UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
 
   
(Mark One)  
þ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
  For the fiscal year ended December 31, 20082009
o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
  For the transition period from          to          
 
Commission filenumber: 0-19311
Biogen Idec Inc.
(Exact name of registrant as specified in its charter)
 
   
Delaware 33-0112644
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
14 Cambridge Center, 02142
Cambridge, Massachusetts
 (Zip code)
(Address of principal executive offices)
  
 
(617) 679-2000
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
 
   
Title of Each Class
 
Name of Each Exchange on Which Registered
 
Common Stock, $0.0005 par value
 The Nasdaq Global Select Market
 
Securities registered pursuant to Section 12(g) of the Act:
None
 
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.  Yes þ     No o
 
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act.  Yes o     No þ
 
Indicate by check mark whether the Registrantregistrant (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 Registrantregistrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes þ     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 ofRegulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files):  Yes þ     No o
 
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 ofRegulation S-K is not contained herein, and will not be contained, to the best of the Registrant’sregistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of thisForm 10-K or any amendment to thisForm 10-K.  þ
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” inRule 12b-2 of the Exchange Act.
 
       
Large accelerated filer þ
 Accelerated filer o Non-accelerated filer o
(Do
Smaller reporting company o
                         (Do not check if a smaller reporting company)Smaller reporting company o
 
Indicate by check mark whether the registrant is a shell company (as defined inRule 12b-2 of the Securities Exchange Act of 1934)Act).  Yes o     No þ
 
The aggregate market value of the Registrant’s Common Stockregistrant’s common stock held by non-affiliates of the Registrantregistrant (without admitting that any person whose shares are not included in such calculation is an affiliate) computed by reference to the price at which the common stock was last sold as of the last business day of the Registrant’sregistrant’s most recently completed second fiscal quarter was $16,179,698,132.$13,005,469,098.
 
As of February 2, 2009,5, 2010, the Registrantregistrant had 297,252,825269,601,262 shares of Common Stock,common stock, $0.0005 par value, issued and outstanding.
 
DOCUMENTS INCORPORATED BY REFERENCE
 
Portions of the definitive Proxy Statementproxy statement for our 20092010 Annual Meeting of Stockholders are incorporated by reference into Part III of this Report.report.
 


 

 
BIOGEN IDEC INC.
 
ANNUAL REPORT ONFORM 10-K
 
For the Year Ended December 31, 20082009
 
TABLE OF CONTENTS
 
       
    Page
 
 Business  1 
  Overview  1 
  Marketed Products  2 
  Other Sources of Revenue  64 
  Late-StageRegistrational Product Candidates5
Other Research and Development Programs  7 
  Patents and Other ResearchProprietary Rights8
Sales, Marketing and Development ProgramsDistribution  9 
  Research and Development Costs9
Patents and Other Proprietary RightsCompetition  10 
  Sales, Marketing and DistributionRegulatory  12 
  Competition13
Regulatory15
Manufacturing and Raw Materials  1916 
  Our Employees  2017 
  Our Executive Officers  2017 
 Risk Factors  2319 
 Unresolved Staff Comments  3329 
 Properties  3430 
 Legal Proceedings  3430 
 Submission of Matters to a Vote of Security Holders  3430 
 
PART II
 Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities  3531 
 Selected Consolidated Financial Data  3733 
 Management’s Discussion and Analysis of Financial Condition and Results of Operations  3834 
 Quantitative and Qualitative Disclosures About Market Risk  6361 
 Consolidated Financial Statements and Supplementary Data  6462 
 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure  6462 
 Controls and Procedures  6462 
 Other Information  6563 
 
PART III
 Directors, Executive Officers and Corporate Governance  6664 
 Executive Compensation  6664 
 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters  6664 
 Certain Relationships and Related Transactions, and Director Independence  6664 
 Principal Accountant Fees and Services  6664 
 
PART IV
 Exhibits, Financial Statement Schedules  6765 
  6866 
  F-1 
 Ex-4.4 Amendment No. 2 to Amended and Restated RightsEx-10.50 Transition Agreement, between Biogen Idec and Mellon Investor Services LLC dated as of January 22, 2009.4, 2010
 Ex-10.19 Amendment to Biogen Idec Inc. 2008 Omnibus Equity PlanEX-10.52 Letter regarding employment arrangement of Robert Hamm dated October 13, 2008April 1, 2009
 Ex-10.25 Amendment to Biogen Idec Inc. 2006 Non-Employee Directors Equity PlanEx-10.58 Letter regarding employment arrangement of Susan Alexander dated OctoberDecember 13, 20082005
 Ex-10.30 Amendment to Biogen Idec Inc. 2005 Omnibus Equity Plan dated October 13, 2008
Ex-10.34 Amendment to Biogen Idec Inc. 2003 Omnibus Equity Plan dated October 13, 2008
Ex-10.45 Amendment to Biogen, Inc. 1985 Non-Qualified Stock Option Plan dated October 13, 2008
Ex-10.51 Biogen Idec Inc. Executive Severance Policy - U.S. Executive Vice President, as amended effective October 13, 2008.
Ex-10.52 Biogen Idec Inc. Executive Severance Policy - International Executive Vice President, as amended effective October 13, 2008.
Ex-10.53 Biogen Idec Inc. Executive Severance Policy - U.S. Senior Vice President, as amended effective October 13, 2008.
Ex-10.54 Biogen Idec Inc. Executive severance Policy - International Senior Vice President, as amended effective October 13, 2008.
Ex-10.59 Second Amendment to Employment Agreement between Biogen Idec and James C. Mullen dated as of December 4, 2008
Ex-10.61 Employment Agreement between Biogen Idec Management Services GmbH and Hans Peter Hasler dated October 15, 2008.
Ex-10.63 First Amendment to Employment Agreement between Biogen Idec and Cecil B. Pickett dated as of October 28, 2008
Ex-10.66 First Amendment to Employment Agreement between Biogen Idec and Craig E. Schneier dated October 8, 2008
Ex-21.1Ex-21 Subsidiaries
 Ex-23.1Ex-23 Consent of PricewaterhouseCoopers LLP - an Independent Registered Public Accounting Firm
 Ex-31.1 Section 302 Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
 Ex-31.2 Section 302 Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
 Ex-32.1 Section 906 Certification of the Chief Executive Officer and the Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
EX-101 INSTANCE DOCUMENT
EX-101 SCHEMA DOCUMENT
EX-101 CALCULATION LINKBASE DOCUMENT
EX-101 LABELS LINKBASE DOCUMENT
EX-101 PRESENTATION LINKBASE DOCUMENT
EX-101 DEFINITION LINKBASE DOCUMENT


NOTE REGARDING FORWARD-LOOKING STATEMENTS
In addition to historical information, this report contains forward-looking statements that are based on our current beliefs and expectations. These forward-looking statements do not relate strictly to historical or current facts and they may be accompanied by such words as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “target,” “will” and other words and terms of similar meaning. Reference is made in particular to forward-looking statements regarding:
• the anticipated level, mix and timing of future product sales, royalty revenues, milestone payments, expenses, liabilities, contractual obligations and amortization of intangible assets;
• the growth trends for TYSABRI and our ability to improve the benefit-risk profile of TYSABRI;
• the assumed remaining life of the core technology relating to AVONEX;
• the markets for our products;
• competitive conditions and the development, timing and impact of competitive products;
• the incidence, timing, outcome and impact of litigation, proceedings related to patents and other intellectual property rights, tax assessments and other legal proceedings;
• our effective tax rate for future periods, our ability to realize the benefits of our deferred tax assets and the treatment of our undistributed foreign earnings of ournon-U.S. subsidiaries;
• the timing and impact of accounting standards;
• the design, costs, development and timing of therapeutic areas and indications targeted by programs in our clinical pipeline;
• the outcome and impact of healthcare reform efforts;
• the timing and outcome of regulatory filings and meetings with regulatory authorities;
• our ability to finance our operations, meet our manufacturing needs and source funding for such activities;
• the impact that our Weston facility will have on our operating expenses and the timing of occupancy;
• the status, intended use and financial impact of our manufacturing facilities;
• our share repurchase programs;
• the drivers for growing our business; and
• our plans to expend additional funds and resources on external business development and research opportunities.
These forward-looking statements are based on our current beliefs and expectations and involve risks and uncertainties that could cause actual results to differ materially from those reflected in such forward-looking statements. Important factors that could cause actual results to differ from our expectations and could negatively impact our financial position and results of operations are discussed in the “Risk Factors” section of this report and elsewhere in this report.
Forward-looking statements, like all statements in this report, speak only as of the date of this report, unless another date is indicated. Unless required by law, we do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
NOTE REGARDING COMPANY AND PRODUCT REFERENCES
Throughout this report, “Biogen Idec,” “we,” “us” and “our” refer to Biogen Idec Inc. and its consolidated subsidiaries, “RITUXAN” refers to both RITUXAN (the trade name for rituximab in the U.S., Canada and Japan) and MabThera (the trade name for rituximab outside the U.S., Canada and Japan), and “ANGIOMAX” refers to both ANGIOMAX (the trade name for bivalirudin in the U.S., Canada and Latin America) and ANGIOX (the trade name for bivalirudin in Europe).


NOTE REGARDING TRADEMARKS
AVONEX®, RITUXAN® and ADENTRI® are registered trademarks, and FUMADERMtm is a trademark of Biogen Idec Inc. or its subsidiaries. TYSABRI® and TOUCH® are registered trademarks of Elan Pharmaceuticals, Inc.;. The following are trademarks of the respective companies listed:
ACTEMRA® — Chugai Seiyaku Kabushiki Kaisha; AMPYRATM — Acorda Therapeutics, Inc.; ANGIOMAX® and ANGIOX® — The Medicines Company; ARZERRATM — Glaxo Group Limited; BETASERON® and BETAFERON® — Bayer Schering Pharma AG; CAMPATH® — Genzyme Corporation; CIMZIA® — UCB Pharma, S.A.; COPAXONE® — Teva Pharmaceutical Industries Limited; ENBREL® — Immunex Corporation; EXTAVIA® — Novartis AG; HUMIRA® — Abbott Biotechnology Ltd.; ONCOVINTM — Eli Lilly and Company; ORENCIA® — Bristol-Myers Squibb Company; REBIF® — Ares Trading S.A.; REMICADE® — Centocor Ortho Biotech Inc.; SIMPONITM — Johnson & Johnson; and TREANDA® — Cephalon, Inc.
NOTE REGARDING REFERENCES TO THE CODIFICATION
In June 2009, the Financial Accounting Standards Board (FASB), issued the FASB Accounting Standards Codification (Codification). Effective July 1, 2009, the Codification became the single source for all authoritative generally accepted accounting principles (GAAP), recognized by the FASB and is required to be applied to financial statements issued for interim and annual periods ending after September 15, 2009. The Codification does not change GAAP and did not impact our financial position or results of operations; however the Codification does change the way we refer to GAAP within our financial statements.


 
PART I
 
Item 1.  Business
 
Overview
 
Biogen Idec Inc. (“we” or “Biogen Idec”)is a global biotechnology company that creates new standards of care in therapeutic areas with high unmet medical needs. Our business strategy is focused on discovering and developingfirst-in-class orbest-in-class products that we can deliver to specialty markets globally. Patients in more than 90 countriesworldwide benefit from Biogen Idec’s significant products that address medical needs in the areas of neurology, oncology and immunology.
 
Marketed Products
 
We currently have four therapeutic products on the market, which are summarized in the table below.
 
               
Product
 Product Indications Revenues to Biogen Idec (in millions) 
    2008  2007  2006 
 
AVONEX®
(interferon beta-1a)
 Relapsing multiple sclerosis $2,202.6  $1,867.8  $1,706.7 
RITUXAN®*
(rituximab)
 Certain B-cell non-Hodgkin’s lymphoma
Rheumatoid arthritis
  1,128.2   926.1   810.9 
TYSABRI®
(natalizumab)
 Relapsing multiple sclerosis
Crohn’s disease
  588.6   229.9   35.8 
FUMADERM®
(dimethylfumarate and monoethylfumarate salts)
 Severe psoriasis  43.4   21.5   9.5 
               
    Revenues to Biogen Idec (in millions) 
Product
 
Summary of Approved Indications
 2009  2008  2007 
 
AVONEX
(interferon beta-1a)
 Multiple sclerosis $2,322.9  $2,202.6  $1,867.8 
RITUXAN
(rituximab)
 Non-Hodgkin’s lymphoma
Rheumatoid arthritis
 $1,094.9  $1,128.2  $926.1 
TYSABRI
(natalizumab)
 Multiple sclerosis
Crohn’s disease
 $776.0  $588.6  $229.9 
FUMADERM
(dimethylfumarate and monoethylfumarate salts)
 Psoriasis $49.6  $43.4  $21.5 
*Outside the United States, Canada and Japan, MabThera is the trade name for rituximab. We refer to rituximab, RITUXAN and MabThera collectively as RITUXAN.
Other Sources of Revenue
We receive royalty revenues on sales by our licensees of other products covered under patents that we control. In 2008, 2007 and 2006, our royalty revenues were $116.2 million, $102.1 million and $86.2 million, respectively.
 
Additional financial information about our product revenues, other revenues and geographic areas in which we operate is set forth in Note 22, Segment Information in “Notes toour Consolidated Financial Statements and in Note 20,Segment Information to our Consolidated Financial Statements.
 
Research and Development
 
We devote significant resources to research and development programs and external business and corporate development efforts.opportunities. We intend to focus our research and development efforts on finding novel therapeutics in areas of high unmet medical need both within our currentcore and emergent focus areas of neurology, oncology, immunology, cardiopulmonary and cardiology as well as in new therapeutic areas. We have 22 pipeline products in Phase 2 trials or beyond. hemophilia.
In 2009, 2008 2007 and 2006,2007, our research and development costs weretotaled $1,283.1 million, $1,072.1 million and $925.2 million, respectively. We incurred charges associated with acquired in-process research and $718.4development of $25.0 million and $84.2 million in 2008 and 2007 respectively. No acquired in-process research and development charges were incurred in 2009.
CEO Retirement
On January 4, 2010, we announced that James C. Mullen will retire as our President and Chief Executive Officer on June 8, 2010, and will retire from our Board of Directors upon the completion of his current term as a director at our 2010 Annual Meeting of Stockholders. We entered into a transition agreement with Mr. Mullen on January 4, 2010, which is filed as an exhibit to this report. Under the transition agreement, we agreed with Mr. Mullen (1) to continue to pay Mr. Mullen’s current base salary of $1.2 million through June 8, 2010, (2) to pay Mr. Mullen a bonus for 2009 calculated as 125% of his 2009 base salary of $1.2 million multiplied by our corporate multiplier for 2009 determined based on our achievement of goals established at the beginning of 2009, (3) to pay Mr. Mullen a bonus for 2010 calculated as 125% of his prorated base salary, (4) to vest all of Mr. Mullen’s unvested equity awards on the date of his retirement, (5) to allow Mr. Mullen to exercise his vested stock options until June 8, 2013 or their expiration, whichever is earlier, and (6) that if we make a public announcement of a transaction that constitutes a change in control prior to June 8, 2010, Mr. Mullen will be entitled to a severance payment in the


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amount of three times the sum of his annual base salary and target bonus and a related tax payment provided under his employment agreement upon consummation of the transaction. We have initiated a search for Mr. Mullen’s successor.
 
Available Information
 
We were formed as a California corporation in 1985 and became a Delaware corporation in 1997. Our principal executive offices are located at 14 Cambridge Center, Cambridge, Massachusetts 02142 and our telephone number is(617) 679-2000. Our website address is www.biogenidec.com. We make available free of charge through the Investor Relations section of our website our Annual Reports onForm 10-K, Quarterly Reports onForm 10-Q, Current Reports onForm 8-K and all amendments to those reports as soon as reasonably practicable after such material is electronically filed with or furnished to the Securities and Exchange Commission or the SEC.(SEC). We include our website address in this Annual Report onForm 10-Kreport only as an inactive textual reference and do not intend it to be an active link to our website. The contents of our website are not incorporated into this filing.


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Marketed Products
 
Our marketed products address the following diseases: multiple sclerosis (MS),; non-Hodgkin’s lymphoma (NHL),; rheumatoid arthritis (RA),; Crohn’s disease (CD); and psoriasis. As part of our ongoing development efforts, we are also seeking to expand our marketed products into other diseases, such as Antineutrophil cytoplasmic antibodies (ANCA) associated vasculitis, chronic lymphocytic leukemia (CLL), lupus nephritis, ANCA-associated vasculitis, multiple myeloma and ulcerative colitis. The approved indications for, and ongoing development of, our marketed products are summarized in the table below. Drug development involves a high degree of risk, and the status, timing and scope of our clinical trials, drug approvals and applications for approval are subject to change. Important factors that could adversely affect our drug development efforts are discussed in the “Risk Factors” section of this report.
 
       
  Approved or
   Development and/or
Product
 ProductTargeted Indications Status Marketing Collaborators
 
AVONEX
 Relapsing MS Approved in U.S. and numerous other countries worldwide None
  
  Ulcerative colitis Phase 2 None
RITUXAN(1)
 Certain B-cell NHL Approved in U.S. and numerous other countries worldwide All RITUXAN Indications:
U.S. — Genentech
Japan — ZenyakuRoche Group and Chugai
Outside U.S. and Japan — Rocheits sublicensees
  
  RA anti-TNF-inadequate responders Approved in U.S. and numerous other countries worldwide See aboveRoche Group and its sublicensees
  
  RA, DMARD naïve and inadequate responders (IR) Phase 3 complete (DMARD naïve) Filed with regulators (DMARD-IR)See above
  
  CLL Phase 3 complete and regulatory filings plannedIn U.S. registration See above
Lupus nephritisPhase 3U.S. — GenentechRoche Group and its sublicensees
  
  ANCA-associated vasculitis Phase 2/3 Roche Group (Our rights are limited to U.S. — Genentech)
TYSABRI(2)
 Relapsing MS Approved in U.S. and numerous other countries worldwide Elan Pharmaceuticals
  
  CD Approved in U.S. Elan Pharmaceuticals
Multiple myelomaPhase 1/2Elan
FUMADERM
 Severe psoriasis Approved in Germany AlmirallNone
(1)RITUXAN is indicated for the treatment of (1)(a) relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent, (b) previously untreated follicular, CD20-positive, B-cell NHL in combination with cyclophosphamide, vincristine and prednisone (CVP) chemotherapy, (c) non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line CVP chemotherapy, and (d) previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, Oncovin and prednisone or other anthracycline-based chemotherapy regimens and (2) moderately- to severely-active RA, in combination with methotrexate, in adult patients who have inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
(2)TYSABRI is indicated for the treatment of (1) relapsing MS as a monotherapy and (2) moderately to severely active CD with evidence of inflammation with an inadequate response to or inability to tolerate conventional CD therapies and TNF inhibitors.


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AVONEX
 
WeAVONEX is one of the leading therapeutic products for relapsing forms of MS with over 135,000 patients currently market and sell AVONEX worldwide for the treatment of relapsing MS.using AVONEX. MS is a progressive neurological disease in which the body loses the ability to transmit messages along nerve cells, leading to a loss of muscle control, paralysis and, in some cases, death. Patients with active relapsing MS experience an uneven pattern of disease progression characterized by periods of stability that are interrupted byflare-ups of the disease after which the patient returns to a new baseline of functioning. AVONEX is a recombinant form of athe interferon beta protein produced in the body by fibroblast cells in response to viral infection. AVONEX has been shown in clinical trials in relapsing MS both to slow the accumulation of disability and to reduce the frequency offlare-ups. AVONEX is approved to treat relapsing MS, including patients with a first clinical episode and MRI features consistent with MS.
AVONEX is on the market in over 70 countries. Based on data from an independent third party research organization, information from our distributors and internal analysis, we believe that AVONEX is the most prescribed therapeutic product for the treatment of MS worldwide. Globally over 135,000 patients use AVONEX.
 
20082009 Developments
 
We continue to work to expand the clinical data available about AVONEX and MS treatments, invest in AVONEX lifecycle development and focus on projects that will help patients adhere to therapy.
In September 2008, we announced that data from the follow-up study known as ASSURANCE showed the long-term benefits of AVONEX therapy in patients with relapsing MS for up to 15 years. The ASSURANCE study represents the long-termfollow-up of patients who participated in the Multiple Sclerosis Collaborative Research Group (MSCRG) trial, the original Phase 3 pivotal trial from which AVONEX was approved. Specifically, the ASSURANCE study showed that patients currently taking AVONEX for up to 15 years versus those not on AVONEX therapy reported: (1) significantly lower disability progression as measured by a mean change in Expanded Disability Scale Scores (EDSS) of 2.3 vs. 3.3 from the MSCRG baseline; (2) lower disability progression


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to EDSS milestones four, six and seven; (3) greater quality of life as measured by the physical component score of the SF-36 health survey; (4) significantly greater sense of independence in self care; and (5) significantly more independent living.
We have also extended the five-year study known as CHAMPIONS for an additional five years. CHAMPIONS was originally designed to determine whether the effect of early treatment with AVONEX in delaying relapses and reducing the accumulation of MS brain lesions could be sustained for up to five years. The study results showed that AVONEX altered the long-term course of MS in patients who began treatment immediately after their initial MS attack compared to initiation of treatment more than two years after onset of symptoms. The five-year study extension is intended to determine if the effects of early treatment with AVONEX can be sustained for up to ten years. We also continue to support Phase 4 investigator-run studies evaluating AVONEX in combination with other therapies.
Outside of MS, we are conducting a Phase 2 trial of AVONEX in ulcerative colitis, a form of inflammatory bowel disease.
• In September 2009, we were issued a U.S. patent for the use of beta interferon for immunomodulation or treating a viral condition, viral disease, cancers or tumors. This patent, which expires in September 2026, covers the treatment of multiple sclerosis with AVONEX.
• In April 2009, we announced data results from an open label, ten-year extension study of MS patients, known as CHAMPIONS, indicating that early treatment with AVONEX reduces relapse rates and may reduce disease progression for up to ten years.
 
RITUXAN
 
RITUXAN is one of the highest sellingmost prescribed oncology therapeutics in the world and has had approximately 1.5with over 2.1 million patient exposures worldwide across all indications. In the United States, RITUXAN is approved fora monoclonal antibody that is used worldwide to treat NHL with the following label indications:
• The treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent;
• The treatment of patients with previously untreated diffuse large B-cell, CD20-positive, NHL, or DLBCL, in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens;
• The treatment of patients with previously untreated follicular, CD20-positive, B-cell NHL in combination with CVP (cyclophosphamide, vincristine and prednisone) chemotherapy; and
• The treatment of patients with non-progressing (including stable disease), low grade CD20-positive, B-cell NHL, as a single agent, after first line CVP chemotherapy.
and RA. NHL is a cancer that affects lymphocytes, which are a type of white blood cell that help to fight infection. RITUXAN is an immunotherapy that targets CD20-positive B-cell lymphocytes involved in certain types of NHL and helps the immune system to eliminate them.
RITUXAN, in combination with methotrexate, is also approved for reducing signs and symptoms and to slow the progression of structural damage in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more tumor necrosis factor, or TNF, inhibitor therapies. RA is a chronic disease that occurs when the immune system mistakenly attacks the body’s joints, resulting in inflammation, pain and joint damage. RITUXAN targets CD20-positive B-cell lymphocytes believed to be involved in RA and helps the immune system to eliminate them.
 
Our revenues from RITUXAN include three components:We collaborate with the Roche Group, through its wholly-owned member Genentech, Inc., on the development and commercialization of RITUXAN. Please read Note 17,Collaborationsto our Consolidated Financial Statements for a description of this collaboration.
2009 Developments
 
 • In November 2009, the U.S. Co-Promotion Profits.  In the United States, we co-promoteFood and Drug Administration (FDA) issued a complete response on applications for RITUXAN in collaboration with Genentech, Inc. All U.S. sales of RITUXAN are recognized by Genentech,plus fludarabine and we record our share of the pre-tax co-promotion profits on a quarterly basis. Genentech provides the primary support functionscyclophosphamide for the commercializationtreatment of RITUXANpeople with CLL, a cancer that affects white blood cells. The FDA has not requested any new data to complete its review of these applications. We and Genentech have engaged in final label discussions with the United StatesFDA and has worldwide manufacturing responsibilities.
expect to finalize these discussions during the first quarter of 2010.
 
 • RestIn October 2009, we announced that the FDA issued a complete response indicating that they did not believe that approval could be supported for RITUXAN in RA patients with an inadequate response to non-biological disease modifying agents.
• In October 2009, data from a Phase 2/3 clinical trial of World Revenues.  OutsideRITUXAN in ANCA-associated vasculitis, known as RAVE, was presented at the United States, F. Hoffman-La Roche Ltd., or Roche, markets and sells RITUXAN, except in Japan whereAmerican College of Rheumatology. The trial met its primary endpoint of noninferiority, showing that RITUXAN is co-marketed by Zenyaku Kogyo Co. Ltd., or Zenyaku, and Chugai Pharmaceutical Co., Ltd., or Chugai, an affiliateas effective as cyclophosphamide in treatingANCA-associated vasculitis, a type of Roche. In Canada, we receive our share of pre-tax co-promotion profits from Roche. Outsideinflammation of the U.S.blood vessels.
• In September 2009, we announced that a Phase 3 study showed that RITUXAN provided significant clinical benefit to patients with low-grade follicular lymphoma who were treated with RITUXAN as maintenance therapy after primary treatment with RITUXAN and Canada,chemotherapy.
• In March 2009, we receive royalties through Genentech on salesannounced that a Phase 3 study of RITUXAN for a period of 11 years from the date of first commercial sale in each country. For the majority of European countries, the first commercial sale of RITUXAN occurred in the second half of 1998.lupus nephritis did not meet its primary endpoint.


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Therefore, we expect a significant decrease in royalty revenues on sales of RITUXAN outside the United States beginning in the latter half of 2009. Specifically, the royalty period with respect to sales in France, Spain, Germany and the United Kingdom will expire in 2009. The royalty period with respect to sales in Italy will expire in 2010. The royalty period with respect to sales in other countries will expire through 2012.
• Expense Reimbursement.  We receive reimbursement from Genentech for our selling and development expenses incurred in the United States.
In the United States, we share responsibility with Genentech for continued development of RITUXAN. Such continued development includes conducting supportive research and post-approval clinical studies and seeking potential approval for additional indications. Under the terms of our collaboration agreement with Genentech, we also have the right to participate with Genentech in the development and commercialization of any anti-CD20 product acquired or developed by Genentech, which we refer to as a New Anti-CD20 Product, as well as the right to participate with Genentech in the development and commercialization of any anti-CD20 product that Genentech licenses from a third party, which we refer to as a Third Party Anti-CD20 Product. Under the terms of the collaboration agreement there are different rights and obligations that apply depending on whether an anti-CD20 product is a New Anti-CD20 Product or a Third Party Anti-CD20 Product. Currently, there is only one New Anti-CD20 Product, ocrelizumab, and only one Third Party Anti-CD20 Product, GA101. We have the right to co-promote with Genentech any New Anti-CD20 Products resulting from such development in the United States. We are currently in arbitration with Genentech as to whether Genentech has the right to develop collaboration products without our approval. See Note 19, Litigation, in “Notes to Consolidated Financial Statements” for a description of that arbitration. Our agreement with Genentech provides that the successful development and commercialization of the first New Anti-CD20 Product will decrease our percentage of co-promotion profits of the collaboration. Ocrelizumab is in Phase 3 trials for rheumatoid arthritis and lupus nephritis and is also in a Phase 2 trial for relapsing MS.
2008 Developments
In April 2008, we and Genentech announced that a Phase 2/3 study of RITUXAN in primary-progressive multiple sclerosis (PPMS) did not meet its primary endpoint, as measured by the time to confirmed disease progression during the 96-week treatment period.
In April 2008, we and Genentech also announced that a Phase 2/3 study of RITUXAN in systemic lupus erythematosus (SLE) did not meet its primary endpoint, defined as the proportion of RIXUTAN treated patients who achieved a major clinical response or partial clinical response compared to placebo at 52 weeks. The study also did not meet any of the six secondary endpoints.
In December 2008, we and Genentech announced the results of two global Phase 3 registrational studies of RITUXAN in CLL, a cancer affecting B-cell lymphocytes. These studies, known as the CLL8 and REACH studies, showed that RITUXAN plus chemotherapy significantly increased the time patients lived without their disease advancing, as defined by the primary endpoint of progression-free survival, when compared to chemotherapy alone. Specifically, in the CLL8 study, 817 patients newly diagnosed with CLL were given RITUXAN combined with chemotherapy, with 41% of such patients experiencing a reduction in the risk of death or cancer progression when compared with those treated with chemotherapy alone. In addition, the REACH study, involving 552 participants, found RITUXAN reduced the risk of cancer progression or death by 35 percent for patients who had a relapse of CLL symptoms after chemotherapy. We and Genentech anticipate submitting an application to the FDA for potential new indications for RITUXAN in first- and second-line treatment of CLL in 2009.
In December 2008, we and Genentech announced that a Phase 3 clinical study of RITUXAN in patients with early RA who have not previously been treated with methotrexate met its primary endpoint. In this study, known as IMAGE, patients received two infusions of either 500 mg or 1000 mg of RITUXAN or placebo for up to two treatment courses in combination with a stable dose of methotrexate. At week 52, only patients in the 1000 mg treatment group met the primary endpoint and showed significantly less progression of joint damage compared to patients who received placebo in combination with methotrexate.


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We, along with Genentech and Roche, initiated a Phase 3 clinical trial of RITUXAN in RA patients who are inadequate responders to disease-modifying anti-rheumatic drugs, or DMARDs, in 2006. In January 2008, we announced that the trial, known as SERENE, met its primary endpoint of a significantly greater proportion of RITUXAN-treated patients achieving an American College of Rheumatology (ACR) 20 response (the proportion of patients who achieve at least 20% improvement) at week 24, compared to placebo. In this trial, patients who received either 500 mg or 1000 mg of RITUXAN as a single treatment course of two infusions in combination with a stable dose of methotrexate displayed a statistically significant improvement in symptoms compared to patients who received placebo in combination with methotrexate. In September 2008, we and Genentech filed for an expansion of the RITUXAN label to include treatment of RA patients who have had an inadequate response to DMARDs.
We, along with Genentech, are conducting a Phase 3 clinical trial of RITUXAN in lupus nephritis, an inflammation of the kidney caused by systemic lupus erythematosus, a disease of the immune system. We anticipate reporting results from this trial in the first half of 2009.
The National Institutes of Health is conducting a Phase 2/3 clinical trial of RITUXAN in ANCA-associated vasculitis, a type of inflammation of the blood vessels. We anticipate that data from this trial will be available in 2009.
TYSABRI
 
We believe that TYSABRI is one of the most efficacious treatments for MS. TYSABRI is a monoclonal antibody (natalizumab) that was initially approved by the FDA in November 2004 to treat relapsing MS to reduce the frequency of clinical relapses.MS. In February 2005, in consultation with the FDA, we and our collaborator Elan Corporation plc or Elan,(Elan) voluntarily suspended the marketing and commercial distribution of TYSABRI based on reports of cases of PMLprogressive multifocal leukoencephalopathy (PML) in patients treated with TYSABRI in clinical studies. PML is an opportunistic viral infection of the brain that often leads to death or severe disability. In July 2006, TYSABRI was reintroduced in the United States,U.S., and introduced in the European Union, as a monotherapy treatment for relapsing MSMS. TYSABRI is also approved in the U.S. to slowtreat CD, which is an inflammatory disease of the progression of disability and reduce the frequency of clinical relapses.intestines.
 
TYSABRI is marketed under risk management or minimization plans as agreed to with local regulatory authorities. In the United States,U.S., TYSABRI was reintroduced with a risk minimization action plan known as the TOUCH Prescribing Program, a rigorous system intended to educate physicians and patients about the risks involved and to assure appropriate use of the product. TYSABRI is currently approved for the treatment of MS in 39 countries.
 
In January 2008, we and Elan announced the FDA’s approval of a supplemental biologics license application, or sBLA, for use of TYSABRI for inducing and maintaining clinical response and remission in adult patients with moderately to severely active CD with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha. TYSABRI became available for the treatment of CD in the United States in the first quarter of 2008.
As of the end of 2008, approximately 37,000 patients were on commercial TYSABRI therapy worldwide. Cumulatively, approximately 48,300 patients have been treated with TYSABRI in the post-marketing setting.
Under the terms of our collaboration with Elan, we are solely responsible for the manufacture of TYSABRI worldwide, and weWe collaborate with Elan on the product’s marketing, commercial distributiondevelopment and ongoing development activities. The collaboration agreement with Elan is designed commercialization of TYSABRI. Please read Note 17,Collaborationsto effect an equal sharingour Consolidated Financial Statements for a description of profits and losses generated by the activities of the collaboration between Elan and us. Under our agreement with Elan, however, if sales of TYSABRI exceed specified thresholds, Elan is required to make milestone payments to us in order to continue sharing equally in the collaboration’s results. During 2008, Elan paid us $75 million to maintain the current profit sharing under our collaboration agreement. In January 2009, Elan paid us an additional $50 million milestone payment to maintain this profit sharing split.
In the United States, we sell TYSABRI to Elan who sells the product to third party distributors. Elan and we co-market the product. The sales price to Elan in the United States is set at the beginning of each quarterly period to effect an approximate equal sharing of the gross margin between Elan and us. In addition, in the United States both parties share equally in the operating costs, which include research and development, selling, general and administrative expenses and other similar costs. For sales outside of the United States, we are responsible for


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distributing TYSABRI to customers and are primarily responsible for all operating activities. We and Elan share equally in the operating results of TYSABRI outside the United States.collaboration.
 
20082009 Developments
 
The FDA’s approval of TYSABRI to treat relapsing MS was based on one-year data from two Phase 3 clinical studies. In September 2008, we and Elan announced that a post hoc analysis of one of these studies showed TYSABRI treatment increases the probability of achieving sustained improvement in physical disability over two years when compared to placebo. This post-hoc analysis provides the first evidence that TYSABRI is associated with a significant improvement in functional outcome, rather than only slowing or preventing progression of disability, in those living with relapsing MS. These findings were presented as a poster presentation at the World Congress on Treatment and Research in Multiple Sclerosis in September 2008.
We initiated the first clinical trial of TYSABRI in oncology in 2008. The objectives of this Phase 1/2 study are to evaluate the safety and potential anti-tumor activity of TYSABRI in patients with relapsed or refractory multiple myeloma.
Since the reintroduction of TYSABRI in the United States and the introduction of TYSABRI outside the United States in July 2006, we have disclosed five cases of progressive multifocal leukoencephalopathy, or PML, a known side effect, in patients taking TYSABRI. These patients are the only confirmed cases of PML reported to us during this period.
• In November 2009, we revised the U.S. prescribing information for TYSABRI to reflect that the risk of developing PML increases with longer treatment duration, and for patients treated for 24 to 36 months is generally similar to the rates seen in clinical trials. The revised label also reflects that there is limited experience beyond three years of treatment.
• In the fourth quarter 2009, the European Medicines Agency (EMA) began a review of TYSABRI to determine whether any additional measures were necessary to ensure the safe use of TYSABRI. In January 2010, the EMA recommended updating the TYSABRI label in the E.U. to reflect that the risk of PML increases after two years of therapy. The EMA also recommended that patients have regular MRI scans and be re-informed of the risk of PML after two years on therapy.
 
FUMADERM
 
We acquired FUMADERM as part of our purchase of Fumapharm AG in June 2006 and subsequently acquired the right to distribute FUMADERM in Germany from Fumedica GmbH effective May 1, 2007. FUMADERM acts as an immunomodulator and is approved in Germany for the treatment of severe psoriasis. The product has been in commercial use in Germany since 1994 and is the most prescribed oral systemic treatment for severe psoriasis in Germany. Psoriasis is a skin disease in which cells build up on the skin surface and form scales and red patches.
 
Other Sources of Revenue
 
Our product line previously included ZEVALIN (ibritumomab tiuxetan), which is part of a treatment regimen for certain B-cell non-Hodgkin’s lymphoma, and AMEVIVE (alefacept), a treatment for certain psoriasis. We have sold or exclusively licensed the rights to these products to third parties and continue to receive royalty or supply agreement revenues based on those products.
We also receive royalties on sales by our licensees of a number of other products covered under patents that we control. For example:own. We have also sold or exclusively licensed to third parties rights to certain products previously included within our product line. Royalty or supply agreement revenues received based upon those products are recorded as corporate partner revenue.
• We receive royalties from Schering-Plough Corporation, or Schering-Plough, on sales of its alpha interferon products in the United States pursuant to an interference settlement covering our alpha interferon patents and patent applications. Schering-Plough sells its INTRON® A (interferon alfa-2b) brand of alpha interferon in the United States for a number of indications, including the treatment of chronic hepatitis B and hepatitis C. Schering-Plough also sells other alpha interferon products for the treatment of hepatitis C, including REBETRON® Combination Therapy containing INTRON A and REBETOL® (ribavirin, USP),PEG-INTRON® (peginterferon alfa-2b), a pegylated form of alpha interferon, and PEG-INTRON in combination with REBETOL. See “Patents and Other Proprietary Rights — Recombinant Alpha Interferon.”
• We hold several patents related to hepatitis B antigens produced by genetic engineering techniques. These antigens are used in recombinant hepatitis B vaccines and in diagnostic test kits used to detect hepatitis B infection. We receive royalties from sales of hepatitis B vaccines in several countries, including the United States, from GlaxoSmithKline plc and Merck and Co. Inc.. We have also licensed our proprietary hepatitis B rights, on anantigen-by-antigen and nonexclusive basis, to several diagnostic kit manufacturers,


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including Abbott Laboratories, the major worldwide marketer of hepatitis B diagnostic kits. See “Patents and Other Proprietary Rights — Recombinant Hepatitis B Antigens.”
• We also receive ongoing royalties on sales of ANGIOMAX® (bivalirudin) by The Medicines Company. The Medicines Company sells ANGIOMAX in the United States, Europe, Canada and Latin America for use as an anticoagulant in combination with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty.
 
Our royalty revenues are dependent upon our licensees’ sales of licensed products which could vary significantly due to competition, manufacturing difficulties and other factors.factors that are outside our control. In addition, the expiration or invalidation of any underlying patents could reduce or eliminate the royalty revenues derived from such patents. Royalties on sales of ANGIOMAX (bivalirudin) by The Medicines Company (TMC) represent our most significant source of other revenue. TMC markets ANGIOMAX primarily in the U.S. and the European Union for use as an anticoagulant in patients undergoing percutaneous coronary intervention. Please read the subsection entitled “Other Revenue — Royalty Revenues” in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of this report for a description of this royalty arrangement and factors that could adversely effect this portion of our revenues.
In 2009, 2008 and 2007, our royalty revenues totaled $124.4 million, $116.2 million and $102.1 million, respectively, and our corporate partner revenues totaled $5.1 million, $13.4 million and $6.6 million, respectively. Additional financial information about our product revenues, other revenues and geographic areas in which we operate is set forth in our Consolidated Financial Statements and in Note 20,Segment Informationto our Consolidated Financial Statements.


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Late-StageRegistrational Product Candidates
 
In addition to the ongoing development of our marketed products, we are currently developing the late stagehave a number of product candidates in or near registrational stage development. Drug development involves a high degree of risk, and the status, timing and scope of our clinical trials, drug approvals and applications for approval are subject to change. Important factors that could adversely affect our drug development efforts are set forthdiscussed in the table below.
Development and/or
Marketing
Product
Product IndicationsStatusCollaborators
BG-12
Relapsing MSPhase 3None
Anti-CD80 MAb (galiximab)Relapsed NHLPhase 3None
Anti-CD23 MAb (lumiliximab)Relapsed CLLPhase 2/3None
Humanized Anti-CD20 MAb (ocrelizumab)RAPhase 3U.S. — Genentech
Japan — Chugai and Zenyaku
Outside U.S. and Japan — Roche
Lupus nephritisPhase 3See above
Lixivaptan
Hyponatremia, commonly seen in acute decompensated heart failurePhase 3Cardiokine
ADENTRI®
Acute decompensated heart failure with renal insufficiencyPhase 3None
“Risk Factors” section of this report.
 
BG-12
 
BG-12 is an oral fumarate derivativecompound that is being tested in relapsing MS and appears to have neuroprotective and anti-inflammatory properties. We acquired BG-12 with the purchase of FumapharmMS. During 2009, we completed patient enrollment in June 2006. Twotwo Phase 3 trials of BG-12 in relapsing MS, known as DEFINE and CONFIRM, for relapsing MS are currently underway evaluating the effect of BG-12 on measurements of clinical relapse, the progression of disability and various MRI measures, with the CONFIRM trial including a glatiramer acetate (Copaxone®)(COPAXONE) reference comparator arm. Both studies have a two year treatment period with each study involving approximately 1,200 to 1,500 patients worldwide. The FDA has granted BG-12 fast track status, which may result in an expedited review.
 
Anti-CD80 MAb (galiximab)Daclizumab
 
GaliximabDaclizumab is a monoclonal antibody (MAb) directed againstthat is being tested in relapsing MS. A Phase 2b trial of daclizumab in MS, known as SELECT, is currently underway. The SELECT trial has a one year treatment period and is expected to involve approximately 600 patients worldwide. The SELECT trial is the CD80 surface antigen on human B-cells that we developed using our Primatized® antibody technology. Anti-CD80 antibodies workfirst of two registrational trials required by bindingregulatory authorities. We expect to begin patient enrollment in a particular protein (the CD80 antigen) on the surface of normal and malignant B-cells. From there, they recruit the body’s natural defenses to attack and kill the marked B-cells. A Phase 3 trial of daclizumab in relapsing MS, known as DECIDE, during the first half of 2010. The DECIDE trial has a two year treatment period and is currently underway thatexpected to involve approximately 1,400 patients worldwide. The DECIDE trial is designedthe second registrational trial required by regulatory authorities.
We collaborate with Facet Biotech Corporation (Facet) on the development and commercialization of daclizumab. In January 2010, we agreed with our collaborator, Facet, to compare treatment with galiximabassume the manufacture of daclizumab and began the process of transferring from Facet the manufacturing technology necessary for us to manufacture daclizumab. Any delay in combination with RITUXAN completing or implementing such transfer could adversely affect the timing of our daclizumab trials. Please read Note 17,Collaborationsto treatment with RITUXAN in combination with placebo in patients with follicular NHL that have relapsed or failed to respond to initial therapy.our Consolidated Financial Statements for a description of this collaboration.
 
Anti-CD23 MAb (lumiliximab)Fampridine
 
LumiliximabFampridine is an oral compound that is being developed as a treatment to improve walking ability in people with MS. In December 2009, we filed for approval of fampridine in the European Union and Canada for this indication. Fampridine was approved in the U.S. on January 22, 2010 under the trade name AMPYRA (dalfampridine). AMPYRA is indicated to improve walking in patients with MS. This was demonstrated by an increase in walking speed. Acorda is developing and marketing AMPYRA in the U.S. We collaborate with Acorda on the development and commercialization of fampridine in markets outside the U.S. Please read Note 17,Collaborationsto our Consolidated Financial Statements for a description of this collaboration.
GA101
GA101 is a monoclonal antibody directed againstthat is being tested in CLL. During the CD23 surface antigen on human B-cells thatsecond half of 2009, we developed using our Primatized® antibody technology. Anti-CD23 antibodies work by bindingbegan patient enrollment in a Phase 3 trial of GA101 in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated CLL. The study is designed to have a particular protein (the CD23 antigen)treatment period of approximately 6 months, with a minimum five yearfollow-up period, and involve approximately 800 patients worldwide.
We collaborate with the Roche Group, through its wholly-owned member Genentech, on the surfacedevelopment and commercialization of normal and malignant B-cells. From there, they recruit the body’s natural defensesGA101. Please read Note 17,Collaborations to attack and kill the marked B-cells. A Phase 2/3 study is currently underway that is designed toour Consolidated Financial Statements for a description of this collaboration.


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compare treatment with lumiliximab in combination with fludarabine, cyclophosphamide and RITUXAN, a standard chemotherapy regimen, to treatment with FCR alone in patients with relapsed or refractory CLL.
Humanized Anti-CD20 MAb (ocrelizumab)
 
This second generation anti-CD20 antibodyOcrelizumab is a humanized monoclonal antibody directed against the CD20 surface antigen on human B-cells, the same antigen that RITUXAN targets. Anti-CD20 antibodies work by binding to a particular protein (the CD20 antigen) on the surface of normalis being tested in RA. We and malignant B-cells. From there, they recruit the body’s natural defenses to attack and kill the marked B-cells. During 2008, our collaborator Genentech initiated a fourthfour Phase 3 trials evaluating ocrelizumab in RA, known as SCRIPT, FEATURE, STAGE and FILM, and a Phase 2 trial known as CINEMA.
The SCRIPT study will evaluate the efficacy and safety of ocrelizumab, for rheumatoid arthritiscompared with placebo, in patients with active RA who have an inadequate response to at least one anti-TNF-alpha therapy. This study has a one year treatment period and involves approximately 800 patients worldwide.
In January 2010, we and Genentech determined that the administrationFEATURE study, which evaluated a single infusion of anti-CD20ocrelizumab versus placebo (with dual infusions as an active control) in seropositive RA patients with an inadequate response to prior therapies, did not meet its primary efficacy endpoint as a single infusioninfusion.
In December 2009, we and Genentech announced that STAGE, which evaluated ocrelizumab in combination with methotrexate, met its primary endpoint of improving signs and symptoms (as measured by criteria, known as the ACR 20 response, established by the American College of Rheumatology) in RA patients who had an inadequate response to methotrexate at both 24 and 48 weeks.
In October 2009, a Phase 3 studysafety review of ocrelizumab data in RA and lupus nephritis (LN) clinical trials was performed revealing an apparent imbalance in opportunistic infections among ocrelizumab-treated RA and LN patients in these clinical trials. Based upon this review, redosing was stopped in FILM, which evaluated ocrelizumab given in combination with methotrexate to methotrexate naïve RA patients. Redosing was also stopped in the Asia Pacific region for lupus nephritis. the SCRIPT, FEATURE and STAGE studies.
The CINEMA study will evaluate the efficacy and safety of ocrelizumab in combination with methotrexate compared with infliximab plus methotrexate in patients with active RA who have an inadequate response to certain anti-TNF-alpha therapies. This study has a treatment period of approximately 6 months and involves approximately 300 patients.
We are currently in arbitrationcollaborate with the Roche Group, through its wholly-owned member Genentech, as on the development and commercialization of ocrelizumab. Please read Note 17,Collaborationsto whether Genentech has the right to develop collaboration products, including ocrelizumab, without our approval. See Note 19, Litigation, in “Notes to Consolidated Financial Statements”Statements for a description of that arbitration.this collaboration.
 
Lixivaptan
 
Lixivaptan is an oral compound for the potential treatment of hyponatremia and chronic heart failure,that is being developedtested in conjunction with our collaborator Cardiokine Biopharma LLC, or Cardiokine. Lixivaptan is a highly potent, non-peptide, selective V2 vasopressin receptor antagonist. It antagonizes the action of vasopressin (also known as antidiuretic hormone) on the V2 receptors in the kidney collecting duct, causing water to be excreted from the kidney, without affecting sodium or other electrolytes. Based on this mechanism of action, lixivaptan shows promise in the treatment of disease states associated with water retention and electrolyte imbalance, including hyponatremia, which is the most commonan electrolyte disorder in clinical practice. Hyponatremia is recognized as an independent contributorthat contributes to negative patient outcomes in many chronic diseases, most notably congestive heart failure as well as cirrhosis and syndrome of inappropriate anti-diuretic hormone. Twomany other chronic diseases. Three Phase 3 studiestrials of lixivaptan forin hyponatremia are currently underway. These studies have a 60 day or six month treatment period and involve approximately 100 to 650 patients worldwide.
 
Pursuant We collaborate with Cardiokine Biopharma LLC on the development and commercialization of lixivaptan. Please read Note 17,Collaborationsto our collaboration agreement with Cardiokine, we paid $50.0 million upfront to Cardiokine and will pay them up to $170.0 million in milestone paymentsConsolidated Financial Statements for successful development and global commercializationa description of lixivaptan, as well as royalties on commercial sales. We will be responsible for the global commercialization of lixivaptan, and Cardiokine has an option for limited copromotion in the United States.this collaboration.
 
ADENTRILong-Acting rFactor IX
 
ADENTRI, an adenosine A1 receptor antagonist,Long-acting recombinant Factor IX (Factor IX) is a proprietary long-acting Factor IX product that is being developed undertested in hemophilia B, a licensing agreementdisorder in which blood clotting is impaired. In January 2010, we began patient enrollment in a Phase 2b/3 trial of Factor IX in hemophilia B, known asB-LONG. This study has a 14 month treatment period and will involve approximately 75 patients. Factor IX has received orphan drug designation for the treatment of hemophilia B from both the FDA and EMA.
We collaborate with CV Therapeutics, Inc. A Phase 3 study is currently underway that is designed Swedish Orphan Biovitrum AB (Biovitrum) on the development and commercialization of Factor IX. Please read Note 17,Collaborationsto evaluate the efficacy and safetyour Consolidated Financial Statements for a description of intravenous ADENTRI for acute decompensated heart failure patients with renal insufficiency.this collaboration.


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PEGylated interferon beta-1a
PEGylated interferon beta-1a is designed to prolong the effects and reduce the dosing frequency of interferon beta-1a. During the first half of 2009, we began patient enrollment in a Phase 3 trial of PEGylated interferon beta-1a in relapsing MS, known as ADVANCE. The study is designed to have a two year treatment period and involve approximately 1,200 patients worldwide. The FDA has granted PEGylated interferon beta-1a fast track status, which may result in an expedited review.
Former Registrational Programs
Based upon the October 2009 safety review of ocrelizumab data in RA and LN clinical trials described above, we decided to close the ocrelizumab BELONG study in LN. The SCRIPT study of ocrelizumab in RA described above remains ongoing. We plan to work with regulators to determine the next step for this program.
In October 2009, after a strategic review of our Anti-CD80 MAb (galiximab) and Anti-CD23 MAb (lumiliximab) programs, we decided to stop recruitment in the lumiliximab LUCID trial in CLL and end the galiximab TARGET trial in NHL. Neither decision was a consequence of any safety concerns. We are evaluating our options for these programs.
In December 2009, we determined to close our ADENTRI clinical trial for the treatment of acute decompensated heart failure with renal insufficiency after reviewing preliminary results from the trial.
 
Other Research and Development Programs
 
We intend to continue to commit significant resources to research and development opportunities. We intend to focus our research and development effortsopportunities, focusing on finding novel therapeutics in areas of high unmet medical need. Our core focus areasHighlighted below are several of our development programs that currently are not in neurology, oncology, immunologyregistrational trials. Drug development involves a high degree of risk, and cardiology, butthe status, timing and scope of our research anddevelopment programs are subject to change. Important factors that could adversely affect our drug development efforts extend to additional therapeutic areas. We dedicate resources to the development of new product candidates and, in some cases, to new applications of existing marketed products and late-stage product candidates. Several of our preclinical and early stage product candidates are highlighteddiscussed in the table below.“Risk Factors” section of this report.
 
         
        Development and/or
Marketing
Therapeutic Area
 Product Candidate IndicationTargeted Indications Status Marketing Collaborators
 
Neurology BIIB014 Parkinson’s disease — early and late stage Phase 2 Vernalis plc
  
  DaclizumabOcrelizumab Relapsing MS Phase 2 Facet Biotech Corporation (formerly part of PDL BioPharma, Inc.)Roche Group
  
  CDP323Neublastin Relapsing MSNeuropathic pain Phase 21 UCB S.A.
  
  Humanized Anti-CD20 MAb(ocrelizumab)Relapsing MSPhase 2U.S.—Genentech Japan—Chugai and Zenyaku Outside U.S. and Japan—Roche
PEG-IFN beta 1aLINGO MS Phase 1  
  
  NeublastinBART Neuropathic painAlzheimer’s Disease Preclinical NsGene A/SNeurimmune SubOne AG
LINGOMSPreclincal
OncologyVolociximab (M200)Solid tumors — non-small cell lung cancerPhase 2Facet Biotech
 Hsp90 Inhibitor (CNF2024) Solid tumors — gastrointestinal stromal tumors Phase 2  
  
  GA101 NHL Phase 2 U.S. — Genentech
(U.S.Roche Group (Our rights only)are limited to U.S.)
  
  GA101Anti-CD80 MAb (galiximab)NHLPhase 2
Anti-CD23 MAb (lumiliximab) CLL Phase 12 U.S. — Genentech
(U.S. rights only)
  
  Anti-IGF-1R (BIIB022) Solid tumors — liver cancerPhase 2
Volociximab (M200)Non-small cell lung cancer Phase 1 Facet Biotech Corporation
  
  Anti-CRIPTO Solid tumors Phase 1  
  
  RAF Inhibitor (BIIB024) Solid tumors Preclinical Sunesis Pharmaceuticals
  
  Anti-Fn14 Solid tumors Preclinical  
Autoimmune and Inflammatory DiseasesImmunology BG-12 RA Phase 2  
  
  Anti-TWEAK RA Phase 1  
  
  Anti-CD40L Fab Systemic lupus erythematosus Preclinical UCB, S.A.
  
  Anti-FcRn Pemphigus Preclinical  
Cardiopulmonary 
CardiovascularLixivaptan ADENTRI (BG9928)Chronic congestiveCongestive heart failure Phase 2 Cardiokine Biopharma LLC
Hemophilia 
AviptadilPulmonary arterial hypertensionPhase 2mondoBiotech AG
Emerging Therapeutic AreasLong acting rFactor IXHemophilia BPhase 1/2aBiovitrum
Long actingLong-acting rFactor VIII Hemophilia A PreclinicalPhase 1 Swedish Orphan Biovitrum AB
Research and Development Costs
For the years ended December 31, 2008, 2007 and 2006, our research and development costs were $1,072.1 million, $925.2 million and $718.4 million, respectively. Additionally, for 2008, 2007 and 2006, we incurred charges associated with acquired in-process research and development of $25.0 million, $84.2 million and $330.5 million, respectively.


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Patents and Other Proprietary Rights
 
Patents are important to developing and protecting our competitive position. We have filed numerousregularly seek patent applicationsprotection in the United StatesU.S. and various otherin selected countries seeking protection ofoutside the U.S. for inventions originating from our research and development including a number of our processes and products. Patents have been issued on many of these applications. We have also obtainedefforts. In addition, we license rights to various patents and patent applications, under licenses with third parties, which providegenerally, in return for the payment of royalties by us. The ultimate degree of patent protection that will be afforded to biotechnology products and processes, including ours, in the United States and in other important markets remains uncertain and is dependent upon the scope of protection decided upon by the patent offices, courts and lawmakers in these countries. There is no certainty that our existingowner. U.S. patents, or others, if obtained, will afford us substantial protection or commercial benefit. Similarly, there is no assurance that our pending patent applications or patent applications licensedas well as most foreign patents, are generally effective for 20 years from third parties will ultimately be granted as patents or that thosethe date the earliest (priority) application was filed; however, U.S. patents that have been issued or are issued inissue on applications filed before June 8, 1995 may be effective until 17 years from the future will standissue date, if they are challenged in court.
A substantial number of patents have already been issued to other biotechnology and biopharmaceutical companies. Competitors may have filed applications for, or have been issued patents and may obtain additional patents and proprietary rights that may relate to products or processes competitive with or similar to our products and processes. Moreover,is later than the 20 year date. In some cases, the patent lawsterm may be extended to recapture a portion of the United Statesterm lost during FDA regulatory review or because of U.S. Patent and Trademark Office (USPTO) delays in prosecuting the application. The duration of foreign countries are distinct and decisions as to patenting, validity of patents and infringement of patents may be resolved differentlyvaries similarly, in different countries. In general, we try to obtain licenses to third party patents, that we deem necessary or desirable for the manufacture, use and sale of our products. We are currently unable to assess the extent to which we may wish to or may be required to acquire rights under such patents and the availability and cost of acquiring such rights, or whether a license to such patents will be available on acceptable terms or at all. There may be patents in the United States or in foreign countries or patents issued in the future that are unavailable to license on acceptable terms. Our inability to obtain such licenses may hinder our ability to market our products.accordance with local law.
 
We are aware that others, including various universitiesalso rely upon unpatented confidential information to remain competitive. We protect such information principally through confidentiality agreements with our employees, consultants, outside scientific collaborators, scientists whose research we sponsor and companies working inother advisers. In the biotechnology field, have filed patent applications and have been granted patents in the United States and in other countries claiming subject matter potentially useful to our business. Some of those patents and patent applications claim only specific products or methods of making such products, while others claim more general processes or techniques useful or now used in the biotechnology industry. There is considerable uncertainty within the biotechnology industry about the validity, scope and enforceability of many issued patents in the United States and elsewhere in the world, and, to date, there is no consistent policy regarding the breadth of claims allowed in biotechnology patents. We cannot currently determine the ultimate scope and validity of patents which may be granted to third parties in the future or which patents might be asserted to be infringed by the manufacture, use and salecase of our products.
There has been, and we expectemployees, these agreements also provide, in compliance with relevant law, that there may continue to be, significant litigation in the industry regarding patentsinventions and other intellectual property rights. We expect that litigation mayconceived by such employees during their employment shall be necessary in some instances to determine the validity and scope of certain of our proprietary rights. Conversely, litigation may be necessary in some instances to determine the validity, scopeand/or noninfringement of certain patent rights claimed by third parties to be pertinent to the manufacture, use or sale of our products. Intellectual property litigation could therefore create business uncertainty and consume substantial financial and human resources. Ultimately, the outcome of such litigation could adversely affect the validity and scope of our patent or other proprietary rights, or, conversely, hinder our ability to market our products. See “Item 3 — Legal Proceedings” for a description of our patent litigation.exclusive property.
 
Our trademarks, including RITUXAN and AVONEX, are important to us and are generally covered by trademark applications or registrations owned or controlled by us in the U.S. PatentUSPTO and the patent offices of other countries. We also use trademarks licensed from third parties, such as the mark TYSABRI which we license from Elan. Trademark Officeprotection varies in accordance with local law, and continues in some countries as long as the mark is used and in other countries. We employ other trademarks in the conduct of our business under license by third parties, for example, we utilizecountries as long as the mark TYSABRI under license from Elan. In addition, AMEVIVE is a registered trademarkregistered. Trademark registrations generally are for fixed but renewable terms.
Our patent position and proprietary rights are subject to certain risks and uncertainties. Please read the “Risk Factors” section of Astellas US LLC,this report for information about certain risks and ZEVALINuncertainties that may affect our patent position and proprietary rights.
Additional information about the patents and other proprietary rights covering our marketed products is a registered trademark of Cell Therapeutics, Inc.set forth below.
 
RecombinantAVONEX and Beta Interferon
 
Third parties have pendingOur U.S. patent applications or issued patentsNo. 7,588,755, granted in September 2009, claims the United States, Europe and other countries with claims to key intermediates in the productionuse of beta interferon. These are known asinterferon for immunomodulation or treating a viral condition, viral disease, cancers or tumors. This patent, which expires in September 2026, covers the Taniguchi patents.treatment of MS with AVONEX.


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Third parties alsoWe have pending patent applications or issued patents with claims to beta interferon itself. These are known as the Rochenon-exclusive rights under certain third-party patents and the Rentschler patents, respectively. We have obtained non-exclusive rights in various countries of the world, including the United States, Japan and Europe,patent applications to manufacture, use and sell AVONEX, our brand ofincluding patents owned by the Japanese Foundation for Cancer Research which expire in 2011 and 2013 in the U.S., and a European patent owned by Rentschler Biotechnologie GmbH and which expires in 2012. Additionally, third parties own pending U.S. patent applications related to recombinant beta interferon, under the Taniguchi, Roche and Rentschler issued patents. The lastinterferon-beta. These applications, which fall outside of the TaniguchiGATT amendments to the U.S. patent statute, are not published by the USPTO and, if they mature into granted patents, expiremay be entitled to a term of seventeen years from the grant date. There is at least one pending interference proceeding in the United States in May 2013USPTO involving such third party applications, and have expired already in other countries of the world. The Roche patents expiredadditional interferences could be declared in the United States in May 2008,future. We are unable to predict which, endedif any, such applications will mature into patents with claims relevant to our obligation to pay Roche royalties on sales of AVONEX in the United States. The Roche patents also have generally expired elsewhere in the world. The Rentschler EU patent expires in July 2012.product.
 
RITUXAN and Anti-CD20 Antibodies
 
We have several issued U.S. patents and U.S. patent applications, and numerous corresponding foreign counterparts, directed to anti-CD20 antibody technology, including RITUXAN. We have also been granted patents covering RITUXAN by the European and Japanese Patent Offices. In the United States ourThe principal patents coveringwith claims to RITUXAN or its uses expire in the drugs or their uses expireU.S. between 2015 and 2018. With regard to2018 and in the rest of the world our principal patents covering the drug products expire in 2013, subject to potentialany available patent term extensionsextensions. In addition, we and our collaborator, Genentech, have filed numerous patent applications directed to anti-CD20 antibodies and their uses to treat various diseases. These pending patent applications have the potential of issuing as patents in countries where such extensions are available. Our recently-grantedthe U.S. and in the rest of world with claims to anti-CD20 antibody molecules for periods beyond that stated above for RITUXAN. In 2008, a European patent in certain European countriesof ours claiming the treatment with


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anti-CD20 antibodies of certain auto-immune indications, including rheumatoid arthritis, has beenwas revoked by the European Patent Office. We are appealing thethat decision. In addition, after revocation actions were filed against the same patent in the UK, we and Genentech agreed that the corresponding patent claims would cover only RITUXAN and not other CD20 antagonist drugs.
 
In addition Genentech, our collaborative partner forcollaborator on RITUXAN, has secured an exclusive license to five U.S. patents and counterpart U.S. and foreign patent applications assigned to Xoma Corporation that relate to chimeric antibodies against the CD20 antigen. These patents expire between 2007 and 2014. Genentech has granted us a non-exclusive sublicense to make, have made, use and sell RITUXAN under these patents and patent applications. We, along with Genentech, share the cost of any royalties due to Xoma in the Genentech/Biogen Idec copromotionour co-promotion territory on sales of RITUXAN. In addition, we and our collaborator, Genentech, have filed numerous patent applications directed to anti-CD20 antibodies and their uses to treat various diseases. These pending patent applications have the potential of issuing as patents in the United States and abroad covering anti-CD20 antibody molecules for periods beyond that stated above for RITUXAN.
Recombinant Alpha Interferon
In 1979, we granted an exclusive worldwide license to Schering-Plough under our alpha interferon patents. Most of our alpha interferon patents have since expired, including expiration of patents in the United States, Japan and all European countries. Schering-Plough pays us royalty payments on U.S. sales of alpha interferon products under an interference settlement entered into in 1998. Under the terms of the interference settlement,Schering-Plough agreed to pay us royalties under certain patents to be issued to Roche and Genentech in consideration of our assignment to Schering-Plough of the alpha interferon patent application that had been the subject of a settled interference with respect to a Roche/Genentech patent. Schering-Plough entered into an agreement with Roche as part of settlement of the interference. The first of the Roche/Genentech patents was issued on November 19, 2002 and has a seventeen-year term. In March 2008, we were issued an alpha interferon patent in Canada which triggered Schering-Plough’s obligation to pay us additional royalties on sales of alpha interferon products in Canada until expiration of the patent in 2025.
Recombinant Hepatitis B Antigens
We have obtained numerous patents in countries around the world, including in the U.S. and in Europe, covering the recombinant production of hepatitis B surface, core and “e” antigens. We have licensed our recombinant hepatitis B antigen patent rights to manufacturers and marketers of hepatitis B vaccines and diagnostic test kits, and receive royalties on sales of the vaccines and test kits by our licensees, as described above under “Principal Licensed Products.” The obligation of GlaxoSmithKline and Merck to pay royalties on sales of hepatitis


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B vaccines and the obligation of our other licensees under our hepatitis B patents to pay royalties on sales of diagnostic products will terminate upon expiration of our hepatitis B patents in each licensed country. Following the conclusion of a successful interference proceeding in the United States, we were granted patents in the United States expiring in 2018. These patents claim hepatitis B virus polypeptides and vaccines and diagnostics containing such polypeptides. Our European hepatitis B patents expired at the end of 1999 and have also since expired in those countries in which we have obtained supplementary protection certificates. See “Item 3 — Legal Proceedings” for a description of our litigation with Classen Immunotherapies, Inc.
 
TYSABRI
 
We are developingand our collaborator, Elan, have patents and patent applications covering TYSABRI in collaboration with Elan. TYSABRI is presently claimed in a number of pendingthe U.S. and other countries. These patents and patent applications cover TYSABRI and issued patents held by both companies in the United States and abroad. These patent applications and patents cover the protein, DNA encoding the protein,related manufacturing methods, and pharmaceutical compositions, as well as various methods of treatment using the product. In the United StatesU.S., the principal patents covering the product and use of the product to treat MS generally expire between 2015 and 2020. Additional U.S. patents and applications covering other indications, including treatment of irritable bowel disease, and methods of manufacturing the product generally expire between 20142012 and 2020, subject to any available patent term extensions.2020. In the remainderrest of the world, patents on the product and methods of manufacturing the product generally expire between 20142015 and 2016,2020, subject to any supplemental protection (i.e., patent term extension) certificates that may be obtained. Both companies have methodIn the rest of world, patents and patent applications covering methods of treatment patents for a variety of indications including the treatment of MS and Crohn’s disease and treatments of inflammation. These patentsusing TYSABRI generally expire in the United States generally between 2012 and 2020 and outside the United States generally between 2012 and 2016, subject to any available patent term extensionsand/or supplemental protection certificates extending such terms.
Trade Secrets and Confidential Know-How
We also rely upon unpatented trade secrets, and we cannot assure that others will not independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose such technology, or that we can meaningfully protect such rights. We require our employees, consultants, outside scientific collaborators, scientists whose research we sponsor and other advisers to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements provide that all confidential information developed or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances. In the case of our employees, the agreement provides that all inventions conceived by such employees shall be our exclusive property. These agreements may not provide meaningful protection or adequate remedies for our trade secrets in the event of use or disclosure of such information.2020.
 
Sales, Marketing and Distribution
 
OurWe focus our sales and marketing efforts are generally focused on specialist physicians in private practice or at major medical centers. We utilize commonuse customary pharmaceutical company practices to market our products and to educate physicians, includingsuch as sales representatives calling on individual physicians, advertisements, professional symposia, direct mail, selling initiatives, public relations and other methods. We provide customer service and other related programs for our products, such as disease and product-specific websites, insurance research services and order, delivery and fulfillment services. We have also established programs in the United StatesU.S. which provide qualified uninsured or underinsured patients with commercialmarketed products at no or reduced charge. Additional information about our sales, marketing and distribution efforts for each of our commercializedmarketed products is set forth below.
 
AVONEX
 
We continue to focus our marketing and sales activities on maximizing the potential of AVONEX in the United StatesU.S. and the rest of world in the face of increased competition. The principal markets for AVONEX are the U.S., Germany, France, and Italy. In the United States,U.S., Canada, Brazil, Argentina, Australia, Japan and most of the major countries of the EU,European Union, we market and sell AVONEX through our own sales forces and marketing groups and distribute AVONEX principally through wholesale distributors of


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pharmaceutical products, mail order specialty distributors or shipping service providers. In other countries, we sell AVONEX to distribution partners who are then responsible for most marketing and distribution activities.
 
RITUXAN
 
In the United States,U.S., we marketcontribute a sales force and sellother resources to the marketing of RITUXAN, in collaboration with Genentechwhich is managed primarily by the Roche Group through dedicated salesits wholly-owned member and marketing staffs.our collaborator Genentech. RITUXAN is generally sold to wholesalers, specialty distributors and directly to hospital pharmacies. SalesMarketing efforts are focused on hematologists, medical oncologists and rheumatologists in private practice, at community hospitals and at major medical centers in the United States. GenentechU.S. The Roche Group provides marketing support services for RITUXAN, including customer service, order entry, shipping, billing, insurance verification assistance, managed care sales support, medical information and sales training.
 
OutsideIn the United States,rest of world, the Roche marketsGroup and sellsits sublicensees market and sell RITUXAN except in Japan where RITUXAN is co-marketed by Zenyaku and Chugai, and we do not participate in these activities.without our participation.


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TYSABRI
 
The principal markets for TYSABRI are the U.S., Germany, France and Italy.
In the United States,U.S., we are principally responsible for marketing TYSABRI for MS and Elan is principally responsible for marketing TYSABRI for Crohn’s disease.CD. We and Elan use our own respective sales forceforces and marketing groupgroups for these marketing activities. In addition, Elan is responsible for TYSABRI distribution in the United States.U.S. and uses a third party distributor to ship TYSABRI directly to customers.
 
OutsideIn the United States,rest of world, we are responsible for TYSABRI marketing and distribution. Wedistribution and we use a combination of our own sales force and marketing group and third party service providers for these activities.providers.
 
FUMADERM
 
Since May 2007, weWe have marketedbeen marketing and distributeddistributing FUMADERM through Almirall Hermal, GmbH,directly in Germany since February 2009 and previously used a third party service provider, and we will assume marketing and distribution activities from Almirall Hermal at the end of February 2009.provider.
 
Competition
 
Competition in the biotechnology and pharmaceutical industries is intense and comes from many and varied sources. We do not believe that any of the industry leaders can be considered dominant in view of the rapid technological change in the industry. We experience significant competition fromsources, including specialized biotechnology firms in the United States, the European Union and elsewhere in the world and from many large pharmaceutical chemical and other companies. Many of our competitors are working to develop products similar to those we are developing or already market.market and have considerable experience in undertaking clinical trials and in obtaining regulatory approval to market pharmaceutical products. Certain of these companies have substantially greater financial, marketing, research and development and human resources than we do. Most large pharmaceutical and biotechnology companies have considerable experience in undertaking clinical trials and in obtaining regulatory approval to market pharmaceutical products.
 
We believe that competition and leadership in the industry will be based on managerial and technological superiority and establishing patent and other proprietary positions through research and development. Leadership in the industry may also be influenced significantly by patents and other forms of protection of proprietary information. A key aspect of such competition is recruiting and retaining qualified scientists and technicians. We believe that we have been successful in attracting skilled and experienced scientific personnel. The achievement of a leadership position also depends largely upon our ability to identify and exploit commercially the products resulting from research and the availability of adequate financial resources to fund facilities, equipment, personnel, clinical testing, manufacturing and marketing. Another key aspect of remaining competitive within the industry is recruiting and retaining qualified scientists and technicians. We believe that we have been successful in attracting skilled and experienced scientific personnel.
 
Competition among products approved for sale may be based, among other things, on patent position, product efficacy, safety, convenience, reliability, availability and price. In addition, early entry of a new pharmaceutical


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product into the market may have important advantages in gaining product acceptance and market share. Accordingly, the relative speed with which we can develop products, complete the testing and approval process and supply commercial quantities of the product to the marketproducts will have an important impact on our competitive position.
 
We may face increased competitive pressures as a result of the emergence of biosimilars. Most of our marketed products, including AVONEX, RITUXAN and TYSABRI, are licensed under the Public Health Service Act as biological products. Unlike small molecule drugs, which are subject to the generic drug provisions (Hatch-Waxman Act) of the U.S. Food, Drug, and Cosmetic Act, currently there currently is no process in the United StatesU.S. for the submission or approval of biological products based upon abbreviated data packages or a showing of sameness to another approved product. There is public dialogue at the FDA and in the Congress, however, regarding the scientific and statutory basis upon which such products, known as biosimilars or follow-on biologics, could be approved and marketed in the United States.U.S. We cannot be certain when, or if, Congress will create a statutory pathway for the approval of biosimilars. In Europe, the European Medicines Agency, or EMEA,Union, the EMA has issued guidelines for approvalapproving of biological products through an abbreviated pathway, and the firstseveral biosimilars have been approved. If a biosimilar version of one of our products were approved, it could have a negative effect onreduce our sales of that product.
 
Additional information about the competition that our marketed products face is set forth below.


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AVONEX AND TYSABRI
 
AVONEX and TYSABRI both compete primarily with three other products:
 
 • REBIF®(interferon-beta-1a)BETASERON (interferon-beta-1b), which is co-promoted by EMD Serono (a subsidiary of Merck Serono) and Pfizer in the United States and sold by Merck Serono in Europe. REBIF generated worldwide revenues of approximately $1.7 billion in 2007.
• BETASERON®(interferon-beta-1b), soldmarketed by Bayer HealthcareHealthCare Pharmaceuticals, (thethe U.S. pharmaceuticals affiliate of Bayer Schering Pharma AG)AG, in the United StatesU.S. and soldis marketed under the name BETAFERON® by Bayer Schering Pharma AG in the EU. EXTAVIA®, a branded version of interferon beta-1b from Novartis AG, has been approved in the European Union. BETASERON and BETAFERON together generated worldwide revenues of approximately $1.4$1.7 billion in 2007.2008. EXTAVIA, a branded version of interferon beta-1b marketed by Novartis AG, is sold in the European Union and was launched in the U.S. in October 2009.
 
 • COPAXONE®(glatiramer acetate) (glatiramer acetate), soldwhich is marketed by Teva Neuroscience, Inc., or Teva,Pharmaceutical Industries Ltd. in the United StatesU.S. and copromoted by Teva Pharmaceutical Industries and Sanofi-Aventis in Europe. COPAXONE generated worldwide revenues of approximately $1.7$2.3 billion in 2007.2008.
• REBIF (interferon-beta-1a), which is co-promoted by EMD Serono, a subsidiary of Merck Serono, and Pfizer Inc. in the U.S. and is marketed by Merck Serono in the European Union. REBIF generated worldwide revenues of approximately $2.0 billion in 2008.
 
Along with us, a number of companies are working to develop products to treat MS that may in the future compete with AVONEX and TYSABRI. For example, alemtuzumab (marketedan oral formulation of cladribine (developed by Bayer HealthCare Pharmaceuticals Inc.)Merck Serono) was filed with the EMA and is in late-stage developmentthe subject of discussions with the FDA regarding a refiling for MS. Some of our current competitors are also working to develop alternative formulationsapproval as therapy for delivery of their products, which may in the future compete with AVONEXMS and TYSABRI. For example, FTY720 (fingolimod) (developed by Novartis AG) has been filed with the EMA and cladribineFDA for approval as an oral therapy for MS. In addition, alemtuzumab (developed by Merck Serono)Genzyme Corporation) and laquinimod (developed by Teva Pharmaceutical Industries) are in late-stage development as oral therapies for the treatment of MS.
 
AVONEX and TYSABRI also face competition from off-label uses of drugs approved for other indications.
 
RITUXAN IN ONCOLOGY
 
A numberRITUXAN competes with several different types of companiestherapies in the oncology market, including:
• CAMPATH (marketed by Bayer HealthCare Pharmaceuticals), which is indicated for B-cell CLL (an unapproved and unpromoted use of RITUXAN).
• TREANDA (marketed by Cephalon) and ARZERRA (marketed by GenMab in collaboration with GlaxoSmithKline), which is indicated for refractory CLL patients to both alemtuzumab and fludarabine (an unapproved and unpromoted use of RITUXAN).
We are working to develop products to treat B-cell NHLs and other forms of NHL that may ultimately compete with RITUXAN. Other potential competitive products include CAMPATH® (marketed by Bayer HealthCare Pharmaceuticals Inc.), which is indicated for B-cell CLL (an unapproved use of RITUXAN), VELCADE® (marketed by Millennium Pharmaceuticals, Inc.) which is indicated for multiple myeloma (an unapproved use of RITUXAN), TREANDA® (marketed by Cephalon), and ARZERRA (marketed by GenMab), for which a BLA has been submitted to treat patients with refractory CLL. In addition to the foregoing products, we arealso aware of other anti-CD20 molecules in development that, if successfully developed and registered, may compete with RITUXAN.RITUXAN in the oncology market.


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RITUXAN IN RA
 
RITUXAN competes with several different types of therapies in the RA market, including:
 
 • traditional therapies for RA, including disease-modifying anti-rheumatic drugs such as steroids, methotrexate and cyclosporine, and pain relievers such as acetaminophen;acetaminophen.
 
 • TNF inhibitors, such as REMICADE® (infliximab), a drug sold worldwide and SIMPONI (golimumab) (marketed by Centocor, Inc., a subsidiary of Johnson & Johnson,Johnson), HUMIRA® (adalimumab), a drug sold (marketed by Abbott Laboratories, andLaboratories), ENBREL® (etanercept), a drug sold (marketed by Amgen, Inc. and Wyeth Pharmaceuticals, Inc.;Pfizer) and CIMZIA (certolizumab pegol) (marketed by UCB, S.A.).
 
 • ORENCIA® (abatacept), a drug developed (marketed by Bristol-Myers Squibb Company; andCompany).
 
 • drugs approved for other indications that are used to treat RA.ACTEMRA (tocilizumab) (marketed by the Roche Group).
 
In addition, a numberWe are also aware of companies are working to developother products to treat RAin development that, if successfully developed and registered, may ultimately compete with RITUXAN in the RA marketplace. For example, Roche has submitted a BLA for ACTEMRA® (tocilizumab) for the treatment of RA.market.


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FUMADERM
 
FUMADERM competes with several different types of therapies in the psoriasis market within Germany, including oral systemics such as methotrexate and cyclosporine and biologic agents such as RAPTIVA® (efalizumab), a drug sold by Genentech.cyclosporine.
 
Regulatory
 
Our current and contemplated activities and the products and processes that will result from such activities are subject to substantial government regulation.
 
Regulation of Pharmaceuticals
 
Before new pharmaceutical products may be sold in the United StatesU.S. and other countries, clinical trials of the products must be conducted and the results submitted to appropriate regulatory agencies for approval. Clinical trial programs must establish efficacy, determine an appropriate dose and regimen, and define the conditions for safe use,use. This is a high-risk process that requires stepwise clinical studies in which the candidate product must successfully meet predetermined endpoints. In the United States,U.S., the results of the preclinical and clinical testing of a product are then submitted to the FDA in the form of a Biologics License Application or BLA,(BLA) or a New Drug Application or NDA.(NDA). In response to a BLA or NDA, the FDA may grant marketing approval, request additional information or deny the application if it determines the application does not provide an adequate basis for approval. Similar submissions are required by authorities in other jurisdictions who independently assess the product and may reach the same or different conclusions. Our initial focus for obtaining marketing approval outside the United StatesU.S. is typically the European Union. There are currently three potential tracks for marketing approval in EUE.U. countries: mutual recognition, decentralized procedures, and centralized procedures. These review mechanisms may ultimately lead to approval in all EU countries within the European Union, but each method grants all participating countries some decision-making authority in product approval.
 
The receipt of regulatory approval often takes a number of years, involvinginvolves the expenditure of substantial resources and depends on a number of factors, including the severity of the disease in question, the availability of alternative treatments and the risks and benefits demonstrated in clinical trials. On occasion, regulatory authorities may require larger or additional studies, leading to unanticipated delay or expense. Even after initial FDA approval or approvals from other regulatory agencies have been obtained, further clinical trials may be required to provide additional data on safety and effectiveness andeffectiveness. Additional trials are required to gain clearance for the use of a product as a treatment for indications other than those initially approved. Furthermore, the FDA and other regulatory agencies require companies to disclose clinical trial results. Failure to disclose such results within applicable time periods could result in penalties, including civil monetary penalties.


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In the United States,U.S., the FDA may grant “accelerated approval” status to products that treat serious or life-threatening illnesses and that provide meaningful therapeutic benefits to patients over existing treatments, but accelerated approval status does not ensure that FDA will ultimately approve the product.treatments. Under this pathway, the FDA may approve a product based on surrogate endpoints, or clinical endpoints other than survival or irreversible morbidity, or when the product is shown to be effective but can be safely used only if access to or distribution of the product is restricted. When approval is based on surrogate endpoints or clinical endpoints other than survival or morbidity, the sponsor will be required to conduct additional clinical studies to verify and describe clinical benefit. When accelerated approval requires restricted use or distribution, the sponsor may be required to establish rigorous systems to assure use of the product under safe conditions. These systems are usually referred to as Risk Minimization Action Plans or RiskMAPs,(RiskMAPs) or Risk Evaluation and Mitigation Strategies or REMS.(REMS). In addition, for all products approved under accelerated approval, sponsors must submit all copies of its promotional materials, including advertisements, to the FDA at least thirty days prior to their initial dissemination. Accelerated approval status does not ensure that FDA will ultimately approve the product. The FDA may also withdraw approval under accelerated approval after a hearing if, for instance, post-marketing studies fail to verify any clinical benefit or it becomes clear that restrictions on the distribution of the product are inadequate to ensure its safe use. The BLA for TYSABRI was approved in MS was initially approved under the accelerated approval pathway based on surrogate endpoints. Aand, after efficacy was confirmed, was approved under a stringent restricted distribution programprogram. TYSABRI was also imposed. The supplemental BLAapproved for TYSABRI for second-line treatment of Crohn’s disease was approved by FDA on January 14, 2008. This indication is subject to the same stringentunder a similar restricted distribution restrictions as TYSABRI for MS.program. We cannot be certain that the FDA will approve any products for thetheir proposed indications whether under accelerated approval or another pathway.


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If the FDA or other regulatory agency approves productsa product or new indications,indication, the agency may require us to conduct additional post-marketing studies. If we fail to conduct the required studies or otherwise fail to comply with the conditions of accelerated approval, the agency may take action to seek to withdraw thatits approval. Legislation has been passed in the United States to also provideIn addition, the FDA with additional powers of sanction regarding non-completion of or non-complianceand EMA can impose financial penalties for failing to comply with certain post-marketing commitments, including RiskMAPs/RiskMAPs and REMS. In Europe, the EMEA has new powers of sanction for non-completion of post-marketing commitments. These sanctions range from a fine of 10% of global product revenue to removal of the product from the market.
 
Regulatory authorities track information on side effects and adverse events reported during clinical studies and after marketing approval. Non-compliance with FDA safety reporting requirements may result in FDA regulatory action that may include civil action or criminal penalties. Side effects or adverse events that are reported during clinical trials can delay, impede, or prevent marketing approval. Similarly, adverse events that are reported after marketing approval can result in additional limitations being placed on the product’s use and, potentially, withdrawal or suspension of the product from the market. For example, in February 2005, in consultation with the FDA, we and Elan voluntarily suspended the marketing and commercial distribution of TYSABRI, and informed physicians that they should suspend dosing of TYSABRI until further notification. These decisions were based on reports of cases of PML that occurred in patients treated with TYSABRI in clinical studies. PML is a rare and frequently fatal demyelinating disease of the central nervous system. In July 2006, TYSABRI was reintroduced in the United States, and introduced in the European Union, as a monotherapy for relapsing MS.
The FDA also has authority over drug products after approval. The FDA may conduct post-marketing safety surveillance and may require additional post-approval studies or clinical trials and mandate label changes as a result of safety findings.trials. These requirements may affect our ability to maintain marketing approval of our products or require us to make significant expenditures to obtain or maintain such approvals. In addition, adverse events that are reported after marketing approval can result in changes to the product’s labeling, additional limitations being placed on the product’s use and, potentially, withdrawal or suspension of the product from the market.
 
If we seek to make certain changes to an approved product, such as adding a new indication, making certain manufacturing changes, or changing manufacturers or suppliers of certain ingredients or components, we will need review and approval of regulatory authorities, including the FDA and EMEA, before theEMA, will need to review and approve such changes can be implemented.in advance.
 
In addition, the FDA regulates all advertising and promotion activities for products under its jurisdiction both prior tobefore and after approval. A company can make only those claims relating to safety and efficacy that are approved by the FDA. However, physicians may prescribe legally available drugs for uses that are not described in the drug’s labeling and that differ from those tested by us and approved by the FDA.labeling. Such off-label uses are common across medical specialties, and often reflect a physician’s belief that the off-label use is the best treatment for patients. The


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FDA does not regulate the behavior of physicians in their choice of treatments, but the FDA regulations do impose stringent restrictions on manufacturers’ communications regarding off-label uses. Failure to comply with applicable FDA requirements may subject a company to adverse publicity, enforcement action by the FDA, corrective advertising, and the full range of civil and criminal penalties available to the FDA.
 
Good manufacturing practices.Manufacturing Practices
The FDA, the EMEAEMA and other regulatory agencies regulate and inspect equipment, facilities, and processes used in the manufacturing of pharmaceutical and biologic products prior to approving a product. If, after receiving clearance from regulatory agencies, a company makes a material change in manufacturing equipment, location, or process, additional regulatory review and approval may be required. We also must adhere to current Good Manufacturing Practices or cGMP, and product-specific regulations enforced by the FDA following product approval. The FDA, the EMEAEMA and other regulatory agencies also conduct regular, periodic visits to re-inspect equipment, facilities, and processes following the initial approval of a product. If, as a result of these inspections, it is determined that our equipment, facilities, or processes do not comply with applicable regulations and conditions of product approval, regulatory agencies may seek civil, criminal, or administrative sanctionsand/or remedies against us, including the suspension of our manufacturing operations.
 
Good Clinical Practices
The FDA, the EMA and other regulatory agencies promulgate regulations and standards, commonly referred to as current Good Clinical Practices (cGCP), for designing, conducting, monitoring, auditing and reporting the results of clinical trials to ensure that the data and results are accurate and that the trial participants are adequately protected. The FDA, the EMA and other regulatory agencies enforce cGCP through periodic inspections of trial sponsors, principal investigators and trial sites. If our study sites fail to comply with applicable cGCP, the clinical data generated in our clinical trials may be deemed unreliable and relevant regulatory agencies may require us to perform additional clinical trials before approving our marketing applications.


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Orphan Drug Act.Act
Under the U.S. Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a “rare disease or condition,” which generally is a disease or condition that affects fewer than 200,000 individuals in the U.S. If a product which has an orphan drug designation subsequently receives the first FDA approval for the indication for which it has such designation, the product is entitled to orphan exclusivity, i.e., the FDA may not approve any other applications to market the same drug for the same indication for a period of seven years following marketing approval, except in certain very limited circumstances, such as if the later product is shown to be clinically superior to the orphan product. Legislation similar to the U.S. Orphan Drug Act has been enacted in other countries, outside of the United States, including within the European Union.
 
Regulation Pertaining to Sales, Marketing and Product Pricing
 
In the United States,U.S., the federal government regularly considers reforming health care coverage and costs. For example, reforms to Medicare have reduced the reimbursement rates for many of our products. Effective January 1, 2005, Medicare pays physicians and suppliers that furnish our products under a payment methodology using average sales price or ASP,(ASP) information. Manufacturers, including us, are required to provide ASP information to the Centers for Medicare and Medicaid Services on a quarterly basis. The manufacturer-submitted information is used to compute Medicare payment rates, which are set at ASP plus 6 percent and updated quarterly. There is a mechanism for comparison of such payment rates to widely available market prices, which could cause further decreases in Medicare payment rates, although this mechanism has yet to be utilized. Effective January 1, 2006, Medicare began to use the same ASP plus 6 percent payment methodology to determine Medicare rates paid for products furnished by hospital outpatient departments. As of January 1, 2009,2010, the reimbursement rate in the hospital outpatient setting is ASP plus 4 percent. If a manufacturer is found to have made a misrepresentation in the reporting of ASP, the statute provides for civil monetary penalties of up to $10,000 for each misrepresentation and for each day in which the misrepresentation was applied.
 
Another payment reform is the addition of an expanded prescription drug benefit for all Medicare beneficiaries known as Medicare Part D. This is a voluntary benefit that is being implementedprovided through private plans under contractual arrangements with the federal government. Like pharmaceutical coverage through private health insurance, Part D plans establish formularies that govern the drugs and biologicals that will be offered and the out- of-pocket obligations for such products. In addition, plans negotiate discounts from drug manufacturers and pass on some of those savings to Medicare beneficiaries.
 
In the U.S., Congress has considered legislation to reform the healthcare system that likely would have an adverse impact on our revenues, by, among other things, increasing the current Medicaid rebate, adding a subsidy for certainout-of-pocket patient costs under Medicare Part D, and assessing a pharmaceutical manufacturer fee. In addition, the passage in the U.S. of legislation defining a pathway for biosimilar products likely would have an adverse impact on our revenues.
Future legislation or regulatory actions implementing recent or future legislation may have a significant effect on our business. Our ability to successfully commercialize products may depend in part on the extent to which reimbursement for the costs of our products and related treatments will be available in the United StatesU.S. and worldwide from government health administration authorities, private health insurers and other organizations. Substantial uncertainty exists as to the reimbursement status of newly approved health care products by third party payors.


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We also participate in the Medicaid rebate program established by the Omnibus Budget Reconciliation Act of 1990, and under multiple subsequent amendments of that law. Sections 6001, 6002, and 6003 of the Deficit Reduction Act of 2005, or DRA, made significant changes to the Medicaid prescription drug provisions of the Social Security Act. These changes include, but are not limited to, revising the definition of average manufacturer price, or AMP, establishing an obligation to report AMP on a monthly basis, in addition to a quarterly basis, establishing a new formula for calculating Federal upper limits, or FULs, requiring rebates for certain physician-administered drugs, and clarifying rebate liability for authorized generic drugs.program. Under the Medicaid rebate program, we pay a rebate for each unit of product reimbursed by Medicaid. The amount of the rebate for each product is set by law as the larger of 15.1% of AMPaverage manufacturer price (AMP) or the difference between AMP and the best price available from us to any commercial or non-governmental customer. The rebate amount must be adjusted upward where the AMP for a product’s first full quarter of sales, when adjusted for increases in the CPI-U, or Consumer Price Index — Urban exceeds the AMP for the current quarter with the upward adjustment equal to the excess amount. The rebate amount is required to be recomputed each quarter based on our report of current AMP and best price for each of our products to the Centers for Medicare and Medicaid Services. The terms of our participation in the program imposes a requirement for us to report revisions to AMP or best price within a period not to exceed 12 quarters from the quarter in which the data was originally due. Any such revisions could have the impact of increasing or decreasing our rebate liability for


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prior quarters, depending on the direction of the revision. In addition, if we were found to have knowingly submitted false information to the government, the statute provides for civil monetary penalties in the amount not to exceed $100,000 per item of false information in addition to other penalties available to the government.
 
The availability of federal funds to pay for our products under the Medicaid and Medicare Part B programs requires that we extend discounts under the 340B/PHS drug pricing program. The 340B/PHS drug pricing program extends discounts to a variety of community health clinics and other entities that receive health services grants from the PHS,Public Health Service, as well as hospitals that serve a disproportionate share of poor Medicare beneficiaries.
 
We also make our products available for purchase by authorized users of the Federal Supply Schedule or FSS,(FSS) of the General Services Administration pursuant to our FSS contract with the Department of Veterans Affairs. Under the Veterans Health Care Act of 1992 or the VHC Act,(VHC Act) we are required to offer deeply discounted FSS contract pricing to four Federalfederal agencies — the Department of Veterans Affairs, the Department of Defense, the Coast Guard and the Public Health Service (including the Indian Health Service) — for federal funding to be made available for reimbursement of any of our products under the Medicaid program and for our products to be eligible to be purchased by those four Federalfederal agencies and certain Federalfederal grantees. FSS pricing to those four Federalfederal agencies must be equal to or less than the “Federal Ceiling Price,” which is discounted, at a minimum, 24% offfrom the Non-Federal Average Manufacturer Price or “Non-FAMP”, for the prior fiscal year. In addition, if we are found to have knowingly submitted false information to the government, the VHC Act provides for civil monetary penalties of notup to exceed $100,000 per false item of information in addition to other penalties available to the government. Under the 2008 National Defense Authorization Act, we are required to treat the TRICARE retail pharmacy program, which reimburses military personnel for drug purchases from retail pharmacies, as an element of the Department of Defense for purposes of the procurement of drugs by federal agencies to ensure that the pharmaceuticals paid for by the Department of Defense under the TRICARE retail pharmacy program are subject to the pricing standards of the VHC Act.
 
