such person then owns. The same provisions of ourstatutsapply whenever such owner increases or decreases its ownership of our share capital or our voting rights to such extent that it goes above or below one of the thresholds described in the preceding sentence. Any person or entity that fails to comply with such notification requirement will, upon the request of one or more shareholders holding at least 5% of our share capital or of our voting rights made at the general shareholders’shareholders' meeting, be deprived of voting rights with respect to the shares in excess of the relevant threshold for all shareholders’shareholders' meetings until the end of a two-year period following the date on which such person or entity complies with the notification requirements.
Change in Control/Anti-takeover
There are no provisions in ourstatuts that would have the effect of delaying, deferring or preventing a change in control of our Company or that would operate only with respect to a merger, acquisition or corporate restructuring involving our Company or any of our subsidiaries. Further, there are no provisions in ourstatutsthat
allow the issuance of preferred stock upon the occurrence of a takeover attempt or the addition of other “anti-takeover”"anti-takeover" measures without a shareholder vote.
Ourstatuts do not include any provisions discriminating against any existing or prospective holder of our securities as a result of such shareholder owning a substantial number of shares.
Trading in Our Own Shares
Under French law, Sanofi may not issue shares to itself. However, we may, either directly or through a financial intermediary acting on our behalf, acquire up to 10% of our issued share capital within a maximum period of 18 months, provided our shares are listed on a regulated market. Prior to acquiring our shares, we must publish a description of the share repurchase program (descriptif du programme de rachat d’actionsd'actions).
We may not cancel more than 10% of our issued share capital over any 24-month period. Our repurchase of shares must not result in our Company holding, directly or through a person acting on our behalf, more than 10% of our issued share capital. We must hold any shares that we repurchase in registered form. These shares must be fully paid up. Shares repurchased by us continue to be deemed “issued”"issued" under French law but are not entitled to dividends or voting rights so long as we hold them directly or indirectly, and we may not exercise the preemptive rights attached to them.
The shareholders, at an extraordinary general shareholders meeting, may decide not to take these shares into account in determining the preemptive rights attached to the other shares. However, if the shareholders decide to take them into account, we must either sell the rights attached to the shares we hold on the market before the end of the subscription period or distribute them to the other shareholders on apro rata basis.
On May 6, 2011,4, 2012, our shareholders approved a resolution authorizing us to repurchase up to 10% of our shares over an 18-month period. Under this authorization, the purchase price for each Sanofi ordinary share may not be greater than €80.00 and the maximum amount that Sanofi may pay for the repurchases is €10,487,982,240.€10,727,350,480. This authorization was granted for a period of 18 months from May 6, 20114, 2012 and cancelled and replaced the authorization granted to the Board of Directors by the general meeting held on May 17, 2010.6, 2011. A description of this share repurchase program as adopted by the Board of Directors on May 6, 2011,4, 2012,(descriptif du programme de rachat d’actionsd'actions) was published on February 28, 2011.March 5, 2012.
Purposes of Share Repurchase Programs
Under the European regulation 2273/2003, dated December 22, 2003 (which we refer to in this section as the “Regulation”"Regulation"), in application of European directive 2003/6/EC, dated January 28, 2003, known as the “Market"Market Abuse Directive” (the “Directive”) relating to share repurchase programs and the stabilization of financial instruments, came into effect on October 13, 2004.
The entry into force of the Regulation has resulted in changes in the manner in which share repurchase programs are implemented. Under the Regulation,Directive", an issuer will benefit from a safe harbor for share transactions
that comply with certain conditions relating in particular to the pricing, volume and timing of transactions (see below) and that are made in connection with a share repurchase program the purpose of which is:
Safe harbor transactions will by definition not be considered market abuses under the Regulation. Transactions that are carried out for other purposes than those mentioned above do not qualify for the safe harbor. However, as permitted by the Directive, which provides for the continuation of existing practices that do not constitute market manipulation and that conform with certain criteria set forth in European directive 2004/72, dated April 29, 2004, the AMF published exceptions on March 22, 2005, October 1, 2008, and March 21, 2011 and March 10, 2012 to permit the following existing market practices:
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The AMF confirmed that all transactions directed at maintaining the liquidity of an issuer’sissuer's shares must be conducted pursuant to a liquidity agreement with a financial services intermediary acting independently.
Pricing, Volume and Other Restrictions
In order to qualify for the safe harbor, the issuer must generally comply with the following pricing and volume restrictions:
In addition, an issuer must not:
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Use of Share Repurchase Programs
Pursuant to the AMF rules, issuers must immediately allocate the repurchased shares to one of the purposes provided for in the Regulation and must not subsequently use the shares for a different purpose. As an exception to the foregoing, shares repurchased with a view to covering stock option plans may, if no longer needed for this purpose, be re-allocated for cancellation or sold in compliance with AMF requirements relating in particular to blackout periods. Shares repurchased in connection with one of the market practices authorized by the AMF (see above) may also be re-allocated to one of the purposes contemplated by the Regulation or sold in compliance with AMF requirements. Shares repurchased with a view to their cancellation must be cancelled within 24 months following their acquisition.
During the year ended December 31, 2011,2012, we used the authority delegated by our shareholders to repurchase our shares on the stock market.
Pursuant to our share repurchase programprograms authorized by our shareholders inon May 3, 2011 and on May 4, 2012, we repurchased 21,655,14013,573,643 of our shares for a weighted average price of €49.60.€60.59, i.e. a total cost of €823 million, €596,000 of which were incurred on brokerage fees and financial transaction taxes (net of income taxes).
On July 27, 2011,April, 26, 2012, the Board of Directors cancelled 2,328,93621,159,445 treasury shares, as follows:
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On November 2, 2011, the Board of Directors cancelled 8,070,453 treasury
In 2010, we also implementedOn October 24, 2012, the Board of Directors cancelled 6,435,924 treasury shares repurchased between April 1, and September 30, 2012 pursuant to the share repurchase program authorized by our shareholders in May 2010 with the aim of supporting the liquidity of the shares through a liquidity contract entered into with an investment service provider in compliance with the ethical code (charte de déontologie) approved by the AMF. We entered into this liquidity contract with Exane BNP Paribas on September 16, 2010. Upon implementation of this contract, we allocated €40,000,000, of which €20,000,000 was initially made available, to the liquidity account.Company.
During 2011,2012, pursuant to the liquidity contract, Exane BNP Paribas purchased 7,569,4176,254,868 of our shares at an average weighted price of €50.69€61.36 for a total amount of €383,803,530 and sold 7,584,4176,254,868 of our shares at an average weighted price of €50.79.€61.48 for a total amount of €384,536,260.
In 2011,2012, of the 5,851,7765,766,116 shares allocated to stock purchase option plans outstanding at December 31, 2010, 85,6602011, 53,790 shares were transferred to grantees of options,options.
As a result, as of December 31, 2011,2012, the 3,150,287 treasury shares, were allocated as follows:
5,766,116 shares, representing 0.28%0.24% of our share capital, were all allocated to outstanding stock purchase option plans;
11,459,687 directly-owned shares, representing 0.85% of our share capital, were allocated to cancellation; and
Noneplans. At the same date, none of the shares was allocated to the liquidity account, even ifthough the liquidity contract was outstanding.
As of December 31, 2011,2012, we directly owned 17,225,8033,150,287 Sanofi shares with a par value of €2 representing around 1.28%0.24% of our share capital and with an estimated value of €940,411,219,€213,000,157, based on the share price at the time of purchase.
Pursuant to the AMF Regulation and the French Commercial Code, issuers trading in their own shares are subject to the following reporting obligations:
Ownership of Shares by Non-French Persons
The French Commercial Code and ourstatuts currently do not limit the right of non-residents of France or non-French persons to own or, where applicable, to vote our securities. However, non-residents of France must file an administrative notice with the French authorities in connection with the acquisition of a controlling interest in our Company. Under existing administrative rulings, ownership of 33 1/1/3% or more of our share capital or voting rights is regarded as a controlling interest, but a lower percentage might be held to be a controlling interest in certain circumstances depending upon factors such as:
Enforceability of Civil Liabilities
We are a limited liability company (société anonyme) organized under the laws of France, and most of our officers and directors reside outside the United States. In addition, a substantial portion of our assets is located in France.
As a result, it may be difficult for investors to effect service of process within the United States upon or obtain jurisdiction over our Company or our officers and directors in U.S. courts in actions predicated on the civil liability provisions of the U.S. securities law. It may also be difficult to enforce against them, either inside or outside the United States, judgments obtained against them in U.S. courts, or to enforce in U.S. courts, judgments obtained against them in courts in jurisdictions outside the United States, in any action based on civil liabilities under the U.S. federal securities laws. There is doubt as to the enforceability against such persons in France, whether in original actions or in actions to enforce judgments of U.S. courts, of liabilities based solely on the U.S. federal securities laws. Actions for enforcement of foreign judgments against such persons would require such persons who are of French nationality to waive their right under Article 15 of the French Civil Code to be sued only in France. We believe that no such French persons have waived such right with respect to actions predicated solely upon U.S. federal securities laws. In addition, actions in the United States under the U.S. federal securities laws could be affected under certain circumstances by the French law No. 80-538 of July 16, 1980, which may preclude or restrict the obtaining of evidence in France or from French persons in connection with such actions. Additionally, awards of punitive damages in actions brought in the United States or elsewhere may be unenforceable in France.
The Facilities Agreement
In connection with the launch of its public tender offer for Genzyme, Sanofi executed on October 2, 2010 a Term Facilities Agreement (the “Facilities Agreement”"Facilities Agreement") with J.P. Morgan plc, Société Générale Corporate & Investment Banking and BNP Paribas (the “Initial"Initial Mandated Lead Arrangers”Arrangers") which was further syndicated by the Initial Mandated Lead Arrangers among other financial institutions, for two unsecured term loan facilities available for drawn downsdrawdowns of up to U.S.$15,000,000,000$15,000,000,000 in the aggregate for the purpose of financing part of the acquisition of Genzyme Corporation, composed of:
The interest rate on each facility was equal to the London Inter-Bank Overnight Rate (or Libor), plus an applicable margin.
On March 29, 2011, available commitments under Facility A were reduced by an amount equivalent to the proceeds of an SEC-registered U.S. bond issue (approximately $7 billion). The remaining unused commitments of this facility were cancelled on April 1, 2011. On April 5, 2011, Sanofi drew down $4 billion under Facility B, and cancelled the remaining balance of $1 billion. On June 28, August 5 and November 3, 2011 Sanofi made early repayments of respectively $1 billion, $1 billion, $2 billion of the Facility B drawdown.
As a result, the Facility B drawdown was fully repaid as of November 3, 2011 and as a consequence, the entire Facilities Agreement expired.
A copy of the Facilities Agreement and an amendment dated February 15, 2011 are on file with the SEC as exhibits 4.1 and 4.2 hereto. Reference isshould be made to such exhibits for a more complete description of the terms and conditions of the Acquisition Facility as amended, and the foregoing summary of such terms and conditions is qualified in its entirety by such exhibits.
The Agreement and Plan of Merger
On February 16, 2011, Sanofi and its wholly owned subsidiary GC Merger Corp. signed an Agreement and Plan of Merger governed by the laws of the Commonwealth of Massachusetts, and subject to the jurisdiction of the courts of the Commonwealth of Massachusetts (the “Merger Agreement”"Merger Agreement"), with Genzyme Corporation (“Genzyme”("Genzyme"). Pursuant to the Merger Agreement, among other things, Sanofi and GC Merger Corp. agreed to amend the outstanding tender offer to acquire all of the outstanding shares of common stock of Genzyme (the “Genzyme Shares”"Genzyme Shares") in order to increase the price per share from $69 to $74 in cash (the “Cash Consideration”"Cash Consideration")
plus one contingent value right (a “CVR”"CVR") to be issued by Sanofi subject to and in accordance with a CVR Agreement described below (collectively, the “Merger Consideration”"Merger Consideration") per Genzyme Share. The Merger Agreement also provided that, subject to the satisfaction or waiver of certain conditions, following consummation of the Amended Offer, GC Merger Corp. would be merged with and into Genzyme, with Genyzme surviving the Merger as a wholly-owned subsidiary of Sanofi (the “Merger”"Merger").
The transaction was completed on April 8, 2011 in accordance with the terms of the Merger Agreement and the public exchange offer at a price of $74 in cash plus the issuance to Genzyme shareholders of one contingent value right (CVR)("CVR") per Genzyme share. The CVRs are listed on the NASDAQ marketGlobal Market and Genzyme is now a fully-consolidated subsidiary.
wholly-owned subsidiary of Sanofi.
The Contingent Value Rights Agreement.
In connection with its acquisition of Genzyme Corporation, now a wholly-owned subsidiary of Sanofi, Sanofi issued one CVR per Genzyme share. On March 30, 2011, Sanofi and the American Stock Transfer & Trust Company, LLC, as trustee entered into a Contingent Value Rights agreement governed by the laws of the State of New York and subject to the jurisdiction of the courts of the State of New York (“("CVR Agreement”Agreement") governing the terms of the CVRs.
Pursuant to the terms of the CVR Agreement, a holder of a CVR is entitled to cash payments upon the achievement of certain milestones, including based on production levelscontractually defined milestones. The first milestone related to manufacturing of Cerezyme®Cerezyme® and Fabrazyme®,Fabrazyme® had to be met by December 31, 2011 in order for the payment to be triggered. This milestone was not met and therefore lapsed. The remaining milestone payments are triggered by timely U.S. regulatory approval of alemtuzumab for treatment of multiple sclerosis (“("Lemtrada™”"), and on achievement of certain aggregate Lemtrada™ sales thresholds within defined periods ("Product Sales Milestones"), as follows:summarized below:
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The CVRs will expire and no payments will be due under the CVR agreement on the earlier of (a) December 31, 2020 and (b) the date that Product Sales Milestone #4 is paid.
Sanofi has agreed to use commercially reasonable efforts to achieve the Cerezyme®/Fabrazyme® Production Milestone, and diligent efforts (as defined in the CVR Agreement) to achieve each of the other milestones above.remaining milestones. For more information on Lemtrada™ see "Item 4.B Business Overview — Pharmaceutical Products — Multiple Sclerosis".
Sanofi has also agreed to use its commercially reasonable efforts to maintain a listing for trading of the CVRs on Nasdaq.the NASDAQ market.
The CVR Agreement does not prohibit Sanofi or any of its subsidiaries or affiliates from acquiring the CVRs, whether in open market transactions, private transactions or otherwise; Sanofi has certain disclosure obligations in connection with such acquisitions under the CVR Agreement. On or after the third anniversary of the launch of Lemtrada™, Sanofi may also, subject to certain terms and conditions as set forth in the CVR Agreement, optionally purchase and cancel all (but not less than all) of the outstanding CVRs at the average trading price of the CVRs if the volume-weighted average CVR trading price is less than fifty cents over forty-five trading days and Lemtrada™ sales in the prior four quarter period were less than one billion U.S. dollars in the aggregate.
A copy of the Merger Agreement and the form of CVR Agreement are on file with the SEC as exhibits 4.3 and 4.4 hereto, respectively. Reference is made to such exhibits for a more complete description of the terms and conditions of the Merger Agreement and the CVR Agreement, and the foregoing summary of such terms and conditions is qualified in its entirety by such exhibits.
French exchange control regulations currently do not limit the amount of payments that we may remit to non-residents of France. Laws and regulations concerning foreign exchange controls do require, however, that all payments or transfers of funds made by a French resident to a non-resident be handled by an accredited intermediary. In France, all registered banks and most credit establishments are accredited intermediaries.
General
The following generally summarizes the material French and U.S. federal income tax consequences to U.S. holders (as defined below) of purchasing, owning and disposing of our ADSs and ordinary shares (collectively the “Securities”"Securities"). This discussion is intended only as a descriptive summary and does not purport to be a complete analysis or listing of all potential tax effects of the purchase, ownership or disposition of our Securities. All of the following is subject to change. Such changes could apply retroactively and could affect the consequences described below.
This summary does not constitute a legal opinion or tax advice. Holders are urged to consult their own tax advisers regarding the tax consequences of the purchase, ownership and disposition of Securities in light of their particular circumstances, including the effect of any U.S. federal, state, local or other national tax laws.
France has recently introduced a comprehensive set of new tax rules applicable to French assets that are held by or in foreign trusts. These rules provideinter alia for the inclusion of trust assets in the settlor's net assets for purpose of applying the French wealth tax, for the application of French gift and death duties to French assets held in trust, for a specific tax on capital on the French assets of foreign trusts not already subject to the French wealth tax and for a number of French tax reporting and disclosure obligations. The following discussion does not address the French tax consequences applicable to Securities held in trusts.If Securities are held in trust, the grantor, trustee and beneficiary are urged to consult their own tax adviser regarding the specific tax consequences of acquiring, owning and disposing of Securities.
The description of the French and U.S. federal income tax consequences set forth below is based on the laws (including, for U.S. federal income tax purposes, the Internal Revenue Code of 1986, as amended (the “Code”"Code"), final, temporary and proposed U.S. Treasury Regulations promulgated thereunder and administrative and judicial interpretations thereof) in force as of the date of this annual report, the Convention Between the Government of the United States of America and the Government of the French Republic for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with Respect to Taxes on Income and Capital of August 31, 1994 (the “Treaty”"Treaty"), which entered into force on December 30, 1995 (as amended by any subsequent protocols, including
the protocol of January 13, 2009), and the tax regulations issued by the French tax authorities (the “Regulations”"Regulations") in force as of the date of this report.U.S. holders are advised to consult their own tax advisers regarding their eligibility for Treaty
benefits, especially with regard to the “Limitations"Limitations on Benefits”Benefits" provision, in light of their own particular circumstances.
For the purposes of this discussion, a U.S. holder is a beneficial owner of Securities that is (i) an individual who is a U.S. citizen or resident for U.S. federal income tax purposes, (ii) a U.S. domestic corporation or certain other entities created or organized in or under the laws of the United States or any state thereof, including the District of Colombia, or (iii) otherwise subject to U.S. federal income taxation on a net income basis in respect of Securities. A non-U.S. holder is a person other than a U.S. holder.
If a partnership holds Securities, the tax treatment of a partner generally will depend upon the status of the partner and the activities of the partnership.If a U.S. holder is a partner in a partnership that holds Securities, the holder is urged to consult its own tax adviser regarding the specific tax consequences of acquiring, owning and disposing of Securities.
French law has enacted new rules relating to trusts, in particular a specific new tax and filing requirements as well as modifications to wealth, estate and gift taxes as they apply to trusts. Given the complex nature of these new rules and the fact that their application varies depending on the status of the trust, the grantor, the beneficiary and the assets held in the trust, the following summary does not address the tax treatment of Securities held in a trust.If Securities are held in trust, the grantor, trustee and beneficiary are urged to consult their own tax adviser regarding the specific tax consequences of acquiring, owning and disposing of Securities.
This discussion is intended only as a general summary and does not purport to be a complete analysis or listing of all potential tax effects of the acquisition, ownership or disposition of the Securities to any particular investor, and does not discuss tax considerations that arise from rules of general application or that are generally assumed to be known by investors. The discussion applies only to investors that hold our Securities as capital assets that have the U.S. dollar as their functional currency, that are entitled to Treaty benefits under the “Limitation"Limitation on Benefits”Benefits" provision contained in the Treaty, and whose ownership of the Securities is not effectively connected to a permanent establishment or a fixed base in France. Certain holders (including, but not limited to, U.S. expatriates, partnerships or other entities classified as partnerships for U.S. federal income tax purposes, banks, insurance companies, regulated investment companies, tax-exempt organizations, financial institutions, persons subject to the alternative minimum tax, persons who acquired the Securities pursuant to the exercise of employee stock options or otherwise as compensation, persons that own (directly, indirectly or by attribution) 5% or more of our voting stock or 5% or more of our outstanding share capital, dealers in securities or currencies, persons that elect to mark their securities to market for U.S. federal income tax purposes and persons holding Securities as a position in a synthetic security, straddle or conversion transaction) may be subject to special rules not discussed below.Holders of Securities are advised to consult their own tax advisers with regard to the application of French tax law and U.S. federal income tax law to their particular situations, as well as any tax consequences arising under the laws of any state, local or other foreign jurisdiction.
French Taxes
Estate and Gift Taxes and Transfer Taxes
In general, a transfer of Securities by gift or by reason of death of a U.S. holder that would otherwise be subject to French gift or inheritance tax, respectively, will not be subject to such French tax by reason of the Convention between the Government of the United States of America and the Government of the French Republic for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with Respect to Taxes on Estates, Inheritances and Gifts, dated November 24, 1978, unless the donor or the transferor is domiciled in France at the time of making the gift or at the time of his or her death, or the Securities were used in, or held for use in, the conduct of a business through a permanent establishment or a fixed base in France.
Generally, transfers Pursuant to Article 235 ter ZD of the French General Tax Code, purchases of Securities (other than ordinary shares) are not subject to a 0.2% French registration or stamp duty. Transferstax on financial transactions provided that Sanofi's market capitalization exceeds 1 billion euros as of ordinary shares issuedDecember 1 of the year preceding the taxation year. A list of companies whose market capitalization exceeds 1 billion euros as of December 1 of the year preceding the taxation year is published annually by the French state. Pursuant to a listed Frenchministerial regulation (arrêté) dated January 11, 2013, Sanofi is included in such list as a company suchwhose market capitalization exceeds 1 billion euros as Sanofi will not beof December 1, 2012 and therefore, purchases of Sanofi's Securities are subject to French registration or stamp duty if such transfers are not evidenced by a written agreement (acte). However, if the transfer is evidenced by a written agreement executed either in France or outside France, the transfertax.
shares would be subject to transfer duty at (i) 3% for the portion of the sale price below €200,000, (ii) 0.5% for the portion of the sale price between €200,000 and €500,000,000, and (iii) 0.25% for the portion of the sale price exceeding €500,000,000.
Wealth Tax
The French wealth taximpôt de solidarité sur la fortuneapplies only to individuals and does not generally apply to the Securities if the holder is a U.S. resident, as defined pursuant to the provisions of the Treaty, provided that the individual does not own directly or indirectly a shareholding exceeding 25% of the financial rights.
U.S. Taxes
Ownership of the Securities
Deposits and withdrawals by a U.S. holder of ordinary shares in exchange for ADSs, will not be taxable events for U.S. federal income tax purposes. For U.S. tax purposes, holders of ADSs will be treated as owners of the ordinary shares represented by such ADSs. Accordingly, the discussion that follows regarding the U.S. federal income tax consequences of acquiring, owning and disposing of ordinary shares is equally applicable to ADSs.
Information Reporting and Backup Withholding Tax
Distributions made to holders and proceeds paid from the sale, exchange, redemption or disposal of Securities may be subject to information reporting to the Internal Revenue Service. Such payments may be subject to backup withholding taxes unless the holder (i) is a corporation or other exempt recipient or (ii) provides a taxpayer identification number and certifies that no loss of exemption from backup withholding has occurred. Holders that are not U.S. persons generally are not subject to information reporting or backup withholding. However, such a holder may be required to provide a certification of its non-U.S. status in connection with payments received within the United States or through a U.S.-related financial intermediary to establish that it is an exempt recipient. Backup withholding is not an additional tax. Amounts withheld as backup withholding may be credited against a holder’sholder's U.S. federal income tax liability. A holder may obtain a refund of any excess amounts withheld under the backup withholding rules by filing the appropriate claim for refund with the Internal Revenue Service and furnishing any required information.
Foreign Asset Reporting
In addition, a U.S. holder that is an individual (and, to the extent provided in future regulations, an entity), may be subject to recently-enacted reporting obligations with respect to ordinary shares and ADSs if the aggregate value of these and certain other "specified foreign financial assets" exceeds $50,000. If required, this disclosure is made by filing Form 8938 with the U.S. Internal Revenue Service. Significant penalties can apply if holders are required to make this disclosure and fail to do so. In addition, a U.S. holder should consider the possible obligation to file a Form TD F 90-22.1 — Foreign Bank and Financial Accounts Report as a result of holding ordinary shares or ADSs. Holders are thus encouraged to consult their U.S. tax advisors with respect to these and other reporting requirements that may apply to their acquisition of ordinary shares and ADSs.
State and Local Taxes
In addition to U.S. federal income tax, U.S. holders of Securities may be subject to U.S. state and local taxes with respect to such Securities.Holders of Securities are advised to consult their own tax advisers with regard to the application of U.S. state and local income tax law to their particular situation.
ADSs-Ordinary Shares
French Taxes
Taxation of Dividends
Under French law, dividends paid by a French corporation, such as Sanofi, to non-residents of France are generally subject to French withholding tax at a rate of 30% (21% for distributions made to individuals that are resident in the European Economic Area, and 15% for distributions made to non-for-profitnot-for-profit organizations with a head office in a Member State of the European Economic Area which would be subject to the tax regime set forth under article 206-5 of the French General Tax Code if its head office were located in France and which meet the criteria set forth in the administrative guidelines 4 H-2-10BOI-RPPM-RCM-30-30-10-70-20120912, n°130). Dividends
Table of January 15, 2010). Dividends Contents
paid by a French corporation, such as Sanofi, towards non-cooperative States or territories, as defined in Article 238-0 A of the French General Tax Code, will generally be subject to French withholding tax at a rate of 55%75%, irrespective of the tax residence of the beneficiary of the dividends if the dividends are received in such States or territories; however, eligible U.S. holders entitled to Treaty benefits under the “Limitation"Limitation on Benefits”Benefits" provision contained in the Treaty who are U.S. residents, as defined pursuant to the provisions of the Treaty and receivingwho receive dividends in non-cooperative States or territories, will not be subject to this 55%75% withholding tax rate.
Under the Treaty, the rate of French withholding tax on dividends paid to an eligible U.S. holder who is a U.S. resident as defined pursuant to the provisions of the Treaty and whose ownership of the ordinary shares or ADSs is not effectively connected with a permanent establishment or fixed base that such U.S. holder has in France, is reduced to 15%, or to 5% if such U.S. holder is a corporation and owns directly or indirectly at least 10% of the share capital of the issuing company andcompany; such U.S. holder may claim a refund from the French tax authorities of the amount withheld in excess of the Treaty rates of 15% or 5%, if any. For U.S. holders that are not individuals but are U.S. residents, as defined pursuant to the provisions of the Treaty, the requirements for eligibility for Treaty benefits, including the reduced 5% or 15% withholding tax rates contained in the “Limitation"Limitation on Benefits”Benefits" provision of the Treaty, are complicated, and certain technical changes were made to these requirements by the protocol of January 13, 2009. U.S. holders are advised to consult their own tax advisers regarding their eligibility for Treaty benefits in light of their own particular circumstances.
Dividends paid to an eligible U.S. holder may immediately be subject to the reduced rates of 5% or 15% provided that such holder establishes before the date of payment that it is a U.S. resident under the Treaty by completing and providing the depositary with a treaty form (Form 5000). Dividends paid to a U.S. holder that has not filed the Form 5000 before the dividend payment date will be subject to French withholding tax at the rate of 30% and then reduced at a later date to 5% or 15%, provided that such holder duly completes and provides the French tax authorities with the treaty forms Form 5000 and Form 5001 before December 31 of the second calendar year following the year during which the dividend is paid. Pension funds and certain other tax-exempt entities are subject to the same general filing requirements as other U.S. holders except that they may have to supply additional documentation evidencing their entitlement to these benefits.
Form 5000 and Form 5001, together with instructions, will be provided by the depositary to all U.S. holders registered with the depositary and isare also available from the U.S. Internal Revenue Service. The depositary will arrange for the filing with the French Tax authorities of all such forms properly completed and executed by U.S. holders of ordinary shares or ADSs and returned to the depositary in sufficient time that they may be filed with the French tax authorities before the distribution so as to obtain immediately a reduced withholding tax rate.
The withholding tax refund, if any, ordinarily is paid within 12 months of filing the applicable French Treasury Form, but not before January 15 of the year following the calendar year in which the related dividend is paid.
Tax on Sale or Other Disposition
In general, under the Treaty, a U.S. holder who is a U.S. resident for purposes of the Treaty will not be subject to French tax on any capital gain from the redemption (other than redemption proceeds characterized as dividends under French domestic law), sale or exchange of ordinary shares or ADSs unless the ordinary shares or the ADSs form part of the business property of a permanent establishment or fixed base that the U.S. holder has in France. Special rules apply to holders who are residents of more than one country.
U.S. Taxes
Taxation of Dividends
For U.S. federal income tax purposes, the gross amount of any distribution paid to U.S. holders (that is, the net distribution received plus any tax withheld therefrom) will be treated as ordinary dividend income to the extent paid or deemed paid out of the current or accumulated earnings and profits of Sanofi (as determined under U.S. federal income tax principles). Dividends paid by Sanofi will not be eligible for the dividends-received deduction generally allowed to corporate U.S. holders.
Subject to certain exceptions for short-term and hedged positions, the U.S. dollar amount of dividends received by an individual U.S. holder with respect to taxable years beginning before January 1, 2013, with respect to the ADSs or our ordinary shares will beis currently subject to taxation at a maximum rate of 15%20% if the dividends are “qualified dividends.”"qualified dividends". Dividends paid on the ordinary shares or ADSs will be treated as qualified dividends if (i) the issuer is eligible for the benefits of a comprehensive income tax treaty with the United States that the Internal Revenue Service has approved for the purposes of the qualified dividend rules and (ii) the issuer was not, in the year prior to the year in which the dividend was paid, and is not, in the year in which the dividend is paid, a
passive foreign investment company (“PFIC”("PFIC"). The Treaty has been approved for the purposes of the qualified dividend rules. Based on our audited financial statements and relevant market and shareholder data, we believe Sanofi was not a PFIC for U.S. federal income tax purposes with respect to its 20112012 taxable year. In addition, based on its audited financial statements and current expectations regarding the value and nature of its assets, the sources and nature of its income, and relevant market and shareholder data, we do not anticipate that Sanofi will become a PFIC for its 20122013 taxable year.Holders of ordinary shares and ADSs should consult their own tax advisers regarding the availability of the reduced dividend tax rate in light of their own particular circumstances.
If you are a U.S. holder, dividend income received by you with respect to ADSs or ordinary shares generally will be treated as foreign source income for foreign tax credit purposes. The limitation on foreign taxes eligible for credit is calculated separately with respect to specific classes of income. Distributions out of earnings and profits with respect to the ADSs or ordinary shares generally will be treated as “passive category”"passive category" income (or, in the case of certain U.S. holders, “general category”"general category" income). Subject to certain limitations, French income tax withheld in connection with any distribution with respect to the ADSs or ordinary shares may be claimed as a credit against the U.S. federal income tax liability of a U.S. holder if such U.S. holder elects for that year to credit all foreign income taxes. Alternatively, such French withholding tax may be taken as a deduction against taxable income. Foreign tax credits will not be allowed for withholding taxes imposed in respect of certain short-term or hedged positions in Securities and may not be allowed in respect of certain arrangements in which a U.S. holder’sholder's expected economic profit is insubstantial.The U.S. federal income tax rules governing the availability and computation of foreign tax credits are complex. U.S. holders should consult their own tax advisers concerning the implications of these rules in light of their particular circumstances.
To the extent that an amount received by a U.S. holder exceeds the allocable share of our current and accumulated earnings and profits, such excess will be applied first to reduce such U.S. holder’sholder's tax basis in its ordinary shares or ADSs and then, to the extent it exceeds the U.S. holder’sholder's tax basis, it will constitute capital gain from a deemed sale or exchange of such ordinary shares or ADSs (see “—"— Tax on Sale or Other Disposition”Disposition", below).
The amount of any distribution paid in euros will be equal to the U.S. dollar value of the euro amount distributed, calculated by reference to the exchange rate in effect on the date the dividend is received by a U.S. holder of ordinary shares (or by the depositary, in the case of ADSs) regardless of whether the payment is in fact converted into U.S. dollars on such date.U.S. holders should consult their own tax advisers regarding the treatment of foreign currency gain or loss, if any, on any euros received by a U.S. holder or depositary that are converted into U.S. dollars on a date subsequent to receipt.
Distributions to holders of additional ordinary shares (or ADSs) with respect to their ordinary shares (or ADSs) that are made as part of a pro rata distribution to all ordinary shareholders generally will not be subject to U.S. federal income tax. However, if a U.S. holder has the option to receive a distribution in shares (or ADSs) or to receive cash in lieu of such shares (or ADSs), the distribution of shares (or ADSs) will be taxable as if the holder had received an amount equal to the fair market value of the distributed shares (or ADSs), and such holder’sholder's tax basis in the distributed shares (or ADSs) will be equal to such amount.
Tax on Sale or Other Disposition
In general, for U.S. federal income tax purposes, a U.S. holder that sells, exchanges or otherwise disposes of its ordinary shares or ADSs will recognize capital gain or loss in an amount equal to the U.S. dollar value of the difference between the amount realized for the ordinary shares or ADSs and the U.S. holder’sholder's adjusted tax basis (determined in U.S. dollars and under U.S. federal income tax rules) in the ordinary shares or ADSs. Such gain or loss generally will be U.S.-source gain or loss, and will be treated as long-term capital gain or loss if the U.S. holder’sholder's holding period in the ordinary shares or ADSs exceeds one year at the time of disposition. If the U.S. holder
is an individual, any capital gain generally will be subject to U.S. federal income tax at preferential rates (currently a maximum of 15%20%) if specified minimum holding periods are met. The deductibility of capital losses is subject to significant limitations.
Medicare Tax
Recently-enacted legislation requires certain U.S. holders who are individuals, estates or trusts to pay a Medicare tax of 3.8% (in addition to taxes they would otherwise be subject to) on their "net investment income" which would include, among other things, dividends and capital gains from the ordinary shares and ADSs.
F. Dividends and Paying Agents
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We are subject to the information requirements of the U.S. Securities Exchange Act of 1934, as amended, or Exchange Act, and, in accordance therewith, we are required to file reports, including this annual report on Form 20-F, and other information with the U.S. Securities and Exchange Commission, or Commission, by electronic means. Our public
You may review a copy of our filings are availablewith the Commission, as well as other information furnished to the public over the InternetCommission, including exhibits and schedules filed with it, at the Commission’s WebsiteCommission's public reference room at 100 F Street, N.E., Room 1580, Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information. In addition, the Commission maintains an Internet site at http://www.sec.gov that contains reports and other information regarding issuers that file electronically with the Commission (these documents are not incorporated by reference in this annual report).
N/A
Item 11. Quantitative and Qualitative Disclosures about Market Risk(1)
General Policy
Liquidity risk, foreign exchange risk and interest rate risk, as well as related counterparty risk, are managed centrally by our dedicated treasury team within the Group Finance Department. Where it is not possible to manage these risks centrally, in particular due to regulatory restrictions (such as foreign exchange controls) or local tax restrictions, credit facilities and/or currency lines, guaranteed whenever necessary by the parent company, are contracted by our subsidiaries locally with banks, under the supervision of the central treasury team.
Our investment and financing strategies, as well as our interest rate and currency hedging strategies, are reviewed monthly by the Group Finance Department.
Our policy on derivatives prohibits speculative exposure.
Liquidity Risk
We operate a centralized treasury platform according to whichwhereby all surplus cash and financing needs of our subsidiaries are invested with or funded by the parent company (where permitted by local legislation). The central treasury department manages the Group’sGroup's current and projected financing (debt, net of cash and cash equivalents), and ensures that the Group is able to meet its financial commitments by maintaining sufficient cash and confirmed credit facilities for the size of our operations and the maturity of our debt.debt (see Notes D.17.c and D.17.g to the consolidated financial statements).
The Group tends to diversifydiversifies its short termshort-term investments with leading banks on money marketusing money-market products available on sightwith instant access or whichwith a maturity is lower than three months. As of December 31, 2011,2012, cash and cash equivalents amounted to 4,124€€6,381 million and short termshort-term investments were mainly made of:comprised:
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As of December 31, 2011,2012, the Group had €10.0€10 billion of undrawn general corporate purpose confirmed credit facilities, of which €3 billion expire in 2012, €0.7December 2013, €0.25 billion in July 2015 and €6.3€6.75 billion in 2016.July 2017. Our credit facilities are not subject to financial covenant ratios.
Our policy is to diversify our sources of funding through public or private issuances of debt securities, in the United States and in France (Euro Medium Term Note program), and by issuing commercial paper in the United States and in France. The average duration of the total debt was 3.2 years as of December 31, 2012, compared to 3.5 years as of December 31, 2011, compared to 3.9 years as of December 31, 2010.2011. Short-term commercial paper programs (U.S. dollar-denominated commercial paper swapped into euro and euro-denominated commercial paper) are used to meet our short-term financing needs. In 2012, the French commercial paper program was not drawn down, whereas average drawdowns under the U.S. commercial paper program were €2.3 billion (maximum €3.3 billion). Drawdowns under these programs are generally renewed for periods of 2one and a half months. In 2011, the average drawdowns under these programs was €3.4 billion (maximum €6.2 billion). As of December 31, 2011, the drawdown under2012, these programs amounted to €0.7 billion.were not drawn down.
In the context of a market-wide liquidity crisis, and/or a downgrade of its rating, the Group could be exposed to difficulties to callin calling up its available cash, available, a scarcity of its sources of funding including the above-mentioned programs, or to a deterioration ofin their conditions.terms. This situation could damage the capacity of the Group to refinance its debt or to issue new debt aton reasonable conditions.terms.
Interest Rate Risk
Having financedSince the financing of the Genzyme acquisition in 2011, the Group manageshas managed its net debt in two currencies, —the euro and the U.S. dollar (see note D.17 to the consolidated financial statements). With the variableThe floating-rate portion of thethis debt exposes the Group is exposed to rises in interest rate increases, largely those ofrates, primarily in the Eonia and Euribor forbenchmark rates (for the euro debteuro) and in the U.S. Libor and Federal Fund Effective forrates (for the U.S. dollar debt.dollar). In this context, in order to minimizereduce the amount and/or volatility of the cost of debt, or volatility, the Group uses interesthas contracted derivative instruments (interest rate swaps, multi-currency interest ratecross-currency swaps and interest rate options which changeoptions). These have the fixed rate / variable rate breakdowneffect of itsaltering the fixed/floating split of the debt. TheThese derivative instruments are denominated either in euros or in U.S. dollars.
As of December 31, 2011,2012, the sensitivity of the total debt, net of cash and cash equivalents to interest rate fluctuations over a full year is as follows:
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Change in 3-month Euribor | Impact on pre-tax net income (€ million) | Impact on income/(expense) recognized directly in equity, before tax (€ million) | |||||
---|---|---|---|---|---|---|---|
+100 bp | (10 | ) | (3 | ) | |||
+25 bp | (2 | ) | (1 | ) | |||
-25 bp | 2 | 1 | |||||
-100 bp | 10 | 3 | |||||
Foreign Exchange Risk
a. Operational Foreign Exchange Risk
A substantial proportionportion of our net sales is generated in countries in which the euro, which is our reporting currency, is not the functional currency. In 2011,2012, for example, 29.8%31% of our consolidated net sales were generated in the United States. Although we also incur expenses in those countries, the impact of those expenses is not enough wholly to offset the impact of exchange rates on net sales. Consequently, our operating income may be materially affected by fluctuations in the exchange rate between the euro and other currencies, primarily the U.S. dollar.
We operate a foreign exchange risk hedging policy to reduce the exposure of our operating income to exchange rate movements. This policy involves regular assessments of our worldwide foreign currency exposure, based on budget estimates of foreign-currency transactions to be carried out by the parent company and its subsidiaries. These transactions mainly comprise sales, purchases, research costs, co-marketing and co-promotion expenses, and royalties. To reduce the exposure of these transactions to exchange rate movements, we may contract currency hedges using liquid financial instruments, such asmainly forward purchases and forward sales of currency as well as callcurrencies, and put options, and combinationsswaps.
Table of currency options (collars).
The table below shows operational currency hedging derivatives in place as of December 31, 2011,2012, with the notional amount translated into euros at the relevant closing exchange rate. See also Note D.20 to the consolidated financial statements for the accounting classification of these instruments as of December 31, 2011.
2012.
Operational foreign exchange derivatives as of December 31, 20112012 (1):
(€ million) | Notional amount | Fair value | ||||||
Forward currency sales | 3,446 | (96 | ) | |||||
Of which • U.S. dollar | 1,779 | (59 | ) | |||||
• Japanese yen | 685 | (22 | ) | |||||
• Russian ruble | 310 | (5 | ) | |||||
• Singaporian dollar | 71 | — | ||||||
• Australian dollar | 63 | (2 | ) | |||||
Forward currency purchases | 1,077 | 7 | ||||||
Of which • Singaporian dollar | 357 | 4 | ||||||
• Swiss franc | 165 | 2 | ||||||
• Japanese yen | 124 | 3 | ||||||
• Hungarian forint | 107 | (4 | ) | |||||
• U.S. dollar | 69 | — | ||||||
Total | 4,523 | (89 | ) |
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As of December 31, 2011, the notional amount of forward currency sales was €3,446 million with a fair value of -€96 million (including forward sales of U.S. dollars of a notional amount of €1,779 million with a fair value of -€59 million). As of December 31, 2011, the notional amount of forward currency purchases was €1,077 million with a fair value of €7 million (including forward purchases of U.S. dollars of a notional amount of €69 million with an immaterial fair value).
As of December 31, 2012, none of these instruments had an expiry date after December 31, 2012February 28, 2013 except for a specific forward currency purchase position for a total amount of £40£33 million whose maturity goes untilexpiring between 2013 and 2015.
These positions mainly hedge future foreign-currency cash flows arising after the balance sheet date in relation to transactions carried out during the year ended December 31, 20112012 and recognized in the balance sheet at that date. Gains and losses on derivative instruments (forward contracts) have been and will continue to be calculated and recognized in parallel with the recognition of gains and losses on the hedged items. Due to this hedging relationship, the foreign exchange profit and loss on these items (derivative instruments and underlying assets as of December 31, 2011)2012) will be close to zero in 2012.2013.
b. Financial Foreign Exchange Risk
Some of our financing activities, such as the cash pooling arrangements for foreign subsidiaries outside the euro zone and our U.S. commercial paper issues, expose certain entities to financial foreign exchange risk (i.e., the risk of changes in the value of loans and borrowings denominated in a currency other than the functional currency of the lender or borrower). The net foreign exchange exposure mainly concernsis hedged by the holding company and is hedged bywith firm financial instruments, usually forward contracts and currency swaps.swaps, dealt with banking counterparties.
The table below shows financial currency hedging instruments in place as of December 31, 2011, calculated using2012, with the notional amount translated into euros at the relevant closing exchange rates prevailing as of that date.rate. See also Note D.20 to the consolidated financial statements for the accounting classification of these instruments as of December 31, 2011.
2012.
Financial foreign exchange derivatives as of December 31, 20112012 (1):
(€ million) | Notional amount | Fair value | Expiry | |||||||||
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Forward currency sales | 3,970 | 38 | ||||||||||
Of which | • U.S. dollar | 1,897 | 1 | 2013 | ||||||||
• Japanese yen | 1,272 | 34 | 2013 | |||||||||
• Czech koruna | 191 | — | 2013 | |||||||||
Forward currency purchases | 2,638 | (12 | ) | |||||||||
Of which | • Pound sterling | 549 | (3 | ) | 2013 | |||||||
• U.S. dollar | 521 | 1 | 2013 | |||||||||
• Singapore dollar | 492 | (4 | ) | 2013 | ||||||||
Total | 6,608 | 26 | ||||||||||
(€ million) | Notional amount | Fair value | Expiry | |||||||||
Forward currency purchases | 2,719 | 24 | ||||||||||
Of which • Pound sterling | 843 | 5 | 2012 | |||||||||
• U.S. dollar | 828 | 10 | 2012 | |||||||||
• Swiss franc | 274 | 1 | 2012 | |||||||||
Forward currency sales | 4,900 | (104 | ) | |||||||||
Of which • U.S. dollar | 2,964 | (89 | ) | 2012 | ||||||||
• Japanese yen | 993 | (17 | ) | 2012 | ||||||||
• Czech koruna | 251 | 4 | 2012 | |||||||||
Total | 7,619 | (80 | ) |
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These forward contracts generate a net financial foreign exchange gain or loss arising from the interest rate gapdifferential between the hedged currency and the euro, given that the foreign exchange gain or loss on the foreign-currency liabilities and receivables is offset by the change in the intrinsic value of the hedging instruments.
As of December 31, 2011,2012, none of the instruments had an expiry date after September 30, 2012.March 31, 2013.
We may also hedge some future foreign-currency investment or divestment cash flows.
c. Other Foreign Exchange Risks
A significant proportion of our consolidated net assets is denominated in U.S. dollars. For a breakdown of net assets see Note D.35.2D.35 to the consolidated financial statement.statements. As a result, any fluctuation in the exchange rate of the U.S. dollar against the euro affects our equity, which can lead us to contract hedges of our net investments in foreign operations.equity. As of December 31, 2011,2012, we had no derivative instruments in place to limit the effect of such fluctuations.
The Group operates a substantial portion of its activity within the euro zone and holds a significant part of its indebtedness and cash and cash equivalent in euro. Eurothis currency, whereas its indebtedness is denominated in the euro and the U.S. dollar (for more information, see Note D.17.e to the consolidated financial statements). The euro is also the reporting currency of the Group. In the specific context of the sovereign debt crisis affecting certain European countries, the allegedthreatened or actual disruption in the usewithdrawal of the euro as currency in one or more European Monetary Union countries and the associated fluctuations in currency exchange rates could have a material effect on our financial condition and earnings, the magnitude and consequences of which are unpredictable.
Counterparty Risk
Our financing and investing operations, as well as our currency and interest rate hedges, are contracted with leading banks. We set limits for investment and derivative transactions with individual banks, depending on the rating of each bank. Compliance with these limits, which are based on notional amounts weighted by the residual maturity and the nature of the commitment, is monitored on a daily basis.
The table below shows our total exposure as of December 31, 20112012 by rating and in terms of our percentage exposure to the dominant counterparts:counterparty.
(€ million) | Cash and cash equivalent (mutual funds excluded) (1) | Notional amounts of currency hedges (2) | Notional amounts of interest hedges | General corporate purpose credit facilities | ||||||||||||
AAA | 200 | — | — | — | ||||||||||||
AA- | 803 | 3,254 | 2,523 | 2,757 | ||||||||||||
A+ | 552 | 6,422 | 2,433 | 4,136 | ||||||||||||
A | 374 | 2,964 | 1,777 | 3,107 | ||||||||||||
A- | 60 | — | — | — | ||||||||||||
BBB ratings and not rated | 99 | — | — | — | ||||||||||||
Not splitted | 157 | — | — | — | ||||||||||||
Total | 2,245 | 12,640 | 6,733 | 10,000 | ||||||||||||
% / rating of the dominant counterparty | 23% / AA- | 17% /A+ | 10% / AA- | 7% /A |
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(€ million) | Cash and cash equivalent (excluding mutual funds) (1) | Notional amounts of currency hedges (2) | Notional amounts of interest hedges (2) | General corporate purpose credit facilities | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
AA- | 608 | 1,095 | 300 | 690 | |||||||||
A+ | 1,029 | 4,452 | 2,016 | 3,195 | |||||||||
A | 1,019 | 5,512 | 2,102 | 5,175 | |||||||||
A- | 100 | — | — | — | |||||||||
BBB+ | 215 | — | — | 250 | |||||||||
BBB | 301 | 262 | 600 | 690 | |||||||||
Not splitted | 145 | — | — | — | |||||||||
Total | 3,417 | 11,321 | 5,018 | 10,000 | |||||||||
% / rating of the dominant counterparty | 18% / AA- | 16% / A | 16% / A | 7% / A | |||||||||
Mutual fundsfund investments are made by the Sanofi parent company. These mutual fundsfund investments are ‘short-termin 'short-term money market’market' and ‘money market’'money market' euro-denominated Fundsfunds based on the European classification used by theAutorité des Marchés Financiers, and ‘money market’'money market' U.S. dollar-denominated Fundsfunds subject to the U.S. Securities and Exchange Commission regulation 2a7.2a-7. They show low volatility, low sensitivity to interest rate risk and a very low probability of loss of principal. DepositaryThe depositary banks of the mutual funds, as well as depositariesand of sanofi-aventisSanofi itself, are at least A+A rated.
Realization of counterparty risk could impact our liquidity in certain circumstances.
Stock Market Risk
It is our policy not to trade on the stock market for speculative purposes.
Item 12. Description of Securities other than Equity Securities
12.A Debt Securities
Not applicable.
12.B Warrants and Rights
Not applicable.
12.C Other Securities
Not applicable.
12.D American Depositary Shares
General
JPMorgan Chase Bank, N.A. (“JPMorgan”("JPMorgan"), as depositary, issues Sanofi ADSs in certificated form (evidenced by an American depositary receipt, or ADR) or book-entry form. Each ADR is a certificate evidencing a specific number of Sanofi ADSs. Each Sanofi ADS represents one-half of one Sanofi ordinary share (or the right to receive one-half of one Sanofi ordinary share) deposited with the Paris, France office of BNP Paribas, as custodian. Each Sanofi ADS also represents an interest in any other securities, cash or other property that may be held by the depositary under the deposit agreement. The depositary’sdepositary's office is located at 1 Chase Manhattan Plaza, Floor 58, New York, New York 10005-1401.
A holder may hold Sanofi ADSs either directly or indirectly through his or her broker or other financial institution. The following description assumes holders hold their Sanofi ADSs directly, in certificated form evidenced by ADRs. Holders who hold the Sanofi ADSs indirectly must rely on the procedures of their broker or other financial institution to assert the rights of ADR holders described in this section. Holders should consult with their broker or financial institution to find out what those procedures are.
WeHolders of Sanofi ADSs do not treathave the same rights as holders of Sanofi ADSs as one of our shareholders, and such holders do not have shareholder rights.shares. French law governs shareholder rights. The depositary is the holder of the Sanofi ordinary shares underlying holders’ Sanofi ADSs. The rights of holders of Sanofi ADSs are set forth in the deposit agreement between Sanofi and JPMorgan and in the ADR. New York law governs the deposit agreement and the ADRs.
The following is a summary of certain terms of the deposit agreement, as amended. The form of our deposit agreement has been filed as an exhibit to our Form F-6 filed on August 7, 2007, and the amendment to our deposit agreement has been filed as an exhibit to Post-Effective Amendment No. 1 to our Form F-6 filed on April 30, 2011. Each of the form and the amendment is incorporated by reference into this document. For more complete information, holders should read the entire deposit agreement (including the amendment) and the ADR itself. Holders may also inspect a copy of the deposit agreement at the depositary’sdepositary's office.
Share Dividends and Other Distributions
Receipt of dividends and other distributions
The depositary has agreed to pay to holders of Sanofi ADSs the cash dividends or other distributions that it or the custodian receives on the deposited Sanofi ordinary shares and other deposited securities after deducting its fees and expenses. Holders of Sanofi ADSs will receive these distributions in proportion to the number of Sanofi ADSs that they hold.
Cash. The depositary will convert any cash dividend or other cash distribution paid on the shares into U.S. dollars if, in its judgment, it can do so on a reasonable basis and can transfer the U.S. dollars to the United States. If the depositary determines that such a conversion and transfer is not possible, or if any approval from the French government is needed and cannot be obtained within a reasonable period, then the depositary may (1) distribute the foreign currency received by it to the holders of Sanofi ADSs or (2) hold the foreign currency distribution (uninvested and without liability for any interest) for the account of holders of Sanofi ADSs.
In addition, if any conversion of foreign currency, in whole or in part, cannot be effected to some holders of Sanofi ADSs, the deposit agreement allows the depositary to distribute the dividends only to those ADR holders to whom it is possible to do so. It will hold the foreign currency it cannot convert into U.S. dollars for the account of the ADR holders who have not been paid. It will not invest the funds it holds and it will not be liable for any interest.
Before making a distribution, any withholding taxes that must be paid under French law will be deducted. The depositary will distribute only whole U.S. dollars and cents and will round fractional cents down to the nearest whole cent.Exchange rate fluctuations during a period when the depositary cannot convert euros into U.S. dollars may result in holders losing some or all of the value of a distribution.
Shares. The depositary may, and at our request will, distribute new ADRs representing any shares we distribute as a dividend or free distribution, if we furnish it promptly with satisfactory evidence that it is legal to do so. At its option, the depositary may distribute fractional Sanofi ADSs. If the depositary does not distribute additional Sanofi ADSs, the outstanding ADRs will also represent the new shares. The depositary may withhold any tax or other governmental charges, or require the payment of any required fees and expenses, prior to making any distribution of additional Sanofi ADSs.
Rights to Receive Additional Shares. If we offer holders of Sanofi ordinary shares any rights to subscribe for additional shares or any other rights, the depositary, after consultation with us, will, in its discretion, either (1) make these rights available to holders or (2) dispose of such rights on behalf of holders and make the net proceeds available to holders. The depositary may make rights available to certain holders but not others if it determines it is lawful and feasible to do so. However, if, under the terms of the offering or for any other reason, the depositary may not make such rights available or dispose of such rights and make the net proceeds available, it will allow the rights to lapse. In that case, holders of Sanofi ADSs will receive no value for them.
In circumstances where rights would not otherwise be distributed by the depositary to holders of Sanofi ADSs, a holder of Sanofi ADSs may nonetheless request, and will receive from the depositary, any instruments or other documents necessary to exercise the rights allocable to that holder if the depositary first receives written notice from Sanofi that (1) Sanofi has elected, in its sole discretion, to permit the rights to be exercised and (2) such holder has executed the documents Sanofi has determined, in its sole discretion, are reasonably required under applicable law.
If the depositary makes rights available to holders of Sanofi ADSs, upon instruction from such holders, it will exercise the rights and purchase the shares on such holder’sholder's behalf. The depositary will then deposit the shares and deliver ADRs to such holders. It will only exercise rights if holders of Sanofi ADSs pay it the exercise price and any other charges the rights require such holders to pay.
U.S. securities laws may restrict the sale, deposit, cancellation or transfer of ADRs issued upon exercise of rights. For example, holders of Sanofi ADSs may not be able to trade Sanofi ADSs freely in the United States. In this case, the depositary may deliver Sanofi ADSs under a separate restricted deposit agreement that will contain the same provisions as the deposit agreement, except for changes needed to implement the required restrictions.
Other Distributions. The depositary will distribute to holders of Sanofi ADSs anything else we may distribute on deposited securities (after deduction or upon payment of fees and expenses or any taxes or other governmental charges) by any means it thinks is legal, equitable and practical. If, for any reason, it cannot make the distribution in that way, the depositary may sell what we distributed and distribute the net proceeds of the sale in the same way it distributes cash dividends, or it may choose any other method to distribute the property it deems equitable and practicable.
The depositary is not responsible if it decides that it is unlawful or impractical to make a distribution available to any holders of Sanofi ADSs. We have no obligation to register Sanofi ADSs, shares, rights or other securities under the U.S. Securities Act of 1933, as amended. We also have no obligation to take any other action to permit the distribution of ADRs, shares, rights or anything else to holders of Sanofi ADSs. This means that holders may not receive the distribution we make on our shares or any value for them if it is illegal or impractical for the depositary to make them available to such holders.
Elective DistributionsDistributions.. Whenever we intend to distribute a dividend payable at the election of shareholders either in cash or in additional shares, we will give prior notice thereof to the depositary and will indicate whether we wish the elective distribution to be made available to holders of Sanofi ADSs. In that case, we will assist the depositary in determining whether that distribution is lawful and reasonably practicable. The depositary will make the election available to holders of Sanofi ADSs only if it is reasonably practicable and if we have provided all the documentation contemplated in the deposit agreement. In that case, the depositary will establish procedures to enable holders of Sanofi ADSs to elect to receive either cash or additional ADSs, in each case as described in the deposit agreement. If the election is not made available to holders of Sanofi ADSs, such holders will receive either cash or additional Sanofi ADSs, depending on what a shareholder in France would receive for failing to make an election, as more fully described in the deposit agreement.
Deposit, Withdrawal and Cancellation
The depositary will deliver ADRs if the holder or his or her broker deposit shares or evidence of rights to receive shares with the custodian. Upon payment of its fees and expenses and any taxes or charges, such as stamp taxes or stock transfer taxes or fees, the depositary will register the appropriate number of Sanofi ADSs in the names the holder requests and will deliver the ADRs to the persons the holder requests at its office.
Obtaining Sanofi ordinary shares
A holder may turn in his or her ADRs at the depositary’sdepositary's office. Upon payment of its fees and expenses and any taxes or charges, such as stamp taxes or stock transfer taxes or fees, the depositary will deliver (1) the underlying shares to an account designated by the holder and (2) any other deposited securities underlying the ADR at the office of a custodian or, at the holder’sholder's request, risk and expense, the depositary will deliver the deposited securities at its office.
Voting Rights
A holder may instruct the depositary to vote the Sanofi ordinary shares underlying his or her Sanofi ADSs at any meeting of Sanofi shareholders, but only if we askrequest that the depositary to ask for holder instructions. Otherwise, holders will not be able to exercise their right to vote unless they withdraw the underlying ordinary shares from the ADR program and vote as an ordinary shareholder. However, holders may not know about the meeting sufficiently in advance to timely withdraw the underlying ordinary shares.
If we ask for holder instructions in connection with a meeting of Sanofi shareholders, the depositary will mail materials to holders of Sanofi ADSs in the manner described under the heading “Notices"Notices and Reports; Rights of Holders to Inspect Books”Books" below. For any instructions to be valid, the depositary must receive them on or before the date specified in the materials distributed by the depositary. The depositary will try, asendeavor, in so far as practical, subject to French law and the provisions of ourstatuts, to vote or to have its agents vote the shares or other deposited securities as holders may validly instruct. The depositary will only vote or attempt to vote shares as holders validly instruct.
We cannot assure holders that they will receive the voting materials in time to ensure that holders can instruct the depositary to vote their shares. As long as they act in good faith, neither the depositary nor its agents will be responsible for failing to carry out voting instructions or for the manner of carrying out voting instructions.This means that holders may not be able to exercise their right to vote and there may be nothing holders can do if their shares are not voted as they requested.
Similar to our shares, Sanofi ADSs evidenced by ADRs that are registered in the name of the same owner for at least two (2) years are eligible for double voting rights so long as certain procedures are followed, as set out in the deposit agreement. For additional information regarding double voting rights, see “Item"Item 10. Additional Information — B. Memorandum and Articles of Association — Voting Rights”Rights".
The deposit agreement allows the depositary and Sanofi to change the voting procedures or require additional voting procedures in addition to the ones described above if necessary or appropriate to comply with French or
United States law or ourstatuts.For example, holders might be required to arrange to have their Sanofi ADSs deposited in a blocked account for a specified period of time prior to a shareholders’shareholders' meeting in order to be allowed to give voting instructions.
Notices and Reports; Rights of Holders to Inspect Books
On or before the first date on which we give notice, by publication or otherwise, of any meeting of holders of shares or other deposited securities, or of any adjourned meeting of such holders, or of the taking of any action in respect of any cash or other distributions or the offering of any rights, we will transmit to the depositary a copy of the notice.
Upon notice of any meeting of holders of shares or other deposited securities, if requested in writing by Sanofi, the depositary will, as soon as practicable, mail to the holders of Sanofi ADSs a notice, the form of which is in the discretion of the depositary, containing (1) a summary in English of the information contained in the notice of meeting provided by Sanofi to the depositary, (2) a statement that the holders as of the close of business on a specified record date will be entitled, subject to any applicable provision of French law and of ourstatuts, to instruct the depositary as to the exercise of the voting rights, if any, pertaining to the amount of shares or other deposited securities represented by their respective ADSs and (3) a statement as to the manner in which such instructions may be given.
The depositary will make available for inspection by ADS holders at the depositary’sdepositary's office any reports and communications, including any proxy soliciting material, received from us that are both (1) received by the depositary as the holder of the deposited securities and (2) made generally available to the holders of such deposited securities by us. The depositary will also, upon written request, send to ADS holders copies of such reports when furnished by us pursuant to the deposit agreement. Any such reports and communications, including any such proxy soliciting material, furnished to the depositary by us will be furnished in English to the extent such materials are required to be translated into English pursuant to any regulations of the SEC.
The depositary will keep books for the registration of ADRs and transfers of ADRs that at all reasonable times will be open for inspection by the holders provided that such inspection is not for the purpose of communicating with holders in the interest of a business or object other than our business or a matter related to the deposit agreement or the ADRs.
Fees and Expenses
Fees Payable By ADS Holders
Pursuant to the deposit agreement, holders of our ADSs may have to pay to JPMorgan, either directly or indirectly, fees or charges up to the amounts set forth in the table below.
Associated Fee | Depositary Action | ||||
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$5.00 or less per 100 ADSs (or portion thereof) | Execution and delivery of ADRs for distributions and dividends in shares and rights to subscribe for additional shares or rights of any other nature and surrender of ADRs for the purposes of withdrawal, including the termination of the deposit agreement | ||||
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Associated Fee | Depositary Action | |
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Registration fees in effect for the registration of transfers of shares generally on the share register of the company or foreign registrar and applicable to transfers of shares to or from the name of JPMorgan or its nominee to the custodian or its nominee on the making of deposits and withdrawals | As applicable |
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A fee equal to the fee for the execution and delivery of ADSs which would have been charged as a result of the deposit of such securities | Distributions of securities other than cash, shares or rights | |
Any other charges payable by JPMorgan, its agents (and their agents), including BNP Paribas, as custodian (by deductions from cash dividends or other cash distributions or by directly billing investors or by charging the book-entry system accounts of participants acting for them) | Servicing of shares or other deposited securities | |
Expenses incurred by JPMorgan | • Cable, telex and facsimile transmission (where expressly provided for in the deposit agreement) | |
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In addition to the fees outlined above, each holder will be responsible for any taxes or other governmental charges payable on his or her Sanofi ADSs or on the deposited securities underlying his or her Sanofi ADSs. The depositary may refuse to transfer a holder’sholder's Sanofi ADSs or allow a holder to withdraw the deposited securities underlying his or her Sanofi ADSs until such taxes or other charges are paid. It may apply payments owed to a holder or sell deposited securities underlying a holder’sholder's Sanofi ADSs to pay any taxes owed, and the holder will remain liable for any deficiency. If it sells deposited securities, it will, if appropriate, reduce the number of Sanofi ADSs to reflect the sale and pay to the holder any proceeds, or send to the holder any property, remaining after it has paid the taxes. For additional information regarding taxation, see "Item 10. Additional Information — E. Taxation".
Fees Paid to Sanofi by the Depositary
JPMorgan, as depositary, has agreed to reimburse Sanofi upfor certain expenses (subject to $4,000,000 per year for expensescertain limits) Sanofi incurs relating to legal fees, investor relations servicing, investor-related presentations, ADR-related advertising and public relations in those jurisdictions in which the ADRs may be listed or otherwise quoted, investor relations channel, perception studies, accountants’accountants' fees in relation to our annual report on Form 20-F or any other expenses directly or indirectly relating to managing the program or servicing the shareholders. The depositary has also agreed to provide additional payments to Sanofi based on certain performance indicators relating to the ADR facility. From January 1, 20112012 to December 31, 2011,2012, Sanofi received from JPMorgan reimbursements equal to the $4,000,000 ceilingof $4,250,000 for expenses incurred in 2011.and no additional payments based on performance of the ADR facility were made. In addition to such reimbursements,amounts, JPMorgan has agreed to waive up to $425,000 annually in servicing fees Sanofi may incur in connection with routine corporate actions such as annual general meetings and divideddividend distributions, as well as for other assistance JPMorgan may provide Sanofi, such as preparation of tax and regulatory compliance feesdocuments for holders and investor relations advisory services.
Changes Affecting Deposited Securities
If we:
then either:
Disclosure of Interests
The obligation of a holder or other person with an interest in our shares to disclose information under French law and under ourstatuts also applies to holders and any other persons, other than the depositary, who have an interest in the Sanofi ADSs. The consequences for failing to comply with these provisions are the same for holders and any other persons with an interest as a holder of our ordinary shares. For additional information regarding these obligations, see “Item"Item 10. Additional Information — B. Memorandum and Articles of Association — Requirements for Holdings Exceeding Certain Percentages”Percentages".
Amendment and Termination
We may agree with the depositary to amend the deposit agreement and the ADRs without the consent of the ADS holders for any reason. If the amendment adds or increases fees or charges, except for taxes and other governmental charges or registration fees, cable, telex or facsimile transmission costs, delivery costs or other such expenses, or prejudices a substantial right of holders of Sanofi ADSs, it will only become effective 30 days after the depositary notifies such holders of the amendment. However, we may not be able to provide holders of Sanofi ADSs with prior notice of the effectiveness of any modifications or supplements that are required to accommodate compliance with applicable provisions of law, whether or not those modifications or supplements could be considered to be materially prejudicial to the substantial rights of holders of Sanofi ADSs.At the time an amendment becomes effective, such holders will be considered, by continuing to hold their ADR, to have agreed to the amendment and to be bound by the ADR and the deposit agreement as amended.
The depositary will terminate the agreement if we ask it to do so. The depositary may also terminate the agreement if the depositary has told us that it would like to resign and we have not appointed a new depositary bank within 90 days. In both cases, the depositary must notify holders of Sanofi ADSs at least 30 days before termination.