We are also subject to various federal and state laws pertaining to health care “fraud and abuse,” including anti-kickback laws and false claims laws. Anti-kickback laws make it illegal for a prescription drug manufacturer to solicit, offer, receive, or pay any remuneration in exchange for, or to induce, the referral of business, including the purchase or prescription of a particular drug. Due to the breadth of the statutory provisions and the absence of guidance in the form of regulations and very few court decisions addressing industry practices, it is possible that our practices might be challenged under anti-kickback or similar laws. False claims laws prohibit anyone from knowingly and willingly presenting, or causing to be presented for payment to third party payors (including Medicare and Medicaid) claims for reimbursed drugs or services that are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items or services. In addition, several states require that companies implement compliance programs or comply with industry ethics codes, adopt spending limits, and report to state governments any gifts, compensation, and other remuneration provided to physicians. Federal legislation, the Physician Payments Sunshine Act of 2009, also has been proposed that would require disclosure to the federal government of payments to physicians. Our activities relating to the sale and marketing of our products may be subject to scrutiny under these laws. Violations of fraud and abusethese laws may be punishable by criminaland/or civil sanctions, including fines and civil monetary penalties, as well as the possibility of exclusion from federal health care programs (including Medicare and Medicaid). If the government were to allege or convict us of violating these laws, our business could be harmed. In addition, there is an ability for private individuals tomay bring similar actions. For a description of litigation in this area in which we are currently involved, see Note 19, Litigation, in “Notes to Consolidated Financial Statements.”


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Our activities could be subject to challenge for the reasons discussed above and due to the broad scope of these laws and the increasing attention being given to them by law enforcement authorities. Further, there are an increasing number of state laws that require manufacturers to make reports to states on pricing and marketing information. Many of these laws contain ambiguities as to what is required to comply with the laws. Given the lack of clarity in laws and their implementation, our reporting actions could be subject to the penalty provisions of the pertinent state authorities.
 
Other Regulations
 
Foreign Corrupt Practices Act.Act
We are also subject to the U.S. Foreign Corrupt Practices Act (FCPA), which prohibits corporations and individuals from paying, offering to pay, or authorizing the payment of anything of value to any foreign government


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official, government staff member, political party, or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect their transactions and to devise and maintain an adequate system of internal accounting controls.
 
NIH Guidelines.Guidelines
We conduct relevant research at all of our research facilities in the United StatesU.S. in compliance with the current U.S. National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules or the NIH Guidelines,(NIH Guidelines) and all other applicable federal and state regulations. By local ordinance, we are required to, among other things, comply with the NIH Guidelines in relation to our facilities in Cambridge, Massachusetts, San Diego, California, and Research Triangle Park, North Carolina and are required to operate pursuant to certain permits.
 
Other Laws.Laws
Our present and future business has been and will continue to be subject to various other laws and regulations. Various laws, regulations and recommendations relating to safe working conditions, laboratory practices, the experimental use of animals, and the purchase, storage, movement, import and export and use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research work are or may be applicable to our activities. Certain agreements entered into by us involving exclusive license rights may be subject to national or supranational antitrust regulatory control, the effect of which also cannot be predicted. The extent of government regulation, which might result from future legislation or administrative action, cannot accurately be predicted.
 
Manufacturing and Raw Materials
 
We are focused on the manufacture of biologics. We currently produce all of our bulk AVONEX, as well as AMEVIVE on a contract basis for Astellas, at our manufacturing facilities located in Research Triangle Park, North Carolina and Cambridge, Massachusetts. We currently produce TYSABRI at our Research Triangle Park facility. We supply the commercial requirements of the antibody for ZEVALIN on a contract basis for Cell Therapeutics, Inc. We manufacture ZEVALIN at our manufacturing facilities in Cambridge, Massachusetts. Genentech is responsible for all worldwide manufacturing activities for bulk RITUXAN and has sourced the manufacturing of certain bulk RITUXAN requirements to an independent third party. We manufacture clinical products in Research Triangle Park, North Carolina and Cambridge, Massachusetts. Our existing licensed manufacturing facilities operate under multiple licenses from the FDA, regulatory authorities in the EU and other regulatory authorities. We use a third party to manufacture the active pharmaceutical ingredient of FUMADERM and another third party to further process that to produce the FUMADERM pill. The chart below outlines the location of our primary manufacturing locations and products manufactured therein:therein.
 
             
  Research
       
  Triangle
       
Product Park, NC  Cambridge, MA  Third Party 
 
AVONEX
  Xü   Xü     
TYSABRI
  Xü         
AMEVIVEX
ZEVALIN
X
FUMADERM
          Xü 
CLINICAL PRODUCTS
  Xü   Xü   Xü 


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In April 2009, the FDA approved our high titer process for the production of TYSABRI. Similar approval was obtained from the EMA in December 2008. The new, higher-yield process is being used to manufacture TYSABRI at our plant in Research Triangle Park, NC.
The Roche Group, through its wholly-owned member Genentech, is responsible for all worldwide manufacturing activities for bulk RITUXAN and has sourced the manufacturing of certain bulk RITUXAN requirements to an independent third party.
We are in the final stages of constructing a large-scale biologicbiologics manufacturing facility in Hillerød, Denmark to be usedwhich is intended to manufacture TYSABRI and other products in our pipeline.large molecule products. The first phase is complete, which included construction of a labeling and packaging facility, administrative building and lab facility;laboratory facility, installation of major equipment;equipment, and partial completion of a bulk manufacturing facility. The second phase of the project, which we commencedbegan in January 2007, involves the completion and fit out of the bulk manufacturing facility and construction of a warehouse. The large scale manufacturing facility is expectedscheduled to be ready for commercial production in 2010. See the section of “Item 1A — Risk Factors” entitled “Welate 2011. Recent manufacturing improvements have maderesulted in favorable production yields on TYSABRI, that have reduced our expected capacity requirements. As a significant investment in constructing a manufacturing facility the success of which depends upon theresult, we are evaluating several alternatives, including whether to delay completion and licensing of the facility and continued demand for our products.”facility.
 
We source all of our fill-finish and the majority of final product storage operations for our products, along with a substantial part of our packaging operations, to a concentrated group of third party contractors. Many of the raw


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materials and supplies required for the production of AVONEX, TYSABRI FUMADERM, ZEVALIN and AMEVIVEFUMADERM are available from various suppliers in quantities adequate to meet our needs. However, due to the unique nature of the production of our products, we do have single source providers of several raw materials. We make efforts to qualify new vendors and to develop contingency plans so that production is not impacted by short-term issues associated with single source providers. Each of our third party service providers, suppliers and manufacturers areis subject to continuing inspection by the FDA or comparable agencies in other jurisdictions. Any delay, interruption or other issues that arise in the manufacture, fill-finish, packaging, or storage of our products, including as a result of a failure of our facilities or the facilities or operations of third parties to pass any regulatory agency inspection, could significantly impair our ability to sell our products.
 
While we believeImportant factors that could adversely affect our existing manufacturing facilities and outside sources will allow us to meet our near-term and long-term manufacturing needs for our current commercial products and our other products currently in clinical trials, additional manufacturing facilities and outside sources may be required to meet our long-term research, development and commercial production needs. See the sections of “Item 1A — Risk Factors” entitled “Problems with manufacturing or with inventory planning could result in our inability to deliver products, inventory shortages or surpluses, product recalls and increased costs”, “We rely on third parties to provide services in connection with the manufacture of our products and, in some instances, the manufacture of the product itself,” and “If we fail to meet the stringent requirements of governmental regulationoperations are discussed in the manufacture“Risk Factors” section of our products, we could incur substantial remedial costs and a reduction in sales.”this report.
 
Our Employees
 
As of December 31, 2008,2009, we had approximately 4,7004,750 employees.
 
Our Executive Officers
 
The following is a list of our executive officers, their ages as of February 6, 20099, 2010 and their principal positions.
 
       
Name
 
Age
 
Position
 
James C. Mullen  5051  Chief Executive Officer and President
Cecil B. Pickett, Ph.D. 63President, Research and Development
Hans Peter HaslerSusan H. Alexander  53Chief Operating Officer
Susan H. Alexander, Esq. 52  Executive Vice President, General Counsel and Corporate Secretary
Paul J. Clancy  4748  Executive Vice President, Finance and Chief Financial Officer
Robert A. Hamm  5758Chief Operating Officer
Michael Lytton52  Executive Vice President, Pharmaceutical Operations & TechnologyCorporate and Business Development
Michael F. MacLean  4344  Senior Vice President and Chief Accounting Officer
Craig Eric Schneier, Ph.D.   6162  Executive Vice President, Human Resources, Public Affairs and Communications


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Reference to “our” or “us” in the following descriptions of the background of our executive officers include Biogen Idec and IDEC Pharmaceuticals Corporation.Corporation, and references to the merger mean the merger of Biogen, Inc. and IDEC Pharmaceuticals Corporation in November 2003.
 
James C. Mullenis our Chief Executive Officer and President and is a director, and has served in these positions since the merger of Biogen, Inc. and IDEC Pharmaceuticals Corporation, or the merger, in November 2003.merger. Mr. Mullen was formerly Chairman of the Board and Chief Executive Officer of Biogen, Inc. He was named Chairman of the Board of Directors of Biogen, Inc. in July 2002, after being named Chief Executive Officer and President of Biogen, Inc. in June 2000. Mr. Mullen joined Biogen, Inc. in 1989 as Director, Facilities and Engineering. He was named Biogen, Inc.’s Vice President, Operations in 1992. From 1996 to 1999, Mr. Mullen served as Vice President, International, with responsibility for building all Biogen, Inc. operations outside North America. From 1984 to 1988, Mr. Mullen held various positions at SmithKline Beckman Corporation (now GlaxoSmithKline plc). Mr. Mullen is a member of the board of directors and executive committee of the Biotechnology Industry Organization or BIO,(BIO) and is a former chairman of the board of BIO. Mr. Mullen is alsohas been a director of PerkinElmer, Inc.
Cecil B. Pickett Ph.D. is our President, Research and Development and has served in that position since September 2006 and has served2004. Mr. Mullen will retire as one of our directors since September 2006. Prior to joining Biogen Idec, he was Corporate Senior Vice PresidentChief Executive Officer and President Schering-Plough Research Institute from March 2002 to September 2006,on June 8, 2010 and before that he was Executive VP of Discovery Research at Schering-Plough Corporation from September 1993 to March 2002. Mr. Pickett is a member of the Institute of Medicine of the National Academy of Sciences. Mr. Pickett iswill retire as a director at our 2010 Annual Meeting of Zimmer Holdings, Inc.
Hans Peter Haslerhas served as our Chief Operating Officer since May 2008, served as our Executive Vice President, Global Neurology, Head of International from October 2007 to May 2008, and has managed our international business since the merger. He previously served as Senior Vice President, Head of International from November 2003 to October 2007. He served as Executive Vice President — International of Biogen, Inc. from July 2003 until the merger, and joined Biogen, Inc as Executive Vice President — Commercial Operations in August 2001. Mr. Hasler joined Biogen, Inc. from Wyeth-Ayerst Pharmaceuticals, Inc., an affiliate of American Home Products, Inc. (AHP), where he served as Senior Vice President, Head of Global Strategic Marketing from 1998 to 2001. Mr. Hasler was a member of the Wyeth/AHP Executive Committee and was chairman of the Commercial Council. From 1993 to 1998, Mr. Hasler served in a variety of senior management capacities for Wyeth-Ayerst Pharmaceuticals, including Managing Director of Wyeth Group, Germany, and General Manager of Wyeth/AHP in Switzerland and Central Eastern Europe. Prior to joining Wyeth-Ayerst Pharmaceuticals, Mr. Hasler served as the Head of Pharma Division at Abbott AG. Mr. Hasler is a director of Acino Holding AG and Santhera Pharmaceuticals Holding AG.Stockholders.
 
Susan H. Alexanderis our Executive Vice President, General Counsel and Corporate Secretary and has served in these positions since January 2006. Prior to that, Ms. Alexander served as the Senior Vice President, General Counsel and Corporate Secretary of PAREXEL International Corporation since September 2003. From June 2001 to September 2003, Ms. Alexander served as General Counsel of IONA Technologies. Prior to that, Ms. Alexander


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served as Counsel at Cabot Corporation from January 1995 to May 2001. Prior to that, Ms. Alexander was a partner at the law firms of Hinckley, Allen & Snyder and Fine & Ambrogne.
 
Paul J. Clancyis our Executive Vice President, Finance and Chief Financial Officer and has served in that position since August 2007. Mr. Clancy joined Biogen Idec in 2001, and has held several senior executive positions, including Vice President of Business Planning, Portfolio Management and U.S. Marketing, and Senior Vice President of Finance with responsibilities for leading the Treasury, Tax, Investor Relations and Business Planning groups. Prior to joining Biogen Idec, he spent 13 years at PepsiCo, serving in a range of financial and general management positions. He holds a B.S. in finance from Babson College and a M.B.A. from Columbia University.
 
Robert A. Hammis our Chief Operating Officer and has served in that position since March 2009. Previously, Mr. Hamm served as Executive Vice President, Pharmaceutical Operations & Technology and has served in that position sincefrom October 2007. Previously, Mr. Hamm served as2007 to March 2009; Senior Vice President, Neurology Strategic Business Unit from January 2006 to October 2007; Senior Vice President, Immunology Business Unit from the merger in November 2003 until January 2006; and in the same capacity with Biogen, Inc. from November 2002 to November 2003. Before that, he served as Senior Vice President — Europe, Africa, Canada and Middle East from October 2001 to November 2002. Prior to that, Mr. Hamm served as Vice President — Sales and Marketing of


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Biogen, Inc. from October 2000 to October 2001. Mr. Hamm previously served as Vice President — Manufacturing from June 1999 to October 2000, Director, Northern Europe and Distributors from November 1996 until June 1999 and Associate Director, Logistics from April 1994 until November 1996. From 1987 until April 1994, Mr. Hamm held a variety of management positions at Syntex Laboratories Corporation, including Director of Operations and New Product Planning, and Manager of Materials, Logistics and Contract Manufacturing. Mr. Hamm ishas been a member of the board of managers of Progenitor Cell Therapy, LLC. since 2006 and was a director of Inhibitex, Inc. from 2005 to 2009.
Michael Lyttonis our Executive Vice President, Corporate and Progenitor Cell Therapy, LLC.Business Development, and has served in that position since February 2009. From 2001 to January 2009, he was a General Partner at Oxford Bioscience Partners, a venture capital firm. Prior to that, he was partner, chairman of the Technology Group and a member of the Executive Committee of the law firm Edwards, Angell, Palmer & Dodge LLP. Prior to that, Mr. Lytton was a junior partner and co-chairman of the Biotechnology Practice of the law firm WilmerHale. Mr. Lytton was a member of the supervisory board of GPC Biotech AG from 2001 to 2009.
 
Michael F. MacLeanis our Senior Vice President and Chief Accounting Officer and has served in that position since December 2006. Mr. MacLean joined us in October 2006 as Senior Vice President. Prior to joining us, Mr. MacLean was a managing director of Huron Consulting, where he provided support regarding financial reporting to management and boards of directors of Fortune 500 companies. From June 2002 to October 2005, Mr. MacLean was a partner at KPMG and he was a partner of Arthur Andersen LLP from September 1999 to May 2002.
 
Craig Eric Schneier, Ph.D. is our Executive Vice President, Human Resources, Public Affairs and Communications and has served in that position since October 2007. Prior to that he was Executive Vice President, Human Resources from November 2003 to October 2007. Mr.Dr. Schneier served as Executive Vice President, Human Resources of Biogen, Inc., a position he held from January 2003 until the merger. He joined Biogen, Inc. in 2001 as Senior Vice President, Strategic Organization Design and Effectiveness, after having served as an external consultant to us for eight years. Prior to joining Biogen, Inc., Mr.Dr. Schneier was president of his own management consulting firm in Princeton, NJ, where he provided consulting services to over 70 of the Fortune 100 companies, as well as several of the largest European and Asian firms. Mr.Dr. Schneier held a tenured professorship at the University of Maryland’s Smith School of Business and has held teaching positions at the business schools of the University of Michigan, Columbia University, and at the Tuck School of Business, Dartmouth College.


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Item 1A.  Risk Factors
 
We are substantially dependent on revenues from our twothree principal products.
 
Our current and future revenues depend substantially upon continued sales of our twothree principal products, AVONEX, RITUXAN and RITUXAN,TYSABRI, which represented approximately 81%substantially all of our total revenues in 2008. Any significant negative developments relating to these two products, such as safety or efficacy issues, the introduction or greater acceptance of competing products or adverse regulatory or legislative developments, would have a material adverse effect on our results of operations.during 2009. Although we have developed and continue to develop additional products for commercial introduction, we expect to be substantially dependent on sales from these twothree products for many years. A decline in sales from eitherAny negative developments relating to any of these two products, wouldsuch as safety or efficacy issues, the introduction or greater acceptance of competing products, including biosimilars, or adverse regulatory or legislative developments may reduce our revenues and adversely affect our business.results of operations.
 
Our near-term success depends on the marketMarket acceptance and successful sales growth of TYSABRI.TYSABRI are important to our success.
 
A substantial portion of our growth in the near-term is dependent on anticipated sales of TYSABRI. TYSABRI is expected to diversify our product offerings and revenues, and to drive additional revenue growth over the next several years. If we are not successful in growing sales of TYSABRI, it would result in a significant reduction in diversification and expected revenuesmaterially and adversely affect our business.growth and plans for the future.
 
Achievement of anticipatedTYSABRI’s sales growth of TYSABRI will depend upon its acceptance by the medical community and patients, which cannot be certain given the significant restrictions on use and the significant safety warnings in the label. Since we reintroduced TYSABRI to the reintroduction of TYSABRI in the United States and its introduction in the European Unionmarket in July 2006, wesome patients taking TYSABRI have disclosed five confirmed casesbeen diagnosed with progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection described in the TYSABRI label. If the incidence of PML a known side effect,were to exceed the rate implied by the TYSABRI label, it could prompt regulatory review and result in significant changes to the label or market withdrawal. The recently revised prescribing information for TYSABRI indicates that the risk of developing PML increases with longer treatment duration, with limited experience beyond 3 years of treatment. This may cause prescribing physicians or patients taking TYSABRI. The occurrenceto suspend treatment with TYSABRI to mitigate the duration risk, which could limit sales. Further increases in incidence rates at various durations of PML or the occurrence of other side effectsexposure could harm acceptance andor limit TYSABRI sales or result in a withdrawal of TYSABRI from the market.growth. Additional regulatory restrictions on the use of TYSABRI andor safety-related labelinglabel changes, including enhanced risk management programs, whether as a result of reports ofadditional cases of PML or otherwise, may significantly reduce expected revenues and require significant expense and management time to address the associated legal and regulatory issues, including enhanced risk management programs. A significant reduction in the acceptance of TYSABRI by the medical community or patients would materially and adversely affect our growth and our plans for the future.issues.
 
As a relatively new entrant to a maturing MS market, TYSABRI sales may be more sensitive to additional new competing products. A number of such products are expected to be approved for use in MS beginning in the coming years.2010. If these products have a similar or more attractive overall profile in terms of efficacy, convenience and safety, future sales of TYSABRI could be limited.limited, which would reduce our revenues.
 
Our long-term success depends upon the successful development and commercialization of other products from our research and development activities.product candidates.
 
Our long-term viability and growth will depend upon the successful development and commercialization of other products from our research and development activities. Product development and commercialization are very expensive and involve a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Success in preclinical work or early stage clinical trials or preclinical work does not ensure that later stage or larger scale clinical trials will be successful. Even if later stage clinical trials are successful, the risk remains that unexpected concerns may arise from additional data or analysis or that obstacles may arise or issues may be identified in connection with review of clinical data with regulatory authorities or that regulatory authorities may disagree with our view of the data or require additional data or information or additional studies.
 
Conducting clinical trials is a complex, time-consuming and expensive process. Our ability to complete our clinical trials in a timely fashion depends in large part on a number of key factors including protocol design, regulatory and institutional review board approval, the rate of patient enrollment in clinical trials, and compliance with extensive current good clinical practice requirements. We have recently opened clinical sites and are enrolling patients in a number of new countries where our experience is more limited, and we are in many cases using the services of third-party contract clinical trial providers. If we fail to adequately manage the design, execution and


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regulatory aspects of our large, complex and diverse clinical trials, our studies and ultimately our regulatory approvals may be delayed or we may fail to gain approval for our product candidates altogether.
 
Our product pipeline includes several small molecule drug candidates. Our small molecule drug discovery platform is not as well developed as our biologics platform, and we will have to make a significant investment of


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time and resources to expand our capabilities in this area. Currently, third party manufacturers supply substantially all of our clinical requirements for small molecules. If these manufacturers fail to deliver sufficient quantities of such drug candidates in a timely and cost-effective manner, it could adversely affect our small molecule drug discovery efforts. If we decide to manufacture clinical or commercial supplies of any small molecule drugs in our own facilities, we will need to invest substantial additional funds and recruit qualified personnel to develop our small molecule manufacturing capabilities.
Adverse safety events can negatively affect our assets, product sales, operations, products in developmentbusiness and stock price.
 
Even after we receive marketing approval for a product, adverse event reportsAdverse safety events involving our marketed products may have a negative impact on our commercialization efforts. Later discovery of safety issues with our products that were not known at the time of their approval by the FDA could cause product liability events, additional regulatory scrutiny and requirements for additional labeling, withdrawal of products from the market and the imposition of fines or criminal penalties. Any of these actions could result in, among other things, material write-offs of inventory and impairments of intangible assets, goodwill and fixed assets. In addition, the reporting of adverse safety events involving our products and public rumors about such events could cause our stock price to decline or experience periods of volatility.
 
If we fail to compete effectively, our business and market position would suffer.
 
The biotechnology and pharmaceutical industry is intensely competitive. We compete in the marketing and sale of our products, the development of new products and processes, the acquisition of rights to new products with commercial potential and the hiring and retention of personnel. We compete with biotechnology and pharmaceutical companies that have a greater number of products on the market and in the product pipeline, greater financial and other resources and other technological or competitive advantages. We cannot be certain that oneOne or more of our competitors will notmay receive patent protection that dominates, blocks or adversely affects our product development or business, will notmay benefit from significantly greater sales and marketing capabilities, or will notand may develop products that are accepted more widely than ours. The introduction of more efficacious, safer, cheaper, or more convenient alternatives to our products that offer advantages in efficacy, safety or ease of use could negatively affectreduce our revenues and reduce the value of our product development efforts. In addition, potentialPotential governmental action in the future could provide a means for competition from developers of follow-on biologics, which could compete on price and differentiation with products that we now or could in the future market.
 
In addition to competing directly with products that are marketed by substantial pharmaceutical competitors, AVONEX, RITUXAN and TYSABRI also face competition from off-label uses of drugs approved for other indications. Some of our current competitors are also working to develop alternative formulations for delivery of their products, which may in the future compete with ours.
 
We depend, to a significant extent, on reimbursement from third party payors and a reduction in the extent of reimbursement could negatively affectreduce our product sales and revenue.
 
Sales of our products are dependent, in large part, on the availability and extent of reimbursement from government health administration authorities, private health insurers and other organizations. Changes in government regulations or private third-party payors’ reimbursement policies may reduce reimbursement for our products and adversely affect our future results.
 
In the United States,U.S., there have been numerous proposals considered at both the federal and state levels the government regularly proposes legislation to reform healthcarefor comprehensive reforms of health care and its cost, and such proposals have received increasing political attention. Init is likely that federal and state legislatures and health agencies will continue to focus on health care reform in the last few years, there have been afuture. Congress has considered legislation to reform the U.S. health care system by expanding health insurance coverage, reducing health care costs and making other changes. While health care reform may increase the number of legislative changespatients who have insurance coverage for our products, it may also include cost containment measures that have affected theadversely affect reimbursement for our products, including, but not limitedproducts. Congress has also considered legislation to change the Medicare Prescription Drug Improvementreimbursement system for outpatient drugs, increase the amount of rebates that manufacturers pay for coverage of their drugs by Medicaid programs and Modernization Actfacilitate the importation of 2003lower-cost prescription drugs that are marketed outside the U.S. Some states are also considering legislation that would control the prices of drugs, and state Medicaid programs are increasingly requesting manufacturers to pay supplemental rebates and requiring prior authorization by the Deficit Reduction Actstate program for use of 2005. The Deficit Reduction Act made significant changes to the Medicaid prescriptionany drug provisions of the Social Security Act, including changes that impose the monthly reporting of price information and that may have an impact on the Medicaidfor which supplemental rebates we pay. In addition, states may more aggressively seek Medicaid rebates as a result of legislation enacted in 2006, which rebate activity could adversely affect our results of operations.are


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not being paid. Managed care organizations as well as Medicaid and other government health administration authorities continue to seek price discounts.discounts and, in some cases, to impose restrictions on the coverage of particular drugs. Government efforts to reduce Medicaid expenses may continuelead to increase theincreased use of managed care organizations.organizations by Medicaid programs. This may result in managed care organizations influencing prescription decisions for a larger segment of the population and a corresponding constraint on prices and reimbursement for our products.


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In addition, some states have implemented and other states are considering price controls or patient-access constraints under the Medicaid program and some states are considering price-control regimes that would apply to broader segments of their populations that are not Medicaid eligible. Other matters also could be the subject of U.S. federal or state legislative or regulatory action that could adversely affect our business, including the importation of prescription drugs that are marketed outside the United States and sold at lower prices as a result of drug price limitations imposed by the governments of various foreign countries.
 
We encounter similar regulatory and legislative issues in most other countries. In the EUEuropean Union and some other international markets, the government provides health care at low cost to consumers and regulates pharmaceutical prices, patient eligibility or reimbursement levels to control costs for the government-sponsored health care system. This international system of price regulations may lead to inconsistent prices. Within the EUEuropean Union and in other countries, some third party trade inthe availability of our products occurs fromin some markets withat lower prices thereby underminingundermines our sales in some markets with higher prices. Additionally, certain countries set prices by reference to the prices in other countries where our products are marketed. Thus, our inability to secure adequate prices in a particular country may also impair our ability to obtain acceptable prices in existing and potential new markets. This may create the opportunity for the third party cross border trade previously mentioned or influence our decision to sell or not to sell thea product, thus affecting our geographic expansion plans.
 
When a new medical product is approved, the availability of government and private reimbursement for that product is uncertain, as is the amount for which that product will be reimbursed. We cannot predict the availability or amount of reimbursement for our product candidates.
 
We depend on collaborators for both product and royalty revenue and the clinical development of future collaboration products, which are outside of our full control.
 
Collaborations between companies on products or programs are a common business practice in the biotechnology industry. Out-licensing typically allows a partner to collect up front payments and future milestone payments, share the costs of clinical development and risk of failure at various points, and access sales and marketing infrastructure and expertise in exchange for certain financial rights to the product or program going to the in-licensing partner. In addition, the obligation of in-licensees to pay royalties or share profits generally terminates upon expiration of the related patents. We have a number of collaborators and partners, and have both in-licensed and out-licensed several products and programs. These collaborations includeare subject to several risks:
 
 • we are not fully in control of the royalty or profit sharing revenues we receive from collaborators, and we cannotwhich may be certain of the timing or potential impact of factors includingadversely affected by patent expirations, pricing or health care reforms, other legal and regulatory developments, failure of our partners to comply with applicable laws and regulatory requirements, the introduction of competitive products, and new indication approvals which may affect the sales of collaboration products;
 
 • where we copromoteco-promote and co-market products with our collaboration partners, any failure on their part to comply with applicable laws and regulatory requirements in the sale and marketing of our products could have an adverse effect on our revenues as well as involve us in possible legal proceedings; and
 
 • collaborations often require the parties to cooperate, and failure to do so effectively could have an adverse impact on product sales by our collaborators and partners, and could adversely affect the clinical development of shared products or programs under joint control.
 
In addition, under our collaboration agreement with Genentech, the successful development and commercialization of the first anti-CD20 product acquired or developed by Genentech will decrease our percentage of the collaboration’s co-promotion profits of the collaboration.profits.
 
If we do not successfully execute our growth initiatives through the acquisition, partnering and in-licensing of products, technologies or companies, our future performance could be adversely affected.
 
In addition to the expansion of our pipelineWe anticipate growing through spending on internal development projects we anticipate growing throughas well as external growth opportunities, which include the acquisition, partnering and in-licensing of products, technologies and companies or the entry into strategic alliances and collaborations. If we are unable to


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complete or manage these external growth opportunities successfully, we may not be able to grow our business in the way that we currently expect. The availability of high quality opportunities is limited and we are not certain that we will be able to identify candidates that we and our shareholders consider suitable candidates or complete transactions on terms that are acceptable to us.us and our shareholders. In order to pursue such opportunities, we may require significant


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additional financing, which may not be available to us on favorable terms, if at all. The availability of such financing is limited by the recent tightening of the global credit markets. In addition, evenEven if we are able to successfully identify and complete acquisitions, we may not be able to integrate them or take full advantage of them and therefore may not realize the benefits that we expect. In addition, third parties may be reluctant to partner with us due to the uncertainty created by the presence on our Board of Directors of two individuals nominated by an activist shareholder and the possibility that activist shareholders may gain additional representation on or control of our Board of Directors. If we are unsuccessful in our external growth program, we may not be able to grow our business significantly and we may incur asset impairment charges as a result of acquisitions that are not successful.
 
If we fail to comply with the extensive legal and regulatory requirements affecting the healthcarehealth care industry, we could face increased costs, penalties and a loss of business.
 
Our activities, and the activities of our collaborators and third party providers, are subject to extensive government regulation and oversight both in the United StatesU.S. and in foreign jurisdictions. PharmaceuticalThe FDA and comparable agencies in other jurisdictions directly regulate many of our most critical business activities, including the conduct of preclinical and clinical studies, product manufacturing, advertising and promotion, product distribution, adverse event reporting and product risk management. States increasingly have been placing greater restrictions on the marketing practices of health care companies. In addition, pharmaceutical and biotechnology companies have been the target of lawsuits and investigations alleging violations of government regulation, including claims asserting submission of incorrect pricing information, impermissible off-label promotion of pharmaceutical products, payments intended to influence the referral of federal or state healthcarehealth care business, submission of false claims for government reimbursement, antitrust violations, or violations related to environmental matters. Violations of governmental regulation may be punishable by criminal and civil sanctions, including fines and civil monetary penalties and exclusion from participation in government programs, including Medicare and Medicaid. In addition to penalties for violation of laws and regulations, we could be required to repay amounts we received from government payors, or pay additional rebates and interest if we are found to have miscalculated the pricing information we have submitted to the government. Whether or not we have complied with the law, an investigation into alleged unlawful conduct could increase our expenses, damage our reputation, divert management time and attention and adversely affect our business.
 
If we fail to meet the stringent requirements of governmental regulation in the manufacture of our products, we could incur substantial remedial costs and a reduction in sales.
 
We and our third party providers are generally required to maintain compliance with current Good Manufacturing Practice or cGMP, and are subject to inspections by the FDA or comparable agencies in other jurisdictions to confirm such compliance. AnyIn addition, the FDA must approve any significant changes ofto our suppliers or modifications of methods of manufacturing require amending our application to the FDA and acceptance of the change by the FDA prior to release of product to the marketplace. Our inability,methods. If we or the inability of our third party service providers tocannot demonstrate ongoing cGMPcurrent Good Manufacturing Practice compliance, could require uswe may be required to withdraw or recall product and interrupt commercial supply of our products. Any delay, interruption or other issues that arise in the manufacture, fill-finish, packaging, or storage of our products as a result of a failure of our facilities or the facilities or operations of third parties to pass any regulatory agency inspection could significantly impair our ability to develop and commercialize our products. Significant noncompliance could also result in the imposition of monetary penalties or other civil or criminal sanctions. This non-compliance could increase our costs, cause us to lose revenue or market share and damage our reputation.
 
Changes in laws affecting the healthcarehealth care industry could adversely affect our revenues and profitability.
 
We and our collaborators and third party providers operate in a highly regulated industry. As a result, governmental actions may adversely affect our business, operations or financial condition, including:
 
 • new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations or decisions, related to health care availability, method of delivery and payment for health care products and services;
 
 • changes in the FDA and foreign regulatory approval processes that may delay or prevent the approval of new products and result in lost market opportunity;


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 • changes in FDA and foreign regulations that may require additional safety monitoring, labeling changes, restrictions on product distribution or use, or other measures after the introduction of our products to market, which could increase our costs of doing business, and adversely affect the future permitted uses of approved products, or otherwise adversely affect the market for our products;


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 • new laws, regulations and judicial decisions affecting pricing or marketing practices; and
 
 • changes in the tax laws relating to our operations.
 
The enactment in the United StatesU.S. of the Medicare Prescription Drug Improvement and Modernization Act of 2003,health care reform, possible legislation which could ease the entry of competing follow-on biologics in the marketplace, andnew legislation or implementation of existing statutory provisions on importation of lower-cost competing drugs from other jurisdictions, and legislation on comparative effectiveness research are examples of changespreviously enacted and possible future changes in laws that could adversely affect our business. In addition, the Food and Drug Administration Amendments Act of 2007 included new authorization for the FDA to require post-market safety monitoring, along with aan expanded clinical trials registry and clinical trials results database, and expanded authority for the FDA to impose civil monetary penalties on companies that fail to meet certain commitments.
 
Problems with manufacturing or with inventory planning could result in our inability to deliver products, inventory shortages, or surpluses, product recalls and increased costs.
 
We manufacture and expectBiologics manufacturing is extremely susceptible to continueproduct loss due to manufacture our own commercial requirementscontamination, equipment failure, or vendor or operator error. In addition, we may need to close a manufacturing facility for an extended period of bulk AVONEX and TYSABRI. Our products are difficulttime due to manufacture and problemsmicrobial, viral or other contamination. Any of these events could result in our manufacturing processes can occur. Our inability to successfully manufacture bulkshipment delays or product and to obtain and maintain regulatory approvals of our manufacturing facilities would harmrecalls, impairing our ability to produce timely sufficient quantities of commercial supplies of AVONEX and TYSABRI to meet demand. Problems with manufacturing processes could result in product defects or manufacturing failures that could require us to delay shipment of products or recall or withdraw products previously shipped, which could result in inventory write-offs and impair our ability to expand into new markets or supply products in existing markets or expand into new markets. In the past, we have had to write downtaken inventory write-offs and incurincurred other charges and expenses for products that failed to meet specifications. Similarspecifications, and we may incur similar charges may occur in the future. In addition, lower than expected demand for our products, including suspension of sales, or a change in product mix may result in less than optimal utilization of our manufacturing facilities and lower inventory turnover, which could result in abnormal manufacturing variance charges, facility impairment charges and charges for excess and obsolete inventory.
 
We rely solely on our manufacturing facility in Research Triangle Park, North Carolina or RTP, for the production of TYSABRI. We have applied toOur global bulk supply of TYSABRI depends on the FDAuninterrupted and the EMEA for approvalefficient operation of a production process, knownthis facility, which could be adversely affected by equipment failures, labor shortages (whether as a second generation high-titer process, which has higher yieldsresult of TYSABRI than the process we currently use. Approval has been granted by the EMEA, but is still pending from the FDA.pandemic flu outbreak or otherwise), natural disasters, power failures and numerous other factors. If we do not obtain approval for that process, we may need to increase our capital spending to add capacity at our RTP manufacturing facility and at the Hillerød, Denmark facility we are completingunable to meet demand for TYSABRI. Such an increase in capital spending would affect our business, cash position and results of operations.
If we cannot produce sufficient commercial requirements of bulk product to meet demand,TYSABRI for any reason, we would need to rely on a limited number of qualified third party contract manufacturers, of which there are only a limited number capable of manufacturing bulk products of the type we require.manufacturers. We cannot be certain that we could reach agreement on reasonable terms, if at all, with those manufacturers. Evenmanufacturers or that the FDA would approve our use of such manufacturers on a timely basis, if we were to reach agreement,at all. Moreover, the transition of theour manufacturing process to a third party could take a significant amount of time. time and involve significant expense.
Our ability to supply productsinvestments in sufficient capacity to meet demand is also dependent upon third party contractors to fill-finish, package and store such products. Any prolonged interruption in the operations ofproperties, including our existing manufacturing facilities, could result in cancellations of shipments or loss of product in the process of being manufactured. Because our manufacturing processes are highly complex and are subject to a lengthy FDA approval process, alternative qualified production capacity may not be available on a timely basis or at all.fully realizable
 
We own or lease real estate primarily consisting of buildings that contain research laboratories, office space, and biologic manufacturing operations, some of which are located in markets that are experiencing high vacancy rates and decreasing property values. If we decide to consolidate or co-locate certain aspects of our business operations, for strategic or other operational reasons, we may dispose of one or more of our properties.
Due to reduced expectations of product demand, improved yields on production and other factors, we may not fully utilize our manufacturing facilities at normal levels resulting in idle time at facilities or substantial excess manufacturing capacity. We are always evaluating our current manufacturing strategy, and may pursue alternatives that include delaying the completion of our Denmark facility or disposing of manufacturing facilities.
If any of our owned properties are held for sale, or disposed of, we may not realize the full investment in these properties and incur significant impairment charges if the fair value of the properties were determined to be lower than their book value. In addition, if we decide to fully or partially vacate a leased property, we may incur significant cost, including lease termination fees, rent expense in excess of sublease income and impairment of leasehold improvements.


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We rely on third parties to provide services in connection with the manufacture of our products and, in some instances, the manufacture of the product itself.
 
We rely on Genentech for all RITUXAN manufacturing. Genentech relies on a third party to manufacture certain bulk RITUXAN requirements. If Genentech or any third party upon which it relies does not manufacture or fill-finish RITUXAN in sufficient quantities and on a timely and cost-effective basis, or if Genentech or any third party does not obtain and maintain all required manufacturing approvals, our business could be harmed.
 
We also source all of our fill-finish and the majority of our final product storage operations, along with a substantial portion of our packaging operations, of the components used with our products, to a concentrated group of third party contractors. Any third party we use to fill-finish, package or store our products to be sold in the U.S. must be licensed by the FDA. As a result, alternative third party providers may not be readily available on a timely basis. The manufacture of products and product components, fill-finish, packaging and storage


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of our products require successful coordination among us and multiple third party providers. Our inability to coordinate these efforts, the lack of capacity available at a third party contractor or any other problems with the operations of these third party contractors could require us to delay shipment of saleable products,products; recall products previously shipped or impair our ability to supply products at all. This could increase our costs, cause us to lose revenue or market share, diminish our profitability andor damage our reputation. Any third party we use to fill-finish, package or store our products to be sold in the United States must be licensed by the FDA. As a result, alternative third party providers may not be readily available on a timely basis.
 
Due to the unique nature of the production ofmanner in which our products there are manufactured, we rely on single source providers of several raw materials. We make every effortefforts to qualify new vendors and to develop contingency plans so that production is not impacted by short-term issues associated with single source providers. Nonetheless, our business could be materially impacted by long-term or chronic issues associated with single source providers.
 
The current creditOur effective tax rate may fluctuate and financial market conditionswe may exacerbate certain risks affecting our business.incur obligations in tax jurisdictions in excess of accrued amounts.
 
Sales of our productsAs a global biotechnology company, we are dependent,subject to taxation in large part, on reimbursement from government health administration authorities, private health insurers, distribution partnersnumerous countries, states and other organizations.jurisdictions. As a result, our effective tax rate is derived from a combination of applicable tax rates in the current credit andvarious places that we operate. In preparing our financial market conditions, these organizationsstatements, we estimate the amount of tax that will become payable in each of such places. Our effective tax rate, however, may be unable to satisfy their reimbursement obligations or may delay payment. In addition, federal and state health authorities may reduce Medicare and Medicaid reimbursements, and private insurers may increase their scrutiny of claims. A reductiondifferent than experienced in the availabilitypast due to numerous factors, including changes in the mix of our profitability from country to country, the results of audits of our tax filings, changes in accounting for income taxes and changes in tax laws. Any of these factors could cause us to experience an effective tax rate significantly different from previous periods or extentour current expectations, which could have an effect on our business and results of reimbursement could negatively affect our product sales and revenue.operations.
 
DueIn addition, our inability to the recent tightening of global credit, there may be a disruptionsecure or delaysustain acceptable arrangements with tax authorities and previously enacted or future changes in the performancetax laws, among other things, may require us to accrue for future tax payments in excess of amounts accrued in our third-party contractors, suppliers or collaborators. We rely on third parties for several important aspects of our business, including portions of our product manufacturing, royalty revenue, clinical development of future collaboration products, conduct of clinical trials, and raw materials. If such third parties are unable to satisfy their commitments to us, our business would be adversely affected.financial statements
 
Our portfolio of marketable securities is significant and is subjectThe Obama administration announced several proposals to market, interest and credit riskreform U.S. tax rules, including proposals that may reduce or eliminate the valuedeferral of U.S. income tax on our investments.
We maintain a significant portfolio of marketable securities.unrepatriated earnings, potentially requiring those earnings to be taxed at the U.S. federal income tax rate, reduce or eliminate our ability to claim foreign tax credits, and eliminate various tax deductions until foreign earnings are repatriated to the U.S. Our earningsfuture reported financial results may be adversely affected by tax rule changes inwhich restrict or eliminate our ability to claim foreign tax credits or deduct expenses attributable to foreign earnings, or otherwise affect the value of this portfolio. In particular, the valuetreatment of our investments may be adversely affected by increases in interest rates, downgrades in the corporate bonds included in our portfolio, instability in the global financial markets that reduces the liquidity of securities included in our portfolio, declines in the value of collateral underlying the mortgage and asset-backed securities included in our portfolio, and by other factors which may result in other than temporary declines in value of the investments. Each of these events may cause us to record charges to reduce the carrying value of our investment portfolio or sell investments for less than our acquisition cost. Although we attempt to mitigate risks within our marketable securities portfolio with the assistance of our investment advisors by investing in high quality securities and continuously monitoring the overall risk profile of our portfolio, the value of our investments may nevertheless decline.unrepatriated earnings.
 
We have made a significant investment in constructing a manufacturing facility the successThe growth of whichour business depends upon the completion and licensing of the facility and continued demand for our products.
We are building a large-scale biologic manufacturing facility in Hillerød, Denmark. We anticipate that the facility will be ready for commercial production in 2010. If we fail to manage the project, or unforeseen events occur, we may incur additional costs to complete the project. Depending on the timing of the completion and licensing of the facility, and our other estimates and assumptions regarding future product sales, the carrying value of all or part of the manufacturing facility or other assets may not be fully recoverable and could result in the recognition of an impairment in the carrying value at the time that such effects are identified. The recognition of impairment in the carrying value, if any, could have a material and adverse affect on our results of operations. For example, if the anticipated demand for TYSABRI does not materialize, the carrying values of our Hillerød, Denmark facility could be impaired, which would negatively impact our results of operations.


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If we are unableability to attract and retain qualified personnel and key relationships, the growth of our business could be harmed.relationships.
 
Our success will depend, to a great extent,The achievement of our commercial, research and development and external growth objectives depends upon our ability to attract and retain qualified scientific, manufacturing, sales and marketing and executive personnel and our ability to develop and maintain relationships with qualified clinical researchers and key distributors. Competition for these people and relationships is intense and we compete with numerouscomes from a variety of sources, including pharmaceutical and biotechnology companies, as well as with universities and non-profit research organizations. Any inability we experience to continueIt may be more difficult for us to attract and retain qualified personnel or developthese people and maintain key relationships could have an adverse effectdue to the uncertainty created by the presence on our abilityBoard of Directors of two


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individuals nominated by an activist shareholder and the possibility that activist shareholders may gain additional representation on or control of our Board of Directors. Our recruitment and retention efforts may also be adversely affected by the announcement that our Chief Executive Officer will retire from that position in June 2010 and the retirement of our President, Research and Development in October 2009. We are currently conducting searches for successors to accomplish our research, developmentChief Executive Officer and external growth objectives.President, Research and Development.
 
Our sales and operations are subject to the risks of doing business internationally.
 
We are increasing our presence in international markets, which subjects us to many risks, such as:
 
 • economic problems that disrupt foreign healthcarehealth care payment systems;
 
 • fluctuations in currency exchange rates;
• difficulties in staffing and managing international operations; 
 
 • the imposition of governmental controls;
 
 • less favorable intellectual property or other applicable laws;
 
 • the inability to obtain any necessary foreign regulatory or pricing approvals of products in a timely manner;
 
 • restrictions on direct investments by foreign entities and trade restrictions;
 
 • changes in tax laws and tariffs;
• difficulties in staffing and managing international operations; and
 
 • longer payment cycles.
 
OurIn addition, our international operations and marketing practices are also subject to regulation and scrutiny by the governments of the other countries in which we operate. In addition,under U.S. law. For example, the Foreign Corrupt Practices Act or FCPA, prohibits U.S. companies and their representatives from offering, promising, authorizing or making payments to foreign officials for the purpose of obtaining or retaining business abroad. In many countries, the healthcarehealth care professionals we regularly interact with may meet the definition of a foreign official for purposes of the FCPA. Additionally, we are subject to other U.S. laws in our international operations.Foreign Corrupt Practices Act. Failure to comply with domestic or foreign laws could result in various adverse consequences, including possible delay in approval or refusal to approve a product, recalls, seizures, withdrawal of an approved product from the market, and the imposition of civil or criminal sanctions.
 
A portionThe presence of directors nominated by an activist shareholder, and the possibility that activist shareholders may gain additional representation on or control of our business is conducted in currencies other thanBoard of Directors could cause uncertainty about the direction of our reporting currency, the U.S. dollar. We recognize foreign currency gains or losses arising from our operations in the period in which we incur those gains or losses. As a result, currency fluctuations among the U.S. dollar and the currencies in which we do business will affect our operating results, often in unpredictable ways.
Our business could be negatively affected as a result of the actions of activist shareholders.business.
 
During 2008 and 2009, proxy contests commenced by entities affiliated with Carl Icahn resulted in the first half2009 election of 2008,two of the Icahn nominees to our Board of Directors. In November 2009, another activist shareholder publicly advocated for certain changes at our company. In January 2010, we defended againstreceived a proxy contest waged bynotice from Icahn Partners and certain of its affiliates that nominatednominating three individuals for election to our Board of Directors at the 2010 annual meeting and proposed amendmentsproposing to amend our bylaws to set the number of directors at twelve. These and other existing or potential shareholders may attempt to gain additional representation on or control of our Board of Directors, the possibility of which may create uncertainty regarding the direction of our business. Perceived uncertainties as to our bylaws atfuture direction may result in the loss of potential acquisitions, collaborations or in-licensing opportunities, and may make it more difficult to attract and retain qualified personnel and business partners. In addition, disagreement among our directors about the direction of our business could impair our ability to effectively execute our strategic plan.
Our 2008 Annual Meeting of Stockholders. Although weand 2009 proxy contests were successful in having our Board’s nominees elected as directors, the proxy contest was disruptive to our operations and caused us to incur substantial costs. Icahn PartnersThe SEC has recently proposed to give shareholders the ability to include their director nominees and certain of its affiliates have commenced a proxy contesttheir proposals relating to our 2009 Annual Meeting of Stockholders nominating four individualsa shareholder nomination process in company proxy materials, which would make it easier for activists to nominate directors to our Board of Directors, proposing amendmentsDirectors. If the SEC implements its proxy access proposal, we may face an increase in the number of shareholder nominees for election to our bylawsBoard of Directors. Future proxy contests and requesting a change inthe presence of additional activist shareholder nominees on our jurisdictionBoard of incorporation. Our businessDirectors could interfere with our ability to execute our strategic plan, be adversely affected because:costly and time-consuming, disrupt our operations and divert the attention of management and our employees.
• Responding to proxy contests and other actions by activist shareholders can be costly and time-consuming, disrupting our operations and diverting the attention of management and our employees;


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• Perceived uncertainties as to our future direction may result in the loss of potential acquisitions, collaborations or in-licensing opportunities, and may make it more difficult to attract and retain qualified personnel and business partners; and
• If individuals are elected to our board of directors with a specific agenda, it may adversely affect our ability to effectively and timely implement our strategic plan and create additional value for our stockholders.
Our operating results are subject to significant fluctuations.
Our quarterly revenues, expenses and net income (loss) have fluctuated in the past and are likely to fluctuate significantly in the future due to the timing of charges and expenses that we may take. In recent periods, for instance, we have recorded charges that include:
• impairments that we are required to take with respect to investments;
• impairments that we are required to take with respect to fixed assets, including those that are recorded in connection with the sale of fixed assets;
• inventory write-downs for failed quality specifications, charges for excessand/or obsolete inventory and charges for inventory write downs relating to product suspensions;
• milestone payments under license and collaboration agreements; and
• the cost of restructurings.
Our revenues are also subject to foreign exchange rate fluctuations due to the global nature of our operations. Although we have foreign currency forward contracts to hedge specific forecasted transactions denominated in foreign currencies, our efforts to reduce currency exchange losses may not be successful. As a result, changes in currency exchange rates may have an adverse impact on our future operating results and financial condition. Additionally, our net income may fluctuate due to the impact of charges we may be required to take with respect to foreign currency hedge transactions. In particular, we may incur higher charges from hedge ineffectiveness than we expect or from the termination of a hedge relationship.
These examples are only illustrative and other risks, including those discussed in these “Risk Factors,” could also cause fluctuations in our reported earnings. In addition, our operating results during any one period do not necessarily suggest the anticipated results of future periods.
If we are unable to adequately protect and enforce our intellectual property rights, our competitors may take advantage of our development efforts or our acquired technology.
 
We have filed numerous patent applications in the United StatesU.S. and various other countries seeking protection of the processes, products and other inventions originating from our research and development, including a number of our processes and products.development. Patents have been issued on many of these applications. We have also obtained rights to various patents and patent applications under licenses with third parties, which provide for the payment of royalties by us. The ultimate degree of patent protection that will be afforded to biotechnology products and processes, including ours, in the United StatesU.S. and in other important markets remains uncertain and is dependent upon the scope of protection decided upon by the patent offices, courts and lawmakers in these countries. Our patents may not afford us substantial protection or commercial benefit. Similarly, our pending patent applications or patent applications licensed from third parties may not ultimately be granted as patents and we may not prevail if patents that have been issued to us are challenged in court. In addition, pending legislation to reform the patent system and court decisions or patent office regulations that place additional restrictions on patent claims or that facilitate patent challenges could also reduce our ability to enforce our patents. We do not know when, or if, changes to the U.S. patent system will become law. If we are unable to protect our intellectual property rights andrights. If we cannot prevent others from exploiting our inventions, we will not derive the benefit from them that we currently expect.


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We also rely upon unpatented trade secrets and other proprietary information, and we cannot assure that others will not independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose such technology, or that we can meaningfully protect such rights. We require our employees, consultants, outside scientific collaborators, scientists whose research we sponsor and other advisers to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements may not provide meaningful protection or adequate remedies for our unpatented proprietary information in the event of use or disclosure of such information.
If our products infringe the intellectual property rights of others, we may incur damages and be required to incur the expense of obtaining a license.
 
A substantial number of patents have already been issued to other biotechnology and biopharmaceuticalpharmaceutical companies. Competitors may have filed applications for, or have been issued patents and may obtain additional patents and proprietaryTo the extent that valid third party patent rights that may relate tocover our products or processes competitive withservices, we or similarour strategic collaborators would be required to ourseek licenses from the holders of these patents in order to manufacture, use or sell these products and processes. Moreover, the patent laws of the United Statesservices, and foreign countries are distinctpayments under them would reduce our profits from these products and decisions as to patenting, validity of patents and infringement of patents may be resolved differently in different countries. In general, we obtain licenses to third party patents that we deem necessary or desirable for the manufacture, use and sale of our products.services. We are currently unable to assesspredict the extent to which we may wish or be required to acquire rights under such patents and the availability and cost of acquiring such rights, or whether a license to such patents will be available on acceptable terms or at all. There may be patents in the United StatesU.S. or in foreign countries or patents issued in the future that are unavailable to license on acceptable terms. Our inability to obtain such licenses may hinder our ability to manufacture and market our products.
 
Uncertainty over intellectual property in the biotechnology industry has been the source of litigation, which is inherently costly and unpredictable.
 
We are aware that others, including various universities and companies working in the biotechnology field, have filed patent applications and have been granted patents in the United StatesU.S. and in other countries claiming subject matter potentially useful to our business. Some of those patents and patent applications claim only specific products or methods of making such products, while others claim more general processes or techniques useful or now used in the biotechnology industry. There is considerable uncertainty within the biotechnology industry about the validity, scope and enforceability of many issued patents in the United StatesU.S. and elsewhere in the world, and, to date, there is no consistent policy regarding the breadth of claims allowed in biotechnology patents. We cannot currently determine the ultimate scope and validity of patents which may be granted to third parties in the future or which patents might be asserted to be infringed by the manufacture, use and sale of our products.
 
There has been, and we expect that there may continue to be, significant litigation in the industry regarding patents and other intellectual property rights. Litigation and administrative proceedings concerning patents and other intellectual property rights may be protracted, expensive and distracting to management. Competitors may sue us as a way of delaying the introduction of our products. Any litigation, including any interference proceedings to


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determine priority of inventions, oppositions to patents in foreign countries or litigation against our partners may be costly and time consuming and could harm our business. We expect that litigation may be necessary in some instances to determine the validity and scope of certain of our proprietary rights. Litigation may be necessary in other instances to determine the validity, scope or noninfringementnon-infringement of certain patent rights claimed by third parties to be pertinent to the manufacture, use or sale of our products. Ultimately, the outcome of such litigation could adversely affect the validity and scope of our patent or other proprietary rights or conversely, hinder our ability to manufacture and market our products.
 
Pending and future product liability claims may adversely affect our business and our reputation.
 
The administration of drugs in humans, whether in clinical studies or commercially, carries the inherent risk of product liability claims whether or not the drugs are actually the cause of an injury. Our products or product candidates may cause, or may appear to have caused, injury or dangerous drug interactions, and we may not learn about or understand those effects until the product or product candidate has been administered to patients for a prolonged period of time.
 
We are subject from time to time to lawsuits based on product liability and related claims. We cannot predict with certainty the eventual outcome of any pending or future litigation. We may not be successful in defending ourselves in the litigation and, as a result, our business could be materially harmed. These lawsuits may result in large judgments or settlements against us, any of which could have a negative effect on our financial condition and business.business if in excess of our insurance coverage. Additionally, lawsuits can be expensive to defend, whether or not they have merit, and the defense of these actions may divert the attention of our management and other resources that would otherwise be engaged in managing our business.
Our operating results are subject to significant fluctuations.
Our quarterly revenues, expenses and net income (loss) have fluctuated in the past and are likely to fluctuate significantly in the future due to the timing of charges and expenses that we may take. In recent periods, for instance, we have recorded charges that include:
• impairments that we are required to take with respect to investments;
• impairments that we are required to take with respect to fixed assets, including those that are recorded in connection with the sale of fixed assets;
• inventory write-downs for failed quality specifications, charges for excess or obsolete inventory and charges for inventory write downs relating to product suspensions;
• milestone payments under license and collaboration agreements;
• payments in connection with acquisitions and other business development activity; and
• the cost of restructurings.
Our revenues are also subject to foreign exchange rate fluctuations due to the global nature of our operations. We recognize foreign currency gains or losses arising from our operations in the period in which we incur those gains or losses. Although we have foreign currency forward contracts to hedge specific forecasted transactions denominated in foreign currencies, our efforts to reduce currency exchange losses may not be successful. As a result, currency fluctuations among our reporting currency, the U.S. dollar, and the currencies in which we do business will affect our operating results, often in unpredictable ways. Additionally, our net income may fluctuate due to the impact of charges we may be required to take with respect to foreign currency hedge transactions. In particular, we may incur higher charges from hedge ineffectiveness than we expect or from the termination of a hedge relationship.
These examples are only illustrative and other risks, including those discussed in these “Risk Factors,” could also cause fluctuations in our reported earnings. In addition, our operating results during any one period do not necessarily suggest the anticipated results of future periods.


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Our effective tax rateCredit and financial market conditions may fluctuate and we may incur obligations in tax jurisdictions in excess of amounts that have been accrued.exacerbate certain risks affecting our business.
 
As a global biotechnology company, weSales of our products are subject to taxation in numerous countries, statesdependent on reimbursement from government health administration authorities, private health insurers, distribution partners and other jurisdictions.organizations. As a result our effective tax rate is derived from a combination of applicable tax ratescredit and financial market conditions, these organizations may be unable to satisfy their reimbursement obligations or may delay payment. In addition, federal and state health authorities may reduce Medicare and Medicaid reimbursements, and private insurers may increase their scrutiny of claims. A reduction in the various countries, statesavailability or extent of reimbursement could reduce our product sales and revenue.
We rely on third parties for several important aspects of our business, including portions of our product manufacturing, royalty revenue, clinical development of future collaboration products, conduct of clinical trials, and raw materials. Such third parties may be unable to satisfy their commitments to us due to tightening of global credit from time to time, which would adversely affect our business.
Our portfolio of marketable securities is significant and subject to market, interest and credit risk that may reduce its value.
We maintain a significant portfolio of marketable securities. Changes in the value of this portfolio could adversely affect our earnings. In particular, the value of our investments may decline due to increases in interest rates, downgrades in the corporate bonds and other jurisdictionssecurities included in which we operate. In preparing our portfolio, instability in the global financial statements, we estimatemarkets that reduces the amountliquidity of tax that will become payablesecurities included in eachour portfolio, declines in the value of collateral underlying the countries, statesmortgage and asset-backed securities included in our portfolio, and other jurisdictions in which we operate. Our effective tax rate, however, may be lower or higher than experienced in the past due to numerous factors, including a change in the mix of our profitability from country to country, changes in accounting for income taxes and changes in tax laws. Anyfactors. Each of these factors could cause us to experience an effective tax rate significantly different from previous periods or our current expectations, which could have an adverse effect on our business and results of operations. In addition, unfavorable results of audits of our tax filings, our inability to secure or sustain arrangements with tax authorities, and recently enacted and future changes in tax laws in jurisdictions in which we operate, among other things,events may cause us to be obligatedrecord charges to accruereduce the carrying value of our investment portfolio or sell investments for future tax paymentsless than our acquisition cost. Although we attempt to mitigate these risks by investing in excesshigh quality securities and continuously monitoring our portfolio’s overall risk profile, the value of amounts accrued in our financial statements.investments may nevertheless decline.
 
Our level of indebtedness could adversely affect our business and limit our ability to plan for or respond to changes in our business.
 
As of December 31, 2008,2009, we had $1,113.1 million$1.1 billion of outstanding indebtedness, and we may incur additional debt in the future. Our level of indebtedness could have significant consequences toadversely affect our business for example, it could:by, among other things:
 
 • increase our vulnerability to general adverse economic and industry conditions;
• requirerequiring us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness, thereby reducing the availability of our cash flow for other purposes, including business development efforts and mergersresearch and acquisitions; anddevelopment;
 
 • limitlimiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate, thereby placing us at a competitive disadvantage compared to our competitors that may have less debt.debt; and
• increasing our vulnerability to general adverse economic and industry conditions.
 
Our business involves environmental risks, which include the cost of compliance and the risk of contamination or injury.
 
Our business and the business of several of our strategic partners, including Genentech and Elan, involveinvolves the controlled use of hazardous materials, chemicals, biologics and radioactive compounds. Biologics manufacturing is extremely susceptible to product loss due to contamination, equipment failure, or vendor or operator error. Although we believe that our safety procedures for handling and disposing of such materials comply with state and federal standards, there will always be the risk of accidental contamination or injury. In addition, microbial or viral contamination may cause the closure of a manufacturing facility for an extended period of time. By law, radioactive materials may only be disposed of at state-approved facilities. We currently store radioactive materials from our California laboratoryon-site because the approval of a disposal site in California for all California-based companies has been delayed indefinitely. If and when a disposal site is approved, we may incur substantial costs related to the disposal of these materials. If we were to become liable for an accident, or if we were to suffer an extended facility shutdown, we could incur significant costs, damages and penalties that could harm our business. Biologics manufacturing also requires permits from government agencies for water supply and wastewater discharge. If we do not obtain appropriate permits, or permits for sufficient quantities of water and wastewater, we could incur significant costs and limits on our manufacturing volumes that could harm our business.


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Several aspects of our corporate governance and our collaboration agreements may discourage a third party from attempting to acquire us.
 
Several factors might discourage a takeover attempt that could be viewed as beneficial to stockholdersshareholders who wish to receive a premium for their shares from a potential bidder. For example:
 
 • we are subject to Section 203 of the Delaware General Corporation Law, which provides that we may not enter into a business combination with an interested stockholdershareholder for a period of three years after the date of


32


the transaction in which the person became an interested stockholder,shareholder, unless the business combination is approved in the manner prescribed in Section 203;
 • our board of directors has the authority to issue, without a vote or action of stockholders, up to 8,000,000shareholders, shares of preferred stock and to fix the price, rights, preferences and privileges of those shares, each of which could be superior to the rights of holders of common stock;
 
 • our collaboration agreement with Elan provides Elan with the option to buy the rights to TYSABRI in the event thatif we undergo a change of control, which may limit our attractiveness to potential acquirers;
 
 • our amended and restated collaboration agreement with Genentech provides that, in the eventif we undergo a change of control, within 90 days Genentech may present an offer to us to purchase our rights to RITUXAN. In an arbitration proceeding brought by Biogen Idec relating to the collaboration agreement, Genentech alleged that the November 2003 transaction in which Idec Pharmaceuticals acquired Biogen and became Biogen Idec constituted such a change of control, an assertion with which we strongly disagree. It is our position that the Biogen Idec merger did not constitute a change of control under our agreement with Genentech and that, even if it did, Genentech’s rights under the change of control provision have long since expired. If the arbitrators decide this issue in favor of Genentech, or if a change of control were to occur in the future and Genentech were to present an offer for the RITUXAN rights, we must either accept Genentech’s offer or purchase Genentech’s rights to RITUXAN on the same terms as its offer. If Genentech presents such an offer, then they will be deemed concurrently to have exercised a right, in exchange for a royalty on net sales in the U.S. of any anti-CD20 product acquired or developed by Genentech or any anti-CD20 product that Genentech licenses from a third party that is developed under the agreement, to purchase our interest in each such product;
 
 • our directors are elected to staggered terms, which prevents the entire board from being replaced in any single year; and
 
 • advance notice is required for nomination of candidates for election as a director and for proposals to be brought before an annual meeting of stockholders.shareholders.
 
Item 1B.  Unresolved Staff Comments
 
None.


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Item 2.  Properties
 
Cambridge, Massachusetts and Surrounding Area
 
Our principal executive offices are located in Cambridge, Massachusetts. In Cambridge, we own approximately 510,000525,000 square feet of real estate space, consisting of a 250,000 square foot building that houses a research laboratory, office spacesspace and a cogeneration plant which total approximately 280,000 square feet and an approximately 260,000245,000 square foot building that contains research, development and quality laboratories.
We lease a total of approximately 440,000450,000 square feet, consistingwhich includes a 70,000 square foot biologics manufacturing facility and additional laboratory and office space of additional office125,000 square feet and manufacturing space, in all or part of four other buildings in Cambridge.255,000 square feet, respectively. In addition, we lease approximately 36,000 square feet of warehouse space in Somerville, Massachusetts, approximately 105,000 square feet of office space in Wellesley, Massachusetts, and approximately 25,000 square feet of office and lablaboratory space in Waltham, Massachusetts. The lease expiration dates for our leased sites in Massachusetts range from 2009 to 2015. We recently
In November 2008, we executed a fifteen year lease on a 356,000 square foot office building in Weston, Massachusetts, which will serve as the future location of our executivegeneral and administrative offices with a planned occupancy during the third quarter ofaround mid-year 2010. We anticipate that the Weston facility will decrease
The expiration dates for our overall occupancy cost per employee.leased sites in Massachusetts range from 2010 to 2025.
 
San Diego and Oceanside, California
 
In San Diego, California, we own approximately 43 acres of land upon which we have our oncology research and development campus. The campus, which totals approximately 355,000 square feet, primarily consists of five interconnected buildings which primarily containhousing laboratory and office space, totaling approximately 350,000 square feet. In July 2007, we sold two parcels of undeveloped property in Oceanside, California, totaling approximately 28 acres of land.space.
 
Research Triangle Park, North Carolina
 
In Research Triangle Park, North Carolina, we own approximately 530,000550,000 square feet of real estate space. This includes a 108,000 square foot biologics manufacturing facility a 232,000of approximately 105,000 square footfeet, a large scale manufacturing plant of approximately 175,000 square feet, a secondwarehouse comprising approximately 60,000 square feet, a large-scale purification facility of 42,000approximately 43,000 square feet, as well as approximately 167,000 square feet of laboratory and a 150,000 square foot laboratory office building.space. We manufacture bulk AVONEX, and TYSABRI at this facility. We plan to use this facility to manufactureand other products in our pipeline and to meet any obligation to manufacture AMEVIVE resulting from our sale of that product to Astellas. We are continuing further upgrades in Research Triangle Park with ongoing construction of several projects to increase our manufacturing flexibility.at this facility. In addition, we lease approximately 44,00057,000 square feet of office space in Durham, North Carolina.
 
Hillerød, Denmark
 
We own approximately 60 acres of propertyland in Hillerød, Denmark. We are in the final stages of constructing a large-scale biologics manufacturing facility of approximately 215,000 square feet in Hillerød, Denmark to be used to manufacture TYSABRI and other products in our pipeline.large molecule products. An administrative building of approximately 50,000 square feet, label and packaging facility of approximately 65,000 square feet, warehouse, utilities and labsupport space of approximately 135,000 square feet, and laboratory facility of approximately 50,000 square feet are currently in use. For a discussion of our plans forAdditional information about this facility is set forth in the Hillerød, Denmark large-scale manufacturing facility, see “Manufacturing“Business — Manufacturing and Raw Materials.”Materials” section of this report.
 
Other International
 
We lease office and laboratory space in Zug, Switzerland, our international headquarters, the United Kingdom, Germany, Austria, Argentina, France, Belgium, Netherlands, Spain, Portugal, Czech Republic, Slovenia, Slovak Republic, Denmark, Sweden, Finland, Norway, Japan, India, China, Australia, New Zealand, Brazil, Hungary and Canada.numerous other countries. The expiration dates for our international leased sites range from 2010 to 2023.
 
Item 3.  Legal Proceedings
 
Please refer to Note 19,Litigation in “Notes to our Consolidated Financial Statements”Statements of this annual report, onForm 10-K, which is incorporated into this item by reference.
 
Item 4.  Submission of Matters to a Vote of Security Holders
 
None.


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PART II
 
Item 5.  Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
 
Market Information
 
Our common stock trades on The NASDAQ Global Select Market under the symbol “BIIB.” The following table shows the high and low sales price for our common stock as reported by The NASDAQ Global Select Market for each quarter in the years ended December 31, 20082009 and 2007.2008:
 
                                
 Common Stock Price  Common Stock Price 
 2008 2007  2009 2008 
 High Low High Low  High Low High Low 
First Quarter $64.49  $54.50  $52.45  $42.86  $53.66  $42.92  $64.49  $54.50 
Second Quarter  67.45   55.68   53.96   43.43  $55.34  $44.56  $67.45  $55.68 
Third Quarter  73.59   45.37   69.00   53.24  $52.12  $44.41  $73.59  $45.37 
Fourth Quarter  52.36   37.21   84.75   53.65  $54.00  $41.75  $52.36  $37.21 
 
Holders
 
As of February 2, 2009,5, 2010, there were approximately 1,1211,097 stockholders of record of our common stock. In addition, as of February 2, 2009, 4065, 2010, 270 stockholders of record of Biogen, Inc. common stock have yet to exchange their shares of Biogen, Inc. common stock for our common stock as contemplated by the merger of Biogen, Inc. and IdecIDEC Pharmaceuticals Corporation or the Merger.in November 2003.
 
Dividends
 
We have not paid cash dividends since our inception. We currently intend to retain all earnings, if any, for use in the expansion of our business and, therefore, do not anticipate paying any cash dividends in the foreseeable future.
Equity Compensation Plan Information
We incorporate information regarding the securities authorized for issuance under our equity compensation plans into this section by reference from the section entitled “Disclosure With Respect To Our Equity Compensation Plans” in the proxy statement for our 2009 Annual Meeting of Stockholders.
Recent Sales of Unregistered Securities
None.near term.
 
Issuer Purchases of Equity Securities
 
A summary of issuerThe following table summarizes our common stock repurchase activity for 2008 is as follows:during the fourth quarter of 2009:
 
                 
           Approximate Dollar
 
        Total Number of
  Value of Shares
 
        Shares Purchased as
  That May Yet Be
 
  Total Number of
  Average Price
  Part of Publicly
  Purchased Under Our
 
  Shares Purchased
  Paid Per Share
  Announced Programs
  Programs
 
Period
 (#)  ($)  (#)  ($ in millions) 
 
2006 Repurchase Program(1)(2)
                
Nov-09  6,000,000   45.17   6,000,000    
2009 Repurchase Program(3)(4)
                
Oct-09          $1,000.0 
Nov-09  2,286,748   46.33   2,286,748   894.0 
Dec-09  6,471,899   48.87   6,471,899   577.6 
                 
Total  14,758,647   46.97         
                 
Issuer Purchases of Equity Securities
 
                 
        Total Number of
    
        Shares Purchased as
  Number of Shares
 
  Total Number of
  Average Price Paid
  Part of Publicly
  That May Yet Be
 
  Shares Purchased
  Per Share
  Announced Program
  Purchased Under Our
 
Period
 (#)  ($)  (#)(a)  Program (#) 
 
March 2008
  4,028,196  $59.61   4,028,196   15,971,804 
April 2008
  4,971,804  $64.27   4,971,804   11,000,000 
December 2008
  3,777,500  $47.41   3,777,500   7,222,500 
                 
Total(a)(b)
  12,777,500  $57.82   12,777,500   7,222,500 
                 


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(a)(1)On October 13,31, 2006, thewe announced that our Board of Directors authorized the repurchase of up to 20.0 million shares of our common stock. TheStock repurchased stockunder this program will provide us with authorized shares for general corporate purposes, such as common stock to be issued under our employee equity and stock purchase plans. This repurchase program doesdid not have an expiration date.date and was completed during the fourth quarter of 2009. We publicly announced thehave used this share repurchase program in our press release dated October 31, 2006, which was furnished to the SEC as Exhibit 99.1 to our current report onForm 8-K filed on October 31, 2006.principally for share stabilization.


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(b)(2)After December 31, 2008,During the first quarter of 2009 we repurchased approximately 1.2 million additional shares of our common stock at a total cost of approximately $57.6 million.million under the 2006 Program.
(3)On October 20, 2009, we announced that our Board of Directors authorized the repurchase of up to $1.0 billion of our common stock in addition to any shares remaining under our 2006 repurchase program. This repurchase program is intended to reduce our shares outstanding, with the objective of returning excess cash to shareholders, and we intend to retire repurchased shares. As of December 31, 2009 approximately 8.8 million shares, at a cost of $422.4 million, have been repurchased under this program, all of which were retired. The number of remaining shares that may yet be purchased under this program is subject to price fluctuations of our common stock.
(4)From January 1, 2010 through February 5, 2010, we repurchased approximately an additional 5.4 million shares under this program at a total cost of approximately $289.4 million, all of which were retired. Approximately $288.2 million remains available for the repurchase of our common stock under the 2009 program.
 
Stock Performance Graph
 
The graph below compares the five-year cumulative total stockholder return on our common stock, the S&P 500 Index and the Nasdaq Pharmaceutical Index, assuming the investment of $100.00 on December 31, 20032004 with dividends being reinvested. The stock price performance in the graph below is not necessarily indicative of future price performance.
 


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Item 6.  Selected Consolidated Financial Data
 
The following financial data should be read in conjunction with our consolidated financial statements and related notes appearing elsewhere in this report onForm 10-K,beginning onpage F-1.F-1 of this report.
 
BIOGEN IDEC INC. AND SUBSIDIARIES
 
SELECTED FINANCIAL DATA
 
                                        
 Years Ended December 31,  For the Years Ended December 31, 
 2008 (6) 2007 (4),(5) 2006 (2),(3) 2005 (1) 2004  2009
 2008
 2007
 2006
 2005
 
(In millions, except per share amounts) (7), (8), (9) (6) (4),(5) (2),(3) (1) 
   (In millions, except per share amounts)   
Results of Operations
                    
Product revenues $3,152.9  $2,839.7  $2,136.8  $1,781.3  $1,617.0 
Revenues from unconsolidated joint business  1,094.9   1,128.2   926.1   810.9   708.9 
Other revenues  129.5   129.6   108.7   90.8   96.6 
           
Product revenues $2,839.7  $2,136.8  $1,781.3  $1,617.0  $1,486.4 
Revenue from unconsolidated joint business  1,128.2   926.1   810.9   708.9   615.7 
Other revenues  129.6   108.7   90.8   96.6   109.5 
Total revenues  4,097.5   3,171.6   2,683.0   2,422.5   2,211.6   4,377.3   4,097.5   3,171.6   2,683.0   2,422.5 
Total costs and expenses  2,883.9   2,391.8   2,243.0   2,186.5   2,168.1   (3,081.9)  (2,883.9)  (2,391.8)  (2,243.0)  (2,186.5)
Income before income tax expense and cumulative effect of accounting change  1,148.9   910.6   492.2   256.2   64.1 
Income before cumulative effect of accounting change  783.2   638.2   213.7   160.7   25.1 
Other income (expense), net  37.3   (57.7)  72.4   58.9   20.2 
           
Income (loss) before income tax expense and cumulative effect of accounting change  1,332.7   1,155.9   852.2   498.9   256.2 
Income tax expense  (355.6)  (365.8)  (272.4)  (278.4)  (95.5)
Cumulative effect of accounting change, net of income tax        3.8                  3.8    
           
Net income  783.2   638.2   217.5   160.7   25.1   977.1   790.1   579.8   224.3   160.7 
Diluted earnings per share:                    
Net income (loss) attributable to noncontrolling interest, net of tax  6.9   6.9   (58.4)  6.8    
           
Net income attributable to Biogen Idec Inc.  $970.1  $783.2  $638.2  $217.5  $160.7 
           
Diluted earnings per share
                    
Income before cumulative effect of accounting change  2.65   1.99   0.62   0.47   0.07  $3.35  $2.65  $1.99  $0.62  $0.47 
Cumulative effect of accounting change, net of income tax        0.01                  0.01    
                      
Diluted earnings per share $2.65  $1.99  $0.63  $0.47  $0.07  $3.35  $2.65  $1.99  $0.63  $0.47 
                      
Shares used in calculating diluted earnings per share  295.0   320.2   345.3   346.2   343.5   289.5   295.0   320.2   345.3   346.2 
           
Financial Condition
                    
Cash, cash equivalents and marketable securities $2,262.8  $2,115.8  $2,314.9  $2,055.1  $2,167.6  $2,457.8  $2,262.8  $2,115.8  $2,314.9  $2,055.1 
Total assets  8,479.0   8,628.8   8,552.8   8,381.7   9,165.8  $8,551.9  $8,479.0  $8,628.8  $8,552.8  $8,381.7 
Notes payable, less current portion  1,085.4   51.8   96.7   43.4   101.9 
Shareholders’ equity  5,806.1   5,534.3   7,149.8   6,905.9   6,826.4 
Notes payable and line of credit, less current portion $1,080.2  $1,085.4  $51.8  $96.7  $43.4 
Total Biogen Idec Inc. shareholders’ equity $6,221.5  $5,806.1  $5,534.3  $7,149.8  $6,905.9 
 
 
(1)Included in costs and expenses in 2005 is a charge of $118.1 million related to facility impairment charges.
 
(2)Included in total costs and expenses in 2006 is a charge of $207.4 million for in-process research and development andfrom the acquisition of Fumapharm AG, a net gain of $6.1 million on the settlement of license agreements associated with Fumapharm AG or Fumapharm, and Fumedica GmbH or Fumedica and a charge of $123.1 million for in process research and development related to the acquisition of Conforma Therapeutics, Inc. or Conforma.


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(3)In connection with theUpon adoption of Statementa new accounting standard, which provided guidance for the accounting of Financial Accounting Standards No. 123 (revised 2004),Share-based Payments, or SFAS 123(R),our share-based compensation programs, we recorded the cumulative effect of an accounting change of $3.8 million, net, as of January 1, 2006.
 
(4)Included in total costs and expenses in 2007 is a charge of $18.4 million for in-process research and development related to the acquisition of Syntonix Pharmaceuticals Inc., or Syntonix, and $64.3 million related to our collaborations with Cardiokine Biopharma LLC and Neurimmune SubOne AG, which we consolidated under FASB Interpretation No. 46,in accordance with the guidance provided by theConsolidationTopic of Variable Interest Entities, or FIN 46(R).the Codification. The $64.3 million was offset by an equal amount of minoritynoncontrolling interest, resulting in no net impact to the results of our operations.


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(5)In July 2007, we purchased 56,424,155 shares of our common stock pursuant to a tender offer. We funded the transaction through existing cash and cash equivalents of $1,490.5 million and a short term loan of $1,500.0 million.
 
(6)Included in total cost and expenses in 2008 is $25.0 million for in process research and development related to a milestone payment made to the former shareholders of Conforma Therapeutics pursuant to the terms of our acquisition of Conforma Therapeutics in 2006.
(7)Total costs and expenses in 2009 includes the $110.0 million upfront payment made to Acorda Therapeutics, Inc. pursuant to our June 30, 2009 collaboration and license agreement to develop and commercialize products containing fampridine in markets outside the U.S.
(8)In 2009, we repurchased 16.0 million shares of our common stock at a cost of $751.2 million under our 2006 and 2009 share repurchase programs.
(9)Changes in tax law in certain state jurisdictions in which we operate and the resolution of multiple federal, state and foreign tax audits, including the effective settlement of several uncertain tax positions resulted in a $58.3 million reduction to our 2009 income tax expense.
 
Item 7.  Management’s Discussion and Analysis of Financial Condition and Results of Operations.Operations
Forward-Looking Information
In addition to historical information, this report contains forward-looking statements that are based on our current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such forward-looking statements. These forward-looking statements do not relate strictly to historical or current facts and they may be accompanied by such words as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “plan,” “project,” “target,” “may,” “will” and other words and terms of similar meaning. Reference is made in particular to forward-looking statements regarding the anticipated level of future product sales, royalty revenues, expenses, contractual obligations, regulatory submissions and approvals, clinical trial results, our long-term growth, the development and marketing of additional products, the impact of competitive products, the incidence or anticipated outcome of pending or anticipated litigation, patent-related proceedings, tax assessments and other legal proceedings, our effective tax rate for future periods, our ability to finance our operations and meet our manufacturing needs, the completion of our manufacturing facility in Hillerød, Denmark, liquidity, and our plans to spend additional capital on external business development and research opportunities. Risk factors which could cause actual results to differ from our expectations and which could negatively impact our financial condition and results of operations are discussed in the section entitled “Risk Factors” in Part II of this report and elsewhere in this report. Forward-looking statements, like all statements in this report, speak only as of the date of this report (unless another date is indicated). Unless required by law, we do not undertake any obligation to publicly update any forward-looking statements.
 
The following discussion should be read in conjunction with our consolidated financial statements and related notes appearing elsewhere in thisForm 10-K,beginning onpage F-1.F-1 of this report.
 
Executive Summary
 
Introduction
Biogen Idec Inc. was formed in 2003 upon the acquisition of Biogen, Inc. by IDEC Pharmaceuticals Corporation in a merger transaction, or the Merger. We areis a global biotechnology company that creates new standards of care in therapeutic areas ofwith high unmet medical needs. We have two licensed biological bulk-manufacturing facilities, including our large-scale manufacturing plantOur business strategy is focused on discovering and developingfirst-in-class orbest-in-class products that we can deliver to specialty markets globally. Patients around the world benefit from Biogen Idec’s significant products that address medical needs in Research Triangle Park, NC, which is onethe areas of the world’s largest cell culture facilities. An additional large-scale manufacturing plant is under construction in Hillerød, Denmark. We conduct research in San Diego, CAneurology, oncology and Cambridge, MA. In 2008, we entered into an agreement with a real estate developer for the construction and leasing of a corporate headquarters in Weston, MA. We anticipate occupancy in 2010. We have additional offices in Canada, Brazil, Argentina, Australia, New Zealand, Japan, China, India and throughout Europe, including our international headquarters in Zug, Switzerland and operate a global distribution network, which covers over 70 countries. We currently employ approximately 4,700 people worldwide.immunology.
 
Results for the year ended December 31, 2008 included total revenue of $4,097.5 million, net income of $783.2 million and diluted net income per share of $2.65. These results reflect continued growth in unit sales of TYSABRI, an increase in revenues from an unconsolidated joint business arrangement due to increased sales of RITUXAN, as well as the impact of price increases in the United States and the favorable impact of exchange rates in rest of world on our AVONEX product. The effect of the increase in revenue was partially offset by an increase in research and development expense due to increased level of Phase 3 clinical trials and other projects, and an increase in selling, general and administrative expense related to a higher level of personnel to sustain AVONEX sales and drive TYSABRI growth. In the fourth quarter of 2008, we completed a reorganization of our domestic and


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international operations, which included the movement of certain personnel and operational functions between Biogen Idec subsidiaries, as well as a restructuring of our supply chain.
Marketed Products
We currently have four marketed products:
• AVONEX® (interferon beta-1a);
• RITUXAN® (rituximab);
• TYSABRI® (natalizumab);
• FUMADERM® (dimethylfumarate and monoethylfumarate salts)
Through December 2007 we recorded product revenue from sales of ZEVALIN (ibritumomab tiuxetan) in the U.S. In December 2007, we sold the U.S. marketing, sales, manufacturing and development rights of ZEVALIN to Cell Therapeutics, Inc., or CTI, for an upfront purchase price of $10.0 million. In December 2008, pursuant to an amendment of the agreement, we received an additional $2.2 million milestone payment. We may receive up to an additional $20.0 million in milestone payments. In addition, we will receive royalty payments on future sales of ZEVALIN. As part of the overall agreement, we entered into a supply agreement with CTI to sell ZEVALIN product through 2014. Our sales of ZEVALIN to Bayer Schering Pharma AG, or Schering AG, for distribution in the EU will be recognized as product revenue and our supply of ZEVALIN to CTI is recognized as corporate partner revenue. We will continue to receive royalty revenues from Schering AG on their sales of ZEVALIN in the EU. The $10.0 million upfront and $2.2 million milestone payment have been deferred and are being recognized in our results of operations over the term of the supply agreement.
Through April 2006, we recorded product revenues from sales of AMEVIVE (alefacept). In April 2006, we sold the worldwide rights to this product to Astellas Pharma US, Inc., or Astellas. We will continue to manufacture and supply this product to Astellas for a period of up to 11 years. Under the terms of the supply agreement, we charge Astellas fixed amounts based on volume. Such amounts will be recognized as corporate partner revenue and are not significant.
Most of our revenues are currently dependent on sales of AVONEX, RITUXAN and TYSABRI. In the near term, we are dependent on the continued sales growth of AVONEX, RITUXAN and TYSABRI to growdrive our overall revenues.revenue growth. In the longer term, our revenue growth is also dependent on the successful clinical development, regulatory approval and launch of new commercial products currently being developed in our pipeline or products or programs that will be in-licensed or acquired.products.
 
Continued growthAs part of global AVONEX unit sales is primarily dependent on maintaining AVONEX’s position as the most prescribed multiple sclerosis, or MS, therapy in the world. In both the U.S.our ongoing research and rest of world, we face increasing competition in the MS market from currently marketed products and future products in late stage development as well as increasing pricing pressure. We continue to generate data showing AVONEX to be an effective and safe choice for MS patients and physicians.
The majority of RITUXAN unit sales are currently from use in the oncology setting. We believe there is additional room for RITUXAN unit sales growth in the immunology setting, where RITUXAN is currently approved for patients with Rheumatoid Arthritis, or RA, with inadequate response to anti-tumor necrosis factor therapies, or TNF-IR. Additional immunology indications for RITUXAN that we are investigating include earlier stage RA patients with inadequate response to disease-modifying anti-rheumatic drugs, or DMARD-IR patients, DMARD-naïve RA patients and lupus nephritis and ANCA-associated vaculitis.
In July 2006, we reintroduced TYSABRI in the U.S. and began to ship internationally for the first time. TYSABRI sales are currently for use in relapsing remitting MS and, following the FDA’s approval in January 2008, Crohn’s disease. Growth in TYSABRI revenue will be dependent on the generation of a larger and longer term safety database, as well as continued acceptance by physicians and MS patients. Since the reintroduction of TYSABRI in the U.S. and the introduction of TYSABRI in the rest of world, we have disclosed five cases of progressive multifocal leukoencephalopathy, or PML, a known side effect, in patients taking TYSABRI in the post


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marketing setting. These patients were the only confirmed cases of PML reported to us during this period. We continue to monitor the growth of TYSABRI unit sales in light of this news and we continue to develop protocols to potentially mitigate the risk and outcome of PML in patients being treated with TYSABRI.
Clinical Studies
Over the past few years,efforts, we have incurred significant expenditures related to conducting clinical studies to develop new pharmaceutical products and explore the utility of our existing products in treating disorders beyond those currently approved in their labels. For 2009, we expect toWe continue to incur significant levels offocus our research and development expenditures. We haveefforts within our core and emergent areas of neurology, oncology, immunology, cardiopulmonary and hemophilia.


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Financial Highlights
The following table is a numbersummary of pipeline products in late stage clinical trials, including over 13 pipeline products in Phase 2 or Phase 3 clinical trials. We are currently developingfinancial results achieved:
                 
        % Change    
  For the Years Ended
  2009
    
  December 31,  Compared
    
(In millions, except per share amounts and percentages) 2009  2008  to 2008    
 
Total revenues $4,377.3  $4,097.5   6.8%    
Income from operations $1,295.4  $1,213.6   6.7%    
Net income attributable to Biogen Idec Inc.  $970.1  $783.2   23.9%    
Diluted earnings per share attributable to Biogen Idec Inc.  $3.35  $2.65   26.4%    
As described below under Results of Operations, our operating results for the late stage product candidates that are set forth below.year ended December 31, 2009, were primarily driven by:
 
  Increased AVONEX worldwide revenue.  Total AVONEX revenues were $2,322.9 million in 2009, representing a 5.5% increase over 2008.
 
  Development and/or
Marketing
Product
Product IndicationsStatusCollaboratorsContinued TYSABRI growth.  Global in-market net sales of TYSABRI totaled $1,059.2 million in 2009. Our share of TYSABRI revenues totaled $776.0 million in 2009, representing an increase of 31.8% over 2008.
 
BG-12
 Relapsing MSU.S. in market net sales of RITUXAN totaled $2,665.5 million in 2009, representing an increase of 3.0% over 2008. Our share of RITUXAN revenues totaled $1,094.9 million in 2009, which is inclusive of our share of co-promotion profits in the U.S. totaling $773.6 million, representing an increase of 5.5% over 2008. This increase was offset by a $79.3 million decrease in our share of revenue on sales of RITUXAN in the rest of world.
 Phase 3None
  
Anti-CD80 MAb (galiximab)Relapsed NHLPhase 3None
Anti-CD23 MAb (lumiliximab)Relapsed CLLPhase 2/3None
Humanized Anti-CD20 MAb (ocrelizumab)RAPhase 3U.S. — Genentech Japan — ChugaiTotal costs and Zenyaku
Outside U.S.expenses increased 6.9% as compared to 2008. This increase was driven by a 19.7% increase in research and Japan — Roche
Lupus nephritisPhase 3See above
Lixivaptan
Hyponatremia, commonly seendevelopment spending and a 58.8% increase in acute decompensated heart failurePhase 3Cardiokine Biopharma LLC
ADENTRI®
Acute decompensated heart failure with renal insufficiencyPhase 3Nonecollaboration profit sharing expense due to TYSABRI growth. These increases were offset by a 5.0% decrease in costs of sales, a reduction in selling, general and administrative expense of 1.5%, and a decrease in amortization of acquired intangible assets of 12.9%.
 
In addition to the expense associated with these late stage trials, other pipeline products arestrong operating results achieved, we generated $1,074.9 million of net cash flows from operations during 2009, which were primarily driven by increases in ongoing or are expected to enter proofour earnings.
Cash and cash equivalents and marketable securities totaled approximately $2,457.8 million as of concept trials inDecember 31, 2009.
 
Business DevelopmentHighlights
 
As part of our business strategy, we have made acquisitions of other businesses, products, product rights or technologies and may continue to make acquisitions in the future. Our cash reserves and other liquid assets are substantial, but these sources of capital may be inadequate to consummate larger acquisitions and it may be necessary for us to raise substantial additional funds in the future to complete transactions. Due to the recent tightening of global credit and the disruption in the financial markets, it may be more difficult to secure such additional financing. In addition, as a result of our acquisition efforts, we may experience significant charges to earnings for merger and related expenses that may include transaction costs, closure costs or acquired in-process research and development charges.
• In October 2009, our Board of Directors authorized the repurchase of up to $1.0 billion of our common stock, with repurchased shares being retired. During 2009, approximately 16.0 million shares at a cost of $751.2 million were repurchased under this and our 2006 share repurchase programs.
• In June 2009, we entered into a collaboration and license agreement with Acorda Therapeutics, Inc. (Acorda) to develop and commercialize products containing fampridine in markets outside the U.S. In July 2009, we made a $110.0 million upfront payment pursuant to this agreement.


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Results of Operations
 
Revenues
 
Revenues wereare summarized as follows (in millions):follows:
 
                                            
 Year Ended December 31,        % Change 
 2008 2007 2006        2009
 2008
 
 For the Years Ended December 31, Compared
 Compared
 
Product Sales                        
(In millions, except percentages) 2009 2008 2007 to 2008 to 2007 
Product:                    
United States $1,472.9   35.9% $1,203.6   37.9% $1,069.5   40.0% $1,638.0  $1,472.9  $1,203.6   11.2%  22.4%
Rest of world  1,366.8   33.4%  933.2   29.5%  711.8   26.5%  1,514.9   1,366.8   933.2   10.8%  46.5%
                        
Total product revenues  2,839.7   69.3%  2,136.8   67.4%  1,781.3   66.5%  3,152.9   2,839.7   2,136.8   11.0%  32.9%
Unconsolidated Joint Business  1,128.2   27.5%  926.1   29.2%  810.9   30.2%
Other Revenues  129.6   3.2%  108.7   3.4%  90.8   3.3%
Unconsolidated joint business  1,094.9   1,128.2   926.1   (3.0)%  21.8%
Other  129.5   129.6   108.7   (0.1)%  19.2%
                        
Total revenues $4,097.5   100.0% $3,171.6   100.0% $2,683.0   100.0% $4,377.3  $4,097.5  $3,171.6   6.8%  29.2%
                        
 
Product Revenues
 
Product revenues wereare summarized as follows (in millions):follows:
 
                         
  Year Ended December 31, 
  2008  2007  2006 
 
AVONEX $2,202.6   77.6% $1,867.8   87.4% $1,706.7   95.9%
TYSABRI  588.6   20.7%  229.9   10.8%  35.8   2.0%
FUMADERM  43.4   1.5%  21.5   1.0%  9.5   0.5%
ZEVALIN  4.8   0.2%  16.9   0.8%  17.8   1.0%
AMEVIVE  0.3   %  0.7      11.5   0.6%
                         
Total product revenues $2,839.7   100.0% $2,136.8   100.0% $1,781.3   100.0%
                         
Cost of Sales
Cost of sales includes the following (in millions):
                         
  Year Ended December 31, 
  2008  2007  2006 
 
Cost of product revenues $397.0   98.8% $330.5   98.6% $270.0   98.4%
Cost of royalty revenues  5.0   1.2%  4.7   1.4%  4.4   1.6%
                         
Cost of sales $402.0   100.0% $335.2   100.0% $274.4   100.0%
                         
During the years ended December 31, 2008, 2007, and 2006, we wrote down approximately $29.8 million, $21.6 million, and $13.0 million, respectively, of inventory which was charged to cost of sales.


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Cost of Product Revenues
Cost of product revenues, included in cost of sales, by product are as follows (in millions):
                         
  Year Ended December 31, 
  2008  2007  2006 
 
AVONEX $272.0   68.5% $258.3   78.2% $234.7   86.9%
TYSABRI  68.5   17.3%  10.4   3.1%  5.3   2.0%
FUMADERM  3.9   1.0%  1.6   0.5%  3.1   1.2%
ZEVALIN  5.6   1.4%  14.0   4.2%  16.2   6.0%
AMEVIVE  8.0   2.0%  3.1   0.9%  10.0   3.7%
Other  39.0   9.8%  43.1   13.1%  0.7   0.2%
                         
Cost of product revenues $397.0   100.0% $330.5   100.0% $270.0   100.0%
                         
                     
           % Change 
           2009
  2008
 
  For the Years Ended December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
AVONEX $2,322.9  $2,202.6  $1,867.8   5.5%  17.9%
TYSABRI  776.0   588.6   229.9   31.8%  156.0%
Other  54.0   48.5   39.1   11.3%  24.0%
                     
Total product revenues $3,152.9  $2,839.7  $2,136.8   11.0%  32.9%
                     
 
AVONEX
 
Revenues from AVONEX wereare summarized as follows (in millions):follows:
 
                                            
 Year Ended December 31,        % Change 
 2008 2007 2006        2009
 2008
 
 For the Years Ended December 31, Compared
 Compared
 
AVONEX                        
U.S.  $1,276.5   58.0% $1,085.0   58.1% $1,022.2   59.9%
(In millions, except percentages) 2009 2008 2007 to 2008 to 2007 
United States $1,406.2  $1,276.5  $1,085.0   10.2%  17.6%
Rest of world  926.1   42.0%  782.8   41.9%  684.5   40.1%  916.7   926.1   782.8   (1.0)%  18.3%
                        
Total AVONEX revenues $2,202.6   100.0% $1,867.8   100.0% $1,706.7   100.0% $2,322.9  $2,202.6  $1,867.8   5.5%  17.9%
                        
 
For 2009 compared to 2008, as well as for 2008 compared to 2007, the increase in U.S. sales of AVONEX increased $191.5 million, or 17.6%,revenue was due to price increases, partially offset by decreased patient demand. Decreased commercial demand resulted in a 7.6% and a 6.0% decline in U.S. AVONEX sales volume in 2009 and 2008, respectively, over their prior year comparative periods. In addition, during 2009, we experienced higher participation in our Access Program, which provides free product demand.to eligible patients.
For 2009 compared to 2008, the decrease in rest of world AVONEX revenue was primarily due to the negative impact of foreign exchange rate changes resulting from the strengthening of the U.S. dollar against relevant foreign currencies, primarily the Euro, offset by increased patient demand and price increases in some countries. For 2008 compared to 2007, rest of world sales of AVONEX increased $143.3 million, or 18.3%, due to increased unit shipments,patient demand, the impact of foreign exchange ratesrate changes and the establishment of additional direct market affiliates. Increased commercial demand


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For 2007 compared to 2006, U.S. salesresulted in increases of AVONEX increased $62.8 million, or 6.1%, primarily due to the impact of price increases. These increases were offset by lower demand. For 2007 compared to 2006,6.3% and 8.6% in rest of world AVONEX sales volume in 2009 and 2008, respectively, over their prior year comparative periods.
AVONEX rest of world revenues for 2009, 2008 and 2007 also include losses of $39.5 million, $8.5 million and $13.1 million, respectively, recognized in relation to the settlement of certain cash flow hedge instruments.
Continued growth of AVONEX increased $98.3 million, or 14.4%,revenue is primarily due todependent on maintaining AVONEX’s position as one of the impact of exchange rates and higher sales volume.
most prescribed MS therapies in the world. We expect to face increasing competition in the MS marketplace in both the U.S. and rest of world from existing and new MS treatments, including oral and other alternative formulations developed by our competitors, the continued growth of TYSABRI and the commercialization of our other pipeline products,product candidates, which may have a continued negative impact toon the unit sales of AVONEX.AVONEX as well as increasing price pressure. We expect future unit sales ofcontinue to generate data showing AVONEX to be dependent to a large extent on our ability to compete successfully with the products of our competitors.an effective and safe choice for MS patients and physicians.
 
TYSABRI
 
Revenues from TYSABRI were as follows (in millions):
                         
  Year Ended December 31, 
  2008  2007  2006 
 
TYSABRI                        
U.S.  $196.4   33.4% $104.4   45.4% $25.8   72.1%
Rest of world  392.2   66.6%  125.5   54.6%  10.0   27.9%
                         
Total TYSABRI revenues $588.6   100.0% $229.9   100.0% $35.8   100.0%
                         
Under the terms of a collaboration agreement with Elan, we manufacture TYSABRI andWe collaborate with Elan Pharma International, Ltd (Elan) an affiliate of Elan Corporation, plc, on the product’s marketing, commercial distributiondevelopment and on-going development activities.commercialization of TYSABRI. Please read Note 17,Collaborationsto our Consolidated Financial Statements for a description of this collaboration.
In the U.S., we sell TYSABRI to Elan who sells the product to third party distributors. Our sales price to Elan in the U.S. is set prior to the beginning of each quarterly period to effect an approximate equal sharing of the gross margin on sales in the U.S. between Elan and us. We recognize revenue


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for sales of TYSABRI in the U.S. upon Elan’s shipment of the product to the third party distributors. In the rest of world markets, we are responsible for distributing TYSABRI to customers and are primarily responsible for all operating activities. We recognize revenue for sales of TYSABRI in the rest of world at the time of product delivery to our customers and distributors.customers.
 
SinceRevenues from TYSABRI include (1) our share of net U.S. sales of TYSABRI from Elan to third-party customers; (2) revenue on sales of TYSABRI in rest of world markets; (3) amortization of deferred revenue amounts related to Elan milestone payments made to us; and (4) gains or losses recognized in relation to the reintroductionsettlement of foreign currency forward contracts that were entered into to hedge forecasted revenues.
Revenues from TYSABRI are summarized as follows:
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
United States $231.8  $196.4  $104.4   18.0%  88.1%
Rest of world  544.2   392.2   125.5   38.8%  212.5%
                     
Total TYSABRI revenues $776.0  $588.6  $229.9   31.8%  156.0%
                     
For 2009 compared to 2008, as well as for 2008 compared to 2007, the increase in U.S. TYSABRI revenue was due to the continued increase in the number of patients using TYSABRI in the U.S. Increased commercial demand resulted in increases of 16.3% and the introduction88.7% in U.S. TYSABRI sales volume for 2009 and 2008, respectively, over their prior year comparative periods. Net sales of TYSABRI from our collaboration partner, Elan, to third-party customers in the U.S. for each of the years ended December 31, 2009, 2008 and 2007 totaled $508.5 million,  $421.6 million and $217.4 million, respectively.
For 2009 compared to 2008, as well as for 2008 compared to 2007, the increase in rest of world TYSABRI revenue was due to the continued increase in the number of patients using TYSABRI in our rest of world markets. Increased commercial demand resulted in increases of 49.0% and 203.8% in U.S. TYSABRI sales volume for 2009 and 2008, respectively, over their prior year comparative periods. The increase in TYSABRI revenues in 2009 was offset by the negative impact of foreign currency exchange rate changes resulting from the strengthening of the U.S. dollar against foreign currencies, primarily the Euro.


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TYSABRI rest of world revenues for 2009 also include losses of $10.1 million recognized in relation to the settlement of certain cash flow hedge instruments; no such losses were recognized in 2008 or 2007 as we did not designate hedges against TYSABRI rest of world revenues in those periods.
In 2009 and 2008, we recognized $7.1 million and $1.5 million respectively of product revenue related to the amortization of the Elan milestone payments.
Since we reintroduced TYSABRI to the market in July 2006, we have disclosed five cases of PML, a known side effect, insome patients taking TYSABRI have been diagnosed with PML, a rare but serious brain infection described in the post marketing setting. These patients wereTYSABRI label. In November 2009, the only confirmed casesU.S. prescribing information for TYSABRI was revised to reflect that the risk of PML reportedincreases with longer treatment duration, and for patients treated for 24 to us during this period. 36 months is generally similar to the rates seen in clinical trials. The revised label also reflects that there is limited experience beyond three years of treatment. In January 2010, the EMA recommended updating the TYSABRI label in the E.U. to reflect that the risk of PML increases after two years of therapy. The EMA also recommended that patients have regular MRI scans and be reinformed of the risk of PML after two years of therapy.
We continue to monitor the growth of TYSABRI unit sales, in light of these results and wewhich may be further impacted by the updated prescribing information. We continue to research and develop protocols to potentially mitigate thethat may reduce risk and outcomeimprove outcomes of PML in patients being treated with TYSABRI. We are working to identify patient or viral characteristics which contribute to the risk of developing PML, including the presence of asymptomatic JC virus infection with a serological assay for antibodies against the JC virus. Our efforts to improve management by physicians of PML and to improve patient outcomes have included researching plasma exchange to more rapidly remove TYSABRI from a patient, and drug screening that identified mefloquine as an anti-JC virus drug candidate.
 
For 2008Other Product Revenues
Other product revenues represent revenues derived from FUMADERM, ZEVALIN and 2007,AMEVIVE and are summarized as follows:
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 
2009
  2008  2007  to 2008  to 2007 
 
FUMADERM $49.6  $43.4  $21.5   14.3%  101.9%
ZEVALIN $4.4  $4.8  $16.9   (8.3)%  (71.6)%
AMEVIVE $  $0.3  $0.7   (100.0)%  (57.1)%
                     
Total other product revenues $54.0  $48.5  $39.1   11.3%  24.0%
                     
Unconsolidated Joint Business Revenues
We collaborate with Genentech on the development and commercialization of RITUXAN. Please read Note 17,Collaborationsto our Consolidated Financial Statements for a description of this collaboration.
The majority of RITUXAN unit sales are for use in oncology as a treatment for certain types of B-cell NHL. We believe there is opportunity for RITUXAN unit sales growth in the immunology setting, where RITUXAN is used as a treatment for certain types of RA. Additional immunology indications for RITUXAN that we recordedare investigating include ANCA-associated vasculitis.
Revenues from unconsolidated joint business consist of (1) our share of pretax co-promotion profits in the U.S.; (2) reimbursement of our selling and development expense in the U.S.; and (3) revenue on sales of TYSABRIRITUXAN in the rest of $588.6 millionworld, which consist of our share of pretax co-promotion profits in Canada and $229.9 million, respectively. royalty revenue on sales of RITUXAN outside the U.S. and Canada by F. Hoffmann-La Roche Ltd. (Roche) and its sublicensees. Pre-tax co-promotion profits are calculated and paid to us by Genentech in the U.S. and by Roche in Canada. Pre-tax co-promotion profits consist of U.S. and Canadian sales of RITUXAN to third-party customers net of discounts and allowances less the cost to manufacture RITUXAN, third-party royalty expenses, distribution, selling and marketing, and joint development expenses incurred by Genentech, Roche and us.


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The following table provides a summary of revenues from unconsolidated joint business:
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
Biogen Idec’s share of co-promotion profits in the U.S.  $773.6  $733.5  $616.8   5.5%  18.9%
Reimbursement of selling and development expenses in the U.S.   65.6   59.7   58.5   9.9%  2.1%
Revenue on sales of RITUXAN in the rest of world   255.7   335.0   250.8   (23.7)%  33.6%
                     
Total unconsolidated joint business revenues $1,094.9  $1,128.2  $926.1   (3.0)%  21.8%
                     
Biogen Idec’s Share of Co-Promotion Profits in the U.S.
The following table provides a summary of amounts comprising our share of co-promotion profits in the U.S.:
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
Product revenues, net $2,665.5  $2,587.4  $2,284.8   3.0%  13.2%
Costs and expenses  724.1   741.0   730.2   (2.3)%  1.5%
                     
Co-promotion profits in the United States $1,941.4  $1,846.4  $1,554.6   5.1%  18.8%
                     
Biogen Idec Inc.’s share of co-promotion profits in the United States $773.6  $733.5  $616.8   5.5%  18.9%
                     
For 2009 compared to 2008, the increase in 2008U.S. RITUXAN product revenue on sales asrecorded by Genentech resulted from continued growth for treatment of B-cell NHL and RA, and price increases. For 2008 compared to 2007 sales isthe increase in U.S. RITUXAN product revenue was primarily due to increased unit shipments due to the growthsales in the numbertreatments of patients using TYSABRI.
For 2007B-cell NHL, CLL (an unapproved and 2006, we have recorded revenue on salesunpromoted use of TYSABRI of $229.9 millionRITUXAN) and $35.8 million, respectively. The increase in 2007 salesRA, and price increases. Collaboration costs and expenses for 2009 as compared to 2006 sales is2008 decreased primarily due to increased unit shipments due to the growthhigher costs incurred in the numberdevelopment of patients using TYSABRI and due to the product being shippedRITUXAN for the entire 12 monthsuse in other indications during 2007 versus being shipped for only six months in 2006.2008.
 
During 2007 and 2006, we had product on hand that had been fully written-off in 2005 due to the uncertainties surrounding the TYSABRI suspension but which was available to fill future orders. As we sold TYSABRI in 2007 and 2006, we realized lower than normal cost of sales and, therefore, higher margins, as we shipped the inventory that had been previously written-off. For 2007 and 2006, cost of sales was approximately $12.6 million and $2.6 million, respectively, lower due to the sale of TYSABRI that had been previously written-off. All TYSABRI inventory that had been previously written-off had been shipped by December 31, 2007.
During the year ended December 31, 2008, pursuant toUnder our collaboration agreement, our current pretax co-promotion profit-sharing formula, which resets annually, provides for a 30% share of co-promotion profits on the first $50.0 million of co-promotion operating profit with Elan, Elan paid us a $75.0 million milestone payment in orderour share increasing to maintain40% if co-promotion operating profits exceed $50.0 million. In 2009, 2008, and 2007, the current collaboration profit sharing split. We recorded this amount as deferred revenue upon receipt and are recognizing this $75.0 million as product revenue in our consolidated statement of income over40% threshold was met during the term offirst quarter.
In addition, under our collaboration agreement, we have rights to collaborate with Elan based on a units of revenue method whereby the revenue recognized is basedGenentech on the ratiodevelopment and commercialization of units shipped in(1) anti-CD20 products that Genentech acquires or develops, which we refer to as New Anti-CD20 Products, and (2) anti-CD20 products that Genentech licenses from a third party, which we refer to as Third Party Anti-CD20 Products. Our collaboration rights for New Anti-CD20 Products are limited to the current period overU.S. and our collaboration rights for Third Party Anti-CD20 Products are dependent upon Genentech’s underlying license rights. There is only one New Anti-CD20 Product, ocrelizumab, and only one Third Party Anti-CD20 Product, GA101.
Our agreement with Genentech also provides that the total units expected to be shipped oversuccessful development and commercialization of the remaining termfirst New Anti-CD20 Product will decrease our percentage of co-promotion profits of the collaboration. We recognized $1.5 million of this milestone as revenuePlease read Note 17,Collaborationsto our Consolidated Financial Statements for additional information regarding the year ended December 31, 2008. Based on the TYSABRI sales levels achieved through the fourth quarter of 2008, in January 2009, Elan paid us an additional milestone payment of $50.0 million in order to maintain the current collaborationpretax co-promotion profit sharing split. Revenue from this milestone payment will also be deferredformula for RITUXAN and recognized on a units of revenue model.
FUMADERM
In connection with our June 2006 acquisition of Fumapharm, we began recognizing revenue on sales of FUMADERM to our distributor, Fumedica, in July 2006. In December 2006, we acquiredNew Anti-CD20 Products sold by us and Genentech following the right to distribute FUMADERM in Germany from Fumedica effective May 1, 2007. In connection with the acquisitionapproval date of the FUMADERM distribution rightsfirst New Anti-CD20 Product. We will participate in Germany, we committed to the repurchase of any inventory Fumedica did not sell by May 1, 2007. As a result of this provision, we deferred the recognition of revenueThird Party Anti-CD20 Products on shipments made to Fumedica through April 30, 2007. We resumed recognizing revenue on sales of FUMADERM into the German market in May 2007. Sales of FUMADERMsimilar financial terms as for 2008, 2007, and 2006 were $43.4 million, $21.5 million, and $9.5 million, respectively. These increases in sales were primarily due to increased volumes.
ZEVALIN
In 2008, 2007, and 2006 sales of ZEVALIN were $4.8 million, $16.9 million, and $17.8 million, respectively. The decrease in total ZEVALIN sales in 2008 as compared to 2007 is primarily due to the sale of the rights to market, sell, manufacture, and develop ZEVALIN in the U.S. to CTI during the fourth quarter of 2007. Beginning in 2008, ZEVALIN product revenue consists only of ZEVALIN sales to Schering AG.ocrelizumab.


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AMEVIVEReimbursement of Selling and Development Expense in the U.S.
 
InAs discussed within Note 17,Collaborationsto our Consolidated Financial Statements, Genentech incurs the majority of continuing development costs for RITUXAN. Expenses incurred by Genentech in the development of RITUXAN are not recorded as research and development expense, but rather reduce our share of co-promotion profits recorded as a component of unconsolidated joint business revenue.
Selling and development expenses, incurred by us in the U.S. and reimbursed by Genentech, increased in 2009 as compared 2008 due to an increase in sales and marketing expense associated with CLL and legal fees.
The increase in selling and development expenses in 2008 compared to 2007 was primarily due to development costs we incurred related to the development of RITUXAN in RA.
Revenue on Sales of RITUXAN in the Rest of World
We record our royalty revenue and 2006,co-promotion profit revenue on sales of AMEVIVE were $0.3 million, $0.7 million, and $11.5 million, respectively. The decreaseRITUXAN in total AMEVIVEthe rest of world on a cash basis. Revenues on sales isof RITUXAN in the rest of world decreased in 2009 compared to 2008 primarily due to royalty expirations in certain of these markets and the negative impact of foreign exchange rate changes.
Revenues on sales of RITUXAN in the rest of world increased in 2008 compared to 2007 due to several factors, including increased market penetration in NHL and increased use in RA.
The royalty period for sales in the rest of world with respect to all products is 11 years from the first commercial sale of such product on acountry-by-country basis. For the majority of European countries, the first commercial sale of RITUXAN occurred in April 2006,the second half of our worldwide rights and infrastructure related1998. Specifically, the royalty periods with respect to sales production,in France, Spain, Germany and marketingthe United Kingdom expired in 2009. The royalty period with respect to sales in Italy will expire in 2010. The royalty periods with respect to sales in other countries will subsequently expire through 2012. As a result of AMEVIVEthese expirations, we expect royalty revenues derived from sales of RITUXAN in the rest of world to Astellas.continue to decline in future years.
 
Although weOther Revenues
Our product line previously included ZEVALIN (ibritumomab tiuxetan) which is part of a treatment regimen for certain B-cell NHL, and AMEVIVE (alefacept), a treatment for certain moderate to severe psoriasis. We have sold or exclusively licensed the rights to this product, wethese products to third parties and continue to reportreceive supply agreement revenues based on those products which are included in corporate partner revenues. We also receive royalties on sales by our licensees of a small amountnumber of other products under patents that we own.
Other revenues are summarized as follows:
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
Royalty revenues $124.4  $116.2  $102.1   7.1%  13.8%
Corporate partner revenues  5.1   13.4   6.6   (61.9)%  103.0%
                     
Other revenues $129.5  $129.6  $108.7   (0.1)%  19.2%
                     
Royalty Revenues
We receive royalties on sales by our licensees of products covered under patents that we own. Sales of licensed products could vary significantly due to competition, manufacturing difficulties and other factors that are not within our control. In addition, the expiration or invalidation of any underlying patents could reduce or eliminate the royalty revenues derived from such patents.
The increase in royalty revenues in 2009 as compared to 2008, as well as in 2008 as compared to 2007, was primarily due to increased sales of ANGIOMAX (bivalirudin) licensed to The Medicines Company (TMC) offset by a decline in royalties from sales of other licensed product and the expiration of certain contracts and license agreements.


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Our most significant source of royalty revenue is derived from sales of ANGIOMAX by TMC. TMC sells ANGIOMAX in the U.S., Europe, Canada, and Latin America for use as an anticoagulant in combination with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty. Royalty revenues related to shipments madethe sales of ANGIOMAX are recognized in an amount equal to the level of net sales achieved during a calendar year multiplied by certainthe royalty rate in effect for that tier under our agreement with TMC. The royalty rate increases based upon which tier of total net sales are earned in any calendar year. The increased royalty rate is applied retroactively to the first dollar of net sales achieved during the year. This formula has the effect of increasing the amount of royalty revenue to be recognized in later quarters. Accordingly, an adjustment is recorded in the period in which an increase in royalty rate has been achieved.
Under the terms of our overseas joint ventures,agreement, TMC is obligated to pay us royalties earned, on acountry-by-country basis, until the later of (1) twelve years from the date of the first commercial sale of ANGIOMAX in such country and (2) the date upon which the product is no longer covered by a patent in such country. The annual royalty rate is reduced by a specified percentage in any country where the product is no longer covered by a patent and where sales have been reduced to a certain volume-based market share. TMC began selling ANGIOMAX in the U.S. in January 2001. The principal U.S. patent that covers ANGIOMAX expires in March 2010. The FDA has granted TMC an additional period of marketing exclusivity for ANGIOMAX in order to investigate its use in pediatric patients. This period expires in September 2010. In the event that third parties sell products comparable to ANGIOMAX after the period of marketing exclusivity expires, we consolidate.would expect a significant decrease in royalty revenues due to lower royalty rates and increased competition.
 
ProvisionsUnconsolidated Joint Business Revenues
We collaborate with Genentech on the development and commercialization of RITUXAN. Please read Note 17,Collaborationsto our Consolidated Financial Statements for Discounts and Allowancesa description of this collaboration.
The majority of RITUXAN unit sales are for use in oncology as a treatment for certain types of B-cell NHL. We believe there is opportunity for RITUXAN unit sales growth in the immunology setting, where RITUXAN is used as a treatment for certain types of RA. Additional immunology indications for RITUXAN that we are investigating include ANCA-associated vasculitis.
 
Revenues from productunconsolidated joint business consist of (1) our share of pretax co-promotion profits in the U.S.; (2) reimbursement of our selling and development expense in the U.S.; and (3) revenue on sales of RITUXAN in the rest of world, which consist of our share of pretax co-promotion profits in Canada and royalty revenue on sales of RITUXAN outside the U.S. and Canada by F. Hoffmann-La Roche Ltd. (Roche) and its sublicensees. Pre-tax co-promotion profits are recognized when allcalculated and paid to us by Genentech in the U.S. and by Roche in Canada. Pre-tax co-promotion profits consist of the following criteria are met: persuasive evidenceU.S. and Canadian sales of an arrangement exists; delivery has occurred or services have been rendered; the seller’s priceRITUXAN to the buyer is fixed or determinable; and collectibility is reasonably assured. Revenues are recordedthird-party customers net of applicable allowances for trade term discounts, wholesaler incentives, Medicaid rebates, Veteran’s Administration, or VA, rebates, managed care rebates, product returns, other applicable allowances and, in 2006, patient assistance and patient replacement goods. The estimates we make with respect to these allowances represent significant judgments.
Effective January 1, 2007, we changed the manner in which we administer our patient assistance and patient replacement goods programs. Prior to January 1, 2007, AVONEX product shipped for these programs was invoiced and recorded as gross product revenue and an offsetting provision for discount and returns was recorded for expected credit requests from the distributor that administers these programs on our behalf (as such, no net revenue was recorded for these shipments). Effective January 1, 2007, we entered into a new arrangement with a distributor. Under the new sales model, gross revenue is not recorded for product shipped to satisfy these programs, and cost of sales is recorded when the product is shipped.
Provisions for discounts and allowances reduced gross product revenues as follows (in millions):
             
  Year Ended December 31, 
  2008  2007  2006 
 
Discounts $67.1  $45.7  $102.9 
Contractual adjustments  149.0   105.2   93.3 
Returns  12.2   22.1   38.7 
             
Total allowances $228.3  $173.0  $234.9 
             
Gross product revenues $3,068.0  $2,309.8  $2,016.2 
             
Percent of gross product revenues  7.4%  7.5%  11.7%
             
less the cost to manufacture RITUXAN, third-party royalty expenses, distribution, selling and marketing, and joint development expenses incurred by Genentech, Roche and us.


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An analysisThe following table provides a summary of the amount of, and change in, reserves is as follows (in millions):revenues from unconsolidated joint business:
 
                 
     Contractual
       
  Discounts  Adjustments  Returns  Total 
 
2008
                
Beginning Balance $6.4  $33.1  $20.4  $59.9 
Current provisions relating to sales in current year  67.1   150.6   14.7   232.4 
Adjustments relating to prior years     (1.6)  (2.5)  (4.1)
Payments/returns relating to sales in current year  (57.8)  (101.2)  (0.1)  (159.1)
Payments/returns relating to sales in prior years  (6.5)  (32.8)  (14.4)  (53.7)
                 
Ending Balance $9.2  $48.1  $18.1  $75.4 
                 
2007
                
Beginning Balance $12.7  $30.5  $17.8  $61.0 
Current provisions relating to sales in current year  45.7   113.1   17.1   175.9 
Adjustments relating to prior years     (7.9)  5.0   (2.9)
Payments/returns relating to sales in current year  (39.4)  (72.3)  (0.4)  (112.1)
Payments/returns relating to sales in prior years  (12.6)  (30.3)  (19.1)  (62.0)
                 
Ending Balance $6.4  $33.1  $20.4  $59.9 
                 
2006
                
Beginning Balance $11.6  $35.7  $2.3  $49.6 
Current provisions relating to sales in current year  102.9   96.4   31.6   230.9 
Adjustments relating to prior years     (3.1)  7.1   4.0 
Payments/returns relating to sales in current year  (90.2)  (63.1)  (16.1)  (169.4)
Payments/returns relating to sales in prior years  (11.6)  (35.4)  (12.5)  (59.5)
Other adjustments        5.4   5.4 
                 
Ending Balance $12.7  $30.5  $17.8  $61.0 
                 
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
Biogen Idec’s share of co-promotion profits in the U.S.  $773.6  $733.5  $616.8   5.5%  18.9%
Reimbursement of selling and development expenses in the U.S.   65.6   59.7   58.5   9.9%  2.1%
Revenue on sales of RITUXAN in the rest of world   255.7   335.0   250.8   (23.7)%  33.6%
                     
Total unconsolidated joint business revenues $1,094.9  $1,128.2  $926.1   (3.0)%  21.8%
                     
 
OurBiogen Idec’s Share of Co-Promotion Profits in the U.S.
The following table provides a summary of amounts comprising our share of co-promotion profits in the U.S.:
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
Product revenues, net $2,665.5  $2,587.4  $2,284.8   3.0%  13.2%
Costs and expenses  724.1   741.0   730.2   (2.3)%  1.5%
                     
Co-promotion profits in the United States $1,941.4  $1,846.4  $1,554.6   5.1%  18.8%
                     
Biogen Idec Inc.’s share of co-promotion profits in the United States $773.6  $733.5  $616.8   5.5%  18.9%
                     
For 2009 compared to 2008, the increase in U.S. RITUXAN product revenue reserves are based on estimatessales recorded by Genentech resulted from continued growth for treatment of the amounts earned or to be claimed on the related sales. These estimates take into consideration our historical experience, current contractual requirements, statutory requirements, specific known market eventsB-cell NHL and trendsRA, and forecasted customer buying patterns. If actual results vary, we may need to adjust these estimates, which could have an effect on earnings in the period of the adjustment.
Product revenue reserves are categorized as follows: discounts, contractual adjustments and returns.
Discount reserves include trade term discounts, wholesaler incentives and, in 2006, patient assistance.price increases. For 2008 compared to 2007 discounts increased $21.4 million, or 46.8%, primarily resulting from increasesthe increase in trade term discounts and wholesaler incentives as a result of price increases. For 2007 compared to 2006, discounts decreased $57.2 million, or 55.6%, resulting from a $67.5 million reduction related to the change of patient assistance to a consignment model, offset by increases in trade term discounts and wholesaler incentives.
Contractual adjustment reserves relate to Medicaid, VA and managed care rebates and other applicable allowances. For 2008 compared to 2007, contractual adjustments increased $43.8 million, or 41.6%,U.S. RITUXAN product revenue was primarily due to the impactincreased unit sales in treatments of higher reservesB-cell NHL, CLL (an unapproved and unpromoted use of RITUXAN) and RA, and price increases. Collaboration costs and expenses for managed care (associated with higher level of activity with respect to rebates and 2008 price increases in the U.S.) and Medicaid and VA programs (associated with 2007 price increases in the U.S.). For 20072009 as compared to 2006, contractual adjustments increased $11.9 million, or 12.8%,2008 decreased primarily due to the impacthigher costs incurred in development of higher reservesRITUXAN for managed care (associated with higher level of activity with respect to rebates and associated with 2007 price increasesuse in the U.S.) and Medicaid and VA programs (associated with 2007 price increases in the U.S.).other indications during 2008.
 
Product return reservesUnder our collaboration agreement, our current pretax co-promotion profit-sharing formula, which resets annually, provides for a 30% share of co-promotion profits on the first $50.0 million of co-promotion operating profit with our share increasing to 40% if co-promotion operating profits exceed $50.0 million. In 2009, 2008, and 2007, the 40% threshold was met during the first quarter.
In addition, under our collaboration agreement, we have rights to collaborate with Genentech on the development and commercialization of (1) anti-CD20 products that Genentech acquires or develops, which we refer to as New Anti-CD20 Products, and (2) anti-CD20 products that Genentech licenses from a third party, which we refer to as Third Party Anti-CD20 Products. Our collaboration rights for New Anti-CD20 Products are established for returns made by wholesalerslimited to the U.S. and our patient replacement goods programcollaboration rights for Third Party Anti-CD20 Products are dependent upon Genentech’s underlying license rights. There is only one New Anti-CD20 Product, ocrelizumab, and only one Third Party Anti-CD20 Product, GA101.
Our agreement with Genentech also provides that the successful development and commercialization of the first New Anti-CD20 Product will decrease our percentage of co-promotion profits of the collaboration. Please read Note 17,Collaborationsto our Consolidated Financial Statements for additional information regarding the pretax co-promotion profit sharing formula for RITUXAN and New Anti-CD20 Products sold by us and Genentech following the approval date of the first New Anti-CD20 Product. We will participate in 2006. In accordance with contractualThird Party Anti-CD20 Products on similar financial terms wholesalers are permitted to return productas for reasons such as damaged or expired product. We also accept returns from our patients for various reasons. For 2008 compared toocrelizumab.


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Reimbursement of Selling and Development Expense in the U.S.
As discussed within Note 17,Collaborationsto our Consolidated Financial Statements, Genentech incurs the majority of continuing development costs for RITUXAN. Expenses incurred by Genentech in the development of RITUXAN are not recorded as research and development expense, but rather reduce our share of co-promotion profits recorded as a component of unconsolidated joint business revenue.
Selling and development expenses, incurred by us in the U.S. and reimbursed by Genentech, increased in 2009 as compared 2008 due to an increase in sales and marketing expense associated with CLL and legal fees.
The increase in selling and development expenses in 2008 compared to 2007 return reserves decreased $9.9 million, or 44.8%,was primarily due to development costs we incurred related to the development of RITUXAN in RA.
Revenue on Sales of RITUXAN in the Rest of World
We record our royalty revenue and co-promotion profit revenue on sales of RITUXAN in the rest of world on a decreasecash basis. Revenues on sales of RITUXAN in estimated product returns. For 2007the rest of world decreased in 2009 compared to 2006, return reserves decreased $16.6 million, or 42.9%,2008 primarily due to royalty expirations in certain of these markets and the negative impact of foreign exchange rate changes.
Revenues on sales of RITUXAN in the rest of world increased in 2008 compared to 2007 due to several factors, including increased market penetration in NHL and increased use in RA.
The royalty period for sales in the rest of world with respect to all products is 11 years from the first commercial sale of such product on acountry-by-country basis. For the majority of European countries, the first commercial sale of RITUXAN occurred in the second half of 1998. Specifically, the royalty periods with respect to sales in France, Spain, Germany and the United Kingdom expired in 2009. The royalty period with respect to sales in Italy will expire in 2010. The royalty periods with respect to sales in other countries will subsequently expire through 2012. As a $15.0 million decreaseresult of these expirations, we expect royalty revenues derived from sales of RITUXAN in the rest of world to continue to decline in future years.
Other Revenues
Our product line previously included ZEVALIN (ibritumomab tiuxetan) which is part of a treatment regimen for certain B-cell NHL, and AMEVIVE (alefacept), a treatment for certain moderate to severe psoriasis. We have sold or exclusively licensed the rights to these products to third parties and continue to receive supply agreement revenues based on those products which are included in corporate partner revenues. We also receive royalties on sales by our licensees of a number of other products under patents that we own.
Other revenues are summarized as follows:
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
Royalty revenues $124.4  $116.2  $102.1   7.1%  13.8%
Corporate partner revenues  5.1   13.4   6.6   (61.9)%  103.0%
                     
Other revenues $129.5  $129.6  $108.7   (0.1)%  19.2%
                     
Royalty Revenues
We receive royalties on sales by our licensees of products covered under patents that we own. Sales of licensed products could vary significantly due to competition, manufacturing difficulties and other factors that are not within our control. In addition, the expiration or invalidation of any underlying patents could reduce or eliminate the royalty revenues derived from such patents.
The increase in royalty revenues in 2009 as compared to 2008, as well as in 2008 as compared to 2007, was primarily due to increased sales of ANGIOMAX (bivalirudin) licensed to The Medicines Company (TMC) offset by a decline in royalties from sales of other licensed product and the expiration of certain contracts and license agreements.


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Our most significant source of royalty revenue is derived from sales of ANGIOMAX by TMC. TMC sells ANGIOMAX in the U.S., Europe, Canada, and Latin America for use as an anticoagulant in combination with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty. Royalty revenues related to patient replacement goodsthe sales of ANGIOMAX are recognized in an amount equal to the level of net sales achieved during a calendar year multiplied by the royalty rate in effect for that tier under our agreement with TMC. The royalty rate increases based upon which tier of total net sales are earned in any calendar year. The increased royalty rate is applied retroactively to the newfirst dollar of net sales model.
Reserves for product returns areachieved during the year. This formula has the effect of increasing the amount of royalty revenue to be recognized in later quarters. Accordingly, an adjustment is recorded in the period in which an increase in royalty rate has been achieved.
Under the related revenueterms of our agreement, TMC is recognized, resultingobligated to pay us royalties earned, on acountry-by-country basis, until the later of (1) twelve years from the date of the first commercial sale of ANGIOMAX in such country and (2) the date upon which the product is no longer covered by a reductionpatent in such country. The annual royalty rate is reduced by a specified percentage in any country where the product is no longer covered by a patent and where sales have been reduced to product sales.a certain volume-based market share. TMC began selling ANGIOMAX in the U.S. in January 2001. The majorityprincipal U.S. patent that covers ANGIOMAX expires in March 2010. The FDA has granted TMC an additional period of wholesaler returns aremarketing exclusivity for ANGIOMAX in order to investigate its use in pediatric patients. This period expires in September 2010. In the event that third parties sell products comparable to ANGIOMAX after the period of marketing exclusivity expires, we would expect a significant decrease in royalty revenues due to product expiration. Expired product return reserves are estimated through a comparison of historical return data, as adjusted, to their related sales on a production lot basis. Historicallower royalty rates of return are determined for each product and are adjusted for known or expected changes in the marketplace specific to each product.increased competition.
 
Unconsolidated Joint Business Revenues
 
We have a collaborationcollaborate with Genentech Inc., or Genentech, that was createdon the development and operates by agreement rather than throughcommercialization of RITUXAN. Please read Note 17,Collaborationsto our Consolidated Financial Statements for a joint venture or other legal entity. Our rights under the termsdescription of our amended and restated collaboration agreement with Genentech include co-exclusive rights to develop, commercialize and marketthis collaboration.
The majority of RITUXAN unit sales are for use in oncology as a treatment for certain types of B-cell NHL. We believe there is opportunity for RITUXAN unit sales growth in the United States and Canada with Genentech. Genentech has the exclusive right to develop, commercialize and market RITUXAN in the rest of the world. We have assigned our rights to develop, commercialize and market RITUXAN in Canada to F. Hoffman-La Roche Ltd., or Roche. Genentech shares a portion of the pretax U.S. co-promotion profits with us and Roche shares a portion of the pretax Canadian co-promotion profits of RITUXAN with us.
In the U.S., we contribute resources to selling and the continued development of RITUXAN. Genentech is responsible for worldwide manufacturing of RITUXAN. Genentech also is responsible for the primary support functions for the commercialization of RITUXAN in the U.S. including selling and marketing, customer service, order entry, distribution, shipping and billing. Genentech also incurs the majority of continuing development costs for RITUXAN. Under the arrangement, we have a limited sales force as well as limited development activity.
Under the terms of separate sublicense agreements between Genentech and Roche, Roche is responsible for commercialization of RITUXAN outside the U.S., except in Japanimmunology setting, where RITUXAN is co-marketed by Zenyaku Kogyo Co. Ltd., or Zenyaku, and Chugai Pharmaceutical Co. Ltd, or Chugai, an affiliateused as a treatment for certain types of Roche. There is no direct contractual arrangement between us and Roche, Zenyaku or Chugai.RA. Additional immunology indications for RITUXAN that we are investigating include ANCA-associated vasculitis.
 
Revenues from unconsolidated joint business consistsconsist of (1) our share of pretax co-promotion profits in the U.S.; (2) reimbursement of our selling and development expense in the U.S.; and (3) revenue on sales of RITUXAN in the rest of world, which consist of our share of pretax co-promotion profits in Canada and (2) royalty revenue fromon sales of RITUXAN outside the U.S. and Canada by F. Hoffmann-La Roche ZenyakuLtd. (Roche) and Chugai.its sublicensees. Pre-tax co-promotion profits are calculated and paid to us by Genentech in the U.S. and by Roche in Canada. Pre-tax co-promotion profits consist of U.S. and Canadian sales of RITUXAN to third-party customers net of discounts and allowances less the cost to manufacture RITUXAN, third-party royalty expenses, distribution, selling and marketing, expenses, and joint development expenses incurred by Genentech, Roche and us.
Revenues from unconsolidated joint business consist of the following (in millions):
             
  Year Ended December 31, 
  2008  2007  2006 
 
Co-promotion profits in the U.S. $733.5  $616.8  $555.8 
Reimbursement of selling and development expenses in the U.S.  59.7   58.5   61.1 
Revenue on sales of RITUXAN outside the U.S.   335.0   250.8   194.0 
             
  $1,128.2  $926.1  $810.9 
             


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Co-promotionThe following table provides a summary of revenues from unconsolidated joint business:
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
Biogen Idec’s share of co-promotion profits in the U.S.  $773.6  $733.5  $616.8   5.5%  18.9%
Reimbursement of selling and development expenses in the U.S.   65.6   59.7   58.5   9.9%  2.1%
Revenue on sales of RITUXAN in the rest of world   255.7   335.0   250.8   (23.7)%  33.6%
                     
Total unconsolidated joint business revenues $1,094.9  $1,128.2  $926.1   (3.0)%  21.8%
                     
Biogen Idec’s Share of Co-Promotion Profits in the U.S.
The following table provides a summary of amounts comprising our share of co-promotion profits in the U.S. consist of the following (in millions):
 
                                
 Year Ended December 31,        % Change 
 2008 2007 2006  For the Years Ended
 2009
 2008
 
 December 31, Compared
 Compared
 
(In millions, except percentages) 2009 2008 2007 to 2008 to 2007 
Product revenues, net $2,587.4  $2,284.8  $2,071.2  $2,665.5  $2,587.4  $2,284.8   3.0%  13.2%
Costs and expenses  741.0   730.2   669.3   724.1   741.0   730.2   (2.3)%  1.5%
                  
Co-promotion profits in the U.S.  $1,846.4  $1,554.6  $1,401.9 
Co-promotion profits in the United States $1,941.4  $1,846.4  $1,554.6   5.1%  18.8%
                  
Biogen Idec’s share of co-promotion profits in the U.S.  $733.5  $616.8  $555.8 
Biogen Idec Inc.’s share of co-promotion profits in the United States $773.6  $733.5  $616.8   5.5%  18.9%
                  
 
NetFor 2009 compared to 2008, the increase in U.S. RITUXAN product revenue on sales of RITUXAN to third-party customers in the U.S. recorded by Genentech resulted from continued growth for treatment of B-cell NHL and RA, and price increases. For 2008 were $2,587.4 million compared to $2,284.8 million2007 the increase in 2007, and $2,071.2 million in 2006. These increases wereU.S. RITUXAN product revenue was primarily due to increased unit sales in treatments of B-cell NHL, and chronic lymphocytic leukemiaCLL (an unapproved and unpromoted use of RITUXAN), increased utilization for and RA, and increasesprice increases. Collaboration costs and expenses for 2009 as compared to 2008 decreased primarily due to higher costs incurred in development of RITUXAN for use in other indications during 2008.
Under our collaboration agreement, our current pretax co-promotion profit-sharing formula, which resets annually, provides for a 30% share of co-promotion profits on the wholesale pricefirst $50.0 million of RITUXAN.co-promotion operating profit with our share increasing to 40% if co-promotion operating profits exceed $50.0 million. In 2009, 2008, and 2007, the 40% threshold was met during the first quarter.
 
In addition, under our collaboration agreement, we have rights to collaborate with Genentech on the development and commercialization of (1) anti-CD20 products that Genentech acquires or develops, which we refer to as New Anti-CD20 Products, and (2) anti-CD20 products that Genentech licenses from a third party, which we refer to as Third Party Anti-CD20 Products. Our collaboration rights for New Anti-CD20 Products are limited to the U.S. and our collaboration rights for Third Party Anti-CD20 Products are dependent upon Genentech’s underlying license rights. There is only one New Anti-CD20 Product, ocrelizumab, and only one Third Party Anti-CD20 Product, GA101.
Our agreement with Genentech also provides that the successful development and commercialization of the first New Anti-CD20 Product will decrease our percentage of co-promotion profits of the collaboration. Please read Note 17,Collaborationsto our Consolidated Financial Statements for additional information regarding the pretax co-promotion profit sharing formula for RITUXAN and New Anti-CD20 Products sold by us and Genentech following the approval date of the first New Anti-CD20 Product. We will participate in Third Party Anti-CD20 Products on similar financial terms as for ocrelizumab.


39


Reimbursement of Selling and Development Expense in the U.S.
As discussed within Note 17,Collaborationsto our Consolidated Financial Statements, Genentech incurs the majority of continuing development costs for RITUXAN. Expenses incurred by Genentech in the development of RITUXAN are not recorded as research and development expense, but rather reduce our share of co-promotion profits recorded as a component of unconsolidated joint business revenue.
Selling and development expenses, incurred by us in the U.S. and reimbursed by Genentech, increased in 2009 as compared 2008 2007,due to an increase in sales and 2006, reimbursements ofmarketing expense associated with CLL and legal fees.
The increase in selling and development expenses in the U.S. were $59.7 million, $58.5 million and $61.1 million, respectively. The increase in 2008 fromcompared to 2007 was primarily due to development costs we incurred related to the development of RITUXAN in RA. The decrease in 2007 from 2006 was primarily due to the reimbursement
Revenue on Sales of development costs when Roche exercised its option to participateRITUXAN in the relapsing remitting multiple sclerosis development program.Rest of World
 
Revenue on sales of RITUXAN outside the U.S. consists of our share of co-promotion profits in Canada and royalty revenue on sales of RITUXAN outside the U.S. and Canada. Our royalty revenue on sales of RITUXAN is based on Roche, Zenyaku and Chugai’s net sales to third-party customers. We record our royalty revenue and co-promotion profit revenue on sales of RITUXAN outsidein the U.S.rest of world on a cash basis. Revenues on sales of RITUXAN outsidein the U.S.rest of world decreased in 2009 compared to 2008 primarily due to royalty expirations in certain of these markets and the negative impact of foreign exchange rate changes.
Revenues on sales of RITUXAN in the rest of world increased in 2008 compared to 2007 and 2006 were $335.0 million, $250.8 million, and $194.0 million, respectively. These increases were due to several factors, including increased market penetration. penetration in NHL and increased use in RA.
The royalty period for sales in the rest of world with respect to all products is 11 years from the first commercial sale of such product on acountry-by-country basis. For the majority of European countries, the first commercial sale of RITUXAN occurred in the second half of 1998. Therefore, we expect a significant decrease in royalty revenues on sales of RITUXAN outside the US and Canada beginning in the latter half of 2009. Specifically, the royalty periodperiods with respect to sales in France, Spain, Germany and the United Kingdom will expire in 2009. As a result, royalty revenue is expected to be in the range of $250.0 million to $290.0 millionexpired in 2009. The royalty period with respect to sales in Italy will expire in 2010. The royalty periodperiods with respect to sales in other countries will subsequently expire through 2012. As a result of these expirations, we expect royalty revenues derived from sales of RITUXAN in the rest of world to continue to decline in future years.
 
Under the amended and restated collaboration agreement, our current pretax co-promotion profit-sharing formula, which resets annually, is as follows:
Biogen Idec’s Share
Other Revenues
Co-promotion Operating Profits
of Co-promotion Profits
First $50 million30%
Greater than $50 million40%
 
In 2008, 2007,Our product line previously included ZEVALIN (ibritumomab tiuxetan) which is part of a treatment regimen for certain B-cell NHL, and 2006,AMEVIVE (alefacept), a treatment for certain moderate to severe psoriasis. We have sold or exclusively licensed the 40% threshold was met during the first quarter.


47


For each calendar year or portion thereof following the approval date of the first New Anti-CD20 Product, the pretax co-promotion profit-sharing formula for RITUXANrights to these products to third parties and New Anti-CD20 Products sold by us and Genentech will change.
Biogen Idec’s
Share of
First New Anti-CD20 Product U.S.
Co-promotion
Co-promotion Operating Profits
Gross Product SalesProfits
First $50 million(1)N/A30%
Greater than $50 millionUntil such sales exceed $150 million
in any calendar year(2)
38%
Or
After such sales exceed $150 million in
any calendar year until such sales
exceed $350 million in any calendar year(3)
35%
Or
After such sales exceed $350 million in
any calendar year(4)
30%
(1)not applicable in the calendar year the first New Anti-CD20 Product is approved if $50 million in co-promotion operating profits has already been achieved in such calendar year through sales of RITUXAN.
(2)if we are recording our share of RITUXAN co-promotion profits at 40%, upon the approval date of the first New Anti-CD20 Product, our share of co-promotion profits for RITUXAN and the New Anti-CD20 Product will be immediately reduced to 38% following the approval date of the first New Anti-CD20 Product until the $150 million in first New Anti-CD20 Product sales level is achieved.
(3)if $150 million in first New Anti-CD20 Product sales is achieved in the same calendar year the first New Anti-CD20 Product receives approval, then the 35% co-promotion profit-sharing rate will not be effective until January 1 of the following calendar year. Once the $150 million in first New Anti-CD20 Product sales level is achieved then our share ofco-promotion profits for the balance of the year and all subsequent years (after the first $50 million inco-promotion operating profits in such years) will be 35% until the $350 million in first New Anti-CD20 Product sales level is achieved.
(4)if $350 million in first New Anti-CD20 Product sales is achieved in the same calendar year that $150 million in new product sales is achieved, then the 30% co-promotion profit-sharing rate will not be effective until January 1 of the following calendar year (or January 1 of the second following calendar year if the first New Anti-CD20 Product receives approval and, in the same calendar year, the $150 million and $350 million in first New Anti-CD20 Product sales levels are achieved). Once the $350 million in first New Anti-CD20 Product sales level is achieved then our share of co-promotion profits for the balance of the year and all subsequent years will be 30%.
Currently, we record our share of expenses incurred for the development of New Anti-CD20 Productscontinue to receive supply agreement revenues based on those products which are included in research and development expense until such time as a New Anti-CD20 Product is approved, at which time we will record our share of pretax co-promotion profits related to the New Anti-CD20 Product in revenues from unconsolidated joint business.
Under our collaboration agreement with Genentech, we willcorporate partner revenues. We also receive a lower royalty percentage of revenue from Genentechroyalties on sales by Roche and Zenyaku of New Anti-CD20 Products, as compared to the royalty percentage of revenue on sales of RITUXAN.
In 2008, under the terms of our collaboration agreement, we paid Genentech $31.5 million to participate in a license agreement with Roche for the developmentlicensees of a Third Party Anti-CD20 Product. This was recorded as research and development cost in our consolidated statementnumber of operations as the product had no alternative future use. In addition, in 2008other products under patents that we received $12.4 million from Genentech pursuant to Roche choosing to participate in a study of RITUXAN in primary-progressive multiple sclerosis. This was recorded as revenue from unconsolidated joint business in our consolidated statement of operations.


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Other Revenueown.
 
Other revenues consist of the following (in millions):are summarized as follows:
 
                         
  Year Ended December 31, 
  2008  2007  2006 
 
Royalties $116.2   89.7% $102.1   93.9% $86.2   94.9%
Corporate partner  13.4   10.3%  6.6   6.1%  4.6   5.1%
                         
  $129.6   100.0% $108.7   100.0% $90.8   100.0%
                         
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
Royalty revenues $124.4  $116.2  $102.1   7.1%  13.8%
Corporate partner revenues  5.1   13.4   6.6   (61.9)%  103.0%
                     
Other revenues $129.5  $129.6  $108.7   (0.1)%  19.2%
                     
 
Royalty Revenues
 
We receive revenues from royalties on sales by our licensees of a number of products covered under patents that we own. Sales of licensed products could vary significantly due to competition, manufacturing difficulties and other factors that are not within our control. OurIn addition, the expiration or invalidation of any underlying patents could reduce or eliminate the royalty revenues on sales of RITUXAN outside the U.S. are included in revenuesderived from unconsolidated joint business in the accompanying consolidated statements of income.such patents.
 
ForThe increase in royalty revenues in 2009 as compared to 2008, as well as in 2008 as compared to 2007, royalty revenue increased $14.1 million, or 13.8%,was primarily due to an increaseincreased sales of ANGIOMAX (bivalirudin) licensed to The Medicines Company (TMC) offset by a decline in royalties from sales levels of certain products under license partially offset byother licensed product and the expiration of certain contracts and decreasedlicense agreements.


40


Our most significant source of royalty revenue is derived from sales of ANGIOMAX by TMC. TMC sells ANGIOMAX in the U.S., Europe, Canada, and Latin America for use as an anticoagulant in combination with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty. Royalty revenues related to the sales of ANGIOMAX are recognized in an amount equal to the level of net sales achieved during a calendar year multiplied by the royalty rate in effect for that tier under our agreement with TMC. The royalty rate increases based upon which tier of total net sales are earned in any calendar year. The increased royalty rate is applied retroactively to the first dollar of net sales achieved during the year. This formula has the effect of increasing the amount of royalty revenue to be recognized in later quarters. Accordingly, an adjustment is recorded in the period in which an increase in royalty rate has been achieved.
Under the terms of our agreement, TMC is obligated to pay us royalties earned, on acountry-by-country basis, until the later of (1) twelve years from the date of the first commercial sale of ANGIOMAX in such country and (2) the date upon which the product is no longer covered by a patent in such country. The annual royalty rate is reduced by a specified percentage in any country where the product is no longer covered by a patent and where sales have been reduced to a certain volume-based market share. TMC began selling ANGIOMAX in the U.S. in January 2001. The principal U.S. patent that covers ANGIOMAX expires in March 2010. The FDA has granted TMC an additional period of marketing exclusivity for ANGIOMAX in order to investigate its use in pediatric patients. This period expires in September 2010. In the event that third parties sell products under license.comparable to ANGIOMAX after the period of marketing exclusivity expires, we would expect a significant decrease in royalty revenues due to lower royalty rates and increased competition.
Provisions for Discounts and Allowances
Revenues from product sales are recorded net of applicable allowances for trade term discounts, wholesaler incentives, Medicaid rebates, Veterans Administration (VA) rebates, managed care rebates, product returns, and other applicable allowances. Reserves established for these discounts and allowances are classified as reductions of accounts receivable (if the amount is payable to our customer) or a liability (if the amount is payable to a party other than our customer). For 20072009 compared to 2006, royalty revenues increased $15.9 million, or 18.4%,2008, as well as 2008 compared to 2007, the increases in total allowances were primarily due to price increases.
Our product revenue reserves are based on estimates of the amounts earned or to be claimed on the related sales. These estimates take into consideration our historical experience, current contractual requirements, statutory requirements, specific known market events and trends and forecasted customer buying patterns. If actual results vary, we may need to adjust these estimates, which could have an effect on earnings in the period of the adjustment.
Reserves for product returns are recorded in the period the related revenue is recognized, resulting in a reduction to product sales. The majority of wholesaler returns are due to product expiration. Expired product return reserves are estimated through a comparison of historical return data, as adjusted, to their related sales on a production lot basis. Historical rates of return are determined for each product and are adjusted for known or expected changes in the marketplace specific to each product.
Reserves for discounts, contractual adjustments and returns that reduced gross product revenues were as follows:
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
Discounts $74.0  $67.1  $45.7   10.3%  46.8%
Contractual adjustments  192.5   149.0   105.2   29.2%  41.6%
Returns  16.6   12.2   22.1   36.1%  (44.8)%
                     
Total allowances $283.1  $228.3  $173.0   24.0%  32.0%
                     
Gross product revenues $3,436.0  $3,068.0  $2,309.8   12.0%  32.8%
                     
Percent of gross product revenues  8.2%  7.4%  7.5%  10.8%  (1.3)%
                     


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Discount reserves include trade term discounts and wholesaler incentives. For 2009 compared to 2008, as well as for 2008 compared to 2007, the increase in sales levels of products under license partially offsetdiscounts was primarily driven by the expiration of royalties under certain contracts.
Royalty revenues may fluctuateincreases in trade term discounts and wholesaler incentives as a result of fluctuations in sales levels of products sold by our licensees from quarterprice increases.
Contractual adjustment reserves relate to quarterMedicaid, VA and managed care rebates and other applicable allowances. For 2009 compared to 2008, as well as for 2008 compared to 2007, contractual adjustments increased primarily due to the timingimpact of higher reserves for managed care (associated with higher level of activity with respect to rebates and extent of major eventsprice increases in the U.S.) and Medicaid and VA programs (associated with price increases in the U.S.).
Product return reserves are established for returns made by wholesalers. In accordance with contractual terms, wholesalers are permitted to return product for reasons such as new indication approvalsdamaged or government-sponsored programs.expired product. We also accept returns from our patients for various reasons. For 2009 compared to 2008, return reserves remained relatively unchanged. For 2008 compared to 2007, return reserves decreased primarily due to a decrease in estimated product returns based on historical trends.
 
Corporate Partner Revenues
Corporate partner revenues represent contract revenues such as ZEVALIN and AMEVIVE and license fees.
Costs and Expenses
 
CostsA summary of total costs and expenses areis as follows (in millions):follows:
 
                                            
 Year Ended December 31,        % Change 
 2008 2007 2006  For the Years Ended
 2009
 2008
 
 December 31, Compared
 Compared
 
(In millions, except percentages) 2009 2008 2007 to 2008 to 2007 
Cost of sales, excluding amortization of acquired intangible assets $402.0   13.9% $335.2   14.0% $274.4   12.3% $382.1  $402.0  $335.2   (5.0)%  19.9%
Research and development  1,072.1   37.2%  925.2   38.7%  718.4   32.0%  1,283.1   1,072.1   925.2   19.7%  15.9%
Selling, general, and administrative  925.3   32.1%  776.1   32.4%  685.0   30.5%
Collaboration profit (loss) sharing  136.0   4.7%  14.0   0.6%  (9.7)  (0.4)%
Selling, general and administrative  911.0   925.3   776.1   (1.5)%  19.2%
Collaboration profit sharing  215.9   136.0   14.0   58.8%  871.4%
Amortization of acquired intangible assets  289.8   332.7   257.5   (12.9)%  29.2%
Acquired in-process research and development  25.0   0.9%  84.2   3.5%  330.5   14.7%     25.0   84.2   (100.0)%  (70.3)%
Amortization of acquired intangible assets  332.7   11.5%  257.5   10.8%  267.0   11.9%
Facility impairments and (gain) loss on disposition, net  (9.2)  (0.3)%  (0.4)     (16.5)  (0.7)%     (9.2)  (0.4)  (100.0)%  2200.0%
Gain on termination of license agreements, net              (6.1)  (0.3)%
                        
Total costs and expenses $2,883.9   100.0% $2,391.8   100.0% $2,243.0   100.0%
Costs and expenses $3,081.9  $2,883.9  $2,391.8   6.9%  20.6%
                        
 
Inventory Write-OffsCost of Sales, Excluding Amortization of Acquired Intangible Assets (Cost of Sales)
 
We periodically review our inventories for excess or obsolete inventory and write-down obsolete or otherwiseComponents of cost of sales are summarized as follows:
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
Cost of product revenues $378.1  $397.0  $330.5   (4.8)%  20.1%
Cost of royalty revenues  4.0   5.0   4.7   (20.0)%  6.4%
                     
Cost of sales $382.1  $402.0  $335.2   (5.0)%  19.9%
                     
For 2009 compared to 2008, the decrease in cost of sales was primarily due to a decrease in write-downs from unmarketable inventory of $12.9 million, decreased production costs of approximately $10.9 million resulting from the implementation of a new high-titer production process which produces higher yields of TYSABRI and an $8.8 million decrease in royalty payments on sales of licensed product due mainly to its estimated net realizable value. If the actual net realizable value is less than thatexpiration of certain contracts and license agreements. These decreases were offset by a $17.0 million increase in costs associated with higher TYSABRI sales volume. In addition, during 2008 we also incurred a $4.3 million period expense related to the shutdown of our manufacturing facility in Research Triangle Park, North Carolina for the implementation of the high-titer production process upgrades.


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estimatedFor 2008 as compared to 2007, the overall increase in cost of sales was primarily due to higher sales volume offset by us, or if it is determined that inventory utilization will further diminish based on estimates of demand, additional inventorydecreased write-downs may be required. Additionally, ourfrom unmarketable inventory.
Write-downs from Unmarketable Inventory
Our products are subject to strict quality control and monitoring which we perform throughout the manufacturing process. Periodically, certain batches or units of product may no longer meet quality specifications or may expire. As a result, included in product cost of revenues were write-downs of commercial inventory that did not meet quality specifications or that became obsolete due to expiration. In all cases product inventory was written-down to its estimated net realizable value.
The shelf life associated with our products is generally between 3 and 48 months, depending on the product. Obsolescence due to dating expiration has nothistorically been a historical concern, given the rapidity in which our products move through the channel. Changes due to our competitors’ price movements have not adversely affected us. We do not provide incentives to our distributors to assume additional inventory levels beyond what is customary in their ordinary course of business.insignificant.
 
We have written-down the followingAmounts written down related to unmarketable inventory which wasare charged to cost of sales, (in millions):and totaled $16.9 million, $29.8 million and $21.6 million for the years ended December 31, 2009, 2008 and 2007, respectively.
 
             
  Year Ended December 31, 
  2008  2007  2006 
 
AVONEX $14.9  $11.1  $4.4 
TYSABRI  7.6   4.0   2.9 
FUMADERM     0.1    
AMEVIVE  6.0   0.1   2.4 
ZEVALIN  1.3   6.3   3.3 
             
  $29.8  $21.6  $13.0 
             
Research and Development
                     
        % Change
  For the Years Ended
 2009
 2008
  December 31, Compared
 Compared
(In millions, except percentages) 2009 2008 2007 to 2008 to 2007
 
Research and development $1,283.1  $1,072.1  $925.2   19.7%  15.9%
 
The write-downs wereWe devote significant resources to research and development programs focusing our efforts on finding novel therapeutics in areas of high unmet medical need within our core and emergent focus areas of neurology, oncology, immunology, cardiopulmonary and hemophilia. Over the resultpast few years, we have incurred significant expenditures related to the development of new product candidates and exploring the following (in millions):
             
  Year Ended December 31, 
  2008  2007  2006 
 
Failed quality specifications $16.0  $12.0  $11.2 
Excess and/or obsolescence  13.8   9.6   1.8 
             
  $29.8  $21.6  $13.0 
             
Research and Development Expensesutility of our existing products in treating disorders in addition to those currently approved in their labels. Costs associated with later stage clinical trials are, in most cases, more significant than those incurred in earlier stages of our pipeline.
 
Research and development expenses totaled $1,072.1 millionconsist of upfront fees and milestones paid to collaborators and expenses incurred in 2008performing research and development activities, including compensation and benefits, facilities expenses, overhead expenses, clinical trial and related clinical manufacturing expenses, fees paid to clinical research organizations (CROs) and other outside expenses. Research and development expenses are expensed as incurred. The timing of upfront fees and milestone payments in the future may cause variability in future research and development expense.
For 2009 compared to $925.22008, research and development expenses increased by $211.0 million, driven primarily by the $110.0 million upfront payment made to Acorda, as well as a net increase of $100.2 million related to the ramp up of clinical trial activity for certain development stage product candidates including lixivaptan, BG-12, humanized anti-CD20 and ADENTRI. In addition, in 2007,2009, we initiated registrational trials in our PEGylated interferon program. The aforementioned increases were offset by a reduction of spending across several programs including baminercept in RA, lumiliximab and $718.4 million in 2006.volociximab.
 
For 2008 compared to 2007, research and development expenses increased by $146.9 million, driven by an increase of $56.4 million related to the continued advancement of our pipeline into Phase 3 clinical trials. In 2008, we initiated a registrational trialstrial in the Lixivaptan and Adentri programsour lixivaptan program, a Phase 2 trial in our ADENTRI program, and continued to execute development plans ofdevelop our BG-12, Anti-CD23,anti-CD80 MAb (galiximab) and Anti-CD80anti-CD23 MAb (lumiliximab) programs. Costs associated with Phase 3 clinical trials are, in most cases, more significant than those incurred in earlier stages of our pipeline. In 2008, we had 8 programs in Phase 3 clinical trials as compared to 5 in 2007. We also increased spendspending in our Anti-CD20anti-CD20 programs which is being developed in both Phase 2 and Phase 3 clinical trials by $46.2 million primarily due to a $31.5 million opt-in payment to participate in the Roche-led GA101 program. The balance of the increase of $44.3 million iswas due to other research and development investments, primarily in our pre clinical and early stage pipeline programs including HSP90, BIIB014, BART and LINGO programs.
 
For 2007 compared to 2006,We expect total research and development expenses increased $206.8 million, primarily dueexpense in 2010 to an increasebe between 24% and 27% of $129.1 million related to the continued advancement of our late stage pipeline which includes a $50.0 million upfront payment to Cardiokine Biopharma LLC for the Lixivaptan collaboration entered into in August of 2007. In addition, in 2007, we initiated registrational trials for the Anti-CD23 and BG-12 programs. In 2007, we had 5 programs in Phase 3 clinical trials as compared to 3 in 2006. The balance of the $77.7 million is due to other research and development investments, primarily in pre clinical and early stage pipeline programs driven bytotal revenue.


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our business development deals with SyntonixMilestone and Conforma, as well as increased spend for the Baminercept-alpha (LTBR-Fc) program in anticipation of the 2007 and 2008 data read outs.Upfront Payments
 
We expect thatMilestone and upfront payments made to our collaboration partners and included within research and development expenses willexpense are summarized as follows:
                         
           % Change    
  For the Years Ended
  2009
  2008
    
  December 31,  Compared
  Compared
    
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007    
 
Total milestone and upfront payments reflected within research and development expense $151.5  $47.6  $52.0   218.3%  (8.5)%    
For 2009 as compared to 2008, the increase in 2009milestone and upfront payments was primarily duethe result of the $110.0 million upfront payment made to the greater number of product candidates in late stage clinical trials.Acorda.
 
Selling, General and Administrative Expenses
                         
           % Change    
  For the Years Ended
  2009
  2008
    
  December 31,  Compared
  Compared
    
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007    
 
Selling, general and administrative $911.0  $925.3  $776.1   (1.5)%  19.2%    
 
Selling, general and administrative expenses totaled $925.3 million in 2008are primarily comprised of compensation and benefits associated with sales and marketing, finance, legal and other administrative personnel, outside marketing and legal expenses and other general and administrative costs.
For 2009 compared to $776.1 million2008, the decrease in 2007,selling, general and $685.1 millionadministrative expenses was primarily driven by the positive impact of foreign currency exchange rate changes and a reduction of expenses reimbursed to Elan for their marketing of TYSABRI for Crohn’s disease in 2006.the U.S. These decreases were offset by costs incurred associated with our geographic expansion into new markets.
 
For 2008 compared to 2007, selling, general and administrative expenses increased $149.2 million, or 19.2%, primarily due to a $90.0 million increase in sales and marketing, of which $55.3 million related to international sales and marketing activities primarily for AVONEX and TYSABRI and a $43.6 million related to an increase in salariescompensation and benefits related tofor general and administrative personnel as well as increases in fees and services.
 
For 2007 compared to 2006,We expect that selling, general and administrative expenses increased $91.0 million, or 13.3%,will increase in 2010 as compared to the total amount incurred in 2009 primarily due to a $65.0 million increase inincreased sales and marketing activities for TYSABRI, primarily in international salessupport of AVONEX and marketing, a $25.5TYSABRI. In addition, under the transition agreement entered into with James C. Mullen, we will incur approximately $21 million net increaseof expense in salaries and benefits relatedthe first half of 2010 all of which relates to increased headcount in general and administrative personnel, a $19.0 million increase in fees and services related to general and administrative matters offset by a $12.1 million decrease in sales and marketing activities for ZEVALIN due to decreased commercial effortsthe modification of his existing equity based compensation awards. The substantial portion of this charge is due to the planned divestiture of this product line.
We do not anticipate a significant increase in total selling, general, and administrative expenses in 2009 as comparedincremental value attributable to the amount incurred in 2008.extension of Mr. Mullen’s stock option awards.
 
Severance and Other Restructuring CostsCollaboration Profit Sharing
 
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
Collaboration profit sharing $215.9  $136.0  $14.1   58.7%  866.3%
Severance and other restructuring costs totaled $5.0 million
Payments are made to Elan for their share of the rest of world net operating profits to effect an equal sharing of collaboration operating profit. These payments include the reimbursement of our portion of third-party royalties that Elan pays on behalf of the collaboration, relating to sales in 2008 as compared to $1.8 millionthe rest of world. These amounts are reflected in 2007 and $3.6 million in 2006. These costs are included in research and development expense and selling, general and administrative expensethe collaboration profit sharing line in our consolidated statements of income. At December 31, 2008, there are no remaining material severance or restructuring accruals on our consolidated balance sheet.
AmortizationOur collaboration profit sharing expense increases as rest of Intangible Assetsworld sales of TYSABRI increase and is impacted by fluctuations in currency exchange rates.
 
For 2009 as compared to 2008, as well as for 2008 as compared to 2007, the increases were due to the continued increase in TYSABRI rest of world sales resulting in a higher rest of world net operating profits to be shared with Elan and 2006, amortizationcausing growth in the third-party royalties Elan paid on behalf of the collaboration.


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For the years ended December 31, 2009, 2008 and 2007, our collaboration profit sharing expense was $332.7included $40.0 million, $257.5$28.4 million and $267.0$9.1 million, respectively.respectively, related to the reimbursement of Elan’s royalty payments.
Amortization of Acquired Intangible Assets
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
Amortization of acquired intangible assets $289.8  $332.7  $257.5   (12.9)%  29.2%
 
Our most significant intangible asset is the core technology related to our AVONEX product. Our amortization policy reflects our belief that the economic benefit of our core technology is consumed as revenue is generated from our AVONEX product. We refer to this amortization methodology as the economic consumption model, which involves calculating a ratio of actual current period sales to total anticipated sales for the life of the product and applying this ratio to the carrying amount of the intangible asset. An analysis of the anticipated lifetime revenue of AVONEX is performed at least annually during our long range planning cycle, and this analysis serves as the basis for the calculation of our economic consumption amortization model. Although we believe this process has allowed us to reliably determine the best estimate of the pattern in which we will consume the economic benefits of our core technology intangible asset, is based on the principles of Statement of Financial Standards No. 142,Goodwill and Other Intangible Assets,or SFAS 142, which requires themodel could result in deferring amortization of intangible assetscharges to reflect the patternfuture periods in which the economic benefitscertain instances, due to continued sales of the intangible asset are consumed. Every year during the third quarter we complete our long range planning cycle, which includes an analysis of the anticipated product sales of AVONEX. The results of this forecast serve as the basis for our assumptions used in the economic consumption amortization model for our core technology intangible asset. We also establish minimum annual amortization amountsat a nominal level after patent expiration or otherwise. In order to ensure that amortization charges are not unreasonably deferred to future periods. See Note 1, Business Overviewperiods, we compare the amount of amortization determined under the economic consumption model against the minimum amount of amortization recalculated each year under the straight-line method. Amortization is then recorded based upon the higher of the amount of amortization determined under the economic consumption model or the minimum amortization amount determined under the straight-line method.
We completed our most recent long range planning cycle in the third quarter of 2009. This analysis is based upon certain assumptions that we evaluate on a periodic basis, such as the anticipated product sales of AVONEX and Summaryexpected impact of Significant Accounting Policies,competitor products and our own pipeline product candidates, as well as the issuance of new patents or the extension of existing patents. Based on this analysis, we have continued to amortize this asset on the economic consumption model for a detailed descriptionthe third and fourth quarters of 2009, and expect to apply the same model for the first two quarters in 2010. The results of our accounting policyanalysis were most significantly impacted by the issuance in September 2009 of a U.S. patent covering the treatment of MS with AVONEX, which resulted in an increase in the total expected lifetime revenue of AVONEX and an extension of the assumed remaining life of our core intangible asset.
As a result of these changes in the total expected lifetime revenues of AVONEX, amortization recorded for the third and fourth quarters of 2009 decreased significantly over their respective prior year comparative periods. Based upon this most recent analysis, amortization of intangible assets.assets, included within our consolidated balance sheet as of December 31, 2009, is expected to be in the range of approximately $160.0 million to $220.0 million for each of the next five years.
 
For 2008 compared to 2007, the increase in amortization expense increased $75.2 million, or 29.2%,was primarily due to the changes in the estimate of the future revenuetotal expected lifetime revenues of AVONEX which serves as the basis for the calculation of economic consumption for core technology that occurred as part of ourthe annual reassessment of amortization expense in the third quarters of 2008 and 2007. The change in the estimate of the future revenue of AVONEX iswas attributable to the expected impact of competitor products, including the commercialization of our own pipeline product candidates.
 
Acquired In-Process Research and Development (IPR&D)
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
Acquired in-process research and development $  $25.0  $84.2   (100.0)%  (70.3)%
Effective January 1, 2009, we adopted a new accounting standard for business combinations, which changes the accounting treatment of acquired IPR&D. For 2007 comparedacquisitions occurring prior to 2006, amortization expense decreased $9.5 million, or 3.6%, primarily due to the changes in estimate of the future revenue of AVONEX, which serves as the basis in our calculation of economic consumption for core technology.January 1, 2009, we measured


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We review ouracquired IPR&D at fair value and expensed it on the acquisition date, or capitalized it as intangible assets if certain criteria were met. However, effective January 1, 2009, acquired IPR&D will be measured at fair value and capitalized as intangible assets and amortized from the date of completion over its estimated useful life. In addition, the acquired IPR&D will be tested for impairment when events or changes in circumstances indicate thatuntil completion of the carrying value of an asset may not be recoverable. No such events or changes in circumstances occurred in 2008. If future events or circumstances indicate that the carrying value of these assets may not be recoverable, we may be required to record additional charges to our results of operations.
In-Process Research and Development (IPR&D)
For 2008, 2007, and 2006, IPR&D charges were $25.0 million, $84.2 million, and $330.5 million, respectively.acquired programs.
 
In 2008, we recorded an IPR&D charge of $25.0 million related to a HSP90-related milestone payment made to the former shareholders of Conforma Therapeutics, Inc. (Conforma) pursuant to the terms of our acquisition of Conforma in 2006.
 
During the year ended December 31, 2007, we recorded IPR&D charges of $84.2 million. The principal components of this amount are as follows: $18.4 million related to the acquisition of Syntonix, approximately $30 million related to the collaboration with Cardiokine Biopharma LLC, or Cardiokine and $34.3 million related to the collaboration with Neurimmune.
• $18.4 million related to the acquisition of Syntonix Pharmaceuticals (Syntonix);
• $30.0 million related to the collaboration with Cardiokine Biopharma LLC (Cardiokine); and
• $34.3 million related to the collaboration with Neurimmune SubOne AG (Neurimmune).
Cardiokine and Neurimmune are variable interest entities as defined in FIN 46(R).under the guidance set forth within theConsolidationTopic of the Codification. The consolidation of these entities resulted in IPR&D charges. The IPR&D charges which have been recorded as a component of operating income. However, because the IPR&D charges relate to the fair value of the underlying technology retained by the parent companies of Cardiokine and Neurimmune, these amounts were allocated to the respective minoritynoncontrolling interests. Consequently, minority interest
We use discounted cash flow models to determine the fair values associated with acquired technologies. These models require the use of $64.3 millionsignificant estimates and assumptions, which include but are not limited to an estimate of future cash flows from product sales resulting from completed and in-process products and the use of discount and probability rates on a project basis. Refer toValuation of Acquired Intangible Assets and In-process Research and Development ExpenseswithinCritical Accounting Estimates for additional discussion.
We believe that the discount rates utilized in our valuations are commensurate with the stage of development of these compounds and uncertainties in the economic estimates associated with each development relationship. The IPR&D charge related to our collaboration with Neurimmune was recorded as a componentdetermined based upon an estimate of non-operating income. In 2006, we recorded $207.4 million and $123.1 millionrevenues expected to be recognized beginning in IPR&D2018 related to the acquisitionsBeta-Amyloid antibody and a discount rate of Fumapharm and Conforma, respectively.
Through December 31, 2008, research and development expenditures15%. The IPR&D charge related to in-process researchour collaboration with Cardiokine was determined assuming a discount rate of 11% and an estimate of revenues expected to be recognized beginning in 2012 for lixivaptan. The amount allocated to IPR&D resulting from the acquisition of Syntonix relates to the development projects acquiredof long-acting recombinant Factor IX and long-acting recombinant Factor VIII assuming estimated revenues expected to be recognized beginning in prior years are $42.9 million, $36.3 million,2012 and $129.3 million related2013, respectively. A discount rate of 13% was used to Syntonix, Conforma, and Fumapharm, respectively.
See Note 2, Acquisitions and Dispositions, and Note 16, Research Collaborations of the Consolidated Financial Statements.
Facility Impairments and (Gain) Loss on Disposition, netvalue these projects.
 
In 2008, as part of the lease agreement describedaddition, in Note 18, Commitments and Contingencies, we sold the development rights on a parcel of land in Cambridge, MA in a non-monetary transaction for $11.4 million. We recorded a pre-tax gain of approximately $9.2 million on the sale. In 2006, we completed the sale of one of the buildings in our Cambridge, Massachusetts facility, known as Bio 1. Proceeds from the sale were approximately $39.5 million. We recorded a pre-tax gain of approximately $15.6 million on the sale. We continued to occupy a minor portion of the building under a leasing arrangement. In 2006, we also sold our clinical manufacturing facility in Oceanside, California, known as NICO for total consideration of $29.0 million. We recorded an immaterial net gain pursuant to this transaction.
Gain on Settlement of License Agreements, net
In 2006, we recorded a net gain on settlement of license agreements, net of $6.1 million as discussed below.
Fumapharm
During 2006, we recorded a gain of $34.2 million coincidentconnection with the acquisition of FumapharmSyntonix in January 2007, we agreed to make additional future consideration payments contingent upon the achievement of certain milestone events. In accordance withEITF 04-1,Accounting for Preexisting Relationships between the Parties to our acquisition agreement, we will make a Business Combination,orEITF 04-1. The gain related$40.0 million milestone payment to the settlementformer shareholders of Syntonix during the first quarter of 2010. This amount will be recorded as a preexisting collaboration agreement between Fumapharmcharge to IPR&D in the first quarter of 2010.
Refer to Note 2,Acquisitions and us. The collaboration agreement was entered into in October 2003 Dispositionsand required payments Note 17,Collaborationsto Fumapharmour Consolidated Financial Statements for additional discussion.
Other Income (Expense), Net
Components of certain royalty amounts. The market rate for such payments was higher at the acquisition date, primarily due to the increased technical feasibility of BG-12. The gain relates to the difference between the royalty rates at the time the agreement was entered intoother income (expense), net, are summarized as compared to the rates at the time the agreement was effectively settled by virtue of our acquisition of Fumapharm.follows:
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
Interest income $48.5  $72.1  $103.6   (32.7)%  (30.4)%
Interest expense  (35.8)  (52.0)  (40.5)  31.2%  (28.4)%
Impairment on investments  (10.6)  (60.3)  (24.4)  82.4%  (147.1)%
Gain (loss) on sales of investments, net  22.8   (1.1)  16.7   2,172.7%  (106.6)%


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Fumedica
During 2006, we recorded a charge of $28.1 million in connection with a settlement agreement with Fumedica Arzneimittel AG and Fumedica Arzneimittel GmbH, collectively Fumedica. The charge related to the settlement of the agreement with Fumedica under which we were contingently obligated to make royalty payments with respect to a successful launch of BG-12 for psoriasis in Germany. Under the terms of the settlement agreement, we will not be required to make any royalty payments to Fumedica if BG-12 is successfully launched for psoriasis in Germany. The $28.1 million was expensed in 2006, as it related to a product that had not reached technological feasibility.
Share-based Compensation Expense
In the year ended December 31, 2008 and 2007, we recorded share-based compensation expense of $146.2 million, and $123.1 million, respectively, associated with SFAS 123(R). In the year ended December 31, 2006, we recorded share-based compensation expense of $126.8 million associated with SFAS 123(R), which is net of a cumulative effect pre-tax adjustment of $5.6 million, or $3.8 million after-tax. The cumulative effect results from the application of an estimated forfeiture rate for current and prior period unvested restricted stock awards.
Our share-based compensation programs consist of share-based awards granted to employees including stock options, restricted stock, performance-based restricted stock units, and restricted stock units, or RSUs, as well as our employee stock purchase plan, or ESPP. The fair value of performance based stock units is based on the market price of our stock on the date of grant and assumes that the performance criteria will be met and the target payout level will be achieved. Compensation expense is adjusted for subsequent changes in the outcome of performance-related conditions until the vesting date.
Other Income (Expense), Net
Other income (expense), net, is as follows (in millions):
             
  Year Ended December 31, 
  2008  2007  2006 
 
Interest income $72.1  $103.6  $101.2 
Interest expense  (52.0)  (40.5)  (0.9)
Impairments of investments  (60.3)  (24.4)  (34.4)
Gain (loss) on sales of investments, net  (1.1)  16.7   (2.8)
Minority interest income (expense)  (6.9)  58.4   (6.8)
Foreign exchange gains (losses), net  (9.8)  3.0   4.9 
Settlement of litigation and claims     0.1   (4.6)
Gain on sale of property     7.1    
Other, net  (6.7)  6.8   (4.5)
             
Total other income (expense), net $(64.7) $130.8  $52.1 
             
                     
           % Change 
  For the Years Ended
  2009
  2008
 
  December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
Foreign exchange gains (losses), net  11.4   (9.8)  3.0   216.3%  (426.7)%
Gain on the sale of property        7.1   0.0%  (100.0)%
Other, net  1.0   (6.6)  6.9   114.9%  (197.1)%
                     
Other income (expense), net $37.3  $(57.7) $72.4   164.5%  (179.8)%
                     
 
Interest Income
 
For 2009 as compared to 2008, interest income decreased primarily due to lower yields on cash, cash equivalents, and marketable securities, offset by higher average cash balances.
For 2008 compared to 2007, interest income decreased $31.5 million, or 30.4%, primarily due to a reduction in cash and cash equivalents due to the funding of our tender offer in July 2007, a net payment of $525.5 million for our term loan facility and other debt, and lower investment yields. For 2007 compared to 2006, interest income increased $2.4 million, or 2.4%, primarily due to higher yields offset by a reduction in cash and cash equivalents due to the funding of our tender offer in July 2007. We expect that further reductions in yields may impact our interest income in 2009.
 
Interest Expense
 
For 2009 as compared to 2008, interest expense decreased primarily due to decreased average debt balances. In addition in 2009, approximately $5.4 million was recorded as a reduction of interest expense due to the amortization of the deferred gain associated with the termination of an interest rate swap in December 2008. This is further described in Note 8,Derivative Instrumentsto our Consolidated Financial Statements.
For 2008 compared to 2007, interest expense increased $11.5 million, or 28.4%, primarily due to an increased average debt balance in 2008 as compared to 2007 as well as $8.9 million of expense incurred in 2008 due to the impact of hedge ineffectiveness


53


as discussed in Note 4,8,Derivative Instrumentsto our Consolidated Financial Instruments. ForStatements.
We capitalized interest costs related to construction in progress totaling approximately $28.5 million, $23.2 million and $10.1 million in 2009, 2008 and 2007, comparedrespectively, which were primarily related to 2006,the development of our large-scale biologic manufacturing facility in Hillerød, Denmark, which as a result reduced our interest expense increased $39.6 million, primarily due toby the increased debt levels relating to our tender offer funded in July 2007 (see Note 21, Tender Offer). As discussed in Note 4, Financial Instruments, in 2008 we terminated certain interest rate swaps. Upon termination ofsame amount. We expect the swaps, the carrying amount of the 6.875% Senior Notes dueinterest capitalized in 2018 increased by $62.8 million as it was accounted for as a fair value hedge. This amountrelation to this facility will be recognized as a reduction of interest expense and amortized using the effective interest rate method over the remaining life of the Senior Notes.decrease in 2010.
 
Impairment on Investments
 
In 2008,April 2009, we implemented newly issued accounting standards which provided guidance for recognition and presentation ofother-than-temporary impairments. The adoption of this guidance did not have a material impact on our financial position or results of operations; however, this standard amended theother-than-temporary impairment model for marketable debt securities. The impairment model for equity securities was not affected. Refer to Note 7,Financial Instrumentsto our Consolidated Financial Statements for additional information on the adoption of this guidance.
In 2009, we recognized impairment losses of $7.0 million on our publicly-held strategic investments and non-marketable securities and an additional $3.6 million in charges for theother-than-temporary impairment on investments was due to an other than temporary decline in the fair value ofour marketable debt securities primarily related to mortgage and asset-backed securities.
In 2008, we recognized impairment losses of $18.6 million on our publicly-held strategic investments and non-marketable securities and an additional $41.7 million in impairment on our marketable debt securities primarily related to mortgage, asset-backed and corporate securities.
In 2007 we recognized impairment losses of $18.4 million on our publicly-held strategic investments and non-marketable securities and an additional $7.5 million in impairment on our marketable debt securities primarily related to non agency mortgage and asset backed securities and corporate securities classified as available for sale as well as other than temporary declines in the fair values of our strategic investments of $18.6 million. In 2007 and 2006, the impairment of investments is primarily due to the other than temporary decline in value in our strategic investments portfolio. asset-backed securities.
We may incur additional impairment charges on these investments in the future.


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Minority Interest
For 2008 compared to 2007, minority interest decreased $65.3 million, primarily due to the recording in 2007 of $64.3 million in minority interest pursuant to the initial consolidation of Cardiokine in August 2007 and Neurimmune in November 2007. For 2007 compared to 2006, minority interest increased $65.2 million, also primarily due to the initial consolidation of Cardiokine and Neurimmune in 2007. The minority interest related to Cardiokine and Neurimmune recorded in 2007 offset an equal charge to IPR&D, which resulted in no net impact to our results of operations for these IPR&D and minority interest charges. Excluding the impact of these consolidations, minority interest expense was $6.9 million, $5.9 million and $6.8 million for the years ended December 31, 2008, 2007 and 2006, respectively.
GainImpairment on Sale of Property
 
We own or lease real estate primarily consisting of buildings that contain research laboratories, office space, and biologic manufacturing operations, some of which are located in markets that are experiencing high vacancy rates and decreasing property values. If we decide to consolidate, co-locate or dispose of certain aspects of our business operations, for strategic or other operational reasons, we may dispose of one or more of our properties. Due to reduced expectations of product demand, improved yields on production and other factors, we may not fully utilize our manufacturing facilities at normal levels resulting in idle time at facilities or substantial excess manufacturing capacity. We are always evaluating our current strategy, as well as other alternatives, including whether to delay completion of the Denmark facility. If any of our owned properties are held for sale, or disposed of, we may not realize the full investment in these properties and incur significant impairment charges if the fair value of the properties were determined to be lower than their book value. In 2007,addition, if we sold approximately 28 acresdecide to fully or partially vacate a leased property, we may incur significant cost, including lease termination fees, rent expense in excess of land in Oceanside, California for $16.5 million. We recorded a pre-tax gainsublease income and impairment of approximately $7.1 million on the sale.leasehold improvements.
 
Income Tax Provision
 
Due to tax law changes in certain jurisdictions, during 2008 we completed a reorganization of our domestic and international corporate structure and moved certain personnel and operational functions between affiliates. We anticipate the restructuring will impact amounts subject to future taxation in the U.S. and foreign jurisdictions. We anticipate the changes in our international structure will have a slight unfavorable impact on our effective tax rate for 2009 and beyond, as compared to our tax rate in 2008. We do not anticipate that the domestic reorganization will have a significant impact on our tax rate in 2009 and beyond as compared to our 2008 tax rate.Tax Rate
                     
        % Change
  For the Years Ended
 2009
 2008
  December 31, Compared
 Compared
(In millions, except percentages) 2009 2008 2007 to 2008 to 2007
 
Effective tax rate on pre-tax income  26.7%  31.6%  32.0%  (15.5)%  (1.3)%
Income tax expense $355.6  $365.8  $272.4   (2.8)%  34.3%
 
Our effective tax rate fluctuates from year to year due to the nature of our global operations. The factors that most significantly impact our effective tax rate include variability in the allocation of our taxable earnings between multiple jurisdictions, changes in tax laws, acquisitions and licensing transactions.
In 2009, our effective tax rate was 31.8%, 29.9% and 56.6% on pre-tax income forimpacted by the years ended December 31, 2008, 2007 and 2006, respectively. following significant items:
• Tax impact from licensing transaction —During 2009, we entered into a collaboration and license agreement with Acorda. As there is no income tax benefit associated with either the $110.0 million upfront payment made to Acorda or our development spending on fampridine outside the U.S., these payments had a 2.1% unfavorable impact on our 2009 effective tax rate.
• Tax impact from changes in tax laws— We established deferred tax assets and adjusted certain deferred tax liabilities, and adjusted our reserves for uncertain tax positions, due to changes in tax laws in certain states in which we operate. This had a favorable effect of 2.3% on our 2009 effective tax rate.
• Tax impact from resolution of tax audits —The resolution of federal, state and foreign tax audits resulted in reducing our reserves for several uncertain tax positions, which had a favorable effect of 2.1% on our 2009 effective tax rate.
Our effective tax rate in 20082009 was higherlower than that in 2007, primarily2008 due to an increasedthe net effect of the three items noted above and a higher percentage of our foreign earnings being subject to U.S. income tax andtaxation in 2008. The effect of the effectsallocation of our reorganization of our international operations during 2008,earnings was partially offset by certain tax credits and deferred tax assets which will be realized as a result of our 2008 domestic reorganization.
 
Our effective tax rate for 2006in 2008 was higher than the rate for 2007 primarily due to a reorganization of our international operations in 2008 and the write-offallocation of non-deductible IPR&Dour earnings subject to U.S. taxation in connection witheach year.
The 2008 domestic and foreign reorganizations to our corporate structure involved the acquisitionsmovement of Conformacertain personnel, operations and Fumapharm, offset by a non-deductible gainprocesses among our affiliates. Our effective tax rate will continue to be dependent on settlementthe allocation of our profits among jurisdictions and the Fumapharm license agreement,percentage of our foreign earnings which are subject to taxation in the U.S.
We expect our 2010 effective tax rate to be between 28% and 30%. This rate does not consider the impact of acquisition-related intangible amortization related to foreign jurisdictionsa potential renewal of the federal research and state taxes, offset by the effect of lower incomedevelopment tax in certainnon-U.S. jurisdictions.
Refer to Note 15, Income Taxes, in “Notes to Consolidated Financial Statements”, for full income tax rate reconciliations for 2008, 2007 and 2006.credit.


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Financial Condition and Liquidity
 
Our financial condition is summarized as follows (in millions):follows:
 
         
  December 31,
  December 31,
 
  2008  2007 
 
Cash and cash equivalents $622.4  $659.7 
Marketable securities and loaned securities — current and non-current  1,640.4   1,456.1 
         
Total cash, cash equivalents, and marketable securities (including loaned securities) $2,262.8  $2,115.8 
         
Working capital $1,534.8  $179.2 
Outstanding borrowings — current and non-current $1,113.1  $1,563.0 
             
        % Change
 
        2009
 
  As of December 31,  Compared
 
(In millions, except percentages) 2009  2008  to 2008 
 
Financial assets:            
Cash and cash equivalents $581.9  $622.4   (6.5)%
Marketable and loaned securities — current  681.8   749.0   (9.0)%
Marketable securities — non-current  1,194.1   891.4   34.0%
             
Total financial assets $2,457.8  $2,262.8   8.6%
             
Borrowings:            
Current portion of notes payable and line of credit $19.8  $27.7   (28.5)%
Notes payable and line of credit  1,080.2   1085.4   (0.5)%
             
Total borrowings $1,100.0  $1,113.1   (1.2)%
             
Working capital $1,765.7  $1,534.8   15.0%
             
 
Our cash, cash equivalents, and marketable securities atFor the year end December 31, 2008, are relatively consistent with the balances at December 31, 2007. However, there2009, certain significant cash flows were several significantas follows:
• $1,074.9 million of cash flows generated from operations, inclusive of the $110.0 million upfront payment made to Acorda on July 1, 2009;
• $751.2 million used for share repurchases;
• $745.4 million in total payments for income taxes;
• $229.1 million used for net purchases of marketable securities; and
• $165.6 million used for purchases of property, plant and equipment.
Significant cash flow activities includingduring 2008 included the net repayment of approximately $513.0$525.5 million of indebtedness, $738.9 million used to fund share repurchases, as well as$222.8 used for the net purchases of marketable securities, and $276.0 million used to purchase property, plant and equipment offset by cash generated from operations of $1,566.5 million and cash received from the termination of our interest rate swaps of $53.9$1,562.4 million. During the year ended December 31, 2008, we paid approximately $72.5 million in milestone and other payments pursuant to our research and development programs, including $31.5 million pursuant to our Genentech agreement, $25.0 million of contingent purchase price in connection with our Conforma acquisition and $10.5 million related to the development of theBeta-Amyloid antibody under our arrangement with Neurimmune Therapeutics AG. We also received $75.0 million pursuant to our Elan collaboration. All of these milestone payments are included in cash from operations except the conforma payment which is included in investing activities on the consolidated statement of cash flows.
 
Until required for use in the business, we invest our cash reserves in bank deposits, certificates of deposit, commercial paper, corporate notes, foreign and U.S. government instruments, and other interest bearing marketable debt instruments in accordance with our investment policy. The value of these securities may be adversely affected which could impact our financial position and our overall liquidity. In particular, the value of our investments may be adversely affected by increases in interest rates, downgrades in the corporate bonds included in our portfolio, instability in the global financial markets that reduces the liquidity of securities included in our portfolio, declines in the value of collateral underlying the mortgage, auto and credit card asset backed securities included in our portfolio, and by other factors which may result in other than temporary declines in value of the investments. Each of these events may cause us to record charges to reduce the carrying value of our investment portfolio or sell investments for less than our acquisition cost. We attempt to mitigate these risks with the assistance of our investment advisors by investing in high quality securities and continuously monitoring the overall risk profile of our portfolio. We also maintain a well diversified portfolio that limits our credit exposure through concentration limits set within our investment policy.
As noted in Note 3, Fair Value Measurements, in “Notes to Consolidated Financial Statements,” a majority of our financial assets and liabilities have been classified as Level 2. These assets and liabilities have been initially valued at the transaction price and subsequently valued utilizing third party pricing services. The pricing services use many observable market inputs to determine value, including reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates, other industry, and economic events. We validate the prices provided by our third party pricing services by understanding the models used, obtaining market values from other pricing sources, and analyzing pricing data in certain instances. The fair values of our foreign currency forward contracts, interest rate swaps, debt instruments and plan assets for deferred compensation are based on market inputs and have been classified as Level 2. While we believe the valuation methodologies are appropriate, the use of valuation methodologies is highly judgmental and changes in methodologies can have a material impact on the values of these assets, our financial position, and overall liquidity. Refer to Item 7A of this Form 10-K, “Quantitative and Qualitative Disclosure About Market Risk,” for further discussion of the impact of changes in interest rates on these investments.


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We have financed our operating and capital expenditures principally through cash flows from our operations. We financed our common stock tender offer in July 2007 through the use of debt and existing cash. We expect to finance our current and planned operating requirements principally through cash from operations, as well as existing cash resources. We believe that theseexisting funds, will be sufficientcash generated from operations and existing sources of, and access to, meetfinancing are adequate to satisfy our operating, working capital, strategic alliance and acquisition, milestone payments, capital expenditures and debt service requirements for the foreseeable future. However,In addition, we plan to opportunistically pursue our stock repurchase program and other business initiatives, including acquisition and licensing activities. We may, from time to time, seek additional funding through a combination of new collaborative agreements, strategic alliances and additional equity and debt financings or from other sources.
 