After termination, the depositary and its agents will be required to do only the following under the deposit agreement: (1) collect distributions on the deposited securities, (2) sell rights and other property as provided in the deposit agreement and (3) deliver shares and other deposited securities upon cancellation of ADRs. Six months or more after termination, the depositary may sell any remaining deposited securities by public or private sale. After that, the depositary will hold the money it receives on the sale, as well as any other cash it is holding under the deposit agreement, for the pro rata benefit of the holders of Sanofi ADSs that have not surrendered their Sanofi ADSs. It will have no liability for interest. Upon termination of the deposit agreement, the depositary’sdepositary's only obligations will be to account for the proceeds of the sale and other cash and with respect to indemnification. After termination, our only obligation will be with respect to indemnification and to pay certain amounts to the depositary.
Limitations on Obligations and Liability to Holders of Sanofi ADSs
The deposit agreement expressly limits our obligations and the obligations of the depositary, and it limits our liability and the liability of the depositary. We and the depositary:
In addition, the depositary will not be liable for any acts or omissions made by a successor depositary. Moreover, neither we nor the depositary nor any of our respective agents will be liable to any holder of Sanofi ADSs for any indirect, special, punitive or consequential damages.
Pursuant to the terms of the deposit agreement, we and the depositary have agreed to indemnify each other under certain circumstances.
Requirements for Depositary Actions
Before the depositary will deliver or register the transfer of Sanofi ADSs, make a distribution on Sanofi ADSs or process a withdrawal of shares, the depositary may require:
The depositary may refuse to deliver Sanofi ADSs, register transfers of Sanofi ADSs or permit withdrawals of shares when the transfer books of the depositary or our transfer books are closed, or at any time if the depositary or we think it advisable to do so.
Right to Receive the Shares Underlying the Sanofi ADSs
Holders have the right to cancel their Sanofi ADSs and withdraw the underlying Sanofi ordinary shares at any time except:
This right of withdrawal may not be limited by any other provision of the deposit agreement.
Pre-Release of Sanofi ADSs
Unless we instruct the depositary not to, the deposit agreement permits the depositary to deliver Sanofi ADSs before deposit of the underlying shares. This is called a pre-release of the Sanofi ADSs. The depositary may also deliver shares upon cancellation of pre-released Sanofi ADSs (even if the Sanofi ADSs are cancelled before the pre-release transaction has been closed out). A pre-release is closed out as soon as the underlying shares are delivered to the depositary. The depositary may receive Sanofi ADSs instead of shares to close out a pre-release. Unless otherwise agreed in writing, the depositary may pre-release Sanofi ADSs only under the following conditions: (1) before or at the time of the pre-release, the person to whom the pre-release is being made must represent to the depositary in writing that it or its customer (i) owns the shares or Sanofi ADSs to be
deposited, (ii) assigns all beneficial rights, title and interest in such shares or ADRs to the depositary in its capacity as depositary and (iii) will not take any action with respect to such shares or ADRs that is inconsistent with the transfer of beneficial ownership, other than in satisfaction of such pre-release; (2) the pre-release must be fully collateralized with cash, U.S. government securities or other collateral that the depositary considers appropriate; (3) the depositary must be able to close out the pre-release on not more than five business days’days' notice; and (4) the depositary may require such further indemnities and credit regulations as it deems appropriate. In addition, the depositary will limit the number of Sanofi ADSs that may be outstanding at any time as a result of pre-release, although the depositary may disregard the limit from time to time, if it thinks it is appropriate to do so. The depositary may retain for its own account any compensation received by it in connection with the foregoing.
Item 13. Defaults, Dividend Arrearages and Delinquencies
N/A
Item 14. Material Modifications to the Rights of Security Holders
N/A
Item 15. Controls and Procedures
(a) Our Chief Executive Officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rule 13a-15(e)) as of the end of the period covered by this Form 20-F, have concluded that, as of such date, our disclosure controls and procedures were effective to ensure that material information relating to Sanofi was timely made known to them by others within the Group.
(b) Report of Management on Internal Control Over Financial Reporting
Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a — 15(f)13a-15(f). Management assessed the effectiveness of internal control over financial reporting as of December 31, 20112012 based on the framework in “Internal"Internal Control — Integrated Framework”Framework" issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
Based on that assessment, management has concluded that the Company’sCompany's internal control over financial reporting was effective as of December 31, 20112012 to provide reasonable assurance regarding the reliability of its financial reporting and the preparation of its financial statements for external purposes, in accordance with generally accepted accounting principles.
Due to its inherent limitations, internal control over financial reporting may not prevent or detect misstatements, and can only provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
The effectiveness of the Company’sCompany's internal control over financial reporting has been audited by PricewaterhouseCoopers Audit and Ernst & Young Audit,et Autres, independent registered public accounting firms, as stated in their report on the Company’sCompany's internal control over financial reporting as of December 31, 2011,2012, which is included herein. See paragraph (c) of the present Item 15, below.
(c) See report of PricewaterhouseCoopers Audit and Ernst & Young Audit,et Autres, independent registered public accounting firms, included under “Item"Item 18. Financial Statements”Statements" on page F-3.
(d) There were no changes to our internal control over financial reporting that occurred during the period covered by this Form 20-F that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
[Reserved]
[Reserved]
Item 16A. Audit Committee Financial Expert
Our Board of Directors has determined that Klaus Pohle, Robert Castaigne, Christian Mulliez and Gérard Van Kemmel, directors serving on the Audit Committee, are independent financial experts within the meaning of §407paragraph 407 of the Sarbanes-Oxley Act of 2002.
The Board of Directors deemed Klaus Pohle to be a financial expert taking into account his education and professional experience in financial matters, accountancy and internal control. The Board of Directors determined that Robert Castaigne qualifies as a financial expert based on his education and his experience as Chief Financial Officer of a major corporation. The Board of Directors deemed Christian Mulliez to be a financial expert taking into account his experience as Vice President, General Manager Administration and Finance of L'Oréal and graduate of theEcole Supérieure des Sciences Economiques et Commerciales (ESSEC). The Board of Directors determined that
Gérard Van Kemmel qualifies as a financial expert based on his experience as a partner at an international accounting firm. The Board of Directors has also determined that Carole Piwnica possesses the requisite knowledge and experience in finance and accounting for Audit Committee membership.
The Board of Directors has determined that all fourfive directors meet the independence criteria of U.S. Securities and Exchange Commission Rule 10A-3, although only Mrs. Piwnica, Mr. Castaigne, Mr. Pohle and Mr. Van Kemmel meet the French AFEP-MEDEF Code criteria of independence applied by the Board of Directors for general corporate governance purposes. (See Item 16.G, below.)
We have adopted a financial code of ethics, as defined in Item 16B. of Form 20-F under the Exchange Act. Our financial code of ethics applies to our Chief Executive Officer, Chief Financial Officer, Chief Accounting Officer and other officers performing similar functions, as designated from time to time. Our financial code of ethics is available on our Website at www.sanofi.com (information on our website is not incorporated by reference in this annual report). A copy of our financial code of ethics may also be obtained without charge by addressing a written request to the attention of Individual Shareholder Relations at our headquarters in Paris. We will disclose any amendment to the provisions of such financial code of ethics on our website.
Item 16C. Principal Accountants’Accountants' Fees and Services
See Note E. to our consolidated financial statements included at Item 18 of this annual report.
Item 16D. Exemptions from the Listing Standards for Audit Committees
N/A
E.Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers
In 2011,2012, Sanofi made the following purchases of its ordinary shares.
Period | (a) Total Number of Shares Purchased | (b) Average Price Paid per Share | (c) Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (1) | (d) Approximate Value of Shares that May Yet Be Purchased Under the Plans or Programs | ||||||||||||
June 2011 | 2,125,000 | € | 52.58 | 2,125,000 | € | 10,376,249,740 | ||||||||||
August 2011 | 5,840,822 | € | 47.96 | 5,840,822 | € | 10,096,123,917 | ||||||||||
September 2011 | 2,229,631 | € | 48.46 | 2,229,631 | € | 9,988,075,999 | ||||||||||
November 2011 | 8,094,187 | € | 48.83 | 8,094,187 | € | 9,592,836,847 | ||||||||||
December 2011 | 3,365,500 | € | 53.16 | 3,365,500 | € | 9,413,926,867 |
Period | (a) Total Number of Shares Purchased | (b) Average Price Paid per Share | (c) Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (1) | (d) Approximate Value of Shares that May Yet Be Purchased Under the Plans or Programs | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
February 2012 | 5,184,555 | € | 56.31 | 5,184,555 | € | 10,435,395,454 | |||||||
March 2012 | 1,953,164 | € | 57.60 | 1,953,164 | € | 10,322,886,122 | |||||||
April 2012 | 375,774 | € | 55.65 | 375,774 | € | 10,301,973,191 | |||||||
May 2012 | 257,373 | € | 57.08 | 257,373 | € | 10,287,283,561 | |||||||
June 2012 | 243,983 | € | 56.58 | 243,983 | € | 10,285,903,172 | |||||||
July 2012 | 2,274,000 | € | 65.61 | 2,274,000 | € | 10,136,695,283 | |||||||
August 2012 | 3,000,206 | € | 66.85 | 3,000,206 | € | 9,936,144,522 | |||||||
September 2012 | 284,588 | € | 65.84 | 284,588 | € | 9,917,407,277 | |||||||
This schedule does not include purchases and sales conducted by Exane under a liquidity contract entered into in 2010 and that is still in effect. For more information see Item 10.BMemorandum and Articles of Association — Use of Share Repurchase Programs.
Item 16F. Change in Registrant’sRegistrant's Certifying Accountant
N/A
Item 16G. Corporate Governance
Sanofi is incorporated under the laws of France, with securities listed on regulated public markets in the United States (New York Stock Exchange) and France (Euronext Paris). Consequently, as described further in our annual report, our corporate governance framework reflects the mandatory provisions of French corporate law, the securities laws and regulations of France and the United States and the rules of the aforementioned public markets. In addition, we generally follow the so-called “AFEP-MEDEF”"AFEP-MEDEF" corporate governance
recommendations for French listed issuers.issuers (hereafter referred to as the "AFEP-MEDEF Code"). As a result, our corporate governance framework is similar in many respects to, and provides investor protections that are comparable to — or in some cases, more stringent than — the corresponding rules of the New York Stock Exchange. Nevertheless, there are important differences to keep in mind.
In line with New York Stock Exchange rules applicable to domestic issuers, Sanofi maintains a board of directors at least half of the members of which are independent. Sanofi evaluates the independence of members of our Board of Directors using the standards of the French AFEP-MEDEF corporate governance recommendationsCode as the principal reference. We believe that AFEP-MEDEF’sAFEP-MEDEF's overarching criteria for independence — no relationship of any kind whatsoever with the Company, its group or the management of either that is such as to color a Board member’smember's judgment — are on the whole consistent with the goals of the New York Stock Exchange’sExchange's rules although the specific tests proposed under the two standards may vary on some points. We note that under the AFEP-MEDEF rules,Code, our non-executive Chairman of the Board has automatically been classified as non-independent although he has no relationship with Sanofi that would cause him to be non-independent under the rules of the New York Stock Exchange. Additionally, we have complied with the audit committee independence and other requirements of the Rule 10A-3 under the U.S. Securities Exchange Act of 1934, as amended, adopted pursuant to the Sarbanes-Oxley Act of 2002. Our Compensation Committee includes non-independent members, which is permitted under the AFEP-MEDEF rulesCode but would not be compliant with the rules of the New York Stock Exchange for domestic issuers.
Under French law, the committees of our Board of Directors are advisory only, and where the New York Stock Exchange Listed Company Manual would vest certain decision-making powers with specific committees by delegation (e.g., nominating appointment or audit committees), under French law our Board of Directors remains under French law the only competent body to take such decisions, albeit taking into account the recommendation of the relevant committees. Additionally, under French corporate law, it is the shareholder meetingShareholders' General Meeting of Sanofi that is competent to appoint our auditors upon the proposal of our Board of Directors;Directors, although our internal rules provideBoard Charter provides that the Board of Directors will make its proposal on the basis of the recommendation of our Audit Committee. We believe that this requirement of French law, together with the additional legal requirement that two sets of statutory auditors be appointed, share the New York Stock Exchange’sExchange's underlying goal of ensuring that the audit of our accounts be conducted by auditors independent from company management.
In addition to the oversight role of our Compensation Committee for questions of management compensation including by way of equity, under French law any option or restricted sharesshare plans or other share capital increases, whether for the benefit of topsenior management or employees, may only be adopted by the Board of Directors pursuant to and within the limits of a shareholder resolution approving the related capital increase and delegating to the Board the authority to implement such operations.
As described above, a number of issues, which could be resolved directly by a board or its committees in the United States, require the additional protection of direct shareholder consultation in France. On the other hand, there is not a tradition of non-executive Board of DirectorDirectors sessions. Our Audit Committee is entirely composed of independent directors as that term is defined in Rule 10A-3 under the U.S. Securities Exchange Act of 1934, as amended, adopted pursuant to the Sarbanes-Oxley Act of 2002. The composition of our Audit Committee, Compensation Committee, and Appointments and Governance Committee includes directors who are also officers or recently retired officers of our principal shareholders.largest shareholder.
As a ‘foreign'foreign private issuer’issuer' under the U.S. securities laws, our Chief Executive Officer and our Chief Financial Officer issue the certifications required by §302 and §906 of the Sarbanes Oxley Act of 2002 on an annual basis (with the filing of our annual report on U.S. Form 20-F) rather than on a quarterly basis as would be the case of a U.S. corporation filing quarterly reports on U.S. Form 10-Q.
French corporate law provides that the Board of Directors must vote to approve a broadly defined range of transactions that could potentially create conflicts of interest between Sanofi on the one hand and its Directors and Chief Executive Officer on the other hand, which are then presented to shareholders for approval at the next annual meeting. This legal safeguard provides shareholders with an opportunity to approve significant aspects of the Chief Executive Officer’sOfficer's compensation package even in the absence of “say"say on pay”pay" legislation in France, and it operates in place of certain provisions of the NYSE Listed Company Manual.
Item 16H. Mine Safety Disclosure
N/A
N/A
See Item 18.
See pages F-1 through F-123F-122 incorporated herein by reference.
1.1 | Articles of association | |||
1.2 | Board Charter | |||
2.1 | Form of Deposit Agreement between Sanofi and JPMorgan Chase Bank, N.A., as depositary (incorporated herein by reference to Exhibit A to the Registration Statement on Form F-6 dated August 7, 2007 relating to our American Depositary Shares, SEC File No. 333-145177) | |||
2.2 | Amendment No.1 to Deposit Agreement between Sanofi and JPMorgan Chase Bank, N.A., as depositary(incorporated herein by reference to Exhibit (a)(2) to Post-Effective Amendment No.1 to Form F-6 dated April 30, 2011 relating to our American Depositary Shares, SEC File No. 333-145177) | |||
2.3 | Instrument defining rights of holders of American Depositary Shares each representing one quarter of a Participating Share Series A (incorporated by reference to Item. 3 Exhibit (a) of the Registration Statement on Form F-6 (Registration No. 33-31904) dated November 21, 1989) | |||
4.1 | Facilities Agreement, dated October 2, 2010, by and among Sanofi-Aventis, BNP Paribas, J.P. Morgan plc and Société Générale Corporate & Investment Banking acting as Initial Mandated Lead Arrangers, Société Générale acting as Facilities Agent, the Companies listed as Additional Borrowers thereto and the Financial Institutions included as Lenders therein. (incorporated by reference to Exhibit (b)(A) of the Tender Offer Statement on Schedule TO filed on October 4, 2010.) | |||
4.2 | Amendment dated February 15, 2011 to the Facilities Agreement, dated October 2, 2010, by and among Sanofi-Aventis, BNP Paribas, J.P. Morgan plc and Société Générale Corporate & Investment Banking acting as Initial Mandated Lead Arrangers, Société Générale acting as Facilities Agent, the Companies listed as Additional Borrowers thereto and the Financial Institutions included as Lenders therein. (incorporated by reference to Exhibit (b)(B) of Amendment No. 15 to the Tender Offer Statement on Schedule TO filed on February 16, 2011) | |||
4.3 | Agreement and Plan of Merger, dated as of February 16, 2011, among Sanofi-Aventis, GC Merger Corp., and Genzyme Corporation (incorporated by reference to Exhibit (d)(1) of Amendment No. 15 to the Tender Offer Statement on Schedule TO filed on February 16, 2011) | |||
4.4 | Form of Contingent Value Rights Agreement by and among Sanofi and Trustee (incorporated by reference to Exhibit (d)(2) of Amendment No. 15 to the Tender Offer Statement on Schedule TO filed on February 16, 2011) | |||
8.1 | List of significant subsidiaries, see | |||
12.1 | Certification by Christopher Viehbacher, Chief Executive Officer, required by Section 302 of the Sarbanes-Oxley Act of 2002 | |||
12.2 | Certification by Jérôme Contamine, Principal Financial Officer, required by Section 302 of the Sarbanes-Oxley Act of 2002 | |||
13.1 | Certification by Christopher Viehbacher, Chief Executive Officer, required by Section 906 of the Sarbanes-Oxley Act of 2002 | |||
13.2 | Certification by Jérôme Contamine, Principal Financial Officer, required by Section 906 of the Sarbanes-Oxley Act of 2002 | |||
23.1 | Consent of Ernst & Young | |||
6, 2013 | ||||
23.2 | Consent of PricewaterhouseCoopers Audit dated March | |||
6, 2013 | ||||
99.1 | Report of the Chairman of the Board of Directors for |
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf.
| ||
| ||
|
Date: March 5, 2012
ANNUAL CONSOLIDATED FINANCIAL STATEMENTS
The financial statements are presented in accordance with
International Financial Reporting Standards (IFRS)
Sanofi | ||||||
| Christopher Viehbacher Chief Executive Officer |
Date: March 6, 2013
ANNUAL CONSOLIDATED FINANCIAL STATEMENTS
The financial statements are presented in accordance with
International Financial Reporting Standards (IFRS)
F-4 – F-5 | ||||
CONSOLIDATED INCOME STATEMENTS | F-6 | |||
F-7 | ||||
F-8 | ||||
F-9 | ||||
F-10 | ||||
– A.Basis of preparation | F-10 – F-11 | |||
– B.Summary of significant accounting policies | F-11 | |||
– C.Alliances | F-36 – F-39 | |||
– D.Detailed notes to the financial statements | F-39 – F-116 | |||
– E.Principal | F-117 | |||
– F.List of principal companies included in the consolidation for the year ended December 31, | F-118 |
REPORT OF INDEPENDENT REGISTERED
PUBLIC ACCOUNTING FIRMS
SANOFI
SANOFI
To the Board of Directors and Shareholders of Sanofi,
We have audited the accompanying consolidated balance sheets of Sanofi and its subsidiaries (together the “Group”"Group") as of December 31, 2012, 2011 2010 and 2009,2010, and the related consolidated statements of income, comprehensive income, changes in equity and cash flows for each of the three years in the period ended December 31, 2011.2012. These financial statements are the responsibility of the Group’sGroup's management. Our responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States), (the “PCAOB”"PCAOB"). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial position of the Group as of December 31, 2012, 2011 2010 and 2009,2010, and the consolidated results of its operations and its cash flows for each of the three years in the period ended December 31, 2011,2012, in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.
We also have audited, in accordance with the standards of the PCAOB, the effectiveness of the Group’sGroup's internal control over financial reporting as of December 31, 2011,2012, based on criteria established in Internal Control — Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated March 5, 20126, 2013 expressed an unqualified opinion thereon.
Neuilly-sur-Seine and Paris-La Défense, March 5, 20126, 2013
PricewaterhouseCoopers Audit | Ernst & Young | |
Xavier Cauchois | Christian Chiarasini |
REPORT OF INDEPENDENT REGISTERED
PUBLIC ACCOUNTING FIRMS
SANOFI
SANOFI
To the Board of Directors and Shareholders of Sanofi,
We have audited internal control over financial reporting of Sanofi and its subsidiaries (together “the Group”"the Group") as of December 31, 2011,2012, based on criteria established in Internal Control — Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). The Group’sGroup's management is responsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Report of Management on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the company’scompany's internal control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States), (the “PCAOB”"PCAOB"). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
A company’scompany's internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’scompany's internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’scompany's assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
In our opinion, the Group maintained, in all material respects, effective internal control over financial reporting as of December 31, 2011,2012, based on the COSO criteria.
We also have audited, in accordance with the standards of the PCAOB, the consolidated balance sheets of the Group as of December 31, 2012, 2011 2010 and 2009,2010, and the related consolidated statements of income, comprehensive income, changes in equity and cash flows for each of the three years in the period ended December 31, 20112012 and our report dated March 5, 20126, 2013 expressed an unqualified opinion thereon.
Neuilly-sur-Seine and Paris-La Défense, March 5, 20126, 2013
PricewaterhouseCoopers Audit | Ernst & Young | |
Xavier Cauchois | Christian Chiarasini |
(€ million) | Note | December 31, 2011 | December 31, 2010 | December 31, 2009 | ||||||||||
ASSETS | ||||||||||||||
Property, plant and equipment | D.3. | 10,750 | 8,155 | 7,830 | ||||||||||
Goodwill | D.4. | 38,079 | 31,932 | 29,733 | ||||||||||
Other intangible assets | D.4. | 23,639 | 12,479 | 13,747 | ||||||||||
Investments in associates and joint ventures | D.6. | 807 | 924 | 955 | ||||||||||
Non-current financial assets | D.7. | 2,399 | 1,644 | 998 | ||||||||||
Deferred tax assets | D.14. | 3,633 | 3,051 | 2,912 | ||||||||||
Non-current assets | 79,307 | 58,185 | 56,175 | |||||||||||
Inventories | D.9. | 6,051 | 5,020 | 4,444 | ||||||||||
Accounts receivable | D.10. | 8,042 | 6,507 | 6,015 | ||||||||||
Other current assets | D.11. | 2,401 | 2,000 | 2,104 | ||||||||||
Current financial assets | D.12. | 173 | 51 | 277 | ||||||||||
Cash and cash equivalents | D.13. - D.17. | 4,124 | 6,465 | 4,692 | ||||||||||
Current assets | 20,791 | 20,043 | 17,532 | |||||||||||
Assets held for sale or exchange (1) | D.8. | 67 | 7,036 | 6,544 | ||||||||||
TOTAL ASSETS | 100,165 | 85,264 | 80,251 |
|
(€ million) | Note | December 31, 2012 | December 31, 2011 (1) | December 31, 2010 | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
ASSETS | ||||||||||||
Property, plant and equipment | D.3. | 10,578 | 10,750 | 8,155 | ||||||||
Goodwill | D.4. | 38,073 | 38,582 | 31,932 | ||||||||
Other intangible assets | D.4. | 20,192 | 23,639 | 12,479 | ||||||||
Investments in associates and joint ventures | D.6. | 487 | 807 | 924 | ||||||||
Non-current financial assets | D.7. | 3,799 | 2,399 | 1,644 | ||||||||
Deferred tax assets | D.14. | 4,377 | 3,633 | 3,051 | ||||||||
Non-current assets | 77,506 | 79,810 | 58,185 | |||||||||
Inventories | D.9. | 6,379 | 6,051 | 5,020 | ||||||||
Accounts receivable | D.10. | 7,507 | 8,042 | 6,507 | ||||||||
Other current assets | D.11. | 2,355 | 2,401 | 2,000 | ||||||||
Current financial assets | D.12. | 178 | 173 | 51 | ||||||||
Cash and cash equivalents | D.13.–D.17. | 6,381 | 4,124 | 6,465 | ||||||||
Current assets | 22,800 | 20,791 | 20,043 | |||||||||
Assets held for sale or exchange (2) | D.8. | 101 | 67 | 7,036 | ||||||||
TOTAL ASSETS | 100,407 | 100,668 | 85,264 | |||||||||
The accompanying notes on pages F-10 to F-123F-122 are an integral part of the consolidated financial statements.
CONSOLIDATED BALANCE SHEETS
(€ million) | Note | December 31, 2011 | December 31, 2010 | December 31, 2009 | ||||||||||
LIABILITIES & EQUITY | ||||||||||||||
Equity attributable to equity holders of Sanofi | D.15. | 56,219 | 53,097 | 48,322 | ||||||||||
Equity attributable to non-controlling interests | D.16. | 170 | 191 | 258 | ||||||||||
Total equity | 56,389 | 53,288 | 48,580 | |||||||||||
Long-term debt | D.17. | 12,499 | 6,695 | 5,961 | ||||||||||
Non-current liabilities related to business combinations and to non-controlling interests | D.18. | 1,336 | 388 | 75 | ||||||||||
Provisions and other non-current liabilities | D.19. | 10,346 | 9,326 | 8,236 | ||||||||||
Deferred tax liabilities | D.14. | 6,011 | 3,808 | 4,933 | ||||||||||
Non-current liabilities | 30,192 | 20,217 | 19,205 | |||||||||||
Accounts payable | 3,183 | 2,800 | 2,654 | |||||||||||
Other current liabilities | D.19.4. | 7,221 | 5,624 | 5,369 | ||||||||||
Current liabilities related to business combinations and to non-controlling interests | D.18. | 220 | 98 | 76 | ||||||||||
Short-term debt and current portion of long-term debt | D.17. | 2,940 | 1,565 | 2,866 | ||||||||||
Current liabilities | 13,564 | 10,087 | 10,965 | |||||||||||
Liabilities related to assets held for sale or exchange (1) | D.8. | 20 | 1,672 | 1,501 | ||||||||||
TOTAL LIABILITIES & EQUITY | 100,165 | 85,264 | 80,251 |
|
(€ million) | Note | December 31, 2012 | December 31, 2011 (1) | December 31, 2010 | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
LIABILITIES & EQUITY | ||||||||||||
Equity attributable to equity holders of Sanofi | D.15. | 57,338 | 56,203 | 53,097 | ||||||||
Equity attributable to non-controlling interests | D.16. | 134 | 170 | 191 | ||||||||
Total equity | 57,472 | 56,373 | 53,288 | |||||||||
Long-term debt | D.17. | 10,719 | 12,499 | 6,695 | ||||||||
Non-current liabilities related to business combinations and to non-controlling interests | D.18. | 1,350 | 1,336 | 388 | ||||||||
Provisions and other non-current liabilities | D.19. | 11,036 | 10,346 | 9,326 | ||||||||
Deferred tax liabilities | D.14. | 5,932 | 6,530 | 3,808 | ||||||||
Non-current liabilities | 29,037 | 30,711 | 20,217 | |||||||||
Accounts payable | 3,190 | 3,183 | 2,800 | |||||||||
Other current liabilities | D.19.4. | 6,758 | 7,221 | 5,624 | ||||||||
Current liabilities related to business combinations and to non-controlling interests | D.18. | 100 | 220 | 98 | ||||||||
Short-term debt and current portion of long-term debt | D.17. | 3,812 | 2,940 | 1,565 | ||||||||
Current liabilities | 13,860 | 13,564 | 10,087 | |||||||||
Liabilities related to assets held for sale or exchange (2) | D.8. | 38 | 20 | 1,672 | ||||||||
TOTAL LIABILITIES & EQUITY | 100,407 | 100,668 | 85,264 | |||||||||
The accompanying notes on pages F-10 to F-123F-122 are an integral part of the consolidated financial statements.
CONSOLIDATED INCOME STATEMENTS
(€ million) | Note | Year ended December 31, | Year ended December 31, 2010 (1) | Year ended December 31, 2009 (1) | ||||||||||
Net sales | D.34. - D.35. | 33,389 | 32,367 | 29,785 | ||||||||||
Other revenues | 1,669 | 1,669 | 1,447 | |||||||||||
Cost of sales | (10,902 | ) | (9,398 | ) | (8,107 | ) | ||||||||
Gross profit | 24,156 | 24,638 | 23,125 | |||||||||||
Research and development expenses | (4,811 | ) | (4,547 | ) | (4,626 | ) | ||||||||
Selling and general expenses | (8,536 | ) | (8,149 | ) | (7,464 | ) | ||||||||
Other operating income | D.25. | 319 | 369 | 861 | ||||||||||
Other operating expenses | D.26. | (315 | ) | (292 | ) | (481 | ) | |||||||
Amortization of intangible assets | (3,314 | ) | (3,529 | ) | (3,528 | ) | ||||||||
Impairment of intangible assets | D.5. | (142 | ) | (433 | ) | (372 | ) | |||||||
Fair value remeasurement of contingent consideration liabilities | D.18. | 15 | — | — | ||||||||||
Restructuring costs | D.27. | (1,314 | ) | (1,384 | ) | (1,080 | ) | |||||||
Other gains and losses, and litigation (2) | D.28. | (327 | ) | (138 | ) | — | ||||||||
Operating income | 5,731 | 6,535 | 6,435 | |||||||||||
Financial expenses | D.29. | (552 | ) | (468 | ) | (325 | ) | |||||||
Financial income | D.29. | 140 | 106 | 27 | ||||||||||
Income before tax and associates and joint ventures | 5,319 | 6,173 | 6,137 | |||||||||||
Income tax expense | D.30. | (455 | ) | (1,430 | ) | (1,399 | ) | |||||||
Share of profit/(loss) of associates and joint ventures | D.31. | 1,070 | 978 | 953 | ||||||||||
Net income | 5,934 | 5,721 | 5,691 | |||||||||||
Attributable to non-controlling interests | D.32. | 241 | 254 | 426 | ||||||||||
Net income attributable to equity holders of Sanofi | 5,693 | 5,467 | 5,265 | |||||||||||
Average number of shares outstanding (million) | D.15.9. | 1,321.7 | 1,305.3 | 1,305.9 | ||||||||||
Average number of shares outstanding after dilution (million) | D.15.9. | 1,326.7 | 1,308.2 | 1,307.4 | ||||||||||
– Basic earnings per share (in euros) | 4.31 | 4.19 | 4.03 | |||||||||||
– Diluted earnings per share (in euros) | 4.29 | 4.18 | 4.03 |
|
|
(€ million) | Note | Year ended December 31, 2012 | Year ended December 31, 2011 | Year ended December 31, 2010 | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Net sales | D.34.–D.35. | 34,947 | 33,389 | 32,367 | ||||||||
Other revenues | 1,010 | 1,669 | 1,669 | |||||||||
Cost of sales | (11,118 | ) | (10,902 | ) | (9,398 | ) | ||||||
Gross profit | 24,839 | 24,156 | 24,638 | |||||||||
Research and development expenses | (4,922 | ) | (4,811 | ) | (4,547 | ) | ||||||
Selling and general expenses | (8,947 | ) | (8,536 | ) | (8,149 | ) | ||||||
Other operating income | D.25. | 562 | 319 | 369 | ||||||||
Other operating expenses | D.26. | (454 | ) | (315 | ) | (292 | ) | |||||
Amortization of intangible assets | (3,291 | ) | (3,314 | ) | (3,529 | ) | ||||||
Impairment of intangible assets | D.5. | (117 | ) | (142 | ) | (433 | ) | |||||
Fair value remeasurement of contingent consideration liabilities | D.18. | (192 | ) | 15 | — | |||||||
Restructuring costs | D.27. | (1,141 | ) | (1,314 | ) | (1,384 | ) | |||||
Other gains and losses, and litigation (1) | D.28. | — | (327 | ) | (138 | ) | ||||||
Operating income | 6,337 | 5,731 | 6,535 | |||||||||
Financial expenses | D.29. | (553 | ) | (552 | ) | (468 | ) | |||||
Financial income | D.29. | 93 | 140 | 106 | ||||||||
Income before tax and associates and joint ventures | 5,877 | 5,319 | 6,173 | |||||||||
Income tax expense | D.30. | (1,134 | ) | (455 | ) | (1,430 | ) | |||||
Share of profit/(loss) of associates and joint ventures | D.31. | 393 | 1,070 | 978 | ||||||||
Net income | 5,136 | 5,934 | 5,721 | |||||||||
Attributable to non-controlling interests | D.32. | 169 | 241 | 254 | ||||||||
Net income attributable to equity holders of Sanofi | 4,967 | 5,693 | 5,467 | |||||||||
Average number of shares outstanding (million) | D.15.9. | 1,319.5 | 1,321.7 | 1,305.3 | ||||||||
Average number of shares outstanding after dilution (million) | D.15.9. | 1,329.6 | 1,326.7 | 1,308.2 | ||||||||
– Basic earnings per share (in euros) | 3.76 | 4.31 | 4.19 | |||||||||
– Diluted earnings per share (in euros) | 3.74 | 4.29 | 4.18 | |||||||||
The accompanying notes on pages F-10 to F-123F-122 are an integral part of the consolidated financial statements.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(€ million) | Year ended December 31, 2011 | Year ended December 31, 2010 | Year ended December 31, 2009 | |||||||||
Net income | 5,934 | 5,721 | 5,691 | |||||||||
Attributable to equity holders of Sanofi | 5,693 | 5,467 | 5,265 | |||||||||
Attributable to non-controlling interests | 241 | 254 | 426 | |||||||||
Other elements of comprehensive income: | ||||||||||||
Actuarial gains (losses) | (677 | ) | (311 | ) | (169 | ) | ||||||
Remeasurement of previously-held equity interests: | ||||||||||||
– Merial (50%) | — | — | 1,379 | |||||||||
– Zentiva (24.9%) | — | — | 108 | |||||||||
Tax effect on above items (1) | 138 | 172 | (318 | ) | ||||||||
Items that may not be reclassified as income | (539 | ) | (139 | ) | 1,000 | |||||||
• Available-for-sale financial assets | 250 | 141 | 110 | |||||||||
• Cash flow hedges | 5 | 17 | (175 | ) | ||||||||
• Change in currency translation difference | (79 | ) | 2,654 | (298 | ) | |||||||
Tax effect on above items (1) | 4 | (20 | ) | 44 | ||||||||
Items that may be reclassified as income | 180 | 2,792 | (319 | ) | ||||||||
Other comprehensive income for the period, net of taxes | (359 | ) | 2,653 | 681 | ||||||||
Total comprehensive income | 5,575 | 8,374 | 6,372 | |||||||||
Attributable to equity holders of Sanofi | 5,346 | 8,109 | 5,945 | |||||||||
Attributable to non-controlling interests | 229 | 265 | 427 |
|
(€ million) | Year ended December 31, 2012 | Year ended December 31, 2011 (1) | Year ended December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Net income | 5,136 | 5,934 | 5,721 | |||||||
Attributable to equity holders of Sanofi | 4,967 | 5,693 | 5,467 | |||||||
Attributable to non-controlling interests | 169 | 241 | 254 | |||||||
Other comprehensive income: | ||||||||||
Actuarial gains (losses) | (1,555 | )(3) | (677 | )(3) | (311 | ) | ||||
Tax effect (2) | 492 | 138 | 172 | |||||||
Items not subsequently reclassifiable to profit or loss | (1,063 | ) | (539 | ) | (139 | ) | ||||
• Available-for-sale financial assets | 1,451 | 250 | 141 | |||||||
• Cash flow hedges | (4 | ) | 5 | 17 | ||||||
• Change in currency translation differences | (532 | ) | (95 | ) | 2,654 | |||||
Tax effect (2) | (117 | ) | 4 | (20 | ) | |||||
Items subsequently reclassifiable to profit or loss | 798 | 164 | 2,792 | |||||||
Other comprehensive income for the period, net of taxes | (265 | ) | (375 | ) | 2,653 | |||||
Comprehensive income | 4,871 | 5,559 | 8,374 | |||||||
Attributable to equity holders of Sanofi | 4,709 | 5,330 | 8,109 | |||||||
Attributable to non-controlling interests | 162 | 229 | 265 | |||||||
The accompanying notes on pages F-10 to F-123F-122 are an integral part of the consolidated financial statements.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(€ million) | Share capital | Additional paid-in capital and retained earnings | Treasury shares | Stock options and other share-based payment | Other comprehensive income (1) | Attributable to equity holders of Sanofi | Attributable to non-controlling interests | Total equity | ||||||||||||||||||||||||
Balance at January 1, 2009 | 2,631 | 44,819 | (552 | ) | 1,581 | (3,613 | ) | 44,866 | 205 | 45,071 | ||||||||||||||||||||||
Other comprehensive income for the period | — | 1,000 | — | — | (320 | ) | 680 | 1 | 681 | |||||||||||||||||||||||
Net income for the period | — | 5,265 | — | — | — | 5,265 | 426 | 5,691 | ||||||||||||||||||||||||
Comprehensive income for the period | — | 6,265 | — | — | (320 | ) | 5 945 | 427 | 6,372 | |||||||||||||||||||||||
Dividend paid out of 2008 earnings (€2.20 per share) | — | (2,872 | ) | — | — | — | (2,872 | ) | — | (2,872 | ) | |||||||||||||||||||||
Payment of dividends and equivalents to non-controlling interests | — | — | — | — | — | — | (418 | ) | (418 | ) | ||||||||||||||||||||||
Share-based payment plans: | ||||||||||||||||||||||||||||||||
• Exercise of stock options | 6 | 134 | — | — | — | 140 | — | 140 | ||||||||||||||||||||||||
• Proceeds from sale of treasury shares on exercise of stock options | — | — | 26 | — | — | 26 | — | 26 | ||||||||||||||||||||||||
• Value of services obtained from employees | — | — | — | 114 | — | 114 | — | 114 | ||||||||||||||||||||||||
• Tax effect on the exercise of stock options | — | — | — | 1 | — | 1 | — | 1 | ||||||||||||||||||||||||
Non-controlling interests generated by acquisitions | — | — | — | — | — | — | 49 | 49 | ||||||||||||||||||||||||
Changes in non-controlling interests without loss of control | — | — | — | — | — | — | (5 | ) | (5 | ) | ||||||||||||||||||||||
Step acquisitions | — | 102 | — | — | — | 102 | — | 102 | ||||||||||||||||||||||||
Balance at December 31, 2009 | 2,637 | 48,448 | (526 | ) | 1,696 | (3,933 | ) | 48,322 | 258 | 48,580 | ||||||||||||||||||||||
Other comprehensive income for the period | — | (139 | ) | — | — | 2,781 | 2,642 | 11 | 2,653 | |||||||||||||||||||||||
Net income for the period | — | 5,467 | — | — | — | 5,467 | 254 | 5,721 | ||||||||||||||||||||||||
Comprehensive income for the period | — | 5,328 | — | — | 2,781 | 8,109 | 265 | 8,374 | ||||||||||||||||||||||||
Dividend paid out of 2009 earnings (€2.40 per share) | — | (3,131 | ) | — | — | — | (3,131 | ) | — | (3,131 | ) | |||||||||||||||||||||
Payment of dividends and equivalents to non-controlling interests | — | — | — | — | — | — | (307 | ) | (307 | ) | ||||||||||||||||||||||
Share repurchase program (2) | — | — | (321 | ) | — | — | (321 | ) | — | (321 | ) | |||||||||||||||||||||
Reduction in share capital (2) | (16 | ) | (404 | ) | 420 | — | — | — | — | — | ||||||||||||||||||||||
Share-based payment plans: | ||||||||||||||||||||||||||||||||
• Exercise of stock options | 1 | 17 | — | — | — | 18 | — | 18 | ||||||||||||||||||||||||
• Proceeds from sale of treasury shares on exercise of stock options | — | — | 56 | — | — | 56 | — | 56 | ||||||||||||||||||||||||
• Value of services obtained from employees | — | — | — | 133 | — | 133 | — | 133 | ||||||||||||||||||||||||
• Tax effects on the exercise of stock options | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||
Non-controlling interests generated by acquisitions | — | — | — | — | — | — | 1 | 1 | ||||||||||||||||||||||||
Changes in non-controlling interests without loss of control | — | (89 | ) | — | — | — | (89 | ) | (26 | ) | (115 | ) | ||||||||||||||||||||
Balance at December 31, 2010 | 2,622 | 50,169 | (371 | ) | 1,829 | (1,152 | ) | 53,097 | 191 | 53,288 | ||||||||||||||||||||||
Other comprehensive income for the period | — | (539 | ) | — | — | 192 | (347 | ) | (12 | ) | (359 | ) | ||||||||||||||||||||
Net income for the period | — | 5,693 | — | — | — | 5,693 | 241 | 5,934 | ||||||||||||||||||||||||
Comprehensive income for the period | — | 5,154 | — | — | 192 | 5,346 | 229 | 5,575 | ||||||||||||||||||||||||
Dividend paid out of 2010 earnings (€2.50 per share) | — | (3,262 | ) | — | — | — | (3,262 | ) | — | (3,262 | ) | |||||||||||||||||||||
Payment of dividends and equivalent to non-controlling interests | — | — | — | — | — | — | (252 | ) | (252 | ) | ||||||||||||||||||||||
Increase in share capital – dividends paid in shares (2) | 76 | 1,814 | — | — | — | 1,890 | — | 1,890 | ||||||||||||||||||||||||
Share repurchase program (2) | — | — | (1,074 | ) | — | — | (1,074 | ) | — | (1,074 | ) | |||||||||||||||||||||
Reduction in share capital (2) | (21 | ) | (488 | ) | 509 | — | — | — | — | — | ||||||||||||||||||||||
Share-based payment plans: | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||
• Exercise of stock options | 4 | 66 | — | — | — | 70 | — | 70 | ||||||||||||||||||||||||
• Issuance of restricted shares | 1 | (1 | ) | — | — | — | — | — | — | |||||||||||||||||||||||
• Proceeds from sale of treasury shares on exercise of stock options | — | — | 3 | — | — | 3 | — | 3 | ||||||||||||||||||||||||
• Value of services obtained from employees | — | — | — | 143 | — | 143 | — | 143 | ||||||||||||||||||||||||
• Tax effects on the exercise of stock options | — | — | — | 8 | — | 8 | — | 8 | ||||||||||||||||||||||||
Change in non-controlling interests without loss of control | — | (2 | ) | — | — | — | (2 | ) | 2 | — | ||||||||||||||||||||||
Balance at December 31, 2011 | 2,682 | 53,450 | (933 | ) | 1,980 | (960 | ) | 56,219 | 170 | 56,389 |
|
|
(€ million) | Share capital | Additional paid-in capital and retained earnings | Treasury shares | Stock options and other share-based payment | Other comprehensive income (1) | Attributable to equity holders of Sanofi | Attributable to non-controlling interests | Total equity | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Balance at January 1, 2010 | 2,637 | 48,448 | (526 | ) | 1,696 | (3,933 | ) | 48,322 | 258 | 48,580 | |||||||||||||||
Other comprehensive income for the period | — | (139 | ) | — | — | 2,781 | 2,642 | 11 | 2,653 | ||||||||||||||||
Net income for the period | — | 5,467 | — | — | — | 5,467 | 254 | 5,721 | |||||||||||||||||
Comprehensive income for the period | — | 5,328 | — | — | 2,781 | 8,109 | 265 | 8,374 | |||||||||||||||||
Dividend paid out of 2009 earnings (€2.40 per share) | — | (3,131 | ) | — | — | — | (3,131 | ) | — | (3,131 | ) | ||||||||||||||
Payment of dividends and equivalents to non-controlling interests | — | — | — | — | — | — | (307 | ) | (307 | ) | |||||||||||||||
Share repurchase program (3) | — | — | (321 | ) | — | — | (321 | ) | — | (321 | ) | ||||||||||||||
Reduction in share capital (3) | (16 | ) | (404 | ) | 420 | — | — | — | — | — | |||||||||||||||
Share-based payment plans: | |||||||||||||||||||||||||
• Exercise of stock options | 1 | 17 | — | — | — | 18 | — | 18 | |||||||||||||||||
• Proceeds from sale of treasury shares on exercise of stock options | — | — | 56 | — | — | 56 | — | 56 | |||||||||||||||||
• Value of services obtained from employees | — | — | — | 133 | — | 133 | — | 133 | |||||||||||||||||
• Tax effects on the exercise of stock options | — | — | — | — | — | — | — | — | |||||||||||||||||
Non-controlling interests generated by acquisitions | — | — | — | — | — | — | 1 | 1 | |||||||||||||||||
Changes in non-controlling interests without loss of control | — | (89 | ) | — | — | — | (89 | ) | (26 | ) | (115 | ) | |||||||||||||
Balance at December 31, 2010 | 2,622 | 50,169 | (371 | ) | 1,829 | (1,152 | ) | 53,097 | 191 | 53,288 | |||||||||||||||
Other comprehensive income for the period (2) | — | (539 | ) | — | — | 176 | (363 | ) | (12 | ) | (375 | ) | |||||||||||||
Net income for the period | — | 5,693 | — | — | — | 5,693 | 241 | 5,934 | |||||||||||||||||
Comprehensive income for the period (2) | — | 5,154 | — | — | 176 | 5,330 | 229 | 5,559 | |||||||||||||||||
Dividend paid out of 2010 earnings (€2.50 per share) | — | (3,262 | ) | — | — | — | (3,262 | ) | — | (3,262 | ) | ||||||||||||||
Payment of dividends and equivalents to non-controlling interests | — | — | — | — | — | — | (252 | ) | (252 | ) | |||||||||||||||
Increase in share capital – dividends paid in shares (3) | 76 | 1,814 | — | — | — | 1,890 | — | 1,890 | |||||||||||||||||
Share repurchase program (3) | — | — | (1,074 | ) | — | — | (1,074 | ) | — | (1,074 | ) | ||||||||||||||
Reduction in share capital (3) | (21 | ) | (488 | ) | 509 | — | — | — | — | — | |||||||||||||||
Share-based payment plans: | — | — | — | — | — | — | — | — | |||||||||||||||||
• Exercise of stock options | 4 | 66 | — | — | — | 70 | — | 70 | |||||||||||||||||
• Issuance of restricted shares | 1 | (1 | ) | — | — | — | — | — | — | ||||||||||||||||
• Proceeds from sale of treasury shares on exercise of stock options | — | — | 3 | — | — | 3 | — | 3 | |||||||||||||||||
• Value of services obtained from employees | — | — | — | 143 | — | 143 | — | 143 | |||||||||||||||||
• Tax effects on the exercise of stock options | — | — | — | 8 | — | 8 | — | 8 | |||||||||||||||||
Change in non-controlling interests without loss of control | — | (2 | ) | — | — | — | (2 | ) | 2 | — | |||||||||||||||
Balance at December 31, 2011 (2) | 2,682 | 53,450 | (933 | ) | 1,980 | (976 | ) | 56,203 | 170 | 56,373 | |||||||||||||||
Other comprehensive income for the period | — | (1,063 | ) | — | — | 805 | (258 | ) | (7 | ) | (265 | ) | |||||||||||||
Net income for the period | — | 4,967 | — | — | — | 4,967 | 169 | 5,136 | |||||||||||||||||
Comprehensive income for the period | — | 3,904 | — | — | 805 | 4,709 | 162 | 4,871 | |||||||||||||||||
Dividend paid out of 2011 earnings (€2.65 per share) | — | (3,487 | ) | — | — | — | (3,487 | ) | — | (3,487 | ) | ||||||||||||||
Payment of dividends and equivalents to non-controlling interests | — | — | — | — | — | — | (178 | ) | (178 | ) | |||||||||||||||
Share repurchase program (3) | — | — | (823 | ) | — | — | (823 | ) | — | (823 | ) | ||||||||||||||
Reduction in share capital (3) | (55 | ) | (1,493 | ) | 1,548 | — | — | — | — | — | |||||||||||||||
Share-based payment plans: | |||||||||||||||||||||||||
• Exercise of stock options (3) | 24 | 621 | — | — | — | 645 | — | 645 | |||||||||||||||||
• Issuance of restricted shares (3) | 2 | (2 | ) | — | — | — | — | — | — | ||||||||||||||||
• Proceeds from sale of treasury shares on exercise of stock options | — | — | 1 | — | — | 1 | — | 1 | |||||||||||||||||
• Value of services obtained from employees | — | — | — | 155 | — | 155 | — | 155 | |||||||||||||||||
• Tax effects on the exercise of stock options | — | — | — | 25 | — | 25 | — | 25 | |||||||||||||||||
Change in non-controlling interests without loss of control (4) | — | (90 | ) | — | — | — | (90 | ) | (20 | ) | (110 | ) | |||||||||||||
Balance at December 31, 2012 | 2,653 | 52,903 | (207 | ) | 2,160 | (171 | ) | 57,338 | 134 | 57,472 | |||||||||||||||
The accompanying notes on pages F-10 to F-123F-122 are an integral part of the consolidated financial statements.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(€ million) | Note | Year ended December 31, 2011 | Year ended December 31, 2010 (1) | Year ended December 31, 2009 (1) | ||||||||||
Net income attributable to equity holders of Sanofi | 5,693 | 5,467 | 5,265 | |||||||||||
Non-controlling interests, excluding BMS (2) | 15 | 17 | 22 | |||||||||||
Share of undistributed earnings of associates and joint ventures | 27 | 52 | (19 | ) | ||||||||||
Depreciation, amortization and impairment of property, plant and equipment and intangible assets | 5,553 | 5,129 | 5,011 | |||||||||||
Gains and losses on disposals of non-current assets, net of tax (3) | (34 | ) | (111 | ) | (27 | ) | ||||||||
Net change in deferred taxes | (1,865 | ) | (1,511 | ) | (1,153 | ) | ||||||||
Net change in provisions | 40 | 461 | 165 | |||||||||||
Cost of employee benefits (stock options and other share-based payments) | 143 | 133 | 114 | |||||||||||
Impact of the workdown of acquired inventories remeasured at fair value | 476 | 142 | 90 | |||||||||||
Unrealized (gains)/losses recognized in income | (214 | ) | 245 | (84 | ) | |||||||||
Operating cash flow before changes in working capital | 9,834 | 10,024 | 9,384 | |||||||||||
(Increase)/decrease in inventories | (232 | ) | (386 | ) | (469 | ) | ||||||||
(Increase)/decrease in accounts receivable | (257 | ) | (96 | ) | (395 | ) | ||||||||
Increase/(decrease) in accounts payable | (87 | ) | 59 | (324 | ) | |||||||||
Net change in other current assets, current financial assets and other current liabilities | 61 | 258 | 406 | |||||||||||
Net cash provided by/(used in) operating activities (4) | 9,319 | 9,859 | 8,602 | |||||||||||
Acquisitions of property, plant and equipment and intangible assets | D.3. - D.4. | (1,782 | ) | (1,662 | ) | (1,826 | ) | |||||||
Acquisitions of investments in consolidated undertakings, net of cash acquired | D.1. | (13,590 | ) | (1,659 | ) | (5,563 | ) | |||||||
Acquisitions of available-for-sale financial assets | D.7. | (26 | ) | (74 | ) | (5 | ) | |||||||
Proceeds from disposals of property, plant and equipment, intangible assets and other non-current assets, net of tax (5) | D.1.3. | 359 | 136 | 87 | ||||||||||
Net change in loans and other financial assets | 338 | (216 | ) | (20 | ) | |||||||||
Net cash provided by/(used in) investing activities | (14,701 | ) | (3,475 | ) | (7,327 | ) | ||||||||
Issuance of Sanofi shares (6) | D.15. | 70 | 18 | 142 | ||||||||||
Dividends paid: | ||||||||||||||
• to shareholders of Sanofi (6) | (1,372 | ) | (3,131 | ) | (2,872 | ) | ||||||||
• to non-controlling interests, excluding BMS (2) | (17 | ) | (7 | ) | (6 | ) | ||||||||
Transactions with non-controlling interests, other than dividends | — | (97 | ) | — | ||||||||||
Additional long-term debt contracted | D.17. | 8,359 | 505 | 4,697 | ||||||||||
Repayments of long-term debt | D.17. | (2,931 | ) | (1,984 | ) | (1,989 | ) | |||||||
Net change in short-term debt | (145 | ) | 314 | (786 | ) | |||||||||
Acquisition of treasury shares | D.15.4. | (1,074 | ) | (321 | ) | — | ||||||||
Disposals of treasury shares, net of tax | D.15. | 3 | 57 | 26 | ||||||||||
Net cash provided by/(used in) financing activities | 2,893 | (4,646 | ) | (788 | ) | |||||||||
Impact of exchange rates on cash and cash equivalents | 1 | 55 | 27 | |||||||||||
Impact of Merial cash and cash equivalents (1) | D.8.1. | 147 | — | — | ||||||||||
Net change in cash and cash equivalents | (2,341 | ) | 1,793 | 514 | ||||||||||
Cash and cash equivalents, beginning of period | 6,465 | 4,692 | 4,226 | |||||||||||
Cash and cash equivalents, end of period | D.13. | 4,124 | 6,465 | 4,692 | ||||||||||
(1) Further to the announcement that Merial and Intervet/Schering-Plough are to be maintained as separate businesses operating independently, the line items in the statement of cash flows for the comparative periods (2010 and 2009) include cash flows generated by the operating investing and financing activities of Merial. The cash and cash equivalents of Merial were reported in the balance sheet in Assets held for sale or exchange as of December 31, 2009 and 2010. |
| |||||||||||||
– Net change in cash and cash equivalents excluding Merial | 1,773 | 466 | ||||||||||||
– Net change in cash and cash equivalents of Merial | 20 | 48 | ||||||||||||
– Net change in cash and cash equivalents including Merial | 1,793 | 514 | ||||||||||||
(2) See note C.1. (3) Including available-for-sale financial assets. (4) Including: | ||||||||||||||
– Income tax paid | (2,815 | ) | (3,389 | ) | (3,019 | ) | ||||||||
– Interest paid | (447 | ) | (475 | ) | (269 | ) | ||||||||
– Interest received | 100 | 62 | 88 | |||||||||||
– Dividends received from non-consolidated entities | 7 | 3 | 5 |
(€ million) | Note | Year ended December 31, 2012 | Year ended December 31, 2011 | Year ended December 31, 2010 | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Net income attributable to equity holders of Sanofi | 4,967 | 5,693 | 5,467 | |||||||||
Non-controlling interests, excluding BMS (1) | D.32. | 20 | 15 | 17 | ||||||||
Share of undistributed earnings of associates and joint ventures | 37 | 27 | 52 | |||||||||
Depreciation, amortization and impairment of property, plant and equipment and intangible assets | 4,907 | 5,553 | 5,129 | |||||||||
Gains and losses on disposals of non-current assets, net of tax (2) | (86 | ) | (34 | ) | (111 | ) | ||||||
Net change in deferred taxes | (916 | ) | (1,865 | ) | (1,511 | ) | ||||||
Net change in provisions (3) | (710 | ) | 40 | 461 | ||||||||
Cost of employee benefits (stock options and other share-based payments) | D.15.2.–D.15.8. | 155 | 143 | 133 | ||||||||
Impact of the workdown of acquired inventories remeasured at fair value | D.35.1. | 23 | 476 | 142 | ||||||||
Unrealized (gains)/losses recognized in income | 106 | (214 | ) | 245 | ||||||||
Operating cash flow before changes in working capital | 8,503 | 9,834 | 10,024 | |||||||||
(Increase)/decrease in inventories | (445 | ) | (232 | ) | (386 | ) | ||||||
(Increase)/decrease in accounts receivable | 368 | (257 | ) | (96 | ) | |||||||
Increase/(decrease) in accounts payable | 67 | (87 | ) | 59 | ||||||||
Net change in other current assets, current financial assets and other current liabilities | (322 | ) | 61 | 258 | ||||||||
Net cash provided by/(used in) operating activities (4) | 8,171 | 9,319 | 9,859 | |||||||||
Acquisitions of property, plant and equipment and intangible assets | D.3.–D.4. | (1,612 | ) | (1,782 | ) | (1,662 | ) | |||||
Acquisitions of investments in consolidated undertakings, net of cash acquired (7) | D.1.–D.18. | (282 | ) | (13,590 | ) | (1,659 | ) | |||||
Acquisitions of available-for-sale financial assets | D.7. | (46 | ) | (26 | ) | (74 | ) | |||||
Proceeds from disposals of property, plant and equipment, intangible assets and other non-current assets, net of tax (5) | 358 | 359 | 136 | |||||||||
Net change in loans and other financial assets | (5 | ) | 338 | (216 | ) | |||||||
Net cash provided by/(used in) investing activities | (1,587 | ) | (14,701 | ) | (3,475 | ) | ||||||
Issuance of Sanofi shares (6) | D.15.1. | 645 | 70 | 18 | ||||||||
Dividends paid: | ||||||||||||
• to shareholders of Sanofi (6) | (3,487 | ) | (1,372 | ) | (3,131 | ) | ||||||
• to non-controlling interests, excluding BMS (1) | (10 | ) | (17 | ) | (7 | ) | ||||||
Transactions with non-controlling interests, other than dividends | (62 | ) | — | (97 | ) | |||||||
Additional long-term debt contracted | D.17. | 1,178 | 8,359 | 505 | ||||||||
Repayments of long-term debt | D.17. | (1,345 | ) | (2,931 | ) | (1,984 | ) | |||||
Net change in short-term debt | (448 | ) | (145 | ) | 314 | |||||||
Acquisition of treasury shares | D.15.4. | (823 | ) | (1,074 | ) | (321 | ) | |||||
Disposals of treasury shares, net of tax | D.15. | 1 | 3 | 57 | ||||||||
Net cash provided by/(used in) financing activities | (4,351 | ) | 2,893 | (4,646 | ) | |||||||
Impact of exchange rates on cash and cash equivalents | 24 | 1 | 55 | |||||||||
Impact of Merial cash and cash equivalents (8) | D.8.2. | — | 147 | — | ||||||||
Net change in cash and cash equivalents | 2,257 | (2,341 | ) | 1,793 | ||||||||
Cash and cash equivalents, beginning of period | 4,124 | 6,465 | 4,692 | |||||||||
Cash and cash equivalents, end of period | D.13. | 6,381 | 4,124 | 6,465 | ||||||||
– Income tax paid | (2,735 | ) | (2,815 | ) | (3,389 | ) | ||||||
– Interest paid | (495 | ) | (447 | ) | (475 | ) | ||||||
– Interest received | 68 | 100 | 62 | |||||||||
– Dividends received from non-consolidated entities | 6 | 7 | 3 | |||||||||
| 1,773 | |||||||||||
– Net change in | 20 |
| 1,793 | |||||||||||
The accompanying notes on pages F-10 to F-123F-122 are an integral part of the consolidated financial statements.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
Sanofi, andtogether with its subsidiaries (“Sanofi”(collectively "Sanofi" or “the Group”"the Group"), is a diversified global healthcare leader engaged in the research, development and marketing of therapeutic solutions focused on patient needs. Sanofi has fundamental strengths in the healthcare field, operating via sixseven growth platforms: Emerging Markets, Diabetes Solutions, Human Vaccines, Consumer Health Care (CHC), Animal Health, New Genzyme and Other Innovative Products. Sanofi, the parent company, is asociété anonyme (a form of limited liability company) incorporated under the laws of France. The registered office is at 54, rue La Boétie, 75008 Paris, France.
Sanofi is listed in Paris (Euronext: SAN) and New York (NYSE: SNY).
The consolidated financial statements for the year ended December 31, 2011,2012, and the notes thereto, were adopted by the Sanofi Board of Directors on February 7, 2012.6, 2013.
A.1. International Financial Reporting Standards (IFRS)
The consolidated financial statements cover the twelve-month periods endingended December 31, 2012, 2011 2010 and 2009.2010.
In accordance with Regulation No. 1606/2002 of the European Parliament and Council of July 19, 2002 on the application of international accounting standards, Sanofi has presented its consolidated financial statements in accordance with IFRS since January 1, 2005. The term “IFRS”"IFRS" refers collectively to international accounting and financial reporting standards (IASs and IFRSs) and to interpretations of the interpretations committees (SIC and IFRIC), mandatorily applicable with mandatory application as of December 31, 2011.2012.
The consolidated financial statements of Sanofi as of December 31, 20112012 have been prepared in compliance with IFRS as issued by the International Accounting Standards Board (IASB) and with IFRS as endorsed by the European Union as of December 31, 2011.2012.
IFRS as endorsed by the European Union as of December 31, 20112012 are available under the heading “IAS/"IAS/IFRS Standards and Interpretations”Interpretations" via the following web link:
http://ec.europa.eu/internal_market/accounting/ias/index_en.htm
The consolidated financial statements have been prepared in accordance with the IFRS general principles of fair presentation, going concern, accrual basis of accounting, consistency of presentation, materiality, and aggregation.
��
New standards, amendments and interpretations applicable in 20112012 with an impact on the consolidated financial statements are described in Note A.2. For standards, amendments and interpretations issued by the IASB that aredo not mandatorily applicablehave mandatory application in 2011,2012, refer to Note B.28.
A.2. New standards, amendments and interpretations applicable in 20112012
In June 2011, the IASB issued an amendment to IAS 1 (Presentation of Financial Statements). The amendment, which has mandatory application for annual periods beginning on or after July 1, 2012, has not yet been endorsed by the European Union, but it may nonetheless be applied provided that it does not contradict existing standards. This amendment requires that components of other comprehensive income that can be reclassified to the income statement be reported separately from those that cannot. The Group presents the information required by this amendment in the consolidated statement of comprehensive income as of December 31, 2011.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The othernew standards, amendments to standards and interpretations issued by the IASB with mandatory application for the Group as from the 20112012 fiscal year are listed below. None of these texts has anThese pronouncements have no impact on the consolidated financial statements of the Group:Group.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
A.3. Use of estimates
The preparation of financial statements requires management to make reasonable estimates and assumptions based on information available at the date of preparationthe finalization of the financial statements, thatstatements. These estimates and assumptions may affect the reported amounts of assets, liabilities, revenues and expenses in the financial statements, and disclosures of contingent assets and contingent liabilities.
liabilities as at the date of the review of the financial statements. Examples of estimates and assumptions include:
provisions relating to product liability claims
Actual results could differ from these estimates.
B. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
B.1. Basis of consolidation
In accordance with IAS 27 (Consolidated and Separate Financial Statements), the consolidated financial statements include the accounts of the Sanofi parent company and those of its subsidiaries, using the full consolidation method. Subsidiaries are entities which the Group controls (i.e. it has the power to govern their financial and operating activities). The existence of effectively exercisable or convertible potential voting rights is taken into account in determining whether control exists. Control is presumed to exist where the Group holds more than 50% of an entity’sentity's voting rights.
Equity interests in entities are consolidated from the date on which exclusive control of the entity is obtained; divested equity interests are deconsolidated on the date on which exclusive control ceases. The Group’sGroup's share of post-acquisition profits or losses is taken to the income statement, while post-acquisition movements in the acquiree’sacquiree's reserves are taken to consolidated reserves.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Entities over which Sanofi exercises joint control are known as “joint ventures”"joint ventures" and are accounted for using the equity method in accordance with the option in IAS 31 (Interests in Joint Ventures).
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Entities over which Sanofi exercises significant influence are accounted for by the equity method in accordance with IAS 28 (Investments in Associates). Significant influence exists where Sanofi has the power to participate in the financial and operating policy decisions of the investee, but without the power to exercise control or joint control over those policies. Significant influence is presumed to exist where the Group owns, directly or indirectly via its subsidiaries, between 20% and 50% of the voting rights of the investee.
Acquisition-related costs are included as a component of the cost of acquiring joint ventures and associates.
Material transactions between consolidated companies are eliminated, as are intragroup profits.
B.2. Foreign currency translation
B.2.1. Accounting for transactions in foreign currencies in individual company accounts
Non-current assets (other than receivables) and inventories acquired in foreign currencies are translated into the functional currency using the exchange rate prevailing at the acquisition date.
Monetary assets and liabilities denominated in foreign currencies are translated using the exchange rate prevailing at the balance sheet date. The resulting gains and losses are recorded in the income statement. However, foreign exchange gains and losses arising from the translation of advances between consolidated subsidiaries for which settlement is neither planned nor likely to occur in the foreseeable future are recognized directly in equity inCurrency translation difference.
B.2.2. Foreign currency translation of the financial statements of foreign subsidiaries
Sanofi reportspresents its consolidated financial statements in euros (€).
In accordance with IAS 21 (The Effects of Changes in Foreign Exchange Rates), each Group subsidiary translates foreign currency transactions into the currency that is most representative of its economic environment (the functional currency).
All assets and liabilities are translated into euros using the exchange rate of the subsidiary’ssubsidiary's functional currency prevailing at the balance sheet date. Income statements are translated using a weighted average exchange rate for the period. The resulting currency translation difference is recognized as a separate component of equity in the consolidated statement of comprehensive income, and is recognized in the income statement only when the subsidiary is sold or is wholly or partially liquidated.
Under the exemptions allowed by IFRS 1, the Sanofi Group elected to eliminate, through equity, all currency translation differences for foreign operations at the January 1, 2004 IFRS transition date.
B.3. Business combinations and transactions with non-controlling interests
B.3.1. Accounting for business combinations, transactions with non-controlling interests and loss of control
Business combinations are accounted for using the acquisition method. Under this method, the acquiree’sacquiree's identifiable assets and liabilities that satisfy the recognition criteria of IFRS 3 are measured initially at their fair values as at the date of acquisition, except for (i) non-current assets classified as held for sale (which are measured at fair value less costs to sell) and except for(ii) assets and liabilities that fall within the scope of IAS 12 (Income Taxes) and IAS 19 (Employee Benefits). Restructuring liabilities are recognized as a liability of the acquiree only if the acquiree has an obligation as of the acquisition date to carry out the restructuring.
Business combinations completed on or after January 1, 2010 are accounted for in accordance with the revised IFRS 3 (Business Combinations) and the amended IAS 27 (Consolidated and Separate Financial Statements). These revised standards are applied prospectively.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The principal accounting rules applicable to business combinations and transactions with non-controlling interests include:
|
In the case of business combinations completed before January 1, 2010 wherecontinue to be accounted for in accordance with the contractual arrangements for the combination included an adjustment to the cost of the combination contingent upon future events, this adjustment was included in the cost of the combination at the acquisition date, if the adjustment was probable and could be measured reliably. If the adjustment was not probable or could not be measured reliably, it was not included in the cost of the combination on initial recognition of the combination. If the adjustment subsequently became probable and reliably measurable, the additional consideration was treated as an adjustment to the cost of the combinationpre-revision IFRS 3 (i.e. as an adjustment tothrough goodwill).
Under the exemptions allowed by IFRS 1, the Sanofi Group elected not to restate in accordance with IFRS 3 any business combinations completed prior to the January 1, 2004 transition date. This includes the combination between Sanofi and Synthélabo that took place in 1999.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Purchase price allocations are performed under the responsibility of management, with assistance from an independent valuer in the case of major acquisitions. Moreover, theThe revised IFRS 3 does not specify thean accounting treatment offor contingent consideration related toarising from a business combination made by an entity prior to the acquisition of control in that entity and recognizedcarried as a liability in itsthe acquired entity's balance sheet. The accounting treatment applied by the Group to such a liability is to measure it at fair value as of the acquisition date and to report it in the line itemLiabilities related to business combinations and to non-controlling interests. This treatment is consistent with that applied to contingent consideration in the books of the acquirer.
B.3.2. Goodwill
The excess of the cost of an acquisition over the Group’sGroup's interest in the fair value of the identifiable assets and liabilities of the acquiree is recognized as goodwill at the date of the business combination.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Goodwill arising on the acquisition of subsidiaries is shown as a separate line in the balance sheet in intangible assets underGoodwill, whereas goodwill arising on the acquisition of associates and joint ventures is recorded inInvestments in associates and joint ventures.
Goodwill arising on the acquisition of foreign entities is measured in the functional currency of the acquired entity and translated using the exchange rate prevailing at the balance sheet date.
In accordance with IAS 36 (Impairment of Assets), goodwill is carried at cost less accumulated impairment (see Note B.6.).
Goodwill is tested for impairment annually for each cash-generating unit (CGU) and whenever events or circumstances indicate that impairment might exist. Such events or circumstances include significant changes liable to have an other-than-temporary impact on the substance of the original investment.
B.4. Other intangible assets
IntangibleOther intangible assets are initially measured at acquisition cost or production cost, including any directly attributable costs of preparing the asset for its intended use, or (in the case of assets acquired in a business combination) at fair value as at the date of the combination. They are amortized on a straight line basis over their useful lives.
The useful lives of intangible assets are reviewed at each reporting date. The effect of any adjustment to useful lives is recognized prospectively as a change of accounting estimate.
Amortization of other intangible assets is recognized in the income statement underAmortization of intangible assets with the exception of amortization of acquired or internally-developed software, which is recognized on the relevant line of the income statement according to the purpose for which the software is used.
The Group does not own any other intangible assets with an indefinite useful lifelife.
Intangible assets (other than goodwill).
Intangible assets are carried at cost less accumulated amortization and accumulated impairment, if any, in accordance with IAS 36 (see Note B.6.).
B.4.1. Research and development not acquired in a business combination
In accordance with IAS 38 (Intangible Assets), internally generated research expenditure is expensed as incurred underResearch and development expenses.
Under IAS 38, internally generated development expenses are recognized as an intangible asset if, and only if, all the following six criteria can be demonstrated: (a) the technical feasibility of completing the
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
development project; (b) the Group’sGroup's intention to complete the project; (c) the Group’sGroup's ability to use the project; (d) the probability that the project will generate future economic benefits; (e) the availability of adequate technical, financial and other resources to complete the project; and (f) the ability to measure the development expenditure reliably.
Due to the risks and uncertainties relating to regulatory approval and to the research and development process, the six criteria for capitalization are considered not to have been met until marketing approval has been obtained from the regulatory authorities. Consequently, internally generated development expenses arising before marketing approval has been obtained, mainly the cost of clinical trials, are expensed as incurred underResearch and development expenses.
Chemical industrial development expenses incurred to develop a second-generation process are incurred after initial regulatory approval has been obtained, in order to improve the industrial process for an active
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
ingredient. To the extent that the six IAS 38 criteria are considered as being met, these expenses are capitalized underOther intangible assetsas incurred.
Payments for separately acquired research and development are capitalized underOther intangible assets provided that they meet the definition of an intangible asset: a resource that is (i) controlled by the Group, (ii) expected to provide future economic benefits, and (iii) identifiable (i.e. is either separable or arises from contractual or legal rights). Under paragraph 25 of IAS 38, the first condition for capitalization (the probability that the expected future economic benefits will flow to the entity) is considered to be satisfied for separately acquired research and development. Because the amount of the payments is determinable, the second condition for capitalization (the cost can be measured reliably) is also met. Consequently, upfront and milestone payments to third parties related to pharmaceutical products for which regulatory marketing approval has not yet been obtained are recognized as intangible assets, and amortized on a straight line basis over their useful lives from the date on which regulatory approval is obtained.
Payments under research and development arrangements relating to access to technology or to databases and payments made to purchase generics files are also capitalized, and amortized over the useful life of the intangible asset.
Subcontracting arrangements, payments for research and development services and continuous payments under research and development collaborations that are unrelated to the outcome of the research and development efforts, are expensed over the service term.
B.4.2. Intangible assets not acquired in a business combination
Licenses other than those related to pharmaceutical products and research projects, in particular software licenses, are capitalized at acquisition cost, including any directly attributable cost of preparing the software for its intended use. Software licenses are amortized on a straight line basis over their useful lives for the Group (three to five years).
Internally generated costs incurred to develop or upgrade software are capitalized if the IAS 38 criteria for recognition as an intangible asset are satisfied, and amortized on a straight line basis over the useful life of the software from the date on which the software is ready for use.
B.4.3. Intangible assets acquired in a business combination
Intangible assets acquired in a business combination which relate to in-process research and development and are reliably measurable are identified separately identified from goodwill and capitalized inOther intangible assets in accordance with IFRS 3 (Business Combinations) and IAS 38 (Intangible Assets). The related deferred tax liability is also recognized.
In-process research and development acquired in a business combination is amortized on a straight line basis over its useful life from the date of receipt of regulatory approval.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Rights to products soldmarketed by the Group are amortized on a straight line basis over their useful lives, determined on the basis of cash flow forecasts that take account of, among other factors, the period of legal protection of the related patents.
B.5. Property, plant and equipment
Property, plant and equipment is initially measured and recognized at acquisition cost, including any directly attributable cost of preparing the asset for its intended use, or (in the case of assets acquired in a business combination) at fair value as at the date of the combination. The component-based approach to accounting for property, plant and equipment is applied. Under this approach, each component of an item of property, plant and
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
equipment with a cost which is significant in relation to the total cost of the item and which has a different useful life from the other components must be depreciated separately.
After initial measurement, property, plant and equipment is carried at cost less accumulated depreciation and impairment, except for land which is carried at cost less impairment.
Subsequent costs are not recognized as assets, unless (i) it is probable that future economic benefits associated with these costs will flow to the Group, and (ii) the costs can be measured reliably.
Day-to-day maintenance costs of property, plant and equipment are expensed as incurred.
Borrowing costs attributable to the financing of items of property, plant and equipment, and incurred during the construction period of such items, are capitalized as part of the acquisition cost of the item.
Government grants relating to non-current assets are deducted from the acquisition cost of the asset to which they relate.
In accordance with IAS 17 Leases,(Leases), items of property, plant and equipment leased by Sanofi as lessee under finance leases are recognized as an asset in the balance sheet, with the related lease obligation recognized as a liability. A lease qualifies as a finance lease if it transfers substantially all the risks and rewards of ownership of the asset to the Group. Assets held under finance leases are carried at the lower of the fair value of the leased asset or the present value of the minimum lease payments, and are depreciated over the shorter of the useful life of the asset or the term of the lease.
The depreciable amount of items of property, plant and equipment, net of any residual value, is depreciated on a straight line basis over the useful life of the asset. The useful life of an asset is usually equivalent to its economic life.
The useful lives of property, plant and equipment are as follows:
Buildings | 15 to 40 years | |||
Fixtures | 10 to 20 years | |||
Plant and equipment | 5 to 15 years | |||
Other | property, plant and equipment | 3 to 15 years |
Useful lives and residual values of property, plant and equipment are reviewed annually. The effect of any adjustment to useful lives or residual values is recognized prospectively as a change of accounting estimate.
Depreciation of property, plant and equipment is recognized as an expense in the income statement, in the relevant classification of expense by function.
B.6. Impairment of property, plant and equipment, intangible assets, and investments in associates and joint ventures
B.6.1. Impairment of property, plant and equipment and intangible assets
Assets that generate separate cash flows and assets included in cash-generating units (CGUs) are assessed for impairment in accordance with IAS 36 (Impairment of Assets), when events or changes in circumstances indicate that the asset or CGU may be impaired.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
A CGU is the smallest identifiable group of assets that generates cash inflows that are largely independent of the cash inflows from other assets or groups of assets.
Under IAS 36, each CGU to which goodwill is allocated must (i) represent the lowest level within the entity at which the goodwill is monitored for internal management purposes, and (ii) not be larger than an operating segment determined in accordance with IFRS 8 (Operating Segments), before application of the IFRS 8 aggregation criteria.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Consequently, the CGUs used by the Group to test goodwill for impairment correspond to the geographical sub-segments of each operating segment.
Quantitative and qualitative indications of impairment (primarily relating to the status of the research and development portfolio, pharmacovigilance, patent litigation, and the launch of competing products) are reviewed at each reporting date. If there is any internal or external indication of impairment, the Group estimates the recoverable amount of the asset or CGU.
Intangible assets not yet available for use (such as capitalized in-process research and development), and CGUs that include goodwill, are tested for impairment annually whether or not there is any indication of impairment, and more frequently if any event or circumstance indicates that they might be impaired. These assets are not amortized.
When there is an internal or external indication of impairment, the Group estimates the recoverable amount of the asset and recognizes an impairment loss whenif the carrying amount of the asset exceeds its recoverable amount. The recoverable amount of the asset is the higher of its fair value less costs to sell or its value in use. To determine the value in use, the Group uses estimates of future cash flows generated by the asset or CGU, prepared using the same methods as those used in the initial measurement of the asset or CGU on the basis of medium-term plans.
In the case of goodwill, estimates of future cash flows are based on a five-year strategic plan plus an extrapolation of the cash flows beyond the five-year plan, plus a terminal value. In the case of other intangible assets, the period used is based on the economic life of the asset.
Estimated cash flows are discounted at long-term market interest rates that reflect the best estimate by Sanofi of the time value of money, the risks specific to the asset or CGU, and economic conditions in the geographical regions in which the business activity associated with the asset or CGU is located.
Certain assets and liabilities that are not directly attributable to a specific CGU are allocated between CGUs on a basis that is reasonable, and consistent with the allocation of the corresponding goodwill.
Impairment losses on intangible assets are recognized underImpairment of intangible assets in the income statement.
B.6.2. Impairment of investments in associates and joint ventures
In accordance with IAS 28 (Investments in Associates), the Group applies the criteria specified in IAS 39 (Financial Instruments: Recognition and Measurement), to determine whether an investment in an associate or joint venture may be impaired (see Note B.8.2.). If an investment is impaired, the amount of the impairment loss is determined by applying IAS 36 (see Note B.6.1.) and recognized inShare of profit/loss of associates and joint ventures.
B.6.3. Reversals of impairment losses charged against property, plant and equipment, intangible assets, and investments in associates and joint ventures
At each reporting date, the Group assesses if events or changes in circumstances indicate that an impairment loss recognized in a prior period in respect of an asset (other than goodwill) or an investment in an associate or joint venture can be reversed. If this is the case, and the recoverable amount as determined based on the new estimates exceeds the carrying amount of the asset, the Group reverses the impairment loss only to the extent of the carrying amount that would have been determined had no impairment loss been recognized for the asset.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Reversals of impairment losses in respect of other intangible assets are recognized in the income statement underline itemImpairment of intangible assets, while reversals of impairment losses in respect of investments in associates and joint ventures are recognized in the income statement underline itemShare of profit/loss of associates and joint ventures. Impairment losses taken against goodwill are never reversed, unless the goodwill is part of the carrying amount of an investment in an associate or joint venture.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
B.7. Assets held for sale or exchange
In accordance with IFRS 5 (Non-Current Assets Held for Sale and Discontinued Operations), non-current assets and groups of assets must be classified as held for sale in the balance sheet if their carrying amount will be recovered principally through a sale transaction rather than through continuing use. Within the meaning of IFRS 5, the term “sale”"sale" also includes exchanges for other assets.
Non-current assets or asset groups held for sale must be available for immediate sale in their present condition, subject only to terms that are usual and customary for sales of such assets, and a sale must be highly probable. Criteria used to determine whether a sale is highly probable include:
Before the initial classification of the non-current asset (or asset group) as “held"held for sale or exchange”exchange", the carrying amounts of the asset (or of all the assets and liabilities in the asset group) must be measured in accordance with the applicable standards.
Subsequent to classification as “held"held for sale or exchange”exchange", the non-current asset (or asset group) is measured at the lower of carrying amount or fair value less costs to sell, with any write-down recognized by means of an impairment loss. Once a non-current asset has been classified as “held"held for sale or exchange”exchange", it is no longer depreciated or amortized.
In a disposal of an equity interest leading to loss of control, all the assets and liabilities of the entity involved are classified as assets or liabilities “held"held for sale”sale" in the balance sheet line itemsAssets held for sale or exchange orLiabilities related to assets held for sale or exchange, provided that the disposal satisfies the IFRS 5 classification criteria.
The profit or loss generated by a held-for-saleheld for sale asset group is reported on a separate line in the income statement for the current period and for the comparative periods presented, provided that the asset group:
Events or circumstances beyond the Group’sGroup's control may extend the period to complete the sale or exchange beyond one year without precluding classification of the asset (or disposal group) inAssets held for sale or exchange provided that there is sufficient evidence that the Group remains committed to the planned sale or exchange.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Finally, in the event of changes to a plan of sale that require an asset no longer to be classified as held for sale, IFRS 5 specifies the following treatment:
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
B.8. Financial instruments
B.8.1. Non-derivative financial assets
Under IFRS, and in accordance with IAS 39 and IAS 32 (Financial Instruments: Presentation), Sanofi has adopted the following classification for non-derivative financial assets, based on the type of asset and on management intent at the date of initial recognition (except for assets already held at the transition date and reclassified at that date in accordance with IFRS 1). The designation and classification of such financial assets are subsequently reassessed at each reporting date.
Non-derivative financial assets are recognized on the date when Sanofi becomes party to the contractual terms of the asset. On initial recognition, financial assets are measured at fair value, plus direct transaction costs in the case of financial assets not designated as fair value through profit or loss.
Classification, presentation and subsequent measurement of non-derivative financial assets are as follows:
These assets are classified in the balance sheet in the line itemsNon-current financial assets, Current financial assets andCash and cash equivalents.
Financial assets at fair value through profit or loss comprise assets held for trading (financial assets acquired principally for the purpose of reselling them in the near term, usually within less than 12 months), and financial instruments designated as fair value through profit and loss on initial recognition in accordance with the conditions for application of the fair value option.
These financial assets are carried at fair value, without any deduction for transaction costs that may be incurred on sale. Realized and unrealized gains and losses resulting from changes in the fair value of these assets are recognized in the income statement, inFinancial income orFinancial expenses.
Realized and unrealized foreign exchange gains and losses on financial assets in currencies other than the euro are recognized in the income statement inFinancial income orFinancial expenses.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Available-for-sale financial assets are non-derivative financial assets that are (i) designated by management as available-for-sale or (ii) not classified as “financial"financial assets at fair value through profit or loss”loss", “held-to-maturity investments”"held-to-maturity investments" or “loans"loans and receivables”receivables". This category includes participating
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
interests in quoted or unquoted companies (other than investments in associates and joint ventures) that management intends to hold on a long-term basis. Available-for-sale financial assets are classified inNon-current financial assets.
Available-for-sale financial assets are measured at fair value, without any deduction for transaction costs that may be incurred on sale. Gains and losses arising from changes in the fair value of these assets, including unrealized foreign exchange gains and losses, are recognized directly in equity in the consolidated statement of comprehensive income in the period in which they occur, except for impairment losses and foreign exchange gains and losses on debt instruments. On derecognition of an available-for-sale financial asset, or on recognition of an impairment loss on such an asset, the cumulative gains and losses previously recognized in equity are recognized in the income statement for the period underFinancial incomeorFinancial expenses.
Interest income and dividends on equity instruments are recognized in the income statement underFinancial income when the Group is entitled to receive payment.
Available-for-sale financial assets in the form of participating interests in companies not quoted in an active market are measured at cost if their fair value cannot be measured reliably; an impairment loss is recognized when there is objective evidence that such an asset is impaired.
Realized foreign exchange gains and losses are recognized in the income statement underFinancial income orFinancial expenses.
Held-to-maturity investments are non-derivative financial assets with fixed or determinable payments and fixed maturities that the Group has the positive intention and ability to hold to maturity.
These investments are measured at amortized cost using the effective interest method.
Sanofi did not hold any such investments during the years endingended December 31, 2012, 2011 2010 or 2009.2010.
Loans and receivables are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. They are presented in current assets, underOther current assets in the case of loans and underAccounts receivable in the case of receivables. Loans with a maturity of more than 12 months are presented in “Long-term"Long-term loans and advances”advances" underNon-current financial assets. Loans and receivables are measured at amortized cost using the effective interest method.
Realized and unrealized foreign exchange gains and losses are recognized in the income statement underFinancial income orFinancial expenses.
B.8.2. Impairment of non-derivative financial assets
Indicators of impairment are reviewed for all non-derivative financial assets at each reporting date. Such indicators include default in contractual payments, significant financial difficulties of the issuer or debtor, probability of bankruptcy, or prolonged or significant decline in quoted market price. An impairment loss is recognized in the income statement if there is objective evidence of impairment resulting from one or more events after the initial recognition of the asset (a “loss-generating event”"loss event") and this loss-generatingloss event has ana reliably measurable impact on the estimated future cash flows of the financial asset or of a(or group of financial assets, which can be reliably estimated.assets).
The impairment loss on loans and receivables, which are measured at amortized cost, is the difference between the carrying amount of the asset and the present value of estimated future cash flows discounted at the financial asset’sasset's original effective interest rate.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
When an impairment loss is identified on an available-for-sale financial asset, the cumulative losses previously recognized directly in equity are recorded in the income statement. The loss recognized in the income
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
statement is the difference between the acquisition cost (net of principal repaymentrepayments and amortization) and the fair value at the time of impairment, less any impairment loss previously recognized in the income statement.
The impairment loss on investments in companies that are not quoted in an active market and are measured at cost is the difference between the carrying amount of the investment and the present value of its estimated future cash flows, discounted at the current market interest rate for similar financial assets.
Impairment losses in respect of loans are recognized underFinancial expenses in the income statement.
Impairment losses in respect of trade receivables are recognized underSelling and general expenses in the income statement.
Impairment losses on investments in companies that are not quoted in an active market and are measured at cost, and on equity instruments classified as available-for-sale financial assets, cannot be reversed through the income statement.
B.8.3. Derivative instruments
Derivative instruments that do not qualify for hedge accounting are initially and subsequently measured at fair value, with changes in fair value recognized in the income statement inOther operating income or inFinancial income orFinancial expenses depending on the nature of the underlying economic item which they are intended to hedge.
Derivative instruments that qualify for hedge accounting are measured in accordance with the hedge accounting requirements of IAS 39 (see Note B.8.4.).
B.8.4. Hedging
Hedging involves the use of derivative financial instruments. Changes in the fair value of these instruments are intended to offset the exposure of the hedged items to changes in fair value.
As part of its overall interest rate risk and foreign exchange risk management policy, the Group enters into various transactions involving derivative instruments. Derivative instruments used in connection with the Group’sGroup's hedging policy may include forward exchange contracts, currency options, interest rate swaps and interest rate options.
Derivative financial instruments qualify as hedging instruments for hedge accounting purposes when (a) at the inception of the hedge there is formal designation and documentation of the hedging relationship and of the risk management strategy and objective; (b) the hedge is expected by management to be highly effective in offsetting the risk; (c) the forecast transaction being hedged is highly probable and presents an exposure to variations in cash flows that could ultimately affect profit or loss; (d) the effectiveness of the hedge can be reliably measured; and (e) the hedge is assessed on an ongoing basis and determined actually to have been highly effective throughout the reporting periods for which the hedge was designated.
These criteria are applied when the Group uses derivative instruments designated as a fair value hedge, a cash flow hedge or a hedge of a net investment in a foreign operation.
A fair value hedge is a hedge of the exposure to changes in fair value of a recognized asset or liability or unrecognized firm commitment that could affect profit or loss.
Changes in fair value of the hedging instrument and changes in fair value of the hedged item attributable to the hedged risk are recognized in the income statement, underOther operating incomefor hedges of operating activities and underFinancial income orFinancial expenses for hedges of investing or financing activities.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
A cash flow hedge is a hedge of the exposure to variability in cash flows attributable to a particular risk associated with a recognized asset or liability, or a highly probable forecast transaction, which could affect profit or loss.
Changes in fair value of the hedging instrument attributable to the effective portion of the hedge are recognized directly in equity in the consolidated statement of comprehensive income. Changes in fair value attributable to the ineffective portion of the hedge are recognized in the income statement underOther operating incomefor hedges of operating activities, and underFinancial income orFinancial expenses for hedges of investing or financing activities.
Cumulative changes in fair value of the hedging instrument previously recognized in equity are transferredreclassified to the income statement when the hedged transaction affects profit or loss. These transferred gains and losses are recorded underOther operating incomefor hedges of operating activities andFinancial income orFinancial expenses for hedges of investing or financing activities.
When a forecast transaction results in the recognition of a non-financial asset or liability, cumulative changes in the fair value of the hedging instrument previously recognized in equity are included in the initial measurement of the asset or liability.
When the hedging instrument expires or is sold, terminated or exercised, the cumulative gain or loss previously recognized in equity remains separately recognized in equity until the forecast transaction occurs. However, if the Group no longer expects the forecast transaction to occur, the cumulative gain or loss previously recognized in equity is recognized immediately in the income statement.
In the case of a hedge of a net investment in a foreign operation, changes in the fair value of the hedging instrument attributable to the effective portion of the hedge are recognized directly in equity in the consolidated statement of comprehensive income. Changes in fair value attributable to the ineffective portion of the hedge are recognized in the income statement underFinancial incomeorFinancial expenses. When the investment in the foreign operation is sold, the changes in the fair value of the hedging instrument previously recognized in equity are transferredreclassified to the income statement underFinancial incomeorFinancial expenses.
Hedge accounting is discontinued when (a) the hedging instrument expires or is sold, terminated or exercised, or (b) the hedge no longer meets the criteria for hedge accounting, or (c) the Group revokes the hedge designation, or (d) management no longer expects the forecast transaction to occur.
B.8.5. Non-derivative financial liabilities
Bank borrowings and debt instruments are initially measured at fair value of the consideration received, net of directly attributable transaction costs.
Subsequently, they are measured at amortized cost using the effective interest method. All costs related to the issuance of borrowings or debt instruments, and all differences between the issue proceeds net of transaction costs and the value on redemption, are recognized underFinancial expensesin the income statement over the term of the debt using the effective interest method.
Liabilities related to business combinations and to non-controlling interests are split into a current portion and a non-current portion. These line items are used to recognize contingent consideration payable in connection with business combinations (see Note B.3.1. for a description of the relevant accounting policy), and the fair value of put options granted to non-controlling interests.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Fair value adjustments to put options granted to non-controlling interests are recognized with a matching entry in equity.
Other non-derivative financial liabilities include trade accounts payable, which are measured at fair value (which in most cases equates to face value) on initial recognition, and subsequently at amortized cost.
B.8.6. Fair value of financial instruments
Under IFRS 7 (Financial Instruments: Disclosures), fair value measurements must be classified using a fair value hierarchy with the following levels:
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The table below sets forth the principles used to measure the fair value of the principal financial assets and liabilities recognized by the Group in its consolidated balance sheet:
| Method used to determine fair value
| ||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Market data | |||||||||||||||||||||||||||||||
Level in IFRS 7 fair value hierarchy | |||||||||||||||||||||||||||||||
Note | Type of financial instrument | Measurement principle | Valuation model | Exchange rate | Interest rate | Volatility | |||||||||||||||||||||||||
D.7. | Available-for-sale financial assets (quoted equity securities) | Fair value | 1 | Quoted market price | N/A | ||||||||||||||||||||||||||
D.7. | Available-for-sale financial assets (unquoted debt securities) | Fair value | 2 | Present value of future cash flows | N/A | Mid swap + z-spread for bonds of comparable risk and maturity | N/A | ||||||||||||||||||||||||
D.7. | Long-term loans and advances | Amortized cost | N/A | The amortized cost of long-term loans and advances at the balance sheet date is not materially different from their fair value. | |||||||||||||||||||||||||||
D.7. | Fair value | 1 | Market value (net asset value) | N/A | |||||||||||||||||||||||||||
D.20. | Forward currency contracts | Fair value | 2 | Present value of future cash flows | ECB Fixing | < 1 year: Mid Money Market > 1 year: Mid Zero Coupon | N/A | ||||||||||||||||||||||||
D.20. | Currency options | Fair value | 2 | Options with no knock-out feature: Garman & Kohlhagen Knock-out options: Merton, Reiner & Rubinstein | ECB Fixing | < 1 year: Mid Money Market > 1 year: Mid Zero Coupon | |||||||||||||||||||||||||
|
| Mid in-the- money | |||||||||||||||||||||||||||||
D.20. | Interest rate swaps | Fair value | 2 | Present value of future cash flows | N/A | < 1 year: Mid Money Market and LIFFE interest rate futures > 1 year: Mid Zero Coupon | N/A | ||||||||||||||||||||||||
D.20. | Cross-currency swaps | Fair value | 2 | Present value of future cash flows | ECB Fixing | < 1 year: Mid Money Market and LIFFE interest rate futures > 1 year: Mid Zero Coupon | N/A | ||||||||||||||||||||||||
D.13. | Investments in collective investment schemes | Fair value | 1 | Market value (net asset value) | N/A | ||||||||||||||||||||||||||
D.13. | Negotiable debt instruments, commercial | Amortized cost | N/A | Because these instruments have a maturity of less than 3 months, amortized cost is regarded as an acceptable approximation of fair value as disclosed in the notes to the consolidated financial statements. | |||||||||||||||||||||||||||
D.17. | Financial liabilities | Amortized cost(2) | N/A |
| |||||||||||||||||||||||||||
D.18. | Liabilities related to business combinations and to non-controlling interests | Fair value | 1 | Quoted market price | N/A | ||||||||||||||||||||||||||
D.18. | Liabilities related to business combinations and to non-controlling interests (except | Fair value(3) | 3 | Contingent consideration payable in a business combination is a financial liability under IAS 32. The fair value of such liabilities is determined by adjusting the contingent consideration at the balance sheet date using the method described in Note D.18. |
|
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The other financial assets and liabilities included in the Groupconsolidated balance sheet are the following:are:
B.8.7. Derecognition of financial instruments
Sanofi derecognizes a financial assetsasset when the contractual rights to cash flows from these assetsthe asset have ended or have been transferred and when the Group has transferred substantially all risks and rewards of ownership of these assets.the asset. If the Group has neither transferred nor retained substantially all the risks and rewards of ownership of these assets, they area financial asset, it is derecognized if the Group does not retain the control of these assets.the asset.
Financial liabilities areA financial liability is derecognized when the Group’sGroup's contractual obligations in respect of such liabilities arethe liability is discharged, or cancelled or expired.
extinguished.
B.8.8. Risks relating to financial instruments
Market risks in respect of non-current financial assets, cash equivalents, derivative instruments and debt are described in the risk factors presented in Item 3.D. and Item 11.
Credit risk is the risk that customers may fail to pay their debts. This risk also arises as a result of the concentration of the Group’sGroup's sales with its largest customers, in particular certain wholesalers in the United States. Customer credit risk is described in the risk factors presented in Item 3.D.
B.9. Inventories
Inventories are measured at the lower of cost or net realizable value. Cost is calculated using the weighted average cost method or the first-in, first-out method, depending on the nature of the inventory.
The cost of finished goods inventories includes costs of purchase, costs of conversion and other costs incurred in bringing the inventories to their present location and condition.
Net realizable value is the estimated selling price in the ordinary course of business less the estimated costs of completion and the estimated costs necessary to make the sale.
B.10. Cash and cash equivalents
Cash and cash equivalents as shown in the consolidated balance sheet and statement of cash flows comprise cash, plus liquid short-term investments that are (i) readily convertible into cash, and (ii) subject to an insignificant risk of changes in value in the event of movements in interest rates.
B.11. Treasury shares
In accordance with IAS 32, Sanofi treasury shares are deducted from equity, irrespective of the purpose for which they are held. No gain or loss is recognized in the income statement on the purchase, sale, impairment or cancellation of treasury shares.
B.12. Provisions for risks
In accordance with IAS 37 (Provisions, Contingent Liabilities and Contingent Assets), Sanofi records a provision where it has a present obligation, whether legal or constructive, as a result of a past event; it is probable that an outflow of resources embodying economic benefits will be required to settle the obligation; and a reliable estimate can be made of the amount of the outflow of resources.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
If the obligation is expected to be settled more than twelve months after the balance sheet date, or has no definite settlement date, the provision is recorded underProvisions and other non-current liabilities.
Provisions relating to the insurance programs in which the Group’sGroup's captive insurance company participates are based on risk exposure estimates calculated by management, with assistance from independent actuaries, using IBNR (Incurred But Not Reported) techniques. These techniques use past claims experience, within the Group and in the market, to estimate future trends in the cost of claims.
Contingent liabilities are not recognized, but are disclosed in the notes to the financial statements unless the possibility of an outflow of economic resources is remote.
Provisions are estimated on the basis of events and circumstances related to present obligations at the balance sheet date, of past experience, and to the best of management’smanagement's knowledge at the date of preparation of the financial statements.
Reimbursements offsetting the probable outflow of resources are recognized as assets only if it is virtually certain that they will be received. Contingent assets are not recognized.
Restructuring provisions are recognized if the Group has a detailed, formal restructuring plan at the balance sheet date and has announced its intention to implement this plan to those affected by it.
No provisions are recorded for future operating losses.
Sanofi records non-current provisions for certain obligations such as legal environmental obligations and litigation where an outflow of resources is probable and the amount of the outflow can be reliably estimated. Where the effect of the time value of money is material, these provisions are measured at the present value of the expenditures expected to be required to settle the obligation, calculated using a discount rate that reflects an estimate of the time value of money and the risks specific to the obligation.
Increases in provisions to reflect the effects of the passage of time are recognized inFinancial expenses.
B.13. Emission rights
Under international agreements, the European Union has committed to reducing greenhouse gas emissions and instituted an emissions allowance trading scheme. Approximately tenSeven Sanofi sites in Europe are directly covered by the scheme. Sanofi accounts for emission allowances as follows: the annual allowances allocated by government are recognized as intangible assets measured at fair value at the date of initial recognition, with a matching liability recognized to reflect the government grant effectively arising from the fact that allowances are issued free of charge. As and when allowances are consumed, they are transferred to “Deliverable allowances”"Deliverable allowances" in order to recognize the liability to government in respect of actual CO2 emissions. If the allocated allowances are insufficient to cover actual emissions, an expense is recognized in order to reflect the additional allowances deliverable; this expense is measured at the market value of the allowances.
B.14. Revenue recognition
Revenue arising from the sale of goods is presented in the income statement underNet sales. Net sales comprise revenue from sales of pharmaceutical products, vaccines, and active ingredients, net of sales returns, of customer incentives and discounts, and of certain sales-based payments paid or payable to the healthcare authorities.
Revenue is recognized when all of the following conditions have been met: the risks and rewards of ownership have been transferred to the customer; the Group no longer has effective control over the goods sold; the amount of revenue and costs associated with the transaction can be measured reliably; and it is probable that the economic benefits associated with the transaction will flow to the Group, in accordance with IAS 18 (Revenue). In particular,
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
the contracts between Sanofi Pasteur and government agencies specify terms for the supply and acceptance of batches of vaccine; revenue is recognized when these conditions are met.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The Group offers various types of price reductions on its products. In particular, products sold in the United States are covered by various governmental programs (such as Medicare and Medicaid) under which products are sold at a discount. Rebates are granted to healthcare authorities, and under contractual arrangements with certain customers. Some wholesalers are entitled to chargeback incentives based on the selling price to the end customer, under specific contractual arrangements. Cash discounts may also be granted for prompt payment.
Returns, discounts, incentives and rebates, as described above, are recognized in the period in which the underlying sales are recognized as a reduction of sales revenue.
These amounts are calculated as follows:
The Group also takes account of factors such as levels of inventory in its various distribution channels, product expiry dates, information about potential discontinuation of products, the entry of competing generics into the market, and the launch of over-the-counter medicines.
In each case, the provisions are subject to continuous review and adjustment as appropriate based on the most recent information available to management.
The Group believes that it has the ability to measure each of the above provisions reliably, using the following factors in developing its estimates:
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Non-product revenues, mainly comprising royalty income from license arrangements that constitute ongoing operations of the Group (see Note C.), are presented inOther revenues.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
B.15. Cost of sales
Cost of sales consists primarily of the industrial cost of goods sold, payments made under licensing agreements, and distribution costs. The industrial cost of goods sold includes the cost of materials, depreciation of property, plant and equipment and software, personnel costs, and other expenses attributable to production.
B.16. Research and development expenses
Internally generated research costs are expensed as incurred.
Internally generated pharmaceutical development costs are also expensed as incurred; they are not capitalized, because the criteria for capitalization are considered not to have been met until marketing approval for the related product has been obtained from the regulatory authorities. Recharges to or contributions from alliance partners are recorded as a reduction inResearch and development expenses.
Note B.4.1. “Research"Research and development not acquired in a business combination”combination" and Note B.4.3. “Intangible"Intangible assets acquired in a business combination”combination" describe the principles applied to the recognition of separately acquired research and development.
B.17. Other operating income and expenses
B. 17.1.B.17.1. Other operating income
Other operating incomeincludes the share of profits that Sanofi is entitled to receive from alliance partners in respect of product marketing agreements. It also includes revenues generated under certain complex agreements, which may include partnership and co-promotion agreements.
Upfront payments received are deferred for as long as a service obligation remains. Milestone payments are assessed on a case by case basis, and recognized in the income statement on delivery of the products and/or provision of the services in question. Revenue generated in connection with these services is recognized on the basis of delivery of the goods or provision of the services to the other contracting party.
This line also includes realized and unrealized foreign exchange gains and losses on operating activities (see Note B.8.4.), and operating gains on disposals not regarded as major disposals (see Note B.20.).
B.17.2. Other operating expenses
Other operating expenses mainly comprise the share of profits that alliance partners are entitled to receive from Sanofi under product marketing agreements.
B.18. Amortization and impairment of intangible assets
B.18.1. Amortization of intangible assets
The expenses recorded in this line item mainly comprise amortization of product rights (see Note D.4.), which are presented as a separate item because the benefit of these rights to the Group’sGroup's commercial, industrial and development functions cannot be separately identified.
Amortization of software is recognized as an expense in the income statement, in the relevant line items of expense by function.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
B.18.2. Impairment of intangible assets
This line item records impairment losses (other than those associated with restructuring) recognized against intangible assets (including goodwill), and any reversals of such impairment losses.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
B.19. Fair value remeasurement of contingent consideration liabilities
Changes in the fair value of contingent consideration that was (i) already carried in the books of thean acquired entity or recognized(ii) granted in connection with a business combination and initially recognized as a liability are reported in profit or loss in accordance with the principles described in Note B.3.1. Such adjustments are reported separately in the income statements,statement, in the line itemFair value remeasurement of contingent consideration liabilities. This line item also includes the effect of the unwinding of discount, and of exchange rate movements where the liability is expressed in a currency other than the functional currency of the reporting entity.
B.20. Restructuring costs and otherOther gains and losses, and litigation
B.20.1. Restructuring costs
Restructuring costsinclude early retirement benefits, compensation for early termination of contracts, and rationalization costs relating to restructured sites. Asset impairment losses directly attributable to restructuring are also recorded on this line. Restructuring costs included on this line relate only to unusual and major restructuring plans.
B.20.2. Other gains and losses, and litigation
This line item includes the impact of material transactions of an unusual nature or amount and which the Group believes it necessary to report separately in the income statement in order to improve the relevance of the financial statements.
The line itemOther gains and losses, and litigationincludes the following:
Impairment
B.21. Financial expenses/expenses and income
B.21.1. Financial expenses
Financial expensesmainly comprise interest charges on debt financing, negative changes in the fair value of financial instruments (where changes in fair value are taken to the income statement), realized and unrealized foreign exchange losses on financing and investing activities, and impairment losses on financial instruments. They also include any reversals of impairment losses on financial instruments.
Financial expenses also include the expenses arising from the unwinding of discount on non-current provisions, except provisions for retirement benefits and other long-term employee benefits. This line does not include cash discounts, which are deducted from net sales.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
B.21.2. Financial income
Financial income includes interest and dividend income, positive changes in the fair value of financial instruments (where changes in fair value are taken to the income statement), realized and unrealized foreign exchange gains on financing and investing activities, and gains or losses on disposals of financial assets.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
B.22. Income tax expense
Income tax expense includes all current and deferred taxes of consolidated companies.
The Sanofi Group accounts for deferred taxes in accordance with IAS 12 (Income Taxes), using the methods described below.
Deferred tax assets and liabilities are recognized on taxable and deductible temporary differences, and on tax loss carry-forwards. Temporary differences are differences between the carrying amount of an asset or liability in the balance sheet and its tax base.
Reforms to French business taxes were enacted on December 31, 2009 and apply as from January 1, 2010. The new tax, the CET (Contribution Economique Territoriale), has two components: the CFE (Cotisation FonciereFoncière des Entreprises) and the CVAE (Cotisation sur la Valeur Ajoutée des Entreprises). The second component is determined by applying a rate to the amount of value added generated by the business during the year.
Given that part of the CVAE component is calculated as the amount by which certain revenues exceed certain expenses, and given that this tax will be borne primarily by companies that own intellectual property rights on income derived from those rights (royalties, and margin on sales to third parties and to other Group companies), the Group regards the CVAE component as meeting the definition of income taxes specified in IAS 12, paragraph 2 (“("taxes which are based on taxable profits”profits").
Deferred tax assets and liabilities are calculated using the tax rate expected to apply in the period when a temporary difference is expected to reverse, based on tax rates enacted or substantively enacted at the balance sheet date.
UnusedDeferred tax assets are recognized in respect of deductible temporary differences, tax losses available for carry-forward and unused tax credits are recognized as deferred tax assets to the extent that itfuture recovery is probable that future taxable profits will be available against which they can be utilized.regarded as probable. The recoverability of deferred tax assets is assessed on a case-by-case basis, taking account of the profit forecasts contained in the Group's long-term business plan.
The Sanofi Group recognizes a deferred tax liability for temporary differences relating to interests in subsidiaries, associates and joint ventures except when the Group is able to control the timing of the reversal of the temporary differences. This applies in particular when the Group is able to control dividend policy and it is probable that the temporary differences will not reverse in the foreseeable future.
No deferred tax is recognized on eliminations of intragroup transfers of interests in subsidiaries, associates or joint ventures.
For consolidation purposes, each tax entity calculates its own net deferred tax position. All net deferred tax asset and liability positions are then aggregated and shown as separate line items on the assets and liabilities sides of the consolidated balance sheet respectively. Deferred tax assets and liabilities can be offset only if (i) the Group has a legally enforceable right to set off current tax assets and current tax liabilities, and (ii) the deferred tax assets and deferred tax liabilities relate to income taxes levied by the same taxation authority.
Deferred taxes are not discounted, except implicitly in the case of deferred taxes on assets and liabilities which are themselves discounted.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Withholding taxes on intragroup royalties and dividends, and on royalties and dividends collected from third parties, are accounted for as current income taxes.
In accounting for business combinations, the Sanofi Group complies with the revised IFRS 3 as regards the recognition of deferred tax assets after the initial accounting period. This means that the Group recognizes in profit or loss for the period any deferred tax assets recognized by the acquiree after the end of this period on temporary differences or tax loss carry-forwards existing at the acquisition date. Under
The positions adopted by the pre-revision IFRS 3, applicable priorGroup in tax matters are based on its interpretation of tax laws and regulations. Some of these positions may be subject to January 1, 2010, such items were recognized as a reduction inuncertainty. The Group assesses the amount of goodwill.
the tax liability to be recognized on the basis of the following assumptions: that its position will be examined by one or more tax authorities on the basis of all relevant information; that a technical assessment is carried out with reference to legislation, case law, regulations, and established practice; and that each position is assessed individually, with no offset or aggregation between positions. The line itemIncome tax expense includes the effect of tax disputes, and any penalties and late payment interest arising from such disputes.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
B.23. Employee benefit obligations
The Sanofi Group offers retirement benefits to employees and retirees of the Group. These benefits are accounted for in accordance with IAS 19 (Employee Benefits).
These benefits are in the form of either defined-contribution plans or defined-benefit plans.
In the case of defined-contribution plans, the contributions paid by Sanofi are expensed in the period in which they occur, and no actuarial estimate is performed.
In the case of defined-benefit plans, Sanofi recognizes its obligations to employees as a liability, based on an actuarial estimate of the rights vested and/or currently vesting in employees and retirees using the projected unit credit method. The amount of the liability is recognized net of the fair value of plan assets.
These estimates are performed at least once a year, and rely on demographic and financial assumptions such as life expectancy, employee turnover, and salary increases. The estimated obligation is discounted.
In the case of multi-employer defined-benefit plans where plan assets cannot be allocated to each participating employer with sufficient reliability, the plan is accounted for as a defined-contribution plan, in accordance with paragraph 30 of IAS 19.
Obligations in respect of other post-employment benefits (healthcare, life insurance) offered by Group companies to employees are also recognized as a liability based on an actuarial estimate of the rights vested or currently vesting in employees and retirees at the balance sheet date.
Actuarial gains and losses relating to defined-benefit plans (pensions and other post-employment benefits), arising from the effects of changes in actuarial assumptions and experience adjustments, are recognized in equity net of deferred taxes via the consolidated statement of comprehensive income, under the option allowed by the amendment to IAS 19.
All unrecognized actuarial gains and losses at the transition date, January 1, 2004, were recognized inEquity attributable to equity holders of Sanofi at that date in accordance with the optional treatment allowed in IFRS 1.
Past service cost is recognized as an expense on a straight-line basis over the average period until the benefits become vested. If benefits are already vested on the introduction of, or changes to, a defined-benefit plan, past service cost is recognized immediately as an expense.
Actuarial gains and losses and past service cost relating to other long-term employee benefits are recognized immediately in the income statement.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
B.24. Share-based payment
B.24.1. Stock option plans
Sanofi has granted a number of equity-settled, share-based payment plans (stock option plans) to some of its employees.
In accordance with IFRS 2 (Share-Based Payment), services received from employees as consideration for stock options are recognized as an expense in the income statement, with the matching entry recognized in equity. The expense corresponds to the fair value of the stock option plans, and is charged to income on a straight-line basis over the four-year vesting period of the plan.
The fair value of stock option plans is measured at the date of grant using the Black-Scholes valuation model, taking into account the expected life of the options. The expense recognized in this evaluation takes into account the expected cancellation rate of the options. The expense is adjusted over the vesting period to reflect the actual cancellation rates resulting from the departure of the holders of the options.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
B.24.2. Employee share ownership plans
The Sanofi Group may offer its employees the opportunity to subscribe to reserved share issues at a discount to the reference market price. Shares allotted to employees under these plans fall within the scope of IFRS 2. The discount is measured at the subscription date and recognized as an expense, with no reduction for any lock-up period.
B.24.3. Restricted share plans
Sanofi may award restricted share plans to certain of its employees. The terms of these plans may make the award contingent on performance criteria for some grantees.
In accordance with IFRS 2, an expense equivalent to the fair value of such plans is recognized on a straight line basis over the vesting period of the plan, with the matching entry credited to equity. Depending on the country, the vesting period of such plans is eitherbetween two orand four years. Plans with a two-year or three-year vesting period are subject to a two-year lock-up period.
The fair value of stock option plans is based on the fair value of the equity instruments granted, representing the fair value of the services received during the vesting period. The fair value of an equity instrument granted under a plan is the market price of the share at the grant date, adjusted for expected dividends during the vesting period.
B.25. Earnings per share
Basic earnings per share is calculated using the weighted average number of shares outstanding during the reporting period, adjusted on a time-weighted basis from the acquisition date to reflect the number of Sanofi shares held by the Group. Diluted earnings per share is calculated on the basis of the weighted average number of ordinary shares, computed using the treasury stock method.
This method assumes that (a) all outstanding dilutive options and warrants are exercised, and (b) the Group acquires its own shares at the quoted market price for an amount equivalent to the cash received as consideration for the exercise of the options or warrants, plus the expense arising on unamortized stock options.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
B.26. Segment information
In accordance with IFRS 8 (Operating Segments), the segment information reported by Sanofi is prepared on the basis of internal management data provided to the Chief Executive Officer, who is the Group’sGroup's chief operating decision maker. The performance of these segments is monitored individually using internal reports and common indicators.
The segments reported by the Group correspond to its operating segments, with no aggregation. The Group is comprisedconsists of three operating segments: Pharmaceuticals, Human Vaccines (Vaccines) and Animal Health. All other activities are combined in a separate segment, Other. These segments reflect the Group’sGroup's internal organizational structure, and are used internally for performance measurement and resource allocation.
Information on operating segments is provided in Note D.34. “Split"Split of net sales”sales" and Note D.35. “Segment information”"Segment information".
B.27. Management of capital
In order to maintain or adjust the capital structure, the Group can adjust the amount of dividends paid to shareholders, or repurchase its own shares, or issue new shares, or issue securities giving access to its capital.
The following objectives are defined under the terms of the Group’sGroup's share repurchase programs:
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
the delivery of shares on the exercise of rights attached to securities giving access to the capital by redemption, conversion, exchange, presentation of a warrant or any other means;
The Group is not subject to any constraints on equity capital imposed by third parties.
The gearing ratio (the ratio of debt, net of cash and cash equivalents to total equity) is a non-GAAP financial indicator used by management to measure overall net indebtedness and to manage the Group’s equity capital.
Total equity includesEquity attributable to equity holders of Sanofi andEquity attributable to non-controlling interests, as shown on the consolidated balance sheet. Debt,We define "Debt, net of cash and cash equivalents is definedequivalents" as (i) the sum total of short-term debt, plus long-term debt plus relatedand interest rate and currency derivatives used to hedge debt, minus (ii) the sum total of cash and cash equivalents and interest rate and currency derivatives used to hedge cash and cash equivalents.
For trends in this ratio, see Note D.17.
B.28. New IFRS standards, amendmentspronouncements issued by the IASB and interpretations applicable from 20122013 onwards
New standards, amendments and interpretationspronouncements applicable in 20112012 with an impact on the consolidated financial statements are described in Note A.2. “New standards, amendments and interpretations applicable in 2011”.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The note below describes standards, amendments and interpretations issued by the IASB that will be mandatorily applicablehave mandatory application in 20122013 or subsequent years, and the Group’sGroup's position regarding future application. None of these standards, amendments or interpretations has been early adopted by the Group.
B.28.1. Standards and amendments applicable to the Sanofi consolidated financial statements
In May 2011, the IASB issued five pronouncementsstandards (or amendments to standards) designed to improve the principles applied in the preparation of consolidated financial statements and the disclosure requirements for joint arrangements and for any type of entity in which an interest is held. NoneIn June 2012, the Accounting Regulatory Committee (ARC) issued a recommendation that these five pronouncements (the first five listed below) should have mandatory application within the European Union no later than annual periods beginning on or after January 1, 2014, with an option for early adoption. The Sanofi Group will apply these standards and amendments (all of these pronouncements have yet beenwhich were endorsed by the European Union:Union in December 2012) with effect from January 1, 2013.
consolidation.
will have no impact on the scope of consolidation.NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
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Two standards — IAS 27 Consolidated(Consolidated and Separated Financial Statements,Statements) and IAS 28 Investments(Investments in Associates,Associates) were amended, to bring them into line with the changes introduced by the publication of IFRS 10, IFRS 11 and IFRS 12.
These new pronouncements will beIn October 2012, the IASB issued an amendment to IFRS 10, IFRS 11 and IFRS 12 on Investment Entities. This amendment is applicable from January 1, 2013.2014, and has not yet been endorsed by the European Union. The Group does not expect this amendment to have an impact on its consolidated financial statements. An investment entity is an entity meeting specific criteria; in particular its corporate purpose is to invest funds in order to obtain returns in the form of capital appreciation or investment income. The amendment requires investment entities to account for their investment in the entities they control at fair value through profit or loss; this is an exception to the IFRS 10 consolidation requirements. The Group does not expect this amendment to have an impact on its consolidated financial statements.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
In May 2011, the IASB and the FASB jointly issued a standard proposing a common definition of fair value, and application guidance. The standard — IFRS 13 Fair(Fair Value Measurement,Measurement) under IFRS — also specifies the disclosures to be made to help users of financial statements understand how fair value is measured. The standard does not change the scope of application of fair value accounting. It will have mandatory application as from January 1, 2013 and has not yet beenwas endorsed by the European Union.Union in December 2012. The Group is currently assessing this new standard, but does not expect it to have a material impact on the financial statements.
In June 2011, the IASB issued thean amended version of IAS 19. The standard19, which will have mandatory application as from January 1, 2013 and has not yet beenwas endorsed by the European Union.Union on June 5, 2012. The amendment makes the main followingmust be applied retrospectively, which means that it must be applied to comparative periods as though it had always been applied.
Applying the amendments to IAS 19 would have had an overall negative impact on net income of €78 million in 2012 and €47 million in 2011. The main components of the impact are:
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In December 2011, the IASB issued two amendments relative toon the offsetting of financial assets and financial liabilities:
liabilities.
These amendments, which do not alter the current accounting treatment of offsetting.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
These amendmentsoffsetting, have no impact on the Group’sGroup's financial statements. They were endorsed by the European Union in December 2012.
TheIn May 2012, the IASB issued twoAnnual Improvements to IFRSs: 2009-2011 Cycle, as part of its annual process of revising and improving existing standards. This pronouncement has not yet been endorsed by the European Union. The amendments in 2010:
Amendment to IFRS 7, Financial Instruments: Disclosures. This amendment isit contains will be applicable to annual periods beginning on or after JulyJanuary 1, 2011, and has been endorsed by the European Union. It is intended to improve disclosure about transfers of financial assets, in particular securitization transactions. It2013. The Group does not alterexpect these amendments to have a material impact on its financial statements. The principal amendments are:
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Amendment
In late 2009, the IASB issued IFRS 9 (Financial Instruments), which has not yet been endorsed by the European Union, provides a practical approach for measuring deferred tax liabilities and deferred tax assets when investment property is measured using the fair value model in IAS 40, Investment Property. Because the Group does not own any investment property measured in accordance with IAS 40, this amendment does not apply to the consolidated financial statements.
In late 2009, the IASB issued IFRS 9, Financial Instruments, which has not yet been endorsed by the European Union:Union. This standard is applicable to annual periods beginning on or after January 1, 2015, and completes the first of the three phases of the IASB financial instruments project. The next two phases will deal with “Financial"Financial Instruments: Amortized Cost and Impairment”Impairment" and “Hedge Accounting”"Hedge Accounting". The three phases of IFRS 9 are intended to replace IAS 39 Financial(Financial Instruments: Recognition and Measurement.Measurement). The Group will assess the overall impact of IFRS 9 once all the phases have been published.
In March 2012, the IASB issued "Government Loans", an amendment to IFRS 1. Because IFRS 1 deals with the first-time adoption of IFRS, this amendment is not applicable to the Group.
B.28.2. New interpretations
The IASB has also issued IFRIC 20 Stripping(Stripping Costs in the Production Phase of a Surface Mine.Mine). This interpretation will be applicable from January 2013, onwards and has not yet been endorsed by the European Union. It does not apply to the activities of the Group.
C.1. Alliance arrangements with Bristol-Myers Squibb (BMS)
Two of the Group’sGroup's leading products were jointly developed with BMS: the anti-hypertensive agent irbesartan (Aprovel®(Aprovel®/Avapro®Avapro®/Karvea®Karvea®) and the anti-atherothrombosis treatment clopidogrel bisulfate (Plavix®(Plavix®/Iscover®Iscover®).
As inventor of the two molecules, Sanofi is paid a royalty on a portion of sales generated by these products (i.e. in the countries of co-promotion and co-marketing).co-marketing territories. The portion of this royalty received by Sanofi on sales generated by BMS in territories under the operational management of BMS (see below) is recorded inOther revenues. As co-developers of the products, Sanofi and BMS each receive equal development royalties from their two licensees, which have been responsible, since 1997, for marketing the products using their local distribution networks, composed of subsidiaries of both groups. These licensees operate in two separate territories: (i) Europe, Africa, Asia and the Middle East, under the operational management of Sanofi; and (ii) other countries (excluding Japan), under the operational management of BMS. In Japan, since June 2008 Aprovel®Aprovel® has been marketed jointly by Shionogi Pharmaceuticals and Dainippon Sumitomo Pharma Co. Ltd.Ltd since June 2008. The alliance with BMS does not cover the rights to Plavix®Plavix® in Japan, where the product is marketed by Sanofi.
The products are marketed in different ways in different countries.
Co-promotion consists of a pooling of sales resources under a single brand name, and is preferably achieved through contracts or through appropriate tax-transparent legal entities. Each partner records directly its share of taxable income.
Co-marketing consists of separate marketing of the products by each local affiliate using its own name and resources under different brand names for the product.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
In certain countries of Eastern Europe, Africa, Asia, Latin America and the Middle East, the products are marketed on an exclusive basis by Sanofi.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
In the territory managed by Sanofi, operations are recognized by the Group as follows:
The line itemNon-controlling interests, excluding BMS in the consolidated statement of cash flows takes account of the specific terms of the alliance agreement.
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In the territory managed by BMS, operations are recognized by the Group as follows:
On September 27, 2012, Sanofi and BMS signed an agreement relating to their alliance following the loss of exclusivity of Plavix® and Avapro®/Avalide® in many major markets.
Under the terms of this new agreement, which took effect on January 1, 2013, BMS will return to Sanofi its rights to Plavix® and Avapro®/Avalide® in all markets worldwide with the exception of Plavix in the U.S. and Puerto Rico, giving Sanofi sole control and freedom to operate commercially. In exchange, BMS will receive royalty payments on Sanofi's sales of branded and unbranded Plavix® and Avapro®/Avalide® worldwide (except for Plavix® in the United States and Puerto Rico) until 2018, and will also receive a payment of $200 million from Sanofi in December 2018, part of which will be to buy out the non-controlling interests (see Notes D.16. and D.18.). Rights to Plavix® in the United States and Puerto Rico remain unchanged and continue to be governed by the terms of the original agreement until December 2019.
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In addition, under the terms of the agreement ongoing disputes between the companies related to the alliance have been resolved. The resolution of these disputes includes various commitments by both companies, including a one-time payment of $80 million by BMS to Sanofi as compensation for the loss caused by the Avalide® supply disruption in the United States in 2011.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
C.2. Alliance arrangements with Regeneron
Zaltrap® (aflibercept) is a solution administered by intravenous perfusion, used in association with 5-fluorouracil, leucovorin and irinotecan (FOLFIRI) as a treatment for metastatic colorectal cancer.
In September 2003, Sanofi and Regeneron signed an agreement to collaborate on the development and commercialization of Zaltrap® (see Note D.21.). Under the terms of this agreement (as amended in 2005), Sanofi is responsible for funding 100% of the development costs, co-promotion rights are shared between Sanofi and Regeneron, and the profits generated from sales of Zaltrap® worldwide (except Japan) are shared equally. Sales of Zaltrap® made by subsidiaries under the control of Sanofi are recognized in consolidated net sales, and the associated costs incurred by those subsidiaries are recognized as operating expenses in the consolidated income statement. Regeneron's share of the profits is recognized in the line itemOther operating expenses, a component of operating income.
Under the terms of the same agreement, Regeneron agreed to repay 50% of the development costs initially funded by Sanofi. Contractually, this amount represents 5% of the residual repayment obligation per quarter, but may not exceed Regeneron's profit share for the quarter unless Regeneron voluntarily decides to make a larger payment in a given quarter.
The agreement also stipulates milestone payments to be made by Sanofi on receipt of specified marketing approvals for Zaltrap® in the United States, within the European Union and in Japan.
In the United States, Zaltrap® is a registered trademark of Regeneron Pharmaceuticals, Inc. The product was approved by the U.S. Food and Drug Administration (FDA) in August 2012, and has been marketed in the United States since that date.
In Japan, Sanofi will develop and commercialize Zaltrap®, with Regeneron entitled to receive a royalty.
In November 2007, Sanofi and Regeneron signed additional agreements under which Sanofi committed to funding the development costs of Regeneron's human monoclonal antibody research program until 2017, up to a maximum of $160 million a year (see Note D.21.). Sanofi has an option to license for further development any antibodies discovered by Regeneron that attain Investigational New Drug (IND) status.
If such an option is exercised, Sanofi is primarily responsible for funding, and co-develops the antibody with Regeneron. Sanofi and Regeneron would share co-promotion rights and profits on sales of the co-developed antibodies. Development costs for the drug candidate are shared between the companies, with Sanofi generally funding these costs up front, except that following receipt of the first positive Phase III trial results for a co-developed drug candidate, subsequent Phase III trial-related costs for that drug candidate are shared 80% by Sanofi and 20% by Regeneron. Once a product begins to be marketed, Regeneron will progressively repay out of its profits 50% of the development costs borne by Sanofi for all antibodies licensed by Sanofi. However, Regeneron are not required to apply more than 10% of its share of the profits from collaboration products in any calendar quarter towards reimbursing Sanofi for these development costs. Under the terms of the collaboration agreement, Sanofi may also be required to make milestone payments based on aggregate sales of antibodies. In 2012, six antibodies were in clinical development; two of which were in Phase III.
If Sanofi does not exercise its licensing option for an antibody under development, Sanofi will be entitled to receive a royalty once the antibody begins to be marketed.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
C.3. Alliance agreements with Warner Chilcott (previously with Procter & Gamble Pharmaceuticals, the “Alliance Partner”"Alliance Partner")
Actonel®Actonel® (risedronate sodium) is a new-generation biphosphonate indicated for the treatment and prevention of osteoporosis. Historically, Actonel®Actonel® was developed and marketed in collaboration with Procter & Gamble Pharmaceuticals. Procter & Gamble sold its pharmaceuticals interests to Warner Chilcott on October 30, 2009. Consequently, Actonel®Actonel® has, since that date, been marketed in collaboration with Warner Chilcott.
This alliance agreement covers the worldwide development and marketing of the product, except for Japan for which the Group holds no rights.
Local marketing arrangements may take various forms:
and the United States and Puerto Rico until March 31, 2010. Sanofi recognizes its share of revenues under the agreement as a component of operating income on theNOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)Other operating income
line. Since April 1, 2010, Sanofi has received royalties from the Alliance Partner on sales made by the Alliance Partner in the United States and Puerto Rico. In the secondary co-promotion territories (the United Kingdom until December 31, 2008, Ireland, Sweden, Finland, Greece, Switzerland, Austria, Portugal and Australia) Sanofi sells the product, and recognizes all the revenues from sales of the product along with the corresponding expenses. The share due to the Alliance Partner is recognized inCost of sales. |
Co-marketing, which applies in Italy, whereby each party to the alliance agreement sells the product in the country under its own name, and recognizes all revenue and expenses from its own operations in its income statement. Each company also markets the product independently under its own brand name in Spain, although Spain is not included in the co-marketing territory.
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In 2010, Sanofi and Warner Chilcott had begunbegan negotiations on the future of their alliance arrangements. In an arbitration proceeding, an arbitration panel decided on July 14, 2011 that the termination by Warner Chilcott of aan ancillary agreement did not entail the termination of the Actonel®Actonel® Alliance. Pursuant to this decision, the alliance will remain in effect until January 1, 2015.
D. PRESENTATION OF THE FINANCIAL STATEMENTS
D.1. Impact of changes in the scope of consolidation
Business combinations completed on or after January 1, 2010 are accounted for using the acquisition method in accordance with the revised IFRS 3. The accounting policies applicable to business combinations are described in Note B.3.1.
D.1.1. Genzyme acquisitionBusiness combinations during 2012
During the year, Sanofi completed the acquisitions of Pluromed, Inc. (Biosurgery) and Newport (Animal Health). The impact of these acquisitions was not material at Group level (see Note D.4.).
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.1.2. Final purchase price allocation for 2011 acquisitions
– Genzyme
Sanofi acquired control of Genzyme Corporation (Genzyme) at a cash price of $74 per share or $20.4 billion (€14.3 billion) on April 4, 2011, the completion date of the public exchange offer for all of the outstanding shares of common stock of Genzyme. Genzyme, a wholly-owned subsidiary of Sanofi, is a biotechnology group headquartered in Cambridge, Massachusetts (United States), whose shares were previously listed on the NASDAQ market. Genzyme’s. Genzyme's primary areas of focus arewere rare diseases, renal-endocrinology,renal endocrinology, oncology and biosurgery. In 2010, Genzyme generated net sales of approximately $4 billion. The group employs nearly 10,000 people and has operations in approximately 70 locations. With this acquisition, Sanofi will expand its reach in biotechnologies and intends to make Genzyme its global center of excellence in rare diseases.
As part of the acquisition, Sanofi issued one contingent value right (CVR) per Genzyme share held toby Genzyme shareholders. Sanofi issued 291 million CVRs.
The CVRs (representing a maximum commitment of $4.1 billion at the acquisition date) are listed on the NASDAQ market under the ticker “GCVRZ” and have been quoted since"GCVRZ". As of April 4, 2011. As of that date,2011, the quoted price per CVR was $2.35, per share totalingequivalent to $685 million (€481 million) for all the sharesCVRs issued. This price was used as the basis for determining the overall fair value of the contingent consideration. In accordance with the revised IFRS 3, this contingent consideration iswas measured at fair value at the acquisition date and included in the price paid to acquire control of Genzyme for the purposes of determining goodwill. The liability related to this contingent consideration is recognized in the balance sheet line itemLiabilities related to business combinations and to non-controlling interests (see Note D.18.).
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Under the terms of the CVR agreement, each CVR entitles the holder to additional cash payments, if certain milestones are met over specified period relating to Lemtrada™ (the registered name submitted to health authorities for the investigational agent alemtuzumab), or if specified production levels of Cerezyme® and Fabrazyme® are met in 2011. The CVRs will expire on the earlier of December 31, 2020, or the attainment of the fourth sales milestone of Lemtrada™. Each milestone and payment may occur once only. The milestones and payments per CVR are summarized below:
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At December 31, 2011, the maximum commitment totaled $3.8 billion, as the Cerezyme® /Fabrazyme® production levels were not reached in 2011.
The provisional purchase price allocation is as follows:
(€ million) | Fair value at acquisition date | |||||||
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Property, plant and equipment | 1,933 | |||||||
Other intangible assets | ||||||||
Non-current financial assets | ||||||||
Inventories | 925 | |||||||
Accounts receivable | 764 | |||||||
Cash and cash equivalents | 1,267 | |||||||
Long-term and short-term debt | (835 | ) | ||||||
Liability related to the | (585 | ) | ||||||
Accounts payable | ( | ) | ||||||
Deferred taxes | ( | ) | ||||||
Other assets and liabilities | ( | ) | ||||||
Net assets of Genzyme as of April 4, 2011 | ||||||||
Goodwill | ||||||||
Purchase price(1) | 14,814 | |||||||
On completion of the valuations carried out during the measurement period, the deferred tax liability was €489 million higher than in the provisional purchase price allocation as of December 31, 2011 (see Note D.1.1 to the financial statements for the year ended December 31, 2011). This increase was mainly due to the finalization of the assessment of the tax regimes applicable to the €10,059 million of intangible assets. This assessment was finalized within the measurement period, in accordance with paragraph 45 of the revised IFRS 3. Consequently, the comparative amounts reported for 2011 have been revised, in accordance with paragraph 49 of the revised IFRS 3.
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Prior to Sanofi’s acquisition of Genzyme,In a business combination completed in May 2009, prior to Sanofi's acquisition of control over Genzyme, Genzyme acquired from Bayer Schering Pharma A.G. (Bayer) the worldwide development and marketing rights to
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
alemtuzumab (under the brand name LemtradaTM), a molecule currently under development for multiple sclerosis, as well as the rights to the products Campath®Campath®, Fludara®Fludara® and Leukine® from Bayer Schering Pharma A.G. (Bayer)Leukine®. As part of this agreement, Bayer is entitled to receive the following contingent payments:
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
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This pre-existing additional contingent purchase consideration iswas measured at its fair value as of April 4, 2011, and iswas recognized as a liability in the balance sheet line itemLiabilities related to business combinations and to non-controlling interests. The amount is remeasured at fair value at each reporting date. The impact of the resulting fair value adjustment is recognized in profit or loss in the line itemFair value remeasurement of contingent consideration liabilities, similarly toin the same way as other contingent consideration on business combinations (see Note D.18.).
The goodwill arising from Sanofi’s acquisition of Genzyme mainly represents the portfolio of future products in the upstream research and development phase not separately identified at the acquisition date; the capacity to renew the existing product portfolio based on specialized organizational structures; the scientific expertise of Genzyme staff; as well as, the advantages gained from creating new growth platforms; expected future synergies; and the other beneficial effects of combining Genzyme with Sanofi. This goodwill does not give rise to any deduction for tax purposes.