On December 4, 2008, Standard & Poor’s upgraded our credit rating from BBB to BBB+. According to public records,Please read the rating action reflects the prospects for continued growth of our multiple sclerosis (MS) franchise and our conservative financial policies. Specifically, Standard & Poor’s stated that our liquidity is more than adequate and that no significant debt is maturing in the near term, which for us is 2013. We have sufficient liquid funds in cash and marketable securities and have access to a $360.0 million credit facility.
See Part I, Item 1A, “Risk Factors” and “Quantitative and Qualitative Disclosures About Market Risk” sections of thisForm 10-K report for risk factorsitems that could negatively impact our cash position and ability to fund future operations.
 
Operating activities
Cash provided by operations is primarily driven by our net income and adjusted for non-cash items. On an ongoing basis, we expect cash provided from operating activities will continue to be our primary source of funds to finance operating needs and capital expenditures. In 2008, 2007, and 2006, net cash provided by operating activities was $1,566.5 million, $1,020.6 million, and $841.3 million, respectively.
The increase in cash from operating activities for 2008 as compared to 2007, was primarily due to higher earnings net of a higher investment in working capital and the proceeds received from the termination of the interest rate swap.
The increase in cash from operating activities in 2007 as compared to 2006 was primarily due to higher earnings. Movements in working capital accounts, which were a use of funds of $77.9 million in 2007 as compared to a use of funds of $103.3 million in 2006, also contributed to this increase.
Investing activities
In 2008, 2007, and 2006, net cash used in investing activities was $365.9 million, $286.6 million, and $599.8 million, respectively.
In 2008, our sources of cash from investing activities consisted primarily of the net proceeds from sales and purchases of marketable securities. Our primary use of cash in investing activities consisted primarily of the purchases of property plant and equipment of $275.9 million. Payments pursuant to acquisitions and licenses were $25.0 million, which related to our 2006 acquisition of Conforma. The change in balance of collateral received under securities lending is reflected as a source of cash in investing activities offset by a use of cash from financing activities.
In 2007, net proceeds from sales of marketable securities of $209.0 million, were used to partially fund the tender offer described in Note 21, Tender Offer. Purchases of property, plant and equipment totaled $284.1 million in 2007. Payments made for acquisitions were $95.8 million in 2007, which primarily related to our acquisition of Syntonix for $42.3 million, and our collaboration payments to Cardiokine Biopharma LLC for $50.0 million and Neurimmune of $2.0 million. The change in balance of collateral received under securities lending is reflected as a use of cash in investing activities offset by a source of cash from financing activities. Additionally, in 2007 we sold our position in a strategic investment for $99.5 million.
In 2006, net cash used to purchase marketable securities was $162.8 million. Purchases of property, plant and equipment totaled $198.3 million for 2006. Payments made for acquisitions were $363.3 million in 2006, which related to our acquisitions of Fumapharm and Conforma. Proceeds from the sale of product lines were $59.8 million in 2006, which related to the sale of AMEVIVE.


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Financing activities
In 2008, 2007, and 2006, net cash used in financing activities was $1,236.7 million, $735.2 million, and $148.4 million, respectively.
The primary increase in use of cash in 2008 was the repayment of our term loan facility of $1,500.0 million, and the purchase of our common stock of $738.9 million, offset in part by the issuance of long-term debt, net, of $987.0 million, and proceeds of $178.5 million relating to the exercise of stock options and purchases of our stock under our share based compensation arrangements.
In 2007, the primary use of cash related to the repurchase of treasury stock via the tender offer of $2,990.5 million. This repurchase was partially funded with cash proceeds from a short-term note of $1,500.0 million. This transaction is described in Note 21, Tender Offer. Additionally, cash proceeds from issuance of stock for our share based compensation arrangements were $489.2 million, which was primarily attributable to the exercise of stock options and participation in our ESPP plan. The change in balance of collateral received under securities lending is reflected as a use of cash in investing activities offset by a source of cash from financing activities.
In 2006, the primary use of cash was $320.3 million for the purchase of treasury stock, offset by $147.0 million in proceeds from issuance of stock for our share based compensation arrangements.
Borrowings
On March 4, 2008, we issued $450.0 million aggregate principal amount of 6.0% Senior Notes due March 1, 2013 and $550.0 million aggregate principal amount of 6.875% Senior Notes due March 1, 2018 for proceeds of $987.0 million, net of issuance costs. Additionally, in connection with the note issuance, we entered into interest rate swaps, which were terminated in December 2008 and are further described in Note 4, Financial Instruments.
We used the proceeds of this offering, along with cash and the proceeds from the liquidation of marketable securities, to repay the $1,500.0 million term loan facility we had entered into in July 2007 in connection with the funding of our June 2007 tender offer.
In June 2007, we also entered into a five-year $400.0 million Senior Unsecured Revolving Credit Facility, which we may use for working capital and general corporate purposes. The bankruptcy of Lehman Brothers Holdings Inc. in September 2008 has eliminated their $40.0 million commitment, thereby reducing the availability of the credit facility to $360.0 million. The terms of this revolving credit facility include various covenants, including financial covenants that require us to not exceed a maximum leverage ratio and under certain circumstance, an interest coverage ratio. As of December 31, 2008, we were in compliance with these covenants and there were no borrowings outstanding under this credit facility.
Tender Offer
On June 27, 2007, pursuant to the terms of a modified “Dutch Auction” tender offer, we accepted for payment 56,424,155 shares of our common stock at a price of $53.00 per share for a purchase price of $2,990.5 million. We funded the tender offer through existing cash and cash equivalents of $1,490.5 million and a $1,500.0 million term loan facility as described in Note 8, Indebtedness. All of the shares repurchased were retired in July 2007.
Commitments
As of December 31, 2008, we have completed the first phase of construction of our large-scale biologic manufacturing facility in Hillerød, Denmark, which included partial completion of a bulk manufacturing component, a labeling and packaging component, and installation of major equipment. We are proceeding with the second phase of the project, including the completion of the large scale bulk manufacturing component and construction of a warehouse. As of December 31, 2008, we had contractual commitments of approximately $14.5 million for the second phase. This second phase of the project is expected to be ready for commercial production in 2010.


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The timing of the completion and anticipated licensing of the bulk manufacturing facility is in part dependent upon market acceptance of TYSABRI. See “Risk Factors — Our near-term success depends on the market acceptance and successful sales growth of TYSABRI.” We continue to evaluate our requirements for TYSABRI inventory and additional manufacturing capacity in light of the approved label and our judgment of the potential market acceptance of TYSABRI in MS, and additional approved indications in the U.S., EU and other jurisdictions.
Share Repurchase Programs
 
In October 2004,2009, our Board of Directors authorized the repurchase of up to $1.0 billion of our common stock, with repurchased shares being retired. This repurchase program does not have an expiration date. As of December 31, 2009, approximately 8.8 million shares at a cost of $422.4 million were repurchased under this program, all of which were retired. From January 1, 2010 through February 5, 2010, we repurchased approximately an additional 5.4 million shares under this program at a total cost of approximately $289.4 million, all of which were also retired. Approximately $288.2 million remains available for the repurchase of our common stock under the 2009 program. The remaining shares that may be purchased under this program is subject to price fluctuations of our common stock.


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In October 2006, our Board of Directors authorized the repurchase of up to 20.0 million shares of our common stock that expired October 4, 2006, under thisstock. This repurchase program we repurchased 7.5 million shares at a costwas completed during the fourth quarter of $320.3 million in 2006. In October 2006, our Board of Directors authorized the repurchase of up to an additional 20.02009. During 2009, approximately 7.2 million shares of our common stock. This repurchase program does not have an expiration date. We havestock were repurchased for approximately $328.8 million under this program. During 2008, approximately 12.8 million shares of our common stock were repurchased for approximately $738.9 million under this program. We used the 2006 share repurchase program principally for share stabilization.
Cash, Cash Equivalents and Marketable Securities
Until required for use in the business, we invest our cash reserves in bank deposits, certificates of deposit, commercial paper, corporate notes, U.S. and foreign government instruments and other interest bearing marketable debt instruments in accordance with our investment policy. We attempt to mitigate credit risk in our cash reserves and marketable securities by maintaining a well diversified portfolio that limits the amount of investment exposure as to institution, maturity, and investment type. In particular, the value of our investments may be adversely affected by increases in interest rates, downgrades in the corporate bonds included in our portfolio, instability in the global financial markets that reduces the liquidity of securities included in our portfolio, and by other factors which may result in other-than-temporary declines in the value of the investments. Each of these events may cause us to record charges to reduce the carrying value of our investment portfolio or sell investments for less than our acquisition cost which could adversely impact our financial position and our overall liquidity.
The increase in cash and marketable securities as of December 31, 2008. Subsequent2009 as compared to December 31, 2008 is primarily due to an increase in cash from operations and proceeds from the issuance of shares under our share-based compensation programs offset by purchases of property, plant and equipment, share repurchases, payments pursuant to our collaboration agreement with Acorda and other collaboration arrangements, and purchases of strategic investments.
Borrowings
There have been no significant changes in our borrowings since December 31, 2008.
On March 4, 2008, we issued $450.0 million aggregate principal amount of 6.0% Senior Notes due March 1, 2013 and $550.0 million aggregate principal amount of 6.875% Senior Notes due March 1, 2018 for proceeds of $987.0 million, net of issuance costs. The credit rating on these notes at December 31, 2009, was Baa3 with a stable outlook by Moody’s Investors Service and BBB+ with a stable outlook by Standard & Poor’s. Additionally, in connection with the issuance of these notes, we entered into interest rate swaps, which were terminated in December 2008 and are further described in Note 6,Fair Value Measurementsto our Consolidated Financial Statements. We used the proceeds of this offering, along with cash and the proceeds from the liquidation of marketable securities, to repay the $1,500.0 million term loan facility we had entered into in July 2007 in connection with the funding of our June 2007 stock repurchase tender offer.
In June 2007, we entered into a five year $400.0 million senior unsecured revolving credit facility, which we may use for future working capital and general corporate purposes. The bankruptcy of Lehman Brothers Holdings Inc. in 2008 resulted in the elimination of their $40.0 million commitment, thereby reducing the availability of the credit facility to $360.0 million. The terms of this revolving credit facility include various covenants, including financial covenants that require us to not exceed a maximum leverage ratio and, under certain circumstances, an interest coverage ratio. As of December 31, 2009, and 2008 there were no borrowings under this credit facility and we were in compliance with applicable covenants.
Working Capital
             
        % Change 
        2009
 
  As of December 31,  Compared
 
(In millions, except percentages) 2009  2008  to 2008 
 
Current assets $2,480.6  $2,458.0   0.9%
Current liabilities  (714.9)  (923.2)  (22.6)%
             
Working capital $1,765.7  $1,534.8   15.0%
             


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We define working capital as current assets less current liabilities. The increase in working capital primarily reflects the overall reduction of current liabilities by $208.3 million primarily driven by a $147.4 million reduction in balances attributable to taxes payable. The change in total current assets was negligible as increases in net receivable balances, inventory and other current assets were offset by decreases in cash and marketable and loaned securities.
Cash Flows
                     
           % Change 
           2009
  2008
 
  For the Years Ended December 31,  Compared
  Compared
 
(In millions, except percentages) 2009  2008  2007  to 2008  to 2007 
 
Net cash flows provided by operating activities $1,074.9  $1,562.4  $1,018.8   (31.2)%  53.4%
Net cash flows used in investing activities $(395.0) $(365.9) $(286.6)  8.0%  27.7%
Net cash flows used in financing activities $(724.2) $(1,234.6) $(733.3)  (41.3)%  68.4%
Operating Activities
Cash flows from operating activities represent the cash receipts and disbursements related to all of our activities other than investing and financing activities. Cash provided by operating activities is primarily driven by our earnings and changes in working capital. We expect cash provided from operating activities will continue to be our primary source of funds to finance operating needs and capital expenditures for the foreseeable future.
Operating cash flow is derived by adjusting net income for:
• Non-cash operating items such as depreciation and amortization, impairment charges and share-based compensation charges;
• Changes in operating assets and liabilities which reflect timing differences between the receipt and payment of cash associated with transactions and when they are recognized in results of operations.
The decrease in cash provided by operating activities for 2009 as compared to 2008 was primarily driven by change in other liabilities and taxes payable, primarily due to an increase in income tax payments of $373.4 million, primarily resulting from increased earnings and the settlement of various audits in 2009, the $110.0 million upfront payment made to Acorda on July 1, 2009 and the payment of certain accrued expenses and other current liabilities.
The increase in cash from operating activities for 2008 as compared to 2007 was primarily due to higher earnings net of a higher investment in working capital and the proceeds received from the termination of the interest rate swap.
Investing Activities
The increase in net cash used in investing activities in 2009 compared to 2008 is primarily due to a decrease in collateral received under our securities lending program offset primarily by a decrease in net purchases of marketable securities and a reduction in purchases of property, plant and equipment. The decline in purchases of property, plant and equipment is primarily attributable to our Hillerød, Denmark manufacturing facility and certain other manufacturing upgrades which are near completion.
The increase in cash used in investing activities in 2008 compared to 2007 is primarily due to an increase in net purchases of marketable securities, offset by cash proceeds from collateral received under securities lending.
In 2009, significant cash flows related to investing activities consisted primarily of net purchases of marketable securities of $229.1 million. Our other primary use of cash in investing activities consisted of the purchases of property, plant and equipment of $165.6 million.
In 2008, significant cash flows related to investing activities consisted of net purchases of marketable securities of $222.8 million and net purchases of property, plant and equipment totaling $276.0 million.


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In 2007, net proceeds from sales of marketable securities of $209.0 million were used to partially fund our 2007 tender offer. Purchases of property, plant and equipment totaled $284.1 million in 2007. Payments made for acquisitions and collaborations were $95.8 million in 2007, which primarily related to our acquisition of Syntonix for $42.3 million and our collaboration payments to Cardiokine for $50.0 million and Neurimmune of $2.0 million. The change in balance of collateral received under securities lending is reflected as a use of cash in investing activities offset by a source of cash from financing activities. Additionally, in 2007 we sold our position in a strategic investment for $99.5 million.
Financing Activities
The decrease in cash used in financing activities in 2009 compared to 2008 is due, principally, to the repayment of our term loan facility of $1,500.0 million in 2008, offset by the issuance of our notes payable, a decrease in the amount of stock options exercised, and a decrease in obligations under our securities lending program.
The increase in cash used in financing activities in 2008 as compared to 2007 is due principally to a reduction in the net proceeds received from borrowings offset by an overall decrease in the amount of common stock repurchased.
In 2009, we repurchased approximately 1.216.0 million additionalshares for $751.2 million under our 2009 and 2006 share repurchase programs.
The primary use of cash in 2008 was for the repayment of our term loan facility of $1,500.0 million and the repurchase of our common stock for $738.9 million, offset in part by the net proceeds of $987.0 million from the issuance of long-term debt and proceeds of $178.5 million from the issuance of shares under this program atour share based compensation programs.
In 2007, the primary use of cash related to the repurchase of our common stock for $2,990.5 million by means of a total costtender offer. This repurchase was partially funded with cash proceeds from a short-term note of $57.6$1,500.0 million. Additionally, cash proceeds from the issuance of shares under our share based compensation programs were $489.2 million, which was attributable to the exercise of stock options and have approximately 6.0 million shares remaining for repurchase availableparticipation in our employee stock purchase plan. The change in balance of collateral received under this program.securities lending is reflected as a use of cash in investing activities offset by a source of cash from financing activities.
 
Contractual Obligations and Off-Balance Sheet Arrangements
 
AtContractual Obligations
The following summarizes our contractual obligations (excluding funding commitments, contingent milestone payments and other off-balance sheet arrangements as described below) as of December 31, 2008,2009, and the effects such obligations are expected to have on our liquidity and cash flows in future periods:
                     
  Payments Due by Period 
     Less than
  1 to 3
  4 to 5
  After
 
(In millions) Total  1 Year  Years  Years  5 Years 
 
Non-cancellable operating leases(1) $381.8  $33.0  $63.0  $58.5  $227.3 
Notes payable and line of credit(2)  1,442.0   84.9   143.8   535.1   678.2 
Purchase obligations(3)  42.4   36.1   6.3       
Defined benefit obligation  5.7            5.7 
                     
Contractual obligations $1,871.9  $154.0  $213.1  $593.6  $911.2 
                     
(1)Includes fifteen-year lease on a 356,000 square foot office building in Weston, Massachusetts, which will serve as the future location of our general and administrative offices with a planned occupancy around mid-year 2010. The initial lease term is from 2010 through 2025 under which the total minimum lease payments are $258.6 million.
(2)Notes payable and line of credit includes principal and interest payments.


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(3)Purchase obligations include our obligations of approximately $6.4 million pursuant to a dedicated resource agreement whereby a laboratory will provide us with dedicated services through 2010, $9.3 million related to the fair value of net liabilities on derivative contracts due in less than one year, approximately $12.0 million related to fixed obligations for the purchase of natural gas and $3.4 million in construction commitments related to our manufacturing facility in Hillerød, Denmark.
The table above excludes tax payments totaling approximately $105.0 million to be made in the first half of 2010 related to the settlement of certain federal and state tax audits in 2009, and also excludes liabilities pertaining to uncertain tax positions as we cannot make a reliable estimate of the period of cash settlement with the respective taxing authorities. As of December 31, 2009, we have approximately $52.6 million of long-term liabilities associated with uncertain tax positions.
Funding Commitments
As of December 31, 2009, we have funding commitments of up to approximately $25.5$24.8 million as part of our investment in biotechnology oriented venture capital funds. In addition,
As of December 31, 2009, we have several ongoing clinical trials. Our most significant clinical trial expenditures are to clinical research organizations (CROs). The contracts with CROs are generally cancellable, with notice, at our option. We have recorded accrued expenses of $31.7 million on our consolidated balance sheet for work done by CROs as of December 31, 2009. We have approximately $460.0 million in cancellable future commitments based on existing CRO contracts as of December 31, 2009 which are not included in the contractual obligations table above as they are cancellable.
Contingent Milestone Payments
Based on our development plans as of December 31, 2009, we have committed to make potential future milestone payments to third parties of up to approximately $1,237.7$1,500.0 million as part of our various collaborations, including licensing and development programs. Payments under these agreements generally become due and payable only upon achievement of certain developmental, regulatoryand/or commercial milestones. Because the achievement of these milestones had not occurred as of December 31, 2008,2009, such contingencies have not been recorded in our financial statements. We expect to makeanticipate that we may pay approximately $29.0$82.0 million of milestone payments in 2009.2010, provided various developmental, regulatory or commercial milestones are achieved.
 
At December 31, 2008, we have several clinical studiesAmounts related to contingent milestone payments are not included in various clinical trial stages. Our most significant clinical trial expendituresthe contractual obligations table above as they are to clinical research organizations, or CROs. The contracts with CROs are generally cancellable, with notice, at our option. We have recorded accrued expensescontingent on the successful achievement of $25.4 million recorded in accrued expenses on our consolidated balance sheet for work done by CROs at December 31, 2008. We have approximately $221.7 million in cancellable future commitments based on existing CRO contracts at December 31, 2008.certain development, regulatory approval and commercial milestones. These milestones may not be achieved.
Other Off-Balance Sheet Arrangements
 
We do not have any significant relationships with entities often referred to as structured finance or special purpose entities which would have been established for the purpose of facilitating off-balance sheet arrangements. As such, we are not exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in such relationships. We consolidate entities within the scope of FIN 46(R) if we are the primary beneficiary.
The following summarizes our contractual obligations (excluding funding and contingent milestone payments as described above and construction commitments disclosed above under “Commitments”) at December 31, 2008, and the effects such obligations are expected to have on our liquidity and cash flows in future periods (in millions):
                     
  Payments Due by Period 
     Less than
  1-3
  4-5
  After
 
  Total  1 Year  Years  Years  5 Years 
 
Non-cancellable operating leases $399.2  $31.4  $67.2  $54.0  $246.6 
Notes payable, including interest  1,515.0   92.9   142.6   562.0   717.5 
Other long-term obligations  24.1   9.8   8.9      5.4 
                     
Total contractual cash obligations $1,938.3  $134.1  $218.7  $616.0  $969.5 
                     
This table includes our obligation of approximately $12.8 million pursuant to a dedicated resource agreement whereby a laboratory will provide us with dedicated services through 2010. This table excludes any liabilities pertaining to uncertain tax positions as we cannot make a reliable estimate of the period of cash settlement with the respective taxing authorities. In connection with the adoption of FASB Interpretation No. 48Accounting for Uncertainty in Income Taxes — an Interpretation of FASB Statement No. 109, or FIN 48, we reclassified


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approximately $113.0 million in reserves for uncertain tax positions from current taxes payable to long term liabilities. At December 31, 2008, we have approximately $145.2 million of long term liabilities associated with uncertain tax positions.
 
Legal Matters
 
SeePlease read Note 19,Litigationto the consolidated financial statementsour Consolidated Financial Statements for a discussion of legal matters as of December 31, 2008.2009.
 
Critical Accounting Estimates
 
The discussion and analysis of our financial conditionposition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America.(U.S. GAAP). The preparation of these consolidated financial statements in accordance with U.S. GAAP requires us to make estimates and assumptionsjudgments that may affect the reported amounts of assets, liabilities, revenues and liabilitiesexpenses, and therelated disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.liabilities. On an ongoing basis, management evaluates its criticalwe evaluate our estimates and judgments, including among others, those related to revenue recognition and related allowances, marketable


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securities, derivatives and hedging activities, inventory, impairments of long-lived assets including intangible assets, impairments of goodwill, income taxes including the valuation allowance for deferred tax assets, valuation of investments, inventory, research and development expenses, purchase accounting, goodwill impairment, stock-based compensation,contingencies and income taxes. Those criticallitigation, and share-based payments. We base our estimates and assumptions are based on our historical experience our observance of trends in the industry, and on various other factorsassumptions that we believe are believed to be reasonable, under the circumstances andresults of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.liabilities. Actual results may differ from these estimates under different assumptions or conditions.
 
We believe the following critical accounting estimates affect our more significant judgmentsestimates and estimatesjudgments used in the preparation of our consolidated financial statements:
 
Revenue Recognition and Accounts Receivable
• Revenue recognition;
• Collaborative relationships;
• Clinical trial expenses;
• Consolidation of variable interest entities;
• Inventory;
• Investments;
• Impairment of financial instruments;
• Impairment of long-lived assets including goodwill;
• Valuation of acquired intangible assets and IPR&D;
• Share-based compensation;
• Income taxes; and
• Contingencies.
 
Product RevenuesRevenue Recognition
 
We recognize revenue when all of the following criteria are met: persuasive evidence of an arrangement exists; delivery of product has occurred or services have been rendered; the seller’s price to the buyer is fixed or determinable; and collectibility is reasonably assured.
Product Revenues
Revenues from product sales are recognized when title and risk of loss have passed to the customer, which is typically upon delivery. However, sales of TYSABRI in the U.S. are recognized on the “sell-through” model, that is, upon shipment of the product by Elan to its third party distributor rather than upon shipment to Elan. The timing of distributor orders and shipments can cause variability in earnings.
Reserves for Discounts and Allowances
 
Revenues are recorded net of applicable reserves for trade term discounts, wholesaler incentives, Medicaid rebates, VA rebates, managed care rebates, product returns and other applicable allowances. Our product revenue reserves are based on estimates of the amounts earned or to be claimed on the related sales. These estimates take into consideration our historical experience, current contractual and statutory requirements, specific known market events and trends and forecasted customer buying patterns. If actual results vary, we may need to adjust these estimates, which could have an effect on earnings in the period of the adjustment. TheseThe estimates we make with respect to these allowances represent the most significant judgments that we make with regard to revenue recognition.
 
RoyaltiesRoyalty Revenues
 
We receive royalty revenues under license agreements with a number of third parties that sell products based on technology we have developed by us or to which we haveown rights. The license agreements provide for the payment of royalties to us based on sales of thethese licensed product.products. There are no future performance obligations on our part


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under these license agreements. We record these revenues based on estimates of the sales that occurred during the relevant period. The relevant period estimates of sales are based on interim data provided by licensees and analysis of historical royalties that have been paid to us, adjusted for any changes in facts and circumstances, as appropriate. We maintain regular communication with our licensees in order to gaugeassess the reasonableness of our estimates. Differences between actual royalty revenues and estimated royalty revenues are reconciled and adjusted for in the period in which they become known, typically the following quarter. Historically, adjustments have not been material based onwhen compared to actual amounts paid by licensees.


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Investments To the extent we do not have sufficient ability to accurately estimate revenues; we record such revenues on a cash basis.
 
We invest in various types of securities, including:
• short-term and long-term marketable securities, principally corporate notes, government securities and other asset backed securities, in which our excess cash balances are invested. Restrictions that limit the amount of investment exposure by institution, maturity and type are detailed in our Investment Policy. The objectives of this policy are safety of principal, liquidity and lastly yield.
• equity securities in certain publicly-traded biotechnology companies some of which we have collaborative agreements with; and
• equity securities of certain companies whose securities are not publicly traded and where fair value is not readily available.
These investments are accounted for in accordanceRevenue Arrangements with Statement of Financial Accounting Standards No. 115,Accounting for Certain Investments in Debt and Equity SecuritiesMultiple Deliverables, or SFAS 115, or APB No. 18,The Equity Method of Accounting for Investments in Common, or APB 18, as appropriate.
 
In accordance with Statement of Financial Accounting Standards No. 157,Fair Value Measurement, or SFAS 157, we have classified our financial assets and liabilities as Level 1, 2 or 3 within the fair value hierarchy. Fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that we have the ability to access. Fair values determined by Level 2 inputs utilize data points that are observable such as quoted prices, interest rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data pointsOctober 2009 a new accounting standard for the assetrecognition of revenue arrangements with multiple deliverables was issued. This standard provides accounting principles and application guidance on whether multiple deliverables exist, how the arrangement should be separated, and how the consideration should be allocated. This new approach is effective prospectively for revenue arrangements entered into or liability.
As notedmaterially modified in Note 3, Fair Value Measurements, a majority of our financial assets and liabilities have been classified as Level 2. These assets and liabilities have been initially valued at the transaction price and subsequently valued utilizing third party pricing services. The pricing services use many observable market inputs to determine value, including reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates, other industry, and economic events. We validate the prices provided by our third party pricing services by understanding the models used, obtaining market values from other pricing sources, and analyzing pricing data in certain instances.
We also have some investments classified as Level 3 whose fair value is initially measured at transaction prices and subsequently valued using the pricing of recent financingand/fiscal years beginning on or by reviewing the underlying economic fundamentals and liquidation value of the companies. We apply judgments and estimates when we validate the prices provided by third parties. after June 15, 2010. While we believedo not expect the valuation methodologies are appropriate, the useadoption of valuation methodologies is highly judgmental and changes in methodologies can have a material impact on our results of operations.
Impairment
In accounting for investments, we evaluate if a decline in the fair value of a marketable security below our cost basis is other-than-temporary, and if so, we record an impairment charge in our consolidated statement of income. The factors that we consider in our assessments for our investments in debt securities include the fair market value of the security, the duration of the security’s decline, and our ability and intentthis standard to hold to maturity. For our investments in equity securities, we consider the fair market value of the security, the duration of the security’s decline as well as prospects for the investee, including favorable clinical trial results, new product initiatives, new collaborative agreements and our intent and ability to hold to recovery. The determination of whether a loss is other than temporary is highly judgmental and can have a material impact on our financial results.position and results of operations, this standard may impact us in the event we complete future transactions or modify existing collaborative relationships. Refer to Note 23,New Accounting Pronouncementsto our Consolidated Financial Statements for additional discussion of this standard and its impact on us.
 
InventoryCollaborative Relationships
 
Inventories are stated atEffective January 1, 2009, we adopted a newly issued accounting standard for the loweraccounting and disclosure of cost or market with cost determined under thefirst-in, first-out, or FIFO, method. Included in inventory are raw materials usedan entity’s collaborative arrangements. This newly issued standard prescribes that certain transactions between collaborators be recorded in the productionincome statement on either a gross or net basis, depending on the characteristics of pre-clinicalthe collaboration relationship. In accordance with this guidance, we must also evaluate our collaborative agreements for proper income statement classification based on the nature of the underlying activity. Amounts due from our collaborative partners related to development activities are generally reflected as a reduction of research and clinicaldevelopment expense because the performance of contract development services is not central to our operations. For collaborations with commercialized products, whichif we are expensedthe principal we record revenue and the corresponding operating costs in their respective line items within our consolidated statements of income. If we are not the principal, we record operating costs as a reduction of revenue. TheRevenue RecognitionTopic of the Codification describes the principal as the party who is responsible for delivering the product or service to the customer, has latitude to determine price, and has the risks and rewards of providing product or service to the customer, including inventory and credit risk.
As discussed within Note 17,Collaborationsto our Consolidated Financial Statements, Genentech incurs the majority of continuing development cost for RITUXAN. Expenses incurred by Genentech in the development of RITUXAN are not recorded as research and development costs when consumed.


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Our policy is to capitalize inventory costs associated withexpense, but rather reduce our products prior to regulatory approval, when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Our accounting policy addresses the attributes that should be considered in evaluating whether the costs to manufactureshare of co-promotion profits recorded as a product have met the definitioncomponent of an asset as stipulated in FASB Concepts Statement No. 6,Elements of Financial Statements — A Replacement of FASB Concepts No. 3, or FASB Concepts Statement No. 6. We assess the regulatory approval process and where the particular product stands in relation to that approval process including any known constraints and impediments to approval, including safety, efficacy and potential labeling restrictions. We evaluate our anticipated research and development initiatives and constraints relating to the product and the indication in which it will be used. We consider our manufacturing environment including our supply chain in determining logistical constraints that could possibly hamper approval or commercialization. We consider the shelf life of the product in relation to the expected timeline for approval and we consider patent related or contract issues that may prevent or cause delay in commercialization. We are sensitive to the significant commitment of capital to scale up production and to launch commercialization strategies. We also base our judgment on the viability of commercialization, trends in the marketplace and market acceptance criteria. Finally, we consider the reimbursement strategies that may prevail with respect to the product and assess the economic benefit that we are likely to realize.
There is a risk inherent in these judgments and any changes we make in these judgments may have a material impact on our results in future periods.
We periodically review our inventories for excess or obsolete inventory and write-down obsolete or otherwise unmarketable inventory to its estimated net realizable value. If the actual net realizable value is less than that estimated by us, or if there are any further determinations that inventory will not be marketable based on estimates of demand, additional inventory write-downs will be required. Additionally, our products are subject to strict quality control and monitoring throughout the manufacturing process. Periodically, certain batches or units of product may no longer meet quality specifications or may expire. As a result, included in costs of goods sold are write-downs of commercial inventory that do not meet quality specifications or became obsolete due to expiration.unconsolidated joint business revenue.
 
Research and DevelopmentClinical Trial Expenses
 
Research and development expenses consist of upfront fees and milestones paid to collaborators and expenses incurred in performing research and development activities including salaries and benefits, facilities expenses, overhead expenses, clinical trial and related clinical manufacturing expenses, contract services and other outside expenses. Research and development expenses are expensed as incurred. The timing of upfront fees and milestone payments in the future may cause variability in future research and development expense. Clinical trial expenses include expenses associated with contract research organizations, or CROs. The invoicing from CROs for services rendered can lag several months. We accrue the cost of services rendered in connection with CRO activities based on our estimate of site management, monitoring costs, and project management costs. We maintain regular communication with our CRO vendorsCROs to gauge the reasonableness of our estimates. Differences between actual clinical trial expenses and estimated clinical trial expenses recorded have not been material and are adjusted for in the period in which they become known.
 
ValuationConsolidation of Acquired Intangible Assets and In-process Research and Development ExpensesVariable Interest Entities
 
We have acquired, and expect to continue to acquire, intangible assets primarily through the acquisition of biotechnology companies. These intangible assets primarily consist of technology associated with human therapeutic products and in-process product candidates. When significant identifiable intangible assets are acquired, an independent third-party valuation firm is generally engaged to assist in determining the fair values of these assets as of the acquisition date. Management will determine the fair value of less significant identifiable intangible assets acquired. Discounted cash flow models are typically used in these valuations, and these models require the use of significant estimates and assumptions including but not limited to:
• estimating the timing of and expected costs to complete the in-process projects;
• projecting regulatory approvals;


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• estimating future cash flows from product sales resulting from completed products and in-process projects; and
• developing appropriate discount rates and probability rates by project.
We believe the fair values assigned to the intangible assets acquired are based upon reasonable estimates and assumptions given available facts and circumstances as of the acquisition dates.
FIN 46(R)
Under FIN 46(R),we consolidate variable interest entities forin which we are the primary beneficiary. For such consolidated entities where we own less than a 100% interest, we record noncontrolling interest in our statement of income for the current results allocated to the third party equity interests. In determining whether we are the primary beneficiary, we consider a number of factors, including determining the expected losses and residual returns of the technologies being developed pursuant to collaborations and other economic risk and reward of such collaborations.


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Discounted cash flow models are typically used in these analyses and these models require the use of significant estimates and assumptions including but not limited to:
 
 • assuming that the research and development efforts will result in an approved commercial product;
 
 • estimating the timing of and expected costs to complete the in-process projects;
 
 • projecting timing of regulatory approvals;
 
 • estimating future cash inflows from product sales or funding from partners resulting from completed products and in-process projects; and
 
 • developing appropriate discount rates and probability rates by project.
 
For such consolidated entities that we own less than a 100% interest, we record minority interest in our statement of income for the current results allocated to the outside equity interests. FIN 46(R) impactsThese factors affect the way we account for certain collaborations and futurecollaborations. Future events may result in our consolidation of companies or related entities with which we have a collaborative arrangement. The consolidation of variable interest entities may have a material effect on our financial conditionand/or and results of operation in future periods.
 
Effective January 1, 2010, a new accounting standard will amend previously issued accounting guidance for the consolidation of variable interest entities and will affect how an enterprise determines whether its variable interest or interests give it a controlling financial interest in a variable interest entity. This new standard may affect how we account for the consolidation of common structures, such as joint ventures, equity method investments, collaboration and other agreements and purchase arrangements. Under this revised guidance, the determination about whether an enterprise should consolidate a variable interest entity is required to be evaluated continuously. Refer to Note 23,New Accounting Pronouncementsto our Consolidated Financial Statements for additional discussion of this standard and its impact on us.
GoodwillInventory
Inventories are stated at the lower of cost or market with cost determined under thefirst-in, first-out (FIFO) method. Included in inventory are raw materials used in the production of pre-clinical and clinical products, which are expensed as research and development costs when consumed.
Capitalization of Inventory Costs
Our policy is to capitalize inventory costs associated with our products prior to regulatory approval, when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. We consider numerous attributes in evaluating whether the costs to manufacture a particular product should be capitalized as an asset. We assess the regulatory approval process and where the particular product stands in relation to that approval process, including any known constraints and impediments to approval, including safety, efficacy and potential labeling restrictions. We evaluate our anticipated research and development initiatives and constraints relating to the product and the indication in which it will be used. We consider our manufacturing environment including our supply chain in determining logistical constraints that could hamper approval or commercialization. We consider the shelf life of the product in relation to the expected timeline for approval and we consider patent related or contract issues that may prevent or cause delay in commercialization. We are sensitive to the significant commitment of capital to scale up production and to launch commercialization strategies. We also base our judgment on the viability of commercialization, trends in the marketplace and market acceptance criteria. Finally, we consider the reimbursement strategies that may prevail with respect to the product and assess the economic benefit that we are likely to realize.
We expense previously capitalized costs related to pre-approval inventory upon a change in such judgment, due to, among other potential factors, a denial or delay of approval by necessary regulatory bodies. As of December 31, 2009 and 2008, the carrying value of our inventory did not include any costs associated with products that had not yet received regulatory approval.
There is a risk inherent in these judgments and any changes we make in these judgments may have a material impact on our results in future periods.


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Obsolescence and Unmarketable Inventory
We periodically review our inventories for excess or obsolete inventory and write-down obsolete or otherwise unmarketable inventory to its estimated net realizable value. If the actual net realizable value is less than that estimated by us, or if it is determined that inventory utilization will further diminish based on estimates of demand, additional inventory write-downs may be required. Additionally, our products are subject to strict quality control and monitoring which we perform throughout the manufacturing process. In the event that certain batches or units of product no longer meet quality specifications or become obsolete due to expiration, we will record a charge to cost of sales to write-down any obsolete or otherwise unmarketable inventory to its estimated net realizable value. In all cases product inventory is carried at the lower of cost or its estimated net realizable value.
Investments
 
We annuallyinvest in various types of securities, including:
• short-term and long-term marketable securities, principally corporate notes, government securities including government sponsored enterprise mortgage-backed securities and credit card and auto loan asset-backed securities, in which our excess cash balances are invested;
• equity securities in certain publicly-traded biotechnology companies, some of which have collaborative agreements with us;
• equity securities of certain companies whose securities are not publicly traded and where fair value is not readily available; and
• investment in biotechnology oriented venture capital funds where fair value is not readily available.
These investments are accounted for in accordance with accounting standards for certain investments in debt and equity securities.
We monitor the financial performance of our portfolio of investments which are subject to concentration limits set within our investment policy to help mitigate and limit the amount of investment exposure as to institution, maturity and investment type. The objectives of this policy are safety of principal, liquidity and yield.
In accordance with the accounting standard for fair value measurements we have classified our financial assets and liabilities as Level 1, 2 or 3 within the fair value hierarchy. Fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that we have the ability to access. Fair values determined by Level 2 inputs utilize data points that are observable such as quoted prices, interest rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data points for the asset or liability.
As noted in Note 6,Fair Value Measurementsto our Consolidated Financial Statements, a majority of our financial assets and liabilities have been classified as Level 2. These assets and liabilities have been initially valued at the transaction price and subsequently valued utilizing third party pricing services. The pricing services use many observable market inputs to determine value, including reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. We validate the prices provided by our third party pricing services by understanding the models used, obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming those securities trade in active markets.
We also have some investments classified as Level 3 whose fair value is initially measured at transaction prices and subsequently valued using the pricing of recent financing or by reviewing the underlying economic fundamentals and liquidation value of the companies. We apply judgments and estimates when we validate the prices provided by third parties. While we believe the valuation methodologies are appropriate, the use of valuation methodologies is highly judgmental and changes in methodologies can have a material impact on our results of operations.


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Impairment of Financial Instruments
Other-than-Temporary Impairments
In April 2009, we implemented newly issued accounting standards which provide guidance for the recognition, measurement and presentation ofother-than-temporary impairments. This newly issued standard amended theother-than-temporary impairment model for debt securities and requires additional disclosures regarding the calculation of credit losses and the factors considered in reaching a conclusion that an investment is notother-than-temporarily impaired. The impairment model for equity securities was not affected.
Prior to our adoption of these new accounting standards in April 2009, we recognized allother-than-temporary impairment amounts related to our debt securities in earnings as required under the previously effective guidance which required that management assert that it had the ability and intent to hold a debt security until maturity or until we recovered the cost of our investment. Under the new accounting standards, another-than-temporary impairment must be recognized through earnings if an investor has the intent to sell the debt security or if it is more likely than not that the investor will be required to sell the debt security before recovery of its amortized cost basis. However, even if an investor does not expect to sell a debt security, expected cash flows to be received must be evaluated to determine if a credit loss has occurred. In the event of a credit loss, only the amount associated with the credit loss is recognized in income. The amount of losses relating to other factors, including those resulting from changes in interest rates, are recorded in accumulated other comprehensive income. The adoption of this guidance did not have a material impact on our financial position or results of operations.
Evaluating Investments forOther-than-Temporary Impairments
We conduct periodic reviews to identify and evaluate each investment that has an unrealized loss, in accordance with the meaning ofother-than-temporary impairment and its application to certain investments, as required under theInvestment for Debt and Equity SecuritiesTopic of the Codification. An unrealized loss exists when the current fair value of an individual security is less than its amortized cost basis. Unrealized losses onavailable-for-sale securities that are determined to be temporary, and not related to credit loss, are recorded, net of tax, in accumulated other comprehensive income.
Foravailable-for-sale debt securities with unrealized losses, management performs an analysis to assess whether we intend to sell or whether we would more likely than not be required to sell the security before the expected recovery of the amortized cost basis. Where we intend to sell a security, or may be required to do so, the security’s decline in fair value is deemed to beother-than-temporary and the full amount of the unrealized loss is recorded within earnings as an impairment loss.
Regardless of our intent to sell a security, we perform additional analysis on all securities with unrealized losses to evaluate losses associated with the creditworthiness of the security. Credit losses are identified where we do not expect to receive cash flows sufficient to recover the amortized cost basis of a security.
For equity securities, when assessing whether a decline in fair value below our cost basis isother-than-temporary, we consider the fair market value of the security, the duration of the security’s decline, and the financial condition of the issuer. We then consider our intent and ability to hold the equity security for a period of time sufficient to recover our carrying value. Where we have determined that we lack the intent and ability to hold an equity security to its expected recovery, the security’s decline in fair value is deemed to beother-than-temporary and is recorded within earnings as an impairment loss.
Impairment of Long-lived Assets including Goodwill
Long-lived Assets Other than Goodwill
We periodically evaluate whether current facts or circumstances indicate that the carrying value of our long-lived assets to be held and used, including property plant and equipment, as well as intangible assets, whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. Factors we consider that could indicate a change in circumstances include, but are not limited to:
• a significant decline in the observable market value of an asset;


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• a significant adverse change in the extent or manner in which an asset is used;
• a significant adverse change or development in strategy or operations that negatively impact the utilization of our long-lived assets;
• a significant change in industry or economic trends;
• significant underperformance of the asset in relation to historical or projected future operating results;
If such circumstances are determined to exist, an estimate of undiscounted future cash flows produced by the long-lived asset, including its eventual residual value, is compared to the carrying value to determine whether impairment exists. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written-down to their estimated fair values.
Determining whether impairment has occurred typically requires various estimates and assumptions, including determining which undiscounted cash flows are directly related to the potentially impaired asset, the useful life over which cash flows will occur, their amount, and the asset’s residual value, if any. We derive the required undiscounted cash flow estimates from our historical experience and our internal business plans.
We did not recognize an impairment charge related to our long-lived assets, other than goodwill, during 2009, 2008 and 2007.
Goodwill
We assess our goodwill balance within our single reporting unit annually and whenever events or changes in circumstances indicate the carrying value of goodwill may not be recoverable in accordance with theIntangibles-Goodwill and OtherTopic of the Codification to determine whether any impairment in this asset may exist and, if so, the extent of such impairment. To doThe provisions of this inguidance require that we perform a two-step impairment test. In the case of goodwillfirst step, we estimatecompare the fair value of eachour reporting unit to its carrying value. If the carrying value of the net assets assigned to our reporting unit exceeds the fair value of our reporting units and compare itunit, then the second step of the impairment test is performed in order to determine the implied fair value of our reporting unit’s goodwill. If the carrying value of our reporting unit’s goodwill exceeds its implied fair value, then the company records an impairment loss equal to the bookdifference.
We calculate the fair value of their net assets. Calculatingour reporting unit utilizing both an income approach and a market approach. The income approach utilizes a discounted cash flow model with multiple scenarios for future growth. The discount is calculated based on our cost of capital rate. The market approach utilizes revenue and other metrics from similar publicly traded companies. The results of both fair value calculations are then compared to our reporting unit’s carrying value. We completed our required annual impairment test in the fourth quarter of 2009, 2008 and 2007 and determined in each of those periods that the carrying value of goodwill was not impaired. In each year, the fair value of our reporting unit, which includes goodwill, was significantly in excess of the carry value of our reporting unit.
The determination of the fair value of a reporting unit is judgmental in nature and involves the use of significant estimates and assumptions. The estimates and assumptions used in calculating fair value include identifying future cash flows, which requires that we make a number of critical legal, economic, market and business assumptions that reflect our best estimates as of the testing date. We believe the methods we use to determine these underlying assumptions and estimates are reasonable. Notwithstanding this, ourOur assumptions and estimates may differ significantly from actual results, or circumstances could change that would cause us to conclude that an impairment now exists or that we previously understated the extent of impairment.
 
Valuation of Acquired Intangible Assets and In-process Research and Development Expenses
We have acquired, and expect to continue to acquire, intangible assets primarily through the acquisition of biotechnology companies. These intangible assets primarily consist of technology associated with human therapeutic products and in-process product candidates. When significant identifiable intangible assets are acquired, we generally engage an independent third-party valuation firm to assist in determining the fair values of these assets as of the acquisition date. Management will determine the fair value of less significant identifiable intangible assets


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acquired. Discounted cash flow models are typically used in these valuations, and these models require the use of significant estimates and assumptions including but not limited to:
• estimating the timing of and expected costs to complete the in-process projects;
• projecting regulatory approvals;
• estimating future cash flows from product sales resulting from completed products and in-process projects; and
• developing appropriate discount rates and probability rates by project.
We believe the fair values assigned to the intangible assets acquired are based upon reasonable estimates and assumptions given available facts and circumstances as of the acquisition dates.
If these projects are not successfully developed, the sales and profitability of the company may be adversely affected in future periods. Additionally, the value of the acquired intangible assets may become impaired. We believe that the foregoing assumptions used in the IPR&D analysis were reasonable at the time of the respective acquisition. No assurance can be given, however, that the underlying assumptions used to estimate expected project sales, development costs or profitability, or the events associated with such projects, will transpire as estimated.
We account for business combinations completed on or after January 1, 2009 in accordance with the revised guidance for accounting for business combinations, which modifies the criteria that must be met to qualify as a business combination and prescribes new accounting requirements, including the accounting treatment associated with acquired IPR&D. Before January 1, 2009 we measured acquired IPR&D at fair value and expensed it on the acquisition date, or capitalized it as intangible assets if certain criteria were met. Effective January 1, 2009, acquired IPR&D is measured at fair value and capitalized as intangible assets and tested for impairment until completion of programs and amortized from the date of completion over its estimated useful life.
Share-based Compensation
 
We make certain assumptions in order to value and expense our share-based compensation. In connection with valuing stock options and our employee stock purchase plan, we use the Black-Scholes model, which requires us to estimate certain subjective assumptions. The key assumptions we make are: the expected volatility of our stock; the expected term of the award; and the expected forfeiture rate. In connection with our restricted stock programs, we make assumptions principally related to the forfeiture rate. In addition, for our performance-vested restricted stock programs, we estimate the performance factor each period end in order to estimate the actual number of shares that will be earned. For example, performance-vested restricted stock programs are usually based on company performance metrics such as annual revenue and earnings per share. Thus, during the performance period, we estimate our full year revenue and earnings per share and then adjust the performance factor after the completion of the full year.
 
We review our valuation assumptions periodically and, as a result, we may change our valuation assumptions used to value share-based awards granted in future periods. Such changes may lead to a significant change in the expense we recognize in connection with share-based payments.


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New forms of equity awards are expected to be granted to certain employees beginning in 2010: restricted stock units which will vest based on market conditions and performance-vested restricted stock units which will be settled in cash. The market based awards require the use of a binomial model or Monte Carlo simulation for valuation at grant date and include key assumptions such as the expected market price of the company’s stock on the vest date and the expected number of vested shares. The cash settled awards will be marked to market at each period end with fluctuations in value reported through earnings. We will apply forfeiture rate assumptions similar to those utilized by us when accounting for our other share-based compensation programs.
Income Taxes
 
In preparing our consolidated financial statements, we estimate our income tax liability in each of the jurisdictions in which we operate by estimating our actual current tax expense together with assessing temporary differences resulting from differing treatment of items for tax and financial reporting purposes. These differences


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result in deferred tax assets and liabilities, which are included in our consolidated balance sheets. Significant management judgment is required in assessing the realizability of our deferred tax assets. In performing this assessment, we consider whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. In making this determination, under the applicable financial accounting standards, we are allowed to consider the scheduled reversal of deferred tax liabilities, projected future taxable income, and the effects of viable tax planning strategies. Our estimates of future taxable income include, among other items, our estimates of future income tax deductions related to the exercise of stock options. In the event that actual results differ from our estimates, we adjust our estimates in future periods and we may need to establish a valuation allowance, which could materially impact our financial position and results of operations.
 
FASB Interpretation No. 48
Effective January 1, 2007, we adopted FIN 48. FIN 48 clarifiesWe account for uncertain tax positions using a “more-likely-than-not” threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors that include, but are not limited to, changes in tax law, the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with FASB Statement No. 109,Accounting for Income Taxes,or SFAS 109. FIN 48 also prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of each tax positionpositions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity and changes in facts or circumstances related to a tax return. Asposition. We evaluate uncertain tax positions on a resultquarterly basis and adjust the level of the adoption of FIN 48, we recognized a reductionliability to reflect any subsequent changes in the relevant facts surrounding the uncertain positions. Our liabilities for uncertain tax positions can be relieved only if the contingency becomes legally extinguished through either payment to the taxing authority or the expiration of the statute of limitations, the recognition of the benefits associated with the position meet the “more-likely-than-not” threshold or the liability becomes effectively settled through the examination process. We consider matters to be effectively settled once the taxing authority has completed all of its required or expected examination procedures, including all appeals and administrative reviews; we have no plans to appeal or litigate any aspect of the tax position; and we believe that it is highly unlikely that the taxing authority would examine or re-examine the related tax position. We also accrue for potential interest and penalties, related to unrecognized tax benefits of $14.2 million, which was recorded as a $1.8 million reduction to the January 1, 2007 balance of our accumulated deficit, a $9.1 million reduction in goodwill and a $3.3 million increase in our deferredincome tax liability.expense.
 
A reconciliationContingencies
We are currently involved in various claims and legal proceedings. On a quarterly basis, we review the status of each significant matter and assess its potential financial exposure. If the potential loss from any claim or legal proceeding is considered probable and the amount can be reasonably estimated, we accrue a liability for the estimated loss. Significant judgment is required in both the determination of probability and the determination as to whether an exposure is reasonably estimable. Because of uncertainties related to these matters, accruals are based only on the best information available at the time. As additional information becomes available, we reassess the potential liability related to pending claims and litigation and may revise our estimates. These revisions in the estimates of the beginningpotential liabilities could have a material impact on our consolidated results of operations and ending amount of unrecognized tax benefits is as follows (in millions):
         
  2008  2007 
 
Balance at January 1 $221.1  $196.8 
Additions based on tax positions related to the current period  21.8   29.7 
Additions for tax positions of prior periods  20.4   83.5 
Reductions for tax positions of prior periods  (13.7)  (70.2)
Settlements     (18.7)
         
Balance at December 31 $249.6  $221.1 
         
Included in the balance of unrecognized tax benefits at December 31, 2008, December 31, 2007, and January 1, 2007, are $155.1 million, $110.5 million, and $98.2 million (net of the federal benefit on state issues), respectively, of unrecognized tax benefits that, if recognized, would affect the effective income tax rate in any future periods. We do not anticipate any significant changes in our positions in the next twelve months.financial position.
 
New Accounting Standards
 
SeePlease read Note 27, 23,New Accounting Pronouncementsto our Consolidated Financial Statements for a discussion of new accounting standards.
 
Item 7A.  Quantitative and Qualitative Disclosures About Market Risk
 
We have operations in Canada, Brazil, Argentina, Australia, New Zealand, Japan, China, and India and throughout Europe in connection with the sale of AVONEX and TYSABRI and in Germany in connection with the sale of FUMADERM. We also receive royalty revenues based on worldwide product sales by our licensees and through Genentech on sales of RITUXAN outsidein the rest of the U.S.world. As a result, our financial position, results of operations and cash flows can be affected by market fluctuations in foreign currency exchange rates, (primarilyprimarily with respect to the Euro, Danish kroner, Swedish krona, British pound, Japanese yen, Canadian dollar and Swiss franc).franc.


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We use foreign currency forward contracts to manage foreign currency risk but do not engage in currency speculation. We use theseThe majority of our forward contracts are used to hedge certain forecasted revenue transactions


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denominated in foreign currencies. AWe also use forward contracts to mitigate the foreign currency exposure related to certain balance sheet items. We have not elected hedge accounting for the balance sheet related items.
The following quantitative information includes the impact of currency movements on forward contracts used in both programs. As of December 31, 2009 and 2008, a hypothetical adverse 10% movement in foreign exchange rates compared to the U.S. dollar across all maturities (for example, a strengthening of the Euro) would result in a hypothetical decrease in the fair value of forward contracts of approximately $64.4 million and $52.4 million.million, respectively. Our use of this methodology to quantify the market risk of such instruments should not be construed as an endorsement of its accuracy or the accuracy of the related assumptions. The quantitative information about market risk is necessarily limited because it does not take into account all foreign currency operating transactions.
 
Certain of our debt instruments are variable rate instruments and our interest expense associated with these instruments is, therefore, subject to changes in market interest rates. AAs of December 31, 2009 and 2008, a 100 basis-point adverse movement (increase in LIBOR) would increase annual interest expense by approximately $0.2 million.million in each period.
 
In addition, the fair value of our marketable securities is subject to change as a result of potential changes in market interest rates. The potential change in fair value for interest rate sensitive instruments has been assessed on a hypothetical 100 basis point adverse movement across all maturities. WeAs of December 31, 2009 and 2008, we estimate that such hypothetical adverse 100 basis point movement would result in a hypothetical loss in fair value of approximately $16.9 million and $12.2 million, respectively, to our interest rate sensitive instruments.
 
The returns from cash, cash equivalents and marketable securities will vary as short-term interest rates change. A 100 basis-point adverse movement (decrease) in short-term interest rates would decrease interest income by approximately $12.5 million and $11.9 million.million as of December 31, 2009 and 2008, respectively.
 
We are exposed to equity price risks on the marketable portion of equity securities included in our portfolio of investments entered into for the promotion of business and strategic objectives. These investments are generally in small capitalization stocks in the biotechnology industry sector. We regularly review the market prices of these investments for impairment purposes. A hypothetical adverse 10% movement in market values would result in a hypothetical loss in fair value of approximately $1.0 million and $0.9 million.million as of December 31, 2009 and 2008, respectively.
 
Item 8.  Consolidated Financial Statements and Supplementary Data
 
The information required by this Item 8 is contained on pagesF-1 throughF-64 F-65 of this Annual Report onForm 10-Kreport and is incorporated herein by reference.
 
Item 9.  Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
 
Not applicable.None.
 
Item 9A.  Controls and Procedures
 
Disclosure Controls and Procedures and Internal Control over Financial Reporting
 
Controls and Procedures
 
We have carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined inRules 13a-15(e) and15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Securities Exchange Act)amended), as of December 31, 2008.2009. Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of the end of thatthe period covered by this report, our disclosure controls and procedures are effective in providing reasonable assuranceensuring that (a) the information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (b) such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure


62


controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives,


64


and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
 
Changes in Internal Control over Financial Reporting
 
Section 404 of the Sarbanes-Oxley Act of 2002 requires us to evaluate annually the effectiveness of our internal controls over financial reporting as of the end of each fiscal year, and to include a management report assessing the effectiveness of our internal control over financial reporting in all annual reports. There were no changes in our internal control over financial reporting during the quarter ended December 31, 20082009 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
 
Management’s Annual Report on Internal Control over Financial Reporting
 
Our management is responsible for establishing and maintaining adequate internal control over our financial reporting. Internal control over financial reporting is defined inRules 13a-15(f) and15d-15(f) under the Securities Exchange Act as a process designed by, or under the supervision of, a company’s principal executive and principal financial officers and effected by a company’s board of directors, management and other personnel 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.principles in the U.S. (U.S. GAAP). Our internal control over financial reporting includes those policies and procedures that:
 
 • pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect theour transactions and dispositions of our assets;
 
 • provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles,U.S. GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
 
 • provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on theour financial statements.
 
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. 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.
 
Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2008.2009. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control — Integrated Framework.
 
Based on our assessment, our management has concluded that, as of December 31, 2008,2009, our internal control over financial reporting is effective based on those criteria.
 
The effectiveness of our internal control over financial reporting as of December 31, 20082009 has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report, which is included herein.
 
Item 9B.  Other Information
 
Not applicable.None.


6563


 
PART III
 
Item 10.  Directors, Executive Officers and Corporate Governance
 
The information concerning our executive officers is set forth under the heading “Our Executive Officers” in Part I of thisForm 10-K. report. The text of our code of business conduct, which includes the code of ethics that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, and persons performing similar functions, is posted on our website, www.biogenidec.com, under the “Corporate“Board of Directors — Corporate Governance” subsection of the “Company”“About Us” section of the site. Disclosure regarding any amendments to, or waivers from, provisions of our code of business conduct, if required, will be included in a Current Report onForm 8-K within four business days following the date of the amendment or waiver, unless website posting of such amendments or waivers is permitted by the rules of The NASDAQ Stock Market, Inc. Our corporate governance principles (also posted on www.biogenidec.com) prohibit our Board of Directors from granting any waiver of the code of ethics for any of our directors or executive officers. We include our website address in this Annual Report onForm 10-Kreport only as an inactive textual reference and do not intend it to be an active link to our website.
 
The response to the remainder of this item is incorporated by reference from the discussion responsive thereto in the sections labeledentitled “Proposal 1, Election of Directors, — Information about our Board of Directors and its Committees” and “Stock Ownership — Section 16(a) Beneficial Ownership Reporting Compliance” and “Miscellaneous — Stockholder Proposals” contained in the proxy statement for our 20092010 annual meeting of stockholders.
 
Item 11.  Executive Compensation
 
The response to this item is incorporated by reference from the discussion responsive thereto in the section labeledsections entitled “Executive Compensation and Related Information” and “Proposal 1, Election of Directors — Compensation Committee Interlocks and Insider Participation” contained in the proxy statement for our 20092010 annual meeting of stockholders.
 
Item 12.  Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
 
The response to this item is incorporated by reference from the discussion responsive thereto in the sections labeledentitled “Stock Ownership” and “Disclosure with Respect to our Equity Compensation Plans” contained in the proxy statement for our 20092010 annual meeting of stockholders.
 
Item 13.  Certain Relationships and Related Transactions, and Director Independence
 
The response to this item is incorporated by reference from the discussion responsive thereto in the sections labeled “Proposal 1 — Election of Directors — Information about our Board of Directors and its Committees,” “Executive Compensation and Related Information — Potential Payments Upon Termination or Change in Control,” andentitled “Certain Relationships and Related Person Transactions” and “Proposal 1, Election of Directors — Director Independence” contained in the proxy statement for our 20092010 annual meeting of stockholders.
 
Item 14.  Principal Accountant Fees and Services
 
The response to this item is incorporated by reference from the discussion responsive thereto in the section labeledentitled “Proposal 2, — Ratification of the Selection of our Independent Registered Public Accounting Firm” contained in the proxy statement for our 20092010 annual meeting of stockholders.


6664


 

 
PART IV
 
Item 15.  Exhibits, Financial Statement Schedules
 
a. (1) Consolidated Financial Statements:
 
The Financial Statementsfinancial statements required to be filed by Item 8 of this Annual Report onForm 10-K,report and filed in this Item 15, are as follows:
 
     
Page Number
in This
Financial Statements
 Form 10-KPage Number
 
  F-2 
  F-3 
  F-4 
  F-5 
  F-7 
  F-64 
 
(2) Financial Statement Schedules
 
Schedules are omitted because they are not applicable, or are not required, or because the information is included in the consolidated financial statements and notes thereto.
 
(3) Exhibits:
 
The exhibits which are filed or furnished with this report or which are incorporated herein by reference are set forth in the Exhibit Index beginning onpage A-1, which is incorporated herein by reference.


6765


 
SIGNATURES
 
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrantregistrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
BIOGEN IDEC INC.
 
 By: 
/s/  James C. Mullen
James C. Mullen
Chief Executive Officer and President
 
Date: February 6, 20099, 2010
 
Pursuant to the requirements the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrantregistrant and in the capacities and on the dates indicated.
 
       
Name
 
Capacity
 
Date
 
     
/s/  James C. Mullen

James C. Mullen
 Director, Chief Executive Officer and President (principal executive officer) February 6, 20099, 2010
     
/s/  Paul J. Clancy

Paul J. Clancy
 Executive Vice President, Finance and Chief
Financial Officer (principal
financial officer)
 February 6, 20099, 2010
     
/s/  Michael F. MacLean

Michael F. MacLean
 Senior Vice President and Chief Accounting Officer
(principal (principal accounting officer)
 February 6, 20099, 2010
     
/s/  Bruce R. RossWilliam D. Young

Bruce R. RossWilliam D. Young
 Director;Director and Chairman of the Board of Directors February 6, 20099, 2010
     
/s/  Lawrence C. BestAlexander J. Denner

Lawrence C. BestAlexander J. Denner
 Director February 6, 20099, 2010
     
/s/  Marijn E. DekkersCaroline D. Dorsa

Marijn E. DekkersCaroline D. Dorsa
 Director February 3, 2009
/s/  Alan B. Glassberg 

Alan B. Glassberg, M.D. 
DirectorFebruary 6, 20099, 2010
     
/s/  Nancy L. Leaming

Nancy L. Leaming
 Director February 6, 20099, 2010
Richard C. Mulligan
Director
     
/s/  Robert W. Pangia

Robert W. Pangia
 Director February 6, 20099, 2010
     
/s/  Stelios Papadopoulos

Stelios Papadopoulos
 Director February 6, 20099, 2010


6866


       
Name
 
Capacity
 
Date
 
     
/s/  Cecil B. PickettBrian S. Posner

Cecil B. PickettBrian S. Posner
 Director February 6, 20099, 2010
     
/s/  Brian S. PosnerBruce R. Ross

Brian S. PosnerBruce R. Ross
 Director February 6, 20099, 2010
     
/s/  Lynn Schenk

Lynn Schenk
 Director February 6, 2009
/s/  Phillip A. Sharp

Phillip A. Sharp, Ph.D. 
DirectorFebruary 6, 2009
/s/  William D. Young

William D. Young
DirectorFebruary 6, 20099, 2010


6967



BIOGEN IDEC INC. AND SUBSIDIARIES
 
 
             
  For the Years Ended December 31, 
  2008  2007  2006 
  (In thousands, except per share amounts) 
 
Revenues:            
Product $2,839,651  $2,136,821  $1,781,313 
Unconsolidated joint business  1,128,238   926,098   810,864 
Other revenues  129,618   108,698   90,872 
             
Total revenues  4,097,507   3,171,617   2,683,049 
             
Costs and expenses:            
Cost of sales, excluding amortization of acquired intangible assets  401,989   335,192   274,383 
Research and development  1,072,058   925,164   718,390 
Selling, general and administrative  925,305   776,103   685,067 
Collaboration profit (loss) sharing  136,041   14,079   (9,682)
Amortization of acquired intangible assets  332,745   257,495   266,998 
Acquired in-process research and development  25,000   84,172   330,520 
Facility impairments and gain on disposition, net  (9,242)  (360)  (16,507)
Gain on settlement of license agreements, net        (6,140)
             
Total costs and expenses  2,883,896   2,391,845   2,243,029 
             
Income from operations  1,213,611   779,772   440,020 
Other income (expense), net  (64,668)  130,823   52,143 
             
Income before income tax provision and cumulative effect of accounting change  1,148,943   910,595   492,163 
Income tax expense  365,776   272,423   278,431 
             
Income before cumulative effect of accounting change  783,167   638,172   213,732 
Cumulative effect of accounting change, net of income tax expense        3,779 
             
Net income $783,167  $638,172  $217,511 
             
Basic earnings per share:            
Income before cumulative effect of accounting change $2.67  $2.02  $0.63 
Cumulative effect of accounting change, net of income tax        0.01 
             
Basic earnings per share $2.67  $2.02  $0.64 
             
Diluted earnings per share:            
Income before cumulative effect of accounting change $2.65  $1.99  $0.62 
Cumulative effect of accounting change, net of income tax        0.01 
             
Diluted earnings per share $2.65  $1.99  $0.63 
             
Weighted-average shares used in calculating:            
Basic earnings per share  292,332   315,836   338,585 
             
Diluted earnings per share  294,984   320,171   345,281 
             
             
  For the Years Ended December 31, 
  2009  2008  2007 
 
Revenues:            
Product $3,152,941  $2,839,651  $2,136,821 
Unconsolidated joint business  1,094,863   1,128,238   926,098 
Other  129,544   129,618   108,698 
             
Total revenues  4,377,348   4,097,507   3,171,617 
             
Costs and expenses:            
Cost of sales, excluding amortization of acquired intangible assets  382,104   401,989   335,192 
Research and development  1,283,068   1,072,058   925,164 
Selling, general and administrative  911,034   925,305   776,103 
Collaboration profit sharing  215,904   136,041   14,079 
Amortization of acquired intangible assets  289,811   332,745   257,495 
Acquired in-process research and development     25,000   84,172 
Gain on dispositions, net     (9,242)  (360)
             
Total costs and expenses  3,081,921   2,883,896   2,391,845 
             
Income from operations  1,295,427   1,213,611   779,772 
Other income (expense), net  37,252   (57,728)  72,396 
             
Income before income tax expense  1,332,679   1,155,883   852,168 
Income tax expense  355,617   365,776   272,423 
             
Net income  977,062   790,107   579,745 
Net income (loss) attributable to noncontrolling interest, net of tax  6,930   6,940   (58,427)
             
Net income attributable to Biogen Idec Inc.  $970,132  $783,167  $638,172 
             
Net income per share:            
Basic earnings per share attributable to Biogen Idec Inc.  $3.37  $2.67  $2.02 
             
Diluted earnings per share attributable to Biogen Idec Inc.  $3.35  $2.65  $1.99 
             
Weighted-average shares used in calculating:            
Basic earnings per share attributable to Biogen Idec Inc.   287,356   292,332   315,836 
             
Diluted earnings per share attributable to Biogen Idec Inc.   289,476   294,984   320,171 
             
 
See accompanying notes to thethese consolidated financial statementsstatements.


F-2


BIOGEN IDEC INC. AND SUBSIDIARIES
 
 
        
 As of December 31,         
 2008 2007  As of December 31, 
 (In thousands, except per share amounts)  2009 2008 
ASSETS
ASSETS
ASSETS
Current assets:                
Cash and cash equivalents $622,385  $659,662  $581,889  $622,385 
Marketable securities  719,586   319,408   681,835   719,586 
Collateral received for loaned securities  29,991   208,209      29,991 
Accounts receivable, net of allowances of $32,047 and $29,341 at December 31, 2008 and 2007, respectively  446,665   392,646 
Accounts receivable, net of allowances of $43,818 and $32,047 at December 31, 2009 and 2008, respectively  551,208   446,665 
Due from unconsolidated joint business  206,925   166,686   193,789   206,925 
Loaned securities  29,446   204,433      29,446 
Inventory  263,602   233,987   293,950   263,602 
Other current assets  139,400   183,376   177,924   139,400 
          
Total current assets  2,458,000   2,368,407   2,480,595   2,458,000 
          
Marketable securities  891,406   932,271   1,194,080   891,406 
Property, plant and equipment, net  1,594,754   1,497,383   1,637,083   1,594,754 
Intangible assets, net  2,161,058   2,492,354   1,871,078   2,161,058 
Goodwill  1,138,621   1,137,372   1,138,621   1,138,621 
Investments and other assets  235,152   201,028   230,397   235,152 
          
Total assets $8,478,991  $8,628,815  $8,551,854  $8,478,991 
          
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:                
Collateral payable on loaned securities $29,991  $208,209  $  $29,991 
Accounts payable  107,417   90,672   118,534   107,417 
Taxes payable  223,260   11,274   75,891   223,260 
Accrued expenses and other  534,887   367,885   500,755   534,887 
Current portion of notes payable and line of credit  27,667   1,511,135   19,762   27,667 
          
Total current liabilities  923,222   2,189,175   714,942   923,222 
          
Notes payable  1,085,431   51,843 
Notes payable and line of credit  1,080,207   1,085,431 
Long-term deferred tax liability  356,017   521,525   240,618   356,017 
Other long-term liabilities  308,238   331,977   254,205   280,369 
          
Total liabilities  2,672,908   3,094,520   2,289,972   2,645,039 
          
Commitments and contingencies (Notes 15, 16, 18 and 19)        
Commitments and contingencies (Notes 16,17,18 and 19)        
Shareholders’ equity:                
Preferred stock, par value $0.001 per share (8,000 shares authorized, of which 1,750 are designated Series A and 1,000 are designated Series X Junior Participating; 8 shares of Series A issued and outstanding with a $551 liquidation value at December 31, 2008 and 2007)      
Common stock, par value $0.0005 per share (1,000,000 shares authorized; 297,253 and 295,698 shares, and 288,046 and 295,698 shares issued and outstanding at December 31, 2008 and 2007, respectively)  149   147 
Preferred stock, par value $0.001 per share (8,000 shares authorized, of which 1,750 are designated Series A and 1,000 are designated Series X Junior Participating; 8 shares of Series A issued and outstanding with a $551 liquidation value at December 31, 2009 and 2008)      
Common stock, par value $0.0005 per share (1,000,000 shares authorized; 288,494 shares issued and 274,855 shares outstanding at December 31, 2009; 297,253 shares issued and 288,046 shares outstanding at December 31, 2008)  144   149 
Additional paid-in capital  6,073,957   5,807,071   5,781,920   6,073,957 
Accumulated other comprehensive income  (11,106)  79,246 
Retained Earnings (Accumulated deficit)  270,180   (352,169)
Treasury stock, at cost; 9,207 and 0 shares at December 31, 2008 and 2007, respectively  (527,097)   
Accumulated other comprehensive income (loss)  50,496   (11,106)
Retained earnings  1,068,890   270,180 
Treasury stock, at cost; 13,639 and 9,207 shares at December 31, 2009 and 2008, respectively  (679,920)  (527,097)
     
Total Biogen Idec Inc. shareholders’ equity  6,221,530   5,806,083 
Noncontrolling interest  40,352   27,869 
          
Total shareholders’ equity  5,806,083   5,534,295   6,261,882   5,833,952 
          
Total liabilities and shareholders’ equity $8,478,991  $8,628,815  $8,551,854  $8,478,991 
          
 
See accompanying notes to thethese consolidated financial statementsstatements.


F-3


BIOGEN IDEC INC. AND SUBSIDIARIES
 
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
 
            
 For the Years Ended December 31,             
 2008 2007 2006  For the Years Ended December 31, 
 (In thousands)  2009 2008 2007 
Cash flows from operating activities:                        
Net income $783,167  $638,172  $217,511  $977,062  $790,107  $579,745 
Adjustments to reconcile net income to net cash flows from operating activities Depreciation and amortization of fixed and intangible assets  462,059   380,293   375,870 
Adjustments to reconcile net income to net cash flows from operating activities:            
Depreciation and amortization of property, plant and equipment and intangible assets  427,961   462,059   380,293 
Acquired in process research and development and license  25,000   136,172   330,520      25,000   136,172 
Minority interest in subsidiaries  6,940   (58,427)  6,770 
Gain on settlement of license agreements, net        (6,140)
Share based compensation  146,207   123,129   126,783 
Share-based compensation  160,902   146,207   123,129 
Cash received upon termination of interest rate swap  53,873            53,873    
Non-cash interest (income) expense and foreign exchange translation loss (gain)  (4,934)  1,444   1,521 
Non-cash interest (income) expense and foreign exchange remeasurement, net  (7,892)  (4,934)  1,444 
Deferred income taxes  (139,549)  (81,555)  (106,337)  (137,351)  (139,549)  (81,555)
Realized (gain) loss on sale of marketable securities and strategic investments  1,078   (16,732)  (1,169)  (23,974)  1,078   (16,732)
Write-down of inventory to net realizable value  29,850   21,599   12,989   16,924   29,850   21,599 
Facility impairments and (gain) loss on disposition, net  (9,242)  (360)  (16,507)
Impairment of investments and other assets  61,644   24,445   34,424 
Gain on sale of property, plant and equipment, net     (9,242)  (360)
Impairment of marketable securities, investments and other assets  16,184   61,644   24,445 
Excess tax benefit from stock options  (27,990)  (69,666)  (31,682)  (3,436)  (27,990)  (69,666)
Changes in assets and liabilities, net:            
Changes in operating assets and liabilities, net:            
Accounts receivable  (57,565)  (70,701)  (37,009)  (100,442)  (57,565)  (70,701)
Due from unconsolidated joint business  (40,239)  2,022   (27,649)  13,136   (40,239)  2,022 
Inventory  (54,204)  (83,192)  (36,637)  (42,772)  (54,204)  (83,192)
Other assets  3,711   238   (20,737)  22,271   3,711   238 
Accrued expenses and other current liabilities  148,467   32,460   13,812   (48,942)  146,420   30,579 
Other liabilities and taxes payable  176,219   41,294   4,935   (194,733)  176,219   41,294 
              
Net cash flows provided by operating activities  1,564,492   1,020,635   841,268   1,074,898   1,562,445   1,018,754 
              
Cash flows from investing activities:                        
Purchases of marketable securities  (3,163,824)  (2,945,244)  (1,949,907)  (3,548,119)  (3,163,824)  (2,945,244)
Proceeds from sales and maturities of marketable securities  2,941,060   3,154,290   1,787,139   3,319,007   2,941,060   3,154,290 
Proceeds from sale of product line        59,800 
Acquisitions, net of cash acquired  (25,000)  (95,789)  (363,251)     (25,000)  (95,789)
Purchases of property, plant and equipment  (275,954)  (284,106)  (198,312)  (165,646)  (275,954)  (284,106)
Proceeds from sale of property, plant and equipment     16,669   74,216         16,669 
Purchase of other investments  (20,373)  (23,672)  (9,458)
Purchases of other investments  (44,086)  (20,373)  (23,672)
Proceeds from the sale of strategic investments     99,489      13,822      99,489 
Collateral received under securities lending  178,218   (208,209)     29,991   178,218   (208,209)
              
Net cash flows used in investing activities  (365,873)  (286,572)  (599,773)  (395,031)  (365,873)  (286,572)
              
Cash flows from financing activities:                        
Purchase of treasury stock  (738,938)  (2,991,184)  (320,268)  (751,170)  (738,938)  (2,991,184)
Proceeds from issuance of stock for share based compensation arrangements  178,486   489,180   146,959 
Proceeds from issuance of stock for share-based compensation arrangements  47,810   178,486   489,180 
Change in cash overdraft  (498)  (5,399)  (11,860)  12,275   (498)  (5,399)
Excess tax benefit from stock options  27,990   69,666   31,682   3,436   27,990   69,666 
Proceeds from borrowings  986,980   1,512,913   17,694      986,980   1,512,913 
Repayments of borrowings  (1,512,474)  (12,042)  (12,617)  (10,867)  (1,512,474)  (12,042)
Repayments of long-term debt     (6,563)           (6,563)
Net capital contribution from noncontrolling interest  4,356   2,047   1,881 
Obligation under securities lending  (178,218)  208,209      (29,991)  (178,218)  208,209 
              
Net cash flows used in financing activities  (1,236,672)  (735,220)  (148,410)  (724,151)  (1,234,625)  (733,339)
              
Net increase (decrease) in cash and cash equivalents  (38,053)  (1,157)  93,085 
Net decrease in cash and cash equivalents  (44,284)  (38,053)  (1,157)
Effect of exchange rate changes on cash and cash equivalents  776   (558)  124   3,788   776   (558)
              
Cash and cash equivalents, beginning of the year  659,662   661,377   568,168   622,385   659,662   661,377 
              
Cash and cash equivalents, end of the year $622,385  $659,662  $661,377  $581,889  $622,385  $659,662 
              
Supplemental cash flow disclosures:                        
Cash paid during the year for:                        
Interest $40,026  $35,439  $  $68,094  $40,026  $35,439 
Income taxes $371,978  $251,928  $397,931  $745,402  $371,978  $251,928 
Non-cash financing activity:                        
Conversion of subordinated notes to common and treasury stock $  $38,986  $  $  $  $38,986 
Issuance of notes to Fumedica $  $  $39,196 
 
See Note 1, Business Overview and Summary of Significant Accounting Policiesto our Consolidated Financial Statements for a discussion of non-cash securities lending activities that occurred during the period.
 
See Note 14,Other Consolidated Financial Statement Detailto our Consolidated Financial Statements for discussion of a non monetary transaction under which we sold the development rights on a parcel of land in Cambridge, MA during 2008.
See accompanying notes to thethese consolidated financial statementsstatements.


F-4


 
BIOGEN IDEC INC. AND SUBSIDIARIES
(In thousands)
 
                                                                                  
           Accumulated
                      Accumulated
 Retained
           
 Convertible
     Additional
 Other
 Deferred
       Total
          Additional
 Other
 Earnings/
     Biogen Idec Inc.
   Total
 
 Preferred Stock Common Stock Paid-in
 Comprehensive
 Stock-Based
 Accumulated
 Treasury Stock Shareholders’
  Preferred Stock Common Stock Paid-in
 Comprehensive
 (Accumulated
 Treasury Stock Shareholders’
 Noncontrolling
 Shareholders’
 
 Shares Amount Shares Amount Capital (Loss) Income Compensation Deficit Shares Amount Equity  Shares Amount Shares Amount Capital Income Deficit) Shares Amount Equity Interest Equity 
 (In thousands, except share amounts) 
Balance, December 31, 2005
  8  $   345,712  $173  $8,206,911  $(13,910) $(42,894) $(1,021,644)  (5,751) $(222,760) $6,905,876 
Balance, December 31, 2006
  8  $   345,637  $173  $8,308,232  $21,855  $(860,827)  (7,463) $(319,655) $7,149,778  $9,839  $7,159,617 
                                                
Comprehensive income:                                                                                            
Net income                              217,511           217,511                           638,172           638,172   (58,427)  579,745 
Unrealized gains on securities available for sale, net of tax of $3,062                      4,793                   4,793 
Unrealized gains on foreign currency forward contracts, net of tax of $236                      510                   510 
Unrealized gains on securities available for sale, net of tax of ($3,984)                      9,124               9,124       9,124 
Unrealized loss on foreign currency forward contracts, net of tax of $2,263                      (3,962)              (3,962)      (3,962)
Unrealized gains on pension benefit obligation, net of tax of ($370)                      2,421               2,421       2,421 
Translation adjustment                      31,205                   31,205                       49,808               49,808   1,397   51,205 
          
Total comprehensive income                                          254,019                                       695,563   (57,030)  638,533 
   
Unrealized losses on pension benefit obligation, net of tax of $437                      (743)                  (743)
Repurchase of common stock for treasury, at cost                                  (7,479)  (320,268)  (320,268)
Issuance of treasury stock under stock option and stock purchase plans                  (30,360)          (56,694)  5,767   223,373   136,319 
Forfeiture of common stock under restricted stock plan          (75)                               
Amortization of deferred stock compensation, net of forfeitures                          229               229 
Deferred stock compensation adjustment for FAS 123R                  (42,665)      42,665                
Compensation expense related to share-based payments                  131,539                       131,539 
Tax benefit from share-based payments                  42,807                       42,807 
                       
Balance, December 31, 2006
  8  $   345,637  $173  $8,308,232  $21,855  $  $(860,827)  (7,463) $(319,655) $7,149,778 
                       
Comprehensive income:                                            
Net income                              638,172           638,172 
Unrealized gains on securities available for sale, net of tax of $3,984                      9,124                   9,124 
Unrealized loss on foreign currency forward contracts, net of tax of $2,263                      (3,962)                  (3,962)
Unrealized gains on pension benefit obligation, net of tax of $370                      2,421                   2,421 
Translation adjustment                      49,808                   49,808 
   
Total comprehensive income                                          695,563 
   
Repurchase and retirement of common stock pursuant to tender offer (Note 21)          (56,424)  (29)  (2,991,155)                      (2,991,184)
Fair value of assets and liabilities acquired and assigned to noncontrolling interest due to the adoption of a new accounting standard for the consolidation of variable interests                                          65,038   65,038 
Capital contribution from noncontrolling interest                                          1,881   1,881 
Repurchase and retirement of common stock pursuant to tender offer          (56,424)  (29)  (2,991,155)                  (2,991,184)      (2,991,184)
Issuance of treasury stock from conversion of subordinated notes payable                              (83,682)  2,850   119,795   36,113                           (83,682)  2,850   119,795   36,113       36,113 
Issuance of common stock from conversion of subordinated notes payable          182      2,371                       2,371           182      2,371                   2,371       2,371 
Issuance of treasury stock under stock option and stock purchase plans                              (33,824)  2,994   135,720   101,896                           (33,824)  2,994   135,720   101,896       101,896 
Issuance of common stock under stock option and stock purchase plans          8,017   4   386,928                       386,932           8,017   4   386,928                   386,932       386,932 
Issuance of treasury stock under stock award plans                  (48,292)          135   465   18,076   (30,081)                  (48,292)      135   465   18,076   (30,081)      (30,081)
Issuance of common stock under stock award plans          45      (2,744)          (676)          (3,420)          45      (2,744)      (676)          (3,420)      (3,420)
Forfeiture of common stock under restricted stock plan          (16)                 2,378   (50)  (2,378)             (16)             2,378   (50)  (2,378)          
Compensation expense related to share-based payments                  128,101                       128,101                   128,101                   128,101       128,101 
Tax benefit from share-based payments                  67,227                       67,227                   67,227                  67,227       67,227 
Cumulative effect adjustment from adoption of FIN 48                  (10,583)          1,585           (8,998)
Adjustment for adoption for accounting of uncertain tax positions                  (10,583)      1,585           (8,998)      (8,998)
Treasury stock reclassifications          (1,743)  (1)  (33,014)      (15,430)  1,204   48,442   (3)      (3)
��                         
Balance, December 31, 2007
  8  $   295,698  $147  $5,807,071  $79,246  $(352,169)    $  $5,534,295  $19,728  $5,554,023 
                         
Comprehensive income:                                                
Net income                          783,167           783,167   6,940   790,107 
Unrealized loss on securities available for sale, net of tax of ($1,123)                      (67)              (67)      (67)
Unrealized loss on foreign currency forward contracts, net of tax of $1,522                      (36,140)              (36,140)      (36,140)
Unrealized loss on pension benefit obligation, net of tax of $0                      (43)              (43)      (43)
Translation adjustment                      (54,102)              (54,102)  (846)  (54,948)
       
Total comprehensive income                                      692,815   6,094   698,909 
Distribution to noncontrolling interest                                          (2,817)  (2,817)
Capital contribution from noncontrolling interest                                          4,864   4,864 
Repurchase of common stock for Treasury, at cost                              (12,778)  (738,938)  (738,938)      (738,938)
Issuance of common stock from conversion of subordinated notes payable          16      227                   227       227 
Issuance of common stock under stock option and stock purchase plans          852   1   34,297       (56,223)  3,380   200,411   178,486       178,486 
Issuance of common stock under stock award plans          688   1   (29,800)      (26,026)  191   11,430   (44,395)      (44,395)
Forfeiture of common stock under restricted stock plan          (1)                                
Compensation expense related to share-based payments                  153,748                   153,748       153,748 
Tax benefit from share-based payments                  29,845                   29,845       29,845 
Treasury stock reclassifications          (1,743)  (1)  (33,014)          (15,430)  1,204   48,442   (3)                  78,569       (78,569)                   
                                                
Balance, December 31, 2007
  8  $   295,698  $147  $5,807,071  $79,246  $  $(352,169)    $  $5,534,295 
Balance, December 31, 2008
  8  $   297,253  $149  $6,073,957  $(11,106) $270,180   (9,207) $(527,097) $5,806,083  $27,869  $5,833,952 
                                                
 
See accompanying notes to thethese consolidated financial statements.


F-5


BIOGEN IDEC INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY — (Continued)
(In thousands)
 
                                             
                 Accumulated
                
  Convertible
        Additional
  Other
  Deferred
           Total
 
  Preferred Stock  Common Stock  Paid-in
  Comprehensive
  Stock-Based
  Retained
  Treasury Stock  Shareholders’
 
  Shares  Amount  Shares  Amount  Capital  (Loss) Income  Compensation  Earnings  Shares  Amount  Equity 
  (In thousands, except share amounts) 
 
Comprehensive income:                                            
Net income                               783,167           783,167 
Unrealized gains on securities available for sale, net of tax of $(1,123)                      (67)                  (67)
Unrealized loss on foreign currency forward contracts, net of tax of $(1,522)                      (36,140)                  (36,140)
Unrealized gains on pension benefit obligation, net of tax of $0                      (43)                  (43)
Translation adjustment                      (54,102)                  (54,102)
                                             
Total comprehensive income                                          692,815 
                                             
Repurchase of common stock for Treasury, at cost                                  (12,778)  (738,938)  (738,938)
Issuance of common stock from conversion of subordinated notes payable          16      227                     227 
Issuance of common stock under stock option and stock purchase plans          852   1   34,297           (56,223)  3,380   200,411   178,486 
Issuance of common stock under stock award plans          688   1   (29,800)          (26,026)  191   11,430   (44,395)
Forfeiture of common stock under restricted stock plan          (1)                             
Compensation expense related to share-based payments                  153,748                       153,748 
Tax benefit from share-based payments                  29,845                       29,845 
Treasury stock reclassification                  78,569           (78,569)           
                      ��                      
Balance, December 31, 2008
  8  $   297,253  $149  $6,073,957  $(11,106) $  $270,180   (9,207) $(527,097) $5,806,083 
                                             
                                                 
                 Accumulated
  Retained
                
              Additional
  Other
  Earnings/
        Biogen Idec Inc.
     Total
 
  Preferred Stock  Common Stock  Paid-in
  Comprehensive
  (Accumulated
  Treasury Stock  Shareholders’
  Noncontrolling
  Shareholders’
 
  Shares  Amount  Shares  Amount  Capital  Income  Deficit)  Shares  Amount  Equity  Interest  Equity 
 
Comprehensive income:                                                
Net income                          970,132           970,132   6,930   977,062 
Unrealized gains on securities available for sale, net of tax of $(379)                      795               795       795 
Unrealized gains on foreign currency forward contracts, net of tax of $(3,582)                      41,668               41,668       41,668 
Unrealized gains on pension benefit obligation, net of tax of $(67)                      501               501       501 
Translation adjustment                      18,638               18,638   1,197   19,835 
                                                 
Total comprehensive income                                      1,031,734   8,127   1,039,861 
Distrbution to noncontrolling interest                                         (2,832)  (2,832)
Capital contribution from noncontrolling interest                                         7,188   7,188 
Repurchase of common stock for Treasury, at cost                              (15,982)  (751,170)  (751,170)      (751,170)
Retirement of common stock pursuant to 2009 stock repurchase plan          (8,759)  (5)  (422,415)          8,759   422,420           
Issuance of treasury stock under stock option and stock purchase plans                          (27,191)  1,181   75,001   47,810       47,810 
Issuance of treasury stock under stock award plans                          (144,231)  1,610   100,926   (43,305)      (43,305)
Compensation expense related to share-based payments                  167,207                   167,207       167,207 
Tax benefit from share-based payments                  (36,829)                  (36,829)      (36,829)
                                                 
Balance, December 31, 2009
  8  $   288,494  $144  $5,781,920  $50,496  $1,068,890   (13,639) $(679,920) $6,221,530  $40,352  $6,261,882 
                                                 
 
See accompanying notes to thethese consolidated financial statements.


F-6


 
BIOGEN IDEC INC. AND SUBSIDIARIES
 
 
1.  Business Overview and Summary of Significant Accounting Policies
 
OverviewBasis of Presentation
Consolidation
 
Biogen Idec Inc. (“Biogen Idec,” “we,” “us” or “the Company”) is an internationala global biotechnology company that creates new standards of care in therapeutic areas with high unmet medical needs. We currently market four products: AVONEX®, RITUXAN®, TYSABRI® and FUMADERM®.
Principles of Consolidation
TheOur consolidated financial statements reflect our financial statements, those of our wholly-owned subsidiaries, certain variable interest entities in which we are the primary beneficiary and those of our joint ventures in Italy and Switzerland, Biogen DompeDompé SRL and Biogen DompeDompé Switzerland Gmbh,GmbH, respectively. In accordance with FASB Interpretation No. 46 (Revised 2003),Consolidation of Variable Interest Entities, or FIN 46(R), we consolidate variable interest entities in which we are the primary beneficiary. For such consolidated entities in which we own less than a 100% interest, we record minoritynet income (loss) attributable to noncontrolling interest in our statementconsolidated statements of income forequal to the ownership interestpercentage of the minority owner.interest retained in the collaborative arrangement by the respective noncontrolling parties. All material intercompany balances and transactions have been eliminated in consolidation.
 
In determining whether we are the primary beneficiary, we consider a number of factors, including determining the expected losses and residual returns of the technologies being developed pursuant to collaborations and other economic risk and reward of such collaborations; these considerations impact the way we account for our existing collaborative relationships and may result in the future consolidation of companies or entities with which we have a collaborative arrangement.
Use of Estimates
 
The preparation of consolidated financial statements in accordance with generally accepted accounting principlesU.S. GAAP requires our management to make estimates and judgments that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-goingongoing basis, we evaluate our estimates and judgments, including those related to revenue recognition and related allowances, marketable securities, derivatives and hedging activities, inventory, impairments of long-lived assets including intangible assets, impairments of goodwill, income taxes including the valuation allowance for deferred tax assets, valuation of long-lived assets and investments, research and development expenses, contingencies and litigation, and share-based payments. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions.
 
Reclassifications
Where specified, certain prior-year amounts have been reclassified to conform to the current year’s presentation.
Translation of Foreign CurrenciesSubsequent Events
 
The functional currencyWe evaluated all events and transactions through February 9, 2009, the date we issued these financial statements. During this period we did not have any material recognizable subsequent events. However, we did have the following nonrecognizable subsequent events:
• In January 2010, Syntonix Pharmaceuticals, Inc. (Syntonix) achieved a significant development milestone obligating us to pay $40.0 million to its former shareholders. As the milestone occurred after December 31, 2009, the obligation is not reflected within our consolidated balance sheet as of that date. Such obligations are recorded when the milestone has been achieved due to the uncertainty surrounding triggering events. Refer to Note 2,Acquisitions and Dispositionsto our Consolidated Financial Statements for additional discussion.


F-7


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Revenue Recognition
We recognize revenue when all of the following criteria are met: persuasive evidence of an arrangement exists; delivery has occurred or services have been rendered; the seller’s price to the buyer is fixed or determinable; and collectibility is reasonably assured.
Product Revenues
Revenues from product sales are recognized when title and risk of loss have passed to the customer, which is typically upon delivery. However, sales of TYSABRI in the U.S. are recognized on the “sell-through” model, that is, upon shipment of the product by Elan Pharma International, Ltd. (Elan), an affiliate of Elan Corporation, plc, Elan to its third party distributor rather than upon shipment to Elan.
Product revenues are recorded net of applicable reserves for mosttrade term discounts, wholesaler incentives, Medicaid rebates, Veterans Administration (VA) rebates, managed care rebates, product returns and other applicable allowances.
Revenues from Unconsolidated Joint Business
We collaborate with the Roche Group, through its wholly-owned member Genentech, Inc., on the development and commercialization of RITUXAN. Revenues from unconsolidated joint business consist of (1) our share of pre-tax co-promotion profits in the U.S.; (2) reimbursement of our foreign subsidiaries is their local currency. Assetsselling and liabilitiesdevelopment expense in the U.S.; and (3) revenue on sales of RITUXAN in the rest of world, which consist of our share of pretax co-promotion profits in Canada and royalty revenue on sales of RITUXAN outside the U.S. and Canada by F. Hoffmann-La Roche Ltd. (Roche) and its sublicensees. Pre-tax co-promotion profits are translated at current ratescalculated and paid to us by Genentech in the U.S. and by Roche in Canada. Pre-tax co-promotion profits consist of exchange atU.S. and Canadian sales of RITUXAN to third-party customers net of discounts and allowances less the balance sheet date. Incomecost to manufacture RITUXAN,third-party royalty expenses, distribution, selling and expense itemsmarketing, and joint development expenses incurred by Genentech, Roche and us. We record our royalty and co-promotion profits revenue on sales of RITUXAN in the rest of world on a cash basis.
Royalty Revenues
We receive royalty revenues on sales by our licensees of other products covered under patents that we own. There are translated at the average exchange rates for the period. Adjustments resulting from the translationno future performance obligations on our part under these license arrangements. We record these revenues based on estimates of the financialsales that occurred during the relevant period. The relevant period estimates of sales are based on interim data provided by licensees and analysis of historical royalties that have been paid to us, adjusted for any changes in facts and circumstances, as appropriate. We maintain regular communication with our licensees in order to assess the reasonableness of our estimates. Differences between actual royalty revenues and estimated royalty revenues are adjusted for in the period in which they become known, typically the following quarter. Historically, adjustments have not been material when compared to actual amounts paid by licensees. To the extent we do not have sufficient ability to accurately estimate revenue, we record revenues on a cash basis.
Milestone Revenues
Under the terms of our collaboration agreement with Elan was required to make milestone payments to us in order to continue sharing equally in the collaboration’s results. These amounts, recorded as deferred revenue upon receipt, are recognized as product revenue in our consolidated statements of income over the term of the collaboration agreement based on a units of revenue method whereby the revenue recognized is based on the ratio of units shipped in the current period over the total units expected to be shipped over the remaining term of the collaboration.


F-8


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Reserves for Discounts and Allowances
We establish reserves for trade term discounts, wholesaler incentives, Medicaid rebates, Veteran’s Administration (VA) rebates, managed care rebates, product returns and other applicable allowances. Reserves established for these discounts and allowances are classified as reductions of accounts receivable (if the amount is payable to our foreign operations into U.S. dollarscustomer) or a liability (if the amount is payable to a party other than our customer).
In addition, we distribute no-charge product to qualifying patients under our patient assistance and patient replacement goods programs. This program is administered through one of our distribution partners, who ships product for qualifying patients from their own inventory purchased from us. Gross revenue and the related reserves are excluded fromnot recorded on product shipped under this program and cost of sales is recorded when the determinationproduct is shipped.
Product revenue reserves are categorized as follows: discounts, contractual adjustments, and returns.
Discount reserves include trade term discounts and wholesaler incentives. Trade term discounts and wholesaler incentive reserves primarily relate to estimated obligations for credits to be granted to wholesalers for remitting payment on their purchases within established incentive periods and credits to be granted to wholesalers for compliance with various contractually-defined inventory management practices, respectively. We determine these reserves based on our experience, including the timing of net incomecustomer payments.
Contractual adjustment reserves primarily relate to Medicaid, VA and managed care rebates.
• Medicaid rebate reserves relate to our estimated obligations to states under established reimbursement arrangements. Rebate accruals are recorded in the same period the related revenue is recognized resulting in a reduction of product revenue and the establishment of a liability which is included in accrued expenses and other current liabilities. Rebate amounts are generally determined at the time of claim by the state, and we generally make cash payments for such amounts within a few weeks of receiving billings from the state.
• VA rebates or chargeback reserves represent our estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices we charge to wholesalers which provide those products. The wholesaler charges us for the difference between what the wholesaler pays for the products and the ultimate selling price to the qualified healthcare providers. Rebate accruals are established in the same period as the related revenue is recognized resulting in a reduction in product revenue and accounts receivable. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider from the wholesaler, and we generally issue credits for such amounts within a few weeks of receiving notification from the wholesaler.
• Managed care rebates reserves represent our estimated obligations to third parties, primarily pharmacy benefit managers. Rebate accruals are recorded in the same period the related revenue is recognized resulting in a reduction to product revenue and the establishment of a liability which is included in accrued expenses and other current liabilities. These rebates result from performance-based offers that are primarily based on attaining contractually specified sales volumes and growth. The calculation of the accrual for these rebates is based on an estimate of the customer’s buying patterns and the resulting applicable contractual rebate rate(s) to be earned over a contractual period.
Allowances for product returns are established for returns made by wholesalers and patients and are recorded in accumulatedthe period the related revenue is recognized, resulting in a reduction to product revenue. In accordance with contractual terms, wholesalers are permitted to return product for reasons such as damaged or expired product. We also accept returns from our patients for various reasons.
Expired product return reserves are estimated through a comparison of historical return data to their related sales on a production lot basis. Historical rates of return are determined for each product and are adjusted for known or expected changes in the marketplace specific to each product.


F-9


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Bad debt reserves are based on our estimated uncollectible accounts receivable. Given our historical experiences with bad debts, combined with our credit management policies and practices, we do not presently maintain significant bad debt reserves.
In addition to the discounts and rebates described above and classified as a reduction of revenue, we also maintain certain customer service contracts with distributors and other comprehensive income,customers in the distribution channel that provide us with inventory management and distribution services. We have established the fair value of these services and classified these customer service contracts as sales and marketing expense. If we had concluded that we did not receive a separate componentidentifiable benefit or have sufficient evidence that the fair value did not exist for these services, we would have been required to classify these costs as a reduction of shareholders’ equity.
Foreign exchange transaction gains and losses are included in the results of operations in other income (expense), net. We had net foreign exchange gains (losses) of $(9.8) million, $3.0 million, and $4.9 million in 2008, 2007, and 2006, respectively.revenue.
 
Cash and Cash Equivalents
 
We consider only those investments which are highly liquid, readily convertible to cash and that mature within three months from date of purchase to be cash equivalents. As of December 31, 2009, cash equivalents were comprised of money market funds and commercial paper.
 
Fair Value Measurements
 
Effective January 1, 2009, we adopted a newly issued accounting standard for fair value measurements of all nonfinancial assets and nonfinancial liabilities not recognized or disclosed at fair value in the financial statements on a recurring basis. The adoption of the accounting standard for these assets and liabilities did not have a material impact on our financial position or results of operations; however, this standard may impact us in subsequent periods and require additional disclosures.
In the second quarter of 2009, we implemented newly issued accounting standards which provide guidance for determining fair value when the volume and level of activity for the asset or liability have significantly decreased and identifying circumstances that indicate that a transaction is not orderly. Specifically, the new standards provide additional guidelines for making fair value measurements more consistent with the principles presented and provide authoritative guidance in determining whether a market is active or inactive, and whether a transaction is distressed. This guidance is applicable to all assets and liabilities (i.e. financial and nonfinancial) and requires enhanced disclosures, including interim and annual disclosure of the input and valuation techniques (or changes in techniques) used to measure fair value and the defining of the major security types comprising debt and equity securities held based upon the nature and risk of the security. The adoption of the new standards did not impact our financial position or results of operations; however, adoption has enhanced disclosures for our investments in marketable debt securities and resulted in the reclassification of certain amounts included within our previously reported disclosures to conform to the presentation adopted in the current year.
Effective January 1, 2008, we implemented Statement of Financial Accounting Standard No. 157, Fair Value Measurement, or SFAS 157,adopted a standard for fair value measurements for our financial assets and liabilities that are re-measured and reported at fair value at each reporting period, and non-financial assets and liabilities that are re-measured and reported at fair value at least


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
annually. In accordance with the provisions of FSPNo. FAS 157-2, Effective Date of FASB Statement No. 157, we have elected to defer implementation of SFAS 157 as it relates to our non-financial assets and non-financial liabilities that are recognized and disclosed at fair value in the financial statements on a nonrecurring basis until January 1, 2009.
The adoption of SFAS 157 for financial assets and liabilities and non-financial assets and liabilities that are re-measured and reported at fair value at least annuallythis guidance did not have an impact on our consolidated financial results.position or results of operations.
 
We have certain financial assets and liabilities recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in SFAS 157. Fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active marketsthe accounting standards for identical assets or liabilities that we have the ability to access. Fair values determined by Level 2 inputs utilize data points that are observable such as quoted prices, interest rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data points for the asset or liability.fair value measurements.
• Level 1 — Fair values are determined utilizing quoted prices (unadjusted) in active markets for identical assets or liabilities that we have the ability to access;
• Level 2 — Fair values are determined by utilizing quoted prices for identical or similar assets and liabilities in active markets or other market observable inputs such as interest rates, yield curves and foreign currency spot rates; and


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BIOGEN IDEC INC. AND SUBSIDIARIES
 
Our publicly traded strategic investments have been classified as Level 1 because their fair value are based on quoted market prices. All of our marketable debt securities have been classified as Level 2. These assets have been initially valued at the transaction price and subsequently valued utilizing market-based inputs, including reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates, other industry, and economic events. The fair values of our foreign currency forward contracts, interest rate swaps, debt instruments and plan assets for deferred compensation are based on market inputs and have been classified as Level 2. We also have some investments classified as Level 3 whose fair value is initially measured at transaction prices and subsequently valued using the pricing of recent financingand/orNOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued) by reviewing the underlying economic fundamentals and liquidation value of the companies.
• Level 3 — Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable.
 
The carrying amounts reflected in the consolidated balance sheets for cash, and cash equivalents, accounts receivable, due from unconsolidated joint business, other current assets, accounts payable, and accrued expenses and other, approximate fair value due to their short-term maturities.
 
InventoryConcentration of Credit Risks
 
Inventories are stated at the lower of cost or market with cost determined under thefirst-in, first-out, or FIFO, method. Included in inventory are raw materials used in the production of pre-clinicalOur primary exposure to credit risk derives from our cash, cash equivalents, marketable securities, and clinical products, which are charged to researchreceivables from customers and development expense when consumed.
The components of inventories are as follows (in millions):
         
  December 31, 
  2008  2007 
 
Raw materials $29.8  $46.4 
Work in process  180.0   155.4 
Finished goods  53.8   32.2 
         
  $263.6  $234.0 
         
Capitalization of Inventory Costs
We capitalize inventory costs associated with our products prior to regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. We consider numerous attributes in evaluating whether the costs to manufacture a particular product should be capitalized as an asset. We assess the regulatory approval process and where the product stands in relation to that approval process including any known constraints and impediments to approval, including safety, efficacy and potential labeling restrictions. We evaluate our anticipated research and development initiatives and constraints relating to the particular product and the indication in which it will be used. We consider our


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
manufacturing environment including our supply chain in determining logistical constraints that could possibly hamper approval or commercialization. We consider the shelf life of the product in relation to the expected timeline for approval and we consider patent related or contract issues that may prevent or cause delay in commercialization. We are sensitive to the significant commitment of capital to scale up production and to launch commercialization strategies. We also base our judgment on the viability of commercialization, trends in the marketplace and market acceptance criteria. Finally, we consider the reimbursement strategies that may prevail with respect to the product and assess the economic benefit that we are likely to realize. We expense previously capitalized costs related to pre-approval inventory upon a change in such judgment, due to, among other potential factors, a denial or delay of approval by necessary regulatory bodies. As of December 31, 2008 and 2007, the carrying value of our inventory did not include any costs associated with products that had not yet received regulatory approval.
Inventory Write-Offs
We periodically review our inventories for excess or obsolete inventory and write-down obsolete or otherwise unmarketable inventory to its estimated net realizable value. If the actual realizable value is less than that estimated by us, or if it is determined that inventory utilization will further diminish based on estimates of demand, additional inventory write-downs may be required.
Our products are subject to strict quality control and monitoring which we perform throughout the manufacturing process. Periodically, certain batches or units of product may no longer meet quality specifications or may expire. As a result, included in cost of sales were write-downs of commercial inventory that did not meet quality specifications or that became obsolete due to dating expiration. In all cases product inventory is written-down to its estimated net realizable value.
We have written-down the following unmarketable inventory, which was charged to cost of sales (in millions):
             
  Year Ended December 31, 
  2008  2007  2006 
 
AVONEX $14.9  $11.1  $4.4 
TYSABRI  7.6   4.0   2.9 
FUMADERM     0.1    
AMEVIVE  6.0   0.1   2.4 
ZEVALIN  1.3   6.3   3.3 
             
  $29.8  $21.6  $13.0 
             
The write-downs were the result of the following (in millions):
             
  Year Ended December 31, 
  2008  2007  2006 
 
Failed quality specifications $16.0  $12.0  $11.2 
Excess and/or obsolescence  13.8   9.6   1.8 
             
  $29.8  $21.6  $13.0 
             
Marketable Securities and Investments
Marketable Securities, including Strategic Investmentscollaborative partners.
 
Until required for use in the business, we invest our cash reserves in bank deposits, certificates of deposit, commercial paper, corporate notes, foreign and U.S. government instruments, asset backedincluding government sponsored enterprise mortgage-backed securities, credit card and auto loan asset-backed securities and other marketable debt instruments.instruments in accordance with our investment policy. We limitmitigate credit risk by maintaining a well diversified portfolio and limiting the amount of investment exposure as to institution, maturity and investment type. At
Concentrations of credit risk with respect to receivables, which are typically unsecured, are generally limited due to the wide variety of customers and markets using our products, as well as their dispersion across many different geographic areas. Our accounts receivable are payable by wholesale distributors, large pharmaceutical companies and public hospitals. We monitor the financial performance and credit worthiness of our large customers so that we can properly assess and respond to changes in their credit profile. Our historical write-offs of accounts receivable have not been significant. As of December 31, 2009 and 2008, allone wholesale distributor accounted for approximately 8.1% and 11.0% of these securities were classified as “available-for-sale” in accordance with Statement ofconsolidated receivables, respectively.


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BIOGEN IDEC INC. AND SUBSIDIARIES
Marketable Securities and Other Investments
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)Marketable Debt Securities
 
Financial Accounting Standards No. 115,Accounting for Certain Investments in Debt and Equity Securities, or SFAS 115. All available-for-saleAvailable-for-sale debt securities are recorded at fair market value and unrealized gains and losses to the extent deemed temporary, are included in accumulated other comprehensive income in shareholders’ equity, net of related tax effects.effects, unless the security has experienced a credit loss, we have determined that we have the intent to sell the security or we have determined that it is more likely than not that we will have to sell the security before its expected recovery. Realized gains and losses are reported in other income (expense) net. Declines in value determined to be other than temporary, net, on available for sale securities are reported in other income (expense) net. This can include losses due to, among other factors, changes in credit quality, interest rates, or value declines resulting from the disruption in the capital markets during the latter half of 2008. Valuation of available-for-sale securities for purposes of determining the amount of gains and losses is based on thea specific identification method.basis.
Strategic Investments
 
As part of our strategic product development efforts, we invest in equity securities of certain biotechnology companies some of which we have collaborative agreements with suchcompanies. These investments are known as strategic investments and are classified as available for saleavailable-for-sale and accounted for as marketable securitiesequity investments or as cost investments under Accounting Principles Board Opinion No. 18,The Equity Methodbased upon our percentage ownership interest and other factors which may indicate the presumption of Accounting for Investments in Common Stock,or APB 18 and related interpretations.significant influence. When assessing whether a decline in the fair value of a strategic investment below our cost basis isother-than-temporary, we consider the fair market value of the security, the duration of the security’s decline, and prospects for the underlying business, including favorable clinical trial results, new product initiatives and new collaborative agreements.agreements with the companies in which we have invested.
 
Non-Marketable Equity Securities
 
We also invest in equity securities of companies whose securities are not publicly traded and where fair value is not readily available. These investments are recorded using either the cost method or the equity method of accounting, depending on our percentage ownership interest and other factors which may indicate the existencepresence of significant influence, as required by APB 18 and related interpretations.influence. We monitor these investments to evaluate whether any decline in their value has occurred that


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
would be other than temporary,other-than-temporary, based on the implied value from any recent rounds of financing completed by the investee,company, public market prices of comparable public companies, and general market conditions.
 
Securities lendingLending
 
We are able to loan certain securities from our portfolio to other institutions. Such securities are classified as loaned securities on the accompanying consolidated balance sheet.sheets. Collateral for the loaned securities, consisting of cash or other securities, is maintained at a rate of approximately 102% of the market value of each loaned security. We previously loaned certain securities from our portfolio to other institutions and held cash as collateral in the amount of $30.0 million and $208.2 million as of December 31, 2008 and 2007, respectively.in relation to such loans. The cash collateral iswas recorded as collateral received for loaned securities on the consolidated balance sheet. We have a current obligation to return the collateral which is reflected as collateral received on loaned securities on the accompanying consolidated balance sheet. IncomeNo such loans were outstanding as of December 31, 2009; accordingly, no collateral was held as of December 31, 2009.
Other-than-Temporary Impairments
In April 2009, we implemented a newly issued accounting standard which provides guidance for the recognition, measurement and presentation ofother-than-temporary impairments. This newly issued standard amended theother-than-temporary impairment model for debt securities and requires additional disclosures regarding the calculation of credit losses and the factors considered in reaching a conclusion that an investment isother-than-temporarily impaired. The impairment model for equity securities was not affected.
Prior to our adoption of this new accounting standard, we recognized allother-than-temporary impairment amounts related to our debt securities in earnings as required under the previously effective guidance which required that management assert that it had the ability and intent to hold a debt security until maturity or until we recovered the cost of our investment. Under the new accounting standards, another-than-temporary impairment must be recognized through earnings if an investor has the intent to sell the debt security or if it is more likely than not that the investor will be required to sell the debt security before recovery of its amortized cost basis. However, even if an investor does not expect to sell a debt security, expected cash flows to be received must be evaluated to determine if a credit loss has occurred. In the event of a credit loss, only the amount associated with the credit loss is recognized in income. The amount of losses relating to other factors, including those resulting from lending securities ischanges in interest rates, are recorded in accumulated other income (expense), net.comprehensive income. The adoption of this guidance did not have a material impact on our financial position or results of operations.
Inventory
Inventories are stated at the lower of cost or market with cost determined under thefirst-in, first-out (FIFO) method. Included in inventory are raw materials used in the production of pre-clinical and clinical products, which are charged to research and development expense when consumed.
We capitalize inventory costs associated with our products prior to regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized.
Inventory Write-Offs
We periodically review our inventories for excess or obsolete inventory and write-down obsolete or otherwise unmarketable inventory to its estimated net realizable value.
 
Property, Plant and Equipment
 
Property, plant and equipment are carried at cost, subject to review for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. Depreciation is generally calculated on the straight-line basis over the estimated useful lives of the assets. Leasehold improvements are amortized over the lesser of the useful life or the term of the respective lease. Maintenance costs are expensed as incurred. Buildings and building components are depreciated over estimated useful lives ranging from 15 to 40 years, machinery and equipment from 6 to 15 years, furniture and fixtures for 7 years and computer software and hardware from 3 to 5 years. Interest costs incurred during the construction of major capital projects are capitalized in accordance with Statement of Financial Accounting Standards No. 34,Capitalization of Interest Costs,or SFAS 34. The interest is capitalized until the underlying asset is ready for its intended use, at which point the interest cost is amortized as depreciation expense over the life of the underlying asset. We capitalize certain direct


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BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
use, at which point the interest costs are amortized as depreciation expense over the life of the underlying asset. We also capitalize certain direct and incremental costs associated with the validation effort required for licensing by regulatory agencies of manufacturing equipment for the production of a commercially approved drug. These costs include primarily direct labor and material and are incurred in preparing the equipment for its intended use. The validation costs are amortized over the life of the related equipment. Maintenance costs are expensed as incurred.
We generally depreciate or amortize the cost of our property, plant and equipment using the straight-line method over the estimated useful lives of the respective assets, which are summarized as follows:
Asset Category
Useful Lives
LandNot depreciated
Buildings15 to 40 years
Leasehold ImprovementsLesser of the useful life or the term of the respective lease
Machinery and Equipment6 to 15 years
Furniture and Fixtures7 years
Computer Software and Hardware3 to 5 years
 
Intangible Assets excluding Goodwill
Effective January 1, 2009, we implemented an amendment to the accounting and disclosure requirements related to intangible assets. This amendment provides guidance for determining the useful life of a recognized intangible asset and requires enhanced disclosures so that users of financial statements are able to assess the extent to which the expected future cash flows associated with the asset are affected by our intent and ability to renew or extend the arrangement. The adoption of this guidance did not impact our financial position or results of operations as this standard was required to be implemented prospectively; however, this standard may impact us in subsequent periods.
 
Our intangible assets consist of patents, licenses, core developed technology, trademarks, and tradenames, core technology, licenses, assembled workforce, and distribution rights, the majority of which arose in connection with the merger of Biogen Inc. and IdecIDEC Pharmaceuticals Corporation or the Merger.Corporation. These intangible assets were recorded at fair value and are stated net of accumulated amortization and impairments.
 
Intangible assets related to patents, core technology, licenses, assembled workforce and distribution rights are amortized over their remaining estimatedThe useful lives ranging from 2 to 20 years.of our intangible assets are primarily based on the legal or contractual life of the underlying patent or contract, which does not include additional years for the potential extension or renewal of the contract or patent. Our amortization policy for intangible assets is based on the generally accepted accounting principles in Statementfor amortization of Financial Standards No. 142,Goodwill and Other Intangible Assets, or SFAS 142,intangible assets, which requires that the amortization of intangible assets reflect the pattern that the economic benefits of the intangible assetassets are consumed. We believe the economic benefit of our core technology is consumed as revenue is generated from our AVONEX product. Every year during the third quarter we complete our long range planning cycle, which includes an analysis of the anticipated product sales of AVONEX. The results of this forecast serve as the basis for our assumptions used in the economic consumption amortization model for our core technology intangible assets. Although we believe our process has allowed us to reliably determine our best estimate of the pattern in which we will consume the economic benefits of the core technology intangible assets, the model results in deferring amortization charges to future periods in certain instances, including the impact of continued sales of the product at a nominal level after patent expiration. Consequently, in establishing our methodology, we considered models that would prevent deferring amortization charges to future periods such as the model described in paragraph 8 of Statement of Financial Standards No. 86,Accounting for the Costs of Computer Software to be Sold, Leased, or Otherwise Marketed,or SFAS 86. In order to ensure amortization charges are not unreasonably deferred to future periods, we use the straight-line method to determine the minimum annual amount of amortization expense, or the minimum. The long range planning process determines whether amortization will be based on an economic consumption or the minimum and, thus, the amount of amortization for the next four quarters. Amortization is currently based on the economic consumption model.
 
Intangible assets related to patents, licenses, core developed technology, assembled workforce, and distribution rights are amortized over their remaining estimated useful lives. Intangible assets related to trademarks and tradenames have indefinite lives, and as a result are not amortized, but are subject to review for impairment. We review our intangible assets with indefinite lives for impairment annually, as of October 31, and whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable.
 
Our most significant intangible asset is the core technology related to our AVONEX product which was established at the time of the merger of Biogen, Inc. and IDEC Pharmaceuticals Corporation. The net book value of this asset as of December 31, 2009 was $1,516.7 million.
We believe the economic benefit of this core technology is consumed as revenue is generated from our AVONEX product. An analysis of the anticipated lifetime revenue of AVONEX is performed at least annually during our long range planning cycle. The results of this forecast serve as the basis for our assumptions used in the economic consumption amortization model for our core technology intangible asset. Although we believe this process has allowed us to reliably determine the best estimate of the pattern in which we will consume the economic benefits of our core technology intangible asset, the model could result in deferring amortization charges to future periods in certain instances due to continued sales of the product at a nominal level after patent expiration or


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
otherwise. In order to ensure amortization charges are not unreasonably deferred to future periods, we use the straight-line method to determine the minimum annual amount of amortization expense (the minimum amortization amount). This minimum amortization amount is recalculated each year based on the remaining unamortized balance of the intangible asset and the remaining estimated useful life of the intangible asset and is compared to the amount of amortization determined under the economic consumption model. We record amortization based upon the higher of the amount of amortization determined under the economic consumption model or the minimum amortization amount determined under the straight-line method.
ImpairmentConcentration of Long-Lived AssetsCredit Risks
 
Long-lived assetsOur primary exposure to be heldcredit risk derives from our cash, cash equivalents, marketable securities, and used,receivables from customers and collaborative partners.
Until required for use in the business, we invest our cash in bank deposits, certificates of deposit, commercial paper, corporate notes, foreign and U.S. government instruments, including property plantgovernment sponsored enterprise mortgage-backed securities, credit card and equipmentauto loan asset-backed securities and other marketable debt instruments in accordance with our investment policy. We mitigate credit risk by maintaining a well diversified portfolio and limiting the amount of investment exposure as to institution, maturity and investment type.
Concentrations of credit risk with respect to receivables, which are typically unsecured, are generally limited due to the wide variety of customers and markets using our products, as well as intangible assetstheir dispersion across many different geographic areas. Our accounts receivable are reviewed for impairment whenever events orpayable by wholesale distributors, large pharmaceutical companies and public hospitals. We monitor the financial performance and credit worthiness of our large customers so that we can properly assess and respond to changes in circumstancestheir credit profile. Our historical write-offs of accounts receivable have not been significant. As of December 31, 2009 and 2008, one wholesale distributor accounted for approximately 8.1% and 11.0% of consolidated receivables, respectively.
Marketable Securities and Other Investments
Marketable Debt Securities
Available-for-sale debt securities are recorded at fair market value and unrealized gains and losses are included in accumulated other comprehensive income in shareholders’ equity, net of related tax effects, unless the security has experienced a credit loss, we have determined that we have the intent to sell the security or we have determined that it is more likely than not that we will have to sell the security before its expected recovery. Realized gains and losses are reported in other income (expense), net, on a specific identification basis.
Strategic Investments
As part of our strategic product development efforts, we invest in equity securities of certain biotechnology companies. These investments are known as strategic investments and are classified asavailable-for-sale and accounted for as marketable equity investments or as cost investments based upon our percentage ownership interest and other factors which may indicate that the carrying amountpresumption of the assets may not be recoverable. Conditions that would necessitate an impairment assessment includesignificant influence. When assessing whether a significant decline in the observablefair value of a strategic investment below our cost basis isother-than-temporary, we consider the fair market value of an asset, a significant change in the extent or mannersecurity, the duration of the security’s decline, and prospects for the underlying business, including favorable clinical trial results, new product initiatives and new collaborative agreements with the companies in which an asset is used, or a significant adverse change that would indicate that the carrying amountwe have invested.
Non-Marketable Equity Securities
We also invest in equity securities of an asset or group of assetscompanies whose securities are not publicly traded and where fair value is not recoverable. Determinationreadily available. These investments are recorded using either the cost method or the equity method of recoverability is basedaccounting, depending on an estimateour percentage ownership interest and other factors which may indicate the presence of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the eventsignificant influence. We monitor these investments to evaluate whether any decline in their value has occurred that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written-down to their estimated fair values. Long-lived assets to be disposed of are carried at fair value less costs to sell.


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BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
would beother-than-temporary, based on the implied value from any recent rounds of financing completed by the company, public market prices of comparable companies, and general market conditions.
Securities Lending
We are able to loan certain securities from our portfolio to other institutions. Such securities are classified as loaned securities on the accompanying consolidated balance sheets. Collateral for the loaned securities, consisting of cash or other securities, is maintained at a rate of approximately 102% of the market value of each loaned security. We previously loaned certain securities from our portfolio to other institutions and held collateral in the amount of $30.0 million as of December 31, 2008 in relation to such loans. The cash collateral was recorded as collateral received for loaned securities on the accompanying consolidated balance sheet. No such loans were outstanding as of December 31, 2009; accordingly, no collateral was held as of December 31, 2009.
Other-than-Temporary Impairments
In April 2009, we implemented a newly issued accounting standard which provides guidance for the recognition, measurement and presentation ofother-than-temporary impairments. This newly issued standard amended theother-than-temporary impairment model for debt securities and requires additional disclosures regarding the calculation of credit losses and the factors considered in reaching a conclusion that an investment isother-than-temporarily impaired. The impairment model for equity securities was not affected.
Prior to our adoption of this new accounting standard, we recognized allother-than-temporary impairment amounts related to our debt securities in earnings as required under the previously effective guidance which required that management assert that it had the ability and intent to hold a debt security until maturity or until we recovered the cost of our investment. Under the new accounting standards, another-than-temporary impairment must be recognized through earnings if an investor has the intent to sell the debt security or if it is more likely than not that the investor will be required to sell the debt security before recovery of its amortized cost basis. However, even if an investor does not expect to sell a debt security, expected cash flows to be received must be evaluated to determine if a credit loss has occurred. In the event of a credit loss, only the amount associated with the credit loss is recognized in income. The amount of losses relating to other factors, including those resulting from changes in interest rates, are recorded in accumulated other comprehensive income. The adoption of this guidance did not have a material impact on our financial position or results of operations.
GoodwillInventory
 
Goodwill relates largelyInventories are stated at the lower of cost or market with cost determined under thefirst-in, first-out (FIFO) method. Included in inventory are raw materials used in the production of pre-clinical and clinical products, which are charged to amounts that arose in connectionresearch and development expense when consumed.
We capitalize inventory costs associated with the Merger and represents the difference between the purchase priceour products prior to regulatory approval when, based on management’s judgment, future commercialization is considered probable and the fair value of the identifiable tangiblefuture economic benefit is expected to be realized.
Inventory Write-Offs
We periodically review our inventories for excess or obsolete inventory and intangiblewrite-down obsolete or otherwise unmarketable inventory to its estimated net assets when accounted for using the purchase method of accounting. Goodwill is not amortized, but isrealizable value.
Property, Plant and Equipment
Property, plant and equipment are carried at cost, subject to periodic review for impairment. Goodwill is reviewed annually, as of October 31, andimpairment whenever events or changes in circumstances indicate that the carrying amount of the goodwill mightasset may not be recoverable.
Income Taxes
The provision Interest costs incurred during the construction of major capital projects are capitalized until the underlying asset is ready for income taxes includes federal, state, local and foreign taxes. Income taxes are accounted for under the liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences of temporary differences between the financial statement carrying amounts and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which the temporary differences are expected to be recovered or settled. We evaluate the realizability of our deferred tax assets and establish a valuation allowance when it is more likely than not that all or a portion of deferred tax assets will not be realized.
We account for uncertain tax positions in accordance with FASB Interpretation No. 48,Accounting for Uncertainty in Income Taxes — an Interpretation of FASB Statement No. 109, or FIN 48. FIN 48 prescribes a recognition threshold and measurement attribute for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return and also provides guidance on various related matters such as derecognition, interest and penalties, and disclosure. We also accrue for potential interest and penalties, related to unrecognized tax benefits in income tax expense.
Derivatives and Hedging Activities
Statement of Financial Accounting Standards No. 133,Accounting for Derivative Instruments and Hedging Activities,or SFAS 133, requires that all derivatives be recognized on the balance sheet at their fair value. Changes in the fair value of derivatives are recorded each period in current earnings or accumulated other comprehensive income (loss), depending on whether a derivative is designated as part of a hedge transaction and, if it is, the type of hedge transaction. We assess, both at inception and on an on-going basis, whether the derivatives that are used in hedging transactions are highly effective in offsetting the changes in cash flows or fair values of the hedged items. We also assess hedge ineffectiveness on a quarterly basis and record the gain or loss related to the ineffective portion to current earnings to the extent significant. If we determine that a forecasted transaction is no longer probable of occurring, we discontinue hedge accounting for the affected portion of the hedge instrument, and any related unrealized gain or loss on the contract is recognized in current earnings.
Comprehensive Income (Loss)
Statement of Financial Accounting Standards No. 130,Reporting Comprehensive Income,or SFAS 130, requires us to display comprehensive income (loss) and its components as part of our financial statements. Comprehensive income (loss) is comprised of net income and other comprehensive income (loss). Other comprehensive income (loss) includes changes in equity that are excluded from net income, such as foreign currency translation adjustments and unrealized holding gains and losses on available-for-sale marketable securities and certain derivative instruments, and effective December 31, 2006, the unfunded amount of our postretirement and pension plans. All of these changes in equity are reflected net of tax.
Segment Information
Statement of Financial Accounting Standards No. 131,Disclosures about Segments of an Enterprise and Related Information,or SFAS 131, establishes standards for reporting information on operating segments in interimintended


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BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
use, at which point the interest costs are amortized as depreciation expense over the life of the underlying asset. We also capitalize certain direct and annual financial statements. incremental costs associated with the validation effort required for licensing by regulatory agencies of manufacturing equipment for the production of a commercially approved drug. These costs include primarily direct labor and material and are incurred in preparing the equipment for its intended use. The validation costs are amortized over the life of the related equipment. Maintenance costs are expensed as incurred.
We operate in one segment,generally depreciate or amortize the cost of our property, plant and equipment using the straight-line method over the estimated useful lives of the respective assets, which is the business of development, manufacturing and commercialization of novel therapeutics for human health care. Our chief operating decision-maker reviews our operating results on an aggregate basis and manages our operationsare summarized as a single operating segment.follows:
Asset Category
Useful Lives
LandNot depreciated
Buildings15 to 40 years
Leasehold ImprovementsLesser of the useful life or the term of the respective lease
Machinery and Equipment6 to 15 years
Furniture and Fixtures7 years
Computer Software and Hardware3 to 5 years
 
Revenue RecognitionIntangible Assets
 
Product RevenuesEffective January 1, 2009, we implemented an amendment to the accounting and disclosure requirements related to intangible assets. This amendment provides guidance for determining the useful life of a recognized intangible asset and requires enhanced disclosures so that users of financial statements are able to assess the extent to which the expected future cash flows associated with the asset are affected by our intent and ability to renew or extend the arrangement. The adoption of this guidance did not impact our financial position or results of operations as this standard was required to be implemented prospectively; however, this standard may impact us in subsequent periods.
 
We recognize revenue when allOur intangible assets consist of patents, licenses, core developed technology, trademarks, tradenames, assembled workforce, and distribution rights, the majority of which arose in connection with the merger of Biogen Inc. and IDEC Pharmaceuticals Corporation. These intangible assets were recorded at fair value and are stated net of accumulated amortization and impairments.
The useful lives of our intangible assets are primarily based on the legal or contractual life of the following criteria are met: persuasive evidence of an arrangement exists; delivery has occurredunderlying patent or services have been rendered;contract, which does not include additional years for the seller’s price to the buyer is fixedpotential extension or determinable; and collectibility is reasonably assured.
Revenues from product sales are recognized when title and risk of loss have passed to the customer, which is typically upon delivery. However, sales of TYSABRI in the U.S. are recognized on the “sell-through” model, that is, upon shipmentrenewal of the product by Elan to its third party distributor rather than upon shipment to Elan. The timing of distributor orders and shipments can cause variability in earnings.
Revenues are recorded net of applicable allowances for trade term discounts, wholesaler incentives, Medicaid rebates, Veteran’s Administration,contract or VA, rebates, managed care rebates, product returns and other applicable allowances.
TYSABRI
In November 2004, TYSABRI was approved by the U.S. Food and Drug Administration, or FDA, as a treatment for relapsing forms of MS to reduce the frequency of clinical relapses. In February 2005, in consultation with the FDA, we and Elan voluntarily suspended the marketing and commercial distribution of TYSABRI, and we informed physicians that they should suspend dosing of TYSABRI until further notification. On June 5, 2006, the FDA approved a supplemental Biologics License Application, or sBLA, for the reintroduction of TYSABRI as a monotherapy treatment for relapsing forms of MS to slow the progression of disability and reduce the frequency of clinical relapses. On June 29, 2006, we and Elan announced that the European Medicines Agency, or EMEA, had approved TYSABRI as a similar treatment. In July 2006, we began to ship TYSABRI in both the United States and rest of world.
Subsequent to the reintroduction of TYSABRI for sale in the U.S. and approval for sale in Europe, we began to ship TYSABRI into both regions in the third quarter of 2006. We manufacture TYSABRI and collaborate with Elan on the product’s marketing, distribution and on-going development activities. The collaboration agreement with Elan is designed to effect an equal sharing of profits and losses generated by the activities of the collaboration between us and Elan. Under our agreement with Elan, however, in the event that sales of TYSABRI exceed specified thresholds, Elan is required to make milestone payments to us in order to continue sharing equally in the collaboration’s results. During the year ended December 31, 2008, pursuant to our collaboration agreement with Elan, Elan paid us a $75.0 million milestone payment in order to maintain the current collaboration profit sharing split. We recorded this amount as deferred revenue upon receipt and are recognizing this $75.0 million as product revenue in our consolidated statement of income over the term of our collaboration with Elan based on a units of revenue method, whereby the revenue recognizedpatent. Our policy is based on the ratiogenerally accepted accounting principles for amortization of units shippedintangible assets, which requires that the amortization of intangible assets reflect the pattern that the economic benefits of the intangible assets are consumed.
Intangible assets related to patents, licenses, core developed technology, assembled workforce, and distribution rights are amortized over their remaining estimated useful lives. Intangible assets related to trademarks and tradenames have indefinite lives, and as a result are not amortized, but are subject to review for impairment. We review our intangible assets with indefinite lives for impairment annually, as of October 31, and whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable.
Our most significant intangible asset is the core technology related to our AVONEX product which was established at the time of the merger of Biogen, Inc. and IDEC Pharmaceuticals Corporation. The net book value of this asset as of December 31, 2009 was $1,516.7 million.
We believe the economic benefit of this core technology is consumed as revenue is generated from our AVONEX product. An analysis of the anticipated lifetime revenue of AVONEX is performed at least annually during our long range planning cycle. The results of this forecast serve as the basis for our assumptions used in the current period overeconomic consumption amortization model for our core technology intangible asset. Although we believe this process has allowed us to reliably determine the total units expected to be shipped over the remaining termbest estimate of the collaboration. We have recognized $1.5 millionpattern in which we will consume the economic benefits of this milestone as revenue forour core technology intangible asset, the year ended December 31, 2008. Based on the TYSABRImodel could result in deferring amortization charges to future periods in certain instances due to continued sales levels achieved through the fourth quarter of 2008, in January 2009, Elan paid us an additional milestone payment of $50.0 million in order to maintain the current collaboration profit sharing split. Revenue from this milestone payment will also be deferred and recognized on a units of revenue model.
In the U.S., we sell TYSABRI to Elan who sells the product to third party distributors. We and Elan co-market the product. The sales price to Elan in the U.S. is set at the beginning of each quarterly period to effect an equala nominal level after patent expiration or


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BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
sharingotherwise. In order to ensure amortization charges are not unreasonably deferred to future periods, we use the straight-line method to determine the minimum annual amount of amortization expense (the minimum amortization amount). This minimum amortization amount is recalculated each year based on the remaining unamortized balance of the gross margin between Elanintangible asset and us. In addition, both parties share equally in the operating costs, which include research and development, selling, general and administrative expenses and other similar costs. Elan’s reimbursement of TYSABRI operating costs is reflected as a reductionremaining estimated useful life of the respective costs within our consolidated statement of income. Sales of TYSABRIintangible asset and is compared to Elan are reported as revenues and are recognized upon Elan’s shipment of the product to third party distributors, at which time all revenue recognition criteria have been met. As of December 31, 2008 and 2007, we had deferred revenue of $6.2 million and $9.0 million, respectively, for shipments to Elan that remained in Elan’s ending inventory.
For sales outside the U.S., we are responsible for distributing TYSABRI to customers and are primarily responsible for all operating activities. Both parties share equally in the operating results of TYSABRI operations outside the U.S. Sales of TYSABRI are reported as revenue and are recognized at the time of shipment of product to our customer, as all revenue recognition criteria have been met. Payments to or from Elan for their share of collaboration net operating profits or losses relating to sales outside the U.S. are reflected in the collaboration profit (loss) sharing line in our consolidated statement of income. For 2008, 2007, and 2006, collaboration profit (loss) sharing was $136.0 million, $14.1 million, and ($9.7) million, respectively, in connection with this arrangement.
Reserves for Discounts and Allowances
We establish reserves for trade term discounts, wholesaler incentives, Medicaid rebates, VA rebates, managed care rebates, product returns and other applicable allowances and in 2006, patient assistance and patient replacement goods. Such reserves are classified as reductions of accounts receivable (if the amount is payable to our customer) or a liability (ifof amortization determined under the amount is payable to a party other than our customer).
Effective January 1, 2007, we changedeconomic consumption model. We record amortization based upon the manner in which we administer our patient assistance and patient replacement goods programs. Prior to January 1, 2007, AVONEX product shipped for these programs was invoiced and recorded as gross product revenue and an offsetting provision for discount and returns was recorded for expected credit requests from the distributor that administers these programs on our behalf (as such, no net revenue was recorded for these shipments). Effective January 1, 2007, we entered into a new arrangement with the distributor. Under the new arrangement, gross revenue is not recorded for product shipped to satisfy these programs, and cost of sales is recorded when the product is shipped.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
An analysishigher of the amount of and change in, reserves is as follows (in millions):
         ��       
     Contractual
       
  Discounts  Adjustments  Returns  Total 
 
2008
                
Beginning Balance $6.4  $33.1  $20.4  $59.9 
Current provisions relating to sales in current year  67.1   150.6   14.7   232.4 
Adjustments relating to prior years     (1.6)  (2.5)  (4.1)
Payments/returns relating to sales in current year  (57.8)  (101.2)  (0.1)  (159.1)
Payments/returns relating to sales in prior years  (6.5)  (32.8)  (14.4)  (53.7)
Other adjustments            
                 
Ending Balance $9.2  $48.1  $18.1  $75.4 
                 
2007
                
Beginning Balance $12.7  $30.5  $17.8  $61.0 
Current provisions relating to sales in current year  45.7   113.1   17.1   175.9 
Adjustments relating to prior years     (7.9)  5.0   (2.9)
Payments/returns relating to sales in current year  (39.4)  (72.3)  (0.4)  (112.1)
Payments/returns relating to sales in prior years  (12.6)  (30.3)  (19.1)  (62.0)
Other adjustments            
                 
Ending Balance $6.4  $33.1  $20.4  $59.9 
                 
2006
                
Beginning Balance $11.6  $35.7  $2.3  $49.6 
Current provisions relating to sales in current year  102.9   96.4   31.6   230.9 
Adjustments relating to prior years     (3.1)  7.1   4.0 
Payments/returns relating to sales in current year  (90.2)  (63.1)  (16.1)  (169.4)
Payments/returns relating to sales in prior years  (11.6)  (35.4)  (12.5)  (59.5)
Other adjustments        5.4   5.4 
                 
Ending Balance $12.7  $30.5  $17.8  $61.0 
                 
The total reserves above were included inamortization determined under the consolidated balance sheet as follows (in millions):
             
  Reduction of
  Current
    
As of December 31,
 Accounts Receivable  Liability  Total 
 
2008 $31.6  $43.8  $75.4 
2007 $28.5  $31.4  $59.9 
The reserves are based on estimates ofeconomic consumption model or the amounts earned or to be claimed onminimum amortization amount determined under the related sales. These estimates take into consideration our historical experience, current contractual requirements and statutory requirements, specific known market events and trends and forecasted customer buying patterns. If actual future results vary, we may need to adjust these estimates, which could have an effect on earnings in the period of the adjustment.
Product revenue reserves are categorized as follows: discounts, contractual adjustments, and returns.
Discounts
Discount reserves include trade term discounts, wholesaler incentives and, in 2006, patient assistance.


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BIOGEN IDEC INC. AND SUBSIDIARIES
straight-line method.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Trade term discounts and wholesaler incentive reserves primarily relate to estimated obligations for credits to be granted to wholesalers for remitting payment on their purchases within established incentive periods and credits to be granted to wholesalers for compliance with various contractually-defined inventory management practices, respectively. We determine these reserves based on our experience, including the timing of customer payments.
In 2006, patient assistance reserves were established to cover no-charge product that we distribute to qualifying patients under our indigent program, Patient Access. The program is administered through one of our distribution partners, who ship product for qualifying patients from their own inventory that was purchased from us. In 2006, the distributor received a credit at the end of each period for product that was administered during the period. A reserve was established through a reduction of product revenues for sales made to the distributor which we estimated may be used to administer our patient assistance program. We determined this reserve based on our experience with the activity under the program. Effective January 1, 2007, gross revenue and the related reserves are not recorded on product shipped under this program.
Contractual Adjustments
Contractual adjustment reserves relate to Medicaid, VA and managed care rebates and other applicable allowances.
Medicaid rebates reserves relate to our estimated obligations to states under established reimbursement arrangements. Rebate accruals are recorded in the same period the related revenue is recognized resulting in a reduction of product revenue and the establishment of a liability. Rebate amounts are generally determined at the time of claim by the state, and we generally make cash payments for such amounts within a few weeks of receiving billings from the state.
VA rebates or chargeback reserves represent our estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices we charge the wholesalers which provide those products. The wholesaler charges us for the difference between what the wholesaler pays for the products and the ultimate selling price to the qualified healthcare providers. Rebate accruals are established in the same period as the related revenue is recognized resulting in a reduction in product revenue. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider, and we generally issue credits for such amounts within a few weeks of receiving notification from the wholesaler.
Managed care rebates reserves represent our estimated obligations to third parties, primarily pharmacy benefit managers. Rebate accruals are recorded in the same period the related revenue is recognized resulting in a reduction to product revenue and the establishment of a liability which is included in other accrued liabilities. These rebates result from performance-based offers that are primarily based on attaining contractually specified sales volumes and growth. The calculation of the accrual for these rebates is based on an estimate of the customer’s buying patterns and the resulting applicable contractual rebate rate(s) to be earned over a contractual period.
Returns
Allowances for product returns are established for returns made by wholesalers and patients. In accordance with contractual terms, wholesalers are permitted to return product for reasons such as damaged or expired product. We also accept returns from our patients for various reasons.
Reserves for product returns are recorded in the period the related revenue is recognized, resulting in a reduction to product revenue. The majority of wholesaler returns are due to product expiration. Expired product return reserves are estimated through a comparison of historical return data to their related sales on a production lot basis. Historical rates of return are determined for each product and are adjusted for known or expected changes in the marketplace specific to each product. As noted above, in 2007, pursuant to the change in the way we administered our patient assistance program, revenue is no longer recorded under this program. The patient return program is administered by the same distribution partner as the patient assistance program. As noted above, in


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
2006, revenue related to product sold to this distribution partner that was used to satisfy patient returns was fully reserved.
During the second quarter of 2006, we recorded an increase in our allowance for expired products of $12.3 million to correct for prior period errors. This increase in the allowance was recorded through an out of period reduction in net product revenue of $6.9 million and an increase in goodwill of $5.4 million. We identified and quantified the errors through an analysis of the historical rate for returns based on volumes of returns and the amount of credit granted to the returning distributors in past periods. At the time of the Merger with Biogen, Inc. in 2003, Biogen, Inc. had understated its allowance for expired product by an estimated $5.4 million due to an incorrect methodology applied in calculating its reserve balance. Had we identified this error at the time of the Merger, the recorded goodwill would have been approximately $5.4 million higher than has been previously reflected. Biogen, Inc.’s methodology was in error because it did not utilize known information in determining critical assumptions used in the basis of calculation. Our application of this incorrect methodology in the post-Merger period resulted in understating this reserve by an additional $6.9 million. In all cases, the correctly calculated rate of return is less than one percent of related gross product revenues. We have determined that the out of period correction of this error in 2006 is not material to our reported results. Additionally, we have determined that the error at the merger date is not material to any prior period balance sheet amounts and the error in the post-merger period is not material to any prior period reported results.
Other
Bad debt reserves are based on our estimated uncollectible accounts receivable. Given our historical experiences with bad debts, combined with our credit management policies and practices, we do not presently maintain significant bad debt reserves.
We have various contracts with distributors that provide for discounts and rebates. These discounts and rebates are classified as a reduction of revenue. We also maintain select customer service contracts with distributors and other customers in the distribution channel. We have established the fair value of these services and classified these customer service contracts as sales and marketing expense. If we had concluded that sufficient evidence of the fair value did not exist for these services, we would have been required to classify these costs as a reduction of revenue.
Concentration of Credit Risks
 
Our primary exposure to credit risk derives from our cash, cash equivalents, marketable securities, and accounts receivable balances.receivables from customers and collaborative partners.
 
Until required for use in the business, we invest our cash reserves in bank deposits, certificates of deposit, commercial paper, corporate notes, foreign and U.S. government instruments, asset backedincluding government sponsored enterprise mortgage-backed securities, credit card and auto loan asset-backed securities and other marketable debt instruments.instruments in accordance with our investment policy. We mitigate credit risk in our cash reserves by maintaining a well diversified portfolio byand limiting the amount of investment exposure as to institution, maturity and investment type.
 
Concentrations of credit risk with respect to receivables, which are typically unsecured, are generally limited due to the wide variety of customers and markets using our products, as well as their dispersion across many different geographic areas. One customerOur accounts receivable are payable by wholesale distributors, large pharmaceutical companies and public hospitals. We monitor the financial performance and credit worthiness of our large customers so that we can properly assess and respond to changes in their credit profile. Our historical write-offs of accounts receivable have not been significant. As of December 31, 2009 and 2008, one wholesale distributor accounted for approximately 11%8.1% and 11.0% of consolidated receivables, at December 31, 2008.respectively.
 
Revenues from Unconsolidated Joint BusinessMarketable Securities and Other Investments
 
Revenues from unconsolidated joint business consistMarketable Debt Securities
Available-for-sale debt securities are recorded at fair market value and unrealized gains and losses are included in accumulated other comprehensive income in shareholders’ equity, net of related tax effects, unless the security has experienced a credit loss, we have determined that we have the intent to sell the security or we have determined that it is more likely than not that we will have to sell the security before its expected recovery. Realized gains and losses are reported in other income (expense), net, on a specific identification basis.
Strategic Investments
As part of our sharestrategic product development efforts, we invest in equity securities of certain biotechnology companies. These investments are known as strategic investments and are classified asavailable-for-sale and accounted for as marketable equity investments or as cost investments based upon our percentage ownership interest and other factors which may indicate the presumption of significant influence. When assessing whether a decline in the fair value of a strategic investment below our cost basis isother-than-temporary, we consider the fair market value of the pretax co-promotion profits generated fromsecurity, the duration of the security’s decline, and prospects for the underlying business, including favorable clinical trial results, new product initiatives and new collaborative agreements with the companies in which we have invested.
Non-Marketable Equity Securities
We also invest in equity securities of companies whose securities are not publicly traded and where fair value is not readily available. These investments are recorded using either the cost method or the equity method of accounting, depending on our co-promotion arrangement with Genentech, Inc., or Genentech, reimbursement from Genentechpercentage ownership interest and other factors which may indicate the presence of our RITUXAN-related sales force and development expenses and royalties from Genentech for sales of RITUXANsignificant influence. We monitor these investments to evaluate whether any decline in their value has occurred that


F-17F-11


 
BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
outsidewould beother-than-temporary, based on the U.S.implied value from any recent rounds of financing completed by F. Hoffmann-La Roche Ltd.,the company, public market prices of comparable companies, and general market conditions.
Securities Lending
We are able to loan certain securities from our portfolio to other institutions. Such securities are classified as loaned securities on the accompanying consolidated balance sheets. Collateral for the loaned securities, consisting of cash or Roche, Zenyaku Kogyo Co. Ltd.,other securities, is maintained at a rate of approximately 102% of the market value of each loaned security. We previously loaned certain securities from our portfolio to other institutions and held collateral in the amount of $30.0 million as of December 31, 2008 in relation to such loans. The cash collateral was recorded as collateral received for loaned securities on the accompanying consolidated balance sheet. No such loans were outstanding as of December 31, 2009; accordingly, no collateral was held as of December 31, 2009.
Other-than-Temporary Impairments
In April 2009, we implemented a newly issued accounting standard which provides guidance for the recognition, measurement and presentation ofother-than-temporary impairments. This newly issued standard amended theother-than-temporary impairment model for debt securities and requires additional disclosures regarding the calculation of credit losses and the factors considered in reaching a conclusion that an investment isother-than-temporarily impaired. The impairment model for equity securities was not affected.
Prior to our adoption of this new accounting standard, we recognized allother-than-temporary impairment amounts related to our debt securities in earnings as required under the previously effective guidance which required that management assert that it had the ability and intent to hold a debt security until maturity or Zenyaku and Chugai Pharmaceutical Co., Ltd, or Chugai, an affiliateuntil we recovered the cost of Roche.our investment. Under the co-promotion arrangement, all U.S. salesnew accounting standards, another-than-temporary impairment must be recognized through earnings if an investor has the intent to sell the debt security or if it is more likely than not that the investor will be required to sell the debt security before recovery of RITUXAN andits amortized cost basis. However, even if an investor does not expect to sell a debt security, expected cash flows to be received must be evaluated to determine if a credit loss has occurred. In the event of a credit loss, only the amount associated costs and expenseswith the credit loss is recognized in income. The amount of losses relating to other factors, including those resulting from changes in interest rates, are recognized by Genentech and we recordrecorded in accumulated other comprehensive income. The adoption of this guidance did not have a material impact on our sharefinancial position or results of the pretax co-promotion profits as defined in our amended and restated collaboration agreement with Genentech. Pretax co-promotion profits under the co-promotion arrangement are derived by taking U.S. net sales of RITUXAN to third-party customers less cost of sales, third-party royalty expenses, distribution, selling and marketing expenses and joint development expenses incurred by Genentech and us. We record royalty revenue on sales of RITUXAN outside the U.S. on a cash basis.operations.
 
Royalty RevenuesInventory
 
Inventories are stated at the lower of cost or market with cost determined under thefirst-in, first-out (FIFO) method. Included in inventory are raw materials used in the production of pre-clinical and clinical products, which are charged to research and development expense when consumed.
We receive royalty revenues under license agreementscapitalize inventory costs associated with a number of third parties that sellour products prior to regulatory approval when, based on technologymanagement’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized.
Inventory Write-Offs
We periodically review our inventories for excess or obsolete inventory and write-down obsolete or otherwise unmarketable inventory to its estimated net realizable value.
Property, Plant and Equipment
Property, plant and equipment are carried at cost, subject to review for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. Interest costs incurred during the construction of major capital projects are capitalized until the underlying asset is ready for its intended


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
use, at which point the interest costs are amortized as depreciation expense over the life of the underlying asset. We also capitalize certain direct and incremental costs associated with the validation effort required for licensing by regulatory agencies of manufacturing equipment for the production of a commercially approved drug. These costs include primarily direct labor and material and are incurred in preparing the equipment for its intended use. The validation costs are amortized over the life of the related equipment. Maintenance costs are expensed as incurred.
We generally depreciate or amortize the cost of our property, plant and equipment using the straight-line method over the estimated useful lives of the respective assets, which are summarized as follows:
Asset Category
Useful Lives
LandNot depreciated
Buildings15 to 40 years
Leasehold ImprovementsLesser of the useful life or the term of the respective lease
Machinery and Equipment6 to 15 years
Furniture and Fixtures7 years
Computer Software and Hardware3 to 5 years
Intangible Assets
Effective January 1, 2009, we have developed orimplemented an amendment to the accounting and disclosure requirements related to intangible assets. This amendment provides guidance for determining the useful life of a recognized intangible asset and requires enhanced disclosures so that users of financial statements are able to assess the extent to which we have rights.the expected future cash flows associated with the asset are affected by our intent and ability to renew or extend the arrangement. The license agreements provideadoption of this guidance did not impact our financial position or results of operations as this standard was required to be implemented prospectively; however, this standard may impact us in subsequent periods.
Our intangible assets consist of patents, licenses, core developed technology, trademarks, tradenames, assembled workforce, and distribution rights, the majority of which arose in connection with the merger of Biogen Inc. and IDEC Pharmaceuticals Corporation. These intangible assets were recorded at fair value and are stated net of accumulated amortization and impairments.
The useful lives of our intangible assets are primarily based on the legal or contractual life of the underlying patent or contract, which does not include additional years for the paymentpotential extension or renewal of royaltiesthe contract or patent. Our policy is based on the generally accepted accounting principles for amortization of intangible assets, which requires that the amortization of intangible assets reflect the pattern that the economic benefits of the intangible assets are consumed.
Intangible assets related to patents, licenses, core developed technology, assembled workforce, and distribution rights are amortized over their remaining estimated useful lives. Intangible assets related to trademarks and tradenames have indefinite lives, and as a result are not amortized, but are subject to review for impairment. We review our intangible assets with indefinite lives for impairment annually, as of October 31, and whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable.
Our most significant intangible asset is the core technology related to our AVONEX product which was established at the time of the merger of Biogen, Inc. and IDEC Pharmaceuticals Corporation. The net book value of this asset as of December 31, 2009 was $1,516.7 million.
We believe the economic benefit of this core technology is consumed as revenue is generated from our AVONEX product. An analysis of the anticipated lifetime revenue of AVONEX is performed at least annually during our long range planning cycle. The results of this forecast serve as the basis for our assumptions used in the economic consumption amortization model for our core technology intangible asset. Although we believe this process has allowed us based onto reliably determine the best estimate of the pattern in which we will consume the economic benefits of our core technology intangible asset, the model could result in deferring amortization charges to future periods in certain instances due to continued sales of the licensed product.product at a nominal level after patent expiration or


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
otherwise. In order to ensure amortization charges are not unreasonably deferred to future periods, we use the straight-line method to determine the minimum annual amount of amortization expense (the minimum amortization amount). This minimum amortization amount is recalculated each year based on the remaining unamortized balance of the intangible asset and the remaining estimated useful life of the intangible asset and is compared to the amount of amortization determined under the economic consumption model. We record these revenuesamortization based upon the higher of the amount of amortization determined under the economic consumption model or the minimum amortization amount determined under the straight-line method.
Impairment of Long-Lived Assets
Long-lived assets to be held and used, including property, plant and equipment as well as intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. Conditions that would necessitate an impairment assessment include a significant decline in the observable market value of an asset, a significant change in the extent or manner in which an asset is used, or a significant adverse change that would indicate that the carrying amount of an asset or group of assets is not recoverable. Determination of recoverability is based on estimatesan estimate of undiscounted future cash flows resulting from the use of the salesasset and its eventual disposition. In the event that occurred duringsuch cash flows are not expected to be sufficient to recover the relevant period. The relevant period estimatescarrying amount of salesthe assets, the assets are based on interim data provided by licenseeswritten-down to their estimated fair values. Long-lived assets to be disposed of are carried at fair value less costs to sell.
Goodwill
Goodwill relates largely to amounts that arose in connection with the merger of Biogen, Inc. and analysisIDEC Pharmaceuticals Corporation and represents the difference between the purchase price and the fair value of historical royalties we have been paid (adjustedthe identifiable tangible and intangible net assets when accounted for anyusing the purchase method of accounting. Goodwill is not amortized, but is subject to periodic review for impairment. Goodwill is reviewed annually, as of October 31, and whenever events or changes in facts and circumstances as appropriate). indicate that the carrying amount of the goodwill might not be recoverable.
We maintain regular communication with our licenseesperform a two-step impairment test. In the first step, we compare the fair value of the reporting unit to its carrying value. If the carrying value of the net assets assigned to the reporting unit exceeds the fair value of the reporting unit, then the second step of the impairment test is performed in order to gaugedetermine the reasonablenessimplied fair value of the reporting unit’s goodwill. If the carrying value of a reporting unit’s goodwill exceeds its implied fair value, then the company records an impairment loss equal to the difference. As described in Note 20,Segment Informationto our estimates. Differences between actual royalty revenues and estimated royalty revenues are reconciled and adjusted forConsolidated Financial Statements, we operate in the period inone business segment which they become known, typically the following quarter. Historically, adjustments have not been material based on actual amounts paid by licensees. There are no future performance obligations onwe consider our part under these license agreements. To the extent we do not have sufficient ability to accurately estimate revenue, we record it on a cash basis.only reporting unit.
 
Research and Development Expenses
 
Research and development expenses consist of upfront fees and milestones paid to collaborators and expenses incurred in performing research and development activities including salaries and benefits, facilities expenses, overhead expenses, clinical trial and related clinical manufacturing expenses, contract services and other outside expenses.activities. Research and development expenses are expensed as incurred. Payments we make for research and development services prior to the services being rendered are recorded as prepaid assets on our consolidated balance sheetsheets and are expensed as the services are provided. We have entered
From time to time, we enter into certain researchdevelopment agreements in which we share expenses with our collaborator.a collaborative partner. We have entered into other collaborations where we are reimbursed for work performed on behalf ofrecord payments received from our collaborative partners. We record the expenses for such work as research and development expenses. If the arrangement is a cost-sharing arrangement and there is a period during which we receive payments from the collaborator, we record payments by the collaboratorpartners for their share of the development effortcosts as a reduction of research and development expense. If the arrangement is a reimbursement of research and development expenses, we record the reimbursement as corporate partner revenue.
FIN 46(R)
Under FIN 46(R),we consolidate variable interest entities for which we are the primary beneficiary. For such consolidated entities in which we own less than a 100% interest, we record minority interest in our statement of income for the current results allocable to the outside equity interests. FIN 46(R) impacts the way we account for certain collaborations and future events may result in our consolidation of companies or related entities with which we have a collaborative arrangement. The consolidation of variable interest entities may have a material effect on our financial conditionand/or results of operation in future periods.


F-18


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
Acquired In-Process Research and Development (IPR&D)
 
Acquired IPR&D represents the fair value assigned to research and development projects that we acquire that have not been completed at the date of acquisition and which have no future alternative use. Accordingly, the fair value of such projects is recorded as in process research and development expense as of the acquisition date.
The value assigned to acquired IPR&D is determined by estimating the costs to develop the acquired technology into commercially viable products, estimating the resulting net cash flows from the projects, and discounting the net cash flows to present


F-14


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
value. The revenue and costs projections used to value acquired IPR&D were, as applicable, reduced based on the probability of developing a new drug. Additionally, the projections considered the relevant market sizes and growth factors, expected trends in technology, and the nature and expected timing of new product introductions by us and our competitors. The resulting net cash flows from such projects are based on management’s estimates of cost of sales, operating expenses, and income taxes from such projects. The rates utilized to discount the net cash flows to their present value were commensurate with the stage of development of the projects and uncertainties in the economic estimates used in the projections described above.
 
If these projects are not successfully developed,Effective January 1, 2009, we account for business combinations completed on or after January 1, 2009 in accordance with the salesrevised guidance for accounting for business combinations, which modifies the criteria that must be met to qualify as a business combination and profitabilityprescribes new accounting requirements, including the accounting treatment associated with acquired IPR&D. Prior to January 1, 2009, we measured acquired IPR&D at fair value and expensed it on acquisition date, or capitalized as an intangible assets if certain criteria were met; however, effective January 1, 2009, acquired IPR&D will be measured at fair value and capitalized as an intangible assets and tested for impairment until completion of the company may be adversely affected in future periods. Additionally,programs and amortized from the valuedate of other acquired intangible assets may become impaired. We believe thatcompletion over the foregoing assumptions used in the IPR&D analysis were reasonable at the time of the respective acquisition. No assurance can be given, however, that the underlying assumptions used to estimate expected project sales, development costs or profitability, or the events associated with such projects, will transpire as estimated.estimated useful life.
 
Earnings per Share
We calculate earnings per share in accordance with Statement of Financial Accounting Standards No. 128,Earnings per Share, or SFAS 128, andEITF 03-06,Participating Securities and the Two — Class Method Under SFAS 128,orEITF 03-06. SFAS 128 andEITF 03-06 together require the presentation of “basic” earnings per share and “diluted” earnings per share.
Basic earnings per share is computed using the two-class method. Under the two-class method, undistributed net income is allocated to common stock and participating securities based on their respective rights to share in dividends. We have determined that our preferred shares meet the definition of participating securities, and have allocated a portion of net income to our preferred shares on a pro rata basis. Net income allocated to preferred shares is excluded from the calculation of basic earnings per share. For basic earnings per share, net income available to holders of common stock is divided by the weighted average number of shares of common stock outstanding. For purposes of calculating diluted earnings per share, net income is adjusted for the after-tax amount of interest associated with convertible debt and net income allocable to preferred shares, and the denominator includes both the weighted average number of shares of common stock outstanding and potential dilutive shares of common stock from stock options, unvested restricted stock awards, restricted stock units and other convertible securities, to the extent they are dilutive.
Accounting for Share-based Compensation
 
Our share-based compensation programs consist of share-basedgrant awards granted to employees includingwhich have included stock options, restricted stock, performance and time-vested restricted stock units, as well asperformance-vested restricted stock units, restricted stock awards and shares issued under our employee stock purchase plan or ESPP and are accounted for under Statement of Financial Accounting Standards No. 123 (revised 2004),Share-Based Payments, or SFAS 123(R)(ESPP). Under this methodology,We charge the estimated fair value of awards is charged against income over the requisite service period, which is generally the vesting period. Where awards are made with non-substantive vesting periods (for instance, where a portion of the award vests upon retirement eligibility), we estimate and recognize expense based on the period from the grant date to the date on which the employee is retirement eligible. For
The fair values of our stock option grants are estimated as of the date of grant using a Black-Scholes option valuation model. The estimated fair values of the stock options, including the effect of estimated forfeitures, are then expensed over the options’ vesting periods. The fair values of our time-vested restricted units and restricted stock awards are based on the market value of our stock on the date of grant. Compensation expense for restricted stock units and restricted stock awards are recognized over the applicable service period, adjusted for the effect of estimated forfeitures.
We apply a graded vesting expense methodology when accounting for our performance-vested restricted stock units. The number of units reflected as granted represents the target number of shares that are eligible to vest in full or in part and are earned subject to the attainment of certain performance criteria established at the beginning of the performance period. The vesting of these awards is also subject to the respective employees’ continued employment. Compensation expense associated with these units is initially based upon the number of shares expected to vest after assessing the probability that certain performance criteria will be met and the associated targeted payout level that is forecasted will be achieved, net of estimated forfeitures. Cumulative adjustments are recorded quarterly to reflect subsequent changes in the estimated outcome of performance-related conditions until the date results are determined.
The purchase price of common stock under the ESPP weis equal to 85% of the lower of (i) the market value per share of the common stock on the participant’s entry date into an offering period or (ii) the market value per share of the common stock on the purchase date. However, for each participant whose entry date is other than the start date of the offering period, the amount shall in no event be less than the market value per share of the common stock as of the beginning of the related offering period. The fair value of the discounted purchases made under the employee stock purchase plan is calculated using the Black-Scholes model. The fair value of the look-back provision plus the 15% discount is recognized as compensation expense over the purchase period. We apply a graded vesting approach because thesince our ESPP provides for multiple purchase periods and is, in substance, a series of linked awards.


F-19F-15


 
BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
Earnings per Share
We calculate earnings per share in accordance with theEarning Per ShareTopic of the Codification which requires the presentation of “basic” earnings per share and “diluted” earnings per share.
Basic earnings per share is computed using the two-class method. Under the two-class method, undistributed net income is allocated to common stock and participating securities based on their respective rights to share in dividends. We have determined that our preferred shares meet the definition of participating securities, and have allocated a portion of net income to our preferred shares on a pro rata basis. Net income allocated to preferred shares is excluded from the calculation of basic earnings per share. For basic earnings per share, net income available to holders of common stock is divided by the weighted average number of shares of common stock outstanding. For purposes of calculating diluted earnings per share, net income is adjusted for the after-tax amount of interest associated with convertible debt and net income allocable to preferred shares, and the denominator includes both the weighted average number of shares of common stock outstanding and potential dilutive shares of common stock from stock options, unvested restricted stock awards, restricted stock units and other convertible securities, to the extent they are dilutive.
Income Taxes
The provision for income taxes includes federal, state, local and foreign taxes. Income taxes are accounted for under the liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences of temporary differences between the financial statement carrying amounts and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which the temporary differences are expected to be recovered or settled. We evaluate the realizability of our deferred tax assets and establish a valuation allowance when it is more likely than not that all or a portion of deferred tax assets will not be realized.
We account for uncertain tax positions using a “more-likely-than-not” threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity and changes in facts or circumstances related to a tax position. We evaluate this tax position on a quarterly basis. We also accrue for potential interest and penalties, related to unrecognized tax benefits in income tax expense.
Derivatives and Hedging Activities
Accounting standards require that all derivatives be recognized on the balance sheets at their fair value. Changes in the fair value of derivatives are recorded each period in current earnings or accumulated other comprehensive income (loss), depending on whether a derivative is designated as part of a hedge transaction and, if it is, the stock option grants is basedtype of hedge transaction. We assess, both at inception and on estimates asan ongoing basis, whether the derivatives that are used in hedging transactions are highly effective in offsetting the changes in cash flows or fair values of the datehedged items. We also assess hedge ineffectiveness on a quarterly basis and record the gain or loss related to the ineffective portion to current earnings to the extent significant. If we determine that a forecasted transaction is no longer probable of grant using a Black-Scholes option valuation model. The fair valueoccurring, we discontinue hedge accounting for the affected portion of all time vested restricted unitsthe hedge instrument, and restricted stock is basedany related unrealized gain or loss on the market valuecontract is recognized in current earnings.
Translation of Foreign Currencies
The functional currency for most of our stock onforeign subsidiaries is their local currency. Assets and liabilities are translated at current rates of exchange at the datebalance sheet date. Income and expense items are translated at the average foreign exchange rates for the period. Adjustments resulting from the translation of grant. Compensation expense for restricted stock and restricted stock units, including the effect of forfeitures, is recognized over the applicable service period. The fair value of performance based stock units is based on the market pricefinancial statements of our stock onforeign operations into U.S. dollars are excluded from the datedetermination of grantnet income and assumes that the performance criteria will be metare recorded in accumulated other comprehensive income, a separate component of shareholders’ equity.


F-16


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Foreign exchange transaction gains and the target payout level will be achieved. Compensation cost is adjusted for subsequent changeslosses are included in the outcomeresults of performance-related conditions until the vesting dates. For certain performance based stock units, we apply a graded vesting approachoperations in other income (expense), net. We had net foreign exchange gains (losses) of $11.4 million, $(9.8) million, and the fair value is based on the market price on the date of the vesting.$3.0 million in 2009, 2008, and 2007, respectively.
 
Assets Held for Sale
 
We consider certain real property and certain other miscellaneous assets as held for sale when they meet the criteria set out in Statementthe accounting standard for impairment or disposal of Financial Accounting Standards No. 144,Accounting for the Impairment or Disposal of Long-Lived Assets, or SFAS 144.long-lived assets.
 
As of December 31, 20082009 and 2007,2008, there were no assets held for sale on the accompanying consolidated balance sheet.sheets.
 
2.  Acquisitions and Dispositions
 
Syntonix Pharmaceuticals, Inc.
 
In January 2007, we acquired 100% of the stock of Syntonix Pharmaceuticals, Inc., or Syntonix, a privately held biopharmaceutical company based in Waltham, Massachusetts.Syntonix. Syntonix focuses on discovering and developing long-acting therapeutic products to improve treatment regimens for chronic diseases, and is engaged in multiple pre-clinical programs in hemophilia. The purchase price was $44.4 million, including transaction costs, and could increase to as much as $124.4 million if certain development milestones with respect to Syntonix’s lead product, long actinglong-acting recombinant Factor IX, a proprietary long-acting factorFactor IX product for the treatment of hemophilia B, are achieved. The purpose ofUnder the acquisition wasagreement we also agreed to enhance our pipelinemake additional future consideration payments upon the achievement of certain milestone events. Future contingent consideration payments, if any, will be recorded as IPR&D. Due to the uncertainty surrounding triggering events related to the attainment of milestones, such charges and to expand into additional specialized markets.
related obligations are generally recorded when the milestone has been achieved. The acquisition was funded from our existing cash on hand and was accounted for as an asset acquisition as Syntonix iswas a development-stage company. As
The purpose of the acquisition was to enhance our pipeline and to expand into additional specialized markets and as a result of the acquisition we obtained the rights to the in-process technology of the Fc-fusion technology platform. Syntonix has two programs in development using the Fc-fusion platform, long actinglong-acting recombinant Factor IX and long actinglong-acting recombinant Factor VIII. Syntonix’s lead product, long actinglong-acting recombinant Factor IX, is a proprietary long-acting factorFactor IX product for the treatment of hemophilia B. Syntonix filed an investigational new drug application with the Food and Drug Administration, or FDA, for long acting recombinant Factor IX in 2007. Long actingLong-acting recombinant Factor VIII is a product being developed for the treatment of hemophilia A and is approximately two years from filingthe subject of a Phase 1 study in hemophilia A.
In January 2010, we initiated patient enrollment in a registrational study for long-acting recombinant Factor IX in hemophilia B. The initiation of this study resulted in the investigational new drug application withachievement of a significant milestone, obligating us to pay $40.0 million to the FDA.former shareholders of Syntonix. As the milestone occurred subsequent to December 31, 2009, the obligation is not reflected in our consolidated balance sheet as of that date and will be reflected as IPR&D expense in the first quarter of 2010.
 
The results of operations of Syntonix are included in our consolidated results of operations from the date of acquisition. We have completed our purchase price allocation for the acquisition as set out below (in millions):below:
 
    
(In millions) Total 
    
Current assets $0.3  $0.3 
Fixed assets  0.2   0.2 
Deferred tax asset  27.8   27.8 
Assembled workforce  0.7   0.7 
In-process research and development  18.4   18.4 
Current liabilities  (3.0)  (3.0)
      
Total purchase price $44.4 
 $44.4    
   


F-20F-17


 
BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
The purchase price included $2.0 million in loan forgiveness and $0.7 million in transaction fees. In addition, $0.3 million of severance charges were accrued as a result of the acquisition.
The amount allocated to IPR&D relates to the development of long actinglong-acting recombinant Factor IX and long actinglong-acting recombinant Factor VIII, which are in a development stage. Since the acquisition in January 2007, we have spent approximately $26.1 million and $5.5 million in research and development costs related to long acting recombinant Factor IX and long acting recombinant Factor VIII, respectively. We expect to incur an additional $29.7 million to complete long acting recombinant Factor IX and an additional $30.3 million to complete long acting recombinant Factor VIII. The estimated revenues from long acting recombinant Factor IX and long acting recombinant Factor VIII are expected to be recognized beginning in 2012 and 2013, respectively. A discount rate of 13% was used to value these projects, which we believe to be commensurate with the stage of development and the uncertainties in the economic estimates described above. At the date of acquisition, these compounds were in development stage, had not reached technological feasibility and had no alternative future use. Accordingly, $18.4 million in IPR&D was expensed upon acquisition.
 
Upon acquisition, we recognized a deferred tax asset of $27.8 million. The deferred tax asset included approximately $12.8 million of net operating loss and research credit carryovers that will be utilized prior to applicable expiration dates, as well as approximately $15.3 million of other deferred tax assets primarily related tostart-up and research expenditures that have been capitalized for tax purposes and are being amortized over the next several years.
 
Future contingent consideration payments, if any, will be recorded as IPR&D. The pro forma impact on total revenue, operating income (loss) and net income (loss) pro forma impacts of the acquisition was not material for the yearsyear ended December 31, 20072007.
We collaborate with Swedish Orphan Biovitrum AB (Biovitrum) on the development and 2006 were not material.commercialization of long-acting recombinant Factor VIII and Factor IX. Please read Note 17,Collaborationsto our Consolidated Financial Statements for a description and summary of activities related to this collaboration.
 
Fumedica AgreementsZEVALIN
 
Our product line previously included ZEVALIN (ibritumomab tiuxetan), which is part of a treatment regimen for certain B-cell NHL. In December 2006,2007, we entered into an agreement with Fumedica. Fumedica is a privately held pharmaceutical company based in Germany and Switzerland that maintains distribution rights to FUMADERM and to whom we were contingently obligated to make royalty payments with respect to a successful launch of BG-12 for psoriasis in Germany. Fumedica hadsold the rights to distribute FUMADERMmarket, sell, manufacture and develop ZEVALIN in Germanythe U.S. to Cell Therapeutics, Inc. (CTI), for an upfront payment of $10.0 million and agreed to supply ZEVALIN product to CTI through April 2009. 2014. In the European Union, we continue to sell ZEVALIN to Bayer Schering Pharma AG (Schering), our licensee for sales of ZEVALIN outside the U.S.
Under the terms of our agreement with CTI, we are further entitled to receive additional payments contingent upon the achievement of certain milestone events. In September 2009, the FDA approved an expansion of ZEVALIN’s label as part of the first line therapy in the treatment of follicular non-Hodgkin’s lymphoma. This approval triggered a $5.5 million payment to us in October 2009. We may receive up to an additional $10.0 million in milestone payments.
In addition, during December 2008 we received an additional $2.2 million payment from CTI pursuant to an amendment to our agreement we have obtained all distribution and marketingwith CTI as well as a $0.8 million consent fee received from CTI upon assigning their rights to FUMADERM effective May 2007. No royalty payments were due under the agreement to a third party in March 2009.
We recognize our sales of ZEVALIN to Schering for distribution in the European Union as product revenue, and underwe recognize sales related to our supply of ZEVALIN to CTI as corporate partner revenue. We continue to recognize royalties received from Schering on their sales of ZEVALIN in the termsEuropean Union within the royalty revenue component of other revenues. The $10.0 million upfront and $7.7 million milestone payments received to date are being recognized in our results of operations over the term of our supply agreement with CTI.
3.  Reserves
Reserves for Discounts and Allowances
Revenues are recorded net of applicable reserves for trade term discounts, wholesaler incentives, Medicaid rebates, VA rebates, managed care rebates, product returns and other applicable allowances. Reserves established for these discounts and allowances are classified as reductions of accounts receivable (if the amount is payable to our customer) or a liability (if the amount is payable to a party other than our customer).


F-18


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Our product revenue reserves are based on estimates of the transition agreement,amounts earned or to be claimed on the related sales. These estimates take into consideration our historical experience, current contractual requirements and statutory requirements, specific known market events and trends and forecasted customer buying patterns. If actual future results vary, we will not be requiredmay need to make any royalty payments to Fumedica if BG-12adjust these estimates, which could have an effect on earnings in the period of the adjustment.
An analysis of the amount of, and change in, reserves is successfully launched for psoriasis in Germany.summarized as follows:
                 
     Contractual
       
(In millions) Discounts  Adjustments  Returns  Total 
 
2009
                
Beginning balance $9.2  $48.1  $18.1  $75.4 
Current provisions relating to sales in current year  74.0   192.5   15.8   282.3 
Adjustments relating to prior years        0.8   0.8 
Payments/returns relating to sales in current year  (60.8)  (124.4)  (0.6)  (185.8)
Payments/returns relating to sales in prior years  (8.5)  (45.9)  (15.2)  (69.6)
                 
Ending balance $13.9  $70.3  $18.9  $103.1 
                 
2008
                
Beginning balance $6.4  $33.1  $20.4  $59.9 
Current provisions relating to sales in current year  67.1   150.6   14.7   232.4 
Adjustments relating to prior years     (1.6)  (2.5)  (4.1)
Payments/returns relating to sales in current year  (57.8)  (101.2)  (0.1)  (159.1)
Payments/returns relating to sales in prior years  (6.5)  (32.8)  (14.4)  (53.7)
                 
Ending balance $9.2  $48.1  $18.1  $75.4 
                 
2007
                
Beginning balance $12.7  $30.5  $17.8  $61.0 
Current provisions relating to sales in current year  45.7   113.1   17.1   175.9 
Adjustments relating to prior years     (7.9)  5.0   (2.9)
Payments/returns relating to sales in current year  (39.4)  (72.3)  (0.4)  (112.1)
Payments/returns relating to sales in prior years  (12.6)  (30.3)  (19.1)  (62.0)
                 
Ending balance $6.4  $33.1  $20.4  $59.9 
                 
 
The fair value of the acquired FUMADERM distribution rights was approximately $11.1 million. This amount has been capitalized andtotal reserves above, included in our consolidated balance sheets, are summarized as follows:
         
  As of December 31, 
(In millions) 2009  2008 
 
Reduction of accounts receivable $43.3  $  31.6 
Current liability  59.8   43.8 
         
Total reserves $103.1  $75.4 
         


F-19


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Reserves for discounts, contractual adjustments and returns that reduced gross product revenues are summarized as follows:
             
  For the Years Ended December 31, 
(In millions, except percentages) 2009  2008  2007 
 
Discounts $74.0  $67.1  $45.7 
Contractual adjustments  192.5   149.0   105.2 
Returns  16.6   12.2   22.1 
             
Total reserves $283.1  $228.3  $173.0 
             
Gross product revenues $3,436.0  $3,068.0  $2,309.8 
             
Percent of gross product revenues  8.2%  7.4%  7.5%
             
4.  Inventory
The components of inventories are summarized as follows:
         
  As of December 31, 
(In millions) 2009  2008 
 
Raw materials $49.2  $  29.8 
Work in process  174.0   180.0 
Finished goods  70.8   53.8 
         
Total inventory $294.0  $263.6 
         
The following table provides a summary of work in process and finished goods by product:
         
  As of December 31, 
(In millions) 2009  2008 
 
AVONEX $76.8  $  79.2 
TYSABRI  144.0   126.2 
Other  24.0   28.4 
         
Total finished goods and work in process $244.8  $233.8 
         
Raw materials  49.2   29.8 
         
Total inventory $294.0  $263.6 
         
Write-downs from Unmarketable Inventory
Amounts written-down related to unmarketable inventory are charged to cost of sales, excluding amortization of acquired intangible assets. Amounts written-down during 2009, 2008, and 2007 totaled $16.9 million, $29.8 million and $21.6 million, respectively.


F-20


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
5.  Intangible Assets and Goodwill
Intangible assets, net of accumulated amortization, impairment charges and will be amortized over approximately two years beginning in May 2007, based on the remaining term of the distribution agreement. The fair value of terminating the pre-existing agreement was approximately $28.1 million. This amount has been expensedadjustments, are summarized as it relates to a product that has not reached technological feasibility. In addition, in connection with this transaction, we committed to total payments of 61.4 million Swiss Francs or approximately $50.5 million, which will be paid to Fumedica in varying amounts from June 2008 through June 2018. Through December 31, 2008, 12 million Swiss Francs or approximately $11.8 million have been paid andfollows:
                           
    As of December 31, 2009  As of December 31, 2008 
  Estimated
    Accumulated
        Accumulated
    
(In millions) Life Cost  Amortization  Net  Cost  Amortization  Net 
 
Out-licensed patents 12 years $578.0  $(306.0) $272.0  $578.0  $(250.3) $327.7 
Core developed technology 15-23 years  3,005.3   (1,472.4)  1,532.9   3,005.3   (1,241.0)  1,764.3 
Trademarks and tradenames Indefinite  64.0      64.0   64.0      64.0 
In-licensed patents 14 years  3.0   (1.1)  1.9   3.0   (0.9)  2.1 
Assembled workforce 4 years  2.1   (1.8)  0.3   2.1   (1.2)  0.9 
Distribution rights 2 years  12.7   (12.7)     12.7   (10.6)  2.1 
                           
Total intangible assets   $3,665.1  $(1,794.0) $1,871.1  $3,665.1  $(1,504.0) $2,161.1 
                           
Intangible Assets
Intangible assets were unchanged as of December 31, 2009 as compared to December 31, 2008 the present valueexclusive of the remaining obligation is $38.6 millionimpact of foreign exchange and amortization.
 
The present valueIn September 2009, we were issued a U.S. patent for the use of beta interferon for immunomodulation or treating a viral condition, viral disease, cancers or tumors. This patent, expiring in September 2026, covers the treatment of multiple sclerosis with AVONEX, which is our brand of recombinant beta interferon and extends the expected remaining life of the payments due under the agreements will be accreted to future value at an interest rate of 5.75%, our incremental borrowing rate at the time of the acquisition.related core intangible asset.
 
FumapharmAmortization of Acquired Intangible Assets
 
             
  For the Years Ended December 31,
(In millions) 2009 2008 2007
 
Amortization of acquired intangible assets $289.8  $332.7  $257.5 
In June 2006,
Our most significant intangible asset is the core technology related to our AVONEX product. We believe the economic benefit of our core technology is consumed as revenue is generated from our AVONEX product, which we completedrefer to as the acquisition of 100%economic consumption amortization model. An analysis of the stockanticipated product sales of Fumapharm, a privately held pharmaceutical company basedAVONEX is performed annually during our long range planning cycle each year. This analysis serves as the basis for the calculation of economic consumption for the core technology intangible asset.
We completed our most recent long range planning cycle in Switzerland that develops therapeutics derived from fumaric acid esters. As partthe third quarter of 2009, which includes an analysis of the acquisition, we acquired FUMADERM, a commercialanticipated product availablesales of AVONEX. Based upon our most recent analysis, amortization of intangible assets included within our consolidated balance sheet as of December 31, 2009 is expected to be in Germanythe range of approximately $160.0 million to $220.0 million for each of the treatment of psoriasis, and BG-12, a clinical-stage compound being studied for the treatment of MS and psoriasis that was being jointlynext five years.


F-21


 
BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
developed by Fumapharm and us. The purpose of this acquisition was to support our goal of developing innovative therapeutic options for people living with MS.
As part of the acquisition, we agreed to pay $220.0 million, of which $218.0 million was paid at closing and $2.0 million was paid in 2008 as partial coverage for any losses incurred as a result of any breach of representations and warranties. We agreed to additional payments of $15.0 million upon achievement of certain regulatory approvals, and additional payments in the event that annual and cumulative sales targets, as defined, are achieved.
The acquisition was funded from our existing cash on hand and has been accounted for as a business combination. Assets and liabilities assumed have been recorded at their fair values as of the date of acquisition. The results of operations for Fumapharm are included from the date of acquisition. Our purchase price allocation for the acquisition is set forth below (in millions):
     
Current assets $6.5 
In process research and development  207.4 
Core technology  16.9 
Developed technology  9.5 
Goodwill  18.5 
Other assets  1.2 
Deferred tax liabilities  (2.8)
Other liabilities  (2.7)
     
  $254.5 
     
Consideration and Gain    
Consideration $220.0 
Gain on settlement of pre-existing license agreement  34.2 
Transaction costs  0.3 
     
  $254.5 
     
The purchase price allocation was completed during the fourth quarter of 2006.
The amount allocated to IPR&D projects relates to the development of BG-12. BG-12 has received positive results from a Phase 2 study of its efficacy and safety for patients with relapsing-remitting MS and, subsequent to the acquisition, we initiated Phase 3 clinical trials. Since the acquisition in June of 2006, we have incurred $129.3 million in research and development costs. We expect to incur approximately an additional $169.0 million to complete the development of BG-12. The estimated revenues from BG-12 are expected to be recognized beginning in 2012. A discount rate of 12% was used to value the project, which we believe to be commensurate with the stage of development and the uncertainties in the economic estimates described above. At the date of acquisition, the development of BG-12 had not yet reached technological feasibility, and the research and development in progress had no alternative future use. Accordingly, $207.4 million in IPR&D was expensed in 2006.
The fair value of intangible assets was based on valuations using an income approach, with estimates and assumptions determined by management. The core technology asset represents a combination of Fumapharm’s processes and procedures related to the design and development of its application products. The developed technology relates to processes and procedures related to products that have reached technological feasibility. Core technology is being amortized over approximately 12 years and the developed technology over approximately 3 years. The excess of purchase price over tangible assets, identifiable intangible assets and assumed liabilities represents goodwill. None of the goodwill or intangible assets acquired is deductible for income tax purposes. As a result, we recorded a deferred tax liability of $2.8 million, based on the tax effect of the amount of the acquired intangible assets other than goodwill with no tax basis.


F-22


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
In addition to the assets acquired, a gain of $34.2 million was recognized coincident with the acquisition of Fumapharm in accordance withEITF 04-1,Accounting for Preexisting Relationships between the Parties to a Business Combination.The gain related to the settlement of a preexisting license agreement between Fumapharm and us. The license agreement in question had been entered into in October 2003 and required us to make payments to Fumapharm of certain royalty amounts. The market rate for such payments was determined to have increased due, principally, to the increased technical feasibility of BG-12. The gain primarily relates to the difference between i) the royalty rates at the time the agreement was entered into as compared to ii) the expected higher royalty rates that would result at the time the agreement was effectively settled by virtue of our acquisition of Fumapharm.
Future contingent consideration payments, if any, will be accounted for as increases to goodwill. The total revenue, operating income (loss) and net income (loss) impacts of the acquisition for the year ended December 31, 2006 was not material.
ConformaGoodwill
 
In May 2006, we completed the acquisition of 100% of the stock of Conforma, a privately-held development stage biopharmaceutical company based in California that focused on the design and development of drugs for the treatment of cancer. The goal of this acquisition wasfollowing table summarizes changes to enable us to broaden our therapeutic opportunities in the field of oncology.goodwill:
 
We acquired all of the issued and outstanding shares of the capital stock of Conforma for $150.0 million, paid at closing. Of this amount, $15.0 million has been escrowed by the sellers pending satisfaction of customary representations and warranties made by Conforma. In 2008, we recorded an IPR&D charge of $25.0 million related to an HSP90 related milestone payment made to the former shareholders of Conforma. Up to an additional $75.0 million could be payable to the sellers upon the achievement of certain future development milestones. Additionally, $0.5 million in transaction costs were incurred and loans of approximately $2.3 million were made to certain non-officer employees of Conforma, which are included in other assets in the accompanying consolidated balance sheet. Such loans are fully collateralized and were made for the purpose of assisting the employees in meeting their tax liabilities.
The acquisition was funded from our existing cash on hand and was accounted for as an asset acquisition as Conforma is a development-stage company. As a result of the acquisition, we obtained the rights to two compounds in Phase 1 clinical trials: CNF1010, a proprietary form of the geldanamycin derivative17-AAG; and CNF2024, or HSP90, a totally synthetic, orally bioavailable heat shock protein 90 inhibitor.
The results of operations of Conforma are included in our results from the date of acquisition. Our completed purchase price allocation for the acquisition is set forth below (in millions):
     
Current assets $2.5 
Fixed assets  0.8 
Deferred tax asset  24.0 
Assembled workforce  1.4 
In process research and development  123.1 
Current liabilities  (1.3)
     
  $150.5 
     
         
  As of December 31, 
(In millions) 2009  2008 
 
Balance as of January 1 $1,138.6  $1,137.4 
Foreign currency translation     1.2 
         
Balance as of December 31 $1,138.6  $1,138.6 
         
 
The amount allocated to IPR&D relates to the developmentAs of HSP90, which is in Phase 1 clinical trials. Since the acquisition in June of 2006,December 31, 2009 we have incurred $36.3 million in research and development costs. We expect to incur approximately an additional $242 million to complete the development of HSP90. The estimated revenues from HSP90, if any, are expected to be recognized beginning in 2013. A discount rate of 12% was used to value the project, which we believe to be commensurate with the stage of development and the uncertainties in the economic


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
estimates described above. At the date of acquisition, this compound had not reached technological feasibility and had no alternative future use. Accordingly, $123.1 million in IPR&D was expensed in 2006.
Upon acquisition, we recognized a deferred tax asset of $24.0 million relating to US federal and state net operating losses and tax credit carryforwards that we acquired from Conforma. The amount allocated to deferred tax assets does not include certain tax attributes, such as net operating losses and research credits, that may not be realized because they are subject to annual limitations under the Internal Revenue Code due to a cumulative ownership change of more than 50% which occurred in connection with our acquisition of Conforma.
Future contingent consideration payments, if any, will be recorded as IPR&D. The total revenue, operating income (loss) and net income (loss) impacts of the acquisition for the year ended December 31, 2006 was not material.
ZEVALIN
In December 2007, we sold the U.S. marketing, sales, and manufacturing and development rights of ZEVALIN® to Cell Therapeutics, Inc., or CTI, for an upfront purchase price of $10.0 million. In December 2008, we received an additional $2.2 million milestone payment pursuant to an amendment to the agreement. We may receive up to an additional $20.0 million in milestone payments. In addition, we will receive royalty payments on future sales of ZEVALIN. As part of the overall agreement, we entered into a supply agreement with CTI to sell ZEVALIN product through 2014. Our sales of ZEVALIN to Bayer Schering Pharma AG, or Schering AG, for distribution in the EU will be recognized as product revenue and our supply of ZEVALIN to CTI will be recognized as corporate partner revenue. We will continue to receive royalty revenues from Schering AG on their sales of ZEVALIN in the EU. The $10.0 million upfront and $2.2 million milestone payment are being recognized in our results of operations over the term of the supply agreement.accumulated impairment losses.
 
3.6.  Fair Value Measurements
 
Summary of Assets and Liabilities Recorded at Fair Value
The following tables below present information about our assets and liabilities that are measured at fair value on a recurring basis as of December 31, 2009 and 2008 and indicatesindicate the fair value hierarchy of the valuation techniques we utilized to determine such fair value. In general, fair values determined by Levelvalue, which is described further within Note 1, inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize data points that are observable such as quoted prices, interest rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data points for the asset or liability.Summary of Significant Accounting Policiesto our Consolidated Financial Statements.
 
A majority of our financial assets and liabilities have been classified as Level 2. These assets and liabilities have been initially valued at the transaction price and subsequently valued typically utilizing third party pricing services. The pricing services use many observable market inputs to determine value, including reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. We obtain an understanding of the models and validate the prices provided by our third party pricing services by understanding the models used, obtaining market values from other pricing sources, and analyzing pricing data in certain instances. The fair values ofinstances and confirming those securities trade in active markets. After completing our foreign currency forward contracts, interest rate swaps, debt instruments and plan assets for deferred compensation are based on market inputs and have been classified as Level 2. As of December 31, 2008 and after completing our


F-24


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
validation procedures, we did not adjust or override any fair value measurements provided by our pricing services. (in millions):
                 
        Significant Other
  Significant
 
  Balance at
  Quoted Prices in
  Observable
  Unobservable
 
  December 31,
  Active Markets
  Inputs
  Inputs
 
Description
 2008  (Level 1)  (Level 2)  (Level 3) 
 
Assets:                
Cash equivalents $500.9  $  $500.9  $ 
Marketable debt securities  1,640.4      1,640.4    
Strategic investments  4.6   4.6       
Venture capital investments  23.9         23.9 
Derivative contracts  1.9      1.9    
Plan assets for deferred compensation  13.3      13.3    
                 
Total $2,185.0  $4.6  $2,156.5  $23.9 
                 
Liabilities:                
Derivative contracts $46.0  $  $46.0  $ 
                 
Total $46.0  $  $46.0  $ 
                 
services as of December 31, 2009 and 2008.
 