The goodwill was determined on the basis of the provisional fair values of the assets and liabilities identified at the time of the acquisition; it will be adjusted, within a period of no more than twelve months from the acquisition date, if these fair values change as a result of circumstances existing at the acquisition date. These fair value adjustments may arise in respect of property, plant and equipment, intangible assets and inventories, upon completion of the necessary valuations, and physical verifications of such assets. The amount of provisions may also be adjusted as a result of ongoing procedures to identify and measure liabilities and contingent liabilities, including tax, environmental risks, and litigation. The amount of deferred taxes may also be adjusted during the purchase price allocation period.
Since the acquisition date, Genzyme has generated net sales of €2,395 million and business operating income of €593 million (see definition in Note D.35. “Segment Information”). Over the same period, Genzyme made a negative contribution of €749 million to consolidated net income (after taking account of expenses during the period associated with the remeasurement of assets at fair value on recognition at the acquisition date). Over the twelve months of the year ended December 31, 2011, Genzyme net sales amounted to €3,133 million.
The acquisition Acquisition-related costs recognized in the periodprofit or loss in 2011 amounted to €65 million, mostly recorded in the line itemOther operating expenses.
The impact of this acquisition, as reflected in the statements of cash flows in the line itemAcquisitions of investments in consolidated entities,undertakings, net of cash acquired,is was a net cash outflow of €13.1 billion.
D.1.2. Other business combinations during 2011
The other acquisitions in 2011 were as follows:
-– BMP Sunstone
On February 24, 2011, Sanofi completed the acquisition of 100% of BMP Sunstone Corporation, a pharmaceutical company previously quoted on the NASDAQ market, which is developing a portfolio of branded pharmaceuticals and healthcare products in China. Through BMP Sunstone, the Group manufactures pediatric and feminine healthcare products, sold in pharmacies across the country.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued) The purchase consideration was €384 million, excluding acquisition-related costs of €4 million that were recognized mainly in the line item
The provisionalfinal purchase price allocation is shownfor this acquisition was completed in the table below:
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|
Since acquisition date, the net sales2012, and business operating income (see definition in Note D.35. “Segment Information”) of the BMP Sunstone entities amounted to €47 million and €0.1 million respectively. The contribution of the BMP Sunstone entities to consolidated net income was €(24) million (amount including the expenses for the period related to the remeasurement of assets at fair value at the acquisition date).
The residual goodwill primarily reflects the advantagesnot materially different from the creation of a new Consumer Health Care growth platformprovisional allocation in China, which supports the launch of new product extensions for current brands and access to certain markets in China and by expected future synergies related to the combination of Sanofi and BMP Sunstone. This amount does not result in a tax deduction.2011.
The acquisition costs recorded in income during the period totaled €4 million, primarily recognized in the line itemOther operating expenses.
-– Topaz Pharmaceuticals, Inc.
In October 2011, Sanofi acquired Topaz Pharmaceuticals Inc., a USU.S. pharmaceutical research company which has developed an innovative anti-parasitic treatment for head lice. An upfront payment of $35 million was made upon closing of the transaction. The agreement provides for other potential milestone payments when the product is authorized forobtains marketing approval and based on the achievementattainment of sales targets. The total amount of thethese payments, including the initialupfront payment, could reach $207.5 million.
The final purchase price allocation for this acquisition was completed in 2012, and was not materially different from the provisional allocation in 2011.
-– Universal Medicare Private Limited
In November 2011, Sanofi acquired the business of Universal Medicare Private Limited, one of the leading Indian producers of neutraceuticals and life management products, including vitamins, antioxidants, mineral supplements and anti-arthritics.anti-arthritics, for a consideration of €83 million.
The amount paid atfinal purchase price allocation for this acquisition was €83 million, including €13 million paid into an escrow account, which will revert tocompleted in 2012, and was not materially different from the seller based on the achievement of the objectives definedprovisional allocation in the supply contract signed with the seller.
2011.
D.1.3. Disposals during 2011
In 2012, Sanofi sold its 39.1% interest in Société Financière des Laboratoires de Cosmétologie Yves Rocher.
On December 19, In 2011, Sanofi sold theits Dermik dermatology business to Valeant Pharmaceuticals International Inc. for a total of €321 million euros.million. The transaction includes all Dermik assets, i.e.including a portfolio of several leading brands in
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
therapeutic and esthetic dermatology like Benzaclin®such as Benzaclin®, Carac®Carac® and Sculptra®Sculptra®, and a manufacturing site in Canada.
Income before tax The pre-tax loss arising from this sale iswas recognized in 2011 in the line itemOther gains and losses, and litigation(see (see Note D.28.).
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
There were no material disposals during the year ended December 31, 2010.
D.1.4. Business combinations during 2010
The principal acquisitions in 2010 were as follows:
-– TargeGen, Inc. (TargeGen)
In July 2010, Sanofi acquired 100% of the capital of TargeGen, Inc., a U.S. biopharmaceutical company developing small moleculemolecules kinase inhibitors for the treatment of certain forms of leukemia, lymphoma and other hematological malignancies and blood disorders. An upfront payment of $75 million was made on completion. The agreement provides for other potential milestone payments at various stages in the development of TG 101348, TargeGen’s101 348, TargeGen's principal product candidate. The total amount of payments (including the upfront payment) could reach $560 million. The final purchase price allocation for this acquisition was not materially different from the provisional allocation.
- Chattem, Inc. (Chattem)
On February 9, 2010, Sanofi successfully completed a cash tender offer for Chattem, based in Chattanooga (United States). Chattem has become Sanofi’sSanofi's platform in the United States for consumer health products and over-the-counter products and has managed the Allegra®Allegra® brand since 2011. The final purchase price allocation for this acquisition was not materially different from the provisional allocation.
The other acquisitions in 2010 were as follows:
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D.1.5. Business combinations during 2009
The principal acquisitions in 2009 were as follows:
- BiPar
On April 27, 2009, Sanofi acquired 100% of BiPar Sciences (BiPar), an American biopharmaceutical company developing novel tumorselective approaches for the treatment of different types of cancers. The purchase price is contingent on the achievement (regarded as probable) of milestones related to the development of BSI-201, and could reach $500 million at the pre-clinical stage. Under the terms of the agreement, an upfront payment of $55 million was made upon closing of the transaction, and a further $5 million will be payable upon completion of a specified development milestone.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
- Medley
On April 27, 2009, Sanofi acquired a 100% equity interest in Medley, the third largest pharmaceutical company in Brazil and a leading generics company in that country. The purchase price, based on an enterprise value of €500 million, was €348 million inclusive of acquisition-related costs.
- Zentiva
On March 11, 2009, Sanofi successfully closed its offer for Zentiva N.V. (Zentiva). As of December 31, 2009, Sanofi held about 99.1% of Zentiva’s share capital. The purchase price was €1,200 million, including acquisition-related costs. Following the buyout of the remaining non-controlling interests, Sanofi held a 100% equity interest in Zentiva as of December 31, 2011.
Previously, Sanofi held a 24.9% interest in Zentiva, which was accounted for as an associate by the equity method (see Note D.6.).
- Shantha Biotechnics
In August 2009, the Group took control of Shantha Biotechnics (Shantha), a vaccines company based in Hyderabad (India), by acquiring the shares of ShanH, the owner of Shantha. In the purchase price allocation, identifiable intangible assets other than goodwill were measured at a fair value of €374 million. This amount includes the acquisition-date value of the Shan5® pentavalent vaccine, which was partially written down in 2010 (see Note D.5.).
The other acquisitions during 2009 were:
D.2. Merial
In March 2010, Sanofi exercised its contractual right to combine its Animal Health business (Merial) with that of Merck (Intervet/Schering-Plough) to form a new joint venture owned equally owned by Merck and Sanofi. Consequently, all of the assets and liabilities of Merial were reported respectively in the line itemsAssets held for sale or exchange andLiabilities related to assets held for sale or exchange, and the net income of Merial was reported in the line itemNet income from the held for exchangeheld-for-exchange Merial business, in accordance with IFRS 5 (see Note B.7.).
However, on March 22, 2011, Merck and Sanofi announced the end of the agreement to form a new joint venture in animal health and the decision to maintain two separate entities, Merial etand Intervet/Schering-Plough, operating independently. This decision was primarily due to the complexity of implementing the proposed transaction, both in terms of the nature and extent of the anticipated divestitures and the length of time necessary for the worldwide regulatoryantitrust review process.
As a result, Sanofi’s stakeSanofi's investment in Merial is no longerhas since January 1, 2011 been presented separately in the relevant line items of the consolidated balance sheet and income statement since January 1, 2011.statement. In accordance with IFRS 5 (see Note B.7.), this change in accounting method has beenwas treated as follows:
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.3. Property, plant and equipment
The impacts related to the reclassification of the Merial net income for €386 million at December 31, 2010 and €175 million at December 31, 2009 in net income from continuing operations, in accordance with IFRS 5.36, are presented in the table below:
(€ million) | At December 31, 2010 | At December 31, 2009 | ||||||
Net sales | 1,983 | 479 | ||||||
Other revenues | 18 | 4 | ||||||
Cost of sales | (681 | ) | (227 | ) | ||||
Gross profit | 1,320 | 256 | ||||||
Research and development costs | (146 | ) | (43 | ) | ||||
Selling and general expenses | (582 | ) | (139 | ) | ||||
Other operating income | 10 | 1 | ||||||
Other operating expenses | (16 | ) | (6 | ) | ||||
Restructuring costs | (12 | ) | — | |||||
Operating income | 574 | 69 | ||||||
Financial expenses | (1 | ) | — | |||||
Financial income | 1 | 2 | ||||||
Income before tax and associates and joint ventures | 574 | 71 | ||||||
Income tax expense | (188 | ) | (35 | ) | ||||
Share of profit/(loss) of associates and joint ventures (1) | — | 139 | ||||||
Net income | 386 | 175 |
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NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Property, plant and equipment (including assets held under finance leases) comprise:
(€ million) | Land | Buildings | Plant & equipment | Fixtures, fittings & other | Property, plant and equipment in process | Total | ||||||||||||||||||
Gross value at January 1, 2009 | 215 | 3,300 | 4,979 | 1,545 | 1,512 | 11,551 | ||||||||||||||||||
Changes in scope of consolidation | 61 | 245 | 199 | 26 | 13 | 544 | ||||||||||||||||||
Acquisitions and other increases | 1 | 32 | 87 | 63 | 1,170 | 1,353 | ||||||||||||||||||
Disposals and other decreases | (3 | ) | (22 | ) | (23 | ) | (157 | ) | (17 | ) | (222 | ) | ||||||||||||
Currency translation differences | 6 | 26 | 24 | 5 | 4 | 65 | ||||||||||||||||||
Transfers | (5 | ) | 463 | 581 | 122 | (1,348 | ) | (187 | ) | |||||||||||||||
Gross value at December 31, 2009 | 275 | 4,044 | 5,847 | 1,604 | 1,334 | 13,104 | ||||||||||||||||||
Changes in scope of consolidation | 1 | 29 | 15 | 5 | 7 | 57 | ||||||||||||||||||
Acquisitions and other increases | 1 | 12 | 57 | 71 | 1,058 | 1,199 | ||||||||||||||||||
Disposals and other decreases | (3 | ) | (14 | ) | (12 | ) | (124 | ) | — | (153 | ) | |||||||||||||
Currency translation differences | 11 | 172 | 134 | 38 | 31 | 386 | ||||||||||||||||||
Transfers | (11 | ) | 312 | 482 | 76 | (1,076 | ) | (217 | ) | |||||||||||||||
Gross value at December 31, 2010 | 274 | 4,555 | 6,523 | 1,670 | 1,354 | 14,376 | ||||||||||||||||||
Merial(1) | 31 | 384 | 208 | 50 | 84 | 757 | ||||||||||||||||||
Changes in scope of consolidation | 72 | 770 | 396 | 13 | 613 | 1,864 | ||||||||||||||||||
Acquisitions and other increases | 5 | 28 | 111 | 82 | 1,214 | 1,440 | ||||||||||||||||||
Disposals and other decreases | (3 | ) | (32 | ) | (19 | ) | (89 | ) | (1 | ) | (144 | ) | ||||||||||||
Currency translation differences | 4 | 60 | (27 | ) | — | 45 | 82 | |||||||||||||||||
Transfers | (8 | ) | 171 | 448 | 284 | (1,060 | ) | (165 | ) | |||||||||||||||
Gross amounts at December 31, 2011 | 375 | 5,936 | 7,640 | 2,010 | 2,249 | 18,210 | ||||||||||||||||||
Accumulated depreciation & impairment at January 1, 2009 | (4 | ) | (1,093 | ) | (2,400 | ) | (1,056 | ) | (37 | ) | (4,590 | ) | ||||||||||||
Depreciation expense | — | (238 | ) | (530 | ) | (161 | ) | — | (929 | ) | ||||||||||||||
Impairment losses | (4 | ) | (73 | ) | (22 | ) | (4 | ) | (5 | ) | (108 | ) | ||||||||||||
Disposals | 2 | 12 | 24 | 148 | 2 | 188 | ||||||||||||||||||
Currency translation differences | — | (4 | ) | (16 | ) | (3 | ) | — | (23 | ) | ||||||||||||||
Transfers | 3 | 87 | 103 | (5 | ) | — | 188 | |||||||||||||||||
Accumulated depreciation & impairment at December 31, 2009 | (3 | ) | (1,309 | ) | (2,841 | ) | (1,081 | ) | (40 | ) | (5,274 | ) | ||||||||||||
Depreciation expense | — | (298 | ) | (623 | ) | (167 | ) | — | (1,088 | ) | ||||||||||||||
Impairment losses | (4 | ) | (29 | ) | 12 | (2 | ) | (6 | ) | (29 | ) | |||||||||||||
Disposals | — | 10 | 1 | 114 | — | 125 | ||||||||||||||||||
Currency translation differences | — | (66 | ) | (67 | ) | (24 | ) | — | (157 | ) | ||||||||||||||
Transfers | 5 | 140 | 42 | 11 | 4 | 202 | ||||||||||||||||||
Accumulated depreciation & impairment at December 31, 2010 | (2 | ) | (1,552 | ) | (3,476 | ) | (1,149 | ) | (42 | ) | (6,221 | ) | ||||||||||||
Changes in scope of consolidation | — | 24 | 18 | 12 | — | 54 | ||||||||||||||||||
Depreciation expense (2) | — | (362 | ) | (700 | ) | (199 | ) | — | (1,261 | ) | ||||||||||||||
Impairment losses | (28 | ) | (184 | ) | (31 | ) | (29 | ) | (15 | ) | (287 | ) | ||||||||||||
Disposals | — | 23 | 3 | 81 | — | 107 | ||||||||||||||||||
Currency translation differences | (1 | ) | (10 | ) | 26 | 1 | (1 | ) | 15 | |||||||||||||||
Transfers | 12 | 151 | 54 | (85 | ) | 1 | 133 | |||||||||||||||||
Accumulated depreciation & impairment at December 31, 2011 | (19 | ) | (1,910 | ) | (4,106 | ) | (1,368 | ) | (57 | ) | (7,460 | ) | ||||||||||||
Carrying amount: January 1, 2009 | 211 | 2,207 | 2,579 | 489 | 1,475 | 6,961 | ||||||||||||||||||
Carrying amount: December 31, 2009 | 272 | 2,735 | 3,006 | 523 | 1,294 | 7,830 | ||||||||||||||||||
Carrying amount: December 31, 2010 | 272 | 3,003 | 3,047 | 521 | 1,312 | 8,155 | ||||||||||||||||||
Carrying amount: December 31, 2011 | 356 | 4,026 | 3,534 | 642 | 2,192 | 10,750 |
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|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The line item “Changes in scope of consolidation” in 2011 primarily represents the initial recognition of the tangible assets followingdecision to maintain two separate entities (Merial and Intervet/Schering-Plough) operating independently.
The value of the tangible assets of the Dermik business disposed of in 2011 (see Note D.1.3.)2009 and 2010 on Merial property plant, and equipment previously classified as
the income statement.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Acquisitions during 2012 amounted to €1,351 million. The Pharmaceuticals segment made acquisitions totaling €1,061 million, primarily investments in industrial facilities (€533 million excluding Genzyme in 2012, versus €510 million in 2011 and €471 million in 2010) and in construction and fitting-out at research sites (€97 million in 2012, versus €124 million in 2011 and €159 million in 2010). Genzyme accounted for €301 million of Pharmaceuticals segment acquisitions in 2012, compared with €218 million in 2011. Acquisitions by the Vaccines segment reached €207 million (versus €302 million in 2011 and €423 million in 2010). The Animal Health segment accounted for €83 million of acquisitions in 2012, versus €78 million in 2011. Acquisitions of property, plant and equipment included €27 million of capitalized interest costs, against €44 million in 2011 and €27 million in 2010.
Firm orders for property, plant and equipment stood at €323 million as of December 31, 2012 (versus €292 million as of December 31, 2011 and €321 million as of December 31, 2010). Property, plant and equipment pledged as security for liabilities amounted to €225 million as of December 31, 2012 (versus €239 million as of December 31, 2011 (€26and €26 million as of December 31, 2010 and €15 million as of December 31, 2009)2010).
In addition, the valuationImpairment tests of property, plant and equipment conducted using the method described in Note B.6,B.6. resulted in the recognition during 2012 of net impairment losses of €152 million. Most of this relates to the reorganization of research and development (see Note D.27.). In 2011, impairment testing led to the recognition of anet impairment losses of €287 million, impairment loss for 2011 primarily relatedrelating mainly to research and development sites as part of the restructuring of this activity and to an industrial site basedfacility in Slovakia. ForIn 2010, an impairment loss of €53 million forwas recognized (mainly on a site held for sale andsale), as well as an impairment loss reversal of €24 million were recognized.million.
Acquisitions for 2011 represent investments made in the Pharmaceuticals segment, primarily investments in industrial facilities (€510 million excluding Genzyme in 2011 versus €471 million in 2010 and €496 million in 2009) and in facilities and equipment at research sites (€124 million in 2011, versus €159 million in 2010 and €325 million in 2009). Genzyme acquisitions since its acquisition date totaled €218 million. In addition, acquisitions in the Vaccines segment totaled €302 million (compared with €423 million in 2010 and €446 million in 2009). Assets acquired in the Animal Health segment totaled €78 million in 2011. Capitalized borrowing costs amounted to €44 million (27 million in 2010 and €30 million in 2009). Firm orders for property, plant and equipment amounted to €292 million at December 31, 2011 (€321 million at December 31, 2010 and €351 million at December 31, 2009).
The table below shows amounts for items of property, plant and equipment held under finance leases:
(€ million) | December 31, 2012 | December 31, 2011 | December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Land | 3 | 7 | 7 | |||||||
Buildings | 86 | 137 | 84 | |||||||
Other property, plant and equipment | 17 | 17 | 15 | |||||||
Total gross value | 106 | 161 | 106 | |||||||
Accumulated depreciation and impairment | (42 | ) | (64 | ) | (78 | ) | ||||
Carrying amount | 64 | 97 | 28 | |||||||
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||
Land | 7 | 7 | 7 | |||||||||
Buildings | 137 | 84 | 99 | |||||||||
Other property, plant and equipment | 17 | 15 | 6 | |||||||||
Total gross value | 161 | 106 | 112 | |||||||||
Accumulated depreciation and impairment | (64 | ) | (78 | ) | (81 | ) | ||||||
Carrying amount | 97 | 28 | 31 |
Future minimum lease payments due under finance leases atas of December 31, 2012 were €100 million (compared with €123 million as of December 31, 2011 were €123 million (versusand €28 million atas of December 31, 2010 and €27 million at December 31, 2009)2010), including interest of €22 million (versus €30 million (versus €3 million atas of December 31, 20102011 and €3 million atas of December 31, 2009)2010).
The payment schedule is as follows:
December 31, 2011 | Payments due by period | |||||||||||||||||||
(€ million) | Total | Under 1 year | From 1 to 3 years | From 3 to 5 years | Over 5 years | |||||||||||||||
Finance lease obligations: | ||||||||||||||||||||
– principal | 92 | 12 | 27 | 28 | 25 | |||||||||||||||
– interest | 31 | 7 | 13 | 7 | 4 | |||||||||||||||
Total | 123 | 19 | 40 | 35 | 29 |
December 31, 2012 | Payments due by period | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Total | Under 1 year | From 1 to 3 years | From 3 to 5 years | Over 5 years | |||||||||||
Finance lease obligations: | ||||||||||||||||
– principal | 78 | 13 | 27 | 27 | 11 | |||||||||||
– interest | 22 | 7 | 9 | 4 | 2 | |||||||||||
Total | 100 | 20 | 36 | 31 | 13 | |||||||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.4. Goodwill and other intangible assets
Other intangible assets break down as follows:
(€ million) | Acquired Aventis R&D | Other Acquired R&D | Rights to marketed Aventis products | Products, trademarks and other rights | Software | Total other intangible assets | ||||||||||||||||||
Gross value at January 1, 2009 | 2,453 | 558 | 30,319 | 1,760 | 585 | 35,675 | ||||||||||||||||||
Changes in scope of consolidation | — | 789 | — | 1,405 | 12 | 2,206 | ||||||||||||||||||
Acquisitions and other increases | — | 275 | — | 62 | 56 | 393 | ||||||||||||||||||
Disposals and other decreases | — | (70 | ) | — | (1 | ) | (2 | ) | (73 | ) | ||||||||||||||
Currency translation differences | (45 | ) | (51 | ) | (451 | ) | 47 | 2 | (498 | ) | ||||||||||||||
Transfers | (87 | ) | (9 | ) | 87 | 11 | 2 | 4 | ||||||||||||||||
Gross value at December 31, 2009 | 2,321 | 1,492 | 29,955 | 3,284 | 655 | 37,707 | ||||||||||||||||||
Changes in scope of consolidation | — | 192 | — | 1,365 | — | 1,557 | ||||||||||||||||||
Acquisitions and other increases | — | 167 | — | 154 | 67 | 388 | ||||||||||||||||||
Disposals and other decreases | — | (7 | ) | — | (3 | ) | (9 | ) | (19 | ) | ||||||||||||||
Currency translation differences | 121 | 61 | 1,669 | 304 | 28 | 2,183 | ||||||||||||||||||
Transfers | (173 | ) | (341 | ) | 173 | 389 | (1 | ) | 47 | |||||||||||||||
Gross value at December 31, 2010 | 2,269 | 1,564 | 31,797 | 5,493 | 740 | 41,863 | ||||||||||||||||||
Merial (1) | — | 674 | — | 3,235 | 70 | 3,979 | ||||||||||||||||||
Changes in scope of consolidation | (42 | ) | 2,235 | (1,044 | ) | 8,122 | 38 | 9,309 | ||||||||||||||||
Acquisitions and other increases | — | 92 | — | 62 | 107 | 261 | ||||||||||||||||||
Disposals and other decreases | — | (13 | ) | — | (9 | ) | (2 | ) | (24 | ) | ||||||||||||||
Currency translation differences | 43 | 154 | 667 | 580 | 7 | 1,451 | ||||||||||||||||||
Transfers | (167 | ) | (444 | ) | 167 | 450 | 11 | 17 | ||||||||||||||||
Gross value at December 31, 2011 | 2,103 | 4,262 | 31,587 | 17,933 | 971 | 56,856 | ||||||||||||||||||
Accumulated amortization & impairment at Jan. 1, 2009 | (1,484 | ) | (47 | ) | (17,399 | ) | (997 | ) | (488 | ) | (20,415 | ) | ||||||||||||
Amortization expense | — | (70 | ) | (3,155 | ) | (303 | ) | (50 | ) | (3,578 | ) | |||||||||||||
Impairment losses, net of reversals | — | (28 | ) | (344 | ) | — | — | (372 | ) | |||||||||||||||
Disposals | — | 69 | — | 2 | — | 71 | ||||||||||||||||||
Currency translation differences | 28 | 2 | 288 | 19 | (1 | ) | 336 | |||||||||||||||||
Transfers | — | 2 | — | (4 | ) | — | (2 | ) | ||||||||||||||||
Accumulated amortization & impairment at Dec. 31, 2009 | (1,456 | ) | (72 | ) | (20,610 | ) | (1,283 | ) | (539 | ) | (23,960 | ) | ||||||||||||
Amortization expense | — | — | (3,050 | ) | (479 | ) | (49 | ) | (3,578 | ) | ||||||||||||||
Impairment losses, net of reversals | (10 | ) | (132 | ) | (117 | ) | (174 | ) | — | (433 | ) | |||||||||||||
Disposals | — | 5 | — | 3 | 9 | 17 | ||||||||||||||||||
Currency translation differences | (75 | ) | (3 | ) | (1,178 | ) | (106 | ) | (24 | ) | (1,386 | ) | ||||||||||||
Transfers | 1 | 62 | — | (108 | ) | 1 | (44 | ) | ||||||||||||||||
Accumulated amortization & impairment at Dec. 31, 2010 | (1,540 | ) | (140 | ) | (24,955 | ) | (2,147 | ) | (602 | ) | (29,384 | ) | ||||||||||||
Changes in scope of consolidation | 42 | — | 832 | 1 | 1 | 876 | ||||||||||||||||||
Amortization expense (2) | — | — | (1,754 | ) | (1,972 | ) | (107 | ) | (3,833 | ) | ||||||||||||||
Impairment losses, net of reversals | — | (101 | ) | 34 | (75 | ) | (1 | ) | (143 | ) | ||||||||||||||
Disposals | — | 13 | — | 8 | 5 | 26 | ||||||||||||||||||
Currency translation differences | (33 | ) | (6 | ) | (591 | ) | (119 | ) | (2 | ) | (751 | ) | ||||||||||||
Transfers | — | — | — | (4 | ) | (4 | ) | (8 | ) | |||||||||||||||
Accumulated amortization & impairment at December 31, 2011 | (1,531 | ) | (234 | ) | (26,434 | ) | (4,308 | ) | (710 | ) | (33,217 | ) | ||||||||||||
Carrying amount: January 1, 2009 | 969 | 511 | 12,920 | 763 | 97 | 15,260 | ||||||||||||||||||
Carrying amount: December 31, 2009 | 865 | 1,420 | 9,345 | 2,001 | 116 | 13,747 | ||||||||||||||||||
Carrying amount: December 31, 2010 | 729 | 1,424 | 6,842 | 3,346 | 138 | 12,479 | ||||||||||||||||||
Carrying amount: December 31, 2011 | 572 | 4,028 | 5,153 | 13,625 | 261 | 23,639 |
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|
(€ million) | Acquired Aventis R&D | Other Acquired R&D | Rights to marketed Aventis products | Products, trademarks and other rights | Software | Total other intangible assets | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gross value at January 1, 2010 | 2,321 | 1,492 | 29,955 | 3,284 | 655 | 37,707 | |||||||||||||
Changes in scope of consolidation | — | 192 | — | 1,365 | — | 1,557 | |||||||||||||
Acquisitions and other increases | — | 167 | — | 154 | 67 | 388 | |||||||||||||
Disposals and other decreases | — | (7 | ) | — | (3 | ) | (9 | ) | (19 | ) | |||||||||
Currency translation differences | 121 | 61 | 1,669 | 304 | 28 | 2,183 | |||||||||||||
Transfers (3) | (173 | ) | (341 | ) | 173 | 389 | (1 | ) | 47 | ||||||||||
Gross value at December 31, 2010 | 2,269 | 1,564 | 31,797 | 5,493 | 740 | 41,863 | |||||||||||||
Merial (1) | — | 674 | — | 3,235 | 70 | 3,979 | |||||||||||||
Changes in scope of consolidation | (42 | ) | 2,235 | (1,044 | ) | 8,122 | 38 | 9,309 | |||||||||||
Acquisitions and other increases | — | 92 | — | 62 | 107 | 261 | |||||||||||||
Disposals and other decreases | — | (13 | ) | — | (9 | ) | (2 | ) | (24 | ) | |||||||||
Currency translation differences | 43 | 154 | 667 | 580 | 7 | 1,451 | |||||||||||||
Transfers (3) | (167 | ) | (444 | ) | 167 | 450 | 11 | 17 | |||||||||||
Gross value at December 31, 2011 | 2,103 | 4,262 | 31,587 | 17,933 | 971 | 56,856 | |||||||||||||
Changes in scope of consolidation | — | 10 | — | 79 | — | 89 | |||||||||||||
Acquisitions and other increases | — | 87 | — | 123 | 83 | 293 | |||||||||||||
Disposals and other decreases | — | (20 | ) | — | (15 | ) | (30 | ) | (65 | ) | |||||||||
Currency translation differences | (36 | ) | (53 | ) | (553 | ) | (296 | ) | (8 | ) | (946 | ) | |||||||
Transfers (3) | (279 | ) | (178 | ) | 279 | 166 | 12 | — | |||||||||||
Gross value at December 31, 2012 | 1,788 | 4,108 | 31,313 | 17,990 | 1,028 | 56,227 | |||||||||||||
Accumulated amortization & impairment at January 1, 2010 | (1,456 | ) | (72 | ) | (20,610 | ) | (1,283 | ) | (539 | ) | (23,960 | ) | |||||||
Amortization expense | — | — | (3,050 | ) | (479 | ) | (49 | ) | (3,578 | ) | |||||||||
Impairment losses, net of reversals | (10 | ) | (132 | ) | (117 | ) | (174 | ) | — | (433 | ) | ||||||||
Disposals and other decreases | — | 5 | — | 3 | 9 | 17 | |||||||||||||
Currency translation differences | (75 | ) | (3 | ) | (1,178 | ) | (106 | ) | (24 | ) | (1,386 | ) | |||||||
Transfers | 1 | 62 | — | (108 | ) | 1 | (44 | ) | |||||||||||
Accumulated amortization & impairment at Dec. 31, 2010 | (1,540 | ) | (140 | ) | (24,955 | ) | (2,147 | ) | (602 | ) | (29,384 | ) | |||||||
Changes in scope of consolidation | 42 | — | 832 | 1 | 1 | 876 | |||||||||||||
Amortization expense (2) | — | — | (1,754 | ) | (1,972 | ) | (107 | ) | (3,833 | ) | |||||||||
Impairment losses, net of reversals | — | (101 | ) | 34 | (75 | ) | (1 | ) | (143 | ) | |||||||||
Disposals and other decreases | — | 13 | — | 8 | 5 | 26 | |||||||||||||
Currency translation differences | (33 | ) | (6 | ) | (591 | ) | (119 | ) | (2 | ) | (751 | ) | |||||||
Transfers | — | — | — | (4 | ) | (4 | ) | (8 | ) | ||||||||||
Accumulated amortization & impairment at December 31, 2011 | (1,531 | ) | (234 | ) | (26,434 | ) | (4,308 | ) | (710 | ) | (33,217 | ) | |||||||
Amortization expense | — | — | (1,452 | ) | (1,839 | ) | (105 | ) | (3,396 | ) | |||||||||
Impairment losses, net of reversals | 12 | (111 | ) | — | (18 | ) | (3 | ) | (120 | ) | |||||||||
Disposals and other decreases | — | 18 | — | 16 | 25 | 59 | |||||||||||||
Currency translation differences | 30 | 4 | 475 | 96 | 6 | 611 | |||||||||||||
Transfers | — | (1 | ) | — | 3 | 26 | 28 | ||||||||||||
Accumulated amortization & impairment at December 31, 2012 | (1,489 | ) | (324 | ) | (27,411 | ) | (6,050 | ) | (761 | ) | (36,035 | ) | |||||||
Carrying amount: January 1, 2010 | 865 | 1,420 | 9,345 | 2,001 | 116 | 13,747 | |||||||||||||
Carrying amount: December 31, 2010 | 729 | 1,424 | 6,842 | 3,346 | 138 | 12,479 | |||||||||||||
Carrying amount: December 31, 2011 | 572 | 4,028 | 5,153 | 13,625 | 261 | 23,639 | |||||||||||||
Carrying amount: December 31, 2012 | 299 | 3,784 | 3,902 | 11,940 | 267 | 20,192 | |||||||||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Movements in goodwill for the last three financial periods are shown below:
(€ million) | Gross value | Impairment | Carrying amount | |||||||||
Balance at January 1, 2009 | 28,188 | (25 | ) | 28,163 | ||||||||
Movements for the period (1) | 1,798 | — | 1,798 | |||||||||
Currency translation differences | (228 | ) | — | (228 | ) | |||||||
Balance at December 31, 2009 | 29,758 | (25 | ) | 29,733 | ||||||||
Movements for the period (1) | 1,017 | — | 1,017 | |||||||||
Currency translation differences | 1,183 | (1 | ) | 1,182 | ||||||||
Balance at December 31, 2010 | 31,958 | (26 | ) | 31,932 | ||||||||
Merial goodwill (2) | 1,210 | — | 1,210 | |||||||||
Genzyme goodwill | 4,086 | — | 4,086 | |||||||||
Other movements for the period (1) | 275 | — | 275 | |||||||||
Currency translation differences | 574 | 2 | 576 | |||||||||
Balance at December 31, 2011 | 38,103 | (24) | 38,079 |
|
|
(€ million) | Gross value | Impairment | Carrying amount | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Balance at January 1, 2010 | 29,758 | (25 | ) | 29,733 | ||||||
Movements for the period (1) | 1,017 | — | 1,017 | |||||||
Currency translation differences | 1,183 | (1 | ) | 1,182 | ||||||
Balance at December 31, 2010 | 31,958 | (26 | ) | 31,932 | ||||||
Merial goodwill (2) | 1,210 | — | 1,210 | |||||||
Genzyme goodwill (3) | 4,575 | — | 4,575 | |||||||
Other movements for the period (1) | 275 | — | 275 | |||||||
Currency translation differences | 588 | 2 | 590 | |||||||
Balance at December 31, 2011 (4) | 38,606 | (24 | ) | 38,582 | ||||||
Acquisitions during the period (1) | 14 | — | 14 | |||||||
Other movements for the period (5) | (144 | ) | — | (144 | ) | |||||
Currency translation differences | (376 | ) | (3 | ) | (379 | ) | ||||
Balance at December 31, 2012 | 38,100 | (27 | ) | 38,073 | ||||||
• Genzyme acquisition (2011)
The Genzyme provisionalfinal purchase price allocation resulted in the initial recognition of intangible assets totaling €10,063€10,059 million atas of the acquisition date (see Note D.1.1.D.1.2.). This figure includes €7,731€7,727 million for marketed products in the fields of rare diseases (primarily Cerezyme®Cerezyme®, Fabrazyme®Fabrazyme® and Myozyme®Myozyme®), renal-endocrinologyrenal endocrinology (primarily Renagel®Renagel®), biosurgery (primarily SynVisc®Synvisc®), and oncology. It also includes €2,148 million for assets relating to Genzyme’sGenzyme's in-process research and development projects, primarily LemtradaTM and eliglustat. The Genzyme brand was valued at €146 million.
• Merial control take-overacquisition (2009)
When Sanofi took control of Merial in 2009, intangible assets were recognized for a total of €3,980 million, includingmillion. This figure includes €3,104 million related tofor marketed products including Frontline®(in particular Frontline®), €674 million relating tofor in-process research and development projects, and €131 million for the Merial brand.
In 2012, some of the acquired research and development (€15 million) came into commercial use, and began to be amortized from the date of marketing approval. The main item involved was a parasiticide for the bovine market in the United States.
In 2011, some of the acquired research and development (€451 million) came into commercial use, during the period, and is beingbegan to be amortized from the date of marketing approval. ThisThe main item involved was primarily Certifect®Certifect® in the United States and the European Union.
• Aventis acquisition (2004)
On August 20, 2004, Sanofi acquired Aventis, a global pharmaceutical group created in 1999 by the merger between Rhône-Poulenc and Hoechst.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
As part of the process of creating the new Group, the two former parent companies — Sanofi-Synthélabo (renamed Sanofi) and Aventis — were merged on December 31, 2004.
The total purchase price as measured under IFRS 3 (Business Combinations) was €52,908 million, of which €15,894 million was settled in cash.
Goodwill arising from the acquisition of Aventis amounted to €28,285 million as of December 31, 2012 (compared with €28,573 million atas of December 31, 2011 (compared withand €28,228 million and €27,221 million atas of December 31, 2010 and December 31, 2009 respectively)2010).
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Rights to marketed products and goodwill arising on the Aventis acquisition were allocated on the basis of the split of the Group’sGroup's operations into business and geographical segments, and valued in the currency of the relevant geographical segment (mainly euros and U.S. dollars) with assistance from an independent valuer. The average period of amortization for marketed products was initially set at 8 years, based on cash flow forecasts which, among other factors, take account of the period of legal protection offered by the related patents.
Rights to marketed Aventis products represent a diversified portfolio of rights relating to many different products. As of December 31, 2011, 76.3%2012, 75% of the carrying amount of these rights related to the Pharmaceuticals segment, and 23.7%25% to the Vaccines segment. The five principal pharmaceutical products in this portfolio by carrying amount accounted for approximately 57.2%
During 2012, some of the total carrying amountacquired Aventis research and development (€279 million) came into commercial use, and began to be amortized from the date of product rights formarketing approval. The main products involved are the Pharmaceuticals business asmultiple sclerosis treatment Aubagio® (teriflunomide) in the United States, and the second-line prostate cancer drug Jevtana® (cabazitaxel) in the rest of December 31, 2011.the world.
During 2011, some of the acquired Aventis acquired research and development (€167 million) came into commercial use, and is beingbegan to be amortized from the date of marketing approval. This is primarilyThe main item involved was the oncology product Jevtana®Jevtana® (cabazitaxel) in the European Union.
In 2010, some of the acquired Aventis research and development (€173 million) came into commercial use. ThisThe main item involved was primarily the oncology drug Jevtana®product Jevtana® (cabazitaxel) in the United States.
• Other acquisitions
In 2009, someAcquisitions of intangible assets (excluding software and business combinations) amounted to €210 million in 2012, most of which related to licensing agreements (for a description of the principal agreements, see Note D.21.).
During 2012, €163 million of acquired Aventis research and development (€87 million)(other than Aventis and Merial acquired R&D) came into commercial use. This primarily represented Sculptra®use; the main item involved was €97 million relating to an anti-parasite product acquired in the United States.Topaz Pharmaceuticals Inc. acquisition (see Note D.1.2.).
Intangible assets relating to CO2 emission quotas amounted to €4.1 million at December 31, 2012, compared with €4.2 million at December 31, 2011.
Other acquisitions
As of December 31, 2011, theThe increase in goodwill and other intangible assets (excluding Genzyme and Merial), was in the year ended December 31, 2011 primarily related to the acquisition of BMP Sunstone (see Note D.1.2.).
The acquisitionsAcquisitions of intangible assets excluding(excluding software and assets recognized in business combinationscombinations) in 2011 amounted to €154 million, primarilymainly related to licenselicensing agreements (see(for a description of the principal agreements, insee Note D.21.).
Increases in goodwill and other intangible assets and during the year ended December 31, 2010 were mainly due to business combinations completed during the year. Details of theThe purchase price allocations for the principal acquisitions made during 2010, are providedas described in Note D.1.4. and, generated the following impacts:
The effects of the final purchase price allocations of the principal acquisitions of 2009 (see Note D.1.5.) were as follows:
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
In 2010, acquired non-Aventis research brought into commercial use mainly comprised Zentiva generics in Eastern Europe, the Japanese encephalitis vaccine, and the Libertas®Libertas® formulation of Actonel®Actonel® in the United States.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Acquisitions of intangible assets during 2009 (other than software and assets recognized in business combinations) totaled €337 million and related mainly to license agreements, including the collaboration agreements with Exelixis and Merrimack.
• Dermik sale (2011)
The change"Change in scope of consolidationconsolidation" line item includes the net book value€212 million carrying amount of the other intangible assets related to(other than goodwill) of the Dermik dermatology business (which was sold to Valeant Pharmaceuticals International, Inc. for €212), and the derecognition of the €77 million and a decrease in goodwill relatedrelating to this business amounting to €77 million.
Dermik.
Amortization of intangible assets is recognized in the income statement underin theAmortization of intangible assets line item except for amortization of software, which is recognized onin the relevant linecomponent of theoperating income statement according to the purpose for which the software is used:
(€ million) | Year ended December 31, 2011 | Year ended December 31, 2010 (1) | Year ended December 31, 2009 (1) | |||||||||
Cost of sales | 13 | 11 | 11 | |||||||||
Research and development expenses | 16 | 11 | 14 | |||||||||
Selling and general expenses | 55 | 26 | 24 | |||||||||
Other gains and losses, and litigation(2) | 18 | — | — | |||||||||
Other operating expenses | 5 | 1 | 1 | |||||||||
Total | 107 | 49 | 50 |
|
|
(€ million) | Year ended December 31, 2012 | Year ended December 31, 2011 | Year ended December 31, 2010 (1) | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Cost of sales | 27 | 13 | 11 | |||||||
Research and development expenses | 13 | 16 | 11 | |||||||
Selling and general expenses | 61 | 55 | 26 | |||||||
Other gains and losses, and litigation (2) | — | 18 | — | |||||||
Other operating expenses | 4 | 5 | 1 | |||||||
Total | 105 | 107 | 49 | |||||||
D.5. Impairment of intangible assets and property, plant and equipment
• Goodwill
The recoverable amount of cash generating units (CGUs) is determined by reference to the value in use of each CGU, based on discounted estimates of the future cash flows from the CGU, in accordance with the policies described in Note B.6.1.
The allocation of goodwill atas of December 31, 20112012 is shown below:
(€ million) | Pharmaceuticals: Europe | Pharmaceuticals: North America | Pharmaceuticals: Other Countries | Vaccines: USA | Vaccines: Other Countries | Animal Health | Group Total | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Goodwill | 15,025 | 14,010 | 6,717 | 751 | 337 | 1,233 | 38,073 | |||||||||||||||
The goodwill arising on Pluromed, Inc. was allocated to the Pharmaceuticals North America CGU. The goodwill arising on Newport was allocated to the Animal Health CGU.
(€ million) | Pharmaceuticals: Europe | Pharmaceuticals: North America | Pharmaceuticals: Other Countries | Vaccines: USA | Vaccines: Other Countries | Animal Health | Group Total | |||||||||||||||||||||
Goodwill | 15,072 | 14,194 | 6,459 | 766 | 339 | 1,249 | 38,079 |
The provisional goodwill arising on Genzyme was allocated to the relevant CGUs in the Pharmaceuticals segment.
The goodwill generated with the Merial takeover was allocated to the Animal Health CGU.
Valuevalue in use of each CGU was determined by applying an after-tax discount rate to estimated future after-tax cash flows.
A separate discount rate is used for each CGU in order to take into account of its specific economic conditions.
The rates used for the impairment test performedtesting in 20112012 were betweenin a range from 7.0% andto 10.5% (notably(principally 8.0% for Pharmaceuticals North America: 8.0%America, and 8.5% for Pharmaceuticals Europe: 8.5%)Europe); an identical value in use for the Group would be obtained by applying a uniqueuniform 9% rate to all the CGUs.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The pre-tax discount rates applied to estimated pre-tax cash flows are calculated by iteration from the previously determinedpreviously-determined value in use. They range from 12.2%12.4% to 14.9%; the equivalent unique14.0%, and equate to a uniform rate is approximatelyof 13% for the Group.Group as a whole.
The assumptions used in testing goodwill for impairment are reviewed annually. Apart from the discount rate, the principal assumptions used in 20112012 were as follows:
Value in use (determined as described above) is compared with carrying amount, and this comparison is then subject to sensitivity analysis with reference to the two principal parameters (discount rate and perpetual growth rate).
Over all the CGUs, no reasonable change in the assumptions used in 2012 would require an impairment of the goodwill tested, before allocation of the Genzyme goodwill, would needloss to be recognized when the usefulagainst goodwill. No impairment loss would be required even if value isin use were to be calculated by using either:using:
used; or
No impairment losses were recognized against goodwill in the years ended December 31, 2012, 2011, 2010, or 2009.2010.
The use of a single discount rate of 9% on each CGU would not have materially changed the sensitivity analyses in 2011.
• Other intangible assets
When there is evidence that an asset may have become impaired, its value in use is calculated by applying a post-tax discount rate to the estimated future post-tax cash flows from that asset. For the purposes of impairment testing, the tax cash flows relating to the asset are determined using a notional tax rate incorporating the notional tax benefit that would result from amortizing the asset if its value in use were regarded as its depreciable amount for tax purposes. Applying post-tax discount rates to post-tax cash flows gives the same values in use as would be obtained by applying pre-tax discount rates to pre-tax cash flows.
The post-tax discount rates used in 20112012 for impairment testing of other intangible assets in the Pharmaceuticals, Vaccines and Animal Health segments were obtained by adjusting the Group’s Weighted Average CostGroup's 8% weighted average cost of Capital of 8%capital to reflect specific country and business risks, giving post-tax rates in a range from 9% to 13%11%.
In most cases, there are no market data that would enable fair value less costs to sell to be determined other than by means of a similar estimate based on future cash flows. Consequently, the recoverable amount is in substance equal to the value in use.
In 2012, impairment testing of other intangible assets (excluding software) resulted in the recognition of a €117 million net impairment loss, mainly comprising:
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
In 2011, the result of the impairment teststesting of other intangible assets (excluding software) resulted in the recognition of a €142 million net impairment loss. This includes:
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
In 2010, impairment losses of €433 million were recognized based on the results of impairment testing of other intangible assets. These losses arose mainly on marketed products (€291 million), including Actonel®Actonel® (due to proposed amendments to the terms of the collaboration agreement with Warner Chilcott, see Note C.2.)Chilcott) and Shan5®Shan5® (due to revised sales projections following requalification of the vaccine by the World Health Organization). Impairment losses recognized in respect of research projects totaled €142 million, and arose mainly from revisions to the development plan for BSI-201 following announcement of the initial results from the Phase III trial in triple-negative metastatic breast cancer and from decisions to halt development on some other projects.
In 2009, impairment losses of €372 million were recognized based on the results of impairment tests. These losses related mainly to the marketed products Actonel®, Benzaclin® and Nasacort®, and took account of changes in the competitive environment and the approval dates of generics.
• Property, plant and equipment
Impairment losses taken against property, plant and equipment are disclosed in Note D.3.
D.6. Investments in associates and joint ventures
For definitions of the terms “associate”"associate" and “joint venture”"joint venture", refer to Note B.1.
Investments in associates and joint ventures break down as follows:
(€ million) | % interest | December 31, 2012 | December 31, 2011 | December 31, 2010 | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sanofi Pasteur MSD | 50.0 | 287 | 313 | 343 | |||||||||
Infraserv GmbH and Co. Höchst KG | 31.2 | 79 | 87 | 92 | |||||||||
Entities and companies managed by Bristol-Myers Squibb (1) | 49.9 | 74 | 307 | 265 | |||||||||
Financière des Laboratoires de Cosmétologie Yves Rocher | — | — | — | 128 | |||||||||
Other investments | — | 47 | 100 | 96 | |||||||||
Total | 487 | 807 | 924 | ||||||||||
(€ million) | % interest | December 31, 2011 | December 31, 2010 | December 31, 2009 | ||||||||||||
Sanofi Pasteur MSD | 50.0 | 313 | 343 | 407 | ||||||||||||
InfraServ Höchst | 31.2 | 87 | 92 | 95 | ||||||||||||
Entities and companies managed by Bristol-Myers Squibb (1) | 49.9 | 307 | 265 | 234 | ||||||||||||
Financière des Laboratoires de Cosmétologie Yves Rocher | 39.1 | — | 128 | 123 | ||||||||||||
Other investments | — | 100 | 96 | 96 | ||||||||||||
Total | 807 | 924 | 955 |
|
Since November 2011, Sanofi has no longer has a representative inbeen represented on the Board of Directors of Financière des Laboratoires de Cosmétologie Yves Rocher and consequently, as a result of the loss of significant influence, no longer recognizesaccounts for this interest using the equity method. This interest was recognized atas an available-for-sale financial asset as of December 31, 2011, and was sold in available-for-sale financial assets (see Note D.7.).August 2012.
The reduction in the carrying amount of the interests in entities and companies managed by Bristol-Myers Squibb during the year ended December 31, 2012 mainly reflects the loss of exclusivity for Plavix® and Avapro® in the United States during 2012.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The financial statements include arm’sarm's length commercial transactions between the Group and certain of its associates and joint ventures.ventures that are regarded as related parties. The principal transactions of this natureand balances with related parties are summarized below:
(€ million) | 2011 | 2010 | 2009 | |||||||||
Sales | 526 | 541 | 517 | |||||||||
Royalties (1) | 1,292 | 1,324 | 1,179 | |||||||||
Accounts receivable (1) | 503 | 441 | 419 | |||||||||
Purchases | 236 | 227 | 247 | |||||||||
Accounts payable | 21 | 22 | 32 | |||||||||
Other liabilities (1) | 404 | 350 | 297 |
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Key financial indicators for associates and joint ventures, excluding the effects of purchase price allocations, are as follows:
Principal associates (1) 100% impact | Principal joint ventures (2) Share held by Sanofi | |||||||||||||||||||||||
(€ million) | 2011 | 2010 | 2009 | 2011 | 2010 | 2009 | ||||||||||||||||||
Non-current assets | 46 | 512 | 526 | 23 | 25 | 27 | ||||||||||||||||||
Current assets | 679 | 1,336 | 1,278 | 195 | 231 | 224 | ||||||||||||||||||
Non-current liabilities | 85 | 468 | 336 | 42 | 100 | 32 | ||||||||||||||||||
Current liabilities | 512 | 690 | 792 | 164 | 142 | 178 | ||||||||||||||||||
Equity attributable to equity holders of Sanofi | 128 | 387 | 391 | 12 | 14 | 41 | ||||||||||||||||||
Non-controlling interests | — | 303 | 285 | — | — | — | ||||||||||||||||||
Net sales | 8,113 | 8,114 | 9,325 | 396 | 459 | 1,203 | ||||||||||||||||||
Cost of sales | 2,118 | 2,130 | 2,397 | 171 | 179 | 359 | ||||||||||||||||||
Operating income | 3,419 | 3,163 | 3,144 | 52 | 49 | 312 | ||||||||||||||||||
Net income | 3,286 | 3,035 | 2,880 | 14 | 8 | 222 |
|
|
D.7. Non-current financial assets
The main items included inNon-current financial assets are:
(€ million) | December 31, 2012 | December 31, 2011 | December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Available-for-sale financial assets | 2,569 | 1,302 | 816 | |||||||
Pre-funded pension obligations (see Note D.19.1.) | 6 | 6 | 4 | |||||||
Long-term loans and advances | 695 | 573 | 483 | |||||||
Assets recognized under the fair value option | 135 | 124 | 121 | |||||||
Derivative financial instruments (see Note D.20.) | 394 | 394 | 220 | |||||||
Total | 3,799 | 2,399 | 1,644 | |||||||
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||
Available-for-sale financial assets | 1,302 | 816 | 588 | |||||||||
Pre-funded pension obligations (see Note D.19.1.) | 6 | 4 | 3 | |||||||||
Long-term loans and advances | 573 | 483 | 256 | |||||||||
Assets recognized under the fair value option | 124 | 121 | 100 | |||||||||
Derivative financial instruments (see Note D.20.) | 394 | 220 | 51 | |||||||||
Total | 2,399 | 1,644 | 998 |
Equity investmentsinterests classified as available-for-sale financial assets include the following publicly traded interests:investments:
Other comprehensive income recognized in respect of available-for-sale financial assets represents unrealized net after-tax gains of €1,745 million as of December 31, 2012 (including €1,669 million for the investment in Regeneron), versus €409 million as of December 31, 2011 and €164 million as of December 31, 2010.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
|
The other comprehensive income recognized forA 10% fall in the stock prices of quoted equity investments classified as available-for-sale financial assets represent unrealized net after-tax gainwould have had the following impact as of €409 million (including €378 million for the investment in Regeneron) at December 31, 2011, €164 million at December 31, 2010 and €38 million at December 31, 2009.2012:
The impact of a 10% fall in stock prices on quoted shares included in available-for-sale assets at December 31, 2011 would have been as follows:
(€ million) | Sensitivity | |||||||
---|---|---|---|---|---|---|---|---|
Other comprehensive income before tax | ( | ) | ||||||
Income before tax | — | |||||||
Total | ( | ) | ||||||
AAs regards other available-for-sale financial assets, a 10% fall in stock prices of other available-for-sale financial assets combined with a simultaneous 0.5% rise in the yield curve would have had the following impact atas of December 31, 2011:2012:
(€ million) | Sensitivity | |||||||
---|---|---|---|---|---|---|---|---|
Other comprehensive income before tax | ( | ) | ||||||
Income before tax | — | |||||||
Total(1) | ( | ) | ||||||
|
Available-for-sale financial assets also include equity investments not quoted in an active market. These investments had a carrying amount of €82 million as of December 31, 2012, €260 million atas of December 31, 2011, and €47 million atas of December 31, 2010, and €31 million at December 31, 2009.2010. The balance at December 31, 2011 also includesreduction in 2012 is related to the interestsale of the investment in Financière des Laboratoires de Cosmétologie Yves Rocher (see Note D.6.).Rocher.
The book valuecarrying amount of Greek government bonds as of December 31, 20112012 was €30€16 million, including €23of which €8 million presentedare reported in currentCurrent financial assets (see Note D.12.).
Long-term loans and advances are measured at amortized cost, which at the balance sheet date was not materially different from their fair value. The increase in long-term loans and advances in 2010 was mainly due to surety paid in connection with ongoing litigation.
Assets recognized under the fair value option represent a portfolio of financial investments held to fund a deferred compensation plan offered to certain employees.
D.8. Assets and liabilities held for sale or exchange
A breakdown as of December 31, 20112012 of assets held for sale or exchange, and of liabilities related to assets held for sale or exchange, is shown below:
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||||||
Merial (1) | D.8.1. | — | 7,019 | 6,540 | ||||||||||||
Other | D.8.2. | 67 | 17 | 4 | ||||||||||||
Total assets held for sale or exchange | 67 | 7,036 | 6,544 | |||||||||||||
Merial (1) | D.8.1. | — | 1,672 | 1,501 | ||||||||||||
Other | D.8.2. | 20 | — | — | ||||||||||||
Total liabilities related to assets held for sale or exchange | 20 | 1,672 | 1,501 |
|
(€ million) | | December 31, 2012 | December 31, 2011 | December 31, 2010 | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Merial (1) | D.8.2. | — | — | 7,019 | ||||||||
Other | D.8.1. | 101 | 67 | 17 | ||||||||
Total assets held for sale or exchange | 101 | 67 | 7,036 | |||||||||
Merial (1) | D.8.2. | — | — | 1,672 | ||||||||
Other | D.8.1. | 38 | 20 | — | ||||||||
Total liabilities related to assets held for sale or exchange | 38 | 20 | 1,672 | |||||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.8.1. Other assets held for sale
As of December 31, 2012, other assets held for sale mainly comprised certain assets of BMP Sunstone held for sale; Zentiva's industrial site at Hlohovec (Slovakia); and research and development sites in the United States and France.
As of December 31, 2011, other assets held for sale mainly comprised assets of the BMP Sunstone sub-group that had been held for sale since the acquisition date, plus research and development sites in France and industrial or tertiary sites in Europe.
As of December 31, 2010, other assets held for sale comprised research and development sites in France.
D.8.2. Merial
As explained in Note D.2., the assets and liabilities of Merial are no longer reported as held for sale or exchange, but instead arehave been reported in the relevant balance sheet line item.
item since January 1, 2011.
The table below shows the assets and liabilities of Merial classified inAssets held for sale or exchange andLiabilities related to assets held for sale or exchange at as of December 31, 2010, and 2009, after elimination of intercompany balances between Merial and other Group companies.
(€ million) | December 31, 2010 | December 31, 2009 (1) | ||||||
Assets | ||||||||
• Property, plant and equipment and financial assets | 811 | 684 | ||||||
• Goodwill | 1,210 | 1,124 | ||||||
• Other intangible assets | 3,961 | 3,683 | ||||||
• Deferred tax assets | 92 | 60 | ||||||
• Inventories | 344 | 425 | ||||||
• Accounts receivable | 405 | 373 | ||||||
• Other current assets | 49 | 64 | ||||||
• Cash and cash equivalents | 147 | 127 | ||||||
Total assets held for sale or exchange | 7,019 | 6,540 | ||||||
Liabilities | ||||||||
• Long-term debt | 4 | 6 | ||||||
• Non-current provisions | 70 | 85 | ||||||
• Deferred tax liabilities | 1,132 | 1,034 | ||||||
• Short-term debt | 24 | 22 | ||||||
• Accounts payable | 161 | 124 | ||||||
• Other current liabilities | 281 | 230 | ||||||
Total liabilities related to assets held for sale or exchange | 1,672 | 1,501 |
(€ million) | 2010 | |||
---|---|---|---|---|
Assets | ||||
| 811 | |||
• Goodwill | 1,210 | |||
• Other intangible assets | 3,961 | |||
• Deferred tax assets | 92 | |||
• Inventories | 344 | |||
• Accounts receivable | 405 | |||
• Other current assets | 49 | |||
• Cash and cash equivalents | 147 | |||
Total assets held for sale or exchange | 7,019 | |||
Liabilities | ||||
• Long-term debt | 4 | |||
• Non-current provisions | 70 | |||
• Deferred tax liabilities | 1,132 | |||
• Short-term debt | 24 | |||
• Accounts payable | 161 | |||
• Other current liabilities | 281 | |||
Total liabilities related to assets held for sale or exchange | 1,672 | |||
Changes in the balances relating to Merial between December 31, 2009 and December 31, 2010 were mainly due to translation effects arising from movements in the U.S. dollar exchange rate between those dates, and to adjustments to the purchase price allocation.
D.8.2. Other assets held for sale
As of December 31, 2011, the assets held for sale were primarily the assets of the sub-group BMP Sunstone held for sale since the acquisition date, and the assets of research and development sites in France, and European industrial or tertiary sites.
As of December 31, 2010, other assets held for sale relate to R&D facilities in France.
As of December 31, 2009, other assets held for sale related to the ongoing divestment of the R&D facilities at Alnwick and Porcheville and of an industrial site. An impairment loss of €107 million was charged against these assets (and recognized underRestructuring costs in the income statement) prior to their reclassification as assets held for sale.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.9. Inventories
Inventories break down as follows:
| December 31, 2012 | December 31, 2011 | December 31, 2010 | |||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ||||||||||||||||||||||||||||
(€ million) | Gross | Impairment | Net | Gross | Impairment | Net | Gross | Impairment | Net | |||||||||||||||||||
Raw materials | 969 | (72 | ) | 897 | 973 | (93 | ) | 880 | 838 | (88 | ) | 750 | ||||||||||||||||
Work in process | 3,755 | (294 | ) | 3,461 | 3,444 | (209 | ) | 3,235 | 2,940 | (255 | ) | 2,685 | ||||||||||||||||
Finished goods | 2,171 | (150 | ) | 2,021 | 2,107 | (171 | ) | 1,936 | 1,714 | (129 | ) | 1,585 | ||||||||||||||||
Total | 6,895 | (516 | ) | 6,379 | 6,524 | (473 | ) | 6,051 | 5,492 | (472 | ) | 5,020 | ||||||||||||||||
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||||||||||||||||||||||||||
Gross | Impairment | Net | Gross | Impairment | Net | Gross | Impairment | Net | ||||||||||||||||||||||||||||
Raw materials | 973 | (93 | ) | 880 | 838 | (88 | ) | 750 | 752 | (96 | ) | 656 | ||||||||||||||||||||||||
Work in process | 3,444 | (209 | ) | 3,235 | 2,940 | (255 | ) | 2,685 | 2,456 | (241 | ) | 2,215 | ||||||||||||||||||||||||
Finished goods | 2,107 | (171 | ) | 1,936 | 1,714 | (129 | ) | 1,585 | 1,709 | (136 | ) | 1,573 | ||||||||||||||||||||||||
Total | 6,524 | (473 | ) | 6,051 | 5,492 | (472 | ) | 5,020 | 4,917 | (473 | ) | 4,444 |
The value of inventories related to Genzyme was €925 million at the acquisition date (see note D.1.1.D.1.2.) and €540 million at December 31, 2011. The amount of the Merial inventories reclassified atas of January 1, 2011 wasamounted to €344 million (see note D.8.1.D.8.2.).
The impact of changes in provisions for impairment of inventories iswas a net expense of €28 million in 2012, compared with €6 million in 2011 and €22 million in 2010 and €26 million in 2009.2010.
Impairment losses against inventories as of December 31, 2011 relate primarily to the product Ketek®.
Inventories pledged as security for liabilities amounted to €14€16 million atas of December 31, 2011.
2012.
D.10. Accounts receivable
Accounts receivable break down as follows:
(€ million) | December 31, 2012 | December 31, 2011 | December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Gross value | 7,641 | 8,176 | 6,633 | |||||||
Impairment | (134 | ) | (134 | ) | (126 | ) | ||||
Net value | 7,507 | 8,042 | 6,507 | |||||||
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||
Gross value | 8,176 | 6,633 | 6,111 | |||||||||
Impairment | (134 | ) | (126 | ) | (96 | ) | ||||||
Net value | 8,042 | 6,507 | 6,015 |
The value of trade receivables related to Genzyme totaled €764 million at the acquisition date (see Note D.1.1.D.1.2.). Merial trade receivables reclassified atas of January 1, 2011 amounted to €405 million (see Note D.8.1.D.8.2.).
The net loss (including the impairmentImpairment losses (net of reversals) onagainst accounts receivablesreceivable (see Note B.8.2.) was a net expense ofamounted to €11 million in 2012, compared with €32 million in both 2011 identical to the amount recorded overand 2010. A net loss of €5 million was booked in 2009.
The gross value of overdue receivables atas of December 31, 2012 was €1,057 million, compared with €1,103 million as of December 31, 2011 was €1,103 million, compared withand €887 million atas of December 31, 2010 and €884 million at December 31, 2009.2010.
(€ million) | Overdue accounts Gross value | Overdue <1 month | Overdue from 1 to 3 months | Overdue from 3 to 6 months | Overdue from 6 to 12 months | Overdue >12 months | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
December 31, 2012 | 1,057 | 371 | 247 | 152 | 126 | 161 | |||||||||||||
December 31, 2011 | 1,103 | 278 | 227 | 187 | 135 | 276 | |||||||||||||
December 31, 2010 | 887 | 255 | 207 | 127 | 97 | 201 | |||||||||||||
(€ million) | Overdue accounts Gross value | Overdue < 1 month | Overdue from 1 to 3 months | Overdue from 3 to 6 months | Overdue from 6 to 12 months | Overdue > 12 months | ||||||||||||||||||
December 31, 2011 | 1,103 | 278 | 227 | 187 | 135 | 276 | ||||||||||||||||||
December 31, 2010 | 887 | 255 | 207 | 127 | 97 | 201 | ||||||||||||||||||
December 31, 2009 | 884 | 288 | 172 | 132 | 110 | 182 |
Amounts overdue by more than one month relate mainly to public-sector customers.
Some Sanofi subsidiaries have assigned receivables to factoring companies or banks, without recourse. Because these receivables were assigned without recourse, they have been derecognized from the balance sheet as of December 31, 2012; the amount involved is €53 million. The residual guarantees relating to these transfers are immaterial.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.11. Other current assets
Other current assets break down as follows:
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||
Taxes payable | 1,455 | 1,188 | 1,019 | |||||||||
Other receivables(1) | 690 | 626 | 914 | |||||||||
Prepaid expenses | 256 | 186 | 171 | |||||||||
Total | 2,401 | 2,000 | 2,104 |
|
(€ million) | December 31, 2012 | December 31, 2011 | December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Taxes recoverable | 1,575 | 1,455 | 1,188 | |||||||
Other receivables (1) | 522 | 690 | 626 | |||||||
Prepaid expenses | 258 | 256 | 186 | |||||||
Total | 2,355 | 2,401 | 2,000 | |||||||
D.12. Current financial assets
Current financial assets break down as follows:
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||
Interest rate derivatives measured at fair value (see Note D.20.) | 90 | 1 | 18 | |||||||||
Currency derivatives measured at fair value (see Note D.20.) | 48 | 27 | 251 | |||||||||
Other current financial assets | 35 | (1) | 23 | 8 | ||||||||
Total | 173 | 51 | 277 |
|
(€ million) | December 31, 2012 | December 31, 2011 | December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Interest rate derivatives measured at fair value (see Note D.20.) | 40 | 90 | 1 | |||||||
Currency derivatives measured at fair value (see Note D.20.) | 82 | 48 | 27 | |||||||
Other current financial assets | 56 | (1) | 35 | (2) | 23 | |||||
Total | 178 | 173 | 51 | |||||||
D.13. Cash and cash equivalents
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||
Cash | 1,029 | 696 | 689 | |||||||||
Cash equivalents(1) | 3,095 | 5,769 | 4,003 | |||||||||
Cash and cash equivalents(2) | 4,124 | 6,465 | 4,692 |
|
|
(€ million) | December 31, 2012 | December 31, 2011 | December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Cash | 904 | 1,029 | 696 | |||||||
Cash equivalents (1) | 5,477 | 3,095 | 5,769 | |||||||
Cash and cash equivalents (2) | 6,381 | 4,124 | 6,465 | |||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.14. Net deferred tax position
The net deferred tax position breaks down as follows:
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||
Deferred tax (excluding Genzyme) on: | ||||||||||||
• Consolidation adjustments (intragroup margin in inventory) | 858 | 875 | 858 | |||||||||
• Provision for pensions and other employee benefits | 1,298 | 1,157 | 1,097 | |||||||||
• Remeasurement of other acquired intangible assets (1) | (3,616 | ) | (3,706 | ) | (4,144 | ) | ||||||
• Recognition of acquired property, plant and equipment at fair value | (64 | ) | (76 | ) | (99 | ) | ||||||
• Equity interests in subsidiaries and investments in affiliates (2) | (661 | ) | (399 | ) | (643 | ) | ||||||
• Tax losses available for carry-forward | 524 | 152 | 70 | |||||||||
• Stock options | 40 | 12 | 21 | |||||||||
• Expenses payable and provisions deductible at the time of payment (3) | 1,493 | 1,349 | 985 | |||||||||
• Other | (71 | ) | (121 | ) | (166 | ) | ||||||
Net deferred tax liability related to Genzyme (4) | (2,179 | ) | — | — | ||||||||
Net deferred tax liability | (2,378 | ) | (757 | ) | (2,021 | ) |
|
|
|
|
As of December 31, 2011, theand €389 million as of December 31, 2010.