The fair values of our cash equivalents, marketable debt securities, derivative instruments and plan assets for deferred compensation are determined through market and observable sources. Our strategic investments are investments in publicly traded equity securities whereare classified as Level 1 assets as their fair value isvalues are readily determinable.
The following table is a roll forward of the fair value of our venture capital investments, where fair value is determined by Level 3 inputs (in millions):
     
  Year
 
  Ended
 
  December 31,
 
Description
 2008 
 
Beginning Balance $28.1 
Total net unrealized gains (losses) included in earnings  (7.6)
Purchases, issuances, and settlements  3.4 
     
Ending Balance $23.9 
     
determinable and based on quoted market prices.
 
Our venture capital investments which represent approximately 0.3% of the total assets at December 31, 2008, are the only assets wherefor which we used Level 3 inputs to determine the fair value. Venture capital investments represented approximately 0.3% of total assets as of December 31, 2009 and 2008. We have funding commitments of up to approximately $24.8 million as part of our investment in these funds. These funds primarily invest in small privately-owned, ventured-backed, biotechnology companies. The fair value of funds has been estimated using the net asset value of our ownership interest in partner’s capital. The investments cannot be redeemed within the funds. Distributions from each will be received as the underlying investments of the fund are liquidated. The funds and therefore a majority of the underlying assets of the funds will not be liquidated in the near future. The underlying assets in these funds are initially measured at transaction prices and subsequently valued using the pricing of recent financingand/or by reviewing the underlying economic fundamentals and liquidation value of the companies. Gains and losses (realized and unrealized) included in earnings for the period are reported in other income (expense), net.
The carrying amounts reflected in the consolidated balance sheets for cash, accounts receivable, due from unconsolidated joint business, other current assets, accounts payable and accrued expenses and other approximate fair value due to their short-term maturities.
At December 31, 2008, the fair values of our debt instruments were as follows (in millions):
     
Credit line from Dompé $16.4 
Notes payable to Fumedica $37.5 
6.0% Senior Notes due 2013 $429.8 
6.875% Senior Notes due 2018 $562.4 


F-25F-22


 
BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The following tables set forth our financial assets and liabilities that were recorded at fair value:
                 
     Quoted
  Significant
    
     Prices
  Other
  Significant
 
  As of
  in Active
  Observable
  Unobservable
 
  December 31,
  Markets
  Inputs
  Inputs
 
(In millions) 2009  (Level 1)  (Level 2)  (Level 3) 
 
Assets:                
Cash equivalents $476.4  $  $476.4  $ 
Marketable debt securities:                
Corporate debt securities  504.1      504.1    
Government securities  1,133.5      1,133.5    
Mortgage and other asset backed securities  238.3      238.3    
Strategic investments  5.9   5.9       
Venture capital investments  21.9         21.9 
Derivative contracts  15.8      15.8    
Plan assets for deferred compensation  13.6      13.6    
                 
Total $2,409.5  $5.9  $2,381.7  $21.9 
                 
Liabilities:                
Derivative contracts $11.1  $  $11.1  $ 
                 
Total $11.1  $  $11.1  $ 
                 
                 
     Quoted
  Significant
    
     Prices
  Other
  Significant
 
  As of
  in Active
  Observable
  Unobservable
 
  December 31,
  Markets
  Inputs
  Inputs
 
(In millions) 2008  (Level 1)  (Level 2)  (Level 3) 
 
Assets:                
Cash equivalents $500.9  $  $500.9  $ 
Marketable debt securities:                
Corporate debt securities  328.5      328.5    
Government securities  1,005.0      1,005.0    
Mortgage and other asset backed securities  306.9      306.9    
Strategic investments  4.6   4.6       
Venture capital investments  23.9         23.9 
Derivative contracts  1.9      1.9    
Plan assets for deferred compensation  13.3      13.3    
                 
Total $2,185.0  $4.6  $2,156.5  $23.9 
                 
Liabilities:                
Derivative contracts $46.0  $  $46.0  $ 
                 
Total $46.0  $  $46.0  $ 
                 
The fair values of our cash equivalents, marketable debt securities, derivative contracts and plan assets for deferred compensation are determined through market and observable sources.


F-23


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The following table provides a roll forward of the fair value of our venture capital investments, where fair value is determined by Level 3 inputs:
         
  As of December 31, 
(In millions) 2009  2008 
 
Beginning balance $  23.9  $    28.1 
Total net unrealized gains (losses) included in earnings  (3.6)  (7.6)
Purchases, issuances, and settlements  1.6   3.4 
         
Ending balance $21.9  $23.9 
         
The fair values of our debt instruments are summarized as follows:
         
  As of December 31, 
(In millions) 2009  2008 
 
Credit line from Dompé $17.2  $16.4 
Notes payable to Fumedica  31.3   37.5 
6.0% Senior Notes due 2013  475.7   429.8 
6.875% Senior Notes due 2018  589.1   562.4 
         
Total fair value $1,113.3  $1,046.1 
         
 
The fair values of our credit line from Dompe and our note payable to Fumedica were estimated using market observable inputs. The fair value of our Senior Notes was determined through market, observable and corroborated sources. Within the hierarchy of fair value measurements, these are Level 2 fair values.
 
4.7.  Financial Instruments
Financial instruments that potentially subject us to concentrations of credit risk are accounts receivable and marketable securities. Wholesale distributors and large pharmaceutical companies account for the majority of our accounts receivable and collateral is generally not required from these customers. To mitigate credit risk, we monitor the financial performance and credit worthiness of our customers. We also maintain a well diversified portfolio of marketable securities that limits our credit exposure through concentration limits set within our investment policy.
 
Marketable Securities, including Strategic Investments
 
The following is a summarytables summarize our marketable securities and strategic investments:
                 
     Gross
  Gross
    
  Fair
  Unrealized
  Unrealized
  Amortized
 
As of December 31, 2009 (In millions): Value  Gains  Losses  Cost 
 
Available-for-Sale
                
Corporate debt securities                
Current $177.2  $1.5  $  $175.7 
Non-current  326.9   5.7   (0.3)  321.5 
Government securities                
Current  501.6   1.2      500.4 
Non-current  631.9   4.1   (0.5)  628.3 
Mortgage and other asset backed securities                
Current  3.0   0.1      2.9 
Non-current  235.3   4.1   (0.5)  231.7 
                 
Totalavailable-for-sale securities
 $1,875.9  $16.7  $(1.3) $1,860.5 
                 
Other Investments
                
Strategic investments, non-current $5.9  $2.7  $(0.3) $3.5 
                 


F-24


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
                 
     Gross
  Gross
    
  Fair
  Unrealized
  Unrealized
  Amortized
 
As of December 31, 2008 (In millions): Value  Gains  Losses  Cost 
 
Available-for-Sale
                
Corporate debt securities                
Current $128.2  $0.4  $  $127.8 
Non-current  200.3   2.6      197.7 
Government securities                
Current  582.8   1.5      581.3 
Non-current  422.2   8.7      413.5 
Mortgage and other asset backed securities                
Current  13.9         13.9 
Non-current  293.0   3.3   (0.3)  290.0 
                 
Totalavailable-for-sale securities
 $1,640.4  $16.5  $(0.3) $1,624.2 
                 
Other Investments
                
Strategic investments, non-current $4.6  $0.5  $(0.1) $4.2 
                 
In the tables above, as of December 31, 2009 and 2008, government securities included $298.8 million and $139.1 million, respectively, of Federal Deposit Insurance Corporation (FDIC) guaranteed senior notes issued by financial institutions under the Temporary Liquidity Guarantee Programs.
Certain commercial paper and short-term debt securities with original maturities of less than 90 days are included in cash and cash equivalents on the accompanying consolidated balance sheets and are not included in the tables above. As of December 31, 2009 and 2008, such commercial paper, including accrued interest, had fair and carrying values of $76.9 million and $42.7 million, respectively, and short-term debt securities had fair and carrying values of $399.5 million and $458.2 million, respectively.
In addition, the balances as of December 31, 2008 include amounts related to loaned securities under our securities lending program.
Summary of Contractual Maturities:Available-for-Sale Securities
The estimated fair value and amortized cost of securities, excluding strategic investments,available-for-sale by contractual maturity are summarized as follows:
                 
  As of December 31, 2009  As of December 31, 2008 
  Estimated
  Amortized
  Estimated
  Amortized
 
(In millions) Fair Value  Cost  Fair Value  Cost 
 
Due in one year or less $522.0  $519.5  $714.9  $713.0 
Due after one year through five years  1,143.7   1,133.4   733.7   722.0 
Due after five years  210.2   207.6   191.8   189.2 
                 
Total $1,875.9  $1,860.5  $1,640.4  $1,624.2 
                 
The average maturity of our marketable securities as of December 31, 2009 and 2008 was 15 months and 13 months, respectively.

F-25


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Proceeds from Maturities and Sales of Marketable Securities, excluding Strategic Investments
The proceeds from maturities and sales of marketable securities, excluding strategic investments, which were primarily reinvested and investments (in millions):resulting realized gains and losses, are summarized as follows:
 
                 
     Gross
  Gross
    
  Fair
  Unrealized
  Unrealized
  Amortized
 
December 31, 2008:
 Value  Gains  Losses  Cost 
 
Available-for-sale
                
Corporate debt securities                
Current $84.8  $0.4  $  $84.4 
Non-current  200.3   2.6      197.7 
U.S. Government securities                
Current  582.8   1.5      581.3 
Non-current  422.2   8.7      413.5 
Other interest bearing securities                
Current  57.3         57.3 
Non-current  293.0   3.3   (0.3)  290.0 
                 
Total available-for-sale securities $1,640.4  $16.5  $(0.3) $1,624.2 
                 
Other Investments
                
Strategic investments, non-current $4.6  $0.5  $(0.1) $4.2 
                 
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Proceeds from maturities and sales $3,319.0  $2,941.1  $3,154.3 
Realized gains $19.8  $15.9  $4.5 
Realized losses $4.0  $17.0  $4.9 
 
The realized losses for the year ended December 31, 2009 and 2008 primarily relate to losses on the sale of corporate debt securities and non-agency mortgage-backed securities.
Strategic Investments
In 2009 we sold two strategic investments for $5.9 million, which resulted in a $3.0 million gain. In 2008, we did not sell any portion of our strategic investments. In 2007, we sold our share in one strategic investment for $99.5 million, which resulted in a $17.2 million gain. Strategic investments are included in investments and other assets on the accompanying consolidated balance sheets.
In addition to the strategic investments and venture capital investments noted in Note 6,Fair Value Measurements, to our Consolidated Financial Statements, we hold other investments in equity securities of certain privately held biotechnology companies and biotechnology oriented venture capital funds accounted for using the cost method. The cost basis of these securities as of December 31, 2009 and 2008 is $73.9 million and $40.8 million, respectively. These securities are also included in investments and other assets on the accompanying consolidated balance sheets.
Impairments
Evaluating Investments forOther-than-Temporary Impairments
We conduct periodic reviews to identify and evaluate each investment that has an unrealized loss, in accordance with the meaning ofother-than-temporary impairment and its application to certain investments, as required by U.S. GAAP. An unrealized loss exists when the current fair value of an individual security is less than its amortized cost basis. Unrealized losses onavailable-for-sale securities that are determined to be temporary, and not related to credit loss, are recorded, net of tax, in accumulated other comprehensive income.
Foravailable-for-sale debt securities with unrealized losses, management performs an analysis to assess whether we intend to sell or whether we would more likely than not be required to sell the security before the expected recovery of the amortized cost basis. Where we intend to sell a security, or may be required to do so, the security’s decline in fair value is deemed to beother-than-temporary and the full amount of the unrealized loss is recorded within earnings as an impairment loss.
Regardless of our intent to sell a security, we perform additional analysis on all securities with unrealized losses to evaluate losses associated with the creditworthiness of the security. Credit losses are identified where we do not expect to receive cash flows sufficient to recover the amortized cost basis of a security.
For equity securities, when assessing whether a decline in fair value below our cost basis isother-than-temporary, we consider the fair market value of the security, the duration of the security’s decline, and the financial condition of the issuer. We then consider our intent and ability to hold the equity security for a period of time sufficient to recover our carrying value. Where we have determined that we lack the intent and ability to hold an equity security to its expected recovery, the security’s decline in fair value is deemed to beother-than-temporary and is recorded within earnings as an impairment loss.


F-26


 
BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
                 
     Gross
  Gross
    
  Fair
  Unrealized
  Unrealized
  Amortized
 
December 31, 2007:
 Value  Gains  Losses  Cost 
 
Available-for-sale
                
Corporate debt securities                
Current $178.3  $0.2  $(0.3) $178.4 
Non-current  309.7   3.5   (0.1)  306.3 
U.S. Government securities                
Current  192.5   0.2   (0.1)  192.4 
Non-current  232.5   4.7      227.8 
Other interest bearing securities                
Current  6.1         6.1 
Non-current  537.0   5.2   (0.5)  532.3 
                 
Total available-for-sale securities $1,456.1  $13.8  $(1.0) $1,443.3 
                 
Other Investments
                
Strategic investments, non-current $16.8  $2.9  $(0.1) $14.0 
                 
Recognition and Measurement ofOther-than-Temporary Impairment
Prior to the adoption of new accounting standards for the recognition, measurement and presentation ofother-than-temporary impairments in April 2009, we recognized allother-than-temporary impairment amounts related to our marketable debt securities in earnings as required under the previously effective guidance which required that management assert that it had the ability and intent to hold a debt security until maturity or until we recovered the cost of our investment.
 
In 2009, 2008, and 2007, we recognized $3.8 million, $16.3 million, and $17.6 million in charges, respectively, for the table above, at December 31,impairment of publicly-held strategic investments and for declines in value of funds that were determined to beother-than-temporary.
In 2009, 2008, U.S. Government securities includes $139.1and 2007, we recorded $3.2 million, $2.3 million, and $0.8 million, respectively, in charges for the impairment for certain investments in privately-held companies and declines in value of FDIC guaranteed senior notes issued by financial institutionsfunds recorded under the Temporary Liquidity Guarantee Program (TLGP). Certain commercial paper and short-term debt securities with original maturities of less than 90 days are included in cash and cash equivalents on the accompanying balance sheet and are not included in the table above. The commercial paper, including accrued interest, has a fair and carrying value of $42.7 million and $368.2 million and short-term debt securities has a fair and carrying value of $458.2 million and $195.1 million at December 31, 2008 and December 31, 2007, respectively.cost method that were determined to beother-than-temporary.
 
The tables above include our loanedIn 2009, we recognized $3.6 million in charges for theother-than-temporary impairment on marketable debt securities. In the years ended December 31,For 2008 and 2007, we recognized $41.7 million and $7.5 million, respectively, in charges for theother-than-temporary impairment of available-for-salemarketable debt securities primarily related to mortgage and asset backed securities that were determined to be other-than-temporary following a decline in value primarily related to adverse market conditions, including less active trading markets, and a change in our investment strategy regarding these assets which no longer provided us with the ability and intent to hold the securities to maturity or until we recovered the cost of our investment. No such charges were recognized in 2006.asset-backed securities.
 
Unrealized losses relate to various debt securities, including U.S. Government issues, corporate bonds and asset-backed securities. The unrealized losses on these securities were primarily caused by a rise in interest ratesand/or an increase in credit spreads subsequent to purchase. We believe that these unrealized losses are temporary, and we have the intent and ability to hold these securities to recovery, which may be at maturity.
The proceeds from maturities and sales of marketable securities, excluding strategic investments, which were primarily reinvested, and resulting realized gains and losses were as follows (in millions):
             
  Year Ended December 31, 
  2008  2007  2006 
 
Proceeds from maturities and sales $2,941.1  $3,154.3  $1,787.1 
Realized gains $15.9  $4.5  $1.9 
Realized losses $17.0  $4.9  $4.7 

F-27


8.  Derivative Instruments
 
BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The estimated fair value and amortized cost of securities, excluding strategic investments, available-for-sale by contractual maturity are as follows (in millions):
         
  December 31, 2008 
  Estimated Fair Value  Amortized Cost 
 
Due in one year or less $714.9  $713.0 
Due after one year through five years  733.7   722.0 
Due after five years  191.8   189.2 
         
Total $1,640.4  $1,624.2 
         
Mortgage and other asset backed securities totaled $306.8 million and include $66.5 million of non-agency mortgage backed securities at December 31, 2008. The average maturity of our marketable securities at December 31, 2008 and 2007 was 13 months and 15 months, respectively.
Strategic Investments
In 2007, we sold our share in one strategic investment for $99.5 million, which resulted in a $17.2 million gain. In 2008 and 2006, we did not sell any portion of strategic investments. Strategic investments are included in investments and other assets on the accompanying balance sheet.
In 2008, 2007, and 2006, we recognized $8.6 million, $16.0 million, and $30.5 million in charges, respectively, for the impairment of publicly-held strategic investments for declines in value that were determined to be other-than-temporary.
We hold other investments in equity securities of certain privately held biotechnology companies or biotechnology oriented venture capital funds. The cost basis of these securities at December 31, 2008 and 2007 is $64.7 million and $52.9 million, respectively. These securities are included in investments and other assets on the accompanying consolidated balance sheet.
In 2008, 2007, and 2006, we recorded $2.3 million, $2.4 million, and $3.9 million, respectively, in charges for the impairment for certain investments in privately held companies or funds that were determined to be other than temporary.
Forward Contracts and Interest Rate Swaps
 
On January 1, 2009, we adopted a newly issued accounting standard which requires additional disclosure about our objectives for using derivative instruments, the level of derivative activity we engage in, and the effect of derivative instruments and related hedged items on our financial position and performance. The adoption of this standard did not impact our financial position or results of operations.
Our primary market exposure is to foreign exchange rates and interest rates. We use certain derivative instruments to help manage these exposures. We execute these instruments with financial institutions we judge to be creditworthy and the majority of these instruments are denominated in currencies of major industrial countries. We do not hold or issue derivative instruments for trading or speculative purposes.
We recognize all derivative instruments as either assets or liabilities at fair value in our consolidated balance sheets. We classify the cash flows from these instruments in the same category as the cash flows from the hedged items.
Forward Contracts
Due to the global nature of our operations, portions of our revenues are in currencies other than the U.S. dollar. The value of revenue measured in U.S. dollars is subject to changes in foreign currencyexchange rates. In order to mitigate these changes we use forward contracts to hedge specific forecasted transactions denominatedlock in foreign currencies. exchange rates. We do not engage in currency speculation.
All foreign currency forward contracts in effect atas of December 31, 2009 and 2008 had durations of 1 to 12 months. These contracts have been designated as cash flow hedges and accordingly, to the extent effective, any unrealized gains or losses on these foreign currency forward contracts are reported in accumulated other comprehensive income (loss). Realized gains and losses for the effective portion of such contracts are recognized within revenue when the completionsale of product in the underlying hedge transaction.currency being hedged is recognized. To the extent ineffective, hedge transaction gains and losses are reported in other income (expense)., net at each reporting date.


F-27


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Foreign currency forward contracts that were entered into to hedge forecasted revenue are summarized as follows:
         
  Notional Amount
 
  As of December 31, 
Foreign Currency: (In millions) 2009  2008 
 
Euro $495.9  $489.4 
Canadian Dollar  22.3   34.1 
         
Total $518.2  $523.5 
         
 
The notional settlement amountportion of the foreign currency forward contracts outstanding at December 31, 2008 was approximately $523.5 million. The fair value of these contracts was a net unrealized loss of $44.1 million andthat was included in accumulated other comprehensive income (loss) within the shareholder’stotal equity atreflected gains of $1.2 million and losses of $44.1 million as of December 31, 2008.2009 and 2008, respectively. We consider the impact of our and our counterparties’ credit risk on the fair value of the contracts as well as the ability of each party to execute its obligations under the contract. As of December 31, 2009 and 2008, respectively, credit risk did not materially change the fair value of our foreign currency forward contracts. The notional settlement amount of the
In relation to our foreign currency forward contracts, outstanding atwe recognize gains and losses in earnings due to hedge ineffectiveness. During the years ended December 31, 2009, 2008 and 2007 we recognized net losses of $1.1 million, $0.2 million, and $2.6 million, respectively. In addition, we recognized $49.7 million, $8.5 million, and $13.1 million, respectively, of losses in product revenue for the settlement of certain effective cash flow hedge instruments for the years ended December 31, 2009, 2008 and 2007, respectively. These settlements were recorded in the same period as the related forecasted revenue.
Interest Rate Swaps
In connection with the issuance of our 6.875% Senior Notes in March 2008, we entered into interest rate swap contracts with an aggregate notional amount of $550.0 million. These contracts were settled in December 2008. Under the settlement we received $53.9 million. As the interest rate swaps were settled in 2008, no hedge ineffectiveness was recognized for the year ended December 31, 2009. In the year ended December 31, 2008, we recognized a net loss of $8.9 million in earnings due to hedge ineffectiveness.
Additionally, upon termination of the swaps in December 2008, the carrying amount of the 6.875% Senior Notes increased $62.8 million. This amount will be recognized as a reduction of interest expense and amortized using the effective interest rate method over the remaining life of the 6.875% Senior Notes. In 2009, approximately $409.2 million. $5.4 million was recorded as a reduction of interest expense.
Summary of Derivatives Designated as Hedging Instruments
The following table summarizes the fair value of theseand presentation in the consolidated balance sheets for derivatives designated as hedging instruments:
                 
  Foreign Currency Contracts 
  Asset Derivatives  Liability Derivatives 
(In millions) Balance Sheet Location  Fair Value  Balance Sheet Location  Fair Value 
 
December 31, 2009  Other Current Assets  $10.8   Accrued Expenses and Other  $9.8 
December 31, 2008  Other Current Assets  $1.9   Accrued Expenses and Other  $46.0 
As noted above, the interest rate swap contracts was a loss of $6.4 million and was includedwere settled in other current liabilities at December 31, 2007.2008.


F-28


 
BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
For ourThe following table summarizes the effect of derivatives designated as hedging instruments on the consolidated statements of income:
                   
  Amount
     Amount
      
  Recognized in
     Reclassified from
      
  Accumulated Other
     Accumulated Other
      
  Comprehensive
     Comprehensive
      
  Income
     Income
    Amount of
 
  on Derivative
  Income Statement
  into Income
  Income Statement
 Gain/(Loss)
 
  Gain/(Loss)
  Location
  Gain/(Loss)
  Location
 Recorded
 
For the Years Ended (In millions) (Effective Portion)  (Effective Portion)  (Effective Portion)  (Ineffective Portion) (Ineffective Portion) 
 
December 31, 2009:
                  
Foreign currency contracts $1.2   Revenue  $(49.7) Other income
(expense)
 $(1.1)
December 31, 2008:
                  
Foreign currency contracts $(44.1)  Revenue  $(8.5) Other income
(expense)
 $0.2 
Interest rate swap $   Interest Expense  $  Interest Expense $(8.9)
                   
December 31, 2007:
                  
Foreign currency contracts $(6.4)  Revenue  $(13.1) Other income
(expense)
 $(2.6)
Other Derivatives
In 2009, we entered into several foreign currency forward contracts in 2008, there was $0.2 million recognized in earnings as a loss due to hedge ineffectiveness. We recognized an $8.5 million negative impact on product revenue formitigate the settlement of certain effective cash flow hedge instruments in 2008. These settlements were recorded in the same period as the related forecasted transactions affecting earnings.
For our foreign currency forward contracts in 2007, there was $2.6 million recognized in earnings as a loss duerisk related to hedge ineffectiveness.certain balance sheet items. We recognized $13.1 million of losses in product revenue for the settlement of certain effective cash flow hedge instruments in 2007. These settlements were recorded in the same period as the related forecasted transactions affecting earnings.
In 2006, there was $0.6 million recognized in earnings as a loss due to hedge ineffectiveness and $0.9 million recognized in earnings as a loss as a result of the discontinuance of cash flowhave not elected hedge accounting because it was no longer probable that the hedge forecasted transaction would occur. We recognized $11.2 millionfor these items. As of losses in product revenue for the settlement of certain effective cash flow hedge instruments through December 31, 2006. These settlements were recorded in2009, the same period as the related forecasted transactions affecting earnings.
As described in Note 8, Indebtedness, we entered into interest rate swaps during 2008 for an aggregate notional amount of our outstanding foreign currency contracts was $188.0 million. The fair value of these contracts was a net asset of $3.8 million. Net gains of $2.5 million were recognized as a component of other income (expense), net related to these contracts in the year ended December 31, 2009.
9.  Indebtedness
Our indebtedness is summarized as follows:
         
  As of December 31, 
(In millions) 2009  2008 
 
Current portion:        
Notes payable to Fumedica $11.2  $10.9 
Credit line from Dompé  8.6   16.8 
         
Current portion of notes payable and line of credit $19.8  $27.7 
         
Non-current portion:        
6.0% Senior notes due 2013 $449.6  $449.6 
6.875% Senior notes due 2018  603.2   608.2 
Notes payable to Fumedica  18.8   27.6 
Credit line from Dompé  8.6    
         
Notes payable and line of credit $1,080.2  $1,085.4 
         
The following is a summary description of our principal indebtedness as of December 31, 2009.
Senior Notes
On March 4, 2008, we issued $450.0 million aggregate principal amount of 6.0% Senior Notes due March 1, 2013 and $550.0 million which were due to expire in March 2018. These interest rate swaps had been designated as fair value hedges and were being used to manage our exposure to changes in interest rates. The interest rate swaps had the effect of changing our fixed interest rate to variable interest rate on $550.0 million of our Senior Notes balance outstanding. During 2008, we recognized a net loss of $8.9 million in earnings due to hedge ineffectiveness. In December 2008, the interest rate swaps were settled. Under the settlement we received $53.9 million. The proceeds from this settlement upon termination are included within the operating section of the statement of cash flows. Upon termination of the swaps, the carryingaggregate principal amount of the 6.875% Senior Notes due inMarch 1, 2018 increased $62.8 million as it was accounted for as a fair value hedge. This will be recognized as a reduction of interest expenseat 99.886% and amortized using the effective interest rate method over the remaining life of the Senior Notes.


F-29


 
BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
5.  Earnings per Share
Basic99.184% of par, respectively. The discount is amortized as additional interest expense over the period from issuance through maturity. These notes are senior unsecured obligations. Interest on the notes is payable March 1 and diluted earnings per shareSeptember 1 of each year. The notes may be redeemed at our option at any time at 100% of the principal amount plus accrued interest and a specified make-whole amount. The notes contain a change of control provision that may require us to purchase the notes under certain circumstances. There is also an interest rate adjustment feature that requires us to pay interest at an increased interest rate on the notes if the credit rating on the notes declines below investment grade. Offering costs of approximately $8.0 million have been recorded as debt issuance costs on our consolidated balance sheet and are calculatedamortized as follows (in millions):
             
  Year Ended December 31, 
  2008  2007  2006 
 
Numerator:            
Income before cumulative effect of accounting change $783.2  $638.2  $213.7 
Cumulative effect of accounting change, net of income tax        3.8 
             
Net income  783.2   638.2   217.5 
Adjustment for net income allocable to preferred stock  (1.3)  (1.0)  (0.3)
             
Net income used in calculating basic earnings per share  781.9   637.2   217.2 
Adjustment for interest, net of interest capitalized and tax         
             
Net income used in calculating diluted earnings per share $781.9  $637.2  $217.2 
             
Denominator:            
Weighted average number of common shares outstanding  292.3   315.8   338.6 
Effect of dilutive securities:            
Stock options and ESPP  1.3   2.6   2.0 
Restricted stock awards  0.1   0.5   0.8 
Time-vested restricted stock units  1.3   1.1   0.4 
Performance-based restricted stock units        0.3 
Convertible promissory notes due 2019     0.2   3.1 
Convertible promissory notes due 2032        0.1 
             
Dilutive potential common shares  2.7   4.4   6.7 
             
Shares used in calculating diluted earnings per share  295.0   320.2   345.3 
             
additional interest expense using the effective interest rate method over the period from issuance through maturity.
 
The following amounts were not includedUpon the issuance of the debt we entered into interest rate swap contracts where we received a fixed rate and paid a variable rate, as further described in Note 8,Derivative Instrumentsto our Consolidated Financial Statements. These contracts have been subsequently terminated. Upon termination of these swaps, the calculationcarrying amount of net income per share because their effects were anti-dilutive (in millions):the 6.875% Senior Notes due in 2018 was increased by $62.8 million. This increase is amortized using the effective interest rate method over the remaining life of the Senior Notes and is being recognized as a reduction of interest expense.
 
             
  Year Ended December 31, 
  2008  2007  2006 
 
Numerator:            
Net income allocable to preferred stock $1.3  $1.0  $0.3 
Adjustment for interest, net of tax         
             
Total $1.3  $1.0  $0.3 
             
Denominator:            
Stock options  6.9   8.2   16.5 
Time-vested restricted stock units  1.5   0.1   0.1 
Convertible preferred stock  0.5   0.5   0.5 
             
Total  8.9   8.8   17.1 
             
We used the proceeds of this borrowing, along with cash and the proceeds from the liquidation of marketable securities, to repay the full $1,500.0 million outstanding under the term loan facility we had entered into in July 2007 in connection with the funding of our June 2007 common stock tender offer. This term loan facility expired upon repayment.
Revolving Credit Facility
We have a $360.0 million senior unsecured revolving credit facility, which may be used for future working capital and general corporate purposes. The facility terminates in June 2012. As of December 31, 2009 and 2008, there were no borrowings under this credit facility and we were in compliance with applicable covenants.
Biogen-Dompé
 
As a result of the tender offer described in Note 21, Tender Offer, earnings per share for the year ended December 31, 2007 reflects2009 and 2008, Biogen-Dompé SRL, a consolidated joint venture, has a loan balance of 12.0 million Euros ($17.2 million) and 12.0 million Euros ($16.7 million), respectively. These balances represent a line of credit from us and Dompé Farmaceutici SpA of 24.0 million Euros, half of which has been eliminated for purposes of presenting our consolidated financial position as it is an intercompany loan. Borrowings under this line of credit are to be made equally between the partners, with any repayments paid in a similar manner. The loan was originally due June 1, 2009; however, a new loan was subsequently executed with a maturity date of December 1, 2011. The interest rate on the line of credit under the new agreements is determined at a weighted averagerate of three month Euro LIBOR plus 150 basis the repurchase of 56,424,155 sharespoints and was 2.2% as of December 31, 2009. The interest rate is reset quarterly and payable quarterly in arrears.
Notes Payable to Fumedica
As of December 31, 2009 and 2008, the notes payable to Fumedica have a present value of 31.2 million Swiss Francs ($30.0 million) and 41.2 million Swiss Francs ($38.6 million), respectively. The notes, which were entered into in connection with the settlement of various agreements associated with Fumedica, are non-interest bearing, have been discounted for financial statement presentation purposes and are being accreted at a rate of 5.75% and are payable in a series of payments through June 27, 2007,2018.


F-30


 
BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
the date the obligation was incurred,Debt Maturity
Our total debt matures as follows:
     
(In millions) As of December 31, 2009
 
2010 $20.1 
2011  11.6 
2012  3.1 
2013  453.1 
2014  3.1 
2015 and thereafter  562.3 
     
Total $1,053.3 
     
The fair value of our debt is disclosed in accordance with FASB Statement No. 150,Note 6,Accounting for CertainFair Value Measurementsto our Consolidated Financial Instruments with Characteristics of Both Liabilities and Equity, or SFAS 150.Statements.
 
6.10.  Share-based PaymentsShareholders’ Equity
 
Share-based compensation expensePreferred Stock
Preferred stock was comprised of the following:
                                     
  As of December 31, 2009  As of December 31, 2008  As of December 31, 2007 
(In thousands) Authorized  Issued  Outstanding  Authorized  Issued  Outstanding  Authorized  Issued  Outstanding 
 
Series A Preferred Stock  1,750   8   8   1,750   8   8   1,750   8   8 
Series X Junior Participating Preferred Stock  1,000         1,000         1,000       
Undesignated  5,250         5,250         5,250       
                                     
   8,000   8   8   8,000   8   8   8,000   8   8 
                                     
We have 8,000,000 shares of Preferred Stock authorized, of which 1,750,000 shares have been designated as Series A Preferred Stock and 1,000,000 shares have been designated as Series X Junior Participating Preferred Stock. The balance may be issued without a vote or action of stockholders from time to time in classes or series with the designations, powers, preferences, and the relative, participating, optional or other special rights of the shares of each such class or series and any qualifications, limitations or restrictions thereon as set forth in the stock certificate. Any such Preferred Stock may rank prior to common stock as to dividend rights, liquidation preference or both, and may have full or limited voting rights and may be convertible into shares of common stock. As of December 31, 2009, 2008 and 2007, there were 8,221 shares of Series A Preferred Stock issued and outstanding. These shares carry a liquidation preference of $67 and are convertible into 60 shares of common stock per share of Preferred Stock. No other shares of Preferred Stock are issued and outstanding as of December 31, 2009, 2008 and 2007.
Stockholder Rights Plan
 
In January 2009, our Board of Directors voted to terminate our stockholders rights plan effective as of January 30, 2009. The plan was scheduled to expire on July 26, 2011 and was originally adopted by the years endedBoard of Directors in 1997. Under the rights plan, each share of our common stock had one “right” attached to it that entitled the holder to purchase our Series X Junior Participating Preferred Stock under the circumstances specified in the rights plan. As a result of our Board of Director’s action, no rights are outstanding or exercisable.
Stock Repurchase Programs
In October 2009, our Board of Directors authorized the repurchase of up to $1.0 billion of our common stock with repurchased shares being retired. This repurchase program does not have an expiration date. As of December 31, 2008 and 2007, we recorded share-based compensation expense2009, approximately 8.8 million shares at a cost of $146.2$422.4 million and $123.1 million, respectively, associated with SFAS 123(R). In the year ended December 31, 2006, we recorded share-based compensation expense of $126.8 million associated with SFAS 123(R), which is net of a cumulative effect pre-tax adjustment of $5.6 million, or $3.8 million after-tax. The cumulative effect results from the application of an estimated forfeiture rate for current and prior period unvested restricted stock awards.
For 2008, 2007, and 2006, share based compensation expense reduced our results of operations as follows (in millions except for earnings per share):
                     
        Year Ended December 31, 2006 
  Year Ended
  Year Ended
  Impact Before
       
  December 31,
  December 31,
  Cumulative
  Cumulative
    
  2008  2007  Effect of
  Effect of
  Effect
 
  Effect on
  Effect on
  Accounting
  Accounting
  on Net
 
  Net Income  Net Income  Change  Change  Income 
 
Income before income taxes $146.2  $123.1  $132.4  $(5.6) $126.8 
Tax effect  45.4   37.5   42.3   (1.8)  40.5 
                     
Net income $100.8  $85.6  $90.1  $(3.8) $86.3 
                     
Basic earnings per share $0.34  $0.27  $0.27  $(0.01) $0.26 
Diluted earnings per share $0.34  $0.27  $0.26  $(0.01) $0.25 
Share-based compensation expense and cost for 2008, 2007, and 2006 is as follows (in millions):
                                     
  Year Ended December 31, 2008  Year Ended December 31, 2007  Year Ended December 31, 2006 
     Restricted
        Restricted
        Restricted
    
  Stock
  Stock &
     Stock
  Stock &
     Stock
  Stock &
    
  Options
  Restricted
     Options
  Restricted
     Options
  Restricted
    
  & ESPP  Stock Units  Total  & ESPP  Stock Units  Total  & ESPP  Stock Units  Total 
 
Research and development $8.2  $51.7  $59.9  $13.0  $38.7  $51.7  $19.5  $33.4  $52.9 
Selling, general and administrative  18.3   75.5   93.8   22.9   53.2   76.1   29.3   53.5   82.8 
                                     
Total $26.5  $127.2  $153.7  $35.9  $91.9  $127.8  $48.8  $86.9  $135.7 
                                     
Pre-tax cumulative effect ofcatch-up
                                (5.6)
                                     
          $153.7          $127.8          $130.1 
                                     
Capitalized share-based payment costs          (7.5)          (4.7)          (3.3)
                                     
Share-based compensation expense         $146.2          $123.1          $126.8 
                                     
For 2008, 2007, and 2006, we capitalized total costs of $7.5 million, $4.7 million, and $3.3 million, respectively, associated with share-based compensation costs to inventory and fixed assets.were repurchased under this


F-31


 
BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
authorization, all of which were retired. From January 1, 2010 through February 5, 2010, we repurchased approximately an additional 5.4 million shares under this program at a total cost of approximately $289.4 million, all of which were also retired. Approximately $288.2 million remains available for the repurchase of our common stock under the 2009 program.
In October 2006, our Board of Directors authorized the repurchase of up to 20.0 million shares of our common stock. As of December 31, 2009, all shares under this program have been repurchased as approximately 7.2 million shares of our common stock were repurchased in 2009 for approximately $328.8 million. In 2008, approximately 12.8 million shares of our common stock were repurchased under this program for approximately $738.9 million.
Reclassifications
The adoption of a newly issued accounting standard for noncontrolling interests on January 1, 2009, changed the accounting and reporting for our minority interests by recharacterizing them as noncontrolling interests and classifying them as a separate component of total shareholders’ equity in our accompanying consolidated balance sheets and consolidated statements of shareholders’ equity. Additionally, net income attributable to noncontrolling interest is now shown separately from net income in the consolidated statements of income. As a result, prior year amounts related to noncontrolling interest have been reclassified to conform to the current year presentation. This reclassification had no effect on our previously reported financial position or results of operations.
In the year ended December 31, 2008, we reclassified amounts within our consolidated statement of shareholders’ equity, resulting in an approximately $78.6 million correction in Additional Paid-in Capital and Retained Earnings (Accumulated Deficit) balances in connection with the re-issuance of treasury stock at a loss.
In the year ended December 31, 2007 we reclassified amounts within our consolidated statements of equity, resulting in an approximately $48.0 million correction in the treasury stock and common stock balances.
11.  Earnings per Share
Basic and diluted earnings per share are calculated as follows:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Numerator:            
Net income attributable to Biogen Idec Inc.  $970.1  $783.2  $638.2 
Adjustment for net income allocable to preferred shares  (1.7)  (1.3)  (1.0)
             
Net income used in calculating basic and diluted earnings per share $968.4  $781.9  $637.2 
             
Denominator:            
Weighted average number of common shares outstanding  287.4   292.3   315.8 
Effect of dilutive securities:            
Stock options and employee stock purchase plan  0.6   1.3   2.6 
Restricted stock awards     0.1   0.5 
Time-vested restricted stock units  1.4   1.3   1.1 
Performance-vested restricted stock units  0.1       
Convertible promissory notes due 2019        0.2 
Convertible promissory notes due 2032         
             
Dilutive potential common shares  2.1   2.7   4.4 
             
Shares used in calculating diluted earnings per share  289.5   295.0   320.2 
             


F-32


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The following amounts were not included in the calculation of net income per basic and diluted share because their effects were anti-dilutive:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Numerator:            
Net income allocable to preferred stock $1.7  $ 1.3  $ 1.0 
             
Denominator:            
Stock options  8.5   6.9   8.2 
Time-vested restricted stock units  2.1   1.5   0.1 
Performance-vested restricted stock units  0.2       
Convertible preferred stock  0.5   0.5   0.5 
             
Total  11.3   8.9   8.8 
             
Earnings per share for the year ended December 31, 2009 reflects, on a weighted average basis, the repurchase of 16.0 million shares of our common stock under our 2009 and 2006 share repurchase programs.
As a result of our 2007 tender offer, earnings per share for the year ended December 31, 2007 reflects, on a weighted average basis, the repurchase of 56.4 million shares as of June 27, 2007, the date the obligation was incurred, in accordance with SFAS 123(R), windfallaccounting standards for earning per share.
12.  Share-based Payments
Share-based Compensation Expense
The following table summarizes share-based compensation expense included within our consolidated statements of income:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Research and development $60.8  $59.9  $51.7 
Selling, general and administrative  106.4   93.8   76.1 
             
Subtotal $167.2  $153.7  $127.8 
Capitalized share-based compensation costs  (6.3)  (7.5)  (4.7)
             
Share-based compensation expense included in total costs and expenses $160.9  $146.2  $123.1 
Income tax effect  (49.4)  (45.4)  (37.5)
             
Share-based compensation expense included in net income attributable to Biogen Idec Inc.  $111.5  $100.8  $85.6 
             


F-33


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Our share-based compensation programs include stock options, time-vested restricted stock units, performance-vested restricted stock units, restricted stock and shares issued under our ESPP. The following table summarizes share-based compensation expense associated with each of these programs:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Stock options $21.6  $20.0  $30.7 
Time-vested restricted stock units  133.7   125.6   75.2 
Performance-vested restricted stock units  4.6   1.1   5.0 
Restricted stock awards     0.5   11.7 
Employee stock purchase plan  7.3   6.5   5.2 
             
Subtotal $167.2  $153.7  $127.8 
Capitalized share-based compensation costs  (6.3)  (7.5)  (4.7)
             
Share-based compensation expense included in total costs and expenses $160.9  $146.2  $123.1 
             
Windfall tax benefits from vesting of stock awards, exercises of stock options and ESPP participation ofwere $3.4 million, $28.0 million, and $69.7 million in 2009, 2008, and $31.7 million were recorded as cash inflows from financing activities in our consolidated statement of cash flows for 2008, 2007, and 2006, respectively. This amount hasThese amounts have been calculated in accordance withunder the alternative transition method described in FSP FAS 123(R) — 3, which we adopted effective the fourth quarter of 2006.accordance with U.S. GAAP.
 
The total amountAs of tax benefit realized during 2008, 2007, and 2006, was $69.9 million, $103.6 million, and $42.8 million, respectively. Cash received from the exercise of stock options in 2008, 2007, and 2006 was approximately $158.3 million, $471.0 million, and $131.8 million, respectively.
At December 31, 2008,2009, unrecognized compensation costs relatingcost related to unvested share-based compensation was approximately $200.0 million.$178.1 million, net of estimated forfeitures. We expect to recognize the cost of these unvested awards over a weighted-average period of 1.4 years.
 
Share-based Compensation Plans
 
We have three share-based compensation plans pursuant to which awards are currently being made: (i)(1) the Biogen Idec Inc. 2006 Non-Employee Directors Equity Plan or the 2006(2006 Directors Plan; (ii)Plan); (2) the Biogen Idec Inc. 2008 Omnibus Equity Plan or the 2008(2008 Omnibus Plan;Plan); and (iii)(3) the Biogen Idec Inc. 1995 Employee Stock Purchase Plan or ESPP.(ESPP). We have six share-based compensation plans pursuant to which outstanding awards have been made, but from which no further awards can or will be made: (i) the IdecIDEC Pharmaceuticals Corporation 1993 Non-Employee Directors Stock Option Plan, or the 1993 Directors Plan; (ii) the IdecIDEC Pharmaceuticals Corporation 1988 Stock Option Plan; (iii) the Biogen, Inc. 1985 Non-Qualified Stock Option Plan; (iv) the Biogen, Inc. 1987 Scientific Board Stock Option Plan:Plan; (v) the Biogen Idec Inc. 2003 Omnibus Equity Plan or the 2003(2003 Omnibus Plan:Plan); and (vi) the Biogen Idec Inc. 2005 Omnibus Equity Plan or the 2005(2005 Omnibus Plan.Plan). We have not made any awards frompursuant to the 2005 Omnibus Plan since our stockholders approved the 2008 Omnibus Plan and do not intend to make any awards frompursuant to the 2005 Omnibus Plan in the future.future, except that unused shares under the 2005 Omnibus Plan have been carried over for use under the 2008 Omnibus Plan.
 
Directors Plan:Plan
In May 2006, our stockholders approved the 2006 Directors Plan for share-based awards to our directors. Awards granted from the 2006 Directors Plan may include options, shares of restricted stock awards, restricted stock units, stock appreciation rights and other awards in such amounts and with such terms and conditions as may be determined by a committee of our Board of Directors, subject to the provisions of the plan. We have reserved a total of 850,000 shares of common stock for issuance under the 2006 Directors Plan. The 2006 Directors Plan provides that awards other than stock options and stock appreciation rights will be counted against the total number of shares reserved under the plan in a 1.5-to-1 ratio.


F-34


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
Omnibus Plans:Plans
In June 2008, our stockholders approved the 2008 Omnibus Equity Plan for share-based awards to our employees. Awards granted from the 2008 Omnibus Plan may include options, shares of restricted stock awards, restricted stock units, performance shares, shares of phantom stock, stock bonuses, stock appreciation rights and other awards in such amounts and with such terms and conditions as may be determined by a committee of our Board of Directors, subject to the provisions of the plan. Shares of common stock available for issuance under the 2008 Omnibus Equity Plan consist of 15.0 million shares reserved for this purpose, plus shares of common stock that remained available for issuance under the 2005 Omnibus Plan on the date that our stockholders approved the 2008 Omnibus Equity Plan, plus shares that are subject to awards under the 2005 Omnibus Plan which remain unissued upon the cancellation, surrender, exchange or termination of such awards. The 2008 Omnibus Equity Plan provides that awards other than stock options and stock appreciation rights will be counted against the total number of shares available under the plan in a 1.5-to-1 ratio.
 
Stock Options
 
All stock option grants to employees are for a ten-year term and generally vest one-fourth per year over four years on the anniversary of the date of grant, provided the employee remains continuously employed with us. Stock option grants to directors are for ten-year terms and generally vest as follows: (i)(1) grants made on the date of a


F-32


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
director’s initial election to our Board of Directors vest one-third per year over three years on the anniversary of the date of grant, and (ii)(2) grants made for service on our Board of Directors vest on the first anniversary of the date of grant, provided in each case that the director continues to serve on our Board of Directors through the vesting date. Options granted under all plans are exercisable at a price per share not less than the fair market value of the underlying common stock on the date of grant. The estimated fair value of options, including the effect of estimated forfeitures, is recognized over the options’ vesting periods. The fair value of the stock option grants awarded in 2009, 2008, 2007, and 20062007 was estimated as of the date of grant using a Black-Scholes option valuation model that uses the following weighted-average assumptions:
 
                        
 Year Ended
  For the Years Ended December 31, 
 December 31,  2009 2008 2007 
 2008 2007 2006 
Expected dividend yield  0.0%  0.0%  0.0%
Expected option life (in years)  4.7   5.1   4.9 
Expected stock price volatility  34.4%  33.6%  34.8%  39.3%  34.4%  33.6%
Risk-free interest rate  2.4%  4.4%  4.4%  1.9%  2.4%  4.4%
Expected option life in years  5.10   4.87   4.87 
Expected dividend yield  0.0%  0.0%  0.0%
Per share grant-date fair value $20.85  $18.78  $16.90  $18.00  $20.85  $18.78 
 
The expected life of options granted is derived using assumed exercise rates based on historical exercise patterns and represents the period of time that options granted are expected to be outstanding. Expected stock price volatility is based upon implied volatility for our exchange-traded options and other factors, including historical volatility. After assessing all available information on either historical volatility, implied volatility, or both, we have concluded that a combination of both historical and implied volatility provides the best estimate of expected volatility. The expected term of options granted is derived using assumed exercise rates based on historical exercise patterns and represents the period of time that options granted are expected to be outstanding. The risk-free interest rate used is determined by the market yield curve based upon risk-free interest rates established by the Federal Reserve, or non-coupon bonds that have maturities equal to the expected term. The dividend yield of zero is based upon the fact that we have not historically granted cash dividends, and do not expect to issue dividends in the foreseeable future. Stock options granted prior to January 1, 2006 were valued based on the grant date fair value of those awards, using the Black-Scholes option pricing model, as previously calculated for pro-forma disclosures under SFAS 123. For 2008, 2007 and 2006, we recorded $20.1 million, $30.7 million and $43.6 million, respectively, of stock compensation cost related to stock options.disclosures.


F-33F-35


 
BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
A summary of stock option activity is presented in the following table (shares are in thousands):table:
 
                
   Weighted
    Weighted
 
   Average
    Average
 
   Exercise
    Exercise
 
 Shares Price 
Outstanding at December 31, 2005  31,306  $45.71 
   
Granted  1,928  $45.18 
Exercised  (4,725) $27.90 
Cancelled  (3,403) $53.55 
(In thousands, except weighted average exercise price) Shares Price 
   
Outstanding at December 31, 2006  25,106  $47.96   25,106  $47.96 
        
Granted  1,470  $51.23   1,470  $51.23 
Exercised  (10,524) $44.84   (10,524) $44.84 
Cancelled  (1,152) $53.97   (1,152) $53.97 
        
Outstanding at December 31, 2007  14,900  $50.03   14,900  $50.03 
        
Granted  1,475  $60.23   1,475  $60.23 
Exercised  (3,769) $41.99   (3,769) $41.99 
Cancelled  (506) $55.70   (506) $55.70 
        
Outstanding at December 31, 2008  12,100  $53.53   12,100  $53.53 
        
Granted  1,031  $49.96 
Exercised  (637) $40.16 
Cancelled  (1,664) $60.74 
     
Outstanding at December 31, 2009  10,830  $52.88 
     
The total intrinsic values of options exercised in 2008, 2007, and 2006, were $85.1 million, $226.7 million, and $92.5 million, respectively. The aggregate intrinsic values of options outstanding at December 31, 2008 and 2007, were $71.4 million and $102.7 million, respectively. The weighted average remaining contractual terms for options outstanding at December 31, 2008 was 5.2 years.
 
Of the options outstanding, 9.28.3 million were exercisable atas of December 31, 2008.2009. The exercisable options had a weighted-average exercise price of $53.48.$52.80. The aggregate intrinsic value of options exercisable as of December 31, 2008 and 20072009 was $53.7 million and $78.5 million, respectively.$45.2 million. The weighted average remaining contractual term for options exercisable atas of December 31, 20082009 was 4.23.8 years.
 
A total of 10.3 million vested and expected to vest options were outstanding as of December 31, 2009. These vested and expected to vest options had a weighted average exercise price of $52.87 and an aggregated intrinsic value of $51.0 million. The weighted average remaining contractual term of vested and expected to vest options as of December 31, 2009 was 4.6 years.
The total intrinsic values of options exercised in 2009, 2008, and 2007, were $6.7 million, $85.1 million, and $226.7 million, respectively. The aggregate intrinsic values of options outstanding as of December 31, 2009 was $52.8 million. The weighted average remaining contractual term for options outstanding as of December 31, 2009 was 4.8 years.
A summary of the amount of tax benefit realized for stock options and cash received from the exercise of stock options is as follows:
             
  For the Years Ended December 31,
(In millions) 2009 2008 2007
 
Tax benefit realized for stock options $1.5  $28.0  $72.4 
Cash received from the exercise of stock options $25.2  $158.3  $471.0 


F-36


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Time-Vested Restricted Stock UnitsSenior Notes
Time-vested restricted stock units, or RSUs, awarded to employees generally vest no sooner than one-third per year over three years on the anniversary of the date of grant, or upon the third anniversary of the date of the grant, provided the employee remains continuously employed with us except as otherwise provided in the plan. Shares of our common stock will be delivered to the employee upon vesting, subject to payment of applicable withholding taxes. Time-vested RSUs awarded to directors for service on our Board of Directors vest on the first anniversary of the date of grant, provided in each case that the director continues to serve on our Board of Directors through the vesting date. Shares of our common stock will be delivered to the director upon vesting. The fair value of all time-vested RSUs is based on the market value of our stock on the date of grant. Compensation expense, including the effect of forfeitures, is recognized over the applicable service period. For 2008, 2007, and 2006, we recorded $125.6 million, $75.2 million, and $31.3 million, respectively, of stock compensation cost related to time-vested RSUs.


F-34


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
A summary of time-vested RSU activity is presented in the following table (shares are in thousands):
         
     Weighted
 
     Average
 
     Grant Date
 
  Shares  Fair Value 
 
Unvested at December 31, 2005    $ 
         
Granted  2,731  $44.47 
Vested  (5) $44.24 
Forfeited  (218) $44.36 
         
Unvested at December 31, 2006  2,508  $44.48 
         
Granted  3,387  $51.19 
Vested  (845) $44.58 
Forfeited  (458) $47.38 
         
Unvested at December 31, 2007  4,592  $49.12 
         
Granted  3,129  $58.42 
Vested  (1,645) $47.93 
Forfeited  (499) $53.95 
         
Unvested at December 31, 2008  5,577  $54.26 
         
The weighted average remaining contractual term for the time-vested RSUs was 1 year at December 31, 2008.
Performance-Based Restricted Stock Units
In the first quarter of 2007, our Board of Directors awarded 30,000 RSUs to our President, Research and Development, under the 2005 Omnibus Plan, subject to certain performance criteria and the employee’s continued employment through December 31, 2007. In February 2008, 27,000 of these RSUs vested and converted into shares of our common stock based on the determination by our Board of Directors that approximately 90% of these RSUs had been earned. A total of 17,227 shares were issued, reflecting the fact that certain shares were withheld for income tax purposes. Additionally, during the second quarter of 2007, our Board of Directors awarded 90,000 RSUs to our President, Research and Development, under the 2005 Omnibus Plan, subject to certain performance criteria. We apply graded vesting when accounting for these RSU’s and the fair value will be based on the market price on the date of vesting. These RSUs will vest annually in equal increments of 30,000 shares over three years and convert into shares of our common stock, subject to attainment of certain performance goals and the employee’s continued employment through the three performance periods, which end December 31, 2008, December 31, 2009, and September 30, 2010, respectively.
In the first quarter of 2006, our Board of Directors awarded 100,000 RSUs to our CEO, under the 2005 Omnibus Plan, subject to certain 2006 financial performance criteria. In February 2007, our Board of Directors determined that the performance criteria had been attained and that 100,000 RSUs would convert into shares of our common stock. A total of 58,250 shares were issued, reflecting the fact that certain shares were withheld for income tax purposes.
During the third quarter of 2005, we granted 1.2 million performance-based RSUs, to be settled in shares of our common stock, to a group of approximately 200 senior employees excluding our CEO. The grants were made under the 2005 Omnibus Plan as part of an initiative to retain certain key personnel. On September 14, 2006, 70% of the RSUs for all employees still in active employment, or 758,262 shares, vested as the required performance goals had been determined to have been achieved. A total of 510,859 shares were issued, reflecting the fact that certain shares were withheld for income tax purposes.


F-35


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
On March 14, 2007, the remaining 30% of the RSUs granted during the third quarter of 2005 were scheduled to vest and convert into shares if the performance goals were attained and the employee was still in active employment. On March 14, 2007, 258,387 shares vested based on the determination by our Board of Directors that approximately 83% of these RSUs had been earned. A total of 172,054 shares were issued, reflecting the fact that certain shares were withheld for income tax purposes.
For 2008, 2007, and 2006, we recorded compensation charges of approximately $1.1 million, $5.0 million, and $33.6 million, respectively, related to performance-based restricted stock units. Compensation cost is adjusted quarterly for subsequent changes in the outcome of performance-related conditions until the vesting date.
A summary of performance-based RSU activity is presented in the following table (shares are in thousands):
         
     Weighted
 
     Average
 
     Grant Date
 
  Shares  Fair Value 
 
Unvested at December 31, 2005  1,154  $40.67 
         
Granted  100  $44.59 
Vested  (758) $40.67 
Forfeited  (85) $40.67 
         
Unvested at December 31, 2006  411  $41.62 
         
Granted  120  $51.55 
Vested  (357) $41.76 
Forfeited  (54) $40.67 
         
Unvested at December 31, 2007  120  $51.55 
         
Granted    $ 
Vested  (27) $49.33 
Forfeited  (3) $49.33 
         
Unvested at December 31, 2008  90  $52.29 
         
The weighted average remaining contractual term for the performance-based RSUs was 1.8 years at December 31, 2008.
Restricted Stock Awards
In 2005, we awarded restricted common stock to our employees under the 2005 Omnibus Plan and the 2003 Omnibus Plan at no cost to the employees. The restricted stock awards, or RSAs, granted under the 2003 Omnibus Plan vested in full on the third anniversary of the date of grant for employees that remained continuously employed with us through the vesting dates. The RSAs granted under the 2005 Omnibus Plan vested at a rate of approximately one-third per year over three years on the anniversary of the date of grant for employees that remained continuously employed with us through the vesting dates.
For 2008 and 2007, we recorded $0.5 million and $11.7 million, respectively, of stock compensation cost related to restricted stock awards. The fair value of all time-vested RSAs is based on the market value of our stock on the date of grant. Compensation expense, including the effect of forfeitures, is recognized over the applicable service period. For 2006, we recorded $21.9 million of stock compensation cost related to restricted stock awards, prior to a first quarter pre-tax cumulative effect catch up credit of $5.6 million or $3.8 million after-tax, resulting from the application of an estimated forfeiture rate for prior period unvested restricted stock awards.


F-36


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
A summary of restricted stock award activity is presented in the following table (shares are in thousands):
         
     Weighted
 
     Average
 
     Grant Date
 
  Shares  Fair Value 
 
Unvested at December 31, 2005  1,440  $53.87 
         
Granted    $ 
Vested  (13) $42.99 
Forfeited  (180) $56.25 
         
Unvested at December 31, 2006  1,247  $53.64 
         
Granted    $ 
Vested  (713) $44.10 
Forfeited  (79) $59.64 
         
Unvested at December 31, 2007  455  $67.54 
         
Granted    $ 
Vested  (454) $67.54 
Forfeited  (1) $67.57 
         
Unvested at December 31, 2008    $ 
         
ESPP
Under the terms of the ESPP, employees can elect to have up to ten percent of their annual compensation (subject to certain dollar limits) withheld to purchase shares of our common stock. The purchase price of the common stock is equal to 85% of the lower of the fair market value of the common stock on the enrollment or purchase date under a look-back provision. In June 2005, our stockholders approved the amendment and restatement of the ESPP, including an increase in the number of shares available for issuance under the ESPP from 4.2 million to 6.2 million shares. At December 31, 2008, a total of 4.4 million shares of our common stock were available for issuance. During 2008, 2007, and 2006, 0.5 million, 0.5 million, and 0.5 million shares, respectively, were issued under the ESPP. We utilize the Black-Scholes model to calculate the fair value of these discounted purchases. The fair value of the look-back provision plus the 15% discount amount is recognized as compensation expense over the purchase period. We apply a graded vesting approach because the plan provides for multiple purchase periods and is, in substance, a series of linked awards. In 2008, 2007, and 2006, we recorded stock compensation cost of approximately $6.5 million, $5.2 million, and $5.2 million, respectively.
Cash received under the ESPP in 2008, 2007, and 2006 was approximately $21.3 million, $18.2 million, and $15.2 million, respectively.


F-37


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
7.  Accumulated Other Comprehensive Income (Loss)
The accumulated balances in comprehensive income (loss) were as follows (in millions):
             
  Year Ended December 31, 
  2008  2007  2006 
 
Translation adjustments $16.9  $71.0  $21.2 
Unrealized holding gains (losses) on investments, net of tax of $(6.2) million, $(5.1) million, and $(1.1) million, respectively  10.5   10.5   1.4 
Unfunded status of pension and postretirement benefit plans, net of tax of $0.1 million, $0.1 million, and $0.4 million, respectively  1.6   1.7   (0.7)
Unrealized losses on derivative instruments, net of tax of $3.9 million, $2.4 million, and $0.1 million, respectively  (40.2)  (4.0)   
             
Total comprehensive income (loss) $(11.2) $79.2  $21.9 
             
See Note 13, Employee Benefit Plans, for discussion of unfunded status of pension and postretirement benefit plans.
8.  Indebtedness
Notes payable consists of the following (in millions):
         
  December 31, 
  2008  2007 
 
Current portion:        
Term loan facility $  $1,500.0 
Note payable to Fumedica  10.9   10.3 
Credit line from Dompé  16.8    
Other     0.8 
         
  $27.7  $1,511.1 
         
Non-current portion:        
6.0% Senior Notes due 2013 $449.6  $ 
6.875% Senior Notes due 2018  608.2    
Note payable to Fumedica  27.6   34.3 
Credit line from Dompé     17.5 
         
  $1,085.4  $51.8 
         
 
On March 4, 2008, we issued $450.0 million aggregate principal amount of 6.0% Senior Notes due March 1, 2013 and $550.0 million aggregate principal amount of 6.875% Senior Notes due March 1, 2018 at 99.886% and 99.184% of par, respectively.
In June and July 2007, in connection with the tender offer described in Note 21, Tender Offer, we entered into a $1,500.0 million term loan facility and borrowed the full $1,500.0 million available under this facility. In March 2008, we used the proceeds from the Senior Notes, along with cash and the proceeds from the liquidation of marketable securities, to repay the $1,500.0 million term loan facility.
In June 2007, we also entered into a five year $400.0 million Senior Unsecured Revolving Credit Facility, which we may use for working capital and general corporate purposes. The bankruptcy of Lehman Brothers


F-38F-29


 
BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
Holdings Inc. has eliminated their $40.0 million commitment, thereby reducing99.184% of par, respectively. The discount is amortized as additional interest expense over the availabilityperiod from issuance through maturity. These notes are senior unsecured obligations. Interest on the notes is payable March 1 and September 1 of each year. The notes may be redeemed at our option at any time at 100% of the principal amount plus accrued interest and a specified make-whole amount. The notes contain a change of control provision that may require us to purchase the notes under certain circumstances. There is also an interest rate adjustment feature that requires us to pay interest at an increased interest rate on the notes if the credit rating on the notes declines below investment grade. Offering costs of approximately $8.0 million have been recorded as debt issuance costs on our consolidated balance sheet and are amortized as additional interest expense using the effective interest rate method over the period from issuance through maturity.
Upon the issuance of the debt we entered into interest rate swap contracts where we received a fixed rate and paid a variable rate, as further described in Note 8,Derivative Instrumentsto our Consolidated Financial Statements. These contracts have been subsequently terminated. Upon termination of these swaps, the carrying amount of the 6.875% Senior Notes due in 2018 was increased by $62.8 million. This increase is amortized using the effective interest rate method over the remaining life of the Senior Notes and is being recognized as a reduction of interest expense.
We used the proceeds of this borrowing, along with cash and the proceeds from the liquidation of marketable securities, to repay the full $1,500.0 million outstanding under the term loan facility we had entered into in July 2007 in connection with the funding of our June 2007 common stock tender offer. This term loan facility expired upon repayment.
Revolving Credit Facility
We have a $360.0 million senior unsecured revolving credit facility, which may be used for future working capital and general corporate purposes. The facility terminates in June 2012. As of December 31, 2009 and 2008, there were no borrowings under this credit facility and we were in compliance with applicable covenants.
Biogen-Dompé
As of December 31, 2009 and 2008, Biogen-Dompé SRL, a consolidated joint venture, has a loan balance of 12.0 million Euros ($17.2 million) and 12.0 million Euros ($16.7 million), respectively. These balances represent a line of credit from us and Dompé Farmaceutici SpA of 24.0 million Euros, half of which has been eliminated for purposes of presenting our consolidated financial position as it is an intercompany loan. Borrowings under this line of credit are to $360.0be made equally between the partners, with any repayments paid in a similar manner. The loan was originally due June 1, 2009; however, a new loan was subsequently executed with a maturity date of December 1, 2011. The interest rate on the line of credit under the new agreements is determined at a rate of three month Euro LIBOR plus 150 basis points and was 2.2% as of December 31, 2009. The interest rate is reset quarterly and payable quarterly in arrears.
Notes Payable to Fumedica
As of December 31, 2009 and 2008, the notes payable to Fumedica have a present value of 31.2 million Swiss Francs ($30.0 million) and 41.2 million Swiss Francs ($38.6 million), respectively. The notes, which were entered into in connection with the settlement of various agreements associated with Fumedica, are non-interest bearing, have been discounted for financial statement presentation purposes and are being accreted at a rate of 5.75% and are payable in a series of payments through June 2018.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Debt Maturity
Our total debt matures as follows:
     
(In millions) As of December 31, 2009
 
2010 $20.1 
2011  11.6 
2012  3.1 
2013  453.1 
2014  3.1 
2015 and thereafter  562.3 
     
Total $1,053.3 
     
The fair value of our debt is disclosed in Note 6,Fair Value Measurementsto our Consolidated Financial Statements.
10.  Shareholders’ Equity
Preferred Stock
Preferred stock was comprised of the following:
                                     
  As of December 31, 2009  As of December 31, 2008  As of December 31, 2007 
(In thousands) Authorized  Issued  Outstanding  Authorized  Issued  Outstanding  Authorized  Issued  Outstanding 
 
Series A Preferred Stock  1,750   8   8   1,750   8   8   1,750   8   8 
Series X Junior Participating Preferred Stock  1,000         1,000         1,000       
Undesignated  5,250         5,250         5,250       
                                     
   8,000   8   8   8,000   8   8   8,000   8   8 
                                     
We have 8,000,000 shares of Preferred Stock authorized, of which 1,750,000 shares have been designated as Series A Preferred Stock and 1,000,000 shares have been designated as Series X Junior Participating Preferred Stock. The balance may be issued without a vote or action of stockholders from time to time in classes or series with the designations, powers, preferences, and the relative, participating, optional or other special rights of the shares of each such class or series and any qualifications, limitations or restrictions thereon as set forth in the stock certificate. Any such Preferred Stock may rank prior to common stock as to dividend rights, liquidation preference or both, and may have full or limited voting rights and may be convertible into shares of common stock. As of December 31, 2009, 2008 and 2007, there were 8,221 shares of Series A Preferred Stock issued and outstanding. These shares carry a liquidation preference of $67 and are convertible into 60 shares of common stock per share of Preferred Stock. No other shares of Preferred Stock are issued and outstanding as of December 31, 2009, 2008 and 2007.
Stockholder Rights Plan
In January 2009, our Board of Directors voted to terminate our stockholders rights plan effective as of January 30, 2009. The plan was scheduled to expire on July 26, 2011 and was originally adopted by the Board of Directors in 1997. Under the rights plan, each share of our common stock had one “right” attached to it that entitled the holder to purchase our Series X Junior Participating Preferred Stock under the circumstances specified in the rights plan. As a result of our Board of Director’s action, no rights are outstanding or exercisable.
Stock Repurchase Programs
In October 2009, our Board of Directors authorized the repurchase of up to $1.0 billion of our common stock with repurchased shares being retired. This repurchase program does not have an expiration date. As of December 31, 2009, approximately 8.8 million shares at a cost of $422.4 million were repurchased under this


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
authorization, all of which were retired. From January 1, 2010 through February 5, 2010, we repurchased approximately an additional 5.4 million shares under this program at a total cost of approximately $289.4 million, all of which were also retired. Approximately $288.2 million remains available for the repurchase of our common stock under the 2009 program.
In October 2006, our Board of Directors authorized the repurchase of up to 20.0 million shares of our common stock. As of December 31, 2009, all shares under this program have been repurchased as approximately 7.2 million shares of our common stock were repurchased in 2009 for approximately $328.8 million. In 2008, approximately 12.8 million shares of our common stock were repurchased under this program for approximately $738.9 million.
Reclassifications
The adoption of a newly issued accounting standard for noncontrolling interests on January 1, 2009, changed the accounting and reporting for our minority interests by recharacterizing them as noncontrolling interests and classifying them as a separate component of total shareholders’ equity in our accompanying consolidated balance sheets and consolidated statements of shareholders’ equity. Additionally, net income attributable to noncontrolling interest is now shown separately from net income in the consolidated statements of income. As a result, prior year amounts related to noncontrolling interest have been reclassified to conform to the current year presentation. This reclassification had no effect on our previously reported financial position or results of operations.
In the year ended December 31, 2008, we reclassified amounts within our consolidated statement of shareholders’ equity, resulting in an approximately $78.6 million correction in Additional Paid-in Capital and Retained Earnings (Accumulated Deficit) balances in connection with the re-issuance of treasury stock at a loss.
In the year ended December 31, 2007 we reclassified amounts within our consolidated statements of equity, resulting in an approximately $48.0 million correction in the treasury stock and common stock balances.
11.  Earnings per Share
Basic and diluted earnings per share are calculated as follows:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Numerator:            
Net income attributable to Biogen Idec Inc.  $970.1  $783.2  $638.2 
Adjustment for net income allocable to preferred shares  (1.7)  (1.3)  (1.0)
             
Net income used in calculating basic and diluted earnings per share $968.4  $781.9  $637.2 
             
Denominator:            
Weighted average number of common shares outstanding  287.4   292.3   315.8 
Effect of dilutive securities:            
Stock options and employee stock purchase plan  0.6   1.3   2.6 
Restricted stock awards     0.1   0.5 
Time-vested restricted stock units  1.4   1.3   1.1 
Performance-vested restricted stock units  0.1       
Convertible promissory notes due 2019        0.2 
Convertible promissory notes due 2032         
             
Dilutive potential common shares  2.1   2.7   4.4 
             
Shares used in calculating diluted earnings per share  289.5   295.0   320.2 
             


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
 
The following isamounts were not included in the calculation of net income per basic and diluted share because their effects were anti-dilutive:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Numerator:            
Net income allocable to preferred stock $1.7  $ 1.3  $ 1.0 
             
Denominator:            
Stock options  8.5   6.9   8.2 
Time-vested restricted stock units  2.1   1.5   0.1 
Performance-vested restricted stock units  0.2       
Convertible preferred stock  0.5   0.5   0.5 
             
Total  11.3   8.9   8.8 
             
Earnings per share for the year ended December 31, 2009 reflects, on a summary descriptionweighted average basis, the repurchase of 16.0 million shares of our principal indebtednesscommon stock under our 2009 and 2006 share repurchase programs.
As a result of our 2007 tender offer, earnings per share for the year ended December 31, 2007 reflects, on a weighted average basis, the repurchase of 56.4 million shares as of June 27, 2007, the date the obligation was incurred, in accordance with accounting standards for earning per share.
12.  Share-based Payments
Share-based Compensation Expense
The following table summarizes share-based compensation expense included within our consolidated statements of income:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Research and development $60.8  $59.9  $51.7 
Selling, general and administrative  106.4   93.8   76.1 
             
Subtotal $167.2  $153.7  $127.8 
Capitalized share-based compensation costs  (6.3)  (7.5)  (4.7)
             
Share-based compensation expense included in total costs and expenses $160.9  $146.2  $123.1 
Income tax effect  (49.4)  (45.4)  (37.5)
             
Share-based compensation expense included in net income attributable to Biogen Idec Inc.  $111.5  $100.8  $85.6 
             


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Our share-based compensation programs include stock options, time-vested restricted stock units, performance-vested restricted stock units, restricted stock and shares issued under our ESPP. The following table summarizes share-based compensation expense associated with each of these programs:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Stock options $21.6  $20.0  $30.7 
Time-vested restricted stock units  133.7   125.6   75.2 
Performance-vested restricted stock units  4.6   1.1   5.0 
Restricted stock awards     0.5   11.7 
Employee stock purchase plan  7.3   6.5   5.2 
             
Subtotal $167.2  $153.7  $127.8 
Capitalized share-based compensation costs  (6.3)  (7.5)  (4.7)
             
Share-based compensation expense included in total costs and expenses $160.9  $146.2  $123.1 
             
Windfall tax benefits from vesting of stock awards, exercises of stock options and ESPP participation were $3.4 million, $28.0 million, and $69.7 million in 2009, 2008, and 2007, respectively. These amounts have been calculated under the alternative transition method in accordance with U.S. GAAP.
As of December 31, 2009, unrecognized compensation cost related to unvested share-based compensation was approximately $178.1 million, net of estimated forfeitures. We expect to recognize the cost of these unvested awards over a weighted-average period of 1.4 years.
Share-based Compensation Plans
We have three share-based compensation plans pursuant to which awards are currently being made: (1) the Biogen Idec Inc. 2006 Non-Employee Directors Equity Plan (2006 Directors Plan); (2) the Biogen Idec Inc. 2008 Omnibus Equity Plan (2008 Omnibus Plan); and (3) the Biogen Idec Inc. 1995 Employee Stock Purchase Plan (ESPP). We have six share-based compensation plans pursuant to which outstanding awards have been made, but from which no further awards can or will be made: (i) the IDEC Pharmaceuticals Corporation 1993 Non-Employee Directors Stock Option Plan; (ii) the IDEC Pharmaceuticals Corporation 1988 Stock Option Plan; (iii) the Biogen, Inc. 1985 Non-Qualified Stock Option Plan; (iv) the Biogen, Inc. 1987 Scientific Board Stock Option Plan; (v) the Biogen Idec Inc. 2003 Omnibus Equity Plan (2003 Omnibus Plan); and (vi) the Biogen Idec Inc. 2005 Omnibus Equity Plan (2005 Omnibus Plan). We have not made any awards pursuant to the 2005 Omnibus Plan since our stockholders approved the 2008 Omnibus Plan and do not intend to make any awards pursuant to the 2005 Omnibus Plan in the future, except that unused shares under the 2005 Omnibus Plan have been carried over for use under the 2008 Omnibus Plan.
Directors Plan
In May 2006, our stockholders approved the 2006 Directors Plan for share-based awards to our directors. Awards granted from the 2006 Directors Plan may include options, shares of restricted stock awards, restricted stock units, stock appreciation rights and other awards in such amounts and with such terms and conditions as may be determined by a committee of our Board of Directors, subject to the provisions of the plan. We have reserved a total of 850,000 shares of common stock for issuance under the 2006 Directors Plan. The 2006 Directors Plan provides that awards other than stock options and stock appreciation rights will be counted against the total number of shares reserved under the plan in a 1.5-to-1 ratio.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Omnibus Plans
In June 2008, our stockholders approved the 2008 Omnibus Plan for share-based awards to our employees. Awards granted from the 2008 Omnibus Plan may include options, shares of restricted stock awards, restricted stock units, performance shares, shares of phantom stock, stock appreciation rights and other awards in such amounts and with such terms and conditions as may be determined by a committee of our Board of Directors, subject to the provisions of the plan. Shares of common stock available for issuance under the 2008 Omnibus Plan consist of 15.0 million shares reserved for this purpose, plus shares of common stock that remained available for issuance under the 2005 Omnibus Plan on the date that our stockholders approved the 2008 Omnibus Plan, plus shares that are subject to awards under the 2005 Omnibus Plan which remain unissued upon the cancellation, surrender, exchange or termination of such awards. The 2008 Omnibus Equity Plan provides that awards other than stock options and stock appreciation rights will be counted against the total number of shares available under the plan in a 1.5-to-1 ratio.
Stock Options
All stock option grants to employees are for a ten-year term and generally vest one-fourth per year over four years on the anniversary of the date of grant, provided the employee remains continuously employed with us. Stock option grants to directors are for ten-year terms and generally vest as follows: (1) grants made on the date of a director’s initial election to our Board of Directors vest one-third per year over three years on the anniversary of the date of grant, and (2) grants made for service on our Board of Directors vest on the first anniversary of the date of grant, provided in each case that the director continues to serve on our Board of Directors through the vesting date. Options granted under all plans are exercisable at a price per share not less than the fair market value of the underlying common stock on the date of grant. The estimated fair value of options, including the effect of estimated forfeitures, is recognized over the options’ vesting periods. The fair value of the stock option grants awarded in 2009, 2008, and 2007 was estimated as of the date of grant using a Black-Scholes option valuation model that uses the following weighted-average assumptions:
             
  For the Years Ended December 31, 
  2009  2008  2007 
 
Expected option life (in years)  4.7   5.1   4.9 
Expected stock price volatility  39.3%  34.4%  33.6%
Risk-free interest rate  1.9%  2.4%  4.4%
Expected dividend yield  0.0%  0.0%  0.0%
Per share grant-date fair value $18.00  $20.85  $18.78 
The expected life of options granted is derived using assumed exercise rates based on historical exercise patterns and represents the period of time that options granted are expected to be outstanding. Expected stock price volatility is based upon implied volatility for our exchange-traded options and other factors, including historical volatility. After assessing all available information on either historical volatility, implied volatility, or both, we have concluded that a combination of both historical and implied volatility provides the best estimate of expected volatility. The risk-free interest rate used is determined by the market yield curve based upon risk-free interest rates established by the Federal Reserve, or non-coupon bonds that have maturities equal to the expected term. The dividend yield of zero is based upon the fact that we have not historically granted cash dividends, and do not expect to issue dividends in the foreseeable future. Stock options granted prior to January 1, 2006 were valued based on the grant date fair value of those awards, using the Black-Scholes option pricing model, as previously calculated for pro-forma disclosures.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
A summary of stock option activity is presented in the following table:
         
     Weighted
 
     Average
 
     Exercise
 
(In thousands, except weighted average exercise price) Shares  Price 
 
Outstanding at December 31, 2006  25,106  $47.96 
         
Granted  1,470  $51.23 
Exercised  (10,524) $44.84 
Cancelled  (1,152) $53.97 
         
Outstanding at December 31, 2007  14,900  $50.03 
         
Granted  1,475  $60.23 
Exercised  (3,769) $41.99 
Cancelled  (506) $55.70 
         
Outstanding at December 31, 2008  12,100  $53.53 
         
Granted  1,031  $49.96 
Exercised  (637) $40.16 
Cancelled  (1,664) $60.74 
         
Outstanding at December 31, 2009  10,830  $52.88 
         
Of the options outstanding, 8.3 million were exercisable as of December 31, 2008.2009. The exercisable options had a weighted-average exercise price of $52.80. The aggregate intrinsic value of options exercisable as of December 31, 2009 was $45.2 million. The weighted average remaining contractual term for options exercisable as of December 31, 2009 was 3.8 years.
A total of 10.3 million vested and expected to vest options were outstanding as of December 31, 2009. These vested and expected to vest options had a weighted average exercise price of $52.87 and an aggregated intrinsic value of $51.0 million. The weighted average remaining contractual term of vested and expected to vest options as of December 31, 2009 was 4.6 years.
The total intrinsic values of options exercised in 2009, 2008, and 2007, were $6.7 million, $85.1 million, and $226.7 million, respectively. The aggregate intrinsic values of options outstanding as of December 31, 2009 was $52.8 million. The weighted average remaining contractual term for options outstanding as of December 31, 2009 was 4.8 years.
A summary of the amount of tax benefit realized for stock options and cash received from the exercise of stock options is as follows:
             
  For the Years Ended December 31,
(In millions) 2009 2008 2007
 
Tax benefit realized for stock options $1.5  $28.0  $72.4 
Cash received from the exercise of stock options $25.2  $158.3  $471.0 


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BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Senior Notes
 
On March 4, 2008, we issued $450.0 million aggregate principal amount of 6.0% Senior Notes due March 1, 2013 and $550.0 million aggregate principal amount of 6.875% Senior Notes due March 1, 2018 at 99.886% and


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
99.184% of par, respectively. The discount will beis amortized as additional interest expense over the period from issuance through maturity. These notes are senior unsecured obligations. Interest on the notes is payable March 1 and September 1 of each year. The notes may be redeemed at our option at any time at 100% of the principal amount plus accrued interest and a specified make-whole amount. The notes contain a change of control provision that may require us to purchase the notes under certain circumstances. There is also an interest rate adjustment feature that requires us to pay interest at an increased interest rate on the notes if the credit rating on the notes declines below investment grade. Offering costs of approximately $8.0 million have been recorded as debt issuance costs on our consolidated balance sheet and will beare amortized as additional interest expense using the effective interest rate method over the period from issuance through maturity. Additionally,
Upon the issuance of the debt we entered into interest rate swapsswap contracts where we received a fixed rate and paid a variable rate, as further described in Note 4,8,Derivative Instrumentsto our Consolidated Financial Instruments thatStatements. These contracts have been subsequently terminated. Upon termination of thethese swaps, the carrying amount of the 6.875% Senior Notes due in 2018 was increased by $62.8 million as it was accounted for as a fair value hedge.million. This will be recognized as a reduction of interest expense andincrease is amortized using the effective interest rate method over the remaining life of the Senior Notes.Notes and is being recognized as a reduction of interest expense.
 
We used the proceeds of this borrowing, along with cash and the proceeds from the liquidation of marketable securities, to repay the full $1,500.0 million outstanding under the term loan facility we had entered into in July 2007 in connection with the funding of our June 2007 common stock tender offer.
This term loan facility expired upon repayment.
 
Revolving credit facilityCredit Facility
 
In June 2007, we entered intoWe have a five-year $400.0$360.0 million Senior Unsecured Revolving Credit Facility,senior unsecured revolving credit facility, which we may usebe used for future working capital and general corporate purposes. The bankruptcy of Lehman Brothers Holdings Inc. has eliminated their $40.0 million commitment, thereby reducing the availability of the credit facility to $360.0 million. This credit facility bears interest at a rate of LIBOR plus 45 basis points. The terms of this revolving credit facility include various covenants, including financial covenants that require us to not exceed a maximum leverage ratio and under certain circumstances, an interest coverage ratio.terminates in June 2012. As of December 31, 2009 and 2008, we were in compliance with these covenants and there were no borrowings under this credit facility.facility and we were in compliance with applicable covenants.
 
Biogen-DompeBiogen-Dompé
 
As of December 31, 2009 and 2008, Biogen-DompeBiogen-Dompé SRL, a consolidated joint venture, has a loan balance of 12.0 million Euros ($17.2 million) and 12.0 million Euros ($16.7 million). This balance represents, respectively. These balances represent a line of credit from us and Dompé Farmaceutici SpA of 2424.0 million Euros, half of which has been eliminated as it is an intercompany loan for purposes of presenting our consolidated financial position.position as it is an intercompany loan. Borrowings under this line of credit are to be made equally between the partners, andwith any repayments are to be paid in a similar manner. The loan was originally due June 1, 2009; however, a new loan was subsequently executed with a maturity date of December 1, 2011. The interest rate ofon the line of credit under the new agreements is determined at a rate of 3three month Euro LIBOR plus 25150 basis points and was 5.535% at2.2% as of December 31, 2008.2009. The interest rate is reset quarterly and payable quarterly in arrears. Any borrowings on the line of credit are due, in full, June 1, 2009.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
Notes Payable to Fumedica
 
As of December 31, 2009 and 2008, the notes payable to Fumedica have a present value of 31.2 million Swiss Francs ($30.0 million) and 41.2 million Swiss Francs ($38.6 million)., respectively. The notes, which were entered into in connection with the settlement of various agreements associated with Fumedica, are non-interest bearing, have been discounted for financial statement presentation purposes and are being accreted at a rate of 5.75% and are payable in a series of payments over the period from 2008 tothrough June 2018. See Note 2, Acquisitions and Dispositions.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
Debt Maturity
 
As of December 31, 2008, ourOur total debt matures as follows (in millions):follows:
 
        
2009 $27.9 
(In millions) As of December 31, 2009
2010 $11.2  $20.1 
2011 $3.0   11.6 
2012 $3.0   3.1 
2013 $453.0   453.1 
2014 and thereafter $565.0 
2014  3.1 
2015 and thereafter  562.3 
   
Total $1,053.3 
   
 
The fair value of theour debt is disclosed in Note 3 “Fair6,Fair Value Measurements”.Measurementsto our Consolidated Financial Statements.
 
9.10.  Intangible Assets and GoodwillShareholders’ Equity
 
Intangible assets and goodwill, net of accumulated amortization, impairment charges and adjustments, are as follows (in millions):Preferred Stock
 
                             
     December 31, 2008  December 31, 2007 
        Accumulated
        Accumulated
    
  Estimated Life  Cost  Amortization  Net  Cost  Amortization  Net 
 
Out-licensed patents  12 years  $578.0  $(250.3) $327.7  $578.0  $(199.1) $378.9 
Core/developed technology  15-20 years   3,005.3   (1,241.0)  1,764.3   3,003.0   (965.2)  2,037.8 
Trademarks & tradenames  Indefinite   64.0      64.0   64.0      64.0 
In-licensed patents  14 years   3.0   (0.9)  2.1   3.0   (0.7)  2.3 
Assembled workforce  4 years   2.1   (1.2)  0.9   2.1   (0.7)  1.4 
Distribution rights  2 years   12.7   (10.6)  2.1   11.8   (3.8)  8.0 
                             
Total     $3,665.1  $(1,504.0) $2,161.1  $3,661.9  $(1,169.5) $2,492.4 
                             
Goodwill  Indefinite  $1,138.6  $  $1,138.6  $1,137.4  $  $1,137.4 
                             
Preferred stock was comprised of the following:
                                     
  As of December 31, 2009  As of December 31, 2008  As of December 31, 2007 
(In thousands) Authorized  Issued  Outstanding  Authorized  Issued  Outstanding  Authorized  Issued  Outstanding 
 
Series A Preferred Stock  1,750   8   8   1,750   8   8   1,750   8   8 
Series X Junior Participating Preferred Stock  1,000         1,000         1,000       
Undesignated  5,250         5,250         5,250       
                                     
   8,000   8   8   8,000   8   8   8,000   8   8 
                                     
We have 8,000,000 shares of Preferred Stock authorized, of which 1,750,000 shares have been designated as Series A Preferred Stock and 1,000,000 shares have been designated as Series X Junior Participating Preferred Stock. The balance may be issued without a vote or action of stockholders from time to time in classes or series with the designations, powers, preferences, and the relative, participating, optional or other special rights of the shares of each such class or series and any qualifications, limitations or restrictions thereon as set forth in the stock certificate. Any such Preferred Stock may rank prior to common stock as to dividend rights, liquidation preference or both, and may have full or limited voting rights and may be convertible into shares of common stock. As of December 31, 2009, 2008 and 2007, there were 8,221 shares of Series A Preferred Stock issued and outstanding. These shares carry a liquidation preference of $67 and are convertible into 60 shares of common stock per share of Preferred Stock. No other shares of Preferred Stock are issued and outstanding as of December 31, 2009, 2008 and 2007.
 
Intangibles, other than GoodwillStockholder Rights Plan
 
Intangibles, other than Goodwill,In January 2009, our Board of Directors voted to terminate our stockholders rights plan effective as of January 30, 2009. The plan was scheduled to expire on July 26, 2011 and was originally adopted by the Board of Directors in 1997. Under the rights plan, each share of our common stock had one “right” attached to it that entitled the holder to purchase our Series X Junior Participating Preferred Stock under the circumstances specified in the rights plan. As a result of our Board of Director’s action, no rights are outstanding or exercisable.
Stock Repurchase Programs
In October 2009, our Board of Directors authorized the repurchase of up to $1.0 billion of our common stock with repurchased shares being retired. This repurchase program does not have an expiration date. As of December 31, 2009, approximately 8.8 million shares at a cost of $422.4 million were unchangedrepurchased under this


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
authorization, all of which were retired. From January 1, 2010 through February 5, 2010, we repurchased approximately an additional 5.4 million shares under this program at a total cost of approximately $289.4 million, all of which were also retired. Approximately $288.2 million remains available for the repurchase of our common stock under the 2009 program.
In October 2006, our Board of Directors authorized the repurchase of up to 20.0 million shares of our common stock. As of December 31, 2009, all shares under this program have been repurchased as approximately 7.2 million shares of our common stock were repurchased in 2009 for approximately $328.8 million. In 2008, approximately 12.8 million shares of our common stock were repurchased under this program for approximately $738.9 million.
Reclassifications
The adoption of a newly issued accounting standard for noncontrolling interests on January 1, 2009, changed the accounting and reporting for our minority interests by recharacterizing them as noncontrolling interests and classifying them as a separate component of total shareholders’ equity in our accompanying consolidated balance sheets and consolidated statements of shareholders’ equity. Additionally, net income attributable to noncontrolling interest is now shown separately from net income in the consolidated statements of income. As a result, prior year amounts related to noncontrolling interest have been reclassified to conform to the current year presentation. This reclassification had no effect on our previously reported financial position or results of operations.
In the year ended December 31, 2008, as compared towe reclassified amounts within our consolidated statement of shareholders’ equity, resulting in an approximately $78.6 million correction in Additional Paid-in Capital and Retained Earnings (Accumulated Deficit) balances in connection with the re-issuance of treasury stock at a loss.
In the year ended December 31, 2007 exclusivewe reclassified amounts within our consolidated statements of equity, resulting in an approximately $48.0 million correction in the treasury stock and common stock balances.
11.  Earnings per Share
Basic and diluted earnings per share are calculated as follows:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Numerator:            
Net income attributable to Biogen Idec Inc.  $970.1  $783.2  $638.2 
Adjustment for net income allocable to preferred shares  (1.7)  (1.3)  (1.0)
             
Net income used in calculating basic and diluted earnings per share $968.4  $781.9  $637.2 
             
Denominator:            
Weighted average number of common shares outstanding  287.4   292.3   315.8 
Effect of dilutive securities:            
Stock options and employee stock purchase plan  0.6   1.3   2.6 
Restricted stock awards     0.1   0.5 
Time-vested restricted stock units  1.4   1.3   1.1 
Performance-vested restricted stock units  0.1       
Convertible promissory notes due 2019        0.2 
Convertible promissory notes due 2032         
             
Dilutive potential common shares  2.1   2.7   4.4 
             
Shares used in calculating diluted earnings per share  289.5   295.0   320.2 
             


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The following amounts were not included in the calculation of net income per basic and diluted share because their effects were anti-dilutive:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Numerator:            
Net income allocable to preferred stock $1.7  $ 1.3  $ 1.0 
             
Denominator:            
Stock options  8.5   6.9   8.2 
Time-vested restricted stock units  2.1   1.5   0.1 
Performance-vested restricted stock units  0.2       
Convertible preferred stock  0.5   0.5   0.5 
             
Total  11.3   8.9   8.8 
             
Earnings per share for the year ended December 31, 2009 reflects, on a weighted average basis, the repurchase of 16.0 million shares of our common stock under our 2009 and 2006 share repurchase programs.
As a result of our 2007 tender offer, earnings per share for the year ended December 31, 2007 reflects, on a weighted average basis, the repurchase of 56.4 million shares as of June 27, 2007, the date the obligation was incurred, in accordance with accounting standards for earning per share.
12.  Share-based Payments
Share-based Compensation Expense
The following table summarizes share-based compensation expense included within our consolidated statements of income:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Research and development $60.8  $59.9  $51.7 
Selling, general and administrative  106.4   93.8   76.1 
             
Subtotal $167.2  $153.7  $127.8 
Capitalized share-based compensation costs  (6.3)  (7.5)  (4.7)
             
Share-based compensation expense included in total costs and expenses $160.9  $146.2  $123.1 
Income tax effect  (49.4)  (45.4)  (37.5)
             
Share-based compensation expense included in net income attributable to Biogen Idec Inc.  $111.5  $100.8  $85.6 
             


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Our share-based compensation programs include stock options, time-vested restricted stock units, performance-vested restricted stock units, restricted stock and shares issued under our ESPP. The following table summarizes share-based compensation expense associated with each of these programs:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Stock options $21.6  $20.0  $30.7 
Time-vested restricted stock units  133.7   125.6   75.2 
Performance-vested restricted stock units  4.6   1.1   5.0 
Restricted stock awards     0.5   11.7 
Employee stock purchase plan  7.3   6.5   5.2 
             
Subtotal $167.2  $153.7  $127.8 
Capitalized share-based compensation costs  (6.3)  (7.5)  (4.7)
             
Share-based compensation expense included in total costs and expenses $160.9  $146.2  $123.1 
             
Windfall tax benefits from vesting of stock awards, exercises of stock options and ESPP participation were $3.4 million, $28.0 million, and $69.7 million in 2009, 2008, and 2007, respectively. These amounts have been calculated under the alternative transition method in accordance with U.S. GAAP.
As of December 31, 2009, unrecognized compensation cost related to unvested share-based compensation was approximately $178.1 million, net of estimated forfeitures. We expect to recognize the cost of these unvested awards over a weighted-average period of 1.4 years.
Share-based Compensation Plans
We have three share-based compensation plans pursuant to which awards are currently being made: (1) the Biogen Idec Inc. 2006 Non-Employee Directors Equity Plan (2006 Directors Plan); (2) the Biogen Idec Inc. 2008 Omnibus Equity Plan (2008 Omnibus Plan); and (3) the Biogen Idec Inc. 1995 Employee Stock Purchase Plan (ESPP). We have six share-based compensation plans pursuant to which outstanding awards have been made, but from which no further awards can or will be made: (i) the IDEC Pharmaceuticals Corporation 1993 Non-Employee Directors Stock Option Plan; (ii) the IDEC Pharmaceuticals Corporation 1988 Stock Option Plan; (iii) the Biogen, Inc. 1985 Non-Qualified Stock Option Plan; (iv) the Biogen, Inc. 1987 Scientific Board Stock Option Plan; (v) the Biogen Idec Inc. 2003 Omnibus Equity Plan (2003 Omnibus Plan); and (vi) the Biogen Idec Inc. 2005 Omnibus Equity Plan (2005 Omnibus Plan). We have not made any awards pursuant to the 2005 Omnibus Plan since our stockholders approved the 2008 Omnibus Plan and do not intend to make any awards pursuant to the 2005 Omnibus Plan in the future, except that unused shares under the 2005 Omnibus Plan have been carried over for use under the 2008 Omnibus Plan.
Directors Plan
In May 2006, our stockholders approved the 2006 Directors Plan for share-based awards to our directors. Awards granted from the 2006 Directors Plan may include options, shares of restricted stock awards, restricted stock units, stock appreciation rights and other awards in such amounts and with such terms and conditions as may be determined by a committee of our Board of Directors, subject to the provisions of the impactplan. We have reserved a total of foreign850,000 shares of common stock for issuance under the 2006 Directors Plan. The 2006 Directors Plan provides that awards other than stock options and stock appreciation rights will be counted against the total number of shares reserved under the plan in a 1.5-to-1 ratio.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Omnibus Plans
In June 2008, our stockholders approved the 2008 Omnibus Plan for share-based awards to our employees. Awards granted from the 2008 Omnibus Plan may include options, shares of restricted stock awards, restricted stock units, performance shares, shares of phantom stock, stock appreciation rights and other awards in such amounts and with such terms and conditions as may be determined by a committee of our Board of Directors, subject to the provisions of the plan. Shares of common stock available for issuance under the 2008 Omnibus Plan consist of 15.0 million shares reserved for this purpose, plus shares of common stock that remained available for issuance under the 2005 Omnibus Plan on the date that our stockholders approved the 2008 Omnibus Plan, plus shares that are subject to awards under the 2005 Omnibus Plan which remain unissued upon the cancellation, surrender, exchange or termination of such awards. The 2008 Omnibus Equity Plan provides that awards other than stock options and stock appreciation rights will be counted against the total number of shares available under the plan in a 1.5-to-1 ratio.
Stock Options
All stock option grants to employees are for a ten-year term and generally vest one-fourth per year over four years on the anniversary of the date of grant, provided the employee remains continuously employed with us. Stock option grants to directors are for ten-year terms and generally vest as follows: (1) grants made on the date of a director’s initial election to our Board of Directors vest one-third per year over three years on the anniversary of the date of grant, and (2) grants made for service on our Board of Directors vest on the first anniversary of the date of grant, provided in each case that the director continues to serve on our Board of Directors through the vesting date. Options granted under all plans are exercisable at a price per share not less than the fair market value of the underlying common stock on the date of grant. The estimated fair value of options, including the effect of estimated forfeitures, is recognized over the options’ vesting periods. The fair value of the stock option grants awarded in 2009, 2008, and 2007 was estimated as of the date of grant using a Black-Scholes option valuation model that uses the following weighted-average assumptions:
             
  For the Years Ended December 31, 
  2009  2008  2007 
 
Expected option life (in years)  4.7   5.1   4.9 
Expected stock price volatility  39.3%  34.4%  33.6%
Risk-free interest rate  1.9%  2.4%  4.4%
Expected dividend yield  0.0%  0.0%  0.0%
Per share grant-date fair value $18.00  $20.85  $18.78 
The expected life of options granted is derived using assumed exercise rates based on historical exercise patterns and represents the period of time that options granted are expected to be outstanding. Expected stock price volatility is based upon implied volatility for our exchange-traded options and other factors, including historical volatility. After assessing all available information on either historical volatility, implied volatility, or both, we have concluded that a combination of both historical and implied volatility provides the best estimate of expected volatility. The risk-free interest rate used is determined by the market yield curve based upon risk-free interest rates established by the Federal Reserve, or non-coupon bonds that have maturities equal to the expected term. The dividend yield of zero is based upon the fact that we have not historically granted cash dividends, and do not expect to issue dividends in the foreseeable future. Stock options granted prior to January 1, 2006 were valued based on the grant date fair value of those awards, using the Black-Scholes option pricing model, as previously calculated for pro-forma disclosures.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
A summary of stock option activity is presented in the following table:
         
     Weighted
 
     Average
 
     Exercise
 
(In thousands, except weighted average exercise price) Shares  Price 
 
Outstanding at December 31, 2006  25,106  $47.96 
         
Granted  1,470  $51.23 
Exercised  (10,524) $44.84 
Cancelled  (1,152) $53.97 
         
Outstanding at December 31, 2007  14,900  $50.03 
         
Granted  1,475  $60.23 
Exercised  (3,769) $41.99 
Cancelled  (506) $55.70 
         
Outstanding at December 31, 2008  12,100  $53.53 
         
Granted  1,031  $49.96 
Exercised  (637) $40.16 
Cancelled  (1,664) $60.74 
         
Outstanding at December 31, 2009  10,830  $52.88 
         
Of the options outstanding, 8.3 million were exercisable as of December 31, 2009. The exercisable options had a weighted-average exercise price of $52.80. The aggregate intrinsic value of options exercisable as of December 31, 2009 was $45.2 million. The weighted average remaining contractual term for options exercisable as of December 31, 2009 was 3.8 years.
A total of 10.3 million vested and expected amortization.to vest options were outstanding as of December 31, 2009. These vested and expected to vest options had a weighted average exercise price of $52.87 and an aggregated intrinsic value of $51.0 million. The weighted average remaining contractual term of vested and expected to vest options as of December 31, 2009 was 4.6 years.
The total intrinsic values of options exercised in 2009, 2008, and 2007, were $6.7 million, $85.1 million, and $226.7 million, respectively. The aggregate intrinsic values of options outstanding as of December 31, 2009 was $52.8 million. The weighted average remaining contractual term for options outstanding as of December 31, 2009 was 4.8 years.
A summary of the amount of tax benefit realized for stock options and cash received from the exercise of stock options is as follows:
             
  For the Years Ended December 31,
(In millions) 2009 2008 2007
 
Tax benefit realized for stock options $1.5  $28.0  $72.4 
Cash received from the exercise of stock options $25.2  $158.3  $471.0 


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Time-Vested Restricted Stock Units
Time-vested restricted stock units (RSUs) awarded to employees generally vest no sooner than one-third per year over three years on the anniversary of the date of grant, or upon the third anniversary of the date of the grant, provided the employee remains continuously employed with us, except as otherwise provided in the plan. Shares of our common stock will be delivered to the employee upon vesting, subject to payment of applicable withholding taxes. RSUs awarded to directors for service on our Board of Directors vest on the first anniversary of the date of grant, provided in each case that the director continues to serve on our Board of Directors through the vesting date. Shares of our common stock will be delivered to the director upon vesting and are not subject to any withholding taxes. The fair value of all RSUs is based on the market value of our stock on the date of grant. Compensation expense, including the effect of forfeitures, is recognized over the applicable service period.
A summary of RSU activity is presented in the following table:
         
     Weighted
 
     Average
 
     Grant Date
 
(In thousands, except weighted average grant date fair value) Shares  Fair Value 
 
Unvested at December 31, 2006  2,508  $44.48 
         
Granted  3,387  $51.19 
Vested  (845) $44.58 
Forfeited  (458) $47.38 
         
Unvested at December 31, 2007  4,592  $49.12 
         
Granted  3,129  $58.42 
Vested  (1,645) $47.93 
Forfeited  (499) $53.95 
         
Unvested at December 31, 2008  5,577  $54.26 
         
Granted  2,674  $48.93 
Vested  (2,421) $52.08 
Forfeited  (445) $53.02 
         
Unvested at December 31, 2009  5,385  $52.72 
         


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Performance-Vested Restricted Stock Units
A summary of performance-vested restricted stock units (PVRSUs) activity is presented in the following table:
         
     Weighted
 
     Average
 
     Grant Date
 
(In thousands, except weighted average grant date fair value) Shares  Fair Value 
 
Unvested at December 31, 2006  411  $41.62 
         
Granted  120  $51.55 
Vested  (357) $41.76 
Forfeited  (54) $40.67 
         
Unvested at December 31, 2007  120  $51.55 
         
Granted    $ 
Vested  (27) $49.33 
Forfeited  (3) $49.33 
         
Unvested at December 31, 2008  90  $52.29 
         
Granted  325  $49.42 
Vested  (30) $52.29 
Forfeited  (97) $51.30 
         
Unvested at December 31, 2009  288  $49.39 
         
2009 Grant Activity
We apply a graded vesting expense methodology when accounting for the PVRSUs issued in 2009. In 2009, approximately 325,000 PVRSUs were granted with a weighted average grant date fair value of $49.42 per share.
The number of PVRSUs reflected as granted represents the target number of shares that are eligible to vest in full or in part and are earned subject to the attainment of certain performance criteria established at the beginning of the performance period, which ended December 31, 2009. Participants may ultimately earn up to 200% of the target number of shares granted in the event that the maximum performance thresholds are attained. Accordingly, additional PVRSUs may be issued upon final determination of the number of awards earned.
Once the earned number of performance-vested awards has been determined, the earned PVRSUs will then vest in three equal increments on (1) the later of the first anniversary of the grant date or the date of results determination; (2) the second anniversary of the grant date; and (3) the third anniversary of the grant date. The vesting of these awards is also subject to the respective employees’ continued employment. Compensation expense associated with these PVRSUs is initially based upon the number of shares expected to vest after assessing the probability that certain performance criteria will be met and the associated targeted payout level that is forecasted will be achieved, net of estimated forfeitures. Cumulative adjustments are recorded quarterly to reflect subsequent changes in the estimated outcome of performance-related conditions until the date results are determined.
2007 Grant Activity
 
In 2007, assembled workforce increased by $0.7 million asour Board of Directors awarded a resulttotal of 120,000 PVRSUs to Dr. Cecil Pickett, our former President, Research and Development. Vesting of these PVRSUs was subject to certain performance criteria established at the beginning of each of four performance periods, beginning January 1 on each of 2007, 2008, 2009 and 2010, and Dr. Pickett’s continued employment through the end of the acquisitionrespective performance periods. In February 2008, a total of Syntonix.27,000 shares were issued based upon the attainment of performance criteria set for 2007. An additional


F-38


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
30,000 shares were issued in February 2009 based on the attainment of performance criteria set for 2008. No additional shares were issued to Dr. Pickett in 2009, 2008 and 2007. Dr. Pickett retired from the position of President, Research and Development effective October 5, 2009. Accordingly, no additional PVRSUs awarded to Dr. Pickett will vest or be issued. Expense previously recognized in relation to unvested awards was reversed in 2009.
Prior Period Grant Activity
 
In the first quarter of 2006, core/developed technology increased by $26.4our Board of Directors awarded 100,000 PVRSUs to our CEO, under the 2005 Omnibus Plan, subject to certain 2006 financial performance criteria. In February 2007, our Board of Directors determined that the performance criteria had been attained and that 100,000 PVRSUs would convert into shares of our common stock. A total of 58,250 shares were issued, reflecting the fact that certain shares were withheld for income tax purposes.
In the third quarter of 2005, we granted 1.2 million PVRSUs, to be settled in shares of our common stock, to a group of approximately 200 senior employees excluding our CEO. On September 14, 2006, 758,262 shares vested for which 510,859 shares were issued, reflecting the fact that certain shares were withheld for income tax purposes. On March 14, 2007, 258,387 shares vested based on the level of performance versus the pre-established goals, for which a total of 172,054 shares were issued, reflecting the fact that certain shares were withheld for income tax purposes. No other shares vested in relation to this 2005 grant.
Restricted Stock Awards
In 2005, we awarded restricted common stock to our employees under the 2005 Omnibus Plan and the 2003 Omnibus Plan. The restricted stock awards (RSAs) granted under the 2003 Omnibus Plan vested in full on the third anniversary of the date of grant for employees that remained continuously employed with us through the vesting dates. The RSAs granted under the 2005 Omnibus Plan vested at a rate of approximately one-third per year over three years on the anniversary of the date of grant for employees that remained continuously employed with us through the vesting dates.
The fair value of all time-vested RSAs is based on the market value of our stock on the date of grant. Compensation expense, including the effect of forfeitures, is recognized over the applicable service period. All awards of restricted stock were fully vested as of December 31, 2008.
A summary of RSA activity is presented in the following table:
         
     Weighted
 
     Average
 
     Grant Date
 
(In thousands, except weighted average grant date fair value) Shares  Fair Value 
 
Unvested at December 31, 2006  1,247  $53.64 
         
Granted    $ 
Vested  (713) $44.10 
Forfeited  (79) $59.64 
         
Unvested at December 31, 2007  455  $67.54 
         
Granted    $ 
Vested  (454) $67.54 
         
Forfeited  (1) $67.57 
         
Unvested at December 31, 2008    $ 
         


F-39


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
ESPP
The purchase price of common stock under the ESPP is equal to 85% of the lower of (1) the market value per share of the common stock on the participant’s entry date into an offering period or (2) the market value per share of the common stock on the purchase date. However, for each participant whose entry date is other than the start date of the offering period, the amount shall in no event be less than the market value per share of the common stock as of the beginning of the related offering period. The fair value of the discounted purchases made under the employee stock purchase plan are calculated using the Black-Scholes model. The fair value of the look-back provision plus the 15% discount is recognized as compensation expense over the purchase period. We apply a graded vesting approach since our ESPP provides for multiple purchase periods and is, in substance, a series of linked awards.
The table below provides a summary of shares issued under our ESPP for 2009, 2008 and 2007, respectively:
             
  For The Years Ended December 31,
(In millions) 2009 2008 2007
 
Shares issued under ESPP  0.6   0.5   0.5 
Cash received under ESPP $22.6  $21.3  $18.2 
13.  Accumulated Other Comprehensive Income (Loss)
Accumulated other comprehensive income (loss) consisted of the following:
         
  As of December 31, 
(In millions) 2009  2008 
 
Translation adjustments $35.6  $17.0 
Unrealized gains on securites available for sale  11.3   10.5 
Unrealized gains (losses) on foreign currency forward contracts  1.5   (40.2)
Unfunded status of pension and postretirement benefit plans  2.1   1.6 
         
Accumulated other comprehensive income (loss) $50.5  $(11.1)
         
Unrealized holding gains on securities available for sale is shown net of tax of $(6.6) million and $(6.2) million as a result of the acquisitionDecember 31, 2009 and 2008, respectively. Unrealized gains (losses) on foreign currency forward contracts is shown net of Fumapharm. The assembled workforce intangible asset increased $1.4tax of $0.3 million, and $3.9 million as a result of the acquisitionDecember 31, 2009 and 2008, respectively. The unfunded status of Conformapension and we obtained $11.1 millionretirement benefit plans is shown net of distribution rightstax as of December 31, 2009 and 2008. Tax amounts in connection with the buy out of an agreement with Fumedica.both years were immaterial. See Note 2, Acquisitions and Dispositions,15,Employee Benefit Plansto our Consolidated Financial Statements for further discussion of these transactions.unfunded status of pension and retirement benefit plans.
 
Amortization expense was $332.7 million, $257.5Amounts comprising noncontrolling interests, as reported in our consolidated statements of equity as of December 31, 2009 and 2008 included accumulated translation adjustments of $2.4 million and $267.0$1.2 million, for 2008, 2007,respectively.
Comprehensive income (loss) and 2006, respectively.its components are presented in the consolidated statements of shareholders’ equity.


F-40


 
BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
Amortization on intangible assets is expected to be in the range of approximately $235 million to $352 million for each of the next five years.
Goodwill
Goodwill was unchanged at December 31, 2008 as compared to December 31, 2007 exclusive of the impact of foreign exchange. Goodwill decreased $17.4 million in 2007 as compared to the balance at December 31, 2006, primarily as a result of certain tax adjustments. Approximately $9.1 million of the adjustments relate to the adoption of FIN 48. (See Note 15, Income Taxes, for discussion on income tax).
 
10.14.  Property, Plant and EquipmentOther Consolidated Financial Statement Detail
 
Property, plant and equipment consists of the following (in millions):Other Income (Expense), Net
 
         
  December 31, 
  2008  2007 
 
Land $108.8  $104.8 
Buildings  676.1   610.1 
Leasehold improvements  80.1   75.6 
Furniture and fixtures  48.1   46.1 
Machinery and equipment  798.5   692.9 
Construction in progress  420.2   388.2 
         
Total cost  2,131.8   1,917.7 
Less accumulated depreciation  (537.0)  (420.3)
         
  $1,594.8  $1,497.4 
         
Components of other income (expense), net, are summarized as follows:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Interest income $48.5  $72.1  $103.6 
Interest expense  (35.8)  (52.0)  (40.5)
Impairment on investments  (10.6)  (60.3)  (24.4)
Gain (loss) on sales of investments, net  22.8   (1.1)  16.7 
Foreign exchange gains (losses), net  11.4   (9.8)  3.0 
Gain on the sale of property        7.1 
Other, net  1.0   (6.6)  6.9 
             
Other income (expense), net $37.3  $(57.7) $72.4 
             
 
Depreciation expense was $129.1 million, $122.6 million, and $108.4 million for 2008, 2007, and 2006, respectively.Interest Expense
 
During 2008 and 2007,In 2009, we incurred interest costs of $69.7 million. This amount was reduced by $28.5 million because we capitalized to construction in progress approximately $23.2 million and $10.1 million, respectively, of interest costs primarily related to the developmentconstruction of our large-scale biologiclarge scale manufacturing facility in Hillerød, Denmark. In addition, in 2009, approximately $5.4 million was recorded as a reduction due to the amortization of the deferred gain associated with the termination of an interest rate swap in December 2008.
In 2008, we incurred interest costs of $66.3 million. This amount was reduced by $23.2 million of capitalized interest on the manufacturing facility in Hillerød, Denmark. In addition, we incurred approximately $8.9 million of expenses related to hedge ineffectiveness on interest rate swaps executed in March 2008.
In 2007, we incurred interest costs of $50.6 million, which were reduced by $10.1 million of capitalized interest on the manufacturing facility in Hillerød, Denmark.
 
At December 31, 2008, $388.4 millionImpairment on Investments
In April 2009, we implemented newly issued accounting standards which provided guidance for recognition and presentation ofother-than-temporary impairments. The adoption of the constructionguidance did not have a material impact on our financial position or results of operations; however, this standard amended theother-than-temporary impairment model for marketable debt securities. The impairment model for equity securities was not affected. Refer to Note 7,Financial Instruments to our Consolidated Financial Statements for additional information on the adoption of this guidance.
In 2009, we recognized impairment losses of $7.0 million on our strategic investments and non-marketable securities. In addition, during 2008 and 2007, we recognized $18.6 million and $18.4 million, respectively, in progress balance wascharges for the impairment of strategic investments and non-marketable securities that were determined to beother-than-temporary.
In 2009, we recognized $3.6 million in charges for theother-than-temporary impairment on marketable debt securities. For 2008 and 2007, we recognized $41.7 million and $7.5 million, respectively, in charges for theother-than-temporary impairment of marketable debt securities primarily related to construction of Hillerød, Denmark. The first phase is completemortgage and involved the partial construction of a bulk manufacturing component, a labeling and packaging component and installation of major equipment. The label and packaging component and lab facility was placed into service in the first quarter of 2007. The second phase of the project involves the completion of the large-scale manufacturing component and construction of a warehouse, and is expected to be ready for commercial production in 2010.
See Note 25, Facility Impairments and Loss (Gain) on Disposition, of details of impairment charges taken.asset-backed securities.


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BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
11.  Other current assets
Reclassification
The adoption of a new issued accounting standard for noncontrolling interests on January 1, 2009, changed the accounting and reporting for our minority interests by recharacterizing them as noncontrolling interest. Prior year amounts related to noncontrolling interest, historically reflected as a component of other income (expense), net, have been reclassified to conform to current year presentation. Amounts previously reported as minority interest are now shown separately from net income in the accompanying consolidated statements of income and total $6.9 million, $6.9 million, and $(58.4) million for the years ended December 31, 2009, 2008 and 2007, respectively. This reclassification had no effect on our previously reported financial position or results of operations. Refer to Note 10,Shareholders’ Equityto our Consolidated Financial Statements for additional information on the adoption of this guidance.
Other Current Assets
 
Other current assets consist of the following (in millions):following:
 
                
 December 31,  As of December 31, 
 2008 2007 
(In millions) 2009 2008 
Deferred tax assets $70.8  $96.4  $88.8  $70.8 
Receivable from collaborations  1.7   12.0   5.3   1.7 
Prepaid expenses  46.4   33.6   52.6   46.4 
Interest receivable  11.8   12.8   10.6   11.8 
Other  8.7   28.6   20.6   8.7 
          
Other current assets $177.9  $139.4 
 $139.4  $183.4      
     
 
12.  Accrued expenses and other
Property, Plant and Equipment, net
Property, plant and equipment are recorded at historical cost, net of accumulated depreciation. Components of property, plant and equipment, net are summarized as follows:
         
  As of December 31, 
(In millions) 2009  2008 
 
Land $111.2  $108.8 
Buildings  669.7   676.1 
Leasehold improvements  73.1   80.1 
Furniture and fixtures  50.7   48.1 
Machinery and equipment  868.2   798.5 
Construction in progress  506.7   420.2 
         
Total cost $2,279.6  $2,131.8 
         
Less: accumulated depreciation  (642.5)  (537.0)
         
Property, plant and equipment, net $1,637.1  $1,594.8 
         
In 2009, 2008, and 2007, we capitalized to construction in progress approximately $28.4 million, $23.2 million and $10.1 million, respectively, of interest costs primarily related to the development of our large-scale biologic manufacturing facility in Hillerød, Denmark.
As of December 31, 2009 and 2008, the construction in progress balance related to the construction of our large-scale biologic manufacturing facility in Hillerød, Denmark totaled $441.2 million and $388.4 million, respectively.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Depreciation expense is summarized as follows:
             
  For the Years Ended December 31,
(In millions) 2009 2008 2007
 
Depreciation expense $137.9  $129.1  $122.6 
Accrued Expenses and Other
 
Accrued expenses and other consists of the following (in millions):following:
 
                
 December 31,  As of December 31, 
 2008 2007 
(In millions) 2009 2008 
Employee compensation and benefits $156.0  $86.0  $123.7  $156.0 
Royalties and licensing fees  40.6   57.6   41.8   40.6 
Collaboration expenses  29.6   5.9   35.7   29.6 
Clinical development expenses  41.5   19.4   43.2   41.5 
Revenue-related rebates  37.7   34.1   52.0   37.7 
CIP Accrual  18.6   32.6 
Construction in progress accrual  12.8   18.6 
Other  210.9   132.3   191.6   210.9 
          
Accrued expenses and other $500.8  $534.9 
 $534.9  $367.9      
     
Gain on Sale of Property, Plant and Equipment, net
In 2008, as part of the lease agreement described in Note 18,Commitments and Contingenciesto our Consolidated Financial Statements, we sold the development rights on a parcel of land in Cambridge, MA for $11.4 million in a non-monetary transaction and we recorded a pre-tax gain of approximately $9.2 million on the sale.
 
13.15.  Employee Benefit Plans
 
401(k) Employee Savings Plan
 
We maintain a 401(k) Savings Plan or 401(k) Plan, which is available to substantially all U.S. regular employees in the U.S. over the age of 21. Participants may make voluntary contributions. We make matching contributions according to the 401(k) Savings Plan’s matching formula. Beginning in January 2008, all past and current matching contributions will vest immediately. Previously, the matching contributions vested over four years of service by the employee. Participant contributions vest immediately. The 401(k) Savings Plan also holds certain transition contributions on behalf of participants who previously participated in the Biogen, Inc. Retirement Plan. Employer contributions for 2008, 2007, and 2006 totaled $20.6 million, $17.8 million, and $12.0 million, respectively.The expense related to our 401(k) Savings Plan primarily consists of our matching contributions.
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Expense related to our 401(k) Savings Plan $27.9  $22.8  $20.2 
 
Deferred CompensationStockholder Rights Plan
 
We maintain a non-qualified deferred compensationIn January 2009, our Board of Directors voted to terminate our stockholders rights plan knowneffective as the Supplemental Savings Plan, or SSP, that allows a select group of U.S. management employeesJanuary 30, 2009. The plan was scheduled to defer a portion of their compensation. The SSP also provides certain credits to highly compensated U.S. employees, which are paidexpire on July 26, 2011 and was originally adopted by the company. These creditsBoard of Directors in 1997. Under the rights plan, each share of our common stock had one “right” attached to it that entitled the holder to purchase our Series X Junior Participating Preferred Stock under the circumstances specified in the rights plan. As a result of our Board of Director’s action, no rights are knownoutstanding or exercisable.
Stock Repurchase Programs
In October 2009, our Board of Directors authorized the repurchase of up to $1.0 billion of our common stock with repurchased shares being retired. This repurchase program does not have an expiration date. As of December 31, 2009, approximately 8.8 million shares at a cost of $422.4 million were repurchased under this


F-31


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
authorization, all of which were retired. From January 1, 2010 through February 5, 2010, we repurchased approximately an additional 5.4 million shares under this program at a total cost of approximately $289.4 million, all of which were also retired. Approximately $288.2 million remains available for the repurchase of our common stock under the 2009 program.
In October 2006, our Board of Directors authorized the repurchase of up to 20.0 million shares of our common stock. As of December 31, 2009, all shares under this program have been repurchased as Restoration Match. approximately 7.2 million shares of our common stock were repurchased in 2009 for approximately $328.8 million. In 2008, approximately 12.8 million shares of our common stock were repurchased under this program for approximately $738.9 million.
Reclassifications
The deferred compensationadoption of a newly issued accounting standard for noncontrolling interests on January 1, 2009, changed the accounting and reporting for our minority interests by recharacterizing them as noncontrolling interests and classifying them as a separate component of total shareholders’ equity in our accompanying consolidated balance sheets and consolidated statements of shareholders’ equity. Additionally, net income attributable to noncontrolling interest is now shown separately from net income in the consolidated statements of income. As a result, prior year amounts related to noncontrolling interest have been reclassified to conform to the current year presentation. This reclassification had no effect on our previously reported financial position or results of operations.
In the year ended December 31, 2008, we reclassified amounts within our consolidated statement of shareholders’ equity, resulting in an approximately $78.6 million correction in Additional Paid-in Capital and Retained Earnings (Accumulated Deficit) balances in connection with the re-issuance of treasury stock at a loss.
In the year ended December 31, 2007 we reclassified amounts within our consolidated statements of equity, resulting in an approximately $48.0 million correction in the treasury stock and common stock balances.
11.  Earnings per Share
Basic and diluted earnings per share are accrued when earned. Such deferred compensation is distributablecalculated as follows:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Numerator:            
Net income attributable to Biogen Idec Inc.  $970.1  $783.2  $638.2 
Adjustment for net income allocable to preferred shares  (1.7)  (1.3)  (1.0)
             
Net income used in calculating basic and diluted earnings per share $968.4  $781.9  $637.2 
             
Denominator:            
Weighted average number of common shares outstanding  287.4   292.3   315.8 
Effect of dilutive securities:            
Stock options and employee stock purchase plan  0.6   1.3   2.6 
Restricted stock awards     0.1   0.5 
Time-vested restricted stock units  1.4   1.3   1.1 
Performance-vested restricted stock units  0.1       
Convertible promissory notes due 2019        0.2 
Convertible promissory notes due 2032         
             
Dilutive potential common shares  2.1   2.7   4.4 
             
Shares used in calculating diluted earnings per share  289.5   295.0   320.2 
             


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The following amounts were not included in cashthe calculation of net income per basic and diluted share because their effects were anti-dilutive:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Numerator:            
Net income allocable to preferred stock $1.7  $ 1.3  $ 1.0 
             
Denominator:            
Stock options  8.5   6.9   8.2 
Time-vested restricted stock units  2.1   1.5   0.1 
Performance-vested restricted stock units  0.2       
Convertible preferred stock  0.5   0.5   0.5 
             
Total  11.3   8.9   8.8 
             
Earnings per share for the year ended December 31, 2009 reflects, on a weighted average basis, the repurchase of 16.0 million shares of our common stock under our 2009 and 2006 share repurchase programs.
As a result of our 2007 tender offer, earnings per share for the year ended December 31, 2007 reflects, on a weighted average basis, the repurchase of 56.4 million shares as of June 27, 2007, the date the obligation was incurred, in accordance with the rulesaccounting standards for earning per share.
12.  Share-based Payments
Share-based Compensation Expense
The following table summarizes share-based compensation expense included within our consolidated statements of the SSP. Deferredincome:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Research and development $60.8  $59.9  $51.7 
Selling, general and administrative  106.4   93.8   76.1 
             
Subtotal $167.2  $153.7  $127.8 
Capitalized share-based compensation costs  (6.3)  (7.5)  (4.7)
             
Share-based compensation expense included in total costs and expenses $160.9  $146.2  $123.1 
Income tax effect  (49.4)  (45.4)  (37.5)
             
Share-based compensation expense included in net income attributable to Biogen Idec Inc.  $111.5  $100.8  $85.6 
             


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Our share-based compensation amountsprograms include stock options, time-vested restricted stock units, performance-vested restricted stock units, restricted stock and shares issued under such plan at December 31,our ESPP. The following table summarizes share-based compensation expense associated with each of these programs:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Stock options $21.6  $20.0  $30.7 
Time-vested restricted stock units  133.7   125.6   75.2 
Performance-vested restricted stock units  4.6   1.1   5.0 
Restricted stock awards     0.5   11.7 
Employee stock purchase plan  7.3   6.5   5.2 
             
Subtotal $167.2  $153.7  $127.8 
Capitalized share-based compensation costs  (6.3)  (7.5)  (4.7)
             
Share-based compensation expense included in total costs and expenses $160.9  $146.2  $123.1 
             
Windfall tax benefits from vesting of stock awards, exercises of stock options and ESPP participation were $3.4 million, $28.0 million, and $69.7 million in 2009, 2008, and 2007, totaledrespectively. These amounts have been calculated under the alternative transition method in accordance with U.S. GAAP.
As of December 31, 2009, unrecognized compensation cost related to unvested share-based compensation was approximately $48.5$178.1 million, net of estimated forfeitures. We expect to recognize the cost of these unvested awards over a weighted-average period of 1.4 years.
Share-based Compensation Plans
We have three share-based compensation plans pursuant to which awards are currently being made: (1) the Biogen Idec Inc. 2006 Non-Employee Directors Equity Plan (2006 Directors Plan); (2) the Biogen Idec Inc. 2008 Omnibus Equity Plan (2008 Omnibus Plan); and (3) the Biogen Idec Inc. 1995 Employee Stock Purchase Plan (ESPP). We have six share-based compensation plans pursuant to which outstanding awards have been made, but from which no further awards can or will be made: (i) the IDEC Pharmaceuticals Corporation 1993 Non-Employee Directors Stock Option Plan; (ii) the IDEC Pharmaceuticals Corporation 1988 Stock Option Plan; (iii) the Biogen, Inc. 1985 Non-Qualified Stock Option Plan; (iv) the Biogen, Inc. 1987 Scientific Board Stock Option Plan; (v) the Biogen Idec Inc. 2003 Omnibus Equity Plan (2003 Omnibus Plan); and (vi) the Biogen Idec Inc. 2005 Omnibus Equity Plan (2005 Omnibus Plan). We have not made any awards pursuant to the 2005 Omnibus Plan since our stockholders approved the 2008 Omnibus Plan and do not intend to make any awards pursuant to the 2005 Omnibus Plan in the future, except that unused shares under the 2005 Omnibus Plan have been carried over for use under the 2008 Omnibus Plan.
Directors Plan
In May 2006, our stockholders approved the 2006 Directors Plan for share-based awards to our directors. Awards granted from the 2006 Directors Plan may include options, shares of restricted stock awards, restricted stock units, stock appreciation rights and other awards in such amounts and with such terms and conditions as may be determined by a committee of our Board of Directors, subject to the provisions of the plan. We have reserved a total of 850,000 shares of common stock for issuance under the 2006 Directors Plan. The 2006 Directors Plan provides that awards other than stock options and stock appreciation rights will be counted against the total number of shares reserved under the plan in a 1.5-to-1 ratio.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Omnibus Plans
In June 2008, our stockholders approved the 2008 Omnibus Plan for share-based awards to our employees. Awards granted from the 2008 Omnibus Plan may include options, shares of restricted stock awards, restricted stock units, performance shares, shares of phantom stock, stock appreciation rights and other awards in such amounts and with such terms and conditions as may be determined by a committee of our Board of Directors, subject to the provisions of the plan. Shares of common stock available for issuance under the 2008 Omnibus Plan consist of 15.0 million shares reserved for this purpose, plus shares of common stock that remained available for issuance under the 2005 Omnibus Plan on the date that our stockholders approved the 2008 Omnibus Plan, plus shares that are subject to awards under the 2005 Omnibus Plan which remain unissued upon the cancellation, surrender, exchange or termination of such awards. The 2008 Omnibus Equity Plan provides that awards other than stock options and stock appreciation rights will be counted against the total number of shares available under the plan in a 1.5-to-1 ratio.
Stock Options
All stock option grants to employees are for a ten-year term and generally vest one-fourth per year over four years on the anniversary of the date of grant, provided the employee remains continuously employed with us. Stock option grants to directors are for ten-year terms and generally vest as follows: (1) grants made on the date of a director’s initial election to our Board of Directors vest one-third per year over three years on the anniversary of the date of grant, and (2) grants made for service on our Board of Directors vest on the first anniversary of the date of grant, provided in each case that the director continues to serve on our Board of Directors through the vesting date. Options granted under all plans are exercisable at a price per share not less than the fair market value of the underlying common stock on the date of grant. The estimated fair value of options, including the effect of estimated forfeitures, is recognized over the options’ vesting periods. The fair value of the stock option grants awarded in 2009, 2008, and 2007 was estimated as of the date of grant using a Black-Scholes option valuation model that uses the following weighted-average assumptions:
             
  For the Years Ended December 31, 
  2009  2008  2007 
 
Expected option life (in years)  4.7   5.1   4.9 
Expected stock price volatility  39.3%  34.4%  33.6%
Risk-free interest rate  1.9%  2.4%  4.4%
Expected dividend yield  0.0%  0.0%  0.0%
Per share grant-date fair value $18.00  $20.85  $18.78 
The expected life of options granted is derived using assumed exercise rates based on historical exercise patterns and represents the period of time that options granted are expected to be outstanding. Expected stock price volatility is based upon implied volatility for our exchange-traded options and other factors, including historical volatility. After assessing all available information on either historical volatility, implied volatility, or both, we have concluded that a combination of both historical and implied volatility provides the best estimate of expected volatility. The risk-free interest rate used is determined by the market yield curve based upon risk-free interest rates established by the Federal Reserve, or non-coupon bonds that have maturities equal to the expected term. The dividend yield of zero is based upon the fact that we have not historically granted cash dividends, and do not expect to issue dividends in the foreseeable future. Stock options granted prior to January 1, 2006 were valued based on the grant date fair value of those awards, using the Black-Scholes option pricing model, as previously calculated for pro-forma disclosures.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
A summary of stock option activity is presented in the following table:
         
     Weighted
 
     Average
 
     Exercise
 
(In thousands, except weighted average exercise price) Shares  Price 
 
Outstanding at December 31, 2006  25,106  $47.96 
         
Granted  1,470  $51.23 
Exercised  (10,524) $44.84 
Cancelled  (1,152) $53.97 
         
Outstanding at December 31, 2007  14,900  $50.03 
         
Granted  1,475  $60.23 
Exercised  (3,769) $41.99 
Cancelled  (506) $55.70 
         
Outstanding at December 31, 2008  12,100  $53.53 
         
Granted  1,031  $49.96 
Exercised  (637) $40.16 
Cancelled  (1,664) $60.74 
         
Outstanding at December 31, 2009  10,830  $52.88 
         
Of the options outstanding, 8.3 million were exercisable as of December 31, 2009. The exercisable options had a weighted-average exercise price of $52.80. The aggregate intrinsic value of options exercisable as of December 31, 2009 was $45.2 million. The weighted average remaining contractual term for options exercisable as of December 31, 2009 was 3.8 years.
A total of 10.3 million vested and expected to vest options were outstanding as of December 31, 2009. These vested and expected to vest options had a weighted average exercise price of $52.87 and an aggregated intrinsic value of $51.0 million. The weighted average remaining contractual term of vested and expected to vest options as of December 31, 2009 was 4.6 years.
The total intrinsic values of options exercised in 2009, 2008, and 2007, were $6.7 million, $85.1 million, and $50.3$226.7 million, respectively. The aggregate intrinsic values of options outstanding as of December 31, 2009 was $52.8 million. The weighted average remaining contractual term for options outstanding as of December 31, 2009 was 4.8 years.
A summary of the amount of tax benefit realized for stock options and cash received from the exercise of stock options is as follows:
             
  For the Years Ended December 31,
(In millions) 2009 2008 2007
 
Tax benefit realized for stock options $1.5  $28.0  $72.4 
Cash received from the exercise of stock options $25.2  $158.3  $471.0 


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Time-Vested Restricted Stock Units
Time-vested restricted stock units (RSUs) awarded to employees generally vest no sooner than one-third per year over three years on the anniversary of the date of grant, or upon the third anniversary of the date of the grant, provided the employee remains continuously employed with us, except as otherwise provided in the plan. Shares of our common stock will be delivered to the employee upon vesting, subject to payment of applicable withholding taxes. RSUs awarded to directors for service on our Board of Directors vest on the first anniversary of the date of grant, provided in each case that the director continues to serve on our Board of Directors through the vesting date. Shares of our common stock will be delivered to the director upon vesting and are not subject to any withholding taxes. The fair value of all RSUs is based on the market value of our stock on the date of grant. Compensation expense, including the effect of forfeitures, is recognized over the applicable service period.
A summary of RSU activity is presented in the following table:
         
     Weighted
 
     Average
 
     Grant Date
 
(In thousands, except weighted average grant date fair value) Shares  Fair Value 
 
Unvested at December 31, 2006  2,508  $44.48 
         
Granted  3,387  $51.19 
Vested  (845) $44.58 
Forfeited  (458) $47.38 
         
Unvested at December 31, 2007  4,592  $49.12 
         
Granted  3,129  $58.42 
Vested  (1,645) $47.93 
Forfeited  (499) $53.95 
         
Unvested at December 31, 2008  5,577  $54.26 
         
Granted  2,674  $48.93 
Vested  (2,421) $52.08 
Forfeited  (445) $53.02 
         
Unvested at December 31, 2009  5,385  $52.72 
         


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Performance-Vested Restricted Stock Units
A summary of performance-vested restricted stock units (PVRSUs) activity is presented in the following table:
         
     Weighted
 
     Average
 
     Grant Date
 
(In thousands, except weighted average grant date fair value) Shares  Fair Value 
 
Unvested at December 31, 2006  411  $41.62 
         
Granted  120  $51.55 
Vested  (357) $41.76 
Forfeited  (54) $40.67 
         
Unvested at December 31, 2007  120  $51.55 
         
Granted    $ 
Vested  (27) $49.33 
Forfeited  (3) $49.33 
         
Unvested at December 31, 2008  90  $52.29 
         
Granted  325  $49.42 
Vested  (30) $52.29 
Forfeited  (97) $51.30 
         
Unvested at December 31, 2009  288  $49.39 
         
2009 Grant Activity
We apply a graded vesting expense methodology when accounting for the PVRSUs issued in 2009. In 2009, approximately 325,000 PVRSUs were granted with a weighted average grant date fair value of $49.42 per share.
The number of PVRSUs reflected as granted represents the target number of shares that are eligible to vest in full or in part and are earned subject to the attainment of certain performance criteria established at the beginning of the performance period, which ended December 31, 2009. Participants may ultimately earn up to 200% of the target number of shares granted in the event that the maximum performance thresholds are attained. Accordingly, additional PVRSUs may be issued upon final determination of the number of awards earned.
Once the earned number of performance-vested awards has been determined, the earned PVRSUs will then vest in three equal increments on (1) the later of the first anniversary of the grant date or the date of results determination; (2) the second anniversary of the grant date; and (3) the third anniversary of the grant date. The vesting of these awards is also subject to the respective employees’ continued employment. Compensation expense associated with these PVRSUs is initially based upon the number of shares expected to vest after assessing the probability that certain performance criteria will be met and the associated targeted payout level that is forecasted will be achieved, net of estimated forfeitures. Cumulative adjustments are recorded quarterly to reflect subsequent changes in the estimated outcome of performance-related conditions until the date results are determined.
2007 Grant Activity
In 2007, our Board of Directors awarded a total of 120,000 PVRSUs to Dr. Cecil Pickett, our former President, Research and Development. Vesting of these PVRSUs was subject to certain performance criteria established at the beginning of each of four performance periods, beginning January 1 on each of 2007, 2008, 2009 and 2010, and Dr. Pickett’s continued employment through the end of the respective performance periods. In February 2008, a total of 27,000 shares were issued based upon the attainment of performance criteria set for 2007. An additional


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
30,000 shares were issued in February 2009 based on the attainment of performance criteria set for 2008. No additional shares were issued to Dr. Pickett in 2009, 2008 and 2007. Dr. Pickett retired from the position of President, Research and Development effective October 5, 2009. Accordingly, no additional PVRSUs awarded to Dr. Pickett will vest or be issued. Expense previously recognized in relation to unvested awards was reversed in 2009.
Prior Period Grant Activity
In the first quarter of 2006, our Board of Directors awarded 100,000 PVRSUs to our CEO, under the 2005 Omnibus Plan, subject to certain 2006 financial performance criteria. In February 2007, our Board of Directors determined that the performance criteria had been attained and that 100,000 PVRSUs would convert into shares of our common stock. A total of 58,250 shares were issued, reflecting the fact that certain shares were withheld for income tax purposes.
In the third quarter of 2005, we granted 1.2 million PVRSUs, to be settled in shares of our common stock, to a group of approximately 200 senior employees excluding our CEO. On September 14, 2006, 758,262 shares vested for which 510,859 shares were issued, reflecting the fact that certain shares were withheld for income tax purposes. On March 14, 2007, 258,387 shares vested based on the level of performance versus the pre-established goals, for which a total of 172,054 shares were issued, reflecting the fact that certain shares were withheld for income tax purposes. No other shares vested in relation to this 2005 grant.
Restricted Stock Awards
In 2005, we awarded restricted common stock to our employees under the 2005 Omnibus Plan and the 2003 Omnibus Plan. The restricted stock awards (RSAs) granted under the 2003 Omnibus Plan vested in full on the third anniversary of the date of grant for employees that remained continuously employed with us through the vesting dates. The RSAs granted under the 2005 Omnibus Plan vested at a rate of approximately one-third per year over three years on the anniversary of the date of grant for employees that remained continuously employed with us through the vesting dates.
The fair value of all time-vested RSAs is based on the market value of our stock on the date of grant. Compensation expense, including the effect of forfeitures, is recognized over the applicable service period. All awards of restricted stock were fully vested as of December 31, 2008.
A summary of RSA activity is presented in the following table:
         
     Weighted
 
     Average
 
     Grant Date
 
(In thousands, except weighted average grant date fair value) Shares  Fair Value 
 
Unvested at December 31, 2006  1,247  $53.64 
         
Granted    $ 
Vested  (713) $44.10 
Forfeited  (79) $59.64 
         
Unvested at December 31, 2007  455  $67.54 
         
Granted    $ 
Vested  (454) $67.54 
         
Forfeited  (1) $67.57 
         
Unvested at December 31, 2008    $ 
         


F-39


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
ESPP
The purchase price of common stock under the ESPP is equal to 85% of the lower of (1) the market value per share of the common stock on the participant’s entry date into an offering period or (2) the market value per share of the common stock on the purchase date. However, for each participant whose entry date is other than the start date of the offering period, the amount shall in no event be less than the market value per share of the common stock as of the beginning of the related offering period. The fair value of the discounted purchases made under the employee stock purchase plan are calculated using the Black-Scholes model. The fair value of the look-back provision plus the 15% discount is recognized as compensation expense over the purchase period. We apply a graded vesting approach since our ESPP provides for multiple purchase periods and is, in substance, a series of linked awards.
The table below provides a summary of shares issued under our ESPP for 2009, 2008 and 2007, respectively:
             
  For The Years Ended December 31,
(In millions) 2009 2008 2007
 
Shares issued under ESPP  0.6   0.5   0.5 
Cash received under ESPP $22.6  $21.3  $18.2 
13.  Accumulated Other Comprehensive Income (Loss)
Accumulated other comprehensive income (loss) consisted of the following:
         
  As of December 31, 
(In millions) 2009  2008 
 
Translation adjustments $35.6  $17.0 
Unrealized gains on securites available for sale  11.3   10.5 
Unrealized gains (losses) on foreign currency forward contracts  1.5   (40.2)
Unfunded status of pension and postretirement benefit plans  2.1   1.6 
         
Accumulated other comprehensive income (loss) $50.5  $(11.1)
         
Unrealized holding gains on securities available for sale is shown net of tax of $(6.6) million and $(6.2) million as of December 31, 2009 and 2008, respectively. Unrealized gains (losses) on foreign currency forward contracts is shown net of tax of $0.3 million, and $3.9 million as of December 31, 2009 and 2008, respectively. The unfunded status of pension and retirement benefit plans is shown net of tax as of December 31, 2009 and 2008. Tax amounts in both years were immaterial. See Note 15,Employee Benefit Plansto our Consolidated Financial Statements for discussion of unfunded status of pension and retirement benefit plans.
Amounts comprising noncontrolling interests, as reported in our consolidated statements of equity as of December 31, 2009 and 2008 included accumulated translation adjustments of $2.4 million and $1.2 million, respectively.
Comprehensive income (loss) and its components are presented in the consolidated statements of shareholders’ equity.


F-40


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
14.  Other Consolidated Financial Statement Detail
Other Income (Expense), Net
Components of other income (expense), net, are summarized as follows:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Interest income $48.5  $72.1  $103.6 
Interest expense  (35.8)  (52.0)  (40.5)
Impairment on investments  (10.6)  (60.3)  (24.4)
Gain (loss) on sales of investments, net  22.8   (1.1)  16.7 
Foreign exchange gains (losses), net  11.4   (9.8)  3.0 
Gain on the sale of property        7.1 
Other, net  1.0   (6.6)  6.9 
             
Other income (expense), net $37.3  $(57.7) $72.4 
             
Interest Expense
In 2009, we incurred interest costs of $69.7 million. This amount was reduced by $28.5 million because we capitalized interest related to the construction of our large scale manufacturing facility in Hillerød, Denmark. In addition, in 2009, approximately $5.4 million was recorded as a reduction due to the amortization of the deferred gain associated with the termination of an interest rate swap in December 2008.
In 2008, we incurred interest costs of $66.3 million. This amount was reduced by $23.2 million of capitalized interest on the manufacturing facility in Hillerød, Denmark. In addition, we incurred approximately $8.9 million of expenses related to hedge ineffectiveness on interest rate swaps executed in March 2008.
In 2007, we incurred interest costs of $50.6 million, which were reduced by $10.1 million of capitalized interest on the manufacturing facility in Hillerød, Denmark.
Impairment on Investments
In April 2009, we implemented newly issued accounting standards which provided guidance for recognition and presentation ofother-than-temporary impairments. The adoption of the guidance did not have a material impact on our financial position or results of operations; however, this standard amended theother-than-temporary impairment model for marketable debt securities. The impairment model for equity securities was not affected. Refer to Note 7,Financial Instruments to our Consolidated Financial Statements for additional information on the adoption of this guidance.
In 2009, we recognized impairment losses of $7.0 million on our strategic investments and non-marketable securities. In addition, during 2008 and 2007, we recognized $18.6 million and $18.4 million, respectively, in charges for the impairment of strategic investments and non-marketable securities that were determined to beother-than-temporary.
In 2009, we recognized $3.6 million in charges for theother-than-temporary impairment on marketable debt securities. For 2008 and 2007, we recognized $41.7 million and $7.5 million, respectively, in charges for theother-than-temporary impairment of marketable debt securities primarily related to mortgage and asset-backed securities.


F-41


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Reclassification
The adoption of a new issued accounting standard for noncontrolling interests on January 1, 2009, changed the accounting and reporting for our minority interests by recharacterizing them as noncontrolling interest. Prior year amounts related to noncontrolling interest, historically reflected as a component of other income (expense), net, have been reclassified to conform to current year presentation. Amounts previously reported as minority interest are included in other long-term liabilitiesnow shown separately from net income in the accompanying consolidated statements of income and total $6.9 million, $6.9 million, and $(58.4) million for the years ended December 31, 2009, 2008 and 2007, respectively. This reclassification had no effect on our previously reported financial position or results of operations. Refer to Note 10,Shareholders’ Equityto our Consolidated Financial Statements for additional information on the adoption of this guidance.
Other Current Assets
Other current assets consist of the following:
         
  As of December 31, 
(In millions) 2009  2008 
 
Deferred tax assets $88.8  $70.8 
Receivable from collaborations  5.3   1.7 
Prepaid expenses  52.6   46.4 
Interest receivable  10.6   11.8 
Other  20.6   8.7 
         
Other current assets $177.9  $139.4 
         
Property, Plant and Equipment, net
Property, plant and equipment are recorded at historical cost, net of accumulated depreciation. Components of property, plant and equipment, net are summarized as follows:
         
  As of December 31, 
(In millions) 2009  2008 
 
Land $111.2  $108.8 
Buildings  669.7   676.1 
Leasehold improvements  73.1   80.1 
Furniture and fixtures  50.7   48.1 
Machinery and equipment  868.2   798.5 
Construction in progress  506.7   420.2 
         
Total cost $2,279.6  $2,131.8 
         
Less: accumulated depreciation  (642.5)  (537.0)
         
Property, plant and equipment, net $1,637.1  $1,594.8 
         
In 2009, 2008, and 2007, we capitalized to construction in progress approximately $28.4 million, $23.2 million and $10.1 million, respectively, of interest costs primarily related to the development of our large-scale biologic manufacturing facility in Hillerød, Denmark.
As of December 31, 2009 and 2008, the construction in progress balance sheets.related to the construction of our large-scale biologic manufacturing facility in Hillerød, Denmark totaled $441.2 million and $388.4 million, respectively.


F-42


 
BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
Depreciation expense is summarized as follows:
             
  For the Years Ended December 31,
(In millions) 2009 2008 2007
 
Depreciation expense $137.9  $129.1  $122.6 
Accrued Expenses and Other
Accrued expenses and other consists of the following:
         
  As of December 31, 
(In millions) 2009  2008 
 
Employee compensation and benefits $123.7  $156.0 
Royalties and licensing fees  41.8   40.6 
Collaboration expenses  35.7   29.6 
Clinical development expenses  43.2   41.5 
Revenue-related rebates  52.0   37.7 
Construction in progress accrual  12.8   18.6 
Other  191.6   210.9 
         
Accrued expenses and other $500.8  $534.9 
         
Gain on Sale of Property, Plant and Equipment, net
In 2008, as part of the lease agreement described in Note 18,Commitments and Contingenciesto our Consolidated Financial Statements, we sold the development rights on a parcel of land in Cambridge, MA for $11.4 million in a non-monetary transaction and we recorded a pre-tax gain of approximately $9.2 million on the sale.
15.  Employee Benefit Plans
401(k) Savings Plan
We maintain a 401(k) Savings Plan which is available to substantially all regular employees in the U.S. over the age of 21. Participants may make voluntary contributions. We make matching contributions according to the 401(k) Savings Plan’s matching formula. Beginning in January 2008, all past and current matching contributions will vest immediately. Previously, the matching contributions vested over four years of service by the employee. Participant contributions vest immediately. The SSP401(k) Savings Plan also holds certain transition contributions on behalf of participants who previously participated in the Biogen, Inc. Retirement Plan. Beginning in 2008, the Restoration Match vests immediately. Previously, the Restoration Match and transition contributions vested over four and seven yearsThe expense related to our 401(k) Savings Plan primarily consists of service, respectively, by the employee. Participant contributions vest immediately. Distributions to participants can be either in one lump sum payment or annual installments as elected by the participants.our matching contributions.
 
Retiree Medical Plan
In 2003, we began to provide medical plan benefits to retirees under the age of 65. The plan terms were modified in 2007 and, accordingly, we recognized no (benefit) cost and no liability remained at December 31, 2008. Net periodic (benefit) cost for 2007, 2006, was $(6.7) million, and $1.4 million, respectively. In 2007, we recognized a benefit, which was primarily related to a modification of the plan in 2007. In 2006, the majority of the expense was related to service cost.
Pension Plan
We currently maintain two retiree benefit plans: a Supplemental Employee Retirement Plan and a defined benefit plan for certain employees in Germany.
The obligations under the plans totaled $5.4 million and $5.0 million at December 31, 2008 and 2007, respectively.
Net periodic pension cost for 2008, 2007, and 2006 was $1.1 million, $1.3 million, and $1.2 million, respectively. The majority of the net period pension costs related to service cost.
14.  Other Income (Expense), Net
Total other income (expense), net, consists of the following (in millions):
             
  December 31, 
  2008  2007  2006 
 
Interest income $72.1  $103.6  $101.2 
Interest expense  (52.0)  (40.5)  (0.9)
Impairments of investments  (60.3)  (24.4)  (34.4)
Gain (Loss) on sales of investments, net  (1.1)  16.7   (2.8)
Minority interest  (6.9)  58.4   (6.8)
Foreign exchange gains (losses), net  (9.8)  3.0   4.9 
Settlement of litigation and claims     0.1   (4.6)
Gain on sale of property     7.1    
Other, net  (6.7)  6.8   (4.5)
             
Total other income (expense), net $(64.7) $130.8  $52.1 
             
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Expense related to our 401(k) Savings Plan $27.9  $22.8  $20.2 
 
Interest Income
For 2008 compared to 2007, interest income decreased $31.5 million, or 30.4%, primarily due to a reduction in cash and cash equivalents due to the funding of our tender offer in July 2007, a net payment of $525.5 million for our term loan facility and other debt, and lower investment yields. For 2007 compared to 2006, interest income increased $2.4 million, or 2.4%, primarily due to higher yields offset by a reduction in cash and cash equivalents due to the funding of our tender offer in July 2007.


F-43


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Interest Expense
For 2008 compared to 2007, interest expense increased $11.5 million, or 28%, primarily due to an increased debt balance in 2008 as compared to 2007 due to the issuance of debt in July 2007 as well as $8.9 million due to the impact of hedge ineffectiveness as discussed in Note 4, Financial Investments. For 2007 compared to 2006, interest expense increased $39.6 million, primarily due to the increased debt levels relating to our tender offer funded in July 2007 (see Note 21, Tender Offer). As discussed in Note 4, Financial Investments, in 2008 we terminated certain interest rate swaps. Upon termination of the swaps, the carrying amount of the 6.875% Senior Notes due in 2018 increased $62.8 million, which will be recognized as a reduction of interest expense and amortized using the effective interest rate method over the remaining life of the Senior Notes.
Impairment on Investments
In 2008, the impairment on investments was due to an other than temporary decline in the fair value of marketable securities of $41.7 million related primarily to non agency mortgage and asset backed securities and corporate securities classified as available for sale as well as other than temporary declines in the fair values of our strategic investments of $18.6 million. In 2007 and 2006, the impairment of investments is primarily due to the other than temporary decline in value in our strategic investments portfolio.
Minority Interest
For 2008 compared to 2007, minority interest decreased $65.3 million, primarily due to the recording in 2007 of $64.3 million in minority interest pursuant to the initial consolidation of Cardiokine Biopharma LLC or Cardiokine in August 2007 and Neurimmune in November 2007. For 2007 compared to 2006, minority interest increased $65.2 million, also primarily due to the initial consolidation of Cardiokine and Neurimmune in 2007. The minority interest related to Cardiokine and Neurimmune recorded in 2007 offset an equal charge to IPR&D, which resulted in no net impact to our results of operations for these IPR&D and minority interest charges. Excluding the impact of these consolidations, minority interest expense was $6.9 million, $5.9 million and $6.8 million for the years ended December 31, 2008, 2007 and 2006, respectively.
Gain on Sale of Property
In 2007, we sold approximately 28 acres of land in Oceanside, California for $16.5 million. We recorded a pre-tax gain of approximately $7.1 million on the sale in other income (expense) as this land was not utilized in our operations.


F-44


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
15.  Income Taxes
Income tax expense
Income before income tax provision and the income tax expense consist of the following (in millions):
             
  Year Ended December 31, 
  2008  2007  2006 
 
Income before income tax provision (benefit):            
Domestic $838.3  $693.9  $525.2 
Foreign  310.6   216.7   (33.0)
             
  $1,148.9  $910.6  $492.2 
             
Income tax expense (benefit):            
Current            
Federal $431.2  $305.9  $355.0 
State  24.3   25.8   15.8 
Foreign  49.8   22.3   13.9 
             
  $505.3  $354.0  $384.7 
             
Deferred            
Federal $(119.2) $(76.7) $(105.3)
State  (20.0)  (4.4)  (0.7)
Foreign  (0.3)  (0.5)  (0.3)
             
  $(139.5) $(81.6) $(106.3)
             
Total income tax expense $365.8  $272.4  $278.4 
             
Deferred tax assets and liabilities
Significant components of our deferred tax assets and liabilities are as follows:
         
  December 31, 
  2008  2007 
 
Tax credits $11.0  $5.5 
Inventory and other reserves  90.4   32.2 
Capitalized costs  36.6   84.9 
Intangibles, net  89.6   77.2 
Net operating loss  33.1   29.6 
Share-based compensation  59.9   70.5 
Other  57.9   40.5 
         
Deferred tax assets $378.5  $340.4 
         
Fair value adjustment $(552.7) $(632.7)
Interest expense on notes payable     (0.3)
Unrealized gain on investments and cumulative translation adjustment  (2.3)  (2.7)
Depreciation, amortization and other  (108.7)  (129.8)
         
Deferred tax liabilities $(663.7) $(765.5)
         


F-45


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Tax Rate
A reconciliation between the U.S. federal statutory tax rate and our effective tax rate is as follows:
             
  Year Ended December 31, 
  2008  2007  2006 
 
Statutory rate  35.0%  35.0%  35.0%
State taxes  1.6   3.0   3.0 
Taxes on foreign earnings  (5.8)  (7.6)  (16.3)
Credits and net operating loss utilization  (2.9)  (3.1)  (0.6)
Fair value adjustment  3.7   3.5   6.2 
IPR&D  0.8   0.7   27.9 
Non-deductible items  (0.8)  (0.6)  0.8 
Other  0.2   (1.0)  0.6 
             
Effective tax rate  31.8%  29.9%  56.6%
             
At December 31, 2008, we had net operating losses and general business credit carryforwards for federal income tax purposes of approximately $64.7 million and $3.2 million, respectively, which begin to expire in 2020. Additionally, for state income tax purposes, we had net operating loss carryforwards of approximately $197.1 million, which begin to expire in 2009. For state income tax purposes, we also had research and investment credit carryforwards of approximately $12.0 million, of which approximately $9.7 million begin to expire in 2009, with the remainder having no prescribed expiration date.
In assessing the realizability of our deferred tax assets, we have considered whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. In making this determination, under the applicable financial reporting standards, we are allowed to consider the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies. Our estimates of future taxable income take into consideration, among other items, our estimates of future income tax deductions related to the exercise of stock options. Based upon the level of historical taxable income and income tax liability and projections for future taxable income over the periods in which the deferred tax assets are utilizable, we believe it is more likely than not that we will realize the benefits of our entire deferred tax assets. In the event that actual results differ from our estimates or we adjust our estimates in future periods, we may need to establish a valuation allowance, which could materially impact our financial position and results of operations.
As of December 31, 2008, undistributed foreign earnings ofnon-U.S. subsidiaries included in consolidated retained earnings aggregated approximately $2,071.3 million. We intend to reinvest these earnings indefinitely in operations outside the U.S. It is not practicable to estimate the amount of additional tax that might be payable if such earnings were remitted to the U.S.
IRS Settlement
During 2007, the IRS completed its examination of Biogen Idec Inc.’s consolidated federal income tax returns for the fiscal years 2003 and 2004 and issued an assessment. We subsequently paid amounts related to issues agreed to with the IRS and are appealing several issues. As a result of this examination activity, we reassessed our liability for income tax contingencies to reflect the IRS findings and recorded a $14.7 million reduction in our liabilities for income tax contingencies during the second quarter of 2007.


F-46


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
During 2005, the Internal Revenue Service, or IRS, completed its examination of legacy Biogen, Inc.’s, now Biogen Idec MA, Inc.’s, consolidated federal income tax returns for the fiscal years 2001 and 2002 and issued an assessment. We subsequently paid the majority of the amounts assessed and are appealing one issue.
Contingency
On September 12, 2006, we received a Notice of Assessment from the Massachusetts Department of Revenue for $38.9 million, which includes penalties and interest, with respect to the 2001, 2002, and 2003 tax years. We believe that we have meritorious defenses to the proposed adjustment and will vigorously oppose the assessment. We believe that the assessment does not impact the level of liabilities for our income tax contingencies. However, there is a possibility that we may not prevail in all of our assertions. If this is resolved unfavorably in the future, this could have a material impact on our future effective tax rate and our results of operations in the period in which an event would occur.
Adoption of FASB Interpretation No. 48
Effective January 1, 2007, we adopted the provisions of FIN 48. FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with SFAS 109. FIN 48 also prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of each tax position taken or expected to be taken in a tax return. As a result of the adoption of FIN 48, we recognized a reduction in the liability for unrecognized tax benefits of $14.2 million, which was recorded as a $1.8 million reduction to the January 1, 2007 balance of our accumulated deficit, a $9.1 million reduction in goodwill and a $3.3 million increase in our deferred tax liability.
A reconciliation of the beginning and ending amount of our unrecognized tax benefits is as follows (in millions):
         
  2008  2007 
 
Balance at January 1 $221.1  $196.8 
Additions based on tax positions related to the current period  21.8   29.7 
Additions for tax positions of prior periods  20.4   83.5 
Reductions for tax positions of prior periods  (13.7)  (70.2)
Settlements     (18.7)
         
Balance at December 31 $249.6  $221.1 
         
Included in the balance of unrecognized tax benefits at December 31, 2008, December 31, 2007, and January 1, 2007, are $155.1 million, $110.5 million, and $98.2 million (net of the federal benefit on state issues), respectively, of unrecognized tax benefits that, if recognized, would affect the effective income tax rate in any future periods. We do not anticipate any significant changes in our positions in the next twelve months other than expected settlements which have been classified as current liabilities within the accompanying balance sheet.
We recognize potential interest and penalties accrued related to unrecognized tax benefits in income tax expense. During 2008 and 2007, we recognized approximately $16.1 million and $14.5 million in interest expense, respectively. Additionally, during 2007, we reduced our interest accrual by $3.3 million due to the completion of an IRS examination as described above. We have accrued approximately $47.7 million and $31.6 million for the payment of interest at December 31, 2008 and December 31, 2007, respectively.
We file income tax returns in the U.S. federal jurisdiction, and various states and foreign jurisdictions. With few exceptions, we are no longer subject to U.S. federal, state and local, ornon-U.S. income tax examinations by tax authorities for years before 2001.


F-47


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
16.  Research Collaborations
In connection with our research and development efforts, we have entered into various collaboration arrangements which provide us with rights to develop, produce and market products using certain know-how, technology and patent rights maintained by the parties. Terms of the various license agreements may require us to make milestone payments upon the achievement of certain product development objectives and pay royalties on future sales, if any, of commercial products resulting from the collaboration.
Neurimmune
In November 2007, we entered into a collaboration agreement with Neurimmune SubOne AG, or Neurimmune, for the worldwide development and commercialization of human antibodies for the treatment of Alzheimer’s disease, or AD. The collaboration agreement is effective for 12 years from the first commercial sale of product using such compound. Neurimmune will conduct research to identify potential therapeutic antibodies and we will be responsible for the development and commercialization of all products. Under the terms of the agreement, we paid a $2.0 million upfront payment and may pay up to $367.5 million in milestone payments, as well as a royalty on net sales of any resulting commercial products. In 2008, we paid $10.5 million in milestone payments. We also will reimburse Neurimmune for certain research and development costs incurred. We have determined that we are the primary beneficiary under FIN 46(R), because we are required to absorb the variability (increases or decreases) in development cost under the collaboration agreement. As a result, we have consolidated the results of Neurimmune and recorded an IPR&D charge of $34.3 million. The amount allocated to IPR&D relates to the development of theBeta-Amyloid antibody. At the effective date of the agreement, this compound had not reached technological feasibility and had no alternative future use. We have allocated the $34.3 million to the minority interest, as charge represents the fair value of theBeta-Amyloid antibody retained by the minority interest holders. As a result, we have recorded a credit in minority interest, which is recorded in other income (expense). The assets and liabilities of Neurimmune are not significant as it is a research and development organization. Through December 31, 2008, we have spent an additional $6.5 million to develop theBeta-Amyloid antibody. We expect to incur approximately an additional $291.7 million to develop theBeta-Amyloid antibody for all indications under development. The estimated revenues from theBeta-Amyloid antibody are expected to be recognized beginning in 2018. A discount rate of 15% was used to value this project, which we believe to be commensurate with the stage of development of theBeta-Amyloid antibody and the uncertainties in the economic estimates described above.
Cardiokine
In August 2007, our collaboration agreement with Cardiokine became effective. The agreement is for the joint development of lixivaptan, an oral compound for the potential treatment of hyponatremia in patients with congestive heart failure. The collaboration agreement is effective for 10 years from the first commercial sale of a product using such compound. We will be responsible for the global commercialization of lixivaptan and Cardiokine has an option for limited co-promotion in the U.S.
Under the terms of the agreement, we paid a $50.0 million upfront payment and will pay up to $170.0 million in milestone payments for successful development and global commercialization of lixivaptan, as well as royalties on commercial sales. The $50.0 million is reflected as research and development expense in the accompanying consolidated statement of income. We have determined that we are the primary beneficiary under FIN 46(R), because we are required to absorb the variability (increases or decreases) in development costs under the collaboration agreement. As a result, we have consolidated the results of Cardiokine and recorded an IPR&D charge of approximately $30.0 million. The amount allocated to IPR&D relates to the development of lixivaptan. At the effective date of the agreement, this compound had not reached technological feasibility and had no alternative future use. We have allocated the approximately $30.0 million to the minority interest, as the charge represents the fair value of the lixivaptan compound retained by the minority interest holders. As a result, we recorded a credit in


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BIOGEN IDEC INC. AND SUBSIDIARIES
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minority interest, which is recorded in other income (expense). The assets and liabilities of Cardiokine are not significant as it is a research and development organization. Through December 31, 2008, we have spent an additional $61.0 million to develop lixivaptan since the agreement became effective. We expect to incur approximately an additional $367.0 million to develop lixivaptan for all indications under development. The estimated revenues from lixivaptan are expected to be recognized beginning in 2012. A discount rate of 11% was used to value this project, which we believe to be commensurate with the stage of development of lixivaptan and the uncertainties in the economic estimates described above.
mondo
On September 14, 2006, we entered into an exclusive collaboration and license agreement with mondoBIOTECH, AG, a private Swiss biotechnology company In June 2007, we entered into a collaboration with a subsidiary of MondoBiotech AG, mondoGen, or mondo, to develop, manufacture and commercialize Aviptadil, a clinical compound for the treatment of pulmonary arterial hypertension, or PAH. In accordance with the agreement, we will be responsible for the global manufacturing, clinical development, regulatory approval and commercialization of Aviptadil. We finalized the development plan for Aviptadil and had mondo initiate additional clinical work in 2007.
Under the terms of the agreement, we paid mondo a $7.5 million upfront payment and will pay up to $30.0 million in milestones payments for successful development and commercialization of Aviptadil in PAH in the U.S. and Europe, as well as royalty payments on commercial sales. The $7.5 million upfront amount was recorded as research and development expense in 2006. We have determined that we are the primary beneficiary under FIN 46(R), because we are required to absorb the variability (increases or decreases) in development costs under the collaboration agreement. As a result, we have consolidated the results of mondo. The assets and liabilities of mondo are not significant as it is a research and development organization. Through December 31, 2008, we have spent an additional $29.9 million on the development of Aviptadil and could incur an additional $134.1 million to develop Aviptadil. We have determined that we are the primary beneficiary under FIN 46(R) and as a result, we consolidate the results of mondo.
Additionally, we have indicated our intention to make a minority equity investment of $5.0 million in mondo in the event that it undertakes an initial public offering.
Alnylam
In September 2006, we entered into a collaboration agreement with Alnylam Pharmaceuticals, Inc., or Alnylam, related to discovery and development of RNAi therapeutics for the potential treatment of PML.
Under the terms of the collaboration, we and Alnylam will initially conduct investigative research into the potential of using RNAi technology to develop up to three therapeutics to treat PML. Of the therapeutics presented, we will select one development candidate and one back up candidate and will be responsible for the development and commercialization of the selected candidate. We would also have the option to develop and commercialize the backup candidate at our discretion. We will fund all research and development activities.
We paid Alnylam an upfront payment of $5.0 million and agreed to additional payments of up to $51.3 million in milestone payments, plus royalties in the event of successful development and utilization of any product resulting from the collaboration. The $5.0 million upfront payment was recorded as research and development expense in 2006.
UCB
In September 2006, we entered into a global collaboration with UCB, S.A., or UCB, to jointly develop and commercialize CDP323 for the treatment of relapsing-remitting MS and other potential indications. CDP323 is an orally active small molecule alpha-4 integrin inhibitor in Phase 2 clinical trials.


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Under terms of the agreement, we paid UCB an upfront payment of $30.0 million and agreed to make development milestone payments to UCB for the first indication of up to $93.0 million, with total milestone payments of up to $71.3 million payable for any additional indications. We will also pay UCB up to $75.0 million in commercialization milestones and will contribute significantly to clinical costs for Phase 2 and Phase 3 studies. All commercialization costs and profits will be shared equally. The $30.0 million upfront payment was recorded as research and development expense in 2006.
Facet Biotech (Formerly PDL BioPharma, Inc.)
In August 2005, we entered in a collaborative agreement with PDL BioPharma, Inc., or PDL, for the joint development, manufacture and commercialization of three Phase 2 antibody products. In 2008, PDL spun off the research and development component of its business into a newly created public entity called Facet Biotech. Our collaboration agreement now resides with Facet Biotech (Facet). Under this agreement, we and Facet will share in the development and commercialization of Daclizumab in MS and indications other than transplant and respiratory diseases, and the development and commercialization of M200, or volociximab, and HuZAF, or fontolizumab, in all indications. Fontolizumab was discontinued during 2006. Both companies will share equally the costs of all development activities and all operating profits from each collaboration product within the U.S. and Europe. We paid Facet a non-refundable upfront licensing fee of $40.0 million for these product candidates, which we concluded had no alternative future uses and was therefore included in research and development expenses in 2005. We also accrued $10.0 million in research and development expense in 2005 for future payments that were determined to be unavoidable. The terms of the collaborative agreement require us to make certain development and commercialization milestone payments upon the achievement of certain program objectives totaling up to $660.0 million over the life of the agreement, of which $560.0 million relates to development, and $100.0 million relates to the commercialization of collaboration products.
In addition to the collaborative agreement, we purchased approximately $100.0 million of common stock, or 3.5% of its common stock, from Facet. We recorded an impairment charge of $18.3 million during 2006 to reflect an other than temporary impairment in the value of the stock we own. In 2007, we sold our entire investment in Facet for $99.5 million, resulting in a gain of $17.2 million.
Sunesis
In December 2002, we entered into a collaboration agreement with Sunesis Pharmaceuticals, Inc., or Sunesis, related to the discovery and development of oral therapeutics for the treatment of inflammatory and autoimmune diseases. In August 2004, we entered into a collaborative agreement with Sunesis to discover and develop small molecule cancer therapeutics targeting primarily kinases. Under the agreement, we acquired exclusive licenses to develop and commercialize certain compounds resulting from the collaboration. Upon signing the agreement, we paid Sunesis a non-refundable upfront license fee of $7.0 million, which was recorded in research and development expenses in 2004. During 2005, we recorded $1.0 million to research and development expense for milestones achieved through the collaboration with Sunesis, of which $0.5 million was paid to Sunesis in 2005. We have committed to paying Sunesis additional amounts upon the completion of certain future research milestones and first and second indication development milestones. If all the milestones were to be achieved based on our plan of research, we would be required to pay up to an additional $302.0 million to Sunesis, excluding royalties.
Under the terms of the agreements, we purchased approximately 4.2 million shares of preferred stock of Sunesis for $20.0 million and, in September 2005, we purchased $5.0 million of common stock of Sunesis as part of their initial public offering, or IPO. At the time of the IPO, our preferred stock was converted into shares of Sunesis common stock and, based on the IPO valuation, we wrote-down the value of our investment in Sunesis by $4.6 million as we had determined that the impairment was other than temporary. Following the IPO, we owned approximately 2.9 million shares, or 9.9% of the common stock. We recorded impairment charges of $4.9 million, $7.4 million and $7.2 million during 2008, 2007, and 2006, respectively, to reflect an other than temporary


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impairments in the value of the stock we own. We now hold a total of 2.9 million shares of Sunesis, representing 8% of total shares outstanding. Our investment in Sunesis is included in investments and other assets and has a fair value of $0.9 million at December 31, 2008.
Vernalis
In June 2004, we entered into a collaborative research and development agreement with Vernalis plc, or Vernalis, aimed at advancing research into Vernalis’ adenosine A2A receptor antagonist program, which targets Parkinson’s disease and other central nervous system disorders. Under the agreement, we received exclusive worldwide rights to develop and commercialize Vernalis’ lead compound, BIIB014, formerly V2006. We paid Vernalis an initial license fee of $10.0 million in July 2004, which was recorded in research and development expenses in 2004. Terms of the collaborative agreement may require us to make milestone payments upon the achievement of certain program objectives and pay royalties on future sales, if any, of commercial products resulting from the collaboration. In June 2004, we made an investment of $5.5 million through subscription for approximately 6.2 million new Vernalis common shares, representing 4.19% of Vernalis’ post-financing issued share capital, and committed to purchase an additional $4.0 million in the event of future Vernalis financing. In March 2005, we purchased approximately 1.4 million additional shares under a qualified offering for $1.8 million, which fully satisfies our investment obligation to Vernalis. We paid development milestones of $3.0 million in 2006. If all the milestones were to be achieved, we would be required to pay up to an additional $85.0 million, excluding royalties, over the remaining life of the agreement. We account for our investment in Vernalis using the cost method of accounting, subject to periodic review of impairment. In 2008 and 2007, we recorded an impairment charge of $0.5 million and $6.3 million, respectively, representing an other than temporary impairment in the stock we own. We now hold a total of approximately 7.6 million shares of Vernalis, representing 2% of total shares outstanding. Our investment in Vernalis is included in investments and other assets and has a fair value of $0.3 million at December 31, 2008.
MPM
In May 2006, we became a limited partner in MPM Bioventures IV- Strategic Fund, LP, a limited partnership that invests in entities that are engaged in the research, development, manufacture, marketingand/or sale of novel biological products or technologies. Due to our percentage of ownership, we account for our investment in this fund under the equity method of accounting. We have committed to contribute up to $10.0 million to the LP and made an initial contribution of $1.1 million to the LP. Through December 31, 2008, we have contributed $3.7 million into the LP, which is included in investments and other assets in our consolidated balance sheets.
In February 2006, we became a limited partner in MPM Bioventures IV-QP, LP, a limited partnership that invests in entities that are engaged in the research, development, manufacture, marketingand/or sale of novel biological products or technologies. Due to our percentage of ownership, we account for our investment in this fund under the cost method of accounting. We have committed to contribute up to $10.0 million to the LP and made an initial contribution of $1.0 million to the LP. Through December 31, 2008, we have contributed $5.2 million into the LP, which is included in investments and other assets in our consolidated balance sheets.
In May 2004, we entered into a limited partnership agreement as a limited partner with MPM Bioventures III GP, LP, to create MPM Bioventures Strategic Fund, LP, or the Strategic Fund. The purpose of the Strategic Fund is to make, manage, and supervise investments in biotechnology companies with novel products or technologies that fit strategically with Biogen Idec. Due to our percentage of ownership, we account for our investment in this fund under the equity method of accounting. The Strategic Fund takes only minority positions in the equity of its investments, and does not seek to engage inday-to-day management of the entities. In February 2006, we adjusted our commitment to the Strategic Fund to approximately $32.0 million over a three-year period. Through December 31, 2008, we contributed $25.4 million to the Strategic Fund.


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
In April 2004, we became a limited partner in MPM Bioventures III-QP, LP, a limited partnership that invests in entities that are engaged in the research, development, manufacture, marketingand/or sale of novel biological products or technologies. Due to our percentage of ownership, we account for our investment in this fund under the cost method of accounting. We have committed to contribute $4.0 million to the LP. Through December 31, 2008, we have contributed $3.9 million into the LP, which is included in investments and other assets in our consolidated balance sheets.
Vetter
In August 2003, Biogen, Inc. entered into a collaboration agreement with Vetter Pharma-Fertigung GmbH & Co. KG, or Vetter, for the fill-finish of our products, including liquid AVONEX and TYSABRI. As of December 31, 2007, we have made milestone payments to Vetter of 35.0 million euros in return for its reserving certain manufacturing capacity for us at its fill-finish facility. Under the terms of the agreement, these payments will reduce payments due on our future purchases of inventory from Vetter over a seven-year period, which commenced in 2007. During 2008 and 2007, we consumed approximately $6.5 million and $5.6 million, respectively, of this asset. Accordingly, as of December 31, 2008, we have recorded $8.4 million and $21.9 million of these payments in other current assets and in investments and other assets, respectively, in our consolidated balance sheets. The related portion of the asset will be reclassified to inventory when purchases from Vetter are made.
Schering
In June 1999, we entered into a collaboration and license agreement with Schering AG, aimed at the development and commercialization of ZEVALIN. Under the terms of the agreement, we may receive milestone and research and development support payments totaling up to $47.5 million, subject to the attainment of product development objectives. Schering AG received exclusive marketing and distribution rights to ZEVALIN outside the U.S., and we will continue to receive royalties on product sales by Schering AG. Under the terms of a separate supply agreement, we are obligated to meet Schering AG’s clinical and commercial requirements for ZEVALIN. Schering AG may terminate these agreements for any reason. Under the above agreement, amounts earned by us and recognized as revenue for contract research and development approximate the research and development expenses incurred under the related agreement. Although in December 2007, we sold our rights to market, sell, manufacture and develop ZEVALIN in the U.S., we still participate in this agreement and we are reimbursed by CTI for our costs incurred in fulfilling our obligation.
Targeted
We had previous agreements that have expired with Targeted Genetics Corporation, or Targeted, for gene therapy and research. We have no ongoing commitments with respect to Targeted. In connection with the expired agreements, however, we acquired shares of Targeted. In 2005, we recognized $9.2 million for impairments of our Targeted investment that was determined to beother-than-temporary. In 2006, we received one million shares of Targeted and $0.5 million in cash in exchange for forgiveness of $5.7 million of debt owed by Targeted to us. We recorded a gain of $3.4 million upon receipt of the shares and the cash payment. As a result of the transactions, as of December 31, 2006, we owned 19.9% of the outstanding shares of Targeted. We account for our investment in Targeted using the cost method. During 2008, we recorded an impairment charge of $2.9 million related to Targeted and at December 31, 2008, we held 2.2 million shares, representing 11% of the outstanding shares, with a fair market value of $0.5 million. This amount is included in investments and other assets on our consolidated balance sheet.
17.  Unconsolidated Joint Business Arrangement
We have a collaboration with Genentech Inc., or Genentech, that was created and operates by agreement rather than through a joint venture or other legal entity. Our rights under the terms of our amended and restated


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collaboration agreement with Genentech include co-exclusive rights to develop, commercialize and market RITUXAN in the United States and Canada with Genentech. Genentech has the exclusive right to develop, commercialize and market RITUXAN in the rest of the world. We have assigned our rights to develop, commercialize and market RITUXAN in Canada to F. Hoffman-La Roche Ltd., or Roche. Genentech shares a portion of the pretax U.S. co-promotion profits with us and Roche shares a portion of the pretax Canadian co-promotion profits of RITUXAN with us.
In the U.S., we contribute resources to selling and the continued development of RITUXAN. Genentech is responsible for worldwide manufacturing of RITUXAN. Genentech also is responsible for the primary support functions for the commercialization of RITUXAN in the U.S. including selling and marketing, customer service, order entry, distribution, shipping and billing. Genentech also incurs the majority of continuing development costs for RITUXAN. Under the arrangement, we have a limited sales force as well as limited development activity.
Under the terms of separate sublicense agreements between Genentech and Roche, Roche is responsible for commercialization of RITUXAN outside the U.S., except in Japan where RITUXAN isco-promoted by Zenyaku and Chugai. There is no direct contractual arrangement between us, Roche, Zenyaku or Chugai.
Revenues from unconsolidated joint business consists of (1) our share of pretax co-promotion profits in the U.S. and Canada and (2) royalty revenue from sales of RITUXAN outside the U.S. and Canada by Roche, Zenyaku and Chugai. Pre-tax co-promotion profits are calculated and paid to us by Genentech in the U.S. and by Roche in Canada. Pre-tax co-promotion profits consist of U.S. and Canadian sales of RITUXAN to third-party customers net of discounts and allowances less the cost to manufacture RITUXAN, third-party royalty expenses, distribution, selling, and marketing expenses, and joint development expenses incurred by Genentech, Roche and us.
Under the amended and restated collaboration agreement, our current pretax co-promotion profit-sharing formula, which resets annually, is as follows:
Co-promotion Operating Profits
Biogen Idec’s Share of Co-promotion Profits
First $50 million30%
Greater than $50 million40%
In 2008, 2007 and 2006, the 40% threshold was met during the first quarter. For each calendar year or portion thereof following the approval date of the first New Anti-CD20 Product, the pretax co-promotion profit-sharing formula for RITUXAN and New Anti-CD20 Products sold by us and Genentech will change to the following:
First New Anti-CD20 Product U.S.
Biogen Idec’s Share
Co-promotion Operating Profits
Gross Product Sales
of Co-promotion Profits
First $50 million(1)N/A30%
Greater than $50 millionUntil such sales exceed $150 million38%
in any calendaryear(2)
Or
After such sales exceed $150 million35%
in any calendar year and until such sales exceed $350 million in any calendaryear(3)
Or
After such sales exceed $350 million30%
in any calendaryear(4)


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(1)not applicable in the calendar year the first New Anti-CD20 Product is approved if $50 million in co-promotion operating profits has already been achieved in such calendar year through sales of RITUXAN.
(2)if we are recording our share of RITUXAN co-promotion profits at 40%, upon the approval date of the first New Anti-CD20 Product, our share of co-promotion profits for RITUXAN and the New Anti-CD20 Product will be immediately reduced to 38% following the approval date of the first New Anti-CD20 Product until the $150 million in first New Anti-CD20 Product sales level is achieved.
(3)if $150 million in first New Anti-CD20 Product sales is achieved in the same calendar year the first New Anti-CD20 Product receives approval, then the 35% co-promotion profit-sharing rate will not be effective until January 1 of the following calendar year. Once the $150 million in first New Anti-CD20 Product sales level is achieved then our share ofco-promotion profits for the balance of the year and all subsequent years’ (after the first $50 million in co-promotion operating profits in such years) will be 35% until the $350 million in first New Anti-CD20 Product sales level is achieved.
(4)if $350 million in new product sales is achieved in the same calendar year that $150 million in new product sales is achieved, then the 30% co-promotion profit-sharing rate will not be effective until January 1 of the following calendar year (or January 1 of the second following calendar year if the first New Anti-CD20 Product receives approval and, in the same calendar year, the $150 million and $350 million in first New Anti-CD20 Product sales levels are achieved). Once the $350 million in first New Anti-CD20 Product sales level is achieved then our share of co-promotion profits for the balance of the year and all subsequent years will be 30%.
Currently, we record our share of expenses incurred for the development of New Anti-CD20 Products in research and development expense until such time as a New Anti-CD20 Product is approved, at which time we will record our share of pretax co-promotion profits related to the New Anti-CD20 Product in revenues from unconsolidated joint business. We record our royalty and co-promotion profits revenue on sales of RITUXAN outside the U.S. on a cash basis. Under the amended and restated collaboration agreement, we will receive lower royalty revenue from Genentech on sales by Roche and Zenyaku of New Anti-CD20 Products, as compared to royalty revenue received on sales of RITUXAN. The royalty period with respect to all products is 11 years from the first commercial sale of such product on acountry-by-country basis.
The amended and restated collaboration agreement provides that, upon the occurrence of a Biogen Idecchange-in-control as described in the agreement, within 90 days of thatchange-in-control, Genentech may present an offer to us to purchase our rights to RITUXAN. We must then accept Genentech’s offer or purchase Genentech’s rights to RITUXAN for an amount proportioned (using the profit sharing ratio between us) to Genentech’s offer. If Genentech presents such an offer in such a situation, then Genentech will be deemed concurrently to have exercised a right, in exchange for a royalty on net sales in the U.S. of any New Anti-CD20 Products or Third Party Anti-CD20 Products developed under the agreement, to purchase our interest in each such product. As discussed in Note 19, Litigation, Genentech asserted for the first time in 2006 that the November 2003 transaction in which Idec acquired Biogen and became Biogen Idec was a change of control under the Collaboration Agreement. We strongly disagree that the Merger was a change of control, but if it was, our position is that Genentech’s rights under thechange-in-control provision in the Collaboration Agreement have long since expired.
Concurrent with the original collaboration agreement, we also entered into an expression technology license agreement with Genentech (for a proprietary gene expression technology developed by us) and a preferred stock purchase agreement providing for certain equity investments in us by Genentech (see Note 20, Shareholders’ Equity).
Under the terms of separate agreements with Genentech, commercialization of RITUXAN outside the U.S. is the responsibility of Roche, except in Japan where RITUXAN isco-promoted by Zenyaku and Chugai. We receive royalties from Genentech on sales by Roche, Zenyaku and Chugai of RITUXAN outside the U.S., and Canada. Revenue on sales of RITUXAN in Canada are received directly from Roche. Under our amended and restated collaborative agreement with Genentech, we will receive lower royalty revenue from Genentech on sales by Roche


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and Zenyaku of New Anti-CD20 Products and only for the first 11 years from the date of first commercial sale of such New Anti-CD20 Products.
Total revenues from unconsolidated joint business consist of the following (in millions):
             
  Year Ended December 31, 
  2008  2007  2006 
 
Co-promotion profits in the U.S.  $733.5  $616.8  $555.8 
Reimbursement of selling and development expenses in the U.S.   59.7   58.5   61.1 
Revenue on sales of RITUXAN outside the U.S.   335.0   250.8   194.0 
             
  $1,128.2  $926.1  $810.9 
             
Revenue on sales of RITUXAN outside the U.S. consists of our share ofco-promotion profits in Canada and royalty revenue on sales of RITUXAN outside the U.S. and Canada. The royalty period with respect to all products is 11 years from the first commercial sale of such product on a country by country basis. RITUXAN was launched in 1998 in most European countries and in 2001 in Japan. Therefore, we expect a significant decrease in royalty revenues on sales of RITUXAN outside the US beginning in the latter half of 2009. Specifically, the royalty period with respect to sales in France, Spain, Germany and the United Kingdom will expire in 2009. As a result, royalty revenue is expected to be in the range of $250.0 million to $290.0 million in 2009. The royalty period with respect to sales in Italy will expire in 2010. The royalty period with respect to sales in other countries will expire through 2012.
In 2008, under the terms of our collaboration agreement, we paid Genentech $31.5 million to participate in a license agreement with Roche for the development of a Third Party Anti-CD20 Product. This was recorded as research and development cost in our consolidated statement of operations as the product had no alternative future use. In addition, in 2008 we received $12.4 million from Genentech pursuant to Roche choosing to participate in a study of RITUXAN in primary-progressive multiple sclerosis. This was recorded as revenue from unconsolidated joint business in our consolidated statement of operations.
18.  Commitments and Contingencies
Leases
In November 2008, we entered into an agreement with a real estate developer for the construction and leasing of a 356,000 square foot office building in Weston, MA. The construction of the building is to commence in 2009, and the completion of the building is slated for 2010. The lease term is from 2010 through 2025, and we have options to extend the term of the lease through 2035. We will account for this lease as an operating lease.
We rent laboratory and office space and certain equipment under noncancellable operating leases. The rental expense under these leases, which terminate at various dates through 2015, amounted to $36.0 million in 2008, $33.1 million in 2007, and $26.2 million in 2006. The lease agreements contain various clauses for renewal at our option and, in certain cases, escalation clauses typically linked to rates of inflation.
At December 31, 2008, minimum rental commitments under noncancellable leases for each of the next five years and total thereafter were as follows (in millions)
                             
  2009  2010  2011  2012  2013  Thereafter  Total 
 
Minimum lease payments $36.4  $36.2  $33.2  $26.9  $27.1  $246.6  $406.4 
Income from subleases  5.0   2.2               7.2 
                             
Net minimum lease payments $31.4  $34.0  $33.2  $26.9  $27.1  $246.6  $399.2 
                             


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Construction Commitments
As of December 31, 2008, we have completed the first phase of construction of our large-scale biologic manufacturing facility in Hillerød, Denmark, which included partial completion of a bulk manufacturing component, a labeling and packaging component, and installation of major equipment. We are proceeding with the second phase of the project, including the completion of the large scale bulk manufacturing component and construction of a warehouse. As of December 31, 2008, we had contractual commitments of approximately $14.5 million for the second phase. This second phase of the project is expected to be ready for commercial production in 2010.
19.  Litigation
Along with several other major pharmaceutical and biotechnology companies, Biogen, Inc. (now Biogen Idec MA, Inc., one of our wholly-owned subsidiaries) or, in some cases, Biogen Idec Inc., was named as a defendant in lawsuits filed by the City of New York and numerous Counties of the State of New York. All of the cases — except for cases filed by the County of Erie, County of Oswego and County of Schenectady (the “Three County Actions”) — are the subject of a Consolidated Complaint (“Consolidated Complaint”), first filed on June 15, 2005 in the U.S. District Court for the District of Massachusetts in Multi-District Litigation No. 1456 (“the MDL proceedings”). The complaints allege that the defendants (i) fraudulently reported the Average Wholesale Price for certain drugs for which Medicaid provides reimbursement (“Covered Drugs”); (ii) marketed and promoted the sale of Covered Drugs to providers based on the providers’ ability to collect inflated payments from the government and Medicaid beneficiaries that exceeded payments possible for competing drugs; (iii) provided financing incentives to providers to over-prescribe Covered Drugs or to prescribe Covered Drugs in place of competing drugs; and (iv) overcharged Medicaid for illegally inflated Covered Drugs reimbursements. Among other things, the complaints allege violations of New York state law and advance common law claims for unfair trade practices, fraud, and unjust enrichment. In addition, the amended Consolidated Complaint alleges that the defendants failed to accurately report the “best price” on the Covered Drugs to the Secretary of Health and Human Services pursuant to rebate agreements, and excluded from their reporting certain discounts and other rebates that would have reduced the “best price.” With respect to the MDL proceedings, some of the plaintiffs’ claims were dismissed, and the parties, including Biogen Idec, began a mediation of the outstanding claims on July 1, 2008. We have not formed an opinion that an unfavorable outcome is either “probable” or “remote” in any of these cases, and do not express an opinion at this time as to their likely outcome or as to the magnitude or range of any potential loss. We believe that we have good and valid defenses to each of these complaints and are vigorously defending against them.
Along with several other major pharmaceutical and biotechnology companies, we were also named as a defendant in a lawsuit filed by the Attorney General of Arizona in the Superior Court of the State of Arizona and transferred to the MDL proceedings. The complaint, as amended on March 13, 2007, is brought on behalf of Arizona consumers and other payors for drugs, and alleges that the defendants violated the state consumer fraud statute by fraudulently reporting the Average Wholesale Price for certain drugs covered by various private and public insurance mechanisms and by marketing these drugs to providers based on the providers’ ability to collect inflated payments from third-party payors. Biogen Idec and other defendants have filed a motion to dismiss the complaint, which is pending. On December 26, 2007, Biogen Idec and other defendants agreed to a mediation, which is now underway. We have not formed an opinion that an unfavorable outcome is either “probable” or “remote,” and do not express an opinion at this time as to the likely outcome of the matter or as to the magnitude or range of any potential loss. We believe that we have good and valid defenses to the complaint and intend vigorously to defend the case.
On June 17, 2006, Biogen Idec filed a Demand for Arbitration against Genentech, Inc. with the American Arbitration Association (“AAA”), which Demand was amended on December 5, 2006 and on January 29, 2008. In the Demand, Biogen Idec alleged that Genentech breached the parties’ Amended and Restated Collaboration Agreement dated June 19, 2003 (the “Collaboration Agreement”), by failing to honor Biogen Idec’s contractual


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
right to participate in strategic decisions affecting the parties’ joint development and commercialization of certain pharmaceutical products, including humanized anti-CD20 antibodies. Genentech filed an Answering Statement in response to Biogen Idec’s Demand in which Genentech denied that it had breached the Collaboration Agreement and alleged that Biogen Idec had breached the Collaboration Agreement. In its Answering Statement, filed in 2006, Genentech also asserted for the first time that the November 2003 transaction in which Idec Pharmaceuticals acquired Biogen and became Biogen Idec was a change of control under the Collaboration Agreement, a position with which we disagree strongly. It is our position that the Biogen Idec merger did not constitute a change of control under the Collaboration Agreement and that, even if it did, Genentech’s rights under the change of control provision, which must be asserted within ninety (90) days of the change of control event, have long since expired. We intend to vigorously assert that position if Genentech persists in making this claim. The hearing has concluded and we anticipate a decision in mid-2009. We have not formed an opinion that an unfavorable outcome is either “probable” or “remote,” and do not express an opinion at this time as to the likely outcome of the matter or as to the magnitude or range of any potential loss. We believe that we have good and valid defenses to Genentech’s allegations in the arbitration and intend vigorously to defend against these allegations.
On September 12, 2006, the Massachusetts Department of Revenue (“DOR”) issued a notice of assessment against Biogen Idec MA, Inc. for $38.9 million of corporate excise tax for 2002, which includes associated interest and penalties. On December 6, 2006, we filed an abatement application with the DOR, seeking abatements for2001-2003. The abatement application was denied on July 24, 2007. On July 25, 2007, we filed a petition with the Massachusetts Appellate Tax Board, seeking abatements of corporate excise tax for2001-2003 and adjustments in certain credits and credit carryforwards for2001-2003. Issues before the Board include the computation of Biogen Idec MA’s sales factor for2001-2003, computation of Biogen Idec MA’s research credits for those same years, and the availability of deductions for certain expenses and partnership flow-through items. We intend to contest this matter vigorously. We believe that the assessment does not impact the level of liabilities for income tax contingencies.
On October 4, 2004, Genentech, Inc. received a subpoena from the U.S. Department of Justice requesting documents related to the promotion of RITUXAN. We market RITUXAN in the U.S. in collaboration with Genentech. Genentech has disclosed that it is cooperating with the associated investigation, and that it has been advised the investigation is both civil and criminal in nature. We are cooperating with the U.S. Department of Justice in its investigation of Genentech. The potential outcome of this matter and its impact on us cannot be determined at this time.
On August 10, 2004, Classen Immunotherapies, Inc. filed suit against us, GlaxoSmithKline, Chiron Corporation, Merck & Co., Inc., and Kaiser-Permanente, Inc. in the U.S. District Court for the District of Maryland contending that we induced infringement of U.S. Patent Nos, 6,420,139, 6,638,739, 5,728,383, and 5,723,283, all of which are directed to various methods of immunization or determination of immunization schedules. All counts asserted against us by Classen were dismissed by the District Court, and the judgment in our favor was affirmed by the U.S. Court of Appeals for the Federal Circuit on December 19, 2008. The plaintiff has filed a petition for rehearing en banc, which is pending. We have not formed an opinion that an unfavorable outcome is either “probable” or “remote,” and do not express an opinion at this time as to the likely outcome of the matter or as to the magnitude or range of any potential loss. We believe that we have good and valid defenses to the plaintiff’s allegations and intend to continue to vigorously defend against these allegations.
In January 2008, the European Commission (“EC”) began an industry-wide antitrust inquiry into competitive conditions within the pharmaceutical sector. As part of the inquiry, the EC requested information from approximately 100 companies, including Biogen Idec. The EC published a preliminary report in November 2008 and has announced that it expects to publish a final report in the spring of 2009. The potential outcome of this matter and its impact on us cannot be determined at this time.