The reserves of the Sanofi subsidiaries which arethat would be taxable in the event of distributionif distributed but for which paymentsno distribution is not planned, and which did not result in the recognition of deferred tax liabilities, and for which payment is not planned, amounted tono deferred tax liability has therefore been recognized, totaled €18.4 billion as of December 31, 2012, compared with €15.7 billion compared withas of December 31, 2011 and €16.2 billion atas of December 31, 2010.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The table below shows when the tax losses available for carry-forward by the Group are due to expire:
(€ million) | Tax losses available for carry-forward (1) | |||
---|---|---|---|---|
2013 | 24 | |||
2014 | 15 | |||
2015 | 30 | |||
2016 | 16 | |||
2017 | 145 | |||
2018 and later (2) | 2,197 | |||
Total at December 31, 2012 | 2,427 | (3) | ||
Total at December 31, 2011 | 2,699 | (4) | ||
Total at December 31, 2010 | 1,028 | (5) | ||
(€ million) | Tax losses available for carry-forward (1) | |||
2012 | 15 | |||
2013 | 4 | |||
2014 | 24 | |||
2015 | 36 | |||
2016 | 37 | |||
2017 and later (2) | 2,583 | |||
Total at December 31, 2011 | 2,699 | |||
Total at December 31, 2010 | 1,028 | |||
Total at December 31, 2009 | 642 |
|
|
Use of these tax loss carry-forwards is limited to the entity in which they arose. In jurisdictions where tax consolidations are in place, tax losses can be netted against taxable income generated by the entities in the same consolidated tax group.
Deferred tax assets not recognized because their future recovery was not regarded as probable given the expected results of the entities in question amounted to €413 million in 2012, €476 million in 2011, and €451 million in 2010 (including €35 million on asset disposals), compared with €486 million in 2009 (including €99 million on asset disposals).
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The effect of recognizing previously unrecognized deferred tax assets in accounting for business combinations (requiring a corresponding adjustment to goodwill) amounted to €88 million in 2009.
D.15. Consolidated shareholders’shareholders' equity
D.15.1. Share capital
The share capital of €2,681,837,622€2,652,685,918 consists of 1,340,918,8111,326,342,959 shares with a par value of €2.
Treasury shares held by the Group are as follows:
| Number of shares in million | % | |||||
---|---|---|---|---|---|---|---|
December 31, 2012 | 3.1 | 0.24% | |||||
December 31, 2011 | 17.2 | 1.28% | |||||
December 31, 2010 | 6.1 | 0.46% | |||||
January 1, 2010 | 9.4 | 0.71% | |||||
Number of shares in million | % | |||||||
December 31, 2011 | 17.2 | 1.28 % | ||||||
December 31, 2010 | 6.1 | 0.46 % | ||||||
December 31, 2009 | 9.4 | 0.71 % | ||||||
January 1, 2009 | 10.0 | 0.76 % |
Treasury shares are deducted from shareholders’shareholders' equity. Gains and losses on disposals of treasury shares are taken directly to equity and are not recognized in net income for the period.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Movements in the share capital of the Sanofi parent company over the last three years are presented below:
Date | Transaction | Number of shares | Share capital (1) | Additional paid-in capital (1) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
January 1, 2010 | 1,318,479,052 | 2,637 | 6,738 | |||||||||
During 2010 | Capital increase by exercise of stock subscription options | 430,033 | 1 | 17 | ||||||||
Board of Directors meeting of April 28, 2010 | Capital reduction by cancellation of treasury shares | (7,911,300 | ) | (16 | ) | (404 | ) | |||||
December 31, 2010 | 1,310,997,785 | 2,622 | 6,351 | |||||||||
During 2011 | Capital increase by exercise of stock subscription options | 1,593,369 | 4 | 66 | ||||||||
During 2011 | Capital increase by issue of restricted shares | 587,316 | 1 | (1 | ) | |||||||
June 16, 2011 | Capital increase by payment of dividends in shares | 38,139,730 | 76 | 1,814 | ||||||||
Board of Directors meeting of July 27, 2011 | Capital reduction by cancellation of treasury shares | (2,328,936 | ) | (5 | ) | (116 | ) | |||||
Board of Directors meeting of November 2, 2011 | Capital reduction by cancellation of treasury shares | (8,070,453 | ) | (16 | ) | (372 | ) | |||||
December 31, 2011 | 1,340,918,811 | 2,682 | 7,742 | |||||||||
During 2012 | Capital increase by exercise of stock subscription options | 11,945,454 | 24 | 621 | ||||||||
During 2012 | Capital increase by issue of restricted shares | 1,074,063 | 2 | (2 | ) | |||||||
Board of Directors meeting of April 26, 2012 | Capital reduction by cancellation of treasury shares | (21,159,445 | ) | (42 | ) | (1,088 | ) | |||||
Board of Directors meeting of October 24, 2012 | Capital reduction by cancellation of treasury shares | (6,435,924 | ) | (13 | ) | (405 | ) | |||||
December 31, 2012 | 1,326,342,959 | 2,653 | 6,868 | |||||||||
Date | Transaction | Number of shares | Share capital (1) | Additional paid-in capital (1) | ||||||||||
January 1, 2009 | 1,315,525,463 | 2,631 | 6,604 | |||||||||||
During 2009 | Capital increase by exercise of stock subscription options | 2,953,589 | 6 | 134 | ||||||||||
December 31, 2009 | 1,318,479,052 | 2,637 | 6,738 | |||||||||||
During 2010 | Capital increase by exercise of stock subscription options | 430,033 | 1 | 17 | ||||||||||
Board of Directors meeting of April 28, 2010 | Capital reduction by cancellation of treasury shares | (7,911,300 | ) | (16 | ) | (404 | ) | |||||||
December 31, 2010 | 1,310,997,785 | 2,622 | 6,351 | |||||||||||
During 2011 | Capital increase by exercise of stock subscription options | 1,593,369 | 4 | 66 | ||||||||||
During 2011 | Capital increase by issue of restricted shares | 587,316 | 1 | (1 | ) | |||||||||
June 16, 2011 | Capital increase by payment of dividends in shares | 38,139,730 | 76 | 1,814 | ||||||||||
Board of Directors meeting of July 27, 2011 | Capital reduction by cancellation of treasury shares | (2,328,936 | ) | (5 | ) | (116 | ) | |||||||
Board of Directors meeting of November 2, 2011 | Capital reduction by cancellation of treasury shares | (8,070,453 | ) | (16 | ) | (372 | ) | |||||||
December 31, 2011 | 1,340,918,811 | 2,682 | 7,742 |
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
For equity related disclosures as required under IFRS 7, refer to Note B.27.
FollowingA total of 11,945,454 shares were issued during 2012 as a result of the exercise of Sanofi stock options, 1,593,369subscription options.
In addition, a total of 1,074,063 shares vested and were issued in the 2011 fiscal year.
In addition, 585,782 bonus2012 under restricted share plans. This total includes 523,477 shares issued in March 2012 under the 2009 France restricted shareMarch 1, 2010 plan, were vested and 533,000 shares issued in 2011.October 2012 to grantees in France under the global plan under which all employees were entitled to 20 shares each.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.15.2. Restricted share plans
Restricted share plans are accounted for in accordance with the policies described in Note B.24.3.
The fair value of this plan is €192 million. This amount is being recognized in profit or loss over the vesting period, with the matching entry recognized directly in equity; the expense recognized in 2012 was €45 million.
The fair value of this plan is €125 million.
The fair value of this plan is €67 million.
The fair value of this plan is €50 million.
The total expense recognized for all restricted share plan is €37 million.
Atplans in the year ended December 31, 2012 was €125 million, compared with €84 million in the year ended December 31, 2011 the total expense for the restricted share plans amounted to €84 million compared withand €36 million atin the year ended December 31, 2010 and €11 million at December 31, 2009.2010.
The number of restricted shares outstanding atnot yet vested as of December 31, 2012 was 10,414,053, comprising 4,584,920 under the 2012 plans, 3,184,240 under the 2011 plans, 1,470,980 under the October 2010 plans, 631,544 under the March 2010 plans, and 542,369 under the March 2009 plans. The number of restricted shares not yet vested was 7,062,324 as of December 31, 2011 was 7,062,324, including 3,266,840 under the plan approved in March 2011, 2,063,440 under the plan approved in October 2010, 1,176,038 under the plan approved in March 2010 and 556,006 under the 2009 plan. There were 4,467,968 restricted shares outstanding atas of December 31, 2010 and 1,181,049 at December 31, 2009.
2010.
D.15.3. Capital increase
On May 6, 2011, the Annual General Meeting of Sanofi shareholders approved the payment of a dividend of €2.50 dividend per share forin respect of the year ended December 31, 2010, fiscal year, with an option for payment in cash or in newly-issued shares of the Company. As a result of the exercise of thisSanofi shares. This option was exercised by shareholders representing 57.8% of the shares, as a result which 38,139,730 new shares were issued for payment of the dividend in shares. The shares issued represent 2.9% of the share capital, which isand led to an increase of €76 million in the share capital and €1,814 million in additional paid-in capital (net of transactions costs to issue dividendsissuance costs).
Capital increases arising from the exercise of Sanofi stock subscription options and restricted share plans are described in shares).
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
There were no share issues reserved for employee share ownership plansemployees in 2009, 2010, 2011 or 2011.2012.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.15.4. Repurchase of Sanofi shares
The Sanofi Shareholders’On May 4, 2012, the Annual General Meeting of Sanofi shareholders approved a share repurchase program for a period of 18 months. Under this program and only this program, the Group repurchased 6,060,150 shares in 2012 for a total amount of €397 million.
On May 6, 2011, authorizedthe Annual General Meeting of Sanofi shareholders approved a share repurchase program for a period of 18 months. Under this program, the Group repurchased 7,513,493 shares in the first half of 2012 for a total amount of €426 million, and 21,655,140 shares in 2011 for a total amount of €1,074 million.
The Sanofi Shareholders’On May 17, 2010, the Annual General Meeting of May 17, 2010 authorizedSanofi shareholders approved a share repurchase program for a period of 18 months. The Group hasdid not repurchasedrepurchase any of its own shares under this program.
Under the share repurchase program authorized by the Shareholders’Annual General Meeting of April 17, 2009, the Group repurchased 5,871,026 shares in 2010 for a total of €321 million.
There were no stock buybacks in 2009.
D.15.5. ReductionReductions in share capital
TheOn October 24, 2012, the Board of Directors onapproved the cancellation of 6,435,924 treasury shares (€418 million), representing 0.49% of the share capital as of that date.
On April 26, 2012, the Board of Directors approved the cancellation of 21,159,445 treasury shares (€1,130 million), representing 1.60% of the share capital as of that date.
On November 2, 2011, the Board of Directors approved the cancellation of 8,070,453 treasury shares (€388 million), representing 0.60% of the share capital as of that date.
The SanofiOn July 27, 2011, the Board of Directors meeting held on July 27, 2011 decided to cancelapproved the cancellation of 2,328,936 treasury shares (€121 million), representing 0.17% of the share capital as of that date.
The SanofiOn April 28, 2010, the Board of Directors on April 28, 2010 decided to cancelapproved the cancellation of 7,911,300 treasury shares (€420 million), representing 0.60% of the share capital as of that date.
These cancellations had no effect on consolidated shareholders’shareholders' equity.
D.15.6. Currency translation differences
Currency translation differences break down as follows:
(€ million) | December 31, 2012 | December 31, 2011 (1) | December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Attributable to equity holders of Sanofi | (1,918 | ) | (1,390 | ) | (1,318 | ) | ||||
Attributable to non-controlling interests | (24 | ) | (16 | ) | (4 | ) | ||||
Total | (1,942 | ) | (1,406 | ) | (1,322 | ) | ||||
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||
Attributable to equity holders of Sanofi | (1,374 | ) | (1,318 | ) | (3,962 | ) | ||||||
Attributable to non-controlling interests | (16 | ) | (4 | ) | (15 | ) | ||||||
Total | (1,390 | ) | (1,322 | ) | (3,977 | ) |
The movement in currency translation differences during the period was mainly due to the effect of changes in the U.S. dollar exchange rate, primarily on goodwill, intangible assets and inventories.
In accordance with the accounting policy described in Note B.8.4., currency translation differencesattributable toequity holders of Sanofi include the post-tax effecteffects of currency hedges of net investments in foreign operations, which amounted tooperations; these effects (after tax) were €72 million at December 31, 2012, €66 million after tax at December 31, 2011, and €85 million after tax at December 31, 2010 and €86 million after tax at December 31, 2009.2010.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.15.7. Other comprehensive income
Movements in other comprehensive income are as follows:
(€ million) | Year ended December 31, 2011 | Year ended December 31, 2010 | Year ended December 31, 2009 | |||||||||
Balance, beginning of period | (1,102 | ) | (3,755 | ) | (4,436 | ) | ||||||
Attributable to equity holders of Sanofi | (1,097 | ) | (3,739 | ) | (4,419 | ) | ||||||
Attributable to non-controlling interests | (5 | ) | (16 | ) | (17 | ) | ||||||
Merial revaluation of previously held equity interest: | ||||||||||||
• Change in fair value (1) | — | — | 1,379 | |||||||||
• Tax effects | — | — | (326 | ) | ||||||||
Zentiva revaluation of previously held equity interest: | ||||||||||||
• Change in fair value (1) | — | — | 108 | |||||||||
• Tax effects | — | — | (28 | ) | ||||||||
Actuarial gains/(losses) | ||||||||||||
• Impact of asset ceiling | — | 1 | 2 | |||||||||
• Actuarial gains/(losses) excluding associates, joint ventures and Merial | (677 | ) | (316 | ) | (169 | ) | ||||||
• Actuarial gains/(losses) on associates and joint ventures | — | (1 | ) | (2 | ) | |||||||
• Actuarial gains/(losses) on Merial | — | 5 | — | |||||||||
• Tax effects | 138 | 172 | 36 | |||||||||
Items that cannot be reclassified to profit or loss | (539 | ) | (139 | ) | 1,000 | |||||||
Available-for-sale financial assets: | ||||||||||||
• Change in fair value (2) | 250 | 141 | 110 | |||||||||
• Tax effects | (5 | ) | (15 | ) | (23 | ) | ||||||
Cash flow hedges: | ||||||||||||
• Change in fair value (3) | 5 | 17 | (175 | ) | ||||||||
• Tax effects | (2 | ) | (6 | ) | 61 | |||||||
Change in currency translation differences | ||||||||||||
• Currency translation differences on foreign subsidiaries (4) | (49 | ) | 2,656 | (280 | ) | |||||||
• Hedges of net investments in foreign operations | (30 | ) | (2 | ) | (18 | ) | ||||||
• Tax effects | 11 | 1 | 6 | |||||||||
Items that may be reclassified to profit or loss | 180 | 2,792 | (319 | ) | ||||||||
Balance, end of period | (1,461 | ) | (1,102 | ) | (3,755 | ) | ||||||
Attributable to equity holders of Sanofi | (1,444 | ) | (1,097 | ) | (3,739 | ) | ||||||
Attributable to non-controlling interests | (17 | ) | (5 | ) | (16 | ) |
|
|
|
|
(€ million) | Year ended December 31, 2012 | Year ended December 31, 2011 (1) | Year ended December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Balance, beginning of period | (1,477 | ) | (1,102 | ) | (3,755 | ) | ||||
Attributable to equity holders of Sanofi | (1,460 | ) | (1,097 | ) | (3,739 | ) | ||||
Attributable to non-controlling interests | (17 | ) | (5 | ) | (16 | ) | ||||
Actuarial gains/(losses) | ||||||||||
• Impact of asset ceiling | 1 | — | 1 | |||||||
• Actuarial gains/(losses) excluding associates and joint ventures | (1,549 | ) | (677 | ) | (311 | ) | ||||
• Actuarial gains/(losses) on associates and joint ventures | (7 | ) | — | (1 | ) | |||||
• Tax effects | 492 | 138 | 172 | |||||||
Items not subsequently reclassifiable to profit or loss | (1,063 | ) | (539 | ) | (139 | ) | ||||
Available-for-sale financial assets: | ||||||||||
• Change in fair value (2) | 1,451 | 250 | 141 | |||||||
• Tax effects | (114 | ) | (5 | ) | (15 | ) | ||||
Cash flow hedges: | ||||||||||
• Change in fair value (3) | (4 | ) | 5 | 17 | ||||||
• Tax effects | 1 | (2 | ) | (6 | ) | |||||
Change in currency translation differences: | ||||||||||
• Currency translation differences on foreign subsidiaries (4) | (542 | ) | (65 | ) | 2,656 | |||||
• Hedges of net investments in foreign operations | 10 | (30 | ) | (2 | ) | |||||
• Tax effects | (4 | ) | 11 | 1 | ||||||
Items subsequently reclassifiable to profit or loss | 798 | 164 | 2,792 | |||||||
Balance, end of period | (1,742 | ) | (1,477 | ) | (1,102 | ) | ||||
Attributable to equity holders of Sanofi | (1,718 | ) | (1,460 | ) | (1,097 | ) | ||||
Attributable to non-controlling interests | (24 | ) | (17 | ) | (5 | ) | ||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.15.8. Share-based payment
Stock option plans
a) Assumption by Sanofi of the obligations of Aventis
Stock subscription option plans
With effect from December 31, 2004, Sanofi substituted for Aventis in all the rights and obligations of the issuer in respect of stock subscription options granted to employees and former corporate officers of Aventis and of related companies (as defined in article L.225-180 of the Commercial Code) and not exercised as of that date.
With effect from December 31, 2004, stock subscription options granted by Aventis and not yet exercised may be exercised in Sanofi shares on the same terms, subject to the adjustments described below. The number and subscription price of the optioned shares have been adjusted to reflect the share exchange ratio applicable to Aventis shareholders, subject to possible further adjustment in the event of future capital transactions. The new terms for the exercise of options, subject to future financial adjustments, are as follows:
b) Description of stock option plans
Stock subscription option plans
2011 On March 5, 2012, the Board of Directors granted 814,050 stock subscription optionoptions at an exercise price of €56.44 per share. The vesting period is four years, and the plan expires on March 5, 2022.
On March 9, 2011, the Board of Directors granted 874,500 stock subscription options at an exercise price of €50.48 per share.
The vesting period is four years, and the plan expires on March 9, 2021.
2010 stock subscription option plan
On March 1, 2010, the Board of Directors granted 8,121,355 stock subscription options at an exercise price of €54.12 per share.
The vesting period is four years, and the plan expires on February 28, 2020.
2009 stock subscription option plan
On March 2, 2009, the Board of Directors granted 7,736,480 stock subscription options at an exercise price of €45.09 per share.
The vesting period is four years, and the plan expires on March 2, 2019.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Stock purchase option plans
The table shows all Sanofi stock purchase option plans still outstanding or under which options were exercised in the year ended December 31, 2011.2012.
Origin | Date of grant | Options granted | Start date of exercise period | Expiration date | Exercise price (€) | Options outstanding at December 31, 2012 | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Synthélabo | 10/18/1994 | 330,200 | 10/18/1999 | 10/18/2014 | 6.01 | 5,200 | |||||||||||||
Synthélabo | 01/12/1996 | 208,000 | 01/12/2001 | 01/12/2016 | 8.56 | 8,870 | |||||||||||||
Synthélabo | 04/05/1996 | 228,800 | 04/05/2001 | 04/05/2016 | 10.85 | 18,500 | |||||||||||||
Synthélabo | 10/14/1997 | 262,080 | 10/14/2002 | 10/14/2017 | 19.73 | 23,442 | |||||||||||||
Synthélabo | 06/25/1998 | 296,400 | 06/26/2003 | 06/25/2018 | 28.38 | 3,500 | |||||||||||||
Synthélabo | 03/30/1999 | 716,040 | 03/31/2004 | 03/30/2019 | 38.08 | 232,025 | |||||||||||||
Sanofi-Synthélabo | 05/22/2002 | 3,111,850 | 05/23/2006 | 05/22/2012 | 69.94 | — | |||||||||||||
Total | 291,537 | ||||||||||||||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Origin | Date of grant | Options granted | Start date of exercise period | Expiration date | Exercise price (€) | Options outstanding at December 31, 2011 | ||||||||||||||||||
Synthélabo | 12/15/1993 | 364,000 | 12/15/1998 | 12/15/2013 | 6.36 | — | ||||||||||||||||||
Synthélabo | 10/18/1994 | 330,200 | 10/18/1999 | 10/18/2014 | 6.01 | 5,700 | ||||||||||||||||||
Synthélabo | 01/12/1996 | 208,000 | 01/12/2001 | 01/12/2016 | 8.56 | 14,070 | ||||||||||||||||||
Synthélabo | 04/05/1996 | 228,800 | 04/05/2001 | 04/05/2016 | 10.85 | 29,470 | ||||||||||||||||||
Synthélabo | 10/14/1997 | 262,080 | 10/14/2002 | 10/14/2017 | 19.73 | 28,242 | ||||||||||||||||||
Synthélabo | 06/25/1998 | 296,400 | 06/26/2003 | 06/25/2018 | 28.38 | 4,100 | ||||||||||||||||||
Synthélabo | 03/30/1999 | 716,040 | 03/31/2004 | 03/30/2019 | 38.08 | 263,745 | ||||||||||||||||||
Sanofi-Synthélabo | 05/10/2001 | 2,936,500 | 05/11/2005 | 05/10/2011 | 64.50 | — | ||||||||||||||||||
Sanofi-Synthélabo | 05/22/2002 | 3,111,850 | 05/23/2006 | 05/22/2012 | 69.94 | 2,858,750 | ||||||||||||||||||
Total | 3,204,077 |
Sanofi shares acquired to cover stock purchase optionsoption plans are deducted from shareholders’shareholders' equity. The exercise of all outstanding stock purchase options would increase shareholders’shareholders' equity by €211€10 million.
Stock subscription option plans
Details of the terms of exercise of stock subscription options granted under the various plans are presented below in Sanofi share equivalents. These options have been granted to certain corporate officers and employees of Group companies.
The table shows all Sanofi stock subscription option plans still outstanding or under which options were exercised in the year ended December 31, 2011.2012.
Origin | Date of grant | Options granted | Start date of exercise period | Expiration date | Exercise price (€) | Options outstanding at December 31, 2012 | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aventis | 03/06/2002 | 1,173,913 | 03/07/2005 | 03/06/2012 | 69.82 | — | |||||||||||||
Aventis | 11/12/2002 | 11,775,414 | 11/13/2005 | 11/12/2012 | 51.34 | — | |||||||||||||
Aventis | 12/02/2003 | 12,012,414 | 12/03/2006 | 12/02/2013 | 40.48 | 1,850,188 | |||||||||||||
Sanofi-Synthélabo | 12/10/2003 | 4,217,700 | 12/11/2007 | 12/10/2013 | 55.74 | 1,359,860 | |||||||||||||
Sanofi-aventis | 05/31/2005 | 15,228,505 | 06/01/2009 | 05/31/2015 | 70.38 | 12,897,536 | |||||||||||||
Sanofi-aventis | 12/14/2006 | 11,772,050 | 12/15/2010 | 12/14/2016 | 66.91 | 9,591,305 | |||||||||||||
Sanofi-aventis | 12/13/2007 | 11,988,975 | 12/14/2011 | 12/13/2017 | 62.33 | 8,632,330 | |||||||||||||
Sanofi-aventis | 03/02/2009 | 7,736,480 | 03/04/2013 | 03/01/2019 | 45.09 | 7,143,460 | |||||||||||||
Sanofi-aventis | 03/01/2010 | 8,121,355 | 03/03/2014 | 02/28/2020 | 54.12 | 7,597,245 | |||||||||||||
Sanofi-aventis | 03/09/2011 | 874,500 | 03/10/2015 | 03/09/2021 | 50.48 | 844,500 | |||||||||||||
Sanofi | 03/05/2012 | 814,050 | 03/06/2016 | 03/05/2022 | 56.44 | 814,050 | |||||||||||||
Total | 50,730,474 | ||||||||||||||||||
Origin | Date of grant | Options granted | Start date of exercise period | Expiration date | Exercise price (€) | Options 2011 | ||||||||||||||||||
Aventis | 03/29/2001 | 612,196 | 03/30/2004 | 03/29/2011 | 68.94 | — | ||||||||||||||||||
Aventis | 11/07/2001 | 13,374,051 | 11/08/2004 | 11/07/2011 | 71.39 | — | ||||||||||||||||||
Aventis | 03/06/2002 | 1,173,913 | 03/07/2005 | 03/06/2012 | 69.82 | 1,173,906 | ||||||||||||||||||
Aventis | 11/12/2002 | 11,775,414 | 11/13/2005 | 11/12/2012 | 51.34 | 4,671,543 | ||||||||||||||||||
Aventis | 12/02/2003 | 12,012,414 | 12/03/2006 | 12/02/2013 | 40.48 | 4,114,243 | ||||||||||||||||||
Sanofi-Synthélabo | 12/10/2003 | 4,217,700 | 12/11/2007 | 12/10/2013 | 55.74 | 3,801,470 | ||||||||||||||||||
Sanofi-aventis | 05/31/2005 | 15,228,505 | 06/01/2009 | 05/31/2015 | 70.38 | 13,196,960 | ||||||||||||||||||
Sanofi-aventis | 12/14/2006 | 11,772,050 | 12/15/2010 | 12/14/2016 | 66.91 | 10,710,140 | ||||||||||||||||||
Sanofi-aventis | 12/13/2007 | 11,988,975 | 12/14/2011 | 12/13/2017 | 62.33 | 11,044,430 | ||||||||||||||||||
Sanofi-aventis | 03/02/2009 | 7,736,480 | 03/04/2013 | 03/01/2019 | 45.09 | 7,244,710 | ||||||||||||||||||
Sanofi-aventis | 03/01/2010 | 8,121,355 | 03/03/2014 | 02/28/2020 | 54.12 | 7,726,085 | ||||||||||||||||||
Sanofi-aventis | 03/09/2011 | 874,500 | 03/10/2015 | 03/09/2021 | 50.48 | 844,500 | ||||||||||||||||||
Total | 64,527,987 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The exercise of all outstanding stock subscription options would increase shareholders’shareholders' equity by approximately €3,821€3,060 million. The exercise of each option results in the issuance of one share.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Summary of stock option plans
A summary of stock options outstanding at each balance sheet date, and of changes during the relevant periods, is presented below:
| | Exercise price | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
| Number of options | Weighted average per share (€) | Total (€ million) | |||||||
Options outstanding at January 1, 2010 | 87,870,341 | 61.87 | 5,436 | |||||||
Options exercisable | 57,717,316 | 63.04 | 3,638 | |||||||
Options granted | 8,121,355 | 54.12 | 440 | |||||||
Options exercised | (1,756,763 | ) | 42.50 | (75 | ) | |||||
Options cancelled (1) | (1,269,312 | ) | 59.56 | (75 | ) | |||||
Options forfeited | (10,694,693 | ) | 67.21 | (719 | ) | |||||
Options outstanding at December 31, 2010 | 82,270,928 | 60.86 | 5,007 | |||||||
Options exercisable | 55,663,453 | 63.63 | 3,542 | |||||||
Options granted | 874,500 | 50.48 | 44 | |||||||
Options exercised | (1,679,029 | ) | 43.11 | (72 | ) | |||||
Options cancelled (1) | (1,137,052 | ) | 57.64 | (66 | ) | |||||
Options forfeited | (12,597,283 | ) | 69.90 | (880 | ) | |||||
Options outstanding at December 31, 2011 | 67,732,064 | 59.54 | 4,033 | |||||||
Options exercisable | 51,916,769 | 62.51 | 3,245 | |||||||
Options granted | 814,050 | 56.44 | 46 | |||||||
Options exercised | (11,999,244 | ) | 53.87 | (646 | ) | |||||
Options cancelled (1) | (557,554 | ) | 58.40 | (33 | ) | |||||
Options forfeited | (4,967,305 | ) | 66.40 | (330 | ) | |||||
Options outstanding at December 31, 2012 | 51,022,011 | 60.17 | 3,070 | |||||||
Options exercisable | 34,622,756 | 64.93 | 2,248 | |||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Exercise price | ||||||||||||
Number of options | Weighted average per share (€) | Total (€ million) | ||||||||||
Options outstanding at January 1, 2009 | 85,304,950 | 62.66 | 5,345 | |||||||||
Options exercisable | 48,713,680 | 59.59 | 2,903 | |||||||||
Options granted | 7,736,480 | 45.09 | 349 | |||||||||
Options exercised | (3,545,344 | ) | 46.69 | (165 | ) | |||||||
Options cancelled(1) | (1,000,535 | ) | 61.72 | (62 | ) | |||||||
Options forfeited | (625,210 | ) | 48.89 | (31 | ) | |||||||
Options outstanding at December 31, 2009 | 87,870,341 | 61.87 | 5,436 | |||||||||
Options exercisable | 57,717,316 | 63.04 | 3,638 | |||||||||
Options granted | 8,121,355 | 54.12 | 440 | |||||||||
Options exercised | (1,756,763 | ) | 42.50 | (75 | ) | |||||||
Options cancelled(1) | (1,269,312 | ) | 59.56 | (75 | ) | |||||||
Options forfeited | (10,694,693 | ) | 67.21 | (719 | ) | |||||||
Options outstanding at December 31, 2010 | 82,270,928 | 60.86 | 5,007 | |||||||||
Options exercisable | 55,663,453 | 63.63 | 3,542 | |||||||||
Options granted | 874,500 | 50.48 | 44 | |||||||||
Options exercised | (1,679,029 | ) | 43.11 | (72 | ) | |||||||
Options cancelled(1) | (1,137,052 | ) | 57.64 | (66 | ) | |||||||
Options forfeited | (12,597,283 | ) | 69.90 | (880 | ) | |||||||
Options outstanding at December 31, 2011 | 67,732,064 | 59.54 | 4,033 | |||||||||
Options exercisable | 51,916,769 | 62.51 | 3,245 |
|
The table below provides summary information about options outstanding and exercisable as of December 31, 2011:2012:
Outstanding | Exercisable | |||||||||||||||||||
Range of exercise prices per share | Number of options | Average residual life (in years) | Weighted average exercise price per share (€) | Number of options | Weighted average exercise price per share (€) | |||||||||||||||
From €1.00 to €10.00 per share | 19,770 | 3.68 | 7.83 | 19,770 | 7.83 | |||||||||||||||
From €10.00 to €20.00 per share | 57,712 | 5.01 | 15.19 | 57,712 | 15.19 | |||||||||||||||
From €20.00 to €30.00 per share | 4,100 | 6.49 | 28.38 | 4,100 | 28.38 | |||||||||||||||
From €30.00 to €40.00 per share | 263,745 | 7.25 | 38.08 | 263,745 | 38.08 | |||||||||||||||
From €40.00 to €50.00 per share | 11,358,953 | 5.27 | 43.42 | 4,114,243 | 40.48 | |||||||||||||||
From €50.00 to €60.00 per share | 17,043,598 | 4.83 | 53.54 | 8,473,013 | 53.31 | |||||||||||||||
From €60.00 to €70.00 per share | 25,787,226 | 4.66 | 65.42 | 25,787,226 | 65.42 | |||||||||||||||
From €70.00 to €80.00 per share | 13,196,960 | 3.42 | 70.38 | 13,196,960 | 122.54 | |||||||||||||||
Total | 67,732,064 | 51,916,769 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
| Outstanding | Exercisable | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Range of exercise prices per share | Number of options | Average residual life (in years) | Weighted average exercise price per share (€) | Number of options | Weighted average exercise price per share (€) | |||||||||||
From €1.00 to €10.00 per share | 14,070 | 2.58 | 7.62 | 14,070 | 7.62 | |||||||||||
From €10.00 to €20.00 per share | 41,942 | 4.12 | 15.81 | 41,942 | 15.81 | |||||||||||
From €20.00 to €30.00 per share | 3,500 | 5.48 | 28.38 | 3,500 | 28.38 | |||||||||||
From €30.00 to €40.00 per share | 232,025 | 6.25 | 38.08 | 232,025 | 38.08 | |||||||||||
From €40.00 to €50.00 per share | 8,993,648 | 5.09 | 44.14 | 1,850,188 | 40.48 | |||||||||||
From €50.00 to €60.00 per share | 10,615,655 | 6.60 | 54.22 | 1,359,860 | 55.74 | |||||||||||
From €60.00 to €70.00 per share | 18,223,635 | 4.43 | 64.74 | 18,223,635 | 64.74 | |||||||||||
From €70.00 to €80.00 per share | 12,897,536 | 2.41 | 70.38 | 12,897,536 | 70.38 | |||||||||||
Total | 51,022,011 | 34,622,756 | ||||||||||||||
Measurement of stock option plans
The fair value of the stock subscription option plan awarded in 20112012 is €6€7 million. This amount is recognized as an expense over the vesting period, with the matching entry to shareholders’recognized directly in equity. On this basis, an expense of €1 million was recognized in the year ended December 31, 2011.2012.
The fair value of the plan awarded in 20102011 was €66€6 million.
The following assumptions were used in determining the fair value of these plans:
The fair value of the options granted in 2012 and 2011 is €8.42 and 2010 is €7.88 and €9.09 per option, respectively.
The expense recognized for stock option plans, and the matching entry taken to shareholders’recognized in equity, was €30 million for 2012 (including €3 million for the Vaccines segment); €59 million for 2011 (including €6 million for the Vaccines segments) compared withsegment); and €97 million for 2010 (including €10 million for the Vaccines segment), and €102 million in 2009 (including €12 million for the Vaccines segment),.
As of December 31, 2011,2012, the total unrecognized cost related to non-vestedof unvested stock option plansoptions was €51€31 million, to be recognized over a weighted average period of 2two years. The current tax benefit related to the exercise of stock options in 2011 is €2.22012 was €15 million (€1 million in 2010 and(versus €2 million in 2009)2011 and €1 million in 2010).
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.15.9. Number of shares used to compute diluted earnings per share
Diluted earnings per share is computed using the number of shares outstanding plus stock options with a potentially dilutive effect.
(in millions) | December 31, 2012 | December 31, 2011 | December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Average number of shares outstanding | 1,319.5 | 1,321.7 | 1,305.3 | |||||||
Adjustment for options with potentially dilutive effect | 4.0 | 1.7 | 1.7 | |||||||
Adjustment for restricted shares with potentially dilutive effect | 6.1 | 3.3 | 1.2 | |||||||
Average number of shares used to compute diluted earnings per share | 1,329.6 | 1,326.7 | 1,308.2 | |||||||
(in millions) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||
Average number of shares outstanding | 1,321.7 | 1,305.3 | 1,305.9 | |||||||||
Adjustment for options with potentially dilutive effect | 1.7 | 1.7 | 1.1 | |||||||||
Adjustment for restricted shares with potentially dilutive effect | 3.3 | 1.2 | 0.4 | |||||||||
Average number of shares used to compute diluted earnings per share | 1,326.7 | 1,308.2 | 1,307.4 |
In 2011,2012, a total of 5632 million stock options were not taken into account in the calculation of diluted earnings per share because they did not have a potentially dilutive effect, compared with 56 million in 2011 and 69.1 million stock options in 2010 and 80.3 million in 2009.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
2010.
D.16. Non-controlling interests
Non-controlling interests in consolidated companies break down as follows:
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||
Non-controlling interests of ordinary shareholders: | ||||||||||||
• BMS (1) | 34 | 41 | 104 | |||||||||
• Zentiva | 21 | 28 | 32 | |||||||||
• Aventis Pharma Ltd India | 58 | 75 | 73 | |||||||||
• Maphar | 7 | 7 | 7 | |||||||||
• Sanofi-aventis Korea | 7 | 7 | 5 | |||||||||
• Shantha Biotechnics | 10 | 9 | 12 | |||||||||
• Other | 33 | 24 | 25 | |||||||||
Total | 170 | 191 | 258 |
(€ million) | December 31, 2012 | December 31, 2011 | December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Non-controlling interests of ordinary shareholders: | ||||||||||
• BMS (1) | — | 34 | 41 | |||||||
• Zentiva | 14 | 21 | 28 | |||||||
• Sanofi India Ltd | 63 | 58 | 75 | |||||||
• Maphar | 7 | 7 | 7 | |||||||
• Sanofi-Aventis Korea | — | 7 | 7 | |||||||
• Shantha Biotechnics | 8 | 10 | 9 | |||||||
• Other | 42 | 33 | 24 | |||||||
Total | 134 | 170 | 191 | |||||||
|
|
D.17. Debt, cash and cash equivalents
The table below shows changes in the Group’sGroup's financial position over the last three years:
(€ million) | December 31, 2012 | December 31, 2011 | December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Long-term debt | 10,719 | 12,499 | 6,695 | |||||||
Short-term debt and current portion of long-term debt | 3,812 | 2,940 | 1,565 | |||||||
Interest rate and currency derivatives used to hedge debt | (433 | ) | (483 | ) | (218 | ) | ||||
Total debt | 14,098 | 14,956 | 8,042 | |||||||
Cash and cash equivalents | (6,381 | ) | (4,124 | ) | (6,465 | ) | ||||
Interest rate and currency derivatives used to hedge cash and cash equivalents | 2 | 27 | — | |||||||
Debt, net of cash and cash equivalents | 7,719 | 10,859 | 1,577 | |||||||
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||
Long-term debt | 12,499 | 6,695 | 5,961 | |||||||||
Short-term debt and current portion of long-term debt | 2,940 | 1,565 | 2,866 | |||||||||
Interest rate and currency derivatives used to hedge debt | (483 | ) | (218 | ) | (7 | ) | ||||||
Total debt | 14,956 | 8,042 | 8,820 | |||||||||
Cash and cash equivalents | (4,124 | ) | (6,465 | ) | (4,692 | ) | ||||||
Interest rate and currency derivative instruments used to hedge cash and cash equivalents | 27 | — | — | |||||||||
Debt, net of cash and cash equivalents | 10,859 | 1,577 | 4,128 |
“Debt,"Debt, net of cash and cash equivalents”equivalents" is a non-GAAP financial indicator used by management and investors to measure the company’scompany's overall net indebtedness.
Trends in the gearing ratio are shown below:
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||
Debt, net of cash and cash equivalents | 10,859 | 1,577 | 4,128 | |||||||||
Total equity | 56,389 | 53,288 | 48,580 | |||||||||
Gearing ratio | 19.3 | % | 3.0 | % | 8.5 | % |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
A reconciliation of carrying amount to value on redemption is shown below:
Value on redemption December 31, | ||||||||||||||||||||||||
(€ million) | Carrying amount: Dec. 31, 2011 | Amortized cost | Adjustment to debt measured at fair value | 2011 | 2010 | 2009 | ||||||||||||||||||
Long-term debt | 12,499 | 54 | (275 | ) | 12,278 | 6,683 | 5,943 | |||||||||||||||||
Short-term debt and current portion of long-term debt | 2,940 | — | (3 | ) | 2,937 | 1,565 | 2,853 | |||||||||||||||||
Interest rate and currency derivatives used to hedge debt | (483 | ) | — | 225 | (258 | ) | (192 | ) | 8 | |||||||||||||||
Total debt | 14,956 | 54 | (53 | ) | 14,957 | 8,056 | 8,804 | |||||||||||||||||
Cash and cash equivalents | (4,124 | ) | — | — | (4,124 | ) | (6,465 | ) | (4,692 | ) | ||||||||||||||
Interest rate and currency derivative instruments used to hedge cash and cash equivalents | 27 | — | (3 | ) | 24 | — | — | |||||||||||||||||
Debt, net of cash and cash equivalents | 10,859 | 54 | (56 | ) | 10,857 | 1,591 | 4,112 |
| | | | Value on redemption December 31, | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Carrying amount: Dec. 31, 2012 | Amortized cost | Adjustment to debt measured at fair value | 2012 | 2011 | 2010 | |||||||||||||
Long-term debt | 10,719 | 45 | (322 | ) | 10,442 | 12,278 | 6,683 | ||||||||||||
Short-term debt and current portion of long-term debt | 3,812 | — | — | 3,812 | 2,937 | 1,565 | |||||||||||||
Interest rate and currency derivatives used to hedge debt | (433 | ) | — | 269 | (164 | ) | (258 | ) | (192 | ) | |||||||||
Total debt | 14,098 | 45 | (53 | ) | 14,090 | 14,957 | 8,056 | ||||||||||||
Cash and cash equivalents | (6,381 | ) | — | — | (6,381 | ) | (4,124 | ) | (6,465 | ) | |||||||||
Interest rate and currency derivatives used to hedge cash and cash equivalents | 2 | — | — | 2 | 24 | — | |||||||||||||
Debt, net of cash and cash equivalents | 7,719 | 45 | (53 | ) | 7,711 | 10,857 | 1,591 | ||||||||||||
a) Principal financing transactions during the year
The financing transactions in 2011that took place during 2012 were as follows:
The Genzyme acquisition was financed as follows:
a €750 million bond issue in the United States for $7 billion;
the issue of US Commercial Paper for $7 billion;
a drawdown on a bridge facility for $4 billion;
the use of available cash for $2.4 billion.
In March 2011, the Group issued a bond for a total amount of $7 billion in six tranches:
$1 billion in bonds maturing March 2012, bearing interest at the $ 3-month Libor rate +0.05%;
$1 billion in bonds maturing March 2013, bearing interest at the $ 3-month Libor rate +0.20%;
$750 million in bonds maturing March 2014, bearing interest at the $ 3-month Libor rate +0.31%;
$750 million in bonds maturing March 2014, bearing interest at an annual rate of 1.625%;
$1.5 billion in bonds maturing March 2016, bearing interest at an annual rate of 2.625%;
$2 billion in bonds maturing March 2021, bearing interest at an annual rate of 4%.
This bond issue was performed under a public bond issue program (shelf registration statement) registered with the US Securities and Exchange Commission (SEC).
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
In addition, in the context of the launch of the tender offer for Genzyme, the Group contracted on October 2, 2010, two credit facilities totaling $15 billion that could be used until July 2, 2011:
|
|
These acquisition facilities were not subject to any financial covenants. The margin of facility B was dependent on the long term credit rating of Sanofi subsequent to the acquisition.
On March 29, 2011, Facility A was reduced by the proceeds from the bond issue in the United States (for the amount of $7 billion). The residual amount of this facility was cancelled on April 1, 2011.
On April 5, 2011, the Group drew $4 billion on Facility B and cancelled the residual amount ($1 billion).
On June 28, 2011, the Group prepaid $1 billion on the draw from Facility B.
On August 5, 2011, the Group prepaid $1 billion on the draw from Facility B.
On November 3, 2011, the Group prepaid the remaining $2 billion drawn on Facility B.
In addition, as a result of the Genzyme acquisition, two bond tranches previously issued by Genzyme are included in the liabilities on the Group’s consolidated balance sheet:
|
|
At the end of a procedure to request approval consent solicitation, these bonds are now secured by the parent company.
Financing transactions related to the company’s current operations:
In September 2011, the Group completed a bond issue for $1 billion, maturing in September 20142017 and bearing interest at an annual rate of 1.2%.1%, carried out in November 2012 under a Euro Medium Term Notes public bond issue program;
Three bond issues were redeemed on maturity:
No bond expired in 2011.
On November 3, 2011 the group contracted the following:
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The Group also repaid on maturity a €200 million loan from the European Investment Bank, originally contracted on December 13, 2007.
During 2012, the Group amended the terms of its €7 billion facility as follows:
On July 16, 2012, the Group agreed an initial one-year extension of its €3 billion syndicated credit facility with the fourteen banks.
b) Debt, net of cash and cash equivalents by type, at value on redemption
(€ million) | December 31, 2012 | December 31, 2011 | December 31, 2010 | |||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Non-current | Current | Total | Non-current | Current | Total | Non-current | Current | Total | |||||||||||||||||||
Bond issues | 9,886 | 2,509 | 12,395 | 11,662 | 1,324 | 12,986 | 5,879 | 92 | 5,971 | |||||||||||||||||||
Other bank borrowings | 478 | 994 | 1,472 | 522 | 562 | 1,084 | 771 | 402 | 1,173 | |||||||||||||||||||
Commercial paper | — | — | — | — | 695 | 695 | — | 735 | 735 | |||||||||||||||||||
Finance lease obligations | 65 | 13 | 78 | 80 | 12 | 92 | 19 | 6 | 25 | |||||||||||||||||||
Other borrowings | 13 | 42 | 55 | 14 | 62 | 76 | 14 | 57 | 71 | |||||||||||||||||||
Bank credit balances | — | 254 | 254 | — | 282 | 282 | — | 273 | 273 | |||||||||||||||||||
Interest rate and currency derivatives used to hedge debt | (124 | ) | (40 | ) | (164 | ) | (143 | ) | (115 | ) | (258 | ) | (194 | ) | 2 | (192 | ) | |||||||||||
Total debt | 10,318 | 3,772 | 14,090 | 12,135 | 2,822 | 14,957 | 6,489 | 1,567 | 8,056 | |||||||||||||||||||
Cash and cash equivalents | — | (6,381 | ) | (6,381 | ) | — | (4,124 | ) | (4,124 | ) | — | (6,465 | ) | (6,465 | ) | |||||||||||||
Interest rate and currency derivatives used to hedge cash and cash equivalents | — | 2 | 2 | — | 24 | 24 | — | — | — | |||||||||||||||||||
Debt, net of cash and cash equivalents | 10,318 | (2,607 | ) | 7,711 | 12,135 | (1,278 | ) | 10,857 | 6,489 | (4,898 | ) | 1,591 | ||||||||||||||||
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||||||||||||||||||||||||||
Non-current | Current | Total | Non-current | Current | Total | Non-current | Current | Total | ||||||||||||||||||||||||||||
Bond issues | 11,662 | 1,324 | 12,986 | 5,879 | 92 | 5,971 | 5,236 | 1,982 | 7,218 | |||||||||||||||||||||||||||
Other bank borrowings | 522 | 562 | 1,084 | 771 | 402 | 1,173 | 678 | 529 | 1,207 | |||||||||||||||||||||||||||
Commercial paper | — | 695 | 695 | — | 735 | 735 | — | — | — | |||||||||||||||||||||||||||
Finance lease obligations | 80 | 12 | 92 | 19 | 6 | 25 | 15 | 9 | 24 | |||||||||||||||||||||||||||
Other borrowings | 14 | 62 | 76 | 14 | 57 | 71 | 14 | 16 | 30 | |||||||||||||||||||||||||||
Bank credit balances | — | 282 | 282 | — | 273 | 273 | — | 317 | 317 | |||||||||||||||||||||||||||
Interest rate and currency derivatives used to hedge debt | (143 | ) | (115 | ) | (258 | ) | (194 | ) | 2 | (192 | ) | (53 | ) | 61 | 8 | |||||||||||||||||||||
Total debt | 12,135 | 2,822 | 14,957 | 6,489 | 1,567 | 8,056 | 5,890 | 2,914 | 8,804 | |||||||||||||||||||||||||||
Cash and cash equivalents | — | (4,124 | ) | (4,124 | ) | — | (6,465 | ) | (6,465 | ) | — | (4,692 | ) | (4,692 | ) | |||||||||||||||||||||
Interest rate and derivative instruments used to hedge cash and cash equivalents | — | 24 | 24 | — | — | — | — | — | — | |||||||||||||||||||||||||||
Debt, net of cash and cash equivalents | 12,135 | (1,278 | ) | 10,857 | 6,489 | (4,898 | ) | 1,591 | 5,890 | (1,778 | ) | 4,112 |
Bond issues madecarried out by the Holding CompanySanofi under the EMTN (EuroEuro Medium Term Notes)Notes (EMTN) program comprise:
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Bond issues madecarried out by the Holding CompanySanofi under the public bond issue program (shelf registration statement) registered with the USU.S. Securities and Exchange Commission (SEC) comprise:
Bonds issued in
Bonds issued in March 2011 [ISIN: US80105NAE58] in the amount of $1 billion, maturing March 2013, and bearing interest at the USD 3-month Libor rate +0.20%;
Bonds issued in
Bonds issued in
Bonds issued in
Bonds issued in
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Bonds issued in
The U.S. dollar issues in US dollars have been retained in this currency and have not been swapped into euros.
Bond issues madecarried out by the Holding CompanySanofi outside the EMTN (Euro Medium Term Notes)program and outside the USU.S. shelf registration statement program (shelf registration statement) comprise:
consist of the December 2007 and February 2008 issues [ISIN: CH0035703070] of CHF400 million (€329331 million), maturing December 2015, bearing annual interest at 3.375%, and swapped into euros at a fixed rate of 4.867%;.
December 2008 and January 2009 issues [ISIN: CH0048787532] amounting to CHF525 million (€432 million), maturing December 2012, bearing annual interest at 3.26%, and swapped into euros as follows: CHF275 million at a fixed rate of 4.894%, and CHF250 million at a floating rate indexed to 3-month Euribor.
Bond issues made by Genzyme Corp. comprise:
Bonds issued in
Bonds issued in
The line “Other borrowings”"Other borrowings" mainly includes:
Participating
In order to manage its liquidity needs for current operations, the Group now has:
option remaining.
The Group ownsalso has two commercial paper programs of €6 billion in France and $10 billion in the United States. In 2011,2012, only the U.S. program was used, with an average drawdown under these programs was €3.4of €2.3 billion (maximum €6.2 billion). A totaland a maximum drawdown of €0.7 billion€3.3 billion. Nothing was drawn down under either of these facilitiesprograms as of December 31, 2011.2012.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The financing in place atas of December 31, 20112012 at the level of the Holding Companyholding company (which manages most of the Group’sGroup's financing needs centrally) is not subject to any financial covenants, and contains no clauses linking credit spreads or fees to the credit rating.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
c) Debt by maturity, at value on redemption
| | Current | Non-current | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | | ||||||||||||||||||||
December 31, 2012 (€ million) | Total | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 and later | |||||||||||||||
Bond issues | 12,395 | 2,509 | 3,094 | 710 | 2,637 | 750 | 2,695 | |||||||||||||||
Other bank borrowings | 1,472 | 994 | 5 | 6 | 7 | 434 | 26 | |||||||||||||||
Commercial paper | — | — | — | — | — | — | — | |||||||||||||||
Finance lease obligations | 78 | 13 | 13 | 14 | 13 | 14 | 11 | |||||||||||||||
Other borrowings | 55 | 42 | — | — | — | — | 13 | |||||||||||||||
Bank credit balances | 254 | 254 | — | — | — | — | — | |||||||||||||||
Interest rate and currency derivatives used to hedge debt | (164 | ) | (40 | ) | — | (87 | ) | — | (3 | ) | (34 | ) | ||||||||||
Total debt | 14,090 | 3,772 | 3,112 | 643 | 2,657 | 1,195 | 2,711 | |||||||||||||||
Cash and cash equivalents | (6,381 | ) | (6,381 | ) | — | — | — | — | — | |||||||||||||
Interest rate and currency derivatives used to hedge cash and cash equivalents | 2 | 2 | — | — | — | — | — | |||||||||||||||
Debt, net of cash and cash equivalents | 7,711 | (2,607 | ) | 3,112 | 643 | 2,657 | 1,195 | 2,711 | ||||||||||||||
Current | Non-current | |||||||||||||||||||||||||||
December 31, 2011 (€ million) | Total | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 and later | |||||||||||||||||||||
Bond issues | 12,986 | 1,324 | 2,423 | 3,133 | 720 | 2,659 | 2,727 | |||||||||||||||||||||
Other bank borrowings | 1,084 | 562 | 482 | 15 | 8 | 9 | 8 | |||||||||||||||||||||
Commercial paper (1) | 695 | 695 | — | — | — | — | — | |||||||||||||||||||||
Finance lease obligations | 92 | 12 | 14 | 13 | 14 | 14 | 25 | |||||||||||||||||||||
Other borrowings | 76 | 62 | — | — | — | — | 14 | |||||||||||||||||||||
Bank credit balances | 282 | 282 | — | — | — | — | — | |||||||||||||||||||||
Interest rate and currency derivatives used to hedge debt | (258 | ) | (115 | ) | (58 | ) | — | (85 | ) | — | — | |||||||||||||||||
Total debt | 14,957 | 2,822 | 2,861 | 3,161 | 657 | 2,682 | 2,774 | |||||||||||||||||||||
Cash and cash equivalents | (4,124 | ) | (4,124 | ) | — | — | — | — | — | |||||||||||||||||||
Interest rate and currency derivative instruments used to hedge cash and cash equivalents | 24 | 24 | — | — | — | — | — | |||||||||||||||||||||
Debt, net of cash and cash equivalents | 10,857 | (1,278 | ) | 2,861 | 3,161 | 657 | 2,682 | 2,774 |
|
Current | Non-Current | |||||||||||||||||||||||||||
December 31, 2010 (€ million) | Total | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 and later | |||||||||||||||||||||
Bond issues | 5,971 | 92 | 420 | 1,638 | 1,200 | 321 | 2,300 | |||||||||||||||||||||
Other bank borrowings | 1,173 | 402 | 203 | 555 | 6 | 7 | — | |||||||||||||||||||||
Commercial paper (1) | 735 | 735 | — | — | — | — | — | |||||||||||||||||||||
Finance lease obligations | 25 | 6 | 6 | 5 | 3 | 3 | 2 | |||||||||||||||||||||
Other borrowings | 71 | 57 | — | — | — | — | 14 | |||||||||||||||||||||
Bank credit balances | 273 | 273 | — | — | — | — | — | |||||||||||||||||||||
Interest rate and currency derivatives used to hedge debt | (192 | ) | 2 | (73 | ) | (46 | ) | — | (75 | ) | — | |||||||||||||||||
Total debt | 8,056 | 1,567 | 556 | 2,152 | 1,209 | 256 | 2,316 | |||||||||||||||||||||
Cash and cash equivalents | (6,465 | ) | (6,465 | ) | — | — | — | — | — | |||||||||||||||||||
Debt, net of cash and cash equivalents | 1,591 | (4,898 | ) | 556 | 2,152 | 1,209 | 256 | 2,316 |
|
Current | Non-Current | |||||||||||||||||||||||||||
December 31, 2009 (€ million) | Total | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 and later | |||||||||||||||||||||
Bond issues | 7,218 | 1,982 | — | 354 | 1,613 | 700 | 2,569 | |||||||||||||||||||||
Other bank borrowings | 1,207 | 529 | 11 | 225 | 433 | 7 | 2 | |||||||||||||||||||||
Commercial paper | — | — | — | — | — | — | — | |||||||||||||||||||||
Finance lease obligations | 24 | 9 | 3 | 3 | 3 | 3 | 3 | |||||||||||||||||||||
Other borrowings | 30 | 16 | — | — | — | — | 14 | |||||||||||||||||||||
Bank credit balances | 317 | 317 | — | — | — | — | — | |||||||||||||||||||||
Interest rate and currency derivatives used to hedge debt | 8 | 61 | — | (7 | ) | (20 | ) | — | (26 | ) | ||||||||||||||||||
Total debt | 8,804 | 2,914 | 14 | 575 | 2,029 | 710 | 2,562 | |||||||||||||||||||||
Cash and cash equivalents | (4,692 | ) | (4,692 | ) | — | — | — | — | — | |||||||||||||||||||
Debt, net of cash and cash equivalents | 4,112 | (1,778 | ) | 14 | 575 | 2,029 | 710 | 2,562 |
| | Current | Non-current | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | | ||||||||||||||||||||
December 31, 2011 (€ million) | Total | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 and later | |||||||||||||||
Bond issues | 12,986 | 1,324 | 2,423 | 3,133 | 720 | 2,659 | 2,727 | |||||||||||||||
Other bank borrowings | 1,084 | 562 | 482 | 15 | 8 | 9 | 8 | |||||||||||||||
Commercial paper (1) | 695 | 695 | — | — | — | — | — | |||||||||||||||
Finance lease obligations | 92 | 12 | 14 | 13 | 14 | 14 | 25 | |||||||||||||||
Other borrowings | 76 | 62 | — | — | — | — | 14 | |||||||||||||||
Bank credit balances | 282 | 282 | — | — | — | — | — | |||||||||||||||
Interest rate and currency derivatives used to hedge debt | (258 | ) | (115 | ) | (58 | ) | — | (85 | ) | — | — | |||||||||||
Total debt | 14,957 | 2,822 | 2,861 | 3,161 | 657 | 2,682 | 2,774 | |||||||||||||||
Cash and cash equivalents | (4,124 | ) | (4,124 | ) | — | — | — | — | — | |||||||||||||
Interest rate and currency derivatives used to hedge cash and cash equivalents | 24 | 24 | — | — | — | — | — | |||||||||||||||
Debt, net of cash and cash equivalents | 10,857 | (1,278 | ) | 2,861 | 3,161 | 657 | 2,682 | 2,774 | ||||||||||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
| | Current | Non-Current | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | | ||||||||||||||||||||
December 31, 2010 (€ million) | Total | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 and later | |||||||||||||||
Bond issues | 5,971 | 92 | 420 | 1,638 | 1,200 | 321 | 2,300 | |||||||||||||||
Other bank borrowings | 1,173 | 402 | 203 | 555 | 6 | 7 | — | |||||||||||||||
Commercial paper (1) | 735 | 735 | — | — | — | — | — | |||||||||||||||
Finance lease obligations | 25 | 6 | 6 | 5 | 3 | 3 | 2 | |||||||||||||||
Other borrowings | 71 | 57 | — | — | — | — | 14 | |||||||||||||||
Bank credit balances | 273 | 273 | — | — | — | — | — | |||||||||||||||
Interest rate and currency derivatives used to hedge debt | (192 | ) | 2 | (73 | ) | (46 | ) | — | (75 | ) | — | |||||||||||
Total debt | 8,056 | 1,567 | 556 | 2,152 | 1,209 | 256 | 2,316 | |||||||||||||||
Cash and cash equivalents | (6,465 | ) | (6,465 | ) | — | — | — | — | — | |||||||||||||
Debt, net of cash and cash equivalents | 1,591 | (4,898 | ) | 556 | 2,152 | 1,209 | 256 | 2,316 | ||||||||||||||
As of December 31, 2011,2012, the main undrawn confirmed general-purpose credit facilities at parentholding company level were as follows:
Year of expiry | Undrawn confirmed credit facilities available (€ million) | |||
---|---|---|---|---|
2013 | 3,000 | |||
2015 | 250 | |||
2017 | 6,750 | |||
Total | 10,000 | |||
Year of expiry | Undrawn confirmed credit facilities available (€ million) | |||
2012 | 3,000 | |||
2015 | 725 | |||
2016 | 6,275 | |||
Total | 10,000 |
As of December 31, 2011,2012, no single counterparty represented more than 7% of undrawn confirmed credit facilities.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
d) Debt by interest rate, at value on redemption
The tables below split debt, net of cash and cash equivalents between fixed and floating rate, and by maturity or contractual repricing date, atas of December 31, 2011.2012. The figures shown are the value on redemption, before the effects of derivative instruments:
| December 31, 2012 | |||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Total | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 and later | |||||||||||||||
Fixed-rate debt | 11,506 | 1,884 | 2,526 | 623 | 2,637 | 1,175 | 2,661 | |||||||||||||||
EUR | 6,468 | |||||||||||||||||||||
USD | 4,783 | |||||||||||||||||||||
% fixed-rate | 82% | |||||||||||||||||||||
Floating-rate debt (maturity based on contractual repricing date) | 2,584 | 2,584 | — | — | — | — | — | |||||||||||||||
EUR | 241 | |||||||||||||||||||||
USD | 1,493 | |||||||||||||||||||||
% floating-rate | 18% | |||||||||||||||||||||
Total debt | 14,090 | 4,468 | 2,526 | 623 | 2,637 | 1,175 | 2,661 | |||||||||||||||
Cash and cash equivalents | (6,379 | ) | (6,379 | ) | — | — | — | — | — | |||||||||||||
EUR | (5,050 | ) | ||||||||||||||||||||
USD | (890 | ) | ||||||||||||||||||||
% floating-rate | 100% | |||||||||||||||||||||
Debt, net of cash and cash equivalents | 7,711 | (1,911 | ) | 2,526 | 623 | 2,637 | 1,175 | 2,661 | ||||||||||||||
December 31, 2011 | ||||||||||||||||||||||||||||
(€ million) | Total | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 and later | |||||||||||||||||||||
Fixed-rate debt | 11,049 | 632 | 1,758 | 2,553 | 720 | 2,659 | 2,727 | |||||||||||||||||||||
EUR | 5,458 | |||||||||||||||||||||||||||
USD | 4,831 | |||||||||||||||||||||||||||
% fixed-rate | 74% | |||||||||||||||||||||||||||
Floating-rate debt (maturity based on contractual repricing date) | 3,908 | 3,908 | — | — | — | — | — | |||||||||||||||||||||
EUR | 312 | |||||||||||||||||||||||||||
USD | 3,010 | |||||||||||||||||||||||||||
% floating-rate | 26% | |||||||||||||||||||||||||||
Framed-rate debt (maturity based on contractual repricing date) | — | — | — | — | — | — | — | |||||||||||||||||||||
EUR | — | |||||||||||||||||||||||||||
USD | — | |||||||||||||||||||||||||||
% framed rate | — | |||||||||||||||||||||||||||
Total debt | 14,957 | 4,540 | 1,758 | 2,553 | 720 | 2,659 | 2,727 | |||||||||||||||||||||
Cash and cash equivalents | (4,100 | ) | (4,100 | ) | — | — | — | — | — | |||||||||||||||||||
EUR | (2,005 | ) | ||||||||||||||||||||||||||
USD | (1,521 | ) | ||||||||||||||||||||||||||
% floating-rate | 100% | |||||||||||||||||||||||||||
Debt, net of cash and cash equivalents | 10,857 | 440 | 1,758 | 2,553 | 720 | 2,659 | 2,727 |
FollowingSince the financing of the Genzyme acquisition in 2011, the Group manageshas managed its net debt in two currencies, the euro and the USU.S. dollar. The variablefloating-rate portion of this debt exposes the Group to an increaserises in interest rates, on the one hand onprimarily in the Eonia and Euribor benchmarksbenchmark rates (for the euro) and onin the other hand on the USU.S. Libor and Federal Fund Effective.Effective rates (for the U.S. dollar).
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
In order to reduce the amount and/or volatility of the cost of debt, Sanofithe Group has contracted derivative instruments (interest rate swaps, multi-currency interest ratecross-currency swaps and interest rate options). This hasThese have the effect of altering the fixed/floating split and the maturity based on contractual repricing dates:
| December 31, 2012 | |||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Total | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 and later | |||||||||||||||
Fixed-rate debt | 6,819 | 1,842 | 947 | 623 | 1,137 | 375 | 1,895 | |||||||||||||||
EUR | 2,411 | |||||||||||||||||||||
USD | 4,400 | |||||||||||||||||||||
% fixed-rate | 48% | |||||||||||||||||||||
Floating-rate debt | 7,271 | 7,271 | — | — | — | — | — | |||||||||||||||
EUR | 4,639 | |||||||||||||||||||||
USD | 1,876 | |||||||||||||||||||||
% floating-rate | 52% | |||||||||||||||||||||
Total debt | 14,090 | 9,113 | 947 | 623 | 1,137 | 375 | 1,895 | |||||||||||||||
Cash and cash equivalents | (6,379 | ) | (6,379 | ) | — | — | — | — | — | |||||||||||||
EUR | (5,920 | ) | ||||||||||||||||||||
USD | (20 | ) | ||||||||||||||||||||
% floating-rate | 100% | |||||||||||||||||||||
Debt, net of cash and cash equivalents | 7,711 | 2,734 | 947 | 623 | 1,137 | 375 | 1,895 | |||||||||||||||
December 31, 2011 | ||||||||||||||||||||||||||||
(€ million) | Total | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 and later | |||||||||||||||||||||
Fixed-rate debt | 6,726 | 427 | 1,758 | 966 | 720 | 1,159 | 1,696 | |||||||||||||||||||||
EUR | 2,515 | |||||||||||||||||||||||||||
USD | 4,212 | |||||||||||||||||||||||||||
% fixed-rate | 45% | |||||||||||||||||||||||||||
Floating-rate debt | 6,299 | 6,299 | — | — | — | — | — | |||||||||||||||||||||
EUR | 3,949 | |||||||||||||||||||||||||||
USD | 1,672 | |||||||||||||||||||||||||||
% floating-rate | 42% | |||||||||||||||||||||||||||
Framed-rate date | 1,932 | 1,932 | — | — | — | — | — | |||||||||||||||||||||
EUR | — | |||||||||||||||||||||||||||
USD | 1,932 | |||||||||||||||||||||||||||
% framed rate | 13% | |||||||||||||||||||||||||||
Total debt | 14,957 | 8,658 | 1,758 | 966 | 720 | 1,159 | 1,696 | |||||||||||||||||||||
Cash and cash equivalents | (4,100 | ) | (4,100 | ) | — | — | — | — | — | |||||||||||||||||||
EUR | (3,380 | ) | ||||||||||||||||||||||||||
USD | (146 | ) | ||||||||||||||||||||||||||
% floating-rate | 100% | |||||||||||||||||||||||||||
Debt, net of cash and cash equivalents | 10,857 | 4,558 | 1,758 | 966 | 720 | 1,159 | 1,696 |
The table below shows the fixed/floating rate split at redemption value after taking account of derivative instruments as of December 31, 20102011 and 2009:2010:
(€ million) | 2011 | % | 2010 | % | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fixed-rate debt | 6,726 | 45% | 5,350 | 66% | |||||||||
Floating-rate debt | 6,299 | 42% | 2,706 | 34% | |||||||||
Capped-rate debt | 1,932 | 13% | — | — | |||||||||
Total debt | 14,957 | 100% | 8,056 | 100% | |||||||||
Cash and cash equivalents | (4,100 | ) | (6,465 | ) | |||||||||
Debt, net of cash and cash equivalents | 10,857 | 1,591 | |||||||||||
(€ million) | 2010 | % | 2009 | % | ||||||||||||
Fixed-rate debt | 5,350 | 66% | 5,940 | 67% | ||||||||||||
Floating-rate debt | 2,706 | 34% | 2,864 | 33% | ||||||||||||
Total debt | 8,056 | 100% | 8,804 | 100% | ||||||||||||
Cash and cash equivalents | (6,465 | ) | (4,692 | ) | ||||||||||||
Debt, net of cash and cash equivalents | 1,591 | 4,112 |
The weighted average interest rate on debt atas of December 31, 20112012 was 2.9%3.0% before derivative instruments and 2.6%2.4% after derivative instruments. All cash and cash equivalents were invested at an average rate of 1.0%0.3% as of December 31, 2011.2012.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Based on the Group’sGroup's level of debt, and taking account of derivative instruments in place as of December 31, 2011,2012, sensitivity to movements in market interest rates over a full year would be as follows in the year ending December 31, 2012:2013:
Change in 3-month Euribor interest rate assumptions | Impact on pre-tax net income (€ million) | Impact on income/(expense) recognized directly in equity, before tax (€ million) | ||||||||
+ 100 bp | (33 | ) | (4 | ) | ||||||
+ 25 bp | (9 | ) | (1 | ) | ||||||
- 25 bp | 10 | 1 | ||||||||
- 100 bp | 41 | (5 | ) |
Change in 3-month Euribor interest rate assumptions | Impact on pre-tax net income (€ million) | Impact on income/(expense) recognized directly in equity, before tax (€ million) | |||||
---|---|---|---|---|---|---|---|
+100 bp | (10 | ) | (3 | ) | |||
+25 bp | (2 | ) | (1 | ) | |||
-25 bp | 2 | 1 | |||||
-100 bp | 10 | 3 | |||||
e) Debt, net of cash and cash equivalents by currency, at value on redemption
The table below shows debt, net of cash and cash equivalents by currency at December 31, 2012, before and after derivative instruments contracted to convert third-party debt into the functional currency of the borrower entity:
| December 31, 2012 | ||||||
---|---|---|---|---|---|---|---|
(€ million) | Before derivative instruments | After derivative instruments | |||||
EUR | 1,659 | 1,129 | |||||
USD | 5,386 | 6,256 | |||||
BRL | 368 | 368 | |||||
CHF | 244 | — | |||||
JPY | 93 | — | |||||
Other currencies | (39 | ) | (42 | ) | |||
Debt, net of cash and cash equivalents | 7,711 | 7,711 | |||||
The table below shows debt, net of cash and cash equivalents by currency at December 31, 2011 before and 2010, after taking account of derivative instruments contracted to convert third-party debt into the functional currency of the borrower entity:
December 31,2011 | ||||||||
(€ million) | Before derivative instruments | After derivative instruments | ||||||
EUR | 3,783 | 3,084 | ||||||
USD | 6,343 | 7,717 | ||||||
CHF | 582 | — | ||||||
JPY | 93 | — | ||||||
Other currencies | 56 | 56 | ||||||
Debt, net of cash and cash equivalents | 10,857 | 10,857 |
The table below shows debt, net of cash and cash equivalents by currency at December 31, 2010 and 2009, after taking account of derivative instruments contracted to convert third-party debt into the functional currency of the borrower entity:
(€ million) | 2010 | 2009 | ||||||
EUR | 1,581 | 4,312 | ||||||
USD | 37 | (22 | ) | |||||
GBP | (65 | ) | (58 | ) | ||||
Other currencies | 38 | (120 | ) | |||||
Debt, net of cash and cash equivalents | 1,591 | 4,112 |
(€ million) | December 31, 2011 | December 31, 2010 | |||||
---|---|---|---|---|---|---|---|
EUR | 3,084 | 1,581 | |||||
USD | 7,717 | 37 | |||||
Other currencies | 56 | (27 | ) | ||||
Debt, net of cash and cash equivalents | 10,857 | 1,591 | |||||
f) Market value of debt, net of cash and cash equivalents
The market value of debt, net of cash and cash equivalents as of December 31, 20112012 was €8,566 million (versus €11,596 million (compared withas of December 31, 2011 and €1,887 million as of December 31, 2010 and €4,3492010); this compares with a value on redemption of €7,711 million as of December 31, 2009) for a value on redemption of2012 (versus €10,857 million as of December 31, 2011 (versusand €1,591 million as of December 31, 2010 and €4,112 million as2010).
Table of December 31, 2009).Contents
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
g) Future contractual cash flows relating to debt and debt hedging instruments
The table below shows the amount of future contractual undiscounted cash flows (principal and interest) relating to debt and to derivative instruments designated as hedges of debt as of December 31, 2011:2012:
| December 31, 2012 | |||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Contractual cash flows by maturity | |||||||||||||||||||||
(€ million) | Total | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 and later | |||||||||||||||
Debt | 15,590 | 4,047 | 3,421 | 882 | 2,855 | 1,314 | 3,071 | |||||||||||||||
– principal | 13,988 | 3,667 | 3,124 | 637 | 2,650 | 1,192 | 2,718 | |||||||||||||||
– interest (1) | 1,602 | 380 | 297 | 245 | 205 | 122 | 353 | |||||||||||||||
Net cash flows related to derivative instruments | (307 | ) | (88 | ) | (84 | ) | (54 | ) | (50 | ) | (13 | ) | (18 | ) | ||||||||
Total | 15,283 | 3,959 | 3,337 | 828 | 2,805 | 1,301 | 3,053 | |||||||||||||||
December 31, 2011 | ||||||||||||||||||||||||||||
Contractual cash flows by maturity | ||||||||||||||||||||||||||||
(€ million) | Total | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 and later | |||||||||||||||||||||
Debt | 16,726 | 3,193 | 3,184 | 3,426 | 877 | 2,852 | 3,194 | |||||||||||||||||||||
– principal | 14,748 | 2,783 | 2,814 | 3,134 | 639 | 2,654 | 2,724 | |||||||||||||||||||||
– interest (1) | 1,978 | 410 | 370 | 292 | 238 | 198 | 470 | |||||||||||||||||||||
Net cash flows related to derivative instruments | (231 | ) | (72 | ) | (66 | ) | (48 | ) | (21 | ) | (28 | ) | 4 | |||||||||||||||
Total | 16,495 | 3,121 | 3,118 | 3,378 | 856 | 2,824 | 3,198 |
|
Future contractual cash flows are shown on the basis of the carrying amount in the balance sheet at the reporting date, without reference to any subsequent management decision that might materially alter the structure of the Group’sGroup's debt or its hedging policy.
Maturities used for credit facility drawdowns are those of the facility, not the drawdown.
The tabletables below showsshow the amount of future contractual undiscounted cash flows (principal and interest) relating to debt and to derivative instruments designated as hedges of debt as of December 31, 20102011 and 2009:2010:
| December 31, 2011 | |||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Contractual cash flows by maturity | |||||||||||||||||||||
(€ million) | Total | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 and later | |||||||||||||||
Debt | 16,726 | 3,193 | 3,184 | 3,426 | 877 | 2,852 | 3,194 | |||||||||||||||
– principal | 14,748 | 2,783 | 2,814 | 3,134 | 639 | 2,654 | 2,724 | |||||||||||||||
– interest (1) | 1,978 | 410 | 370 | 292 | 238 | 198 | 470 | |||||||||||||||
Net cash flows related to derivative instruments | (231 | ) | (72 | ) | (66 | ) | (48 | ) | (21 | ) | (28 | ) | 4 | |||||||||
Total | 16,495 | 3,121 | 3,118 | 3,378 | 856 | 2,824 | 3,198 | |||||||||||||||
| December 31, 2010 | |||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Contractual cash flows by maturity | |||||||||||||||||||||
(€ million) | Total | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 and later | |||||||||||||||
Debt | 9,354 | 1,699 | 875 | 2,418 | 1,360 | 462 | 2,540 | |||||||||||||||
– principal | 8,150 | 1,447 | 632 | 2,200 | 1,208 | 347 | 2,316 | |||||||||||||||
– interest (1) | 1,204 | 252 | 243 | 218 | 152 | 115 | 224 | |||||||||||||||
Net cash flows related to derivative instruments | (229 | ) | (5 | ) | (83 | ) | (49 | ) | 3 | (89 | ) | (6 | ) | |||||||||
Total | 9,125 | 1,694 | 792 | 2,369 | 1,363 | 373 | 2,534 | |||||||||||||||
December 31, 2010 | ||||||||||||||||||||||||||||
Contractual cash flows by maturity | ||||||||||||||||||||||||||||
(€ million) | Total | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 and later | |||||||||||||||||||||
Debt | 9,354 | 1,699 | 875 | 2,418 | 1,360 | 462 | 2,540 | |||||||||||||||||||||
– principal | 8,150 | 1,447 | 632 | 2,200 | 1,208 | 347 | 2,316 | |||||||||||||||||||||
– interest (1) | 1,204 | 252 | 243 | 218 | 152 | 115 | 224 | |||||||||||||||||||||
Net cash flows related to derivative instruments | (229 | ) | (5 | ) | (83 | ) | (49 | ) | 3 | (89 | ) | (6 | ) | |||||||||||||||
Total | 9,125 | 1,694 | 792 | 2,369 | 1,363 | 373 | 2,534 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued) |
|
December 31, 2009 | ||||||||||||||||||||||||||||
Contractual cash flows by maturity | ||||||||||||||||||||||||||||
(€ million) | Total | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 and later | |||||||||||||||||||||
Debt | 10,118 | 3,049 | 231 | 797 | 2,254 | 844 | 2,943 | |||||||||||||||||||||
– principal | 8,681 | 2,737 | 6 | 570 | 2,052 | 709 | 2,607 | |||||||||||||||||||||
– interest (1) | 1,437 | 312 | 225 | 227 | 202 | 135 | 336 | |||||||||||||||||||||
Net cash flows related to derivative instruments | (14 | ) | 51 | 8 | (9 | ) | (24 | ) | 2 | (42 | ) | |||||||||||||||||
Total | 10,104 | 3,100 | 239 | 788 | 2,230 | 846 | 2,901 |
|
D.18. Liabilities related to business combinations and non-controlling interests
For a description of the nature of liabilities reported in the line itemLiabilities related to business combinations and to non-controlling interests, refer to Note B.8.5. The principal acquisitions are described in Note D.1.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Obligations relating to business combinations mainly comprise contingent consideration in the form of milestone payments payable to the vendor and linked to development on projects conducted by the acquiree. The accounting treatment of contingent consideration is described in Note B.3.1. With effect from January 1, 2010, the fair value of contingent consideration in respect of products under development factors in (i) the probability that the project will succeed and (ii) the time value of money.
Movements in liabilities related to business combinations and to non-controlling interests were as follows:
(€ million) | Year ended December 31, 2011 | Year ended December 31, 2010 | ||||||
Balance, beginning of period | 486 | 151 | ||||||
split as follows: | ||||||||
• non-current | 388 | 75 | ||||||
• current | 98 | 76 | ||||||
New business combinations | 1,141 | 219 | ||||||
Payments made | (99 | ) | (52 | ) | ||||
Fair value remeasurement (including unwinding of discount) | (19 | ) | 5 | |||||
Other movements | (5 | ) | 155 | |||||
Currency translation differences | 52 | 8 | ||||||
Balance, end of period | 1,556 | 486 | ||||||
split as follows: | ||||||||
• non-current | 1,336 | 388 | ||||||
• current | 220 | 98 |
New business combinations
| Liabilities related to business combinations | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Liabilities related to non-controlling interests (1) | CVRs issued in connection with the acquisition of Genzyme (2) | Bayer contingent consideration arising from the Genzyme acquisition | Other | Total (6) | |||||||||||
Balance at January 1, 2011 | 134 | — | — | 352 | 486 | |||||||||||
New business combinations | — | 481 | 585 | 75 | 1,141 | |||||||||||
Payments made | — | (2 | ) | (53 | ) | (44 | ) | (99 | ) | |||||||
Fair value remeasurements through profit or loss (including unwinding of discount) | — | (211 | ) | 127 | 69 | (15 | ) | |||||||||
Other movements | (4 | ) | — | — | (5 | ) | (9 | ) | ||||||||
Currency translation differences | 3 | — | 35 | 14 | 52 | |||||||||||
Balance at December 31, 2011 | 133 | 268 | 694 | 461 | 1,556 | |||||||||||
New business combinations | 64 | — | — | 18 | 82 | |||||||||||
Payments made | — | (54 | )(3) | (101 | ) | (33 | ) | (188 | ) | |||||||
Fair value remeasurements through profit or loss (including unwinding of discount) (4) | — | 127 | 44 | 21 | 192 | |||||||||||
Other movements | (5 | ) | — | — | (154 | )(5) | (159 | ) | ||||||||
Currency translation differences | — | (20 | ) | (5 | ) | (8 | ) | (33 | ) | |||||||
Balance at December 31, 2012 | 192 | 321 | 632 | 305 | 1,450 | |||||||||||
income statement line item
Fair valueThe Bayer contingent consideration liability was assumed on the acquisition of Genzyme in 2011.
In a business combination completed in May 2009, prior to Sanofi's acquisition of control over Genzyme, Genzyme acquired from Bayer Schering Pharma A.G. (Bayer) the worldwide development and marketing rights to alemtuzumab (under the brand name LemtradaTM), a molecule currently under development for 2011 aremultiple sclerosis, as follows:well as the rights to the products Campath®, Fludara® and Leukine®. In exchange, Bayer is entitled to receive the following payments:
| ||||
| ||||
| ||||
| ||||
|
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The fair value of this liability was measured at €632 million as of December 31, 2012, compared with €694 million as of December 31, 2011.
The balanceAs of these liabilities atDecember 31, 2012, the end of each period breaks down as follows:
(€ million) | December 31, 2011 | December 31, 2010 | ||||||
Liabilities related to non-controlling interests (1) | 133 | 134 | ||||||
Liabilities related to business combinations | 1,423 | 352 | ||||||
Including: | ||||||||
• CVRs issued in connection with the acquisition of Genzyme(2) | 268 | — | ||||||
• Bayer contingent consideration resulting from the acquisition of Genzyme | 694 | — | ||||||
• Other | 461 | 352 | ||||||
Balance, end of period | 1,556 | 486 |
|
|
The put options reported above were granted to non-controlling interests in connection with acquisitions completed during 2010, and relate to Sanofi-Aventis Vostok and Hangzhou Sanofi Minsheng Consumer Healthcare Co. Ltd (see Note D.1.4.).
Otherother liabilities related to business combinations as of December 31, 2011 mainly comprisecomprised contingent consideration related to the acquisitions of TargeGen (€159 million),156 million, versus €159 million as of December 31, 2011 and €94 million as of December 31, 2010) and of BiPar (€73 million, versus €74 million as of December 31, 2011 and €70 million as of December 31, 2010). Having reviewed the results of the Phase IIb trial of FOV-1101, which led to a reassessment of its commercial prospects, Sanofi decided to pursue development of this product via a sub-licensing agreement with an as yet unidentified third party. Consequently, the Fovea contingent consideration liability (€151 million), and BiPar (€74 million).million as of December 31, 2011, €155 million as of December 31, 2010) was reversed during 2012 as an adjustment to goodwill, in accordance with the pre-revision IFRS 3.
The table below sets forth the maximum amount of contingent consideration payable:payable and firm commitments to buy out non-controlling interests:
December 31, 2012 | ||||||||||||||||
Payments due by period | ||||||||||||||||
(€ million) | Total | Less than 1 year | From 1 to 3 years | From 3 to 5 years | More than 5 years | |||||||||||
Commitments relating to contingent consideration in connection with business combinations (1) and buyouts of non-controlling interests (2) | 4,993 | 341 | 1,135 | 560 | 2,957 | |||||||||||
These commitments amounted to €5,578 million as of December 31, 2011. The reduction in the commitment during 2012 was mainly attributable to the repurchase of 40 million CVRs.
December 31, 2011 | ||||||||||||||||||||
Payments due by period | ||||||||||||||||||||
(€ million) | Total | Less than 1 year | From 1 to 3 years | From 3 to 5 years | More than 5 years | |||||||||||||||
Obligations related to business combinations(1) | 5,578 | 496 | 1,144 | 718 | 3,220 |
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.19. Provisions and other liabilities
Provisions and other non-current liabilities break down as follows:
(€ million) | Provisions for pensions and other benefits (D.19.1.) | Restructuring provisions (D.19.2.) | Other provisions (D.19.3.) | Other non-current liabilities | Total | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
January 1, 2010 | 4,342 | 257 | 3,533 | 104 | 8,236 | |||||||||||
Changes in scope of consolidation | 21 | — | 27 | — | 48 | |||||||||||
Increases in provisions and other liabilities | 442 | 731 | 857 | (2) | 11 | 2,041 | ||||||||||
Provisions utilized | (587 | ) | (65 | ) | (386 | ) | (41 | ) | (1,079 | ) | ||||||
Reversals of unutilized provisions | (82 | ) | (56 | ) | (259 | )(3) | — | (397 | ) | |||||||
Transfers(1) | (305 | ) | 119 | 81 | (7 | ) | (112 | ) | ||||||||
Unwinding of discount | — | 27 | 34 | 1 | 62 | |||||||||||
Unrealized gains and losses | — | — | (35 | ) | 33 | (2 | ) | |||||||||
Currency translation differences | 96 | 4 | 108 | 5 | 213 | |||||||||||
Actuarial gains/losses on defined-benefit plans (4) | 316 | — | — | — | 316 | |||||||||||
December 31, 2010 | 4,243 | 1,017 | 3,960 | 106 | 9,326 | |||||||||||
Merial (5) | 64 | — | 48 | 4 | 116 | |||||||||||
Changes in scope of consolidation | 35 | — | 150 | 20 | 205 | |||||||||||
Increases in provisions and other liabilities | 414 | 500 | 470 | (2) | 15 | 1,399 | ||||||||||
Provisions utilized | (510 | ) | (29 | ) | (138 | ) | — | (677 | ) | |||||||
Reversals of unutilized provisions | (97 | ) | (19 | ) | (363 | )(3) | — | (479 | ) | |||||||
Transfers (1) | (3 | ) | (327 | ) | (23 | ) | (9 | ) | (362 | ) | ||||||
Unwinding of discount | 1 | 38 | 40 | — | 79 | |||||||||||
Unrealized gains and losses | — | — | 1 | (27 | ) | (26 | ) | |||||||||
Currency translation differences | 68 | 2 | 13 | 5 | 88 | |||||||||||
Actuarial gains/losses on defined-benefit plans (4) | 677 | — | — | — | 677 | |||||||||||
December 31, 2011 | 4,892 | 1,182 | 4,158 | 114 | 10,346 | |||||||||||
Increases in provisions and other liabilities | 449 | 554 | 744 | (2) | — | 1,747 | ||||||||||
Provisions utilized | (803 | ) | (24 | ) | (240 | ) | (4 | ) | (1,071 | ) | ||||||
Reversals of unutilized provisions | (186 | ) | (5 | ) | (636 | )(3) | — | (827 | ) | |||||||
Transfers(1)/(6) | (108 | ) | (292 | ) | (324 | ) | (11 | ) | (735 | ) | ||||||
Unwinding of discount | — | 45 | 42 | — | 87 | |||||||||||
Currency translation differences | (26 | ) | 1 | (33 | ) | (1 | ) | (59 | ) | |||||||
Actuarial gains/losses on defined-benefit plans (4) | 1,548 | — | — | — | 1,548 | |||||||||||
December 31, 2012 | 5,766 | 1,461 | 3,711 | 98 | 11,036 | |||||||||||
(€ million) | Provisions for pensions and other benefits (D.19.1.) | Restructuring provisions (D.19.2.) | Other provisions (D.19.3.) | Other non-current liabilities | Total | |||||||||||||||
January 1, 2009 | 4,068 | 366 | 3,084 | 212 | 7,730 | |||||||||||||||
Changes in scope of consolidation | 13 | — | 228 | 9 | 250 | |||||||||||||||
Increases in provisions and other liabilities | 683 | 183 | 1,256 | (2) | — | 2,122 | ||||||||||||||
Provisions utilized | (603 | ) | (61 | ) | (251 | ) | (10 | ) | (925 | ) | ||||||||||
Reversals of unutilized provisions | (130 | ) | (1 | ) | (753 | ) (3) | (24 | ) | (908 | ) | ||||||||||
Transfers (1) | 133 | (232 | ) | (104 | ) | (70 | ) | (273 | ) | |||||||||||
Unwinding of discount | — | 3 | 36 | 1 | 40 | |||||||||||||||
Unrealized gains and losses | — | — | — | (12 | ) | (12 | ) | |||||||||||||
Currency translation differences | 9 | (1 | ) | 37 | (2 | ) | 43 | |||||||||||||
Actuarial gains/losses on defined-benefit plans (4) | 169 | — | — | — | 169 | |||||||||||||||
December 31, 2009 | 4,342 | 257 | 3,533 | 104 | 8,236 | |||||||||||||||
Changes in scope of consolidation | 21 | — | 27 | — | 48 | |||||||||||||||
Increases in provisions and other liabilities | 442 | 731 | 857 | (2) | 11 | 2,041 | ||||||||||||||
Provisions utilized | (587 | ) | (65 | ) | (386 | ) | (41 | ) | (1,079 | ) | ||||||||||
Reversals of unutilized provisions | (82 | ) | (56 | ) | (259 | ) (3) | — | (397 | ) | |||||||||||
Transfers(1) | (305 | ) | 119 | 81 | (7 | ) | (112 | ) | ||||||||||||
Unwinding of discount | — | 27 | 34 | 1 | 62 | |||||||||||||||
Unrealized gains and losses | — | — | (35 | ) | 33 | (2 | ) | |||||||||||||
Currency translation differences | 96 | 4 | 108 | 5 | 213 | |||||||||||||||
Actuarial gains/losses on defined-benefit plans (4) | 316 | — | — | — | 316 | |||||||||||||||
December 31, 2010 | 4,243 | 1,017 | 3,960 | 106 | 9,326 | |||||||||||||||
Merial (5) | 64 | — | 48 | 4 | 116 | |||||||||||||||
Changes in scope of consolidation | 35 | — | 150 | 20 | 205 | |||||||||||||||
Increases in provisions and other liabilities | 414 | 500 | 470 | (2) | 15 | 1,399 | ||||||||||||||
Reversals of utilized provisions | (510 | ) | (29 | ) | (138 | ) | — | (677 | ) | |||||||||||
Reversals of unutilized provisions | (97 | ) | (19 | ) | (363 | ) (3) | — | (479 | ) | |||||||||||
Transfers (1) | (3 | ) | (327 | ) | (23 | ) | (9 | ) | (362 | ) | ||||||||||
Unwinding of discount | 1 | 38 | 40 | — | 79 | |||||||||||||||
Unrealized gains and losses | — | — | 1 | (27 | ) | (26 | ) | |||||||||||||
Currency translation differences | 68 | 2 | 13 | 5 | 88 | |||||||||||||||
Actuarial gains/losses on defined-benefit plans (4) | 677 | — | — | — | 677 | |||||||||||||||
December 31, 2011 | 4,892 | 1,182 | 4,158 | 114 | 10,346 |
|
|
|
|
|
Other current liabilities are described in Note D.19.4.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.19.1. Provisions for pensions and other benefits
The Group and its subsidiaries have a significant number of pension plans covering the majority of their employees. The specific features (benefit formulas, funding policies and types of assets held) of the plans vary depending on laws and regulations in the particular country in which the employees work. Several of these plans are defined-benefit plans and cover some members of the Board of Directors as well as employees.
Actuarial valuations of the Group’sGroup's benefit obligations were computed by management with assistance from external actuaries as of December 31, 2012, 2011 2010, and 2009.2010. These calculations incorporate the following elements:
2010.
2010.
Inflation rate | 2011 | 2010 | 2009 | |||||||||
– Euro zone | 2% | 2% | 2% | |||||||||
– United States | 2.75% | 2.75% | 3% | |||||||||
– United Kingdom | 3% | 3.25% | 3.1% |
Inflation rate | 2012 | 2011 | 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
– Euro zone | 2% | 2% | 2% | |||||||
– United States | 2.75% | 2.75% | 2.75% | |||||||
– United Kingdom | 2.8% | 3% | 3.25% | |||||||
| Pensions and other long-term benefits | Other post-employment benefits | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year ended December 31, | Year ended December 31, | |||||||||||||||||
Discount rate | 2012 | 2011 | 2010 | 2012 | 2011 | 2010 | |||||||||||||
Weighted average for all regions: | 3.31% | 4.61% | 4.97% | 3.78% | 4.62% | 5.45% | |||||||||||||
– Euro zone | 2.25% or 3% | (1) | 4.25% or 4.75% | 4.25% or 4.75% | 3% | 4.75% | 4.75% | ||||||||||||
– United States | 3.75% | 4.5% | 5.5% | 3.75% | 4.5% | 5.5% | |||||||||||||
– United Kingdom | 4.25% | 5% | 5.5% | 4.25% | 5% | 5.5% | |||||||||||||
Pensions and other long-term benefits | Other post-employment benefits | |||||||||||||||||||||||
Year ended December 31 | Year ended December 31 | |||||||||||||||||||||||
Discount rate | 2011 | 2010 | 2009 | 2011 | 2010 | 2009 | ||||||||||||||||||
Weighted average for all regions: | 4.61% | 4.97% | 5.34% | 4.62% | 5.45% | 5.76% | ||||||||||||||||||
– Euro zone | 4.25% or 4.75% | (1) | 4.25% or 4.75% | 4.5% or 5.25% | 4.75% | 4.75% | 5.25% | |||||||||||||||||
– United States | 4.5% | 5.5% | 5.75% | 4.5% | 5.5% | 5.75% | ||||||||||||||||||
– United Kingdom | 5% | 5.5% | 5.75% | 5% | 5.5% | 5.75% |
|
The discount rates used are based on market rates for high quality corporate bonds (AA) the term of which approximates that ofwith a duration close to the expected benefit payments of the plans. The benchmarks used to determine these discount rates were the same in 2012, 2011 and 2010.
Sensitivity analysis of pension plans and other post-employment benefits in the principal countries shows that a 0.5% reduction in discount rates would increase the Group’sGroup's obligation by approximately €630€789 million, of which approximately €195€248 million would relate to the United Kingdom, €160€214 million to Germany, €115€168 million to France and €160€159 million to the United States.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
| Pensions and other long-term benefits | Other post-employment benefits | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year ended December 31, | Year ended December 31, | |||||||||||||||||
Long-term rate of return on plan assets | 2012 | 2011 | 2010 | 2012 | 2011 | 2010 | |||||||||||||
Range of rates of return | 1.7% - 12.5% | 1.7% - 14% | 2% - 13.5% | 6.75% | 7.5% | 8% | |||||||||||||
Weighted average for all regions: | 6.24% | 6.48% | 6.86% | 6.75% | 7.5% | 8% | |||||||||||||
– Germany | 6.25% | 6.25% | 6.75% | — | — | — | |||||||||||||
– United States | 6.75% | 7.5% | 8% | 6.75% | 7.5% | 8% | |||||||||||||
– United Kingdom | 6% | 6.25% | 6.5% | — | — | — | |||||||||||||
Pensions and other long-term benefits | Other post-employment benefits | |||||||||||||||||||||||
Year ended December 31 | Year ended December 31 | |||||||||||||||||||||||
Expected long-term rate of return on plan assets | 2011 | 2010 | 2009 | 2011 | 2010 | 2009 | ||||||||||||||||||
Range of rates of return: | 1.7% – 12.5% | 1.7% – 14% | 2% – 13.5% | 6.75% | 7.5% | 8% | ||||||||||||||||||
Weighted average for all regions: | 6.24% | 6.48% | 6.86% | 6.75% | 7.5% | 8% | ||||||||||||||||||
– Germany | 6.25% | 6.25% | 6.75% | — | — | — | ||||||||||||||||||
– United States | 6.75% | 7.5% | 8% | 6.75% | 7.5% | 8% | ||||||||||||||||||
– United Kingdom | 6% | 6.25% | 6.5% | — | — | — |
The average long-term rates of return on plan assets were determined on the basis of actual long-term rates of return in the financial markets. These returns vary according to the asset category (equities, bonds, real estate, other). As a general rule, Sanofi applies the risk premium concept in assessing the return on equities relative to bond yields.
An analysis of the sensitivity of the benefit cost to changes in the expected long-term rate of return on plan assets shows that a 0.5% reduction in the rate of return would increase the benefit cost by approximately €30€34 million.
The weighted average allocation of funds invested in Group pension plans is shown below:
| Funds invested | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Asset category (percentage) | 2012 | 2011 | 2010 | |||||||
Equities | 48% | 47% | 50% | |||||||
Bonds | 44% | 49% | 47% | |||||||
Real estate | 4% | 2% | 2% | |||||||
Cash and other | 4% | 2% | 1% | |||||||
Total | 100% | 100% | 100% | |||||||
Funds invested | ||||||||||||
Asset category (percentage) | 2011 | 2010 | 2009 | |||||||||
Equities | 47% | 50% | 51% | |||||||||
Bonds | 49% | 47% | 46% | |||||||||
Real estate | 2% | 2% | 1% | |||||||||
Cash | 2% | 1% | 2% | |||||||||
Total | 100% | 100% | 100% |
The target allocation of funds invested as of December 31, 20112012 is not materially different from the actual allocation as of December 31, 20102011 and December 31, 2009.2010.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The table below reconciles the net obligation in respect of the Group’sGroup's pension plans and other employee benefits with the amounts recognized in the consolidated financial statements:
Pensions and other long-term benefits | Other post-employment benefits (healthcare cover) | |||||||||||||||||||||||
(€ million) | 2011 | 2010 (1) | 2009 (1) | 2011 | 2010 (1) | 2009 (1) | ||||||||||||||||||
Valuation of obligation: | ||||||||||||||||||||||||
Beginning of period | 9,559 | 8,924 | 7,742 | 429 | 376 | 368 | ||||||||||||||||||
Merial | 207 | — | — | 1 | — | — | ||||||||||||||||||
Service cost | 265 | 240 | 218 | 13 | 14 | 16 | ||||||||||||||||||
Contributions from plan members | — | 5 | 4 | — | — | — | ||||||||||||||||||
Interest cost | 458 | 454 | 446 | 22 | 22 | 21 | ||||||||||||||||||
Actuarial (gain)/loss | 366 | 593 | 759 | 23 | 22 | 1 | ||||||||||||||||||
Plan amendments | — | 15 | 219 | — | — | — | ||||||||||||||||||
Currency translation differences | 169 | 259 | 64 | 13 | 27 | (6 | ) | |||||||||||||||||
Plan curtailments/settlements | (80 | ) | (69 | ) | (131 | ) | (8 | ) | (13 | ) | (4 | ) | ||||||||||||
Changes in scope of consolidation, transfers | 105 | (283 | ) (2) | 145 | — | 1 | — | |||||||||||||||||
Benefits paid | (574 | ) | (579 | ) | (542 | ) | (23 | ) | (20 | ) | (20 | ) | ||||||||||||
Obligation at end of period | 10,475 | 9,559 | 8,924 | 470 | 429 | 376 | ||||||||||||||||||
Fair value of plan assets: | ||||||||||||||||||||||||
Beginning of period | 5,661 | 4,876 | 3,957 | 51 | 44 | 41 | ||||||||||||||||||
Merial | 144 | — | — | — | — | |||||||||||||||||||
Expected return on plan assets | 367 | 347 | 278 | 3 | 4 | 3 | ||||||||||||||||||
Difference between actual and expected return on plan assets | (290 | ) | 252 | 547 | (2 | ) | 3 | 6 | ||||||||||||||||
Currency translation differences | 113 | 185 | 49 | 1 | 4 | (2 | ) | |||||||||||||||||
Contributions from plan members | 9 | 5 | 4 | — | — | — | ||||||||||||||||||
Employer’s contributions | 331 | 400 | 405 | 3 | 1 | 1 | ||||||||||||||||||
Plan settlements | (4 | ) | (1 | ) | (5 | ) | — | — | — | |||||||||||||||
Changes in scope of consolidation, transfers | 73 | 5 | — | — | — | — | ||||||||||||||||||
Benefits paid | (409 | ) | (408 | ) | (359 | ) | (6 | ) | (5 | ) | (5 | ) | ||||||||||||
Fair value of plan assets at end of period | 5,995 | 5,661 | 4,876 | 50 | 51 | 44 | ||||||||||||||||||
Net amount shown in the balance sheet: | ||||||||||||||||||||||||
Net obligation | 4,480 | 3,898 | 4,048 | 420 | 378 | 332 | ||||||||||||||||||
Unrecognized past service cost | (23 | ) | (45 | ) | (49 | ) | 8 | 7 | 6 | |||||||||||||||
Effect of asset ceiling | 1 | 1 | 2 | — | — | — | ||||||||||||||||||
Net amount shown in the balance sheet | 4,458 | 3,854 | 4,001 | 428 | 385 | 338 | ||||||||||||||||||
Amounts recognized in the balance sheet: | ||||||||||||||||||||||||
Pre-funded obligations (see Note D.7.) | (6 | ) | (4 | ) | (3 | ) | — | — | — | |||||||||||||||
Obligations provided for(3) | 4,464 | 3,858 | 4,004 | 428 | 385 | 338 | ||||||||||||||||||
Net amount recognized | 4,458 | 3,854 | 4,001 | 428 | 385 | 338 | ||||||||||||||||||
Benefit cost for the period: | ||||||||||||||||||||||||
Service cost | 256 | 240 | 218 | 13 | 14 | 16 | ||||||||||||||||||
Interest cost | 458 | 454 | 446 | 22 | 22 | 21 | ||||||||||||||||||
Expected return on plan assets | (367 | ) | (347 | ) | (278 | ) | (3 | ) | (4 | ) | (3 | ) | ||||||||||||
Amortization of past service cost | 21 | 20 | 224 | — | — | — | ||||||||||||||||||
Recognition of actuarial (gains)/losses | 4 | 44 | 38 | — | — | — | ||||||||||||||||||
Effect of plan curtailments | (77 | ) | (69 | ) | (122 | ) | (8 | ) | (13 | ) | (4 | ) | ||||||||||||
Effect of plan settlements | 1 | — | (3 | ) | — | — | — | |||||||||||||||||
Benefit cost for the period | 296 | 342 | 523 | 24 | 19 | 30 |
|
|
|
| Pensions and other long-term benefits | Other post-employment benefits (healthcare cover) | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | 2012 | 2011 | 2010 (1) | 2012 | 2011 | 2010 (1) | |||||||||||||
Valuation of obligation: | |||||||||||||||||||
Beginning of period | 10,475 | 9,559 | 8,924 | 470 | 429 | 376 | |||||||||||||
Merial | — | 207 | — | — | 1 | — | |||||||||||||
Service cost | 262 | 265 | 240 | 24 | 13 | 14 | |||||||||||||
Contributions from plan members | — | — | 5 | — | — | — | |||||||||||||
Interest cost | 462 | 458 | 454 | 21 | 22 | 22 | |||||||||||||
Actuarial (gain)/loss | 1,911 | 366 | 593 | 53 | 23 | 22 | |||||||||||||
Plan amendments | 6 | — | 15 | 1 | — | — | |||||||||||||
Currency translation differences | (17 | ) | 169 | 259 | (9 | ) | 13 | 27 | |||||||||||
Plan curtailments/settlements | (455 | ) | (80 | ) | (69 | ) | — | (8 | ) | (13 | ) | ||||||||
Changes in scope of consolidation, transfers | (18 | ) | 105 | (283 | )(2) | — | — | 1 | |||||||||||
Benefits paid | (605 | ) | (574 | ) | (579 | ) | (21 | ) | (23 | ) | (20 | ) | |||||||
Obligation at end of period | 12,021 | 10,475 | 9,559 | 539 | 470 | 429 | |||||||||||||
Fair value of plan assets: | |||||||||||||||||||
Beginning of period | 5,995 | 5,661 | 4,876 | 50 | 51 | 44 | |||||||||||||
Merial | — | 144 | — | — | — | — | |||||||||||||
Expected return on plan assets | 378 | 367 | 347 | 3 | 3 | �� | 4 | ||||||||||||
Difference between actual and expected return on plan assets | 357 | (290 | ) | 252 | 3 | (2 | ) | 3 | |||||||||||
Currency translation differences | — | 113 | 185 | (1 | ) | 1 | 4 | ||||||||||||
Contributions from plan members | 5 | 9 | 5 | — | — | — | |||||||||||||
Employer's contributions | 582 | 331 | 400 | — | 3 | 1 | |||||||||||||
Plan settlements | (166 | ) | (4 | ) | (1 | ) | — | — | — | ||||||||||
Changes in scope of consolidation, transfers | (10 | ) | 73 | 5 | — | — | — | ||||||||||||
Benefits paid | (401 | ) | (409 | ) | (408 | ) | (4 | ) | (6 | ) | (5 | ) | |||||||
Fair value of plan assets at end of period | 6,740 | 5,995 | 5,661 | 51 | 50 | 51 | |||||||||||||
Net amount shown in the balance sheet: | |||||||||||||||||||
Net obligation | 5,281 | 4,480 | 3,898 | 488 | 420 | 378 | |||||||||||||
Unrecognized past service cost | (15 | ) | (23 | ) | (45 | ) | 6 | 8 | 7 | ||||||||||
Effect of asset ceiling | — | 1 | 1 | — | — | — | |||||||||||||
Net amount shown in the balance sheet | 5,266 | 4,458 | 3,854 | 494 | 428 | 385 | |||||||||||||
Amounts recognized in the balance sheet: | |||||||||||||||||||
Pre-funded obligations (see Note D.7.) | (6 | ) | (6 | ) | (4 | ) | — | — | — | ||||||||||
Obligations provided for (3) | 5,272 | 4,464 | 3,858 | 494 | 428 | 385 | |||||||||||||
Net amount recognized | 5,266 | 4,458 | 3,854 | 494 | 428 | 385 | |||||||||||||
Benefit cost for the period: | |||||||||||||||||||
Service cost | 257 | 256 | 240 | 24 | 13 | 14 | |||||||||||||
Interest cost | 462 | 458 | 454 | 21 | 22 | 22 | |||||||||||||
Expected return on plan assets | (378 | ) | (367 | ) | (347 | ) | (3 | ) | (3 | ) | (4 | ) | |||||||
Amortization of past service cost | 13 | 21 | 20 | (1 | ) | — | — | ||||||||||||
Recognition of actuarial (gains)/losses | 55 | 4 | 44 | — | — | — | |||||||||||||
Effect of plan curtailments | (229 | ) | (77 | ) | (69 | ) | — | (8 | ) | (13 | ) | ||||||||
Effect of plan settlements | (60 | ) | 1 | — | — | — | — | ||||||||||||
Benefit cost for the period | 120 | 296 | 342 | 41 | 24 | 19 | |||||||||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Actuarial gains and losses on pensions, other long-term and post-employment benefits break down as follows:
(€ million) | 2012 | 2011 | 2010 | 2009 | 2008 | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Actuarial gains/(losses) arising during the period (1) | (1,604 | ) | (681 | ) | (360 | ) | (207 | ) | (786 | ) | ||||||
Comprising: | ||||||||||||||||
• gains/(losses) on experience adjustments | 319 | (266 | ) | 169 | 531 | (1,326 | ) | |||||||||
• gains/(losses) on changes in assumptions (2) | (1,923 | ) | (415 | ) | (529 | ) | (738 | ) | 540 | |||||||
Breakdown of experience adjustments: | ||||||||||||||||
• gains/(losses) on plan assets (3) | 360 | (292 | ) | 255 | 553 | (1,360 | ) | |||||||||
• gains/(losses) on obligations | (41 | ) | 26 | (86 | ) | (22 | ) | 34 | ||||||||
Amount of obligations at the balance sheet date | 12,560 | 10,945 | 9,988 | 9,300 | 8,110 | |||||||||||
Fair value of plan assets at the balance sheet date | 6,791 | 6,045 | 5,712 | 4,920 | 3,998 | |||||||||||
(€ million) | 2011 | 2010 | 2009 | 2008 | 2007 | |||||||||||||||
Actuarial gains/(losses) arising during the period(1) | (681 | ) | (360 | ) | (207 | ) | (786 | ) | 289 | |||||||||||
Comprising: | ||||||||||||||||||||
• gains/(losses) on experience adjustments | (266 | ) | 169 | 531 | (1,326 | ) | (135 | ) | ||||||||||||
• gains/(losses) on changes in assumptions(2) | (415 | ) | (529 | ) | (738 | ) | 540 | 424 | ||||||||||||
Breakdown of experience adjustments: | ||||||||||||||||||||
• gains/(losses) on plan assets(3) | (292 | ) | 255 | 553 | (1,360 | ) | (160 | ) | ||||||||||||
• gains/(losses) on obligations | 26 | (86 | ) | (22 | ) | 34 | 25 | |||||||||||||
Amount of obligations at the balance sheet date | 10,945 | 9,988 | 9,300 | 8,110 | 8,820 | |||||||||||||||
Fair value of plan assets at the balance sheet date | 6,045 | 5,712 | 4,920 | 3,998 | 5,413 |
|
|
|
The net pre-tax actuarial loss recognized directly in equity (excluding associates)associates and joint ventures) was €3,693 million at December 31, 2012, versus €2,145 million at December 31, 2011 versusand €1,459 million at December 31, 2010 and €1,143 million at2010.
At December 31, 2009.
As of December 31, 2011,2012, the present value of obligations in respect of pensions and other long-term benefits under wholly or partially funded plans was €8,913€9,672 million, and the present value of unfunded obligations was €2,349 million (versus €8,913 million and €1,562 million (versus respectivelyat December 31, 2011, and €7,589 million and €1,969 million at December 31, 2010, and €6,897 million and €2,027 million at December 31, 2009)respectively).
In Germany, Sanofi is a member of aPensionskasse multi-employer plan. This is a defined-benefit plan accounted for as a defined-contribution plan in accordance with the accounting policy described in Note B.23. Plan contributions cover the current level of annuities. However, the obligation arising from future increases in annuity rates is recognized as part of the overall pension obligation; it amounted to €655 million at December 31, 2012, versus €489 million at December 31, 2011 versusand €487 at December 31, 2010, and €449 million at December 31, 2009.2010.
The table below shows the sensitivity of (i) the benefit cost recognized in the consolidated income statement, and (ii) the obligation in the consolidated balance sheet, to changes in healthcare costs associated with other post-employment benefits.
(€ million) | Sensitivity of assumptions | |||||||
---|---|---|---|---|---|---|---|---|
1% increase in healthcare costs | ||||||||
• Impact on benefit cost for the period | 3 | |||||||
• Impact on obligation in the balance sheet | ||||||||
1% reduction in healthcare costs | ||||||||
• Impact on benefit cost for the period | ( | ) | ||||||
• Impact on obligation in the balance sheet | ( | ) | ||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The total cost of pensions and other benefits, which amounted to €320€161 million in 2011,2012, is split as follows:
(€ million) | Year ended December 31, 2012 | Year ended December 31, 2011 | Year ended December 31, 2010 (1) | |||||||
---|---|---|---|---|---|---|---|---|---|---|
• Cost of sales | 122 | 117 | 121 | |||||||
• Research and development expenses | 74 | 81 | 98 | |||||||
• Selling and general expenses | 65 | 160 | 155 | |||||||
• Other operating (income)/expenses, net | (20 | ) | 43 | 51 | ||||||
• Financial expenses (2) | 10 | — | 9 | |||||||
• Other gains and losses, and litigation (3) | — | (4 | ) | — | ||||||
• Restructuring costs | (90 | ) | (77 | ) | (73 | )(4) | ||||
Total | 161 | 320 | 361 | |||||||
(€ million) | Year ended December 31, 2011 | Year ended December 31, 2010 (1) | Year ended December 31, 2009 (1) | |||||||||
• Cost of sales | 117 | 121 | 111 | |||||||||
• Research and development expenses | 81 | 98 | 98 | |||||||||
• Selling and general expenses | 160 | 155 | 195 | |||||||||
• Other operating expenses | 43 | 51 | 59 | |||||||||
• Financial expenses (2) | — | 9 | 13 | |||||||||
• Other gains and losses, and litigation (3) | (4 | ) | — | — | ||||||||
• Restructuring costs | (77 | ) | (73 | ) (4) | 77 | |||||||
Total | 320 | 361 | 553 |
|
|
|
|
The timing of estimated future estimated benefit payments on unfunded pensionspension and post employment benefits is as followspost-employment plans as of December 31, 2011:2012 is as follows:
(€ million) | Total | Less than 1 year | From 1 to 3 years | From 3 to 5 years | More than 5 years | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Estimated payments | 1,741 | 60 | 115 | 133 | 1,433 | |||||||||||
(€ million) | Total | Less than 1 year | From 1 to 3 years | From 3 to 5 years | More than 5 years | |||||||||||||||
Estimated payments | 1,453 | 64 | 121 | 140 | 1,128 |
The table below shows the expected cash outflows on pensions, other long-term benefits and post employmentpost-employment benefits over the next ten years:
(€ million) | Pensions and other benefits | |||
Estimated employer’s contribution in 2012 | 353 | |||
Estimated benefit payments: | ||||
2012 | 619 | |||
2013 | 618 | |||
2014 | 586 | |||
2015 | 607 | |||
2016 | 620 | |||
2017 to 2021 | 3,528 |
(€ million) | Pensions and other benefits | |||
---|---|---|---|---|
Estimated employer's contribution in 2013 | 268 | |||
Estimated benefit payments: | ||||
2013 | 651 | |||
2014 | 602 | |||
2015 | 602 | |||
2016 | 624 | |||
2017 | 680 | |||
2018 to 2022 | 3,528 | |||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.19.2. Restructuring provisions
The table below shows movements in restructuring provisions classified in non-current liabilities and current liabilities:
(€ million) | December 31, 2012 | December 31, 2011 | December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Balance, beginning of period | 1,930 | 1,611 | 1,018 | |||||||
of which: | ||||||||||
• Classified in non-current liabilities | 1,182 | 1,017 | 257 | |||||||
• Classified in current liabilities | 748 | 594 | 761 | |||||||
Change in provisions recognized in profit or loss for the period | 857 | 861 | 1,073 | |||||||
Provisions utilized | (728 | ) | (592 | ) | (839 | ) | ||||
Transfers | 109 | (2) | 1 | 322 | (1) | |||||
Unwinding of discount | 45 | 38 | 27 | |||||||
Currency translation differences | — | 11 | 10 | |||||||
Balance, end of period | 2,213 | 1,930 | 1,611 | |||||||
of which: | ||||||||||
• Classified in non-current liabilities | 1,461 | 1,182 | 1,017 | |||||||
• Classified in current liabilities | 752 | 748 | 594 | |||||||
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||
Balance, beginning of period | 1,611 | 1,018 | 678 | |||||||||
of which: | ||||||||||||
• Classified in non-current liabilities | 1,017 | 257 | 366 | |||||||||
• Classified in current liabilities | 594 | 761 | 312 | |||||||||
Change in provisions recognized in profit or loss for the period | 861 | 1,073 | 837 | |||||||||
Provisions utilized | (592 | ) | (839 | ) | (388 | ) | ||||||
Transfers | 1 | 322 | (1) | (110 | ) | |||||||
Unwinding of discount | 38 | 27 | 3 | |||||||||
Currency translation differences | 11 | 10 | (2 | ) | ||||||||
Balance, end of period | 1,930 | 1,611 | 1,018 | |||||||||
of which: | ||||||||||||
• Classified in non-current liabilities | 1,182 | 1,017 | 257 | |||||||||
• Classified in current liabilities | 748 | 594 | 761 |
|
ProvisionProvisions for employee termination benefits at December 31, 20112012 amounted to €1,672€1,982 million versus €1,265(versus €1,672 million at December 31, 2010, mainly covering the2011), and primarily covered redundancy programs announced as part of the adaptation of sales forces, R&D and industrial operations in France, the United States, and some other European countries. The provision relating to France (€933was €1,515 million at December 31, 2011 compared with €8892012, versus €933 million at December 31, 2010) mainly represents2011. Charges to provisions during the period included €646 million for the adaptation of the Group's resources in France (see Note D.27.).
The provision for France includes the present value of gross annuities under early retirement plans (including those already in place, and those provided for in 2012) not outsourced as of thatthe balance sheet date, plus social security charges and “Fillon”"Fillon" levies on those annuities and on outsourced annuities. The average residual period of carry under these plans was 3.33.5 years as of December 31, 2011 versus 3.62012 (3.3 years atas of December 31, 2010.2011). In 2011, the2012, premiums amount paid in connection with the outsourcing of annuities wasamounted to €7 million (most of which related to an increase in the period of carry for existing annuities in response to the raising of the statutory retirement age); this compares with €6 million versus €241 million at December 31, 2010.in 2011.
The timing of future termination benefit payments is as follows:
Year ended December 31, 2011 | ||||||||||||||||||||
Benefit payments by period | ||||||||||||||||||||
(€ million) | Total | Less than 1 year | From 1 to 3 years | From 3 to 5 years | More than 5 years | |||||||||||||||
Employee termination benefits | ||||||||||||||||||||
• France | 933 | 189 | 231 | 339 | 174 | |||||||||||||||
• Other countries | 739 | 465 | 235 | 21 | 18 | |||||||||||||||
Total | 1,672 | 654 | 466 | 360 | 192 |
Year ended December 31, 2010 | ||||||||||||||||||||
Benefit payments by period | ||||||||||||||||||||
(€ million) | Total | Less than 1 year | From 1 to 3 years | From 3 to 5 years | More than 5 years | |||||||||||||||
Employee termination benefits | ||||||||||||||||||||
• France | 889 | 233 | 263 | 217 | 176 | |||||||||||||||
• Other countries | 376 | 226 | 127 | 13 | 10 | |||||||||||||||
Total | 1,265 | 459 | 390 | 230 | 186 |
Year ended December 31, 2012 | ||||||||||||||||
Benefit payments by period | ||||||||||||||||
(€ million) | Total | Less than 1 year | From 1 to 3 years | From 3 to 5 years | More than 5 years | |||||||||||
Employee termination benefits | ||||||||||||||||
• France | 1,515 | 400 | 644 | 382 | 89 | |||||||||||
• Other countries | 467 | 257 | 179 | 24 | 7 | |||||||||||
Total | 1,982 | 657 | 823 | 406 | 96 | |||||||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Movements during 2011 recognized in profit or loss for the period mainly comprise expenses relating to measures taken to adapt sales and R&D functions in Western Europe and North America.
An analysis of restructuring costs by type is provided in Note D.27.
Year ended December 31, 2011 | ||||||||||||||||
Benefit payments by period | ||||||||||||||||
(€ million) | Total | Less than 1 year | From 1 to 3 years | From 3 to 5 years | More than 5 years | |||||||||||
Employee termination benefits | ||||||||||||||||
• France | 933 | 189 | 231 | 339 | 174 | |||||||||||
• Other countries | 739 | 465 | 235 | 21 | 18 | |||||||||||
Total | 1,672 | 654 | 466 | 360 | 192 | |||||||||||
D.19.3. Other provisions
Other provisions include provisions for risks and litigation relating to environmental, tax, commercial and product liability risks, and for litigation.matters.
(€ million) | December 31, 2012 | December 31, 2011 | December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Tax exposures | 2,114 | 2,409 | 2,228 | |||||||
Environmental risks and remediation | 728 | 764 | 781 | |||||||
Product liability risks, litigation and other | 869 | 985 | 951 | |||||||
Total | 3,711 | 4,158 | 3,960 | |||||||
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||
Tax exposures | 2,409 | 2,228 | 2,009 | |||||||||
Environmental risks and remediation | 764 | 781 | 695 | |||||||||
Product liability risks, litigation and other | 985 | 951 | 829 | |||||||||
Total | 4,158 | 3,960 | 3,533 |
Provisions for tax exposures are recorded if the Group is exposed to a probable risk resulting from a tax position adopted by the Group or a subsidiary, and the risk has been quantified at the balance sheet date.
Provisions for “Environmentalenvironmental risks and remediation”remediation mainly relate to contingencies arising from business divestments. The movement during 2010 includes €105 million charged to restructuring costs in connection with the adaptation of chemical industrial facilities in France (see Note D.27.).divestitures.
Identified environmental risks are covered by provisions estimated on the basis of the costs Sanofi believes it will be obliged to meet over a period not exceeding (other than in exceptional cases) 30 years. The Group expects that €126€99 million of these provisions will be utilized in 20122013, and €293€286 million over the period from 20132014 through 2016.2017.
“Product"Product liability risks, litigation and other”other" mainly comprises provisions for risks relating to product liability (including “IBNR”IBNR provisions as described in Note B.12.), government investigations, regulatory or competitionantitrust law claims, or contingencies arising from business divestmentsdivestitures (other than environmental risks).
The main pending legal and arbitral proceedings and government investigations are described in Note D.22.
A full risk and litigation assessment is performed with the assistance of the Group’sGroup's legal advisers, and provisions are recorded as required by circumstances in accordance with the principles described in Note B.12.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.19.4. Other current liabilities
Other current liabilities break down as follows:
(€ million) | December 31, 2012 | December 31, 2011 | December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Taxes payable | 935 | 1,060 | 785 | |||||||
Employee-related liabilities | 1,909 | 1,957 | 1,411 | |||||||
Restructuring provisions (see Note D.19.2.) | 752 | 748 | 594 | |||||||
Interest rate derivatives (see Note D.20.) | 2 | 27 | 3 | |||||||
Currency derivatives (see Note D.20.) | 40 | 218 | 104 | |||||||
Amounts payable for acquisitions of non-current assets | 222 | 191 | 267 | |||||||
Other liabilities | 2,898 | 3,020 | 2,460 | |||||||
Total | 6,758 | 7,221 | 5,624 | |||||||
(€ million) | December 31, 2011 | December 31, 2010 | December 31, 2009 | |||||||||
Taxes payable | 1,060 | 785 | 631 | |||||||||
Employee-related liabilities | 1,957 | 1,411 | 1,458 | |||||||||
Restructuring provisions (see Note D.19.2.) | 748 | 594 | 761 | |||||||||
Interest rate derivatives (see Note D.20.) | 27 | 3 | 62 | |||||||||
Currency derivatives (see Note D.20.) | 218 | 104 | 119 | |||||||||
Amounts payable for acquisitions of non-current assets | 191 | 267 | 251 | |||||||||
Other liabilities | 3,020 | 2,460 | 2,087 | |||||||||
Total | 7,221 | 5,624 | 5,369 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
This item includes the current portion of provisions for litigation, sales returns and other risks;risks, amounts due to associates and joint ventures (see Note D.6.), and amounts due to governmental agencies and the healthcare authorities (see Note D.23.).
D.20. Derivative financial instruments and market risks
The table below shows the fair value of derivative instruments as of December 31, 2011:2012:
(€ million) | Non-current assets | Current assets | Total assets | Non- current liabilities | Current liabilities | Total liabilities | Fair value at 2011 (net) | Fair value at Dec. 31, | Fair value at Dec. 31, 2009 (net) | |||||||||||||||||||||||||||
Currency derivatives | 1 | 48 | 49 | — | (218 | ) | (218 | ) | (169 | ) | (104 | ) | 132 | |||||||||||||||||||||||
• operational | 1 | 12 | 13 | — | (102 | ) | (102 | ) | (89 | ) | (27 | ) | (46 | ) | ||||||||||||||||||||||
• financial | — | 36 | 36 | — | (116 | ) | (116 | ) | (80 | ) | (77 | ) | 178 | |||||||||||||||||||||||
Interest rate derivatives | 393 | 90 | 483 | — | (27 | ) | (27 | ) | 456 | 218 | 7 | |||||||||||||||||||||||||
Total | 394 | 138 | 532 | — | (245 | ) | (245 | ) | 287 | 114 | 139 |
(€ million) | Non- current assets | Current assets | Total assets | Non- current liabilities | Current liabilities | Total liabilities | Fair value at Dec. 31, 2012 (net) | Fair value at Dec. 31, 2011 (net) | Fair value at Dec. 31, 2010 (net) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Currency derivatives | 1 | 82 | 83 | — | (40 | ) | (40 | ) | 43 | (169 | ) | (104 | ) | |||||||||||||||
• operational | 1 | 30 | 31 | — | (14 | ) | (14 | ) | 17 | (89 | ) | (27 | ) | |||||||||||||||
• financial | — | 52 | 52 | — | (26 | ) | (26 | ) | 26 | (80 | ) | (77 | ) | |||||||||||||||
Interest rate derivatives | 393 | 40 | 433 | — | (2 | ) | (2 | ) | 431 | 456 | 218 | |||||||||||||||||
Total | 394 | 122 | 516 | — | (42 | ) | (42 | ) | 474 | 287 | 114 | |||||||||||||||||
Objectives of the use of derivative financial instruments
Sanofi uses derivative instruments to manage operational exposure to movements in exchange rates, and financial exposure to movements in interest rates and exchange rates (where the debt or receivable is not contracted in the functional currency of the borrower or lender entity). Less frequently, Sanofi uses equity derivatives in connection with the management of its portfolio of equity investments.
Sanofi performs periodic reviews of its transactions and contractual agreements in order to identify any embedded derivatives, which are accounted for separately from the host contract in accordance with IAS 39. As of December 31, 2011, Sanofi had no material embedded derivatives.
derivatives as of December 31, 2012, 2011 and 2010.
Counterparty risk
As of December 31, 2011,2012, all currency and interest rate hedges were contracted with leading banks, and no single counterparty accounted for more than 13% of the notional amount of the Group’sGroup's overall currency and interest rate positions.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
a) Currency derivatives used to manage operational risk exposures
Sanofi operates a foreign exchange risk hedging policy to reduce the exposure of operating income to fluctuations in foreign currencies, in particular the U.S. dollar. This policy involves regular assessments of the Group’sGroup's worldwide foreign currency exposure, based on budget estimates of foreign-currency transactions to be carried out by the parent company and its subsidiaries. These transactions mainly comprise sales, purchases, research costs, co-marketing and co-promotion expenses, and royalties. To reduce the exposure of these transactions to exchange rate movements, Sanofi contracts economic hedges using liquid financialderivative instruments, such asprimarily forward purchases and sales of currency and as applicable, call and put options, and combinations of currency options (collars).
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The table below shows operational currency hedging instruments in place as of December 31, 2011,2012, with the notional amount translated into Euroseuros at the relevant closing exchange rate:
As of December 31, 2012 | | | Of which derivatives designated as cash flow hedges | Of which derivatives not eligible for hedge accounting | ||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Notional amount | Fair value | | Notional amount | Fair value | Of which recognized in equity | | Notional amount | Fair value | |||||||||||||||||
Forward currency sales | 2,972 | 21 | — | — | — | 2,972 | 21 | |||||||||||||||||||
• of which U.S. dollar | 972 | 6 | — | — | — | 972 | 6 | |||||||||||||||||||
• of which Japanese yen | 485 | 15 | — | — | — | 485 | 15 | |||||||||||||||||||
• of which Russian rouble | 368 | (3 | ) | — | — | — | 368 | (3 | ) | |||||||||||||||||
• of which Singapore dollar | 271 | — | — | — | — | 271 | — | |||||||||||||||||||
• of which Chinese yuan renminbi | 255 | 1 | — | — | — | 255 | 1 | |||||||||||||||||||
Forward currency purchases | 944 | (4 | ) | — | — | — | 944 | (4 | ) | |||||||||||||||||
• of which Singapore dollar | 231 | (4 | ) | — | — | — | 231 | (4 | ) | |||||||||||||||||
• of which Hungarian forint | 166 | (3 | ) | — | — | — | 166 | (3 | ) | |||||||||||||||||
• of which Swiss franc | 110 | — | — | — | — | 110 | — | |||||||||||||||||||
• of which Chinese yuan renminbi | 94 | — | 94 | — | ||||||||||||||||||||||
• of which U.S. dollar | 69 | — | — | — | — | 69 | — | |||||||||||||||||||
Total | 3,916 | 17 | — | — | — | 3,916 | 17 | |||||||||||||||||||
As of December 31, 2011 | Of which derivatives designated as cash flow hedges | Of which derivatives not eligible for hedge accounting | ||||||||||||||||||||||||||
(€ million) | Notional amount | Fair value | Notional amount | Fair value | Of which recognized in equity | Notional amount | Fair value | |||||||||||||||||||||
Forward currency sales | 3,446 | (96 | ) | — | — | — | 3,446 | (96 | ) | |||||||||||||||||||
• of which U.S. dollar | 1,779 | (59 | ) | — | — | — | 1,779 | (59 | ) | |||||||||||||||||||
• of which Japanese Yen | 685 | (22 | ) | — | — | — | 685 | (22 | ) | |||||||||||||||||||
• of which Russian ruble | 310 | (5 | ) | — | — | — | 310 | (5 | ) | |||||||||||||||||||
• of which Singapore dollar | 71 | — | — | — | — | 71 | — | |||||||||||||||||||||
• of which Australian dollar | 63 | (2 | ) | — | — | — | 63 | (2 | ) | |||||||||||||||||||
Forward currency purchases | 1,077 | 7 | — | — | — | 1,077 | 7 | |||||||||||||||||||||
• of which Singapore dollar | 357 | 4 | — | — | — | 357 | 4 | |||||||||||||||||||||
• of which Swiss franc | 165 | 2 | — | — | — | 165 | 2 | |||||||||||||||||||||
• of which Japanese Yen | 124 | 3 | — | — | — | 124 | 3 | |||||||||||||||||||||
• of which Hungarian forint | 107 | (4 | ) | — | — | — | 107 | (4 | ) | |||||||||||||||||||
• of which U.S. dollar | 69 | — | — | — | — | 69 | — | |||||||||||||||||||||
Total | 4,523 | (89 | ) | — | — | — | 4,523 | (89 | ) |
As of December 31, 2011,2012, none of these instruments had onan expiry date after December 31, 2012,February 28, 2013, with the exception of a forward purchase of GBP40GBP 33 million expiring between 20122013 and 2015.
These positions mainly hedge material future foreign-currency cash flows arising after the balance sheet date in relation to transactions carried out during the year ended December 31, 20112012 and recognized in the balance sheet at that date. Gains and losses on these hedging instruments (forward contracts) are calculated and recognized in parallel with the recognition of gains and losses on the hedged items. Consequently, we do not expect the commercial foreign exchange result to begain or loss recognized on these items (hedges and hedged instruments) in 2012 is not expected2013 to be material.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The table below shows operational currency hedging instruments in place as of December 31, 2011, with the notional amount translated into euros at the relevant closing exchange rate:
As of December 31, 2011 | | | Of which derivatives designated as cash flow hedges | Of which derivatives not eligible for hedge accounting | ||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Notional amount | Fair value | | Notional amount | Fair value | Of which recognized in equity | | Notional amount | Fair value | |||||||||||||||||
Forward currency sales | 3,446 | (96 | ) | — | — | — | 3,446 | (96 | ) | |||||||||||||||||
• of which U.S. dollar | 1,779 | (59 | ) | — | — | — | 1,779 | (59 | ) | |||||||||||||||||
• of which Japanese yen | 685 | (22 | ) | — | — | — | 685 | (22 | ) | |||||||||||||||||
• of which Russian rouble | 310 | (5 | ) | — | — | — | 310 | (5 | ) | |||||||||||||||||
• of which Singapore dollar | 71 | — | — | — | — | 71 | — | |||||||||||||||||||
• of which Australian dollar | 63 | (2 | ) | — | — | — | 63 | (2 | ) | |||||||||||||||||
Forward currency purchases | 1,077 | 7 | — | — | — | 1,077 | 7 | |||||||||||||||||||
• of which Singapore dollar | 357 | 4 | — | — | — | 357 | 4 | |||||||||||||||||||
• of which Swiss franc | 165 | 2 | — | — | — | 165 | 2 | |||||||||||||||||||
• of which Japanese yen | 124 | 3 | — | — | — | 124 | 3 | |||||||||||||||||||
• of which Hungarian forint | 107 | (4 | ) | — | — | — | 107 | (4 | ) | |||||||||||||||||
• of which U.S. dollar | 69 | — | — | — | — | 69 | — | |||||||||||||||||||
Total | 4,523 | (89 | ) | — | — | — | 4,523 | (89 | ) | |||||||||||||||||
The table below shows operational currency hedging instruments in place as of December 31, 2010, with the notional amount translated into Euroseuros at the relevant closing exchange rate:
As of December 31, 2010 | Of which derivatives designated as cash flow hedges | Of which derivatives not eligible for hedge accounting | ||||||||||||||||||||||||||
(€ million) | Notional amount | Fair value | Notional amount | Fair value | Of which recognized in equity | Notional amount | Fair value | |||||||||||||||||||||
Forward currency sales | 2,444 | (25 | ) | — | — | — | 2,444 | (25 | ) | |||||||||||||||||||
• of which U.S. dollar | 1,380 | (12 | ) | — | — | — | 1,380 | (12 | ) | |||||||||||||||||||
• of which Russian ruble | 248 | (7 | ) | — | — | — | 248 | (7 | ) | |||||||||||||||||||
• of which Japanese Yen | 202 | (4 | ) | — | — | — | 202 | (4 | ) | |||||||||||||||||||
• of which Pound sterling | 95 | 2 | — | — | — | 95 | 2 | |||||||||||||||||||||
• of which Australian dollar | 60 | (1 | ) | — | — | — | 60 | (1 | ) | |||||||||||||||||||
Forward currency purchases | 257 | (2 | ) | — | — | — | 257 | (2 | ) | |||||||||||||||||||
• of which Hungarian forint | 84 | (1 | ) | — | — | — | 84 | (1 | ) | |||||||||||||||||||
• of which U.S. dollar | 51 | (1 | ) | — | — | — | 51 | (1 | ) | |||||||||||||||||||
• of which Canadian dollar | 31 | — | — | — | — | 31 | — | |||||||||||||||||||||
• of which Russian ruble | 30 | — | — | — | — | 30 | — | |||||||||||||||||||||
• of which Japanese Yen | 18 | — | — | — | — | 18 | — | |||||||||||||||||||||
Total | 2,701 | (27 | ) | — | — | — | 2,701 | (27 | ) |
As of December 31, 2010 | | | Of which derivatives designated as cash flow hedges | Of which derivatives not eligible for hedge accounting | ||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Notional amount | Fair value | | Notional amount | Fair value | Of which recognized in equity | | Notional amount | Fair value | |||||||||||||||||
Forward currency sales | 2,444 | (25 | ) | — | — | — | 2,444 | (25 | ) | |||||||||||||||||
• of which U.S. dollar | 1,380 | (12 | ) | — | — | — | 1,380 | (12 | ) | |||||||||||||||||
• of which Russian rouble | 248 | (7 | ) | — | — | — | 248 | (7 | ) | |||||||||||||||||
• of which Japanese yen | 202 | (4 | ) | — | — | — | 202 | (4 | ) | |||||||||||||||||
• of which Pound sterling | 95 | 2 | — | — | — | 95 | 2 | |||||||||||||||||||
• of which Australian dollar | 60 | (1 | ) | — | — | — | 60 | (1 | ) | |||||||||||||||||
Forward currency purchases | 257 | (2 | ) | — | — | — | 257 | (2 | ) | |||||||||||||||||
• of which Hungarian forint | 84 | (1 | ) | — | — | — | 84 | (1 | ) | |||||||||||||||||
• of which U.S. dollar | 51 | (1 | ) | — | — | — | 51 | (1 | ) | |||||||||||||||||
• of which Canadian dollar | 31 | — | — | — | — | 31 | — | |||||||||||||||||||
• of which Russian rouble | 30 | — | — | — | — | 30 | — | |||||||||||||||||||
• of which Japanese yen | 18 | — | — | — | — | 18 | — | |||||||||||||||||||
Total | 2,701 | (27 | ) | — | — | — | 2,701 | (27 | ) | |||||||||||||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The table below shows operational currency hedging instruments in place as of December 31, 2009, with the notional amount translated into euros at the relevant closing exchange rate.
As of December 31, 2009 | Of which derivatives designated as cash flow hedges | Of which derivatives not eligible for hedge accounting | ||||||||||||||||||||||||||
(€ million) | Notional amount | Fair value | Notional amount | Fair value | Of which recognized in equity | Notional amount | Fair value | |||||||||||||||||||||
Forward currency sales | 2,800 | (51 | ) | 583 | (7 | ) | (7 | ) | 2,217 | (44 | ) | |||||||||||||||||
• of which U.S. dollar | 1,757 | (41 | ) | 367 | (5 | ) | (5 | ) | 1,390 | (36 | ) | |||||||||||||||||
• of which Japanese yen | 269 | 1 | 150 | (1 | ) | (1 | ) | 119 | 2 | |||||||||||||||||||
• of which Russian ruble | 132 | (4 | ) | — | — | — | 132 | (4 | ) | |||||||||||||||||||
• of which Pound sterling | 111 | — | — | — | — | 111 | — | |||||||||||||||||||||
• of which Hungarian forint | 104 | (1 | ) | — | — | — | 104 | (1 | ) | |||||||||||||||||||
Forward currency purchases | 377 | 6 | — | — | — | 377 | 6 | |||||||||||||||||||||
• of which Hungarian forint | 114 | 3 | — | — | — | 114 | 3 | |||||||||||||||||||||
• of which U.S. dollar | 69 | — | — | — | — | 69 | — | |||||||||||||||||||||
• of which Pound sterling | 68 | 1 | — | — | — | 68 | 1 | |||||||||||||||||||||
• of which Canadian dollar | 42 | 1 | — | — | — | 42 | 1 | |||||||||||||||||||||
• of which Swiss franc | 20 | — | — | — | — | 20 | — | |||||||||||||||||||||
Put options purchased | 448 | 14 | 20 | 1 | — | 428 | 13 | |||||||||||||||||||||
• of which U.S. dollar | 278 | 8 | — | — | — | 278 | 8 | |||||||||||||||||||||
Call options written | 881 | (17 | ) | 20 | (1 | ) | — | 861 | (16 | ) | ||||||||||||||||||
• of which U.S. dollar | 555 | (10 | ) | — | — | — | 555 | (10 | ) | |||||||||||||||||||
Put options written | 278 | (8 | ) | — | — | — | 278 | (8 | ) | |||||||||||||||||||
• of which U.S. dollar | 278 | (8 | ) | — | — | — | 278 | (8 | ) | |||||||||||||||||||
Call options purchased | 555 | 10 | — | — | — | 555 | 10 | |||||||||||||||||||||
• of which U.S. dollar | 555 | 10 | — | — | — | 555 | 10 | |||||||||||||||||||||
Total | 5,339 | (46 | ) | 623 | (7 | ) | (7 | ) | 4,716 | (39 | ) |
b) Currency and interest rate derivatives used to manage financial risk exposures
Cash pooling arrangements for foreign subsidiaries outside the euro zone, and some of the Group’sGroup's financing activities, expose certain entities to financial foreign exchange risk. This is the risk of changes in the value of borrowings and loans denominated in a currency other than the functional currency of the borrower or lender. This risk is hedged by the Sanofi parent company using currency swaps or forward contracts, and mainly affects the Sanofi parent company.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The table below shows operationalfinancial currency hedging instruments in place as of December 31, 2011,2012, with the notional amount translated into euros at the relevant closing exchange rate:
| 2012 | 2011 | 2010 | |||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Notional amount | Fair value | Expiry | Notional amount | Fair value | Expiry | Notional amount | Fair value | Expiry | |||||||||||||||||||
Forward currency sales | 3,970 | 38 | 4,900 | (104 | ) | 2,728 | (64 | ) | ||||||||||||||||||||
• of which U.S. dollar | 1,897 | 1 | 2013 | 2,964 | (89 | ) | 2012 | 862 | (26 | ) | 2012 | |||||||||||||||||
• of which Japanese yen | 1,272 | 34 | 2013 | 993 | (17 | ) | 2012 | 904 | (24 | ) | 2011 | |||||||||||||||||
• of which Czech koruna | 191 | — | 2013 | 251 | 4 | 2012 | 359 | (7 | ) | 2011 | ||||||||||||||||||
Forward currency purchases | 2,638 | (12 | ) | 2,719 | 24 | 2,086 | (13 | ) | ||||||||||||||||||||
• of which Pound sterling | 549 | (3 | ) | 2013 | 843 | 5 | 2012 | 565 | (11 | ) | 2011 | |||||||||||||||||
• of which U.S. dollar | 521 | 1 | 2013 | 828 | 10 | 2012 | 814 | (8 | ) | 2011 | ||||||||||||||||||
• of which Singapore dollar | 492 | (4 | ) | 2013 | 191 | 5 | 2012 | 20 | — | 2011 | ||||||||||||||||||
Total | 6,608 | 26 | 7,619 | (80 | ) | 4,814 | (77 | ) | ||||||||||||||||||||
2011 | 2010 | 2009 | ||||||||||||||||||||||||||||||||||
(€ million) | Notional amount | Fair value | Expiry | Notional amount | Fair value | Expiry | Notional amount | Fair value | Expiry | |||||||||||||||||||||||||||
Forward currency purchases | 2,719 | 24 | — | 2,086 | (13 | ) | — | 6,760 | 185 | — | ||||||||||||||||||||||||||
• of which Pound sterling | 843 | 5 | 2012 | 565 | (11 | ) | 2011 | 433 | 2 | 2010 | ||||||||||||||||||||||||||
• of which U.S. dollar | 828 | 10 | 2012 | 814 | (8 | ) | 2011 | 5,634 | 180 | 2010 | ||||||||||||||||||||||||||
• of which Swiss franc | 274 | 1 | 2012 | 95 | 2 | 2011 | 152 | 1 | 2010 | |||||||||||||||||||||||||||
Forward currency sales | 4,900 | (104 | ) | — | 2,728 | (64 | ) | — | 3,169 | (7 | ) | — | ||||||||||||||||||||||||
• of which U.S. dollar | 2,964 | (89 | ) | 2012 | 862 | (26 | ) | 2012 | 1,634 | (28 | ) | 2010 | ||||||||||||||||||||||||
• of which Japanese yen | 993 | (17 | ) | 2012 | 904 | (24 | ) | 2011 | 837 | 18 | 2010 | |||||||||||||||||||||||||
• of which Czech koruna | 251 | 4 | 2012 | 359 | (7 | ) | 2011 | 394 | 7 | 2010 | ||||||||||||||||||||||||||
Total | 7,619 | (80 | ) | 4,814 | (77 | ) | 9,929 | 178 |
These forward contracts generate a net financial foreign exchange gain or loss arising from the interest rate gapdifferential between the hedged currency and the euro, given that the foreign exchange gain or loss on the foreign-currency liabilitiesborrowings and receivablesloans is offset by the change in the intrinsic value of the hedging instruments. In addition, the Group may hedge some future foreign-currency cash flows relating to investment or divestment transactions.
FollowingSince the financing of the Genzyme acquisition, the Group manageshas managed its net debt in two currencies, the euro and the U.S. dollar (see Note D.17.)D.17). The variablefloating-rate portion of this debt exposes the Group to an increaserises in interest rates, primarily on the one hand onin the Eonia and Euribor benchmark rates (for the euro) and on the other hand onin the U.S. Libor and Federal Fund Effective.Effective rates (for the U.S. dollar). In this context, in order to reduce the costamount and/or volatility of itsthe cost of debt, we usethe Group uses interest rate swaps, cross-currency swaps and interest rate options that alter the fixed/floating structuresplit of our debt. DerivativeThese derivative instruments are denominated partially denominated in euros and partially in U.S. dollars.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
TheseThe table below shows instruments wereof this type in place as followsof December 31, 2012:
| Notional amounts by expiry date as of December 31, 2012 | | Of which derivatives designated as fair value hedges | Of which derivatives designated as cash flow hedges | ||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | | 2013 | 2014 | 2015 | 2016 | 2017 | 2019 | Total | | Fair value | | Notional amount | Fair value | | Notional amount | Fair value | Of which recognized in equity | |||||||||||||||||||||||||||||||
Interest rate swaps | ||||||||||||||||||||||||||||||||||||||||||||||||
– Pay floating/receive 2.73% | — | — | — | 500 | — | — | 500 | 45 | 500 | 45 | — | — | — | |||||||||||||||||||||||||||||||||||
– Pay floating/receive 2.38% | — | 1,200 | — | 1,000 | — | 800 | 3,000 | 251 | 3,000 | 251 | — | — | — | |||||||||||||||||||||||||||||||||||
– Pay floating/receive 0.57% | — | — | — | — | 375 | — | 375 | 2 | 375 | 2 | — | — | — | |||||||||||||||||||||||||||||||||||
– Pay floating/receive 1.15% | — | — | — | — | 428 | — | 428 | 2 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||
– Pay floating/receive 0.34% | — | 379 | — | — | — | — | 379 | 2 | 379 | 2 | — | — | — | |||||||||||||||||||||||||||||||||||
Cross-currency swaps | ||||||||||||||||||||||||||||||||||||||||||||||||
– Pay € floating/receive JPY floating | 92 | — | — | — | — | — | 92 | 40 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||
– Pay € 4.87%/receive CHF 3.38% | — | — | 244 | — | — | — | 244 | 91 | — | — | 244 | 91 | 4 | |||||||||||||||||||||||||||||||||||
Currency swaps hedging USD investments | ||||||||||||||||||||||||||||||||||||||||||||||||
– Pay USD/receive € | 872 | — | — | — | — | — | 872 | (2 | ) | — | — | — | — | — | ||||||||||||||||||||||||||||||||||
Total | 964 | 1,579 | 244 | 1,500 | 803 | 800 | 5,890 | 431 | 4,254 | 300 | 244 | 91 | 4 | |||||||||||||||||||||||||||||||||||
The table below shows instruments of this type in place as of December 31, 2011:
| Notional amounts by expiry date as of December 31, 2011 | | Of which derivatives designated as fair value hedges | Of which derivatives designated as cash flow hedges | |||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | | 2012 | 2013 | 2014 | 2015 | 2016 | 2019 | 2021 | Total | | Fair value | | Notional amount | Fair value | | Notional amount | Fair value | Of which recognized in equity | |||||||||||||||||||||||||||||||||
Caps | |||||||||||||||||||||||||||||||||||||||||||||||||||
– Purchases of caps 0.50% | 1,932 | — | — | — | — | — | — | 1,932 | 1 | — | — | 1,932 | 1 | (1 | ) | ||||||||||||||||||||||||||||||||||||
Interest rate swaps | |||||||||||||||||||||||||||||||||||||||||||||||||||
– Pay floating/receive 2.73% | — | — | — | — | 500 | — | — | 500 | 34 | 500 | 34 | — | — | — | |||||||||||||||||||||||||||||||||||||
– Pay floating/receive 2.38% | — | — | 1,200 | — | 1,000 | 800 | — | 3,000 | 204 | 3,000 | 204 | — | — | — | |||||||||||||||||||||||||||||||||||||
– Pay floating/receive 1.86% | — | — | — | — | — | — | 232 | 232 | (1 | ) | 232 | (1 | ) | — | — | — | |||||||||||||||||||||||||||||||||||
– Pay floating/receive 0.34% | — | — | 386 | — | — | — | — | 386 | 1 | 386 | 1 | — | — | — | |||||||||||||||||||||||||||||||||||||
Cross-currency swaps | |||||||||||||||||||||||||||||||||||||||||||||||||||
– Pay € floating/receive JPY floating | — | 92 | — | — | — | — | — | 92 | 58 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||
– Pay € 4.89%/receive CHF 3.26% | 180 | — | — | — | — | — | — | 180 | 48 | — | — | 180 | 48 | 1 | |||||||||||||||||||||||||||||||||||||
– Pay € 4.87%/receive CHF 3.38% | — | — | — | 244 | — | — | — | 244 | 96 | — | — | 244 | 96 | 11 | |||||||||||||||||||||||||||||||||||||
– Pay € floating/receive CHF 3.26% | 167 | — | — | — | — | — | — | 167 | 42 | 167 | 42 | — | — | — | |||||||||||||||||||||||||||||||||||||
Currency swaps hedging USD investments | |||||||||||||||||||||||||||||||||||||||||||||||||||
– Pay USD/receive € | 1,404 | — | — | — | — | — | — | 1,404 | (27 | ) | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||
Total | 3,683 | 92 | 1,586 | 244 | 1,500 | 800 | 232 | 8,137 | 456 | 4,285 | 280 | 2,356 | 145 | 11 | |||||||||||||||||||||||||||||||||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Notional amounts by expiry date as of December 31, 2011 | Of which derivatives designated as cash flow hedges | Of which derivatives not eligible | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
(€ million) | 2012 | 2013 | 2014 | 2015 | 2016 | 2019 | 2021 | Total | Fair value | Notional | Fair value | Notional | Fair value | Of which recognized in equity | ||||||||||||||||||||||||||||||||||||||||||
Caps | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
– Purchases of Caps 0.50% | 1,932 | — | — | — | — | — | — | 1,932 | 1 | — | — | 1,932 | 1 | (1 | ) | |||||||||||||||||||||||||||||||||||||||||
Interest rate swaps | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
– Pay floating / receive 2.73% | — | — | — | — | 500 | — | — | 500 | 34 | 500 | 34 | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
– Pay floating / receive 2.38% | — | — | 1,200 | — | 1,000 | 800 | — | 3,000 | 204 | 3,000 | 204 | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
– Pay floating / receive 1.86% | — | — | — | — | — | — | 232 | 232 | (1 | ) | 232 | (1 | ) | — | — | — | ||||||||||||||||||||||||||||||||||||||||
– Pay floating / receive 0.34% | — | — | 386 | — | — | — | — | 386 | 1 | 386 | 1 | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Cross Currency Swaps | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
– Pay € floating / Receive JPY floating | — | 92 | — | — | — | — | — | 92 | 58 | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
– Pay € 4.89% / receive CHF 3.26 % | 180 | — | — | — | — | — | — | 180 | 48 | — | — | 180 | 48 | 1 | ||||||||||||||||||||||||||||||||||||||||||
– Pay € 4.87% / receive CHF 3.38% | — | — | — | 244 | — | — | — | 244 | 96 | — | — | 244 | 96 | 11 | ||||||||||||||||||||||||||||||||||||||||||
– Pay € floating / receive CHF 3.26% | 167 | — | — | — | — | — | — | 167 | 42 | 167 | 42 | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Currency swaps hedging USD investments | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
– Pay USD / receive € | 1,404 | — | — | — | — | — | — | 1,404 | (27 | ) | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
Total | 3,683 | 92 | 1,586 | 244 | 1,500 | 800 | 232 | 8,137 | 456 | 4,285 | 280 | 2,356 | 145 | 11 |
The table below shows instruments of this type in place as of December 31, 2010:
Notional amounts by expiry date as of December 31, 2010 | Of which derivatives designated as fair value hedges | Of which derivatives cash flow hedges | ||||||||||||||||||||||||||||||||||||||||||||||
(€ million) | 2011 | 2012 | 2013 | 2015 | 2016 | Total | Fair value | Notional amount | Fair value | Notional amount | Fair value | Of which recognized in equity | ||||||||||||||||||||||||||||||||||||
Interest rate swaps | ||||||||||||||||||||||||||||||||||||||||||||||||
– Pay floating / receive 2.73% | — | — | — | — | 500 | 500 | 12 | 500 | 12 | — | — | — | ||||||||||||||||||||||||||||||||||||
Cross currency Swaps | ||||||||||||||||||||||||||||||||||||||||||||||||
– Pay € floating / receive JPY floating | — | — | 92 | — | — | 92 | 47 | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||
– Pay € 4.89% / receive CHF 3.26% | — | 180 | — | — | — | 180 | 41 | — | — | 180 | 41 | 1 | ||||||||||||||||||||||||||||||||||||
– Pay € 4.87% / receive CHF 3.38% | — | — | — | 244 | — | 244 | 82 | — | — | 244 | 82 | 6 | ||||||||||||||||||||||||||||||||||||
– Pay € floating/ receive CHF 3.26% | — | 167 | — | — | — | 167 | 38 | 167 | 38 | — | — | — | ||||||||||||||||||||||||||||||||||||
Currency swaps | ||||||||||||||||||||||||||||||||||||||||||||||||
– pay € / receive USD | 489 | — | — | — | — | 489 | (2 | ) | — | — | — | — | — | |||||||||||||||||||||||||||||||||||
Total | 489 | 347 | 92 | 244 | 500 | 1,672 | 218 | 667 | 50 | 424 | 123 | 7 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The table below shows instruments of this type in place as of December 31, 2009:
Notional amounts by expiry date as of December 31, 2009 | Of which derivatives designated as fair value hedges | Of which derivatives designated as cash flow hedges | ||||||||||||||||||||||||||||||||||||||||||
(€ million) | 2010 | 2012 | 2013 | 2015 | Total | Fair value | Notional amount | Fair value | Notional amount | Fair value | Of which recognized in equity | |||||||||||||||||||||||||||||||||
Interest rate swaps | ||||||||||||||||||||||||||||||||||||||||||||
– Pay floating / receive 1.27% | 1,000 | — | — | — | 1,000 | 2 | 1,000 | 2 | — | — | — | |||||||||||||||||||||||||||||||||
Cross currency swaps | ||||||||||||||||||||||||||||||||||||||||||||
– Pay € floating / receive £ 5.50% | 299 | — | — | — | 299 | (62 | ) | 299 | (62 | ) | — | — | — | |||||||||||||||||||||||||||||||
– Pay € floating / receive JPY floating | — | — | 92 | — | 92 | 21 | — | — | — | — | — | |||||||||||||||||||||||||||||||||
– Pay € floating / receive CHF 2.75% | 122 | — | — | — | 122 | 16 | 122 | 16 | — | — | — | |||||||||||||||||||||||||||||||||
– Pay € 4.89% / receive CHF 3.26% | — | 180 | — | — | 180 | 3 | — | — | 180 | 3 | (2 | ) | ||||||||||||||||||||||||||||||||
– Pay € 4.87% / receive CHF 3.38% | — | — | — | 244 | 244 | 23 | — | — | 244 | 23 | (2 | ) | ||||||||||||||||||||||||||||||||
– Pay € floating / receive CHF 3.26% | — | 167 | — | — | 167 | 4 | 167 | 4 | — | — | — | |||||||||||||||||||||||||||||||||
Total | 1,421 | 347 | 92 | 244 | 2,104 | 7 | 1,588 | (40 | ) | 424 | 26 | (4 | ) |
The change in the structure of the Group’s debt arising from these financial instruments is described in Note D.17., which also includes an analysis of the Group’s sensitivity to interest rates.
| Notional amounts by expiry date as of December 31, 2010 | | Of which derivatives designated as fair value hedges | Of which derivatives designated as cash flow hedges | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | | 2011 | 2012 | 2013 | 2015 | 2016 | Total | | Fair value | | Notional amount | Fair value | | Notional amount | Fair value | Of which recognized in equity | |||||||||||||||||||||||||||||
Interest rate swaps | |||||||||||||||||||||||||||||||||||||||||||||
– Pay floating/receive 2.73% | — | — | — | — | 500 | 500 | 12 | 500 | 12 | — | — | — | |||||||||||||||||||||||||||||||||
Cross-currency swaps | |||||||||||||||||||||||||||||||||||||||||||||
– Pay € floating/receive JPY floating | — | — | 92 | — | — | 92 | 47 | — | — | — | — | — | |||||||||||||||||||||||||||||||||
– Pay € 4.89%/receive CHF 3.26% | — | 180 | — | — | — | 180 | 41 | — | — | 180 | 41 | 1 | |||||||||||||||||||||||||||||||||
– Pay € 4.87%/receive CHF 3.38% | — | — | — | 244 | — | 244 | 82 | — | — | 244 | 82 | 6 | |||||||||||||||||||||||||||||||||
– Pay € floating/receive CHF 3.26% | — | 167 | — | — | — | 167 | 38 | 167 | 38 | — | — | — | |||||||||||||||||||||||||||||||||
Currency swaps | |||||||||||||||||||||||||||||||||||||||||||||
– pay €/receive USD | 489 | — | — | — | — | 489 | (2 | ) | — | — | — | — | — | ||||||||||||||||||||||||||||||||
Total | 489 | 347 | 92 | 244 | 500 | 1,672 | 218 | 667 | 50 | 424 | 123 | 7 | |||||||||||||||||||||||||||||||||
D.21. Off balance sheet commitments
The off balance sheet commitments presented below are shown at their nominal value.
D.21.1. Off balance sheet commitments relating to operating activities
The Group’sGroup's off balance sheet commitments are analyzedbreak down as follows:
December 31, 2011 | Payments due by period | |||||||||||||||||||
(€ million) | Total | Under 1 year | From 1 to 3 years | From 3 to 5 years | Over 5 years | |||||||||||||||
• Operating lease obligations | 1,456 | 284 | 406 | 245 | 521 | |||||||||||||||
• Irrevocable purchase commitments (1) | ||||||||||||||||||||
– given | 3,041 | 1,672 | 608 | 325 | 436 | |||||||||||||||
– received | (247 | ) | (105 | ) | (76 | ) | (42 | ) | (24 | ) | ||||||||||
• Research and development license agreements | ||||||||||||||||||||
– future service commitments(2) | 944 | 196 | 307 | 416 | 25 | |||||||||||||||
– potential milestone payments(3) | 2,822 | 175 | 297 | 444 | 1,906 | |||||||||||||||
Total | 8,016 | 2,222 | 1,542 | 1,388 | 2,864 |
|
|
|
December 31, 2012 | Payments due by period | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Total | Under 1 year | From 1 to 3 years | From 3 to 5 years | Over 5 years | |||||||||||
• Operating lease obligations | 1,296 | 250 | 367 | 220 | 459 | |||||||||||
• Irrevocable purchase commitments (1) | ||||||||||||||||
– given | 2,913 | 1,513 | 651 | 368 | 381 | |||||||||||
– received | (209 | ) | (106 | ) | (67 | ) | (14 | ) | (22 | ) | ||||||
• Research and development license agreements | ||||||||||||||||
– future service commitments (2) | 767 | 181 | 286 | 276 | 24 | |||||||||||
– potential milestone payments (3) | 2,201 | 149 | 267 | 295 | 1,490 | |||||||||||
Firm commitment under the agreement with BMS (4) | 82 | — | — | — | 82 | |||||||||||
Total | 7,050 | 1,987 | 1,504 | 1,145 | 2,414 | |||||||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The Group leases certain of its properties and equipment used in the ordinary course of business under operating leases. Future minimum lease payments due under non-cancelable operating leases at December 31, 2011 amounted to2012 were €1,296 million (versus €1,456 million (versusat December 31, 2011 and €1,291 million at December 31, 2010 and €1,197 million at December 31, 2009)2010).
Total rental expense recognized in the year ended December 31, 20112012 was €294 million (versus €324 million (versusin 2011 and €281 million at December 31, 2010 and €279 million at December 31, 2009.in 2010).
Research and development license agreements
In pursuance of its strategy, the Group may acquire technologies and rights to products. Such acquisitions may be made in various contractual forms: acquisitions of shares, loans, license agreements, joint development, and co-marketing. These contracts usually involve upfront payments on signature of the agreement, development milestone payments, and royalties. Some of these complex agreements include undertakings to finance research programs in future years and payments contingent upon specified development milestones, the granting of approvals or licenses, or the attainment of sales targets once a product is on the market.
The item “Research"Research and development license agreements”agreements" line comprises future service commitments to finance research and development or technology, and potential milestone payments regarded as reasonably possible (i.e. all potential milestone payments relating to projects in the development phase)phase, for which the future financial consequences are known and considered as probable and for which there is a sufficiently reliable estimate). This item excludes commitments relating to projects in the research phase (€4.25 billion in 2011 and €4.12012, €4.2 billion in 2010)2011) and payments contingent upon the attainment of sales targets once a product is on the market (€4.44.7 billion in 2011 and €3.32012, €4.4 billion in 2010)2011).
Potential milestone payments relating to Pharmaceuticals segment development projects of the Pharmaceuticals segment amountedamount to €2.6€2 billion, out of which €2.1€1.4 billion relatedrelates to the mainprincipal collaboration agreements described below.
In January 2008
both type 1 and type 2 diabetes. |
In December 2009, Sanofi and the U.S. biotechnology company Alopexx Pharmaceuticals, (LLC)LLC simultaneously signed (i) a collaboration agreement, and (ii) an option for a license on an antibody for the prevention and treatment of infections originating in the bacterium that causes plague and other serious infections.
End
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
agreement.
Sanofi amounted to €0.6 billion.
Sanofi has also entered into the following major agreements, which are currently in a less advanced research phase:
December 2010: an exclusive global licensing option with Oxford BioTherapeutics for three existing antibodies, plus a research and collaboration agreement to discover and validate new targets in oncology.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
|
Sanofi Pasteur has entered into a number of collaboration agreements. Milestone payments relating to development projects under those agreements amounted to €0.2 billion in 2011.2012.
In December 2009, Sanofi Pasteur signed a donation letter to the World Health Organization (WHO). The terms of the agreement committed Sanofi Pasteur to donate 10% of its future output of vaccines against A(H1N1), A(H5N1) or any other influenza strain with pandemic potential, up to a maximum of 100 million doses. Since this agreement was put in place, Sanofi Pasteur has already donated to the WHO some of the doses covered by the commitment.
D.21.2. Off balance sheet commitments related to the financing of the Group
The undrawnUndrawn credit facilities break down as follows:
December 31, 2012 | Payments due by period | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Total | Under 1 year | From 1 to 3 years | From 3 to 5 years | Over 5 years | |||||||||||
General-purpose credit facilities | 10,021 | 3,020 | 250 | 6,750 | 1 | |||||||||||
December 31, 2011 | Payments due by period | |||||||||||||||||||
(€ million) | Total | Under 1 year | From 1 to 3 years | From 3 to 5 years | Over 5 years | |||||||||||||||
General-purpose facilities | 10,046 | 3,046 | — | 7,000 | — |
As of December 31, 2010,2012, total credit facilities amounted to €10,021 million (versus €10,046 million as of December 31, 2011 and €23,464 million as of December 31, 2010 including Genzyme acquisition facilities amounted to €23,464 million.facilities).
Guarantees given and received (mainly surety bonds) are as follows:
(€ million) | 2011 | 2010 | 2009 | |||||||||
Guarantees given | 3,296 | 2,558 | 2,358 | |||||||||
Guarantees received | (751 | ) | (185 | ) | (171 | ) |
(€ million) | 2012 | 2011 | 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Guarantees given | 4,311 | 3,296 | 2,558 | |||||||
Guarantees received | (185 | ) | (224 | ) | (185 | ) | ||||
D.21.3. Off balance sheet commitments relating to the scope of consolidation
The maximum amount of contingent consideration related to business combinations is presented in Note D.18.
D.22. Legal and Arbitral Proceedings
Sanofi and its affiliates are involved in litigation, arbitration and other legal proceedings. These proceedings typically are related to product liability claims, intellectual property rights (particularly claims against generic companies seeking to limit the patent protection of Sanofi products), competition law and trade practices, commercial claims, employment and wrongful discharge claims, tax assessment claims, waste disposal and pollution claims, and claims under warranties or indemnification arrangements relating to business divestitures. Provisions related to legal and arbitral proceedings are recorded in accordance with the principles described in Note B.12.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Most of the issues raised by these claims are highly complex and subject to substantial uncertainties; therefore, the probability of loss and an estimation of damages are difficult to ascertain. Contingent liabilities are cases for which either we are unable to make a reasonable estimate of the expected financial effect that will result from ultimate resolution of the proceeding, or a cash outflow is not probable. In either case, a brief description of the nature of the contingent liability is disclosed and, where practicable, an estimate of its financial effect, an indication of the uncertainties relating to the amount and timing of any outflow, and the possibility of any reimbursement are provided in application of paragraph 86 of IAS 37.
In the cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed, we have indicated our losses or the amount of provision accrued that is the estimate of the probable loss.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
In a limited number of ongoing cases, while we are able to make a reasonable estimate of the expected loss or range of the possible loss and have accrued a provision for such loss, we believe that publication of this information on a case-by-case basis or by class would seriously prejudice the Company’sCompany's position in the ongoing legal proceedings or in any related settlement discussions. Accordingly, in those cases, we have disclosed information with respect to the nature of the contingency but have not disclosed our estimate of the range of potential loss, in accordance with paragraph 92 of IAS 37.
These assessments can involve a series of complex judgments about future events and can rely heavily on estimates and assumptions. Our assessments are based on estimates and assumptions that have been deemed reasonable by management. We believe that the aggregate provisions recorded for the above matters are adequate based upon currently available information. However, given the inherent uncertainties related to these cases and involved in estimating contingent liabilities, we could in the future incur judgments that could have a material adverse effect on our net income in any particular period.
Long term provisions other than provisions for pensions and other benefits and restructuring provisions are disclosed in Note D.19.3.
a) Products
• Sanofi Pasteur Hepatitis B Vaccine Product Litigation
Since 1996, more than 180 lawsuits have been filed in various French civil courts against Sanofi Pasteur SA and/or Sanofi Pasteur MSD S.N.C., the former a French subsidiary of Sanofi, and the latter a joint venture company with Merck & Co., Inc. In such lawsuits, the plaintiffs allege that they suffer from a variety of neurological disorders and autoimmune diseases, including multiple sclerosis and Guillain-Barré syndrome as a result of receiving the hepatitis B vaccine. The French Supreme Court (Cour de Cassation), in July 2009, upheld a decision of the Court of Appeals of Lyon ordering Sanofi Pasteur MSD S.N.C. to pay damages of €120,000 to a claimant whose multiple sclerosis appeared shortly after her vaccination against the hepatitis B virus; however, in several cases before and after the July 2009 decision, theCour de Cassation upheld several decisions of various Courts of Appeals (including the Court of Appeals of Paris), rejecting claims alleging such causal link. Nevertheless, it is difficult to provide an opinion on the evolution and final outcome of these cases. A number of claims remain to be adjudicated and there can be no assurance that cases decided to date will be representative of future decisions and that additional claims will not be filed in France or other countries.
In January 2008, both the legal entity Sanofi Pasteur MSD S.N.C., and a corporate officer of this company, as well as a former corporate officer of Sanofi Pasteur, S.A., were placed under investigation in an ongoing criminal inquiry in France relating to alleged side effects caused by the hepatitis B vaccine. Since March 2012, Sanofi Pasteur and the former chief executive officer of Sanofi Pasteur have been placed under an "advised witness" status.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
• Plavix®Plavix® Product Litigation
Over 250Around 444 lawsuits, involving approximately 2,857 claimants have been filed against affiliates of the Group and Bristol-Myers Squibb seeking recovery under state law for personal injuries allegedly sustained in connection with the use of Plavix®Plavix®. The actions are venued in several jurisdictions, including the federal and/or state courts of New Jersey, New York, California, Pennsylvania, and Illinois. Defendants filed an application beforeThe defendants have exercised their right to terminate the Judicial Panel on Multidistrict Litigation (JPML) for coordinated proceedings and seeking the transfer of current and future federal cases to the U.S. District Court for the District of New Jersey. The application was denied. A tolling agreement (agreement which tolls or suspends the running of the statute of limitations) remains in effect for, effective September 1, 2012, with respect to unfiled claims by potential additional potential plaintiffs. AtIt is not possible, at this stage, ofto assess reliably the litigation, a reasonable estimate of the financial effectoutcome of these cases is not practicable.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
lawsuits or the potential financial impact on the Company.
b) Patents
• Ramipril Canada Patent Litigation
Sanofi is involved in a number of legal proceedings involving companies which market generic Altace®Altace® (ramipril) in Canada. Notwithstanding proceedings initiated by Sanofi, the following eight manufacturers: Apotex (in 2006), Teva (formerly Novopharm), Sandoz and Cobalt (in 2007), and Riva, Genpharm, Ranbaxy and Pro Doc (in 2008),manufacturers obtained marketing authorizations from the Canadian Minister of Health for generic versions of ramipril in Canada. Following the marketing of these products, Sanofi filed patent infringement actions against all eightthose companies. In thea patent infringement actions against Apotex and Teva,action, the Federal Court of Canada ruled on June 29, 2009 that the patent asserted patentby Sanofi was invalid. Sanofi's leave to appeal the judgment was denied in 2012. Each of Teva, Apotex and Riva initiated Section 8 damages claims against Sanofi, seeking compensation for their alleged inability to market a generic ramipril during the time taken to resolve the proceedings against the Canadian Ministry of Health. The Teva and Apotex Section 8 trials were heard early 2012 respectively and the Court issued its decision on May 11, 2012 setting down the parameters for calculating total damages owed. Sanofi and Teva reached an agreement in June 2012 on a confidential amount to satisfy Teva's claim and in November 2012, Apotex was awarded CAD 221 million. Sanofi has appealed the Court's decisions in both the Apotex and Teva trials have been scheduled forSection 8 cases to the first quarterFederal court of 2012, while theAppeal. The Riva Section 8 trial has been scheduled forstayed until the third quarterApotex and Teva cases are decided on appeal.
• Plavix® Patent Litigation in Australia
In August, 2007, GenRX (a subsidiary of 2012. Sanofi’s appealsApotex) obtained registration of a generic clopidogrel bisulfate product on the Australian Register of Therapeutic Goods. At the same time, GenRX filed a patent invalidation action with the Federal Court of Canada decisions on theAustralia, seeking revocation of Sanofi's Australian enantiomer patent invalidity was dismissed byclaiming clopidogrel salts (a "nullity action"). In September 2007, Sanofi obtained a preliminary injunction from the Federal Court preventing commercial launch of Appealthis generic clopidogrel bisulfate product until judgment on November 2, 2011the substantive issues of patent validity and Sanofi has sought leaveinfringement. In February 2008, Spirit Pharmaceuticals Pty. Ltd. also filed a nullity action against Sanofi's Australian enantiomer patent. The Spirit proceeding was consolidated with the Apotex proceeding.
In August, 2008, the Australian Federal Court confirmed that the claim in Sanofi's Australian enantiomer patent directed to clopidogrel bisulfate (the salt form in Plavix®) was valid and the patent infringed. On appeal, the Full Federal Court of Australia held in September 2009 that all claims in the patent are invalid. Sanofi's appeal to the Australia Supreme Court. Neither appeal suspendsCourt was denied in March 2010. The security bond posted by Sanofi in connection with the advancementpreliminary injunction obtained in 2007 was subsequently increased from Australian $40 million to Australian $204 million (€160 million as of December 31, 2012). Apotex is now seeking damages for having been subject to an injunction.
The Australia Department of Health and Ageing (the "Department") has notified Sanofi that it claims to be entitled to money damages from Sanofi related to the existing damages claims.Apotex preliminary injunction. The Department has not yet taken any formal legal action associated with this claim.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
c) Government Investigations, Competition Law and Regulatory Claims
• Civil Suits — Pricing and Marketing Practices
Average Wholesale Prices (AWP) Class Actions. Aventis Pharmaceuticals Inc. (API) is a defendant in several U.S. lawsuits seeking damages on behalf of multiple putative classes of individuals and entities that allegedly overpaid for certain pharmaceuticals as a result of the AWP pricing which were used to set Medicare and Medicaid reimbursement levels. Aventis Behring and Sanofi-Synthélabo Inc. were also defendants in some of these cases. These suits allege violations of various statutes, including state unfair trade, unfair competition, consumer protection and false claim statutes.
A group of eleven defendants, including Sanofi defendants, reached a tentative global settlement of the claims of the insurers and consumers, for a total of U.S.$125 million. The defendants’ respective shares of the settlement amount are confidential. This settlement was granted preliminary approval by the U.S. District Court in Boston in early July 2008. In December 2011, the Court granted the settlement final approval. Once any objections are resolved, this will resolve all class action suits of the U.S. District Court in Boston. Sanofi’s share of the global settlement is fully covered by existing reserves.
• §340B Suit. On August 18, 2005, the County of Santa Clara, California filed a suit against Aventis Pharmaceuticals Inc. and fourteen other pharmaceutical companies originally in the Superior Court of the State of California, County of Alameda, alleging that the defendants had overcharged Public Health Service entities for their pharmaceutical products in breach of pharmaceutical pricing agreements between the defendants and the Secretary of Health and Human Services. Subsequently, the case was removed to the U.S. District for the Northern District of California. In May 2009, the Court denied the plaintiffs’ motion for class certification without prejudice. All proceedings in the District Court were stayed pending the decision of the Supreme Court concerning whether plaintiffs have a private right of action. On March 29, 2011, the U.S. Supreme Court issued an opinion concluding that plaintiffs do not have a private right of action, ruling in favor of Aventis Pharmaceuticals and fourteen other defendants, and restoring an order of dismissal that previously had been entered by the U.S. District Court for the Northern District of California. Accordingly, the District Court is expected to receive, in due course, a mandate ordering it to dismiss this case.
• Cipro®Cipro® Antitrust Litigation
Since August 2000, Aventis Pharmaceuticals Inc. (API) has been a defendant in several related cases in U.S. state and federal courts alleging that API and certain other pharmaceutical manufacturers violated U.S. antitrust laws and various state laws by settling a patent dispute regarding the brand-name prescription drug Cipro®Cipro® in a manner which allegedly delayed the arrival of generic competition.
In March 2005, the U.S. District Court for the
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Eastern District of New York granted Sanofi’sSanofi's summary judgment motions, and issued a judgment in favor of API and the other defendants in this litigation. By Order entered October 15, 2008, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court’sCourt's ruling in the appeal by indirect purchaser plaintiffs; the direct purchaser plaintiffs’plaintiffs' appeal was heard by the U.S. Court of Appeals for the Second Circuit in April 2009. On April 29, 2010, the Federal Circuit affirmed the District Court’sCourt's ruling dismissing the direct purchasers’purchasers' case on summary judgment. The direct purchaser plaintiffs requested a rehearing en banc, which was denied by the Federal Circuit in September 2010. Following an appeal to the U.S. Supreme Court by the direct purchaser plaintiffs, on March 7, 2011, the U.S. Supreme Court denied the direct purchaser plaintiff’splaintiff's petition for a writ of certiori, thus ending the federal litigation relating to CiproCipro®.There is one case remaining in California which is stayed pending the decision of the US Supreme Court in®In re. K-Dur Antitrust Litigation.
• DDAVP®DDAVP® Antitrust Litigation
Subsequent to the decision of the U.S. District Court for the Southern District of New York in February 2005 holding the patent rights at issue in the DDAVP®DDAVP® tablet litigation to be unenforceable as a result of inequitable conduct, eight putative class actions have been filed claiming injury as a result of Ferring B.V. and Aventis Pharmaceuticals Inc.’s's alleged scheme to monopolize the market for DDAVP®DDAVP® tablets in violation of the Sherman Act and the antitrust and deceptive trade practices statutes of several states. On November 6, 2006, the District Court dismissed these claims. Oral argument on plaintiffs’ appeal of the decision to dismiss was heard by the U.S. Court of Appeals for the Second Circuit in 2008. By Order dated October 16, 2009, the appellate court reversed and remanded the case back to the District Court. Petitions for rehearing and rehearing en banc were denied. In August 2011, Aventis Pharmaceuticals and Ferring reached an agreement with direct purchaser plaintiffs resolving their claims. Aventis Pharmaceuticals Inc. agreed to resolve these claims for U.S.$3.5 $3.5 million.
In December 2012, Aventis Pharmaceuticals reached a settlement with the indirect purchasers for U.S. $800 000.
• Plavix® Antitrust Claim
On March 23, 2006, the U.S. retailer, The Kroger Co., filed an antitrust complaint in the District Court for the Southern District of Ohio against Sanofi, Bristol-Myers Squibb Co. and Apotex Corp. alleging antitrust violations by the defendants in relation to their tentative agreement to settle the U.S. Plavix® patent litigation (see “Item 8 — Patents — Apotex Settlement Claim” above). Seventeen other complaints have since been filed by direct and indirect purchasers of Plavix® on the same or similar grounds. Plaintiffs seek relief including injunctive relief and monetary damages. Defendants have moved to dismiss the consolidated direct and indirect purchasers’ complaints. Following Orders entered by the U.S. District Court for the Southern District of Ohio in October 2009, and in January 2011, dismissing the claims of the direct purchasers and indirect purchasers respectively, Plaintiffs have not appealed, thus ending these matters.
• Lovenox®Lovenox® Antitrust Litigation
In August 2008, Eisai Inc. (Eisai) brought suit against Sanofi U.S. LLC and Sanofi U.S. Inc. in the U.S. District Court for the District of New Jersey alleging that certain contracting practices for Lovenox®Lovenox® violate federal and state antitrust laws. The proceedings are in the discovery phase. An estimate of the financial effect of this case is not practicable at this stage of the litigation.
Sanofi U.S. LLC and Sanofi U.S. Inc. filed a separate state court lawsuit against Eisai and two individuals who are current employees of Eisai and former employees of Sanofi U.S. and/or its predecessors. Sanofi U.S. alleges that the individuals took confidential information from Sanofi U.S. predecessors to Eisai in breach of their employment agreements with Sanofi, and that such confidential information has been utilized by them and by Eisai to the detriment of Sanofi U.S. This litigation is stayed.
d) Other litigation and arbitration
• Hoechst Shareholder Litigation
On December 21, 2004, the extraordinary general meeting of Sanofi’sSanofi's German subsidiary Hoechst AG (now Hoechst GmbH) approved a resolution transferring the shares held by minority shareholders to Sanofi for compensation of €56.50 per share. Certain minority shareholders filed claims contesting the validity of the resolution, preventing its registration with the commercial register of Frankfurt and its entry into effect.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
On July 12, 2005, this litigation was settled. As a consequence, the squeeze out has been registered in the commercial register making Sanofi the sole shareholder of Hoechst AG.
According to the settlement agreement, the cash compensation has been increased to €63.80 per share. The cash compensation was further increased by another €1.20 per share for those outstanding shareholders whointer alia
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
alia waived in advance any increase of the cash compensation obtained through a judicial appraisal proceeding(Spruchverfahren) brought by former minority shareholders. Minority shareholders representing approximately 5 million shares did not accept such offer.
Subsequently, a number of former minority shareholders of Hoechst initiated a judicial appraisal proceeding with the District Court of Frankfurt (Landgericht Frankfurt am MainFrankfurt-am-Main) contesting the amount of the cash compensation paid in the squeeze out. In its decision dated January 27, 2012, the District Court of Frankfurt ruled in favor of Sanofi, confirming the amount of €63.80 per share as adequate cash compensation. Plaintiffs may appeal.A number of opt-out shareholders have filed an appeal with the Appeals Court of Frankfurt.
• Zimulti® /Acomplia®Zimulti®/Acomplia® (rimonabant) Class Action
In November 2007, a purported class action was filed in the U.S. District Court for the Southern District of New York on behalf of purchasers of Sanofi shares. The complaint charged Sanofi and certain of its current and former officers and directors with violations of the Securities Exchange Act of 1934. The complaint alleged that defendants’defendants' statements regarding rimonabant (a product withdrawn from the market, formerly registered and marketed under the trademark Acomplia®Acomplia® in Europe and Zimulti®Zimulti® in the US) were materially false and misleading when made because defendants allegedly concealed data concerning certain alleged secondary effects of rimonabant, in particular, suicidality in patients suffering from depression. In September 2009, the motion was dismissed with prejudice. The plaintiffs filed a motion for reconsideration. On July 27, 2010, the U.S. District Court for the Southern District of New York granted plaintiff’splaintiff's motion to reconsider and authorized plaintiffs to submit an amended complaint. In November 2010, the District Court heard arguments on Sanofi’sSanofi's motion to dismiss plaintiffs’plaintiffs' amended complaint. By Order dated March 31, 2011, the U.S. District Court for the Southern District of New York dismissed a number of individual defendants, however, denied Sanofi’sSanofi's request to dismiss the company, as well as one of its current officers and one of its former officers. On November 11, 2011, Plaintiffsplaintiffs filed a motion for class certification. Oral argument on plaintiff's motion for class certification took place on September 19, 2012. Discovery is on-going. A reliable measure of potential liabilities arising from this purported class action is not possible at this stage of the litigation.
• Merial Heartgard®Heartgard® Advertisement Claim
On August 31, 2009, a purportedputative class action lawsuit was filed against Merial before the U.S. District Court for the Northern District of Mississippi, alleging that Merial engaged in false and misleading advertising of Heartgard®Heartgard® and Heartgard®Heartgard® Plus by claiming 100% efficacy in the prevention of heartworm disease, as well as the prevention of zoonotic diseases. Plaintiffs also request punitive damages and a permanent injunction with respect to the alleged advertising. The proceedings are ongoing and the class has not been certified yet. Merial filed a motion for summary judgment. A reliable measure of potential liabilities arising from this putative class action is not possible at this stage of the litigation.
• Merial Frontline®Frontline® Advertisement Claim
From October 2011 through January 2012, ten putative class actions were filed against Merial in various U.S. federal courts, each alleging that the plaintiffs sustained damages after purchasing defendants’defendants' products (Merial’s Frontline®(Merial's Frontline® and /or Certifect®Certifect® brands and Bayer’s Advantage®Bayer's Advantage® and Advantix®Advantix® brands) for their pets’pets' flea problems. These actions have been transferred to the U.S. District Court for the Northern District of Ohio for coordinated proceedingsand consolidated in a multi-district litigation.
The complaints seek injunctive relief and contain counts for violations of consumer protection or deceptive trade practices acts, false advertising, breach of implied and express warranty and violations of the
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Magnuson-Moss Warranty Act. Four of the complaints seek U.S.$32 billion in damages, two complaints seek greater than U.S.$4 billion in damages, and the remaining four complaints seek damages in excess of U.S.$5 million, which is merely the jurisdictional threshold. The proceedings are ongoing and nomillion. No class has been certified.certified yet. In October 2012, defendants filed a motion for summary judgment. Discovery is ongoing. A reliable measure of potential liabilities arising from this putative class action litigation is currently not possible.
e) Contingencies arising from certain Business Divestitures
Sanofi and its subsidiaries, Hoechst and Aventis Agriculture, divested a variety of mostly chemical, including agro-chemical, businesses as well as certain health product businesses in previous years. As a result of these divestitures, the Group is subject to a number of ongoing contractual and legal obligations regarding the state of the sold businesses, their assets, and their liabilities.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
• Aventis Behring Retained Liabilities
The divestment of Aventis Behring and related protein therapies assets became effective on March 31, 2004. The purchase agreement contained customary representations and warranties running from Sanofi as seller to CSL Limited as purchaser. Sanofi has indemnification obligations that generally expired on March 31, 2006 (the second anniversary of the closing date). However, some indemnification obligations, having a longer duration, remain in effect, for example, indemnification obligations relating to the due organization, capital stock and ownership of Aventis Behring Companies runs through March 31, 2014, and product liability indemnification through March 31, 2019, subject to an extension for claims related to certain types of product liability notified before such date. Furthermore, for tax-related issues, the indemnification obligation of Sanofi covers all taxable periods that end on or before the closing date and expires thirty days after the expiration of the applicable statute of limitations. In addition, the indemnification obligations relating to certain specified liabilities, including HIV liability, survive indefinitely.
Under the indemnification agreement, Sanofi is generally obligated to indemnify CSL Limited, only to the extent indemnifiable, losses exceeding U.S.$10 million and up to a maximum aggregate amount of U.S.$300 million. For environmental claims, the indemnification due by Sanofi equals 90% of the indemnifiable losses. Product liability claims are generally treated separately, and the aggregate indemnification is capped at U.S.$500 million. Certain indemnification obligations, including those related to HIV liability, as well as tax claims, are not capped in amount.
• Aventis CropScience Retained Liabilities
The sale by Aventis Agriculture S.A. and Hoechst GmbH (both legacy companies of Sanofi) of their aggregate 76% participation in Aventis CropScience Holding (ACS) to Bayer and Bayer CropScience AG (BCS), the wholly owned subsidiary of Bayer which holds the ACS shares, was effective on June 3, 2002. The stock purchase agreement dated October 2, 2001, contained customary representations and warranties with respect to the sold business, as well as a number of indemnifications, in particular with respect to: environmental liabilities (the representations and warranties and the environmental indemnification are subject to a cap of €836 million, except for certain legal representations and warranties and specific environmental liabilities, notably third-party site claims such as (i) the natural resources damages (NRD) claim filed by the state of New Jersey against BCS in 2007 in relation to the Factory Lane site, and (ii) a remediation and NRD project underway in Portland, Oregon)liabilities); taxes; certain legal proceedings; claims related to StarLink®StarLink® corn; and certain pre-closing liabilities, in particular, product liability cases (which are subject to a cap of €418 million). There are various periods of limitation depending upon the nature or subject of the indemnification claim. Further, Bayer and BCS are subject to a number of obligations regarding mitigation and cooperation.
Starting with a first settlement agreement signed in December 2005, Aventis Agriculture and Hoechst GmbH have resolved a substantial number of disputes with Bayer and BCS, AG, including the termination of arbitration proceedings initiated in August 2003 for an alleged breach of a financial statement-related representation contained in the stock purchase agreement, and numerous other warranty and indemnification claims asserted under the stock purchase agreement, including claims relating to certain environmental and product liabilities. A number of other outstanding claims remain unresolved.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
LLRICE601 and LLRICE604 — U.S. LitigationLitigation:: BCS has sent Sanofi notice of potential claims for indemnification under various provisions of the stock purchase agreement. These potential claims relate to several hundred individual complaints that have been filed since August 2006 by rice growers, millers, and distributors in U.S. state and federal courts against a number of current and former subsidiaries (collectively the “CropScience Companies”"CropScience Companies") which were part of the ACS group prior to Bayer’sBayer's acquisition of the ACS shares.
Plaintiffs in these cases seek to recover damages in connection with the detection of trace amounts of the genetically modified rice called “Liberty Link®"Liberty Link® Rice 601”601" (also known as “LLRICE601”"LLRICE601") or “Liberty Link®"Liberty Link® Rice 604”604" (also known as “LLRICE604”"LLRICE604") in samples of commercial long-grain rice. LLRICE601 and LLRICE604, each a variety of long grain rice genetically altered to resist Liberty®Liberty® Herbicide, were grown in field tests in the United States from the years 1998 to 2001. Plaintiffs assert a number of causes of action, alleging that the CropScience Companies failed to take adequate measures to prevent cross-pollination or commingling of LLRICE601 and/or LLRICE604 with conventional rice.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
In July 2011, BCS reached settlement agreements with attorneys representing U.S. long-grain rice growers at a total amount of U.S.$750 million, thus settling cases that were part of the U.S. federal multi-district litigation, as well as those cases before state courts. The settlement agreement with state court grower plaintiffs does not include certain cases which reached verdicts in Arkansas State Court, as well as certain grower cases that were settled separately from the global settlement, where the courtBCS has awarded plaintiffspaid in such casesjudgement or settlement a collective total of approximately U.S.$54 million in compensatory and punitive damages.67 million.
With respect to one of those cases, the Arkansas Supreme Court upheld the state court jury award of U.S.$42 million in punitive damages, ruling that the statutory cap on punitive damages is unconstitutional. BCS has reached settlement with a number of non-grower plaintiffs, primarily millers and European importers, for a total of approximately U.S.$80203 million. In March 2011, an Arkansas State Court jury awarded Riceland Foods U.S.$11.8 million in compensatory damages and U.S.$125 million in punitive damages. In June 2011 (prior to the above-mentioned Arkansas Supreme Court decision) punitive damages were reduced to U.S.$1 million in application of the statutory cap. Both BCS and Riceland have appealed the decision.decision, and in January 2013, reached a settlement resolving Riceland's claims. Non-grower casestrials are scheduled for trial through 2012.2013.
Sanofi denies direct or indirect liability for these cases, and has so notified BCS.
In a related development, the FDA has concluded that the presence of LLRICE601 in the food and feed supply poses no safety concerns and, on November 24, 2006, the United States Department of Agriculture (USDA) announced it would deregulate LLRICE601. With respect to LLRICE 604, the USDA announced, in March 2007, that the PAT protein contained in LLRICE604 has a long history of safe use and is present in many deregulated products. Further to an investigation regarding the causation chain that led to contamination, in October 2007, the USDA declined to pursue enforcement against BCS.
• Aventis Animal Nutrition Retained Liabilities
Aventis Animal Nutrition S.A. and Aventis (both legacy companies of Sanofi) signed an agreement for the sale to Drakkar Holdings S.A. of the Aventis Animal Nutrition business effective in April 2002. The sale agreement contained customary representations and warranties. Sanofi’sSanofi's indemnification obligations ran through April 2004, except for environmental indemnification obligations (which run through April 2012), tax indemnification obligations (which run through the expiration of the applicable statutory limitation period), and antitrust indemnification obligations (which extend indefinitely). The indemnification undertakings are subject to an overall cap of €223 million, with a lower cap for certain environmental claims. Indemnification obligations for antitrust and tax claims are not capped.
• Celanese AG Retained Liabilities
The demerger of the specialty chemicals business from Hoechst to Celanese AG (now trading as “Celanese GmbH”"Celanese GmbH") became effective on October 22, 1999. Under the demerger agreement between Hoechst and
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Celanese, Hoechst expressly excluded any representations and warranties regarding the shares and assets demerged to Celanese. However, the following obligations of Hoechst are ongoing:
While all obligations of Hoechst (i) resulting from public law or (ii) pursuant to current or future environmental laws or (iii) vis-à-vis third parties pursuant to private or public law related to contamination (as defined) have been transferred to Celanese in full, Hoechst splits with Celanese any such cost incurred under these obligations applying a 2:1 ratio. The liability for indemnification of Hoechst under the demerger agreement is with Celanese and an affiliate.
To the extent Hoechst is liable to purchasers of certain of its divested businesses (as listed in the demerger agreement), Celanese and an affiliate are liable to indemnify Hoechst, as far as environmental damages are concerned, for aggregate liabilities up to €250 million, liabilities exceeding such amount will be borne by Hoechst alone up to €750 million, and amounts exceeding €750 million will be borne 2/3 by Hoechst and 1/3 by Celanese without any further caps.
Compensation paid to third parties by Celanese through December 31, 2011,2012, was significantly below the first threshold of €250 million.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
• Rhodia Retained Liabilities
In connection with the initial public offering of Rhodia in 1998, Rhône-Poulenc (later named Aventis, to which Sanofi is the legal successor in interest) entered into an environmental indemnification agreement with Rhodia on May 26, 1998 under which, subject to certain conditions, Rhodia was entitled to claim indemnification from Aventis with respect to direct losses resulting from third-party claims or public authority injunctions for environmental damages. Aventis and Rhodia entered into a settlement agreement on March 27, 2003 under the terms of which the parties settled all environmental claims in connection with the environmental indemnification agreement.
Notwithstanding this settlement agreement, Rhodia and certain of its subsidiaries have unsuccessfully sought indemnification for environmental costs in the United States and Brazil. In both instances, the suits were decided in favor of Sanofi, with the court holding that the settlement precluded the indemnification claims. The decision in Brazil was under appeal by Rhodia. On September 6, 2011, the Court of Appeals rendered a decision favorable to Sanofi, confirming that the Environmental Settlement concluded in March 2003 precludes any claim from Rhodia in these matters. In 2012, Rhodia may appeal tofiled a motion for reconsideration of this decision before the Supreme Court of Appeals in Brazil.
Sao Paulo.
On April 13, 2005, Rhodia initiated anad hoc arbitration procedure seeking indemnification from Sanofi for the financial consequences of the environmental liabilities and pension obligations that were allocated to Rhodia through the various operations leading to the formation of Rhodia in 1997, amounting respectively to €125 million and €531 million. Rhodia additionally sought indemnification for future costs related to transferred environmental liabilities and coverage of all costs necessary to fully fund the transfer of pension liabilities out of Rhodia’sRhodia's accounts.
The arbitral tribunal determined that it has no jurisdiction to rule on pension claims and that Rhodia’sRhodia's environmental claims are without merit. In May 2008, the Paris Court of Appeals rejected the action initiated by Rhodia to nullify the 2006 arbitral award in favor of Sanofi.
On July 10, 2007, Sanofi was served with a civil suit brought by Rhodia before the Commercial Court of Paris (Tribunal de Commerce de Paris) seeking indemnification on the same grounds as described above. The allegations before the Commercial Court of Paris are comparable to those asserted in Rhodia’sRhodia's arbitration demand. On February 10, 2010, Rhodia submitted its pleadings brief (conclusions récapitulatives) in which it has asked the Court to hold that Sanofi was at fault in failing to provide Rhodia with sufficient capital to meet its pension obligations and environmental liabilities, and has claimed indemnification in the amount of €1.3 billion for retirement commitments and approximately €311 million for environmental liabilities. On December 14, 2011, the
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Commercial Court of Paris ruled in favor of Sanofi, rejecting all of Rhodia’sRhodia's allegations and claims. Rhodia has appealed this decision.
• Rhodia Shareholder Litigation
In January 2004, two minority shareholders of Rhodia and their respective investment vehicles filed two claims before the Commercial Court of Paris (Tribunal de Commerce de Paris) against Aventis, to which Sanofi is successor in interest, together with other defendants including former directors and statutory auditors of Rhodia from the time of the alleged events. The claimants seek a judgment holding the defendants collectively liable for alleged management errors and for alleged publication of misstatements between 1999 and 2002, andinter alia regarding Rhodia’sRhodia's acquisition of the companies Albright & Wilson and ChiRex. These shareholders seek a finding of joint and several liability for damages to be awarded to Rhodia in an amount of €925 million for alleged harm to the Company (a derivative action), as well as personal claims of €4.3 million and €125.4 million for their own alleged individual losses. Sanofi contests both the substance and the admissibility of these claims.
Sanofi is also aware of three criminal complaints filed in France by the same plaintiffs and of a criminal investigation order issued by the Paris public prosecutor following the submission of the report issued by theAutorité des Marchés Financiers regarding Rhodia’sRhodia's financial communications. In 2006, the Commercial Court of Paris accepted Sanofi and the other defendants’defendants' motion to stay the civil litigation pending the conclusion of the criminal proceedings. The plaintiffs’plaintiffs' appeals against this decision, first before the Court of Appeals, and then before the French Supreme Court (Cour de Cassation), were both rejected.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
• Clariant Retained Liabilities — Specialty Chemicals Business
Hoechst conveyed its specialty chemicals business to Clariant AG (Clariant) pursuant to a 1997 agreement. While Clariant has undertaken to indemnify Hoechst for all costs incurred for environmental matters relating to purchased sites, certain ongoing indemnification obligations of Hoechst for environmental matters in favor of Clariant can be summarized as follows:
• InfraServInfraserv Höchst Retained Liabilities
By the Asset Contribution Agreement dated December 19/20, 1996, as amended in 1997, Hoechst contributed all lands, buildings, and related assets of the Hoechst site at Frankfurt-Höchst to InfraServ HöchstInfraserv GmbH & Co. Höchst KG. InfraServInfraserv Höchst undertook to indemnify Hoechst against environmental liabilities at the Höchst site and with respect to certain landfills. As consideration for the indemnification undertaking, Hoechst transferred to InfraServInfraserv Höchst approximately €57 million to fund reserves. In 1997, Hoechst also agreed it would reimburse current and future InfraServInfraserv Höchst environmental expenses up to €143 million. As a former owner of the land and as a former user of the landfills, Hoechst may ultimately be liable for costs of remedial action in excess of this amount.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.23. Provisions for discounts, rebates and sales returns
Adjustments between gross sales and net sales, as described in Note B.14., are recognized either as provisions or as reductions in accounts receivable, depending on their nature.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The table below shows movements in these items:
(€ million) | Government and State programs(2) | Managed Care and GPO programs(3) | Charge- back incentives | Rebates and discounts | Sales returns | Other deductions | Total | |||||||||||||||||||||
January 1, 2009 | 286 | 185 | 82 | 261 | 183 | 52 | 1,049 | |||||||||||||||||||||
Current provision related to current period sales | 566 | 433 | 904 | 2,036 | 204 | 128 | 4,271 | |||||||||||||||||||||
Net change in provision related to prior period sales | 19 | 7 | — | 12 | (7 | ) | — | 31 | ||||||||||||||||||||
Payments made | (477 | ) | (431 | ) | (903 | ) | (1,893 | ) | (175 | ) | (136 | ) | (4,015 | ) | ||||||||||||||
Currency Translation differences | (8 | ) | (7 | ) | (3 | ) | 9 | (3 | ) | 2 | (10 | ) | ||||||||||||||||
December 31, 2009 | 386 | 187 | 80 | 425 | 202 | 46 | 1,326 | |||||||||||||||||||||
Current provision related to current period sales | 937 | 410 | 1,246 | 3,058 | 357 | 127 | 6,135 | |||||||||||||||||||||
Net change in provision related to prior period sales | (4 | ) | (11 | ) | 8 | 14 | 12 | (4 | ) | 15 | ||||||||||||||||||
Payments made | (663 | ) | (400 | ) | (1,225 | ) | (2,719 | ) | (255 | ) | (126 | ) | (5,388 | ) | ||||||||||||||
Currency Translation differences | 16 | 15 | 6 | 35 | 17 | 5 | 94 | |||||||||||||||||||||
December 31, 2010 | 672 | 201 | 115 | 813 | 333 | 48 | 2,182 | |||||||||||||||||||||
Merial(1) | — | — | 1 | 69 | 1 | 8 | 79 | |||||||||||||||||||||
Genzyme | 7 | — | 4 | 132 | 39 | 12 | 194 | |||||||||||||||||||||
Current provision related to current period sales | 1,224 | 496 | 1,569 | 4,075 | 348 | 152 | 7,864 | |||||||||||||||||||||
Net change in provisions related to prior period sales | (5 | ) | (35 | ) | 13 | 22 | (4 | ) | (2 | ) | (11 | ) | ||||||||||||||||
Payments made | (1,125 | ) | (466 | ) | (1,548 | ) | (3,897 | ) | (311 | ) | (125 | ) | (7,472 | ) | ||||||||||||||
Currency Translation differences | 18 | 7 | 6 | (9 | ) | 9 | 3 | 34 | ||||||||||||||||||||
Balance at December 31, 2011 | 791 | 203 | 160 | 1,205 | 415 | 96 | 2,870 |
(€ million) | Government and State programs (2) | Managed Care and GPO programs (3) | Charge- back incentives | Rebates and discounts | Sales returns | Other deductions | Total | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
January 1, 2010 | 386 | 187 | 80 | 415 | 190 | 46 | 1,304 | |||||||||||||||
Current provision related to current period sales | 937 | 410 | 1,246 | 3,058 | 357 | 127 | 6,135 | |||||||||||||||
Net change in provision related to prior period sales | (4 | ) | (11 | ) | 8 | 14 | 12 | (4 | ) | 15 | ||||||||||||
Payments made | (670 | ) | (400 | ) | (1,225 | ) | (2,804 | ) | (261 | ) | (126 | ) | (5,486 | ) | ||||||||
Currency translation differences | 17 | 15 | 6 | 36 | 19 | 5 | 98 | |||||||||||||||
December 31, 2010 | 666 | 201 | 115 | 719 | 317 | 48 | 2,066 | |||||||||||||||
Merial (1) | — | — | 1 | 69 | 1 | 8 | 79 | |||||||||||||||
Genzyme | 7 | — | 4 | 132 | 39 | 12 | 194 | |||||||||||||||
Current provision related to current period sales | 1,224 | 496 | 1,569 | 4,159 | 349 | 152 | 7,949 | |||||||||||||||
Net change in provision related to prior period sales | (5 | ) | (35 | ) | 13 | 22 | (5 | ) | (2 | ) | (12 | ) | ||||||||||
Payments made | (1,132 | ) | (466 | ) | (1,548 | ) | (4,135 | ) | (322 | ) | (125 | ) | (7,728 | ) | ||||||||
Currency translation differences | 20 | 7 | 6 | 9 | 11 | 3 | 56 | |||||||||||||||
December 31, 2011 | 780 | 203 | 160 | 975 | 390 | 96 | 2,604 | |||||||||||||||
Current provision related to current period sales | 1,713 | 522 | 2,368 | 4,574 | 432 | 261 | 9,870 | |||||||||||||||
Net change in provision related to prior period sales | (56 | ) | (34 | ) | (22 | ) | 9 | (23 | ) | 1 | (125 | ) | ||||||||||
Payments made | (1,422 | ) | (517 | ) | (2,345 | ) | (4,807 | ) | (347 | ) | (260 | ) | (9,698 | ) | ||||||||
Currency translation differences | (15 | ) | (3 | ) | (3 | ) | 3 | (10 | ) | (3 | ) | (31 | ) | |||||||||
Balance at December 31, 2012 | 1,000 | 171 | 158 | 754 | 442 | 95 | 2,620 | |||||||||||||||
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D.24. Personnel costs
Total personnel costs break down as follows:
(€ million) | Year ended December 31, 2012 | Year ended December 31, 2011 | Year ended December 31, 2010 (1) | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Salaries | 6,151 | 5,940 | 5,121 | |||||||
Social security charges (including defined-contribution pension plans) | 1,883 | 1,716 | 1,555 | |||||||
Stock options and other share-based payment expense | 155 | 143 | 133 | |||||||
Defined-benefit pension plans | 212 | 358 | 340 | |||||||
Other employee benefits | 267 | 262 | 238 | |||||||
Total | 8,668 | 8,419 | 7,387 | |||||||
(€ million) | Year ended December 31, 2011 | Year ended December 31, 2010 (1) | Year ended December 31, 2009 (1) | |||||||||
Salaries | 5,940 | 5,121 | 5,019 | |||||||||
Social security charges (including defined-contribution pension plans) | 1,716 | 1,555 | 1,510 | |||||||||
Stock options and other share-based payment expense | 143 | 133 | 114 | |||||||||
Defined-benefit pension plans | 358 | 340 | 404 | |||||||||
Other employee benefits | 262 | 238 | 233 | |||||||||
Total | 8,419 | 7,387 | 7,280 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The total number of employees at December 31, 20112012 was 113,719,111,974, compared with 113,719 at December 31, 2011 and 101,575 at December 31, 2010 and 104,867 at December 31, 2009 (these employee numbers are unaudited).
Employee numbers by function as of December 31 are shown below (unaudited):
December 31, 2011 | December 31, 2010 (1) | December 31, 2009 (1) | ||||||||||
Production | 44,415 | 37,504 | 36,849 | |||||||||
Research and development | 18,823 | 16,983 | 19,132 | |||||||||
Sales force | 32,874 | 32,686 | 34,292 | |||||||||
Marketing and support functions | 17,607 | 14,402 | 14,594 | |||||||||
Total | 113,719 | 101,575 | 104,867 |
|
| December 31, 2012 | December 31, 2011 | December 31, 2010 (1) | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Production | 45,035 | 44,415 | 37,504 | |||||||
Research and development | 17,066 | 18,823 | 16,983 | |||||||
Sales force | 32,270 | 32,874 | 32,686 | |||||||
Marketing and support functions | 17,603 | 17,607 | 14,402 | |||||||
Total | 111,974 | 113,719 | 101,575 | |||||||
D.25. Other operating income
Other operating income amounted tototaled €562 million in 2012, compared with €319 million in 2011 compared withand €369 million in 2010 and €861 million in 2009.2010.
This line includes income arising under alliance agreements in the Pharmaceuticals segment (€202258 million in 2012, versus €202 million in 2011 versusand €315 million in 2010 and €646 million in 2009)2010), in particular the agreement on the worldwide development and marketing of Actonel®Actonel® (see Note C.2.C.3.) and the Group’sGroup's share of profits on Copaxone® in 2010 and 2009.Copaxone®.
In 2012, it also included the impact of the favorable outcome of litigation relating to a license.
It also includes operating Other items recorded on this line include net foreign exchange gains and losses representing a(representing net losslosses of €(5)€41 million in 2012, €5 million in 2011 compared with a net loss of €(141)and €141 million in 2010 and a net gain of €40 million in 20092010) and proceeds from disposals related to ongoing operations which amounted to(€59 million in 2012, versus €56 million in 2011 and €54 million in 2010, and €56 million in 2009.
2010).
D.26. Other operating expenses
Other operating expenses amounted to €454 million in 2012, €315 million in 2011 versusand €292 million in 2010 and €481 million in 2009.2010. This item includes shares of profits due to alliance partners (other than BMS and the Alliance Partner under the Actonel®Actonel® agreement) under product marketing agreements, primarily in Europe, Japan, the United States and Canada (€12166 million in 2012, versus €121 million in 2011 and €169 million in 2010, and €1862010).
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
In 2012, Sanofi paid $109 million in 2009).an out-of-court settlement with the office of the Massachusetts District Attorney, the U.S. Department of Justice and various other U.S. states to resolve all claims arising from the investigation into the distribution of samples of Hyalgan®, a former Sanofi product.
The costs for the Genzyme acquisitionAlso included on this line is an additional provision of €116 million (before taxes) relating to litigation in Canada in respect of ramipril, recognized in 2011 as other operating expenses amounted €65 million (see Note D.1.1.).2012.
This item alsoFinally, this line includes for 2011, an expense of €40 million in 2012 (versus €43 million (€51 million in 2010)2011) relating to pensions and other benefits for Group retirees.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.27. Restructuring costs
Restructuring costs recognizedamounted to €1,141 million in 2012, versus €1,314 million in 2011 amounted to €1,314 million, (€1,384and €1,384 million in 2010, and €1,080 million in 2009) and break down as follows:
(€ million) | Year ended December 31, 2012 | Year ended December 31, 2011 | Year ended December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Employee-related expenses | 860 | 840 | 817 | |||||||
Expenses related to property, plant and equipment | 221 | 422 | 184 | |||||||
Compensation for early termination of contracts (other than contracts of employment) | 7 | 27 | 35 | |||||||
Decontamination costs | 2 | 22 | 105 | |||||||
Other restructuring costs | 51 | 3 | 243 | |||||||
Total | 1,141 | 1,314 | 1,384 | |||||||
(€ million) | Year ended December 31, 2011 | Year ended December 31, 2010 | Year ended December 31, 2009 | |||||||||
Employee-related expenses | 840 | 817 | 869 | |||||||||
Expenses related to property, plant and equipment | 422 | 184 | 146 | |||||||||
Compensation for early termination of contracts (other than contracts of employment) | 27 | 35 | 19 | |||||||||
Decontamination costs | 22 | 105 | 30 | |||||||||
Other restructuring costs | 3 | 243 | 16 | |||||||||
Total | 1,314 | 1,384 | 1,080 |
TheThese restructuring costs reflect measures announced by the Group to implement aas part of the major transformation project initiated in 2009 to adapt the group’s entitiesGroup's structures to meet future challenges.
In 2012, these costs include provisions of €646 million recognized in the year ended December 31, 2012 following the announcement of a realignment of the Group's resources in France. These measures cover changes in the scope of activities of the Group's Research and Development sites during the next three years, the reorganization of industrial facilities in the Vaccines segment, and the streamlining of the Group's support functions. The restructuring costs recognized during the year also reflect the ongoing transformation of industrial facilities in Europe, adjustments to sales forces worldwide, and the integration of Genzyme. In addition, an impairment loss of €107 million was recognized against property, plant and equipment in France in connection with the reorganization of Research and Development operations.
The restructuring costs recognized in 2011 primarily reflect:reflected the transformation and reorganization of Research and Development operations, measures taken to adapt the Group's industrial facilities in Europe, adjustments to the sales forces in the United States and Europe, the implementation of multi country organizations (MCOs) in Europe, and the integration of Genzyme entities worldwide.
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In 2010, restructuring costs related primarily to measures announced by the Group aimed at transforming theto continue transformation of its Research and Development operations, to upgrade its chemical manufacturing sites to biotech and vaccine production, and to reorganize its sales formforces in the United States and Europe. These costs also includeincluded the impact of pension reforms on existing early retirement reform on the CAA plans already existing in France.
In 2009, restructuring costs related primarily to measures announced in June 2009 by the Group to transform the Research and Development operations in France in order to promote innovation and adapt central support functions to streamline the organization. These costs essentially represent personnel expenses for early retirement benefits and early termination indemnities under voluntary departure plans. In France, approximately 1,000 jobs in Research and Development and 450 jobs in support functions are affected.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.28. Other gains and losses, and litigation
Other gains and losses atfor the year ended December 31, 2011 include:included:
the
;
In 2011, this line item also includes a €210 million incomein compensation for the indemnification of a loss caused by the marketingsale of a counterfeit generic version of Plavix®Plavix® in the United States in 2006.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
In 2010, this line item reportedshowed an expense of €138 million, relating to an adjustment to vendor’svendor's guarantee provisions in connection with past divestments.divestitures.
The Group made no major divestmentsdivestitures in 2010either 2012 or 2009.
2010.
D.29. Financial income and expenses
Financial income and expenses break down as follows:
(€ million) | Year ended December 31, 2012 | Year ended December 31, 2011 | Year ended December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Cost of debt (1) | (417 | ) | (425 | ) | (385 | ) | ||||
Interest income | 68 | 100 | 61 | |||||||
Cost of debt, net of cash and cash equivalents | (349 | ) | (325 | ) | (324 | ) | ||||
Non-operating foreign exchange gains/(losses) | (17 | ) | 10 | (20 | ) | |||||
Unwinding of discount on provisions (2) | (87 | ) | (83 | ) | (68 | ) | ||||
Gains/(losses) on disposals of financial assets | 37 | 25 | 61 | |||||||
Impairment losses on financial assets, net of reversals (3) | (30 | ) | (58 | ) | (6 | ) | ||||
Other items | (14 | ) | 19 | (5 | ) | |||||
Net financial income/(expenses) | (460 | ) | (412 | ) | (362 | ) | ||||
comprising: Financial expenses | (553 | ) | (552 | ) | (468 | ) | ||||
Financial income | 93 | 140 | 106 | |||||||
(€ million) | Year ended December 31, 2011 | Year ended December 31, 2010 | Year ended December 31, 2009 | |||||||||
Cost of debt (1) | (425 | ) | (385 | ) | (310 | ) | ||||||
Interest income | 100 | 61 | 88 | |||||||||
Cost of debt, net of cash and cash equivalents | (325 | ) | (324 | ) | (222 | ) | ||||||
Non-operating foreign exchange gains/(losses) | 10 | (20 | ) | (67 | ) | |||||||
Unwinding of discount on provisions (2) | (83 | ) | (68 | ) | (42 | ) | ||||||
Gains/(losses) on disposals of financial assets | 25 | 61 | 3 | |||||||||
Impairment losses on financial assets, net of reversals (3) | (58 | ) | (6 | ) | (2 | ) | ||||||
Other items | 19 | (5 | ) | 32 | ||||||||
Net financial income/(expenses) | (412 | ) | (362 | ) | (298 | ) | ||||||
comprising: Financial expenses | (552 | ) | (468 | ) | (325 | ) | ||||||
Financial income | 140 | 106 | 27 |
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In 2011, 2010 and 2009, the impact of the ineffective portion of hedging relationships was not material.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.30. Income tax expense
The Group has opted for tax consolidations in a number of countries, principally France, Germany, the United Kingdom and the United States.
The table below shows the split of income tax expense between current and deferred taxes:
(€ million) | Year ended December 31, 2012 | Year ended December 31, 2011 | Year ended December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Current taxes | (2,050 | ) | (2,359 | ) | (2,929 | ) | ||||
Deferred taxes | 916 | 1,904 | 1,499 | |||||||
Total | (1,134 | ) | (455 | ) | (1,430 | ) | ||||
(€ million) | Year ended December 31, 2011 | Year ended December 31, 2010 | Year ended December 31, 2009 | |||||||||
Current taxes | (2,359 | ) | (2,929 | ) | (2,551 | ) | ||||||
Deferred taxes | 1,904 | 1,499 | 1,152 | |||||||||
Total | (455 | ) | (1,430 | ) | (1,399 | ) |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
The difference between the effective tax rate and the standard corporate income tax rate applicable in France is explained as follows:
(as a percentage) | Year ended December 31, 2011 | Year ended December 31, 2010 | Year ended December 31, 2009 | |||||||||
Standard tax rate applicable in France | 34 | 34 | 34 | |||||||||
Impact of reduced-rate income tax on royalties in France | (11 | ) | (10 | ) | (8 | ) | ||||||
Impact of change in net deferred tax liabilities as a result of changes in tax laws and rates(1) | (4 | ) | — | 1 | ||||||||
Impact of the French-American Advance Pricing Agreement (APA) 2006-2010 | (7 | ) | — | — | ||||||||
Impact of the ratification of the Franco-American treaty on deferred tax liabilities relating to tax cost of distributions made from reserves | — | — | (2 | ) | ||||||||
Impact of tax borne by BMS for the territory managed by Sanofi (see Note D.32.) | (1 | ) | (2 | ) | (3 | ) | ||||||
Other items | (2 | ) | 1 | 1 | ||||||||
Effective tax rate | 9 | 23 | 23 |
|
The “Other items”
(as a percentage) | Year ended December 31, 2012 | Year ended December 31, 2011 | Year ended December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Standard tax rate applicable in France | 34 | 34 | 34 | |||||||
Difference between French tax rates and tax rates applicable to foreign subsidiaries (1) | (6 | ) | (3 | ) | (2 | ) | ||||
Impact of reduced-rate income tax on royalties in France | (6 | ) | (11 | ) | (10 | ) | ||||
Impact of change in net deferred tax liabilities as a result of changes in tax laws and rates (2) | — | (4 | ) | — | ||||||
Tax rate differential on intragroup margin in inventory (3) | (1 | ) | (1 | ) | — | |||||
Impact of the Franco-American Advance Pricing Agreement (APA) 2006-2010 (4) | — | (7 | ) | — | ||||||
Impact of tax borne by BMS for the territory managed by Sanofi (see Note D.32.) | (1 | ) | (1 | ) | (2 | ) | ||||
Other items (5) | (1 | ) | 2 | 3 | ||||||
Effective tax rate | 19 | 9 | 23 | |||||||
In December 2011, the French and American governments entered into an Advance Pricing Agreement (APA) for fiscal years 2006 to 2011.with the competent Japanese authorities covering the period from 2012 through 2014. The APA procedure is one in which tax authorities from severalone or more countries negotiate and conclude an agreement for a prospective period to determine transfer pricing methods applicable to transactions between subsidiaries of the same parent company.
For the periods presented, the amount of deferred tax assets recognized in profit or loss that were initially subject to impairment losses on a business combination is immaterial.
Article 6 of the French Amending Finance Bill for 2012, enacted August 16, 2012, introduced an additional corporate income tax contribution of 3% on amounts distributed by French or foreign companies and entities that are subject to corporate income tax in France. This contribution, the trigger point for which is the decision by the shareholders' general meeting to make the distribution, has not been taken into account in measuring the Group's deferred tax assets and liabilities. It will apply to future distributions of dividends by Sanofi.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.31. Share of profit/loss of associates and joint ventures
This item mainly comprises the share of co-promotion profits attributable to Sanofi for territories covered by entities majority-owned by BMS (see Note C.1.). The impact of the BMS alliance in 20112012 was €1,671€643 million, before deducting the tax effect of €223 million (versus €1,671 million with a tax effect of €601 million (versusin 2011, and €1,551 million in 2010 with a tax effect of €571 million and €1,229 million, tax effect of €444 million in 2009)2010).
It also includes the share of profits or losses from other associates and joint ventures, for non-significant amountsthe amount of which was immaterial in 2012, 2011 and 2010 and for €168 million in 2009, an amount that includes the effects of the Aventis acquisition (amortization and impairment other intangible assets).
2010.
D.32. Net income attributable to non-controlling interests
This line includes the share of co-promotion profits attributable to BMS for territories covered by entities majority-owned by the GroupSanofi (see Note C.1.). The amount involved was €149 million in 2012, €226 million in 2011, and €237 million in 2010, and €405 million in 2009.
2010. There is no tax effect, because BMS receives its share before tax.
It also includes the share of net income attributable to other non-controlling interests for(€20 million in 2012, €15 million in 2011, and €17 million in 2010, and €21 million in 2009.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
2010).
D.33. Related party transactions
The principal related parties of Sanofi are companies over which the Group has control or significant influence, joint ventures, key management personnel, and principal shareholders.
The Group has not entered into any transactions with any key management personnel. Financial relations with the Group’sGroup's principal shareholders, in particular the Total group (until September 2012), fall within the ordinary course of business and were immaterial in the years ended December 31, 2011,2012, December 31, 20102011 and December 31, 2009.2010.
TheA list of the principal companies the Group controls is presented in Note F.1. These companies are fully consolidated as(as described in Note B.1., and the transactions). Transactions between these companies, and between the parent company and its subsidiaries, are eliminated when preparing the consolidated financial statements.
Transactions concluded with companies over which the Group has significant influence and with joint ventures are presented in Note D.6.
Key management personnel include corporate officers (including two directors during 2012 and 2011, and three directors in 2010, and 2009,who were covered by supplementary pension plans:plans, see Item 6.B.) and the members of the Executive Committee (9 members during 2012, 2011 2010 and 2009.)2010).
The table below shows, by type, the compensation paid to key management personnel:
(€ million) | Year ended December 31, 2012 | Year ended December 31, 2011 | Year ended December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Short-term benefits (1) | 24 | 21 | 23 | |||||||
Post-employment benefits | 10 | 10 | 12 | |||||||
Share-based payment (2) | 8 | 5 | 6 | |||||||
Total recognized in the income statement | 42 | 36 | 41 | |||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
(€ million) | Year ended December 31, 2011 | Year ended December 31, 2010 | Year ended December 31, 2009 | |||||||||
Short-term benefits(1) | 21 | 23 | 22 | |||||||||
Post-employment benefits | 10 | 12 | 11 | |||||||||
Share-based payment(2) | 5 | 6 | 5 | |||||||||
Total recognized in the income statement | 36 | 41 | 38 |
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The aggregate amount of supplementary pension obligations to certain corporate officers and key management personnelto members of the Executive Committee was €162 million at December 31, 2012, compared with €121 million at December 31, 2011 compared withand €130 million at December 31, 2010 and €149 million at December 31, 2009.(the increase is mainly due to a fall in discount rates during 2012). The aggregate amount of retirement benefits payable to certain corporate officers and key management personnel was €5 million at December 31, 2012, 2011 and 2010 and €10 million at December 31, 2009.
2010.
D.34. Split of net sales
Credit risk is the risk that customers (wholesalers, distributors, pharmacies, hospitals, clinics or government agencies) may fail to pay their debts. The Group manages credit risk by pre-vetting customers in order to set credit limits and risk levels and asking for guarantees or insurance where necessary, performing controls, and monitoring qualitative and quantitative indicators of accounts receivable balances such as the period of credit taken and overdue payments.
Customer credit risk also arises as a result of the concentration of the Group’sGroup's sales with its largest customers, in particular certain wholesalers in the United States. The Group’sGroup's three largest customers respectively accounted for approximately 6.8%6.5%, 5.5%5.3% and 5.1%5.2% of gross revenues in 2011.2012.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Net sales
NetThe net sales of Sanofi comprise net sales generated by the Pharmaceuticals segment, the Vaccines segment and the Animal Health segment. The table below shows sales of flagship products and other major pharmaceuticalspharmaceutical products:
Year ended December 31, | ||||||||||||
(€ million) | 2011 | 2010 | 2009 | |||||||||
Lantus® | 3,916 | 3,510 | 3,080 | |||||||||
Apidra® | 190 | 177 | 137 | |||||||||
Insuman® | 132 | 133 | 131 | |||||||||
Amaryl® | 436 | 478 | 416 | |||||||||
Other diabetes products | 10 | — | — | |||||||||
Sub-total: Diabetes | 4,684 | 4,298 | 3,764 | |||||||||
Lovenox® | 2,111 | 2,806 | 3,043 | |||||||||
Plavix® | 2,040 | 2,083 | 2,623 | |||||||||
Taxotere® | 922 | 2,122 | 2,177 | |||||||||
Aprovel® | 1,291 | 1,327 | 1,236 | |||||||||
Eloxatine® | 1,071 | 427 | 957 | |||||||||
Multaq® | 261 | 172 | 25 | |||||||||
Jevtana® | 188 | 82 | — | |||||||||
Stilnox®/ Ambien®/ Ambien® CR/ Myslee® | 490 | 819 | 873 | |||||||||
Allegra® | 580 | 607 | 731 | |||||||||
Copaxone® | 436 | 513 | 467 | |||||||||
Tritace® | 375 | 410 | 429 | |||||||||
Depakine® | 388 | 372 | 329 | |||||||||
Xatral® | 200 | 296 | 296 | |||||||||
Actonel® | 167 | 238 | 264 | |||||||||
Nasacort® | 106 | 189 | 220 | |||||||||
Other Products | 5,773 | 6,064 | 5,947 | |||||||||
Consumer Health Care | 2,666 | 2,217 | 1,430 | |||||||||
Generics | 1,746 | 1,534 | 1,012 | |||||||||
Cerezyme® | 441 | — | — | |||||||||
Myozyme® / Lumizyme® | 308 | — | — | |||||||||
Fabrazyme® | 109 | — | — | |||||||||
Renagel® / Renvela® | 415 | — | — | |||||||||
SynVisc® | 256 | — | — | |||||||||
Other Genzyme products | 866 | — | — | |||||||||
Genzyme sub-total (1) | 2,395 | — | — | |||||||||
Total Pharmaceuticals | 27,890 | 26,576 | 25,823 |
| Year ended December 31, | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
(€ million) | 2012 | 2011 | 2010 | |||||||
Lantus® | 4,960 | 3,916 | 3,510 | |||||||
Apidra® | 230 | 190 | 177 | |||||||
Amaryl® | 421 | 436 | 478 | |||||||
Insuman® | 135 | 132 | 133 | |||||||
Other diabetes products | 36 | 10 | — | |||||||
Total: Diabetes | 5,782 | 4,684 | 4,298 | |||||||
Taxotere® | 563 | 922 | 2,122 | |||||||
Eloxatine® | 956 | 1,071 | 427 | |||||||
Jevtana® | 235 | 188 | 82 | |||||||
Zaltrap® | 25 | — | — | |||||||
Mozobil® | 96 | 59 | — | |||||||
Other Oncology products (1) | 519 | 389 | 59 | |||||||
Total: Oncology | 2,394 | 2,629 | 2,690 | |||||||
Lovenox® | 1,893 | 2,111 | 2,806 | |||||||
Plavix® | 2,066 | 2,040 | 2,083 | |||||||
Aprovel®/CoAprovel® | 1,151 | 1,291 | 1,327 | |||||||
Allegra® | 553 | 580 | 607 | |||||||
Stilnox®/Ambien®/Ambien® CR/Myslee® | 497 | 490 | 819 | |||||||
Copaxone® | 24 | 436 | 513 | |||||||
Depakine® | 410 | 388 | 372 | |||||||
Tritace® | 345 | 375 | 410 | |||||||
Multaq® | 255 | 261 | 172 | |||||||
Xatral® | 130 | 200 | 296 | |||||||
Actonel® | 134 | 167 | 238 | |||||||
Nasacort® | 71 | 106 | 189 | |||||||
Renagel®/Renvela® (1) | 653 | 415 | — | |||||||
Synvisc®/Synvisc-One® (1) | 363 | 256 | — | |||||||
Aubagio® | 7 | — | — | |||||||
Total: Multiple Sclerosis | 7 | — | — | |||||||
Cerezyme® (1) | 633 | 441 | — | |||||||
Myozyme®/Lumizyme® (1) | 462 | 308 | — | |||||||
Fabrazyme® (1) | 292 | 109 | — | |||||||
Other Rare Diseases products (1) | 391 | 264 | — | |||||||
Total: Rare Diseases (1) | 1,778 | 1,122 | — | |||||||
Total: New Genzyme (1) | 1,785 | 1,122 | — | |||||||
Other Products | 5,513 | 5,927 | 6,005 | |||||||
Consumer Health Care | 3,008 | 2,666 | 2,217 | |||||||
Generics | 1,844 | 1,746 | 1,534 | |||||||
Total: Pharmaceuticals | 28,871 | 27,890 | 26,576 | |||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Net sales of the principal product ranges of the Vaccines segment are shown below:
| Year ended December 31, | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
(€ million) | 2012 | 2011 | 2010 | |||||||
Polio/Pertussis/Hib Vaccines | 1,184 | 1,075 | 984 | |||||||
Influenza Vaccines | 884 | 826 | 1,297 | |||||||
Meningitis/Pneumonia Vaccines | 650 | 510 | 527 | |||||||
Adult Booster Vaccines | 496 | 465 | 449 | |||||||
Travel and Endemics Vaccines | 364 | 370 | 382 | |||||||
Other Vaccines | 319 | 223 | 169 | |||||||
Total: Vaccines | 3,897 | 3,469 | 3,808 | |||||||
Year ended December 31, | ||||||||||||
(€ million) | 2011 | 2010 | 2009 | |||||||||
Influenza Vaccines | 826 | 1,297 | 1,062 | |||||||||
– of which seasonal vaccines | 826 | 845 | 597 | |||||||||
– of which pandemic vaccines | — | 452 | 465 | |||||||||
Pediatric Combination and Poliomyelitis Vaccines | 1,075 | 984 | 968 | |||||||||
Meningitis/Pneumonia Vaccines | 510 | 527 | 538 | |||||||||
Adult Booster Vaccines | 465 | 449 | 406 | |||||||||
Travel and Endemics Vaccines | 370 | 382 | 313 | |||||||||
Other Vaccines | 223 | 169 | 196 | |||||||||
Total Vaccines | 3,469 | 3,808 | 3,483 |
ForNet sales of the principal product ranges of the Animal Health segment net sales of the primary products are shown below:
(€ million) | 2011 | 2010 | 2009 (1) | |||||||||
Frontline® and other fipronil-based products | 764 | 774 | 195 | |||||||||
Vaccines | 662 | 627 | 131 | |||||||||
Avermectine | 372 | 355 | 90 | |||||||||
Other Animal Health products | 232 | 227 | 63 | |||||||||
Total Animal Health | 2,030 | 1,983 | 479 |
(1) Since September 18, 2009.
(€ million) | 2012 | 2011 | 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Frontline® and other fipronil-based products | 775 | 764 | 774 | |||||||
Vaccines | 730 | 662 | 627 | |||||||
Avermectin | 423 | 372 | 355 | |||||||
Other Animal Health products | 251 | 232 | 227 | |||||||
Total: Animal Health | 2,179 | 2,030 | 1,983 | |||||||
D.35. Segment information
As indicated in Note B.26., Sanofi has the following operating segments: Pharmaceuticals, Human Vaccines (Vaccines) and Animal Health. All other activities are combined in a separate segment, Other.
In March 2011, Sanofi and Merck announced the mutual termination of their agreement to create a new Animal Health joint venture. Following this announcement, the Animal Health business has beenwas identified as an operating segment on the basis of information now used internally by Managementmanagement to measure operational performance and to allocate resources.
The Pharmaceuticals segment covers research, development, production and marketing of medicines, including those comingoriginating from Genzyme (see D.1.1.D.1.2.). The Sanofi pharmaceuticals portfolio consists of flagship products, plus a broad range of prescription medicines, generic medicines, and consumer health products. This segment also includes all associates whose activities are related to pharmaceuticals, in particular the entities majority owned by BMS.
The Vaccines segment is wholly dedicated to vaccines, including research, development, production and marketing. This segment includes the Sanofi Pasteur MSD joint venture.
The Animal Health segment comprises the research, development, production and marketing activities of Merial, which offers a complete range of medicines and vaccines for a wide variety of animal species.
The Other segment includes all activities that do not qualify as reportable segments under IFRS 8. This segment includes the Group’sSanofi's interest in the Yves Rocher group until the date of loss of significant influence loss (see Note D.6.), and the effects of retained commitments in respect of divested activities.
Inter-segment transactions are not material.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.35.1. Segment results
Sanofi reports segment results on the basis of “Business"Business operating income”income". This indicator (compliant with IFRS 8) is used internally to measure operational performance and allocate resources.
Business operating income is derived fromOperating income, adjusted as follows:
|
amortization and impairment losses charged against intangible assets (other than software) are eliminated;
the share
Segment results are shown in the tables below:
Year ended December 31, 2011 | ||||||||||||||||||||
(€ million) | Pharmaceuticals | Vaccines | Animal Health | Other | Total | |||||||||||||||
Net sales | 27,890 | 3,469 | 2,030 | — | 33,389 | |||||||||||||||
Other revenues | 1,622 | 25 | 22 | — | 1,669 | |||||||||||||||
Cost of sales | (8,368 | ) | (1,404 | ) | (654 | ) | — | (10,426 | ) | |||||||||||
Research and development expenses | (4,101 | ) | (564 | ) | (146 | ) | — | (4,811 | ) | |||||||||||
Selling and general expenses | (7,376 | ) | (542 | ) | (617 | ) | (1 | ) | (8,536 | ) | ||||||||||
Other operating income and expenses | (13 | ) | — | (7 | ) | 24 | 4 | |||||||||||||
Share of profit/(loss) of associates and joint ventures | 1,088 | 1 | — | 13 | 1,102 | |||||||||||||||
Attributable to non-controlling interests | (246 | ) | — | (1 | ) | — | (247 | ) | ||||||||||||
Business operating income | 10,496 | 985 | 627 | 36 | 12,144 | |||||||||||||||
Financial income and expenses | (412 | ) | ||||||||||||||||||
Income tax expense | (2,937 | ) | ||||||||||||||||||
Business net income | 8,795 |
| Year ended December 31, 2012 | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Pharmaceuticals | Vaccines | Animal Health | Other | Total | |||||||||||
Net sales | 28,871 | 3,897 | 2,179 | — | 34,947 | |||||||||||
Other revenues | 933 | 44 | 33 | — | 1,010 | |||||||||||
Cost of sales | (8,759 | ) | (1,635 | ) | (701 | ) | — | (11,095 | ) | |||||||
Research and development expenses | (4,219 | ) | (539 | ) | (164 | ) | — | (4,922 | ) | |||||||
Selling and general expenses | (7,666 | ) | (611 | ) | (669 | ) | (1 | ) | (8,947 | ) | ||||||
Other operating income and expenses | 98 | (7 | ) | 3 | 14 | 108 | ||||||||||
Share of profit/(loss) of associates and joint ventures | 432 | (1 | ) | (7 | ) | — | 424 | |||||||||
Net income attributable to non-controlling interests | (171 | ) | — | (1 | ) | — | (172 | ) | ||||||||
Business operating income | 9,519 | 1,148 | 673 | 13 | 11,353 | |||||||||||
| Year ended December 31, 2011 | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Pharmaceuticals | Vaccines | Animal Health | Other | Total | |||||||||||
Net sales | 27,890 | 3,469 | 2,030 | — | 33,389 | |||||||||||
Other revenues | 1,622 | 25 | 22 | — | 1,669 | |||||||||||
Cost of sales | (8,368 | ) | (1,404 | ) | (654 | ) | — | (10,426 | ) | |||||||
Research and development expenses | (4,101 | ) | (564 | ) | (146 | ) | — | (4,811 | ) | |||||||
Selling and general expenses | (7,376 | ) | (542 | ) | (617 | ) | (1 | ) | (8,536 | ) | ||||||
Other operating income and expenses | (13 | ) | — | (7 | ) | 24 | 4 | |||||||||
Share of profit/(loss) of associates and joint ventures | 1,088 | 1 | — | 13 | 1,102 | |||||||||||
Net income attributable to non-controlling interests | (246 | ) | — | (1 | ) | — | (247 | ) | ||||||||
Business operating income | 10,496 | 985 | 627 | 36 | 12,144 | |||||||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Year ended December 31, 2010 (1) | ||||||||||||||||||||
(€ million) | Pharmaceuticals | Vaccines | Animal Health | Other | Total | |||||||||||||||
Net sales | 26,576 | 3,808 | 1,983 | — | 32,367 | |||||||||||||||
Other revenues | 1,623 | 28 | 18 | — | 1,669 | |||||||||||||||
Cost of sales | (7,316 | ) | (1,371 | ) | (615 | ) | — | (9,302 | ) | |||||||||||
Research and development expenses | (3,884 | ) | (517 | ) | (155 | ) | — | (4,556 | ) | |||||||||||
Selling and general expenses | (6,962 | ) | (603 | ) | (604 | ) | (2 | ) | (8,171 | ) | ||||||||||
Other operating income and expenses | 177 | 14 | (6 | ) | (108 | ) | 77 | |||||||||||||
Share of profit/(loss) of associates and joint ventures | 1,009 | 19 | — | 8 | 1,036 | |||||||||||||||
Attributable to non-controlling interests | (258 | ) | 1 | — | — | (257 | ) | |||||||||||||
Business operating income | 10,965 | 1,379 | 621 | (102 | ) | 12,863 | ||||||||||||||
Financial income and expenses | (362 | ) | ||||||||||||||||||
Income tax expense | (3,286 | ) | ||||||||||||||||||
Business net income | 9,215 |
|
Year ended December 31, 2009 (1) | ||||||||||||||||||||
(€ million) | Pharmaceuticals | Vaccines | Animal Health | Other | Total | |||||||||||||||
Net sales | 25,823 | 3,483 | 479 | — | 29,785 | |||||||||||||||
Other revenues | 1,412 | 31 | 4 | — | 1,447 | |||||||||||||||
Cost of sales | (6,527 | ) | (1,326 | ) | (176 | ) | — | (8,029 | ) | |||||||||||
Research and development expenses | (4,091 | ) | (491 | ) | (46 | ) | — | (4,628 | ) | |||||||||||
Selling and general expenses | (6,762 | ) | (561 | ) | (146 | ) | (2 | ) | (7,471 | ) | ||||||||||
Other operating income and expenses | 387 | (3 | ) | (5 | ) | 1 | 380 | |||||||||||||
Share of profit/(loss) of associates and joint ventures | 792 | 41 | 178 | (2) | 8 | 1,019 | ||||||||||||||
Attributable to non-controlling interests | (426 | ) | (1 | ) | — | — | (427 | ) | ||||||||||||
Business operating income | 10,608 | 1,173 | 288 | 7 | 12,076 | |||||||||||||||
Financial income and expenses | (298 | ) | ||||||||||||||||||
Income tax expense | (3,149 | ) | ||||||||||||||||||
Business net income | 8,629 |
|
|
“Business net income” is determined by taking “Business operating income” and adding financial income and deducting financial expenses, including the related income tax effects.
“Business net income” is defined asNet income attributable to equity holders of Sanofiexcluding (i) amortization of intangible assets; (ii) impairment of intangible assets; (iii) Fair value remeasurement of contingent consideration liabilities, (iv) other impacts associated with acquisitions (including impacts of acquisitions on associates and joint ventures); (v) restructuring costs (including restructuring costs relating to associates and joint ventures), (vi) other gains and losses, and litigation; (vii) the impact resulting from the absence of amortization of the Merial tangible assets in 2010 and starting September 18, 2009 (in accordance
| Year ended December 31, 2010 | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Pharmaceuticals | Vaccines | Animal Health | Other | Total | |||||||||||
Net sales | 26,576 | 3,808 | 1,983 | — | 32,367 | |||||||||||
Other revenues | 1,623 | 28 | 18 | — | 1,669 | |||||||||||
Cost of sales | (7,316 | ) | (1,371 | ) | (615 | ) | — | (9,302 | ) | |||||||
Research and development expenses | (3,884 | ) | (517 | ) | (155 | ) | — | (4,556 | ) | |||||||
Selling and general expenses | (6,962 | ) | (603 | ) | (604 | ) | (2 | ) | (8,171 | ) | ||||||
Other operating income and expenses | 177 | 14 | (6 | ) | (108 | ) | 77 | |||||||||
Share of profit/(loss) of associates and joint ventures | 1,009 | 19 | — | 8 | 1,036 | |||||||||||
Net income attributable to non-controlling interests | (258 | ) | 1 | — | — | (257 | ) | |||||||||
Business operating income | 10,965 | 1,379 | 621 | (102 | ) | 12,863 | ||||||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
with IFRS 5), (viii) the tax effect related to the items listed above and (ix) effects of major tax disputes and, as an exception for 2011, the retroactive effect (2006-2010) on the tax liability resulting from the agreement signed on December 22, 2011 by France and the United States on transfer prices (APA-Advance Pricing Agreement), for which the amount is deemed to be significant, and (x) the share of non-controlling interests in items (i) through (ix). The items listed in iii), v) and vi) correspond to those reported in the income statement line itemsFair value remeasurement of contingent consideration liabilities, Restructuring costs, andOther gains and losses, and litigation.
The table below shows the reconciliation between “Business"Business net income”income" andNet income — attributed to equity holders of Sanofi:Income before tax and associates and joint ventures:
(€ million) | Year ended December 31, 2011 | Year ended December 31, 2010 (1) | Year ended December 31, 2009 (1) | |||||||||||
Business net income | 8,795 | 9,215 | 8,629 | |||||||||||
(i) | Amortization of intangible assets | (3,314 | ) | (3,529 | ) | (3,528 | ) | |||||||
(ii) | Impairment of intangible assets | (142 | ) | (433 | ) | (372 | ) | |||||||
(iii) | Fair value remeasurement of contingent consideration liabilities | 15 | — | |||||||||||
(iv) | Expenses arising from the impact of acquisitions on inventories (2) | (476 | ) | (142 | ) | (90 | ) | |||||||
(v) | Restructuring costs | (1,314 | ) | (1,384 | ) | (1,080 | ) | |||||||
(vi) | Other gains and losses, and litigation (3) | (327 | ) | (138 | ) | — | ||||||||
(vii) | Impact of the non depreciation of property, plant and equipment of Merial (in accordance with IFRS 5) | — | 77 | 21 | ||||||||||
(viii) | Tax effects of: | 1,905 | 1,856 | 1,644 | ||||||||||
– amortization of intangible assets | 1,178 | 1,183 | 1,130 | |||||||||||
– impairment of intangible assets | 37 | 143 | 136 | |||||||||||
– Fair value remeasurement of contingent consideration liabilities | 34 | — | — | |||||||||||
– expenses arising from the impact of acquisitions on inventories | 143 | 44 | 24 | |||||||||||
– restructuring costs | 399 | 466 | 360 | |||||||||||
– other gains and losses, and litigation | 114 | 46 | ||||||||||||
– non depreciation of property, plant and equipment of Merial (IFRS 5) | — | (26 | ) | (6 | ) | |||||||||
(iv)/(ix) | Other tax items | 577 | (4) | — | 106 | |||||||||
(x) | Share of items listed above attributable to non-controlling interests | 6 | 3 | 1 | ||||||||||
(iv)/(v) | Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures (5) | (32 | ) | (58 | ) | (66 | ) | |||||||
Net income attributable to equity holders of Sanofi | 5,693 | 5,467 | 5,265 |
|
|
|
|
|
(€ million) | Year ended December 31, 2012 | Year ended December 31, 2011 | Year ended December 31, 2010 | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Business operating income | 11,353 | 12,144 | 12,863 | |||||||
Share of profit/loss of associates and joint ventures (1) | (424 | ) | (1,102 | ) | (1,036 | ) | ||||
Net income attributable to non-controlling interests (2) | 172 | 247 | 257 | |||||||
Amortization of intangible assets | (3,291 | ) | (3,314 | ) | (3,529 | ) | ||||
Impairment of intangible assets | (117 | ) | (142 | ) | (433 | ) | ||||
Fair value remeasurement of contingent consideration liabilities | (192 | ) | 15 | — | ||||||
Expenses arising from the impact of acquisitions on inventories (3) | (23 | ) | (476 | ) | (142 | ) | ||||
Restructuring costs | (1,141 | ) | (1,314 | ) | (1,384 | ) | ||||
Other gains and losses, and litigation (4) | — | (327 | ) | (138 | ) | |||||
Impact of the discontinuation of depreciation of the property, plant and equipment of Merial (IFRS 5) | — | — | 77 | |||||||
Operating income | 6,337 | 5 731 | 6,535 | |||||||
Financial expense | (553 | ) | (552 | ) | (468 | ) | ||||
Financial income | 93 | 140 | 106 | |||||||
Income before tax and associates and joint ventures | 5,877 | 5,319 | 6,173 | |||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.35.2. Other segment information
The tables below show the split by operating segment of (i) the carrying amount of investments in associates and joint ventures, (ii) acquisitions of property, plant and equipment, and (iii) acquisitions of intangible assets.
The principal associates and joint ventures are: for the Pharmaceuticals segment, the entities majority owned by BMS (see Note C.1.), Handok InfraServ(divested October 30, 2012), Infraserv GmbH & Co. Höchst KG, and for the Vaccines segment, Sanofi Pasteur MSD. The Other segment includes the equity associate Yves Rocher, which is no longer recognized usingceased to be accounted for by the equity method as ofeffective November 2011 (see note D.6.).
Acquisitions of intangible assets and property, plant and equipment correspond to acquisitions made during the period.
| 2012 | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Pharmaceuticals | Vaccines | Animal Health | Other | Total | |||||||||||
Investments in associates and joint ventures | 192 | 292 | 3 | — | 487 | |||||||||||
Acquisitions of property, plant and equipment | 1,024 | 216 | 79 | — | 1,319 | |||||||||||
Acquisitions of intangible assets | 276 | 9 | 8 | — | 293 | |||||||||||
| 2011 | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Pharmaceuticals | Vaccines | Animal Health | Other | Total | |||||||||||
Investments in associates and joint ventures | 488 | 319 | — | — | 807 | |||||||||||
Acquisitions of property, plant and equipment | 1,136 | 323 | 77 | — | 1,536 | |||||||||||
Acquisitions of intangible assets | 223 | 8 | 15 | — | 246 | |||||||||||
| 2010 | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Pharmaceuticals | Vaccines | Animal Health | Other | Total | |||||||||||
Investments in associates and joint ventures | 446 | 350 | — | 128 | 924 | |||||||||||
Acquisitions of property, plant and equipment | 779 | 416 | 88 | — | 1,283 | |||||||||||
Acquisitions of intangible assets | 335 | 43 | 1 | — | 379 | |||||||||||
2009 | ||||||||||||||||||||
(€ million) | Pharmaceuticals | Vaccines | Animal Health | Other | Total | |||||||||||||||
Investments in associates and joint ventures | 420 | 412 | 5 | 123 | 960 | |||||||||||||||
Acquisitions of property, plant and equipment | 940 | 465 | 33 | — | 1,438 | |||||||||||||||
Acquisitions of intangible assets | 364 | 16 | 8 | — | 388 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
D.35.3. Information by geographical region
The geographical information on net sales provided below is based on the geographical location of the customer.
In accordance with IFRS 8, the non-current assets reported below exclude financial instruments, deferred tax assets, and pre-funded pension obligations.
| 2012 | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Total | Europe | of which France | North America | of which United States | Other countries | |||||||||||||
Net sales | 34,947 | 11,056 | 2,846 | 11,440 | 10,873 | 12,451 | |||||||||||||
Non-current assets: | |||||||||||||||||||
• property, plant and equipment | 10,578 | 6,707 | 4,073 | 2,696 | 2,285 | 1,175 | |||||||||||||
• intangible assets | 20,192 | 4,417 | 11,400 | 4,375 | |||||||||||||||
• goodwill | 38,073 | 15,025 | 15,994 | 7,054 | |||||||||||||||
2011 | ||||||||||||||||||||||||
(€ million) | Total | Europe | of which France | North America | of which United States | Other countries | ||||||||||||||||||
Net sales | 33,389 | 11,796 | 3,106 | 10,511 | 9,957 | 11,082 | ||||||||||||||||||
Non-current assets: | ||||||||||||||||||||||||
• property, plant and equipment | 10,750 | 6,857 | 4,128 | 2,768 | 2,374 | 1,125 | ||||||||||||||||||
• intangible assets | 23,639 | 5,537 | 15,422 | 2,680 | ||||||||||||||||||||
• goodwill | 38,079 | 15,072 | 16,209 | 6,798 |
| 2011 | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Total | Europe | of which France | North America | of which United States | Other countries | |||||||||||||
Net sales | 33,389 | 11,796 | 3,106 | 10,511 | 9,957 | 11,082 | |||||||||||||
Non-current assets: | |||||||||||||||||||
• property, plant and equipment | 10,750 | 6,857 | 4,128 | 2,768 | 2,374 | 1,125 | |||||||||||||
• intangible assets | 23,639 | 5,537 | 15,422 | 2,680 | |||||||||||||||
• goodwill (1) | 38,582 | 15,238 | 16,365 | 6,979 | |||||||||||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
| 2010 | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(€ million) | Total | Europe | of which France | North America | of which United States | Other countries | |||||||||||||
Net sales | 32,367 | 12,198 | 3,092 | 10,333 | 9,790 | 9,836 | |||||||||||||
Non-current assets: | |||||||||||||||||||
• property, plant and equipment | 8,155 | 5,764 | 3,603 | 1,510 | 1,091 | 881 | |||||||||||||
• intangible assets | 12,479 | 3,773 | 5,835 | 2,871 | |||||||||||||||
• goodwill | 31,932 | 13,718 | 13,264 | 4,950 | |||||||||||||||
2010 | ||||||||||||||||||||||||
(€ million) | Total | Europe | of which France | North America | of which United States | Other countries | ||||||||||||||||||
Net sales (1) | 32,367 | 12,198 | 3,092 | 10,333 | 9,790 | 9,836 | ||||||||||||||||||
Non-current assets: | ||||||||||||||||||||||||
• property, plant and equipment | 8,155 | 5,764 | 3,603 | 1,510 | 1,091 | 881 | ||||||||||||||||||
• intangible assets | 12,479 | 3,773 | 5,835 | 2,871 | ||||||||||||||||||||
• goodwill | 31,932 | 13,718 | 13,264 | 4,950 |
|
2009 | ||||||||||||||||||||||||
(€ million) | Total | Europe | of which France | North America | of which United States | Other countries | ||||||||||||||||||
Net sales (1) | 29,785 | 12,237 | 3,261 | 10,021 | 9,573 | 7,527 | ||||||||||||||||||
Non-current assets: | ||||||||||||||||||||||||
• property, plant and equipment | 7,830 | 5,734 | 3,436 | 1,375 | 1,018 | 721 | ||||||||||||||||||
• intangible assets | 13,747 | 4,636 | 5,930 | 3,181 | ||||||||||||||||||||
• goodwill | 29,733 | 13,528 | 11,419 | 4,786 |
|
As described in Note D.5. to the consolidated financial statements, France is not a cash-generating unit. Consequently, information about goodwill is provided for Europe.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
E. PRINCIPAL ACCOUNTANTS’ACCOUNTANTS' FEES AND SERVICES
PricewaterhouseCoopers Audit and Ernst & Young Auditet Autres served as independent auditors of Sanofi for the year ended December 31, 20112012 and for all other reporting periods covered by this annual report on Form 20-F. The table below shows fees charged by these firms and member firms of their networks to Sanofi and other consolidated companiessubsidiaries in the years ended December 31, 20112012 and 2010.2011.
Ernst & Young | PricewaterhouseCoopers | |||||||||||||||||||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||||||||||||||||||
(€ million) | Amount | % | Amount | % | Amount | % | Amount | % | ||||||||||||||||||||||||
Audit | ||||||||||||||||||||||||||||||||
Audit opinion, review of statutory and consolidated financial statements (1) | 13.6 | 92 | % | 12.8 | 92 | % | 17.9 | 91 | % | 13.5 | 93 | % | ||||||||||||||||||||
– Sanofi S.A. | 3.5 | 3.7 | 4.1 | 3.7 | ||||||||||||||||||||||||||||
– fully consolidated subsidiaries | 10.1 | 9.1 | 13.8 | 9.8 | ||||||||||||||||||||||||||||
Other audit-related services (2) | 1.0 | 7 | % | 1.0 | 7 | % | 1.3 | 7 | % | 0.7 | 5 | % | ||||||||||||||||||||
– Sanofi S.A. | 0.3 | — | 0.9 | — | ||||||||||||||||||||||||||||
– fully consolidated subsidiaries | 0.7 | 1.0 | 0.4 | 0.7 | ||||||||||||||||||||||||||||
Sub-total | 14.6 | 99 | % | 13.8 | 99 | % | 19.2 | 98 | % | 14.2 | 98 | % | ||||||||||||||||||||
Non-audit services | ||||||||||||||||||||||||||||||||
Tax | 0.1 | 0.1 | 0.4 | 0.3 | ||||||||||||||||||||||||||||
Other | — | — | — | — | ||||||||||||||||||||||||||||
Sub-total | 0.1 | 1 | % | 0.1 | 1 | % | 0.4 | 2 | % | 0.3 | 2 | % | ||||||||||||||||||||
TOTAL | 14.7 | 100 | % | 13.9 | 100 | % | 19.6 | 100 | % | 14.5 | 100 | % |
|
|
| Ernst & Young | PricewaterhouseCoopers | |||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2012 | 2011 | 2012 | 2011 | |||||||||||||||||||||
(€ million) | Amount | % | Amount | % | Amount | % | Amount | % | |||||||||||||||||
Audit: | |||||||||||||||||||||||||
Audit opinion, review of statutory and consolidated financial statements (1) | 15.4 | 96% | 13.6 | 92% | 15.6 | 92% | 17.9 | 91% | |||||||||||||||||
– Sanofi S.A. | 3.9 | 3.5 | 4.0 | 4.1 | |||||||||||||||||||||
– fully consolidated | 11.5 | 10.1 | 11.6 | 13.8 | |||||||||||||||||||||
Other audit-related services (2) | 0.5 | 3% | 1.0 | 7% | 1.2 | 7% | 1.3 | 7% | |||||||||||||||||
– Sanofi S.A. | — | 0.3 | 0.3 | 0.9 | |||||||||||||||||||||
– fully consolidated | 0.5 | 0.7 | 0.9 | 0.4 | |||||||||||||||||||||
Sub-total (3) | 15.9 | 99% | 14.6 | 99% | 16.8 | 99% | 19.2 | 98% | |||||||||||||||||
Non-audit services: | |||||||||||||||||||||||||
Tax | 0.1 | 0.1 | 0.1 | 0.4 | |||||||||||||||||||||
Other | — | — | — | — | |||||||||||||||||||||
Sub-total | 0.1 | 1% | 0.1 | 1% | 0.1 | 1% | 0.4 | 2% | |||||||||||||||||
TOTAL | 16.0 | 100% | 14.7 | 100% | 16.9 | 100% | 19.6 | 100% | |||||||||||||||||
Audit Committee Pre-approval and Procedures
The Group Audit Committee has adopted a policy and established certain procedures for the pre-approvalapproval of audit and other permitted audit-related services, and for the pre-approval of permitted non-audit services to be provided by the independent auditors. In 2011,2012, the Audit Committee established a budget breaking down permitted audit-related services and non-audit services by type of service, and the related fees to be paid.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
F. LIST OF PRINCIPAL COMPANIES INCLUDED IN THE CONSOLIDATION FOR THE YEAR ENDED DECEMBER 31, 20112012
F.1. Principal fully consolidated companies
The principal companies in the Group’sGroup's areas of operations and business segments are:
Europe | Financial interest %
| |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aventis Beteiligungsverwaltung GmbH | Germany | 100 | ||||||||||||
Sanofi-Aventis Deutschland GmbH | Germany | 100 | ||||||||||||
Hoechst GmbH | Germany | 100 | ||||||||||||
Winthrop Arzneimittel GmbH | Germany | 100 | ||||||||||||
Zentiva Inhalationsprodukte GmbH | Germany | 100 | ||||||||||||
Merial GmbH | Germany | 100 | ||||||||||||
Genzyme GmbH | Germany | 100 | ||||||||||||
Sanofi-Aventis | Austria | 50.1 | ||||||||||||
Sanofi-Aventis GmbH | Austria | 100 | ||||||||||||
Sanofi-Aventis Belgium S.A.N.V. | Belgium | 100 | ||||||||||||
Sanofi European Treasury Center | Belgium | 100 | ||||||||||||
Genzyme Flanders BVBA | Belgium | 100 | ||||||||||||
Merial Norden A/S | Denmark | 100 | ||||||||||||
Sanofi-Aventis Denmark A/S | Denmark | 100 | ||||||||||||
Sanofi Winthrop BMS partnership (JV DK)(1) | Denmark | 50.1 | ||||||||||||
Merial Laboratorios S.A. | Spain | 100 | ||||||||||||
Sanofi-Aventis SA | Spain | 100 | ||||||||||||
Finland | 50.1 | |||||||||||||
Sanofi-Aventis OY | Finland | 100 | ||||||||||||
Sanofi-Aventis Europe | France | 100 | ||||||||||||
Sanofi-Aventis Participations | France | 100 | ||||||||||||
Sanofi Pasteur Participations | France | 100 | ||||||||||||
Sanofi-Aventis Amérique du Nord | France | 100 | ||||||||||||
Sanofi Pasteur Holding | France | 100 | ||||||||||||
Aventis Pharma S.A. | France | 100 | ||||||||||||
Sanofi Pasteur | France | 100 | ||||||||||||
Aventis Agriculture | France | 100 | ||||||||||||
Fovea Pharmaceuticals | France | 100 | ||||||||||||
Francopia | France | 100 | ||||||||||||
Winthrop Médicaments | France | 100 | ||||||||||||
Sanofi Chimie | France | 100 | ||||||||||||
Sanofi Participations | France | 100 | ||||||||||||
Sanofi Pharma Bristol-Myers Squibb | France | 50.1 | ||||||||||||
Sanofi | France | 100 | ||||||||||||
Sanofi-Aventis France | France | 100 | ||||||||||||
Sanofi-Aventis Groupe | France | 100 | ||||||||||||
Sanofi-Aventis Recherche et Développement | France | 100 | ||||||||||||
Sanofi Winthrop Industrie | France | |||||||||||||
100 | ||||||||||||||
Merial | SAS | France | 100 | |||||||||||
Genzyme SAS | France | 100 | ||||||||||||
Genzyme Polyclonals | France | 100 | ||||||||||||
Chattem Greece S.A. | Greece | 100 | ||||||||||||
Greece | 100 | |||||||||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Europe | Financial interest % | |||||||
---|---|---|---|---|---|---|---|---|
Chinoin Private Co. Ltd | Hungary | 99.6 | ||||||
Hungary | 99.6 | |||||||
Chattem Global Consumer Products Limited | Ireland | 100 | ||||||
Carraig Insurance Ltd | Ireland | 100 | ||||||
Sanofi-Aventis Ireland | Limited | Ireland | 100 | |||||
Genzyme Ireland Limited | Ireland | 100 | ||||||
Merial Italia S.p.A. | Italy | 100 | ||||||
Italy | 100 | |||||||
Norway | 100 | |||||||
Sanofi Winthrop BMS partnership | Norway | 50.1 | ||||||
Netherlands | 100 | |||||||
Sanofi Winthrop | Netherlands | 50.1 | ||||||
Netherlands | 100 |
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
| ||||||
Poland | 100 | |||||
Winthrop Farmaceutica Portugal, | Portugal | 100 | ||||
Portugal | 100 | |||||
Sanofi Winthrop | Portugal | 50.1 | ||||
Sanofi-Aventis, s.r.o. | Czech Republic | 100 | ||||
Zentiva Group, a.s. | Czech Republic | 100 | ||||
Zentiva k.s. | Czech Republic | 100 | ||||
Sanofi-Aventis Romania SRL | Romania | 100 | ||||
Aventis Pharma | United Kingdom | 100 | ||||
Chattem Limited (U.K.) | United Kingdom | 100 | ||||
United Kingdom | 100 | |||||
Sanofi Pasteur Holding Ltd | United Kingdom | 100 | ||||
United Kingdom | 100 | |||||
United Kingdom | 100 | |||||
Winthrop Pharmaceuticals UK | United Kingdom | 100 | ||||
Fisons Limited | United Kingdom | 100 | ||||
May and Baker Limited | United Kingdom | 100 | ||||
Genzyme Limited | United Kingdom | 100 | ||||
Merial Limited | United Kingdom | 100 | ||||
Merial Animal Health | United Kingdom | 100 | ||||
ZAO Aventis Pharma | Russia | 100 | ||||
Russia | 51 | |||||
Zentiva Pharma o.o.o. | Russia | 100 | ||||
Slovakia | 100 | |||||
Zentiva | Slovakia | |||||
Sanofi-Aventis AB | Sweden | 100 | ||||
Sanofi | Switzerland | 100 | ||||
Sanofi-Aventis (Suisse) SA | Switzerland | 100 | ||||
Sanofi-Aventis Ilaclari | Turkey | 100 | ||||
Winthrop Ilac Anonim Sirketi | Turkey | 100 | ||||
Turkey | 100 | |||||
Zentiva Saglik Urunleri | Turkey | 100 | ||||
Limited Liability Company | Ukraine | 100 |
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
United States | Financial interest %
| |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Armour Pharmaceutical Company (US) | United States | 100 | ||||||||||
Aventis Inc. (US) | United States | 100 | ||||||||||
Aventisub Inc. (US) | United States | 100 | ||||||||||
Aventis Holdings Inc. (US) | United States | 100 | ||||||||||
Aventis Pharmaceuticals Inc. (US) | United States | 100 | ||||||||||
BiPar Sciences | United States | 100 | ||||||||||
Carderm Capital L.P. (US) | United States | 100 | ||||||||||
Chattem Inc. | United States | 100 | ||||||||||
Merial, | United States | 100 | ||||||||||
Merial Select, Inc. | United States | 100 | ||||||||||
Sanofi US Services Inc. | United States | 100 | ||||||||||
Sanofi-Aventis US | ||||||||||||
United States | 100 | |||||||||||
Sanofi Pasteur Biologics, | United States | 100 | ||||||||||
Sanofi Pasteur Inc. (US) | United States | 100 | ||||||||||
United States | 100 | |||||||||||
United States | 100 | |||||||||||
TargeGen Inc. | United States | 100 | ||||||||||
Sanofi Pasteur VaxDesign Corporation | United States | 100 | ||||||||||
BMP Sunstone Corporation (US) | United States | 100 | ||||||||||
Genzyme Corporation | United States | 100 | ||||||||||
Sanofi-Topaz Inc. | United States | 100 | ||||||||||
United States | 100 | |||||||||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Other countries | Financial interest % | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
South Africa | 100 | |||||||||||
Winthrop Pharmaceuticals | South Africa | 100 | ||||||||||
Winthrop Pharma Saïdal S.P.A. | Algeria | 70 | ||||||||||
Sanofi-Aventis Algérie | Algeria | 100 | ||||||||||
Merial Argentina S.A. | Argentina | 100 | ||||||||||
Sanofi-Aventis Argentina S.A. | Argentina | 100 | ||||||||||
Quimica Medical | Argentina | 100 | ||||||||||
Sanofi-Aventis Australia Pty Limited | Australia | 100 | ||||||||||
Australia | 100 | |||||||||||
Australia | 100 | |||||||||||
Australia | 100 | |||||||||||
Australia | 100 | |||||||||||
Australia | 100 | |||||||||||
MCP Direct Pty Ltd | Australia | 100 | ||||||||||
Carlson Health Pty Ltd | Australia | 100 | ||||||||||
Merial Australia | Australia | 100 | ||||||||||
Brazil | 100 | |||||||||||
Sanofi-Aventis Comercial e Logistica Ltda | Brazil | 100 | ||||||||||
Sanofi-Aventis Farmaceutica Ltda | Brazil | 100 | ||||||||||
Medley Comercial e Logistica Ltda | Brazil | 100 | ||||||||||
Medley | Brazil | 100 | ||||||||||
Merial Canada, Inc. | Canada | 100 | ||||||||||
Sanofi Pasteur Limited | ||||||||||||
Canada | 100 | |||||||||||
Sanofi-Aventis Canada Inc. | Canada | 100 | ||||||||||
Sanofi Consumer Health Inc./Sanofi Santé Grand Public Inc. | ||||||||||||
Canada | 100 | |||||||||||
Sanofi-Aventis de Chile SA | Chile | 100 | ||||||||||
Sanofi | China | 100 | ||||||||||
China | 100 | |||||||||||
China | 100 | |||||||||||
Shenzhen Sanofi Pasteur Biological Products Co. Ltd | China | 100 | ||||||||||
Hangzhou Sanofi Minsheng Consumer Healthcare Co., Ltd | China | 60 | ||||||||||
China | 99 | |||||||||||
Sunstone | China | 100 | ||||||||||
Winthrop Pharmaceuticals de Colombia SA | Colombia | 100 | ||||||||||
Sanofi-Aventis de Colombia | Colombia | 100 | ||||||||||
Korea | ||||||||||||
Sanofi-Aventis Gulf F.Z.E. | United Arab Emirates | 100 | ||||||||||
Egypt | 99.8 | |||||||||||
Sanofi-Aventis del Ecuador | Ecuador | 100 | ||||||||||
Guatemala | 100 | |||||||||||
Sunstone China | Hong Kong | 100 | ||||||||||
Hong Kong | 100 | |||||||||||
India | 100 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
India | 60.4 | |||||
Shantha Biotechnics | India | |||||
PT | Indonesia | 100 | ||||
PT Aventis Pharma | Indonesia | 75 | ||||
Japan | 100 | |||||
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
Other countries | Financial interest % | |||||
---|---|---|---|---|---|---|
Sanofi-Aventis | Japan | 51 | ||||
Sanofi Pasteur | Japan | 100 | ||||
Merial | Japan | 80 | ||||
Genzyme JP KK | Japan | 100 | ||||
Winthrop Pharmaceuticals (Malaysia) | Malaysia | 100 | ||||
Sanofi-Aventis (Malaysia) | Malaysia | 100 | ||||
Maphar | Morocco | 80.6 | ||||
Sanofi-Aventis | Morocco | 100 | ||||
Merial | Mexico | 100 | ||||
Sanofi Pasteur | Mexico | 100 | ||||
Sanofi-Aventis de Mexico | Mexico | 100 | ||||
Sanofi-Aventis Winthrop SA de CV | Mexico | 100 | ||||
Mexico | 100 | |||||
Pakistan | 52.9 | |||||
Sanofi-Aventis de Panama S.A. | Panama | 100 | ||||
Sanofi-Aventis Latin America SA | Panama | 100 | ||||
Peru | 100 | |||||
Chattem Peru S.R.L. | Peru | 100 | ||||
Sanofi-Aventis Philippines | Philippines | 100 | ||||
Sanofi-Aventis de la | Dominican Rep. | 100 | ||||
Aventis Pharma (Manufacturing) Pte. Ltd | Singapore | 100 | ||||
Sanofi-Aventis Singapore | Singapore | 100 | ||||
Taiwan | 100 | |||||
Sanofi-Synthélabo (Thailand) Ltd | Thailand | 100 | ||||
Thailand | 100 | |||||
Sanofi-Aventis Pharma Tunisie | Tunisia | 100 | ||||
Winthrop Pharma Tunisie | Tunisia | 100 | ||||
Sanofi-Aventis de Venezuela SA | Venezuela | 100 | ||||
Sanofi-Synthélabo Vietnam Pharmaceutical Shareholding | Vietnam | 70 | ||||
Vietnam | 100 | |||||
The Group has also consolidated Merial and its subsidiaries since September 18, 2009, the date on which control was acquired (see Note D.8.1.D.8.2.).
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
F.2. Principal associates and joint ventures
Financial interest % | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Germany | 31.2 | |||||||||||
Bristol-Myers | Canada | 49.9 | ||||||||||
Bristol-Myers | United States | 49.9 | ||||||||||
Bristol-Myers | United States | 49.9 | ||||||||||
Bristol-Myers | United States | 49.9 | ||||||||||
Bristol-Myers | United States | 49.9 | ||||||||||
Bristol-Myers | United States | 49.9 | ||||||||||
Sanofi Pasteur MSD | France | 50 | ||||||||||
F-123