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
On October 27, 2008, Sanofi-Aventis Deutschland GmbH (“Sanofi”) filed suit against Genentech and Biogen Idec in federal court in Texas (E.D. Tex.) claiming that Rituxan and certain other Genentech products infringe U.S. Patents 5,849,522 (the “ ‘522 patent”) and 6,218,140 (the ‘‘‘140 patent”). Sanofi seeks preliminary and permanent injunctions, compensatory and exemplary damages, and other relief. On October 27, 2008, Genentech and Biogen Idec filed a complaint against Sanofi, Sanofi-Aventis U.S. LLC, and Sanofi-Aventis U.S. Inc. in federal court in California (N.D. Cal.) seeking a declaratory judgment that Rituxan and other Genentech products do not infringe the ‘522 patent or the ‘140 patent, and a declaratory judgment that those patents are invalid. In addition, on October 24, 2008, Hoechst GmbH filed with the ICC International Court of Arbitration (Paris) a request for arbitration against Genentech, relating to a terminated agreement between Hoechst’s predecessor and Genentech that pertained to the above-referenced patents and related patents outside the U.S. Hoechst is seeking payment of royalties on sales of Genentech products, damages for breach of contract, and other relief. We have not formed an opinion that an unfavorable outcome is either “probable” or “remote,” and do not express an opinion at this time as to the likely outcome of the matters or as to the magnitude or range of any potential loss. We believe that we have good and valid defenses and intend vigorously to defend against the allegations against us.
In addition, we are involved in product liability claims and other legal proceedings generally incidental to our normal business activities. While the outcome of any of these proceedings cannot be accurately predicted, we do not believe the ultimate resolution of any of these existing matters would have a material adverse effect on our business or financial conditions.
20.  Shareholders’ Equity
Preferred Stock
Preferred stock was comprised of the following (in thousands):
                         
  December 31, 2008  December 31, 2007 
  Authorized  Issued  Outstanding  Authorized  Issued  Outstanding 
 
Series A Preferred Stock  1,750   8   8   1,750   8   8 
Series X Junior Participating Preferred Stock  1,000         1,000       
Undesignated  5,250         5,250       
                         
   8,000   8   8   8,000   8   8 
                         
We have 8,000,000 shares of Preferred Stock authorized, of which 1,750,000 shares have been designated as Series A Preferred Stock and 1,000,000 shares have been designated as Series X Junior Participating Preferred Stock. The balance may be issued without a vote or action of stockholders from time to time in classes or series with the designations, powers, preferences, and the relative, participating, optional or other special rights of the shares of each such class or series and any qualifications, limitations or restrictions thereon as set forth in the stock certificate. Any such Preferred Stock may rank prior to common stock as to dividend rights, liquidation preference or both, and may have full or limited voting rights and may be convertible into shares of common stock. As of December 31, 2008 and 2007, there were 8,221 shares of Series A Preferred Stock issued and outstanding. These shares carry a liquidation preference of $67 and are convertible into 60 shares of common stock per share of Preferred Stock. No other shares of Preferred Stock are issued and outstanding as of December 31, 2008 and 2007.
Stockholder Rights Plan
 
In January 2009, our Board of Directors voted to terminate our stockholders rights plan effective as of January 30, 2009. The plan was scheduled to expire on July 26, 2011 and was originally adopted by the Board of Directors in 1997. Under the rights plan, each share of our common stock had one “right” attached to it that entitled


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
the holder to purchase our Series X Junior Participating Preferred Stock under the circumstances specified in the rights plan. As a result of our Board of Director’s action, no rights are outstanding or exercisable.
 
Stock Repurchase Programs
 
In October 2004,2009, our Board of Directors authorized the repurchase of up to $1.0 billion of our common stock with repurchased shares being retired. This repurchase program does not have an expiration date. As of December 31, 2009, approximately 8.8 million shares at a cost of $422.4 million were repurchased under this


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
authorization, all of which were retired. From January 1, 2010 through February 5, 2010, we repurchased approximately an additional 5.4 million shares under this program at a total cost of approximately $289.4 million, all of which were also retired. Approximately $288.2 million remains available for the repurchase of our common stock under the 2009 program.
In October 2006, our Board of Directors authorized the repurchase of up to 20.0 million shares of our common stock. TheAs of December 31, 2009, all shares under this program have been repurchased stock will provide us with treasury shares for general corporate purposes, such as common stock to be issued under our employee equity and stock purchase plans. This repurchase program expired October 4, 2006. During 2006, we repurchased 7.5 million shares at a cost of $320.3 million. During 2005, we repurchased 7.5 million shares at a cost of $324.3 million.
In October 2006, our Board of Directors authorized the repurchase of up to an additional 20.0approximately 7.2 million shares of our common stock. Thestock were repurchased stock will provide us with treasury sharesin 2009 for general corporate purposes, such as common stock to be issued under our employee equity and stock purchase plans. This repurchase program does not have an expiration date. We repurchasedapproximately $328.8 million. In 2008, approximately 12.8 million shares of our common stock for $738.9 million under the share repurchase program as of December 31, 2008. Subsequent to December 31, 2008, wewere repurchased an additional 1.2 million shares for a cost of $57.6 million and have approximately 6.0 million shares remaining available for repurchase under this program.program for approximately $738.9 million.
 
ReclassificationReclassifications
The adoption of a newly issued accounting standard for noncontrolling interests on January 1, 2009, changed the accounting and reporting for our minority interests by recharacterizing them as noncontrolling interests and classifying them as a separate component of total shareholders’ equity in our accompanying consolidated balance sheets and consolidated statements of shareholders’ equity. Additionally, net income attributable to noncontrolling interest is now shown separately from net income in the consolidated statements of income. As a result, prior year amounts related to noncontrolling interest have been reclassified to conform to the current year presentation. This reclassification had no effect on our previously reported financial position or results of operations.
 
In the year ended December 31, 2008, we reclassified amounts within theour consolidated statement of shareholder’sshareholders’ equity, resulting in an approximately $78.6 million correction in Additional Paid-in Capital and Retained Earnings (Accumulated Deficit) balances in connection with the re-issuance of treasury stock at a loss.
In the year ended December 31, 2007 we reclassified amounts within theour consolidated statements of stockholders equity, resulting in an approximately $48.0 million correction in the treasury stock and common stock balances.
 
21.11.  Tender OfferEarnings per Share
 
On June 27, 2007, pursuant toBasic and diluted earnings per share are calculated as follows:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Numerator:            
Net income attributable to Biogen Idec Inc.  $970.1  $783.2  $638.2 
Adjustment for net income allocable to preferred shares  (1.7)  (1.3)  (1.0)
             
Net income used in calculating basic and diluted earnings per share $968.4  $781.9  $637.2 
             
Denominator:            
Weighted average number of common shares outstanding  287.4   292.3   315.8 
Effect of dilutive securities:            
Stock options and employee stock purchase plan  0.6   1.3   2.6 
Restricted stock awards     0.1   0.5 
Time-vested restricted stock units  1.4   1.3   1.1 
Performance-vested restricted stock units  0.1       
Convertible promissory notes due 2019        0.2 
Convertible promissory notes due 2032         
             
Dilutive potential common shares  2.1   2.7   4.4 
             
Shares used in calculating diluted earnings per share  289.5   295.0   320.2 
             


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The following amounts were not included in the termscalculation of net income per basic and diluted share because their effects were anti-dilutive:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Numerator:            
Net income allocable to preferred stock $1.7  $ 1.3  $ 1.0 
             
Denominator:            
Stock options  8.5   6.9   8.2 
Time-vested restricted stock units  2.1   1.5   0.1 
Performance-vested restricted stock units  0.2       
Convertible preferred stock  0.5   0.5   0.5 
             
Total  11.3   8.9   8.8 
             
Earnings per share for the year ended December 31, 2009 reflects, on a tender offer, we accepted for payment 56,424,155weighted average basis, the repurchase of 16.0 million shares of our common stock under our 2009 and 2006 share repurchase programs.
As a result of our 2007 tender offer, earnings per share for the year ended December 31, 2007 reflects, on a weighted average basis, the repurchase of 56.4 million shares as of June 27, 2007, the date the obligation was incurred, in accordance with accounting standards for earning per share.
12.  Share-based Payments
Share-based Compensation Expense
The following table summarizes share-based compensation expense included within our consolidated statements of income:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Research and development $60.8  $59.9  $51.7 
Selling, general and administrative  106.4   93.8   76.1 
             
Subtotal $167.2  $153.7  $127.8 
Capitalized share-based compensation costs  (6.3)  (7.5)  (4.7)
             
Share-based compensation expense included in total costs and expenses $160.9  $146.2  $123.1 
Income tax effect  (49.4)  (45.4)  (37.5)
             
Share-based compensation expense included in net income attributable to Biogen Idec Inc.  $111.5  $100.8  $85.6 
             


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Our share-based compensation programs include stock options, time-vested restricted stock units, performance-vested restricted stock units, restricted stock and shares issued under our ESPP. The following table summarizes share-based compensation expense associated with each of these programs:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Stock options $21.6  $20.0  $30.7 
Time-vested restricted stock units  133.7   125.6   75.2 
Performance-vested restricted stock units  4.6   1.1   5.0 
Restricted stock awards     0.5   11.7 
Employee stock purchase plan  7.3   6.5   5.2 
             
Subtotal $167.2  $153.7  $127.8 
Capitalized share-based compensation costs  (6.3)  (7.5)  (4.7)
             
Share-based compensation expense included in total costs and expenses $160.9  $146.2  $123.1 
             
Windfall tax benefits from vesting of stock awards, exercises of stock options and ESPP participation were $3.4 million, $28.0 million, and $69.7 million in 2009, 2008, and 2007, respectively. These amounts have been calculated under the alternative transition method in accordance with U.S. GAAP.
As of December 31, 2009, unrecognized compensation cost related to unvested share-based compensation was approximately $178.1 million, net of estimated forfeitures. We expect to recognize the cost of these unvested awards over a weighted-average period of 1.4 years.
Share-based Compensation Plans
We have three share-based compensation plans pursuant to which awards are currently being made: (1) the Biogen Idec Inc. 2006 Non-Employee Directors Equity Plan (2006 Directors Plan); (2) the Biogen Idec Inc. 2008 Omnibus Equity Plan (2008 Omnibus Plan); and (3) the Biogen Idec Inc. 1995 Employee Stock Purchase Plan (ESPP). We have six share-based compensation plans pursuant to which outstanding awards have been made, but from which no further awards can or will be made: (i) the IDEC Pharmaceuticals Corporation 1993 Non-Employee Directors Stock Option Plan; (ii) the IDEC Pharmaceuticals Corporation 1988 Stock Option Plan; (iii) the Biogen, Inc. 1985 Non-Qualified Stock Option Plan; (iv) the Biogen, Inc. 1987 Scientific Board Stock Option Plan; (v) the Biogen Idec Inc. 2003 Omnibus Equity Plan (2003 Omnibus Plan); and (vi) the Biogen Idec Inc. 2005 Omnibus Equity Plan (2005 Omnibus Plan). We have not made any awards pursuant to the 2005 Omnibus Plan since our stockholders approved the 2008 Omnibus Plan and do not intend to make any awards pursuant to the 2005 Omnibus Plan in the future, except that unused shares under the 2005 Omnibus Plan have been carried over for use under the 2008 Omnibus Plan.
Directors Plan
In May 2006, our stockholders approved the 2006 Directors Plan for share-based awards to our directors. Awards granted from the 2006 Directors Plan may include options, shares of restricted stock awards, restricted stock units, stock appreciation rights and other awards in such amounts and with such terms and conditions as may be determined by a committee of our Board of Directors, subject to the provisions of the plan. We have reserved a total of 850,000 shares of common stock for issuance under the 2006 Directors Plan. The 2006 Directors Plan provides that awards other than stock options and stock appreciation rights will be counted against the total number of shares reserved under the plan in a 1.5-to-1 ratio.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Omnibus Plans
In June 2008, our stockholders approved the 2008 Omnibus Plan for share-based awards to our employees. Awards granted from the 2008 Omnibus Plan may include options, shares of restricted stock awards, restricted stock units, performance shares, shares of phantom stock, stock appreciation rights and other awards in such amounts and with such terms and conditions as may be determined by a committee of our Board of Directors, subject to the provisions of the plan. Shares of common stock available for issuance under the 2008 Omnibus Plan consist of 15.0 million shares reserved for this purpose, plus shares of common stock that remained available for issuance under the 2005 Omnibus Plan on the date that our stockholders approved the 2008 Omnibus Plan, plus shares that are subject to awards under the 2005 Omnibus Plan which remain unissued upon the cancellation, surrender, exchange or termination of such awards. The 2008 Omnibus Equity Plan provides that awards other than stock options and stock appreciation rights will be counted against the total number of shares available under the plan in a 1.5-to-1 ratio.
Stock Options
All stock option grants to employees are for a ten-year term and generally vest one-fourth per year over four years on the anniversary of the date of grant, provided the employee remains continuously employed with us. Stock option grants to directors are for ten-year terms and generally vest as follows: (1) grants made on the date of a director’s initial election to our Board of Directors vest one-third per year over three years on the anniversary of the date of grant, and (2) grants made for service on our Board of Directors vest on the first anniversary of the date of grant, provided in each case that the director continues to serve on our Board of Directors through the vesting date. Options granted under all plans are exercisable at a price of $53.00 per share not less than the fair market value of the underlying common stock on the date of grant. The estimated fair value of options, including the effect of estimated forfeitures, is recognized over the options’ vesting periods. The fair value of the stock option grants awarded in 2009, 2008, and 2007 was estimated as of the date of grant using a Black-Scholes option valuation model that uses the following weighted-average assumptions:
             
  For the Years Ended December 31, 
  2009  2008  2007 
 
Expected option life (in years)  4.7   5.1   4.9 
Expected stock price volatility  39.3%  34.4%  33.6%
Risk-free interest rate  1.9%  2.4%  4.4%
Expected dividend yield  0.0%  0.0%  0.0%
Per share grant-date fair value $18.00  $20.85  $18.78 
The expected life of options granted is derived using assumed exercise rates based on historical exercise patterns and represents the period of time that options granted are expected to be outstanding. Expected stock price volatility is based upon implied volatility for our exchange-traded options and other factors, including historical volatility. After assessing all available information on either historical volatility, implied volatility, or both, we have concluded that a combination of both historical and implied volatility provides the best estimate of expected volatility. The risk-free interest rate used is determined by the market yield curve based upon risk-free interest rates established by the Federal Reserve, or non-coupon bonds that have maturities equal to the expected term. The dividend yield of zero is based upon the fact that we have not historically granted cash dividends, and do not expect to issue dividends in the foreseeable future. Stock options granted prior to January 1, 2006 were valued based on the grant date fair value of those awards, using the Black-Scholes option pricing model, as previously calculated for pro-forma disclosures.


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
A summary of stock option activity is presented in the following table:
         
     Weighted
 
     Average
 
     Exercise
 
(In thousands, except weighted average exercise price) Shares  Price 
 
Outstanding at December 31, 2006  25,106  $47.96 
         
Granted  1,470  $51.23 
Exercised  (10,524) $44.84 
Cancelled  (1,152) $53.97 
         
Outstanding at December 31, 2007  14,900  $50.03 
         
Granted  1,475  $60.23 
Exercised  (3,769) $41.99 
Cancelled  (506) $55.70 
         
Outstanding at December 31, 2008  12,100  $53.53 
         
Granted  1,031  $49.96 
Exercised  (637) $40.16 
Cancelled  (1,664) $60.74 
         
Outstanding at December 31, 2009  10,830  $52.88 
         
Of the options outstanding, 8.3 million were exercisable as of December 31, 2009. The exercisable options had a weighted-average exercise price of $52.80. The aggregate intrinsic value of options exercisable as of December 31, 2009 was $45.2 million. The weighted average remaining contractual term for options exercisable as of December 31, 2009 was 3.8 years.
A total of 10.3 million vested and expected to vest options were outstanding as of December 31, 2009. These vested and expected to vest options had a weighted average exercise price of $52.87 and an aggregated intrinsic value of $51.0 million. The weighted average remaining contractual term of vested and expected to vest options as of December 31, 2009 was 4.6 years.
The total intrinsic values of options exercised in 2009, 2008, and 2007, were $6.7 million, $85.1 million, and $226.7 million, respectively. The aggregate intrinsic values of options outstanding as of December 31, 2009 was $52.8 million. The weighted average remaining contractual term for options outstanding as of December 31, 2009 was 4.8 years.
A summary of the amount of tax benefit realized for stock options and cash received from the exercise of stock options is as follows:
             
  For the Years Ended December 31,
(In millions) 2009 2008 2007
 
Tax benefit realized for stock options $1.5  $28.0  $72.4 
Cash received from the exercise of stock options $25.2  $158.3  $471.0 


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Time-Vested Restricted Stock Units
Time-vested restricted stock units (RSUs) awarded to employees generally vest no sooner than one-third per year over three years on the anniversary of the date of grant, or upon the third anniversary of the date of the grant, provided the employee remains continuously employed with us, except as otherwise provided in the plan. Shares of our common stock will be delivered to the employee upon vesting, subject to payment of applicable withholding taxes. RSUs awarded to directors for service on our Board of Directors vest on the first anniversary of the date of grant, provided in each case that the director continues to serve on our Board of Directors through the vesting date. Shares of our common stock will be delivered to the director upon vesting and are not subject to any withholding taxes. The fair value of all RSUs is based on the market value of our stock on the date of grant. Compensation expense, including the effect of forfeitures, is recognized over the applicable service period.
A summary of RSU activity is presented in the following table:
         
     Weighted
 
     Average
 
     Grant Date
 
(In thousands, except weighted average grant date fair value) Shares  Fair Value 
 
Unvested at December 31, 2006  2,508  $44.48 
         
Granted  3,387  $51.19 
Vested  (845) $44.58 
Forfeited  (458) $47.38 
         
Unvested at December 31, 2007  4,592  $49.12 
         
Granted  3,129  $58.42 
Vested  (1,645) $47.93 
Forfeited  (499) $53.95 
         
Unvested at December 31, 2008  5,577  $54.26 
         
Granted  2,674  $48.93 
Vested  (2,421) $52.08 
Forfeited  (445) $53.02 
         
Unvested at December 31, 2009  5,385  $52.72 
         


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Performance-Vested Restricted Stock Units
A summary of performance-vested restricted stock units (PVRSUs) activity is presented in the following table:
         
     Weighted
 
     Average
 
     Grant Date
 
(In thousands, except weighted average grant date fair value) Shares  Fair Value 
 
Unvested at December 31, 2006  411  $41.62 
         
Granted  120  $51.55 
Vested  (357) $41.76 
Forfeited  (54) $40.67 
         
Unvested at December 31, 2007  120  $51.55 
         
Granted    $ 
Vested  (27) $49.33 
Forfeited  (3) $49.33 
         
Unvested at December 31, 2008  90  $52.29 
         
Granted  325  $49.42 
Vested  (30) $52.29 
Forfeited  (97) $51.30 
         
Unvested at December 31, 2009  288  $49.39 
         
2009 Grant Activity
We apply a graded vesting expense methodology when accounting for the PVRSUs issued in 2009. In 2009, approximately 325,000 PVRSUs were granted with a weighted average grant date fair value of $49.42 per share.
The number of PVRSUs reflected as granted represents the target number of shares that are eligible to vest in full or in part and are earned subject to the attainment of certain performance criteria established at the beginning of the performance period, which ended December 31, 2009. Participants may ultimately earn up to 200% of the target number of shares granted in the event that the maximum performance thresholds are attained. Accordingly, additional PVRSUs may be issued upon final determination of the number of awards earned.
Once the earned number of performance-vested awards has been determined, the earned PVRSUs will then vest in three equal increments on (1) the later of the first anniversary of the grant date or the date of results determination; (2) the second anniversary of the grant date; and (3) the third anniversary of the grant date. The vesting of these awards is also subject to the respective employees’ continued employment. Compensation expense associated with these PVRSUs is initially based upon the number of shares expected to vest after assessing the probability that certain performance criteria will be met and the associated targeted payout level that is forecasted will be achieved, net of estimated forfeitures. Cumulative adjustments are recorded quarterly to reflect subsequent changes in the estimated outcome of performance-related conditions until the date results are determined.
2007 Grant Activity
In 2007, our Board of Directors awarded a total of 120,000 PVRSUs to Dr. Cecil Pickett, our former President, Research and Development. Vesting of these PVRSUs was subject to certain performance criteria established at the beginning of each of four performance periods, beginning January 1 on each of 2007, 2008, 2009 and 2010, and Dr. Pickett’s continued employment through the end of the respective performance periods. In February 2008, a total of 27,000 shares were issued based upon the attainment of performance criteria set for 2007. An additional


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
30,000 shares were issued in February 2009 based on the attainment of performance criteria set for 2008. No additional shares were issued to Dr. Pickett in 2009, 2008 and 2007. Dr. Pickett retired from the position of President, Research and Development effective October 5, 2009. Accordingly, no additional PVRSUs awarded to Dr. Pickett will vest or be issued. Expense previously recognized in relation to unvested awards was reversed in 2009.
Prior Period Grant Activity
In the first quarter of 2006, our Board of Directors awarded 100,000 PVRSUs to our CEO, under the 2005 Omnibus Plan, subject to certain 2006 financial performance criteria. In February 2007, our Board of Directors determined that the performance criteria had been attained and that 100,000 PVRSUs would convert into shares of our common stock. A total of 58,250 shares were issued, reflecting the fact that certain shares were withheld for income tax purposes.
In the third quarter of 2005, we granted 1.2 million PVRSUs, to be settled in shares of our common stock, to a group of approximately 200 senior employees excluding our CEO. On September 14, 2006, 758,262 shares vested for which 510,859 shares were issued, reflecting the fact that certain shares were withheld for income tax purposes. On March 14, 2007, 258,387 shares vested based on the level of performance versus the pre-established goals, for which a total of 172,054 shares were issued, reflecting the fact that certain shares were withheld for income tax purposes. No other shares vested in relation to this 2005 grant.
Restricted Stock Awards
In 2005, we awarded restricted common stock to our employees under the 2005 Omnibus Plan and the 2003 Omnibus Plan. The restricted stock awards (RSAs) granted under the 2003 Omnibus Plan vested in full on the third anniversary of the date of grant for employees that remained continuously employed with us through the vesting dates. The RSAs granted under the 2005 Omnibus Plan vested at a rate of approximately one-third per year over three years on the anniversary of the date of grant for employees that remained continuously employed with us through the vesting dates.
The fair value of all time-vested RSAs is based on the market value of our stock on the date of grant. Compensation expense, including the effect of forfeitures, is recognized over the applicable service period. All awards of restricted stock were fully vested as of December 31, 2008.
A summary of RSA activity is presented in the following table:
         
     Weighted
 
     Average
 
     Grant Date
 
(In thousands, except weighted average grant date fair value) Shares  Fair Value 
 
Unvested at December 31, 2006  1,247  $53.64 
         
Granted    $ 
Vested  (713) $44.10 
Forfeited  (79) $59.64 
         
Unvested at December 31, 2007  455  $67.54 
         
Granted    $ 
Vested  (454) $67.54 
         
Forfeited  (1) $67.57 
         
Unvested at December 31, 2008    $ 
         


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
ESPP
The purchase price of $2,990.5 million. Ascommon stock under the obligationESPP is equal to 85% of $2,990.5 million was incurredthe lower of (1) the market value per share of the common stock on June 27, 2007 and fundedthe participant’s entry date into an offering period or (2) the market value per share of the common stock on July 2, 2007, pursuant to Statementthe purchase date. However, for each participant whose entry date is other than the start date of Financial Accounting Standards No. 150,Accounting for Certain Financial Instruments with Characteristicsthe offering period, the amount shall in no event be less than the market value per share of both Liabilities and Equity, or SFAS 150, we recorded the presentcommon stock as of the beginning of the related offering period. The fair value of the obligation of $2,988.2 million on June 27, 2007, anddiscounted purchases made under the $2.3 million difference betweenemployee stock purchase plan are calculated using the presentBlack-Scholes model. The fair value of the obligation and funded amount waslook-back provision plus the 15% discount is recognized as interest expense.compensation expense over the purchase period. We fundedapply a graded vesting approach since our ESPP provides for multiple purchase periods and is, in substance, a series of linked awards.
The table below provides a summary of shares issued under our ESPP for 2009, 2008 and 2007, respectively:
             
  For The Years Ended December 31,
(In millions) 2009 2008 2007
 
Shares issued under ESPP  0.6   0.5   0.5 
Cash received under ESPP $22.6  $21.3  $18.2 
13.  Accumulated Other Comprehensive Income (Loss)
Accumulated other comprehensive income (loss) consisted of the tender offer through existing cash and cash equivalentsfollowing:
         
  As of December 31, 
(In millions) 2009  2008 
 
Translation adjustments $35.6  $17.0 
Unrealized gains on securites available for sale  11.3   10.5 
Unrealized gains (losses) on foreign currency forward contracts  1.5   (40.2)
Unfunded status of pension and postretirement benefit plans  2.1   1.6 
         
Accumulated other comprehensive income (loss) $50.5  $(11.1)
         
Unrealized holding gains on securities available for sale is shown net of $1,490.5tax of $(6.6) million and $1,500.0$(6.2) million borrowed underas of December 31, 2009 and 2008, respectively. Unrealized gains (losses) on foreign currency forward contracts is shown net of tax of $0.3 million, and $3.9 million as of December 31, 2009 and 2008, respectively. The unfunded status of pension and retirement benefit plans is shown net of tax as of December 31, 2009 and 2008. Tax amounts in both years were immaterial. See Note 15,Employee Benefit Plansto our short-term loan facilityConsolidated Financial Statements for discussion of unfunded status of pension and retirement benefit plans.
Amounts comprising noncontrolling interests, as describedreported in Note 8, Indebtedness. We retired allour consolidated statements of these sharesequity as of December 31, 2009 and 2008 included accumulated translation adjustments of $2.4 million and $1.2 million, respectively.
Comprehensive income (loss) and its components are presented in July 2007. In connection with this retirement, in accordance with our policy, we recorded an approximately $2,991 million reduction in treasury stock and additionalpaid-in-capital.the consolidated statements of shareholders’ equity.


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BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
 
22.14.  Other Consolidated Financial Statement Detail
Other Income (Expense), Net
Components of other income (expense), net, are summarized as follows:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Interest income $48.5  $72.1  $103.6 
Interest expense  (35.8)  (52.0)  (40.5)
Impairment on investments  (10.6)  (60.3)  (24.4)
Gain (loss) on sales of investments, net  22.8   (1.1)  16.7 
Foreign exchange gains (losses), net  11.4   (9.8)  3.0 
Gain on the sale of property        7.1 
Other, net  1.0   (6.6)  6.9 
             
Other income (expense), net $37.3  $(57.7) $72.4 
             
Interest Expense
In 2009, we incurred interest costs of $69.7 million. This amount was reduced by $28.5 million because we capitalized interest related to the construction of our large scale manufacturing facility in Hillerød, Denmark. In addition, in 2009, approximately $5.4 million was recorded as a reduction due to the amortization of the deferred gain associated with the termination of an interest rate swap in December 2008.
In 2008, we incurred interest costs of $66.3 million. This amount was reduced by $23.2 million of capitalized interest on the manufacturing facility in Hillerød, Denmark. In addition, we incurred approximately $8.9 million of expenses related to hedge ineffectiveness on interest rate swaps executed in March 2008.
In 2007, we incurred interest costs of $50.6 million, which were reduced by $10.1 million of capitalized interest on the manufacturing facility in Hillerød, Denmark.
Impairment on Investments
In April 2009, we implemented newly issued accounting standards which provided guidance for recognition and presentation ofother-than-temporary impairments. The adoption of the guidance did not have a material impact on our financial position or results of operations; however, this standard amended theother-than-temporary impairment model for marketable debt securities. The impairment model for equity securities was not affected. Refer to Note 7,Financial Instruments to our Consolidated Financial Statements for additional information on the adoption of this guidance.
In 2009, we recognized impairment losses of $7.0 million on our strategic investments and non-marketable securities. In addition, during 2008 and 2007, we recognized $18.6 million and $18.4 million, respectively, in charges for the impairment of strategic investments and non-marketable securities that were determined to beother-than-temporary.
In 2009, we recognized $3.6 million in charges for theother-than-temporary impairment on marketable debt securities. For 2008 and 2007, we recognized $41.7 million and $7.5 million, respectively, in charges for theother-than-temporary impairment of marketable debt securities primarily related to mortgage and asset-backed securities.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Reclassification
The adoption of a new issued accounting standard for noncontrolling interests on January 1, 2009, changed the accounting and reporting for our minority interests by recharacterizing them as noncontrolling interest. Prior year amounts related to noncontrolling interest, historically reflected as a component of other income (expense), net, have been reclassified to conform to current year presentation. Amounts previously reported as minority interest are now shown separately from net income in the accompanying consolidated statements of income and total $6.9 million, $6.9 million, and $(58.4) million for the years ended December 31, 2009, 2008 and 2007, respectively. This reclassification had no effect on our previously reported financial position or results of operations. Refer to Note 10,Shareholders’ Equityto our Consolidated Financial Statements for additional information on the adoption of this guidance.
Other Current Assets
Other current assets consist of the following:
         
  As of December 31, 
(In millions) 2009  2008 
 
Deferred tax assets $88.8  $70.8 
Receivable from collaborations  5.3   1.7 
Prepaid expenses  52.6   46.4 
Interest receivable  10.6   11.8 
Other  20.6   8.7 
         
Other current assets $177.9  $139.4 
         
Property, Plant and Equipment, net
Property, plant and equipment are recorded at historical cost, net of accumulated depreciation. Components of property, plant and equipment, net are summarized as follows:
         
  As of December 31, 
(In millions) 2009  2008 
 
Land $111.2  $108.8 
Buildings  669.7   676.1 
Leasehold improvements  73.1   80.1 
Furniture and fixtures  50.7   48.1 
Machinery and equipment  868.2   798.5 
Construction in progress  506.7   420.2 
         
Total cost $2,279.6  $2,131.8 
         
Less: accumulated depreciation  (642.5)  (537.0)
         
Property, plant and equipment, net $1,637.1  $1,594.8 
         
In 2009, 2008, and 2007, we capitalized to construction in progress approximately $28.4 million, $23.2 million and $10.1 million, respectively, of interest costs primarily related to the development of our large-scale biologic manufacturing facility in Hillerød, Denmark.
As of December 31, 2009 and 2008, the construction in progress balance related to the construction of our large-scale biologic manufacturing facility in Hillerød, Denmark totaled $441.2 million and $388.4 million, respectively.


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Depreciation expense is summarized as follows:
             
  For the Years Ended December 31,
(In millions) 2009 2008 2007
 
Depreciation expense $137.9  $129.1  $122.6 
Accrued Expenses and Other
Accrued expenses and other consists of the following:
         
  As of December 31, 
(In millions) 2009  2008 
 
Employee compensation and benefits $123.7  $156.0 
Royalties and licensing fees  41.8   40.6 
Collaboration expenses  35.7   29.6 
Clinical development expenses  43.2   41.5 
Revenue-related rebates  52.0   37.7 
Construction in progress accrual  12.8   18.6 
Other  191.6   210.9 
         
Accrued expenses and other $500.8  $534.9 
         
Gain on Sale of Property, Plant and Equipment, net
In 2008, as part of the lease agreement described in Note 18,Commitments and Contingenciesto our Consolidated Financial Statements, we sold the development rights on a parcel of land in Cambridge, MA for $11.4 million in a non-monetary transaction and we recorded a pre-tax gain of approximately $9.2 million on the sale.
15.  Employee Benefit Plans
401(k) Savings Plan
We maintain a 401(k) Savings Plan which is available to substantially all regular employees in the U.S. over the age of 21. Participants may make voluntary contributions. We make matching contributions according to the 401(k) Savings Plan’s matching formula. Beginning in January 2008, all past and current matching contributions will vest immediately. Previously, the matching contributions vested over four years of service by the employee. Participant contributions vest immediately. The 401(k) Savings Plan also holds certain transition contributions on behalf of participants who previously participated in the Biogen, Inc. Retirement Plan. The expense related to our 401(k) Savings Plan primarily consists of our matching contributions.
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Expense related to our 401(k) Savings Plan $27.9  $22.8  $20.2 
Deferred Compensation Plan
We maintain a non-qualified deferred compensation plan, known as the Supplemental Savings Plan (SSP), that allows a select group of management employees in the U.S. to defer a portion of their compensation. The SSP also provides certain credits to highly compensated U.S. employees, which are paid by the company. These credits are known as the Restoration Match. The deferred compensation amounts are accrued when earned. Such deferred compensation is distributable in cash in accordance with the rules of the SSP. Deferred compensation amounts


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
under such plan as of December 31, 2009 and 2008 totaled approximately $63.6 million and $48.5 million, respectively, and are included in other long-term liabilities in the accompanying consolidated balance sheets. The SSP also holds certain transition contributions on behalf of participants who previously participated in the Biogen, Inc. Retirement Plan. Beginning in 2008, the Restoration Match vests immediately. Previously, the Restoration Match and transition contributions vested over four and seven years of service, respectively, by the employee. Participant contributions vest immediately. Distributions to participants can be either in one lump sum payment or annual installments as elected by the participants.
Pension Plan
We currently maintain retiree benefit plans which include, a defined benefit plan for employees in our German affiliate and other insignificant defined benefit plans in certain other countries in which we have an operating presence.
The obligations under the German plan totaled $5.7 million and $4.8 million as of December 31, 2009 and 2008, respectively.
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Net periodic pension cost related to the German plan $1.1  $1.0  $1.3 
16.  Income Taxes
Income Tax Expense
Income before income tax provision and the income tax expense consist of the following:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Income before income taxes (benefit):            
Domestic $1,073.8  $829.2  $664.9 
Foreign  258.9   326.7   187.3 
             
Total $1,332.7  $1,155.9  $852.2 
             
Income tax expense (benefit):            
Current            
Federal $439.9  $431.2  $305.9 
State  3.1   24.3   25.8 
Foreign  50.0   49.8   22.3 
             
Total $493.0  $505.3  $354.0 
             
Deferred            
Federal $(94.8) $(119.2) $(76.7)
State  (39.0)  (20.0)  (4.4)
Foreign  (3.6)  (0.3)  (0.5)
             
Total $(137.4) $(139.5) $(81.6)
             
             
Total income tax expense $355.6  $365.8  $272.4 
             


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Deferred Tax Assets and Liabilities
Significant components of our deferred tax assets and liabilities are summarized as follows:
         
  As of December 31, 
(In millions) 2009  2008 
 
Tax credits $35.2  $11.0 
Inventory, deferred revenue and other reserves  166.4   90.4 
Capitalized costs  8.7   36.6 
Intangibles, net  83.2   89.6 
Net operating loss  30.5   33.1 
Share-based compensation  60.8   59.9 
Other  60.6   57.9 
         
Deferred tax assets $445.4  $378.5 
         
Purchased intangible assets $(475.4) $(552.7)
Unrealized gain on investments and cumulative translation adjustment  (6.3)  (2.3)
Depreciation, amortization and other  (115.6)  (108.7)
         
Deferred tax liabilities $(597.3) $(663.7)
         
Tax Rate
Reconciliation between the U.S. federal statutory tax rate and our effective tax rate is summarized as follows:
             
  For the Years Ended December 31, 
(In percentages) 2009  2008  2007 
 
Statutory rate  35.0%  35.0%  35.0%
State taxes  (0.1)  1.6   3.2 
Taxes on foreign earnings  (5.0)  (5.8)  (8.1)
Credits and net operating loss utilization  (3.8)  (2.9)  (3.3)
Purchased intangible assets  2.0   3.7   3.7 
IPR&D     0.8   0.8 
Permanent items  (1.3)  (0.9)  (0.6)
Other  (0.1)  0.1   1.3 
             
Effective tax rate  26.7%  31.6%  32.0%
             
As of December 31, 2009, we had net operating losses and general business credit carry forwards for federal income tax purposes of approximately $59.3 million and $3.2 million, respectively, which begin to expire in 2020. Additionally, for state income tax purposes, we had net operating loss carry forwards of approximately $195.8 million, which begin to expire in 2010. For state income tax purposes, we also had research and investment credit carry forwards of approximately $49.2 million, of which approximately $46.9 million begin to expire in 2010, with the remainder having no prescribed expiration date.
In assessing the realizability of our deferred tax assets, we have considered whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. In making this determination, under the applicable financial reporting standards, we are allowed to consider the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies. Our estimates of future taxable income take into consideration, among other items, our estimates of future income tax deductions related to the exercise of stock options. Based upon the level of historical


F-45


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
taxable income and income tax liability and projections for future taxable income over the periods in which the deferred tax assets are utilizable, we believe it is more likely than not that we will realize the benefits of our entire deferred tax assets. In the event that actual results differ from our estimates or we adjust our estimates in future periods, we may need to establish a valuation allowance, which could materially impact our financial position and results of operations.
As of December 31, 2009, undistributed foreign earnings ofnon-U.S. subsidiaries included in consolidated retained earnings aggregated approximately $2.2 billion. We intend to reinvest these earnings indefinitely in operations outside the U.S. It is not practicable to estimate the amount of additional tax that might be payable if such earnings were remitted to the U.S.
Accounting for Uncertainty in Income Taxes
Effective January 1, 2007, we adopted a new accounting standard concerning the accounting for income tax contingencies. This standard clarified the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements. As a result of the adoption, we recognized a reduction in the liability for unrecognized tax benefits of $14.2 million, which was recorded as a $1.8 million reduction to the January 1, 2007 balance of our accumulated deficit, a $9.1 million reduction in goodwill and a $3.3 million increase in our deferred tax liability.
A reconciliation of the beginning and ending amount of our unrecognized tax benefits is summarized as follows:
             
(In millions) 2009  2008  2007 
 
Balance at January 1 $249.6  $221.1  $196.8 
Additions based on tax positions related to the current period  14.4   21.8   29.7 
Additions for tax positions of prior periods  77.4   20.4   83.5 
Reductions for tax positions of prior periods  (88.7)  (13.7)  (70.2)
Settlements  (105.6)     (18.7)
             
Balance at December 31 $147.1  $249.6  $221.1 
             
We and our subsidiaries are routinely examined by various taxing authorities. We file income tax returns in the U.S. federal jurisdiction, and various states and foreign jurisdictions. With few exceptions, we are no longer subject to U.S. federal tax examination for years before 2007 or state, local, ornon-U.S. income tax examinations by tax authorities for years before 2001.
Included in the balance of unrecognized tax benefits as of December 31, 2009, 2008, and 2007 are $42.8 million, $155.1 million, and $110.5 million (net of the federal benefit on state issues), respectively, of unrecognized tax benefits that, if recognized, would affect the effective income tax rate in future periods.
We do not anticipate any significant changes in our positions in the next twelve months other than expected settlements which have been classified as current liabilities within the accompanying balance sheet.
We recognize potential interest and penalties accrued related to unrecognized tax benefits in income tax expense. During 2009 we recognized a net interest benefit of approximately $3.1 million. During 2008 and 2007, we recognized approximately $16.1 million and $14.5 million in interest expense, respectively. We have accrued approximately $33.1 million and $47.7 million for the payment of interest as of December 31, 2009 and 2008, respectively.
Contingency
In September 2006, the Massachusetts Department of Revenue (DOR) issued a Notice of Assessment against Biogen Idec MA, Inc. for $38.9 million of corporate excise tax for 2002, which includes associated interest and penalties. The assessment asserts that the portion of sales attributable to Massachusetts, the computation of our


F-46


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
research and development credits, and the availability of certain deductions were not appropriate, resulting in unpaid taxes for those years. In December 2006, we filed an abatement application with the DOR seeking abatements for2001-2003, which was denied. In July 2007, we filed a petition with the Massachusetts Appellate Tax Board seeking abatements of corporate excise tax for2001-2003 and adjustments in certain credits and credit carryforwards for2001-2003. We anticipate that the trial will take place in 2010. In the fourth quarter of 2009, the DOR completed its audit fieldwork of our 2004, 2005 and 2006 tax filings. We believe that the DOR may make an assessment for taxes, interest and penalties claiming that our computation and deductions for these periods were also inappropriate. We believe that positions taken in our tax filings are valid and we have meritorious defenses to the assessment. We will vigorously oppose the assessment through the appeals and litigation process.
Our tax filings for 2007 and 2008 have not yet been audited by the DOR but have been prepared in a manner consistent with prior filings which may result in an assessment for those years. Due to tax law changes effective January 1, 2009, the computations and deductions at issue in previous tax filings will not be part of our tax filings starting in 2009.
There is a possibility that we may not prevail in defending all of our assertions with the DOR. If these matters are resolved unfavorably in the future, the resolution could have a material adverse impact on our future effective tax rate and our results of operations.
Settlements
During 2007, the IRS completed its examination of our consolidated federal income tax returns for our fiscal years 2003 and 2004. We subsequently paid amounts related to issues agreed to with the IRS, appealed several other issues and adjusted our income tax contingencies based on the result of the examination.
During 2009, the IRS completed its examination of our consolidated income tax returns for our fiscal years 2005 and 2006. We then reached an agreement to pay an amount to settle all matters related to the 2005 and 2006 years and resolve those matters under appeal related to 2003 and 2004. There are no remaining U.S. federal income tax contingencies for the periods prior to tax year 2007.
During 2009, the California Franchise Tax Board completed its examination of our worldwide income tax returns for fiscal years 2003 through 2007 and issued assessments for each period. We agreed to these assessments and will make payments to settle all matters related to these audits. There are no remaining California income tax contingencies related to the periods prior to tax year 2008.
We have also reached agreement with Arizona concerning our outstanding matters in that state and completed an audit of our transfer pricing in Denmark.
As a result of these 2009 domestic settlements, and completion of the related audits, we have made payments totaling approximately $118.0 million during 2009 and will make payments of approximately $105.0 million in the first half of 2010, which have been accrued as of December 31, 2009. We have also reduced our net unrecognized tax benefits by approximately $123.5 million, of which approximately $28.0 million was recorded as a benefit in our consolidated statement of income in 2009.
17.  Collaborations
In connection with our business strategy, we have entered into various collaboration agreements which provide us with rights to develop, produce and market products using certain know-how, technology and patent rights maintained by our collaborative partners. Terms of the various collaboration agreements may require us to make milestone payments upon the achievement of certain product research and development objectives and pay royalties on future sales, if any, of commercial products resulting from the collaboration.
Effective January 1, 2009, we adopted a newly issued accounting standard for the accounting and disclosure of an entity’s collaborative arrangements. This newly issued standard prescribes that certain transactions between


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
collaborators be recorded in the income statement on either a gross or net basis, depending on the characteristics of the collaboration relationship, and provides for enhanced disclosure of collaborative relationships. In accordance with this guidance, we must also evaluate our collaborative agreements for proper income statement classification based on the nature of the underlying activity. Amounts due from our collaborative partners related to development activities are generally reflected as a reduction of research and development expense because the performance of contract development services is not central to our operations. For collaborations with commercialized products, if we are the principal (as defined in reporting revenue as a principal versus net as an agent as required by theRevenue RecognitionTopic of the Codification) we record revenue and the corresponding operating costs in their respective line items within our consolidated statements of income. If we are not the principal, we record operating costs as a reduction of revenue. The guidance describes the principal as the party who is responsible for delivering the product or service to the customer, has latitude to determine price, and has the risks and rewards of providing product or service to the customer, including inventory and credit risk. The adoption of this newly issued accounting standard did not impact our financial position or results of operations; however it resulted in enhanced disclosures for our collaboration activities.
Roche Group — Genentech
We collaborate with the Roche Group, through its wholly-owned member Genentech, Inc., on the development and commercialization of RITUXAN. We also have rights to collaborate with Genentech on the development and commercialization of (1) anti-CD20 products that Genentech acquires or develops, which we refer to as New Anti-CD20 Products, and (2) anti-CD20 products that Genentech licenses from a third party, which we refer to as Third Party Anti-CD20 Products. Currently, there is only one New Anti-CD20 Product, ocrelizumab, and only one Third Party Anti-CD20 Product, GA101. Our collaboration rights for New Anti-CD20 Products are limited to the U.S. and our collaboration rights for Third Party Anti-CD20 Products are dependent upon Genentech’s underlying license rights. A joint development committee (JDC) composed of three members from each company must unanimously approve a development plan for each specific indication of certain pharmaceutical products, and Genentech has responsibility for implementing JDC approved development plans in accordance with the provisions of our collaboration agreement. In the event that we undergo a change in control, as defined in the collaboration agreement, Genentech has the right to present an offer to buy the rights to RITUXAN, and we must either accept Genentech’s offer or purchase Genentech’s rights to RITUXAN on the same terms as its offer. If Genentech presents such an offer, then they will be deemed concurrently to have exercised a right, in exchange for a royalty on net sales in the U.S. of any anti-CD20 product acquired or developed by Genentech or any anti-CD20 product that Genentech licenses from a third party that is developed under the agreement, to purchase our interest in each such product. Our collaboration with Genentech was created through a contractual arrangement and not through a joint venture or other legal entity.
While Genentech is responsible for the worldwide manufacturing of RITUXAN, development and commercialization rights and responsibilities under this collaboration are divided as follows:
U.S.
We share with Genentech co-exclusive rights to develop, commercialize and market RITUXAN and New Anti-CD20 Products in the U.S. Although we contribute to the marketing and continued development of RITUXAN, we have a limited sales force dedicated to RITUXAN and limited development activity. Genentech is primarily responsible for the commercialization of RITUXAN in the U.S. Its responsibilities include selling and marketing, customer service, order entry, distribution, shipping and billing, and other administrative support. Genentech also incurs the majority of continuing development costs for RITUXAN.
Canada
We and Genentech have assigned our rights to develop, commercialize and market RITUXAN, in Canada to Roche.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Outside the U.S. and Canada
We have granted Genentech exclusive rights to develop, commercialize and market RITUXAN outside the U.S. and Canada. Under the terms of separate sublicense agreements between Genentech and Roche, development and commercialization of RITUXAN outside the U.S. and Canada is the responsibility of Roche and its sublicensees. We do not have any direct contractual arrangements with Roche or it sublicensees.
Revenues from unconsolidated joint business consists of (1) our share of pretax co-promotion profits in the U.S. (2) reimbursement of our selling and development expenses in the U.S.; and (3) revenue on sales of RITUXAN in the rest of world, which consist of our share of pretax co-promotion profits in Canada and royalty revenue on sales of RITUXAN outside the U.S. and Canada by Roche, and its sublicensees. Pre-tax co-promotion profits are calculated and paid to us by Genentech in the U.S. and by Roche in Canada. Pre-tax co-promotion profits consist of U.S. and Canadian sales of RITUXAN to third-party customers net of discounts and allowances less the cost to manufacture RITUXAN, third-party royalty expenses, distribution, selling, and marketing expenses, and joint development expenses incurred by Genentech, Roche and us. We record our royalty and co-promotion profits revenue on sales of RITUXAN in the rest of world on a cash basis.
Revenues from unconsolidated joint business consist of the following:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Biogen Idec’s share of co-promotion profits in the U.S.  $773.6  $733.5  $616.8 
Reimbursement of selling and development expenses in the U.S.   65.6   59.7   58.5 
Revenue on sales of RITUXAN in the rest of world   255.7   335.0   250.8 
             
Total unconsolidated joint business revenues $1,094.9  $1,128.2  $926.1 
             
Under the collaboration agreement, our current pretax co-promotion profit-sharing formula, which resets annually, provides for a 30% share of co-promotion profits on the first $50.0 million of co-promotion operating profit with our share increasing to 40% if co-promotion operating profits exceed $50.0 million. In 2009, 2008, and 2007, the 40% threshold was met during the first quarter.
Our agreement with Genentech provides that the successful development and commercialization of the first New Anti-CD20 Product will decrease our percentage of co-promotion profits of the collaboration. Specifically, for each calendar year or portion thereof following the approval date of the first New Anti-CD20 Product, the pretax co-promotion profit-sharing formula for RITUXAN and New Anti-CD20 Products sold by us and Genentech will change as follows:
First New Anti-CD20 Product
Biogen Idec’s Share
Co-promotion Operating Profits
U.S. Gross Product Sales
of Co-promotion Profits
First $50 million(1)Not Applicable30%
Greater than $50 millionUntil such sales exceed $150 million in any calendar year(2)38%
Or
After such sales exceed $150 million in any calendar year until such sales exceed $350 million in any calendar year(3)35%
Or
After such sales exceed $350 million in any calendar year(4)30%


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
(1)Not applicable in the calendar year the first New Anti-CD20 Product is approved if $50 million in co-promotion operating profits has already been achieved in such calendar year through sales of RITUXAN.
(2)If we are recording our share of RITUXAN co-promotion profits at 40%, upon the approval date of the first New Anti-CD20 Product, our share of co-promotion profits for RITUXAN and the New Anti-CD20 Product will be immediately reduced to 38% following the approval date of the first New Anti-CD20 Product until the $150 million in first New Anti-CD20 Product sales level is achieved.
(3)If $150 million in first New Anti-CD20 Product sales is achieved in the same calendar year the first New Anti-CD20 Product receives approval, then the 35% co-promotion profit-sharing rate will not be effective until January 1 of the following calendar year. Once the $150 million in first New Anti-CD20 Product sales level is achieved then our share of co-promotion profits for the balance of the year and all subsequent years (after the first $50 million in co-promotion operating profits in such years) will be 35% until the $350 million in first New Anti-CD20 Product sales level is achieved.
(4)If $350 million in first New Anti-CD20 Product sales is achieved in the same calendar year that $150 million in new product sales is achieved, then the 30% co-promotion profit-sharing rate will not be effective until January 1 of the following calendar year (or January 1 of the second following calendar year if the first New Anti-CD20 Product receives approval and, in the same calendar year, the $150 million and $350 million in first New Anti-CD20 Product sales levels are achieved). Once the $350 million in first New Anti-CD20 Product sales level is achieved then our share of co-promotion profits for the balance of the year and all subsequent years will be 30%.
We will participate in Third Party Anti-CD20 Products on similar financial terms as for ocrelizumab.
Currently, we record our share of the expenses incurred by the collaboration for the development of New Anti-CD20 Products and Third Party Anti-CD20 Products in research and development expense in our consolidated statements of income. We incurred $62.5 million, $43.6 million, and $26.1 million in development expense related to New Anti-CD20 Products and Third Party Anti-CD20 Products for the years ended December 31, 2009, 2008, and 2007, respectively. Reimbursement to Genentech for our share of these costs occurs through the net amount of co-promotion profits in the U.S. remitted to us. After a New Anti-CD20 Product or Third Party Anti-CD20 Product is approved, we will record our share of the development expenses related to that product as a reduction of our share of pretax co-promotion profits in revenues from unconsolidated joint business.
Elan
We collaborate with Elan on the development, manufacture and commercialization of TYSABRI. Under the terms of our collaboration agreement, we manufacture TYSABRI and collaborate with Elan on the product’s marketing, commercial distribution and ongoing development activities. The agreement is designed to effect an equal sharing of profits and losses generated by the activities of our collaboration. Under the agreement, however, once sales of TYSABRI exceeded specific thresholds, Elan was required to make milestone payments to us in order to continue sharing equally in the collaboration’s results. As of December 31, 2009, Elan has made milestone payments to us of $75.0 million in the third quarter of 2008 and $50.0 million in the first quarter of 2009. We have recorded these amounts as deferred revenue upon receipt and are recognizing the entire $125.0 million as product revenue in our consolidated statements of income over the term of the collaboration agreement based on a units of revenue method whereby the revenue recognized is based on the ratio of units shipped in the current period over the total units expected to be shipped over the remaining term of the collaboration. No additional milestone payments are required under the agreement to maintain the current profit sharing split. Our collaboration agreement provides Elan or us with the option to buy the rights to TYSABRI in the event that the other company undergoes a change of control (as defined in the collaboration agreement).
In the U.S., we sell TYSABRI to Elan who sells the product to third party distributors. Our sales price to Elan in the U.S. is set prior to the beginning of each quarterly period to effect an approximate equal sharing of the gross margin between Elan and us. We recognize revenue for sales in the U.S. of TYSABRI upon Elan’s shipment of the


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
product to the third party distributors, at which time all revenue recognition criteria have been met. As of December 31, 2009 and 2008, we had deferred revenue of $23.6 million and $6.2 million, respectively, for shipments to Elan that remained in Elan’s ending inventory pending shipment of the product to the third party distributors. We incur manufacturing and distribution costs, research and development expenses, commercial expenses, and general and administrative expenses. We record these expenses to their respective line items within our consolidated statements of income when they are incurred. Research and development and sales and marketing expenses are shared equally with Elan and the reimbursement of these expenses is recorded as reductions of the respective expense categories. During the years ended December 31, 2009, 2008 and 2007, we recorded $25.3 million, $23.6 million, and $21.5 million, respectively, as reductions of research and development expense for reimbursements from Elan. In addition, for the years ended December 31, 2009, 2008 and 2007, we recorded $62.5 million, $33.7 million, and $37.9 million, respectively, as reductions of selling, general and administrative expense for reimbursements from Elan.
In the rest of world, we are responsible for distributing TYSABRI to customers and are primarily responsible for all operating activities. Generally, we recognize revenue for sales of TYSABRI in the rest of world at the time of product delivery to our customers. Payments are made to Elan for their share of the rest of world net operating profits to effect an equal sharing of collaboration operating profit. These payments also include the reimbursement for our portion of third-party royalties that Elan pays on behalf of the collaboration relating to rest of world sales. These amounts are reflected in the collaboration profit sharing line in our consolidated statements of income. For the years ended December 31, 2009, 2008 and 2007, $215.9 million, $136.0 million, and $14.1 million, respectively, was reflected in the collaboration profit sharing line for our collaboration with Elan. As rest of world sales of TYSABRI increase, our collaboration profit sharing expense is expected to increase.
Acorda
On June 30, 2009, we entered into a collaboration and license agreement with Acorda Therapeutics, Inc. (Acorda) to develop and commercialize products containing fampridine in markets outside the U.S. The transaction represents a sublicensing of an existing license agreement between Acorda and Elan. The parties have also entered into a related supply agreement. The $110.0 million upfront payment made on July 1, 2009 to Acorda was recorded as research and development expense during the second quarter 2009 as the product candidate had not received regulatory approval. Fampridine was approved in the U.S. on January 22, 2010 under the trade name AMPYRA (dalfampridine). AMPYRA is indicated to improve walking in patients with MS. This was demonstrated by an increase in walking speed. Acorda is developing and marketing AMPYRA in the U.S.
Under the terms of the agreement, we will commercialize fampridine and any aminopyridine products developed in our territory and will also have responsibility for regulatory activities and future clinical development of fampridine in those markets. We may incur additional milestone payments of up to $400.0 million based upon the successful achievement of regulatory and commercial sales milestones. We will also make tiered royalty payments to Acorda on sales outside of the U.S. The consideration that we pay for products will reflect all amounts due from Acorda to Elan for sales in markets outside the U.S., including royalties owed. We can also carry out future joint development activities under a cost-sharing arrangement.
Elan will continue to manufacture commercial supply of fampridine based upon its existing supply agreement with Acorda. Under the existing agreements with Elan, Acorda will pay Elan 7% of the upfront and milestone payments that Acorda receives from us.


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
A summary of activity related to this collaboration is as follows:
             
  For the Years Ended
 
  December 31, 
(In millions) 2009  2008  2007 
 
Upfront and milestones payments made to Acorda $110.0  $  $ 
Total expense incurred by Biogen Idec Inc. excluding upfront and milestone payments $4.7  $  $ 
Total expense reflected within our consolidated statements of income $114.7  $  $ 
A summary of activity related to this collaboration since inception, along with an estimate of additional future development expense expected to be incurred by us, is as follows:
     
  As of
  December 31,
(In millions) 2009
 
Total upfront and milestone payments made to Acorda $110.0 
Total development expense incurred by Biogen Idec Inc., excluding upfront and milestone payments $4.7 
Estimate of additional amounts to be incurred by us in development of fampridine $45.0 
Neurimmune
We have a collaboration agreement with Neurimmune SubOne AG (Neurimmune), a subsidiary of Neurimmune Therapeutics AG, for the development and commercialization of antibodies for the treatment of Alzheimer’s disease. Neurimmune will conduct research to identify potential therapeutic antibodies and we will be responsible for the development, manufacturing and commercialization of all products. We may pay Neurimmune up to $360.0 million in remaining milestone payments, as well as royalties on sales of any resulting commercial products. Milestone payments are reflected within our consolidated statements of income when achieved. The royalty term for sales in each country will be no less than 12 years from the first commercial sale of product using such compound in such country.
We have determined that we are the primary beneficiary of Neurimmune in accordance with the guidance provided by theConsolidationTopic of the Codification because we control the activities of the collaboration and are required to fund 100% of the research and development costs incurred in support of the collaboration agreement. As such, we consolidate the results of Neurimmune and recorded an IPR&D charge of $34.3 million in 2007 upon signing of the collaboration agreement. The amount allocated to IPR&D relates to the development of theBeta-Amyloid antibody compound which, as of the effective date of the agreement, had not reached technological feasibility and had no alternative future use. We allocated the IPR&D charge to noncontrolling interest, as the IPR&D charge represents the fair value of the underlying technology retained by the parent.
The assets and liabilities of Neurimmune are not significant as it is a research and development organization. Amounts that we reimburse Neurimmune for research and development expenses incurred in support of the collaboration are reflected in research and development expense in our statements of income.
A summary of activity related to this collaboration is as follows:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Upfront and milestone payments made to Neurimumune $7.5  $10.5  $2.0 
Total expense incurred by Biogen Idec Inc. excluding upfront and milestone payments $9.0  $5.9  $0.6 
Total expense reflected within our consolidated statements of income $16.5  $16.4  $2.6 


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
A summary of activity related to this collaboration since inception, along with an estimate of additional future development expense expected to be incurred by us, is as follows:
     
  As of
  December 31,
(In millions) 2009
 
Total upfront and milestone payments made to Neurimumune $20.0 
Total development expense incurred by Biogen Idec Inc. excluding upfront and milestone payments $15.5 
Estimate of additional amounts to be incurred by us in development of the lead compound $530.0 
Cardiokine
We collaborate with Cardiokine Biopharma LLC (Cardiokine), a subsidiary of Cardiokine Inc., on the joint development of lixivaptan, an oral compound for the potential treatment of hyponatremia in patients with congestive heart failure. The royalty term under our collaboration agreement for sales in each country will be no less than 10 years from the first commercial sale of a lixivaptan product in such country. If successful, we will be responsible for certain development activities, manufacturing and global commercialization of lixivaptan, and Cardiokine has an option for limitedco-promotion in the U.S.  Based upon our current development plans, we may pay up to $125.0 million in remaining development milestone payments as well as royalties on commercial sales under the terms of our collaboration agreement.
We have determined that we are the primary beneficiary of Cardiokine in accordance with the guidance provided by theConsolidationTopic of the Codification because we control the activities of the collaboration and are required to fund 90% of the development costs under the collaboration agreement. As such, we consolidate the results of Cardiokine and recorded an IPR&D charge of $30.0 million in 2007 upon signing the collaboration agreement. The amount allocated to IPR&D relates to the development of the lixivaptan compound which, as of the effective date of the agreement, had not reached technological feasibility and had no alternative future use. We allocated the IPR&D charge to noncontrolling interest, as the IPR&D charge represents the fair value of the underlying technology retained by the parent. The assets and liabilities of Cardiokine are not significant as it is a research and development organization.
A summary of activity related to this collaboration is as follows:
             
  For the Years Ended December 31, 
(In millions) 2009  2008  2007 
 
Upfront and milestone payments made to Cardiokine $20.0  $  $50.0 
Total expense incurred by collaboration $66.5  $50.5  $17.2 
Biogen Idec Inc.’s share of expense reflected within our consolidated statements of income $79.8  $45.5  $65.5 
Collaboration expense allocated to noncontrolling interests, net of tax $6.7  $5.0  $1.7 
A summary of activity related to this collaboration since inception, along with an estimate of additional future development expense expected to be incurred by us, is as follows:
     
  As of
  December 31,
(In millions) 2009
 
Total upfront and milestone payments made to Cardiokine $70.0 
Total development expense incurred by Biogen Idec Inc. excluding upfront and milestone payments $122.8 
Estimate of additional amounts to be incurred by us in development of lixivaptan (all indications) $430.0 


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Biovitrum
We have a collaboration agreement with Biovitrum to jointly develop and commercialize long-acting recombinant Factor VIII and Factor IX for the treatment of hemophilia. Under the agreement, development costs are shared equally. We have commercial rights to North America and Biovitrum has commercial rights to Europe. Each party shares in the other’s net sales based on a royalty percentage of up to 33.3%. All other territories are to be managed by a third party with us and Biovitrum sharing equally in all royalties, license fees and other revenues arising from arrangements with third party licenses and distributors.
Amounts incurred by us in the development of long-acting recombinant Factor VIII and Factor IX are reflected as research and development expense in our consolidated statements of income, reduced by amounts due from Biovitrum. A summary of collective activity related to these programs is as follows:
             
  For the Years Ended
  December 31,
(In millions) 2009 2008 2007
 
Total expense incurred by collaboration $44.9  $37.7  $26.7 
Total expense reflected within our consolidated statements of income $22.5  $18.8  $13.3 
A summary of activity related to this collaboration since inception, along with an estimate of additional future development expense expected to be incurred by us, is as follows:
     
  As of
  December 31,
(In millions) 2009
 
Total upfront and milestone payments received from Biovitrum $5.0 
Total development expense incurred by Biogen Idec Inc., excluding upfront and milestone payments $54.6 
Estimate of additional amounts to be incurred by us in development of Factors XIII and IX $135.0 
Under the agreement, Biovitrum may pay us an additional $18.0 million in milestone payments.
MondoBiotech
In December 2009, pursuant to our agreement with mondoBIOTECH AG and certain of its subsidiaries (Mondobiotech), we notified Mondobiotech that we would terminate our interest in continuing to fund, develop and commercialize Aviptadil, the collaboration’s only product, and have retained the right to receive a percentage of future milestones and royalties received by Mondobiotech from third parties related to the Aviptadil program. In accordance with the terms of the agreement, we made a final payment of $1.25 million in December 2009, bringing total 2009 payments to Mondobiotech to $13.3 million.
We had previously determined that we were the primary beneficiary of Mondobiotech because we were required to fund 100% of the development costs under the terms agreed. As such, we consolidated the results of Mondobiotech. Upon terminating our development interest, we ceased to consolidate the results of Mondobiotech because we no longer were responsible for funding development costs. Therefore, our consolidated financial statements as of December 31, 2009 no longer include the assets and liabilities of Mondobiotech. The assets and liabilities of Mondobiotech previously consolidated within our financial statements were not significant as Mondobiotech is a research and development organization. Expenses incurred by the collaboration were previously reflected in research and development expense in our consolidated statements of income.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
A summary of activity related to this collaboration is as follows:
             
  For the Years Ended
  December 31,
(In millions) 2009 2008 2007
 
Total expense incurred by collaboration $12.1  $14.4  $13.7 
Total expense reflected within our consolidated statements of income $12.1  $14.4  $13.7 
A summary of activity related to this collaboration since inception is as follows:
     
  As of
  December 31,
(In millions) 2009
 
Total upfront and milestone payments made to Mondobiotech $7.5 
Total development expense incurred by Biogen Idec Inc., excluding upfront and milestone payments $42.0 
UCB
In June 2009, UCB, S.A., (UCB) and we announced the discontinuation of the Phase 2 clinical trial for this collaboration’s only product candidate due to the absence of clinically relevant efficacy. Since the inception of our collaboration agreement with UCB, we have incurred a total of $101.0 million in research and development expenses for the development and commercialization of an oral alpha4 integrin antagonist for the treatment of relapsing remitting MS.
A summary of activity related to this collaboration is as follows:
             
  For the Years Ended
  December 31,
(In millions) 2009 2008 2007
 
Total expense incurred by collaboration $31.8  $33.6  $34.2 
Biogen Idec Inc., share of expense reflected within our consolidated statements of income $21.0  $21.9  $24.2 
A summary of activity related to this collaboration since inception, along with an estimate of additional future development expense expected to be incurred by us, is as follows:
     
  As of
 
  December 31,
 
(In millions) 2009 
 
Total upfront and milestone payments made to UCB $30.0 
Total development expense incurred by Biogen Idec Inc., excluding upfront and milestone payments $71.0 
Estimate of additional amounts to be incurred by us in development of the compound in this indication $2.0 
Facet Biotech
We have a collaboration agreement with Facet Biotech Corporation (Facet) aimed at advancing the development and commercialization of daclizumab in MS and volociximab in solid tumors. Daclizumab is a humanized monoclonal antibody that binds to the IL-2 receptor on activated T cells. Volociximab is an anti-angiogenic chimeric antibody directed against alpha5 beta1 integrin. Under the agreement, development and commercialization costs and profits are shared equally. We may incur up to an additional $210.0 million of payments upon achievement of development and commercial milestones.
In January 2010, we agreed with our collaborator, Facet, to assume the manufacture of declizumab and began the process of transferring from Facet the manufacturing technology necessary for us to manufacture declizumab.


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
A summary of activity related to this collaboration is as follows:
             
  For the Years Ended
  December 31,
(In millions) 2009 2008 2007
 
Total expense incurred by collaboration $40.8  $65.7  $41.3 
Biogen Idec Inc. share of expense reflected within our consolidated statements of income $20.4  $32.8  $20.7 
A summary of activity related to this collaboration since inception, along with an estimate of additional future development expense expected to be incurred by us, is as follows:
     
  As of
  December 31,
(In millions) 2009
 
Total upfront and milestone payments made to Facet $50.0 
Total development expense incurred by Biogen Idec Inc., excluding upfront and milestone payments $122.5 
Estimate of additional amounts to be incurred by us in development of current indications of daclizumab and volociximab $475.0 
Vernalis
We have a collaboration agreement with Vernalis plc (Vernalis) aimed at advancing the development and commercialization of an adenosine A2a receptor antagonist for treatment of Parkinson’s disease. Under the agreement, we received exclusive worldwide rights to develop and commercialize the compound. We are responsible for funding all development costs and may incur up to an additional $85.0 million of milestone payments upon achievement of certain objectives, as well as royalties on commercial sales.
A summary of activity related to this collaboration is as follows:
             
  For the Years Ended
  December 31,
(In millions) 2009 2008 2007
 
Total expense incurred by collaboration and reflected within our consolidated statements of income $14.8  $16.9  $9.6 
A summary of activity related to this collaboration since inception, along with an estimate of additional future development expense expected to be incurred by us, is as follows:
     
  As of
  December 31,
(In millions) 2009
 
Total upfront and milestone payments made to Vernalis $13.0 
Total development expense incurred by Biogen Idec Inc. excluding upfront and milestone payments $69.7 
Estimate of additional amounts to be incurred by Biogen Idec Inc. in development of the compound in this indication $225.0 


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
As of December 31, 2008, we held a total of approximately 7.6 million shares of Vernalis. During 2009, due to a reverse stock split, we received one new share for every twenty shares previously owned. As a result, as of December 31, 2009, we held a total of approximately 0.4 million shares of Vernalis. As of December 31, 2009 and 2008, our investment in Vernalis had a fair value of approximately $0.5 million and $0.3 million, respectively.
Our investment in Vernalis, which is included within investments and other assets, is subject to periodic review of impairment. In 2008 and 2007, we recorded an impairment charge of $0.5 million and $6.3 million, respectively, representing another-than-temporary impairment in the stock we own. No impairment was recognized related to this investment during 2009.
18.  Commitments and Contingencies
Leases
We rent laboratory and office space and certain equipment under noncancellable operating leases. These lease agreements contain various clauses for renewal at our option and, in certain cases, escalation clauses typically linked to rates of inflation. Rental expense under these leases, which terminate at various dates through 2025, amounted to $36.4 million in 2009, $36.0 million in 2008, and $33.1 million in 2007.
As of December 31, 2009, minimum rental commitments under noncancellable leases for each of the next five years and total thereafter were as follows:
                             
(In millions) 2010  2011  2012  2013  2014  Thereafter  Total 
 
Minimum lease payments(1) $33.0  $33.1  $29.9  $29.8  $28.7  $227.3  $381.8 
Income from subleases  (0.7)                 (0.7)
                             
Net minimum lease payments $32.3  $33.1  $29.9  $29.8  $28.7  $227.3  $381.1 
                             
(1)Includes fifteen-year lease on a 356,000 square foot office building in Weston, Massachusetts, which will serve as the future location of our general and administrative offices with a planned occupancy around mid-year 2010. The initial lease term is from 2010 through 2025 under which the total minimum lease payments are $258.6 million.
Other Funding Commitments
As of December 31, 2009, we have funding commitments of up to approximately $24.8 million in biotechnology oriented venture capital funds.
As of December 31, 2009, we have accrued expenses totaling approximately $31.7 million on our consolidated balance sheet related to clinical research organizations for expenditures incurred in relation to ongoing clinical trials.
Contingent Milestone Payments
Based on our development plans as of December 31, 2009, we have committed to make potential future milestone payments to third parties of up to approximately $1,500.0 million as part of our various collaborations, including licensing and development programs. Payments under these agreements generally become due and payable only upon achievement of certain developmental, regulatory or commercial milestones. Because the achievement of these milestones had not occurred as of December 31, 2009, such contingencies have not been recorded in our financial statements.
19.  Litigation
Along with several other major pharmaceutical and biotechnology companies, Biogen, Inc. (now Biogen Idec MA, Inc., one of our wholly-owned subsidiaries) or, in some cases, Biogen Idec Inc., was named as a defendant in lawsuits filed by the City of New York and numerous Counties of the State of New York. All of the cases — except for


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
cases filed by the County of Erie, County of Oswego and County of Schenectady (Three County Actions) — are the subject of a Consolidated Complaint, first filed on September 15, 2005 in the U.S. District Court for the District of Massachusetts in Multi-District Litigation No. 1456 (MDL proceedings). The complaints allege that the defendants (i) fraudulently reported (or caused others to report incorrectly) the Average Wholesale Price for certain drugs for which Medicaid provides reimbursement (Covered Drugs); (ii) marketed and promoted the sale of Covered Drugs to providers based on the providers’ ability to collect inflated payments from the government and Medicaid beneficiaries that exceeded payments possible for competing drugs; (iii) provided financing incentives to providers to over-prescribe Covered Drugs or to prescribe Covered Drugs in place of competing drugs; and (iv) overcharged Medicaid for illegally inflated Covered Drugs reimbursements. Among other things, the complaints allege violations of New York state law and advance common law claims for unfair trade practices, fraud, and unjust enrichment. In addition, the amended Consolidated Complaint alleges that the defendants failed to accurately report the “best price” on the Covered Drugs to the Secretary of Health and Human Services pursuant to rebate agreements, and excluded from their reporting certain discounts and other rebates that would have reduced the “best price.” With respect to the MDL proceedings, some of the plaintiffs’ claims were dismissed, and the parties, including Biogen Idec, began a mediation of the outstanding claims on July 1, 2008. We have not formed an opinion that an unfavorable outcome is either “probable” or “remote” in any of these cases, and do not express an opinion at this time as to their likely outcome or as to the magnitude or range of any potential loss. We believe that we have good and valid defenses to each of these complaints and are vigorously defending against them.
In 2006, the Massachusetts Department of Revenue (DOR) issued a notice of assessment against Biogen Idec MA, Inc. for $38.9 million of corporate excise tax with respect to the 2002 tax year, which includes associated interest and penalties. On December 6, 2006, we filed an abatement application with the DOR, seeking abatements for 2001, 2002 and 2003 tax years. The abatement application was denied on July 24, 2007. On July 25, 2007, we filed a petition with the Massachusetts Appellate Tax Board, seeking, among other items, abatements of corporate excise tax for 2001, 2002 and 2003 tax years and adjustments in certain credits and credit carry forwards for 2001, 2002 and 2003 tax years. Issues before the Board include the computation of Biogen Idec MA’s sales factor for 2001, 2002 and 2003 tax years, computation of Biogen Idec MA’s research credits for those same years, and the availability of deductions for certain expenses and partnership flow-through items. We anticipate that the trial will take place in 2010. We intend to contest this matter vigorously.
On October 4, 2004, Genentech, Inc. received a subpoena from the U.S. Department of Justice requesting documents related to the promotion of RITUXAN. We market RITUXAN in the United States in collaboration with Genentech. We cooperated in the government’s investigation. It is our understanding that the government has not taken any action against Genentech as a result of the investigation. We therefore do not expect to report further on this matter.
On October 27, 2008, Sanofi-Aventis Deutschland GmbH (Sanofi) filed suit against Genentech and Biogen Idec in federal court in Texas (E.D. Tex.) (Texas Action) claiming that RITUXAN and certain other Genentech products infringe U.S. Patents 5,849,522 (‘522 patent) and 6,218,140 (‘140 patent). Sanofi seeks preliminary and permanent injunctions, compensatory and exemplary damages, and other relief. On October 27, 2008, Genentech and Biogen Idec filed a complaint against Sanofi, Sanofi-Aventis U.S. LLC, and Sanofi-Aventis U.S., Inc. in federal court in California (N.D. Cal.) (California Action) seeking a declaratory judgment that RITUXAN and other Genentech products do not infringe the ‘522 patent or the ‘140 patent, and a declaratory judgment that those patents are invalid. (Sanofi-Aventis U.S. LLC and Sanofi-Aventis U.S., Inc. were later dismissed voluntarily.) On May 22, 2009, the United States Court of Appeals for the Federal Circuit granted Genentech’s and our petition for a writ of mandamus transferring the Texas Action to the federal court in California, and denied Sanofi’s petition for rehearing on August 10, 2009. The Texas Action has been consolidated with the California Action and we refer to the two actions together as the Consolidated Actions. We have not formed an opinion that an unfavorable outcome in the Consolidated Actions is either “probable” or “remote,” and do not express an opinion at this time as to the likely outcome of the matters or as to the magnitude or range of any potential loss. We believe that we have good and valid defenses and intend vigorously to defend against the allegations against us.


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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
On October 24, 2008, Hoechst GmbH filed with the ICC International Court of Arbitration (Paris) a request for arbitration against Genentech, relating to a terminated license agreement between Hoechst’s predecessor and Genentech that pertained to the above-referenced patents and related patents outside the U.S. The license was entered as of January 1, 1991 and was terminated by Genentech on October 27, 2008. We understand that Hoechst seeks payment of royalties on sales of Genentech products, including RITUXAN, damages for breach of contract, and other relief. Although we are not a party to the arbitration, any damages awarded to Hoescht based on sales of RITUXAN may be a cost allocable to our collaboration with Genentech. Under the collaboration agreement, we may be responsible for a portion of any such damages. We have not formed an opinion that an unfavorable outcome in the arbitration is either “probable” or “remote,” and do not express an opinion at this time as to the likely outcome of the matter or as to the magnitude or range of any potential loss.
In addition, we are involved in product liability claims and other legal proceedings generally incidental to our normal business activities. While the outcome of any of these proceedings cannot be accurately predicted, we do not believe the ultimate resolution of any of these existing matters would have a material adverse effect on our business or financial conditions.
20.  Segment Information
 
We operate in one business segment, which is the business of development, manufacturing and commercialization of novel therapeutics for human healthcare and, therefore, our chief operating decision-maker manages the operations of our Company as a single operating segment. Enterprise-wide disclosures about product revenues, other revenues and long-lived assets by geographic area and information relating to major customers are presented below. Revenues are primarily attributed to individual countries based on location of the customer or licensee.
 
Revenue by product is summarized as follows (in millions):follows:
 
                                                                        
 Year Ended December 31,  For the Years Ended December 31, 
 2008 2007 2006  2009 2008 2007 
   Rest of
     Rest of
     Rest of
    United
 Rest of
   United
 Rest of
   United
 Rest of
   
 US World Total US World Total US World Total 
(In millions) States World Total States World Total States World Total 
AVONEX $1,276.5  $926.1  $2,202.6  $1,085.0  $782.8  $1,867.8  $1,022.2  $684.5  $1,706.7  $1,406.2  $916.7  $2,322.9  $1,276.5  $926.1  $2,202.6  $1,085.0  $782.8  $1,867.8 
AMEVIVE     0.3   0.3   0.3   0.4   0.7   5.0   6.5   11.5 
ZEVALIN     4.8   4.8   13.9   3.0   16.9   16.4   1.4   17.8 
FUMADERM     43.4   43.4      21.5   21.5      9.5   9.5 
TYSABRI  196.4   392.2   588.6   104.4   125.5   229.9   25.9   9.9   35.8   231.8   544.2   776.0   196.4   392.2   588.6   104.4   125.5   229.9 
Other     54.0   54.0      48.5   48.5   14.2   24.9   39.1 
                                      
Total product revenues $1,472.9  $1,366.8  $2,839.7  $1,203.6  $933.2  $2,136.8  $1,069.5  $711.8  $1,781.3  $1,638.0  $1,514.9  $3,152.9  $1,472.9  $1,366.8  $2,839.7  $1,203.6  $933.2  $2,136.8 
                                      
 
Our geographic information is summarized as follows (in millions):
 
                                                
December 31, 2008
 US Europe Germany Asia Other Total 
December 31, 2009
 U.S. Europe Germany Asia Other Total 
Product revenues from external customers $1,472.9  $822.6  $354.5  $36.5  $153.2  $2,839.7  $1,638.0  $913.7  $374.8  $47.9  $178.5  $3,152.9 
Revenues from unconsolidated joint business $793.2  $272.3  $  $21.7  $41.0  $1,128.2  $839.2  $190.2  $  $24.1  $41.4  $1,094.9 
Other revenues from external customers $96.5  $32.8  $0.3  $  $  $129.6  $102.8  $26.2  $0.5  $  $  $129.5 
Long-lived assets $1,111.2  $658.8  $2.5  $4.2  $1.2  $1,777.9  $1,092.7  $705.6  $1.4  $3.6  $2.1  $1,805.4 
 
In 2008, we recorded revenue from two wholesale distributors accounting for a total of 16.2% and 13.1% of product revenue, respectively.
                                                
December 31, 2007
 US Europe Germany Asia Other Total 
December 31, 2008
 U.S. Europe Germany Asia Other Total 
Product revenues from external customers $1,203.6  $565.9  $231.1  $4.2  $132.0  $2,136.8  $1,472.9  $822.6  $354.5  $36.5  $153.2  $2,839.7 
Revenues from unconsolidated joint business $675.3  $200.2  $  $18.1  $32.5  $926.1  $793.2  $272.3  $  $21.7  $41.0  $1,128.2 
Other revenues from external customers $78.1  $27.0  $0.4  $3.2  $  $108.7  $96.5  $32.8  $0.3  $  $  $129.6 
Long-lived assets $1,145.7  $494.9  $2.6  $3.5  $2.0  $1,648.7  $1,111.2  $658.8  $2.5  $4.2  $1.2  $1,777.9 
 
In 2007, we recorded revenue from two wholesale distributors accounting for a total of 19.4% and 15.2% of total product revenue, respectively.
                         
December 31, 2006
 US  Europe  Germany  Asia  Other  Total 
 
Product revenues from external customers $1,069.5  $455.2  $135.8  $0.4  $120.4  $1,781.3 
Revenues from unconsolidated joint business $616.8  $150.2  $  $16.7  $27.2  $810.9 
Other revenues from external customers $61.4  $18.8  $0.1  $10.5  $  $90.8 
In 2006, we recorded revenue from one specialty distributor and three wholesale distributors accounting for a total of 15%, 18%, 14%, and 12% of total product revenue, respectively.
Approximately 28%, 29%, and 30% of our total revenues in 2008, 2007, and 2006, respectively, are derived from our joint business arrangement with Genentech (see Note 17, Unconsolidated Joint Business Arrangement). Included in long lived assets in Europe at December 31, 2008 and 2007 is approximately $611.5 million and $480.5 million, respectively, related to our operations in Denmark.
In 2008, we discovered that amounts previously disclosed in our 2007 financial statements forlong-lived assets in the US, Europe, Asia and Other of $1,021.3 million, $1,516.6 million, $3.1 million, and $89.7 million, respectively, inappropriately includedlong-term marketable securities, as well as misclassifications in geographic categories, principally between the US and Europe.


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BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
                         
December 31, 2007
 U.S.  Europe  Germany  Asia  Other  Total 
 
Product revenues from external customers $1,203.6  $565.9  $231.1  $4.2  $132.0  $2,136.8 
Revenues from unconsolidated joint business $675.3  $200.2  $  $18.1  $32.5  $926.1 
Other revenues from external customers $78.1  $27.0  $0.4  $3.2  $  $108.7 
Long-lived assets $1,145.7  $494.9  $2.6  $3.5  $2.0  $1,648.7 
23.  Severance and Other Restructuring Costs
 
DuringRevenues from Unconsolidated Joint Business
Approximately 25%, 28%, and 29% of our total revenues in 2009, 2008, we incurred $5.0and 2007, respectively, are derived from our joint business arrangement with Genentech (see Note 17,Collaborationsto our Consolidated Financial Statements).
Significant Customers
We recorded revenue from two wholesale distributors accounting for 17.7% and 12.3% of gross product revenues in 2009, 16.2% and 13.1% of gross product revenues in 2008 and 19.4% and 15.2% of gross product revenues in 2007.
Other
Included in long-lived assets in Europe as of December 31, 2009, 2008 and 2007 is approximately $665.8 million, in restructuring costs, primarily$611.5 million and $480.5 million, respectively, related to the reorganization of our legal structure and the consolidation of certain organizational functions, which are includedoperations in research and development and selling, general and administrative expense. During 2007, we incurred $1.8 million in restructuring costs, primarily related to the Syntonix acquisition and the ZEVALIN divestiture, which are included in selling, general and administrative expense. During 2006, we incurred restructuring costs associated with acquisitions and planned dispositions. Specifically, we incurred $1.2 million in severance costs associated with the acquisition of Conforma, and $1.7 million related in headcount reductions related to the planned disposition of our ZEVALIN product line. At December 31, 2008, there are no material remaining restructuring accruals on our consolidated balance sheets.Denmark.
 
24.21.  Guarantees
 
AtAs of December 31, 2009 and 2008, we did not have nosignificant liabilities recorded for guarantees, as defined by No. 45,Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others, an interpretation of FASB Statements No. 5, 57, and 107 and Rescission of FASB Interpretation No. 34,or FIN 45, as the value of our guarantees are not material.guarantees.
 
We enter into indemnification provisions under our agreements with other companies in the ordinary course of business, typically with business partners, contractors, clinical sites and customers. Under these provisions, we generally indemnify and hold harmless the indemnified party for losses suffered or incurred by the indemnified party as a result of our activities. These indemnification provisions generally survive termination of the underlying agreement. The maximum potential amount of future payments we could be required to make under these indemnification provisions is unlimited. However, to date we have not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. As a result, the estimated fair value of these agreements is minimal. Accordingly, we have no liabilities recorded for these agreements as of December 31, 2008.
In connection with the relocation from leased facilities to our research campus in San Diego, California, we entered into a lease assignment, in January 2005, with Tanox West, Inc., or Tanox, for a manufacturing facility in San Diego for which we had outstanding lease obligations through September 2008. This lease has expired2009 and as of December 31, 2008, we have no obligations under this lease.
25.  Facility Impairments and Loss (Gain) on Dispositions
In 2008, as part of the lease agreement described in Note 18, Commitments and Contingencies, we sold the development rights on a parcel of land in Cambridge, MA for $11.4 million in a non monetary transaction and we recorded a pre-tax gain of approximately $9.2 million on the sale. In December 2006, we completed the sale of a research building at our Cambridge, Massachusetts facility. Proceeds from the sale were approximately $39.5 million. We recorded a pre-tax gain of $15.6 million on the sale. We continue to occupy a minor portion of the building under a leasing arrangement. In April 2006, we sold the worldwide rights and other assets of AMEVIVE for $59.8 million, including $43.7 million of inventory on hand, to Astellas Pharma US, Inc. As of December 31, 2005, our AMEVIVE assets held for sale included $8.0 million, net, related to intangible assets, and $5.4 million of property, plant and equipment, net, and were reported separately in current assets on the consolidated balance sheet. The pre-tax gain on this sale of approximately $2.8 million was deferred and is being recognized over the period of a related long-term supply contract. In February 2006, we sold our clinical manufacturing facility in Oceanside, California, known as NICO. The assets associated with the facility were included in assets held for sale on our consolidated balance sheet as of December 31, 2005. Total consideration was $29.0 million. In 2005, we recorded impairment charges totaling $28.0 million to reduce the carrying value of NICO to its net realizable value. No additional loss resulted from completion of the sale.respectively.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
26.  Quarterly Financial Data (Unaudited)
                     
  First
  Second
  Third
  Fourth
    
  Quarter(e)  Quarter  Quarter  Quarter  Total Year 
  (In millions, except per share amounts) 
 
2008
                    
Total revenues $942.2  $993.4  $1,093.0  $1,068.9  $4,097.5 
Product revenue  665.1   684.5   758.3   731.8   2,839.7 
Unconsolidated joint business revenue  247.2   278.8   299.0   303.2   1,128.2 
Other revenue  29.9   30.1   35.7   33.9   129.6 
Total expenses and taxes  779.5   781.4   861.5   827.7   3,249.7 
Other income, net  0.4   (5.5)  (24.7)  (34.9)  (64.7)
Net income  163.1   206.6   206.8   206.7   783.2 
Basic earnings per share  0.55   0.71   0.71   0.71   2.67 
Diluted earnings per share  0.54   0.70   0.70   0.70   2.65 
                     
  First
  Second
  Third
  Fourth
    
  Quarter(a)  Quarter  Quarter (b),(c)  Quarter(d)  Total Year 
  (In millions, except per share amounts) 
 
2007
                    
Total revenues $715.9  $773.2  $789.2  $893.3  $3,171.6 
Product revenue  484.4   518.6   529.6   604.2   2,136.8 
Unconsolidated joint business revenue  207.2   230.6   234.6   253.7   926.1 
Other revenue  24.3   24.0   25.0   35.4   108.7 
Total expenses and taxes  606.1   618.6   714.7   724.8   2,664.2 
Other income, net  21.7   31.5   44.9   32.7   130.8 
Net income  131.5   186.1   119.4   201.2   638.2 
Basic earnings per share  0.39   0.55   0.41   0.68   2.02 
Diluted earnings per share  0.38   0.54   0.41   0.67   1.99 
(a)The first quarter of 2007 includes a charge of $18.4 million for in-process research and development related to the acquisition of Syntonix.
(b)The third quarter of 2007 includes a charge of approximately $30 million for in-process research and development related to our collaboration with Cardiokine Biopharma LLC. This amount was offset by minority interest income of approximately $30 million, representing the value of the underlying technology retained by the parent company of Cardiokine Biopharma LLC.
(c)In July 2007, we purchased 56,424,155 shares of our common stock pursuant to a tender offer. We funded the transaction in July 2007 through existing cash and cash equivalents of $1,490.5 million and by obtaining a short term loan for $1,500.0 million.
(d)The fourth quarter of 2007 includes a charge of $34.3 million for in-process research and development related to our collaboration with Neurimmune. This amount was offset by minority interest income of $34.3 million, representing the value of the underlying technology retained by the parent company of Neurimmune.
(e)The first quarter of 2008 includes a charge of $25.0 million for in process research and development related to a milestone payment made to the former stockholders of Conforma pursuant to our acquisition of Conforma in 2006.


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BIOGEN IDEC INC. AND SUBSIDIARIES
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
 
 
27.22.  Quarterly Financial Data (Unaudited)
                     
  First
  Second
  Third
  Fourth
  Total
 
(In millions, except per share amounts) Quarter(b)  Quarter(c)  Quarter  Quarter(d)(e)  Year 
 
2009
                    
Product revenues $733.4  $791.0  $801.7  $826.8  $3,152.9 
Unconsolidated joint business revenues $278.8  $275.6  $283.9  $256.6  $1,094.9 
Other revenues $24.3  $26.7  $34.9  $43.6  $129.5 
Total revenues $1,036.5  $1,093.3  $1,120.5  $1,127.0  $4,377.3 
Total costs and expenses and income tax expense $796.8  $963.1  $850.3  $827.3  $3,437.5 
Other income (expense), net $6.8  $14.7  $9.4  $6.4  $37.3 
Net income attributable to Biogen Idec Inc.  $244.0  $142.8  $277.7  $305.6  $970.1 
Basic earnings per share attributable to Biogen Idec Inc.  $0.85  $0.49  $0.96  $1.07  $3.37 
Diluted earnings per share attributable to Biogen Idec Inc.  $0.84  $0.49  $0.95  $1.06  $3.35 
                     
  First
  Second
  Third
  Fourth
  Total
 
(In millions, except per share amounts) Quarter(a)  Quarter  Quarter  Quarter  Year 
 
2008
                    
Product revenues $665.1  $684.5  $758.3  $731.8  $2,839.7 
Unconsolidated joint business revenues $247.2  $278.8  $299.0  $303.2  $1,128.2 
Other revenues $29.9  $30.1  $35.7  $33.9  $129.6 
Total revenues $942.2  $993.4  $1,093.0  $1,068.9  $4,097.5 
Total costs and expenses and income tax expense $779.5  $781.4  $861.5  $827.3  $3,249.7 
Other income (expense), net $3.1  $(4.0) $(23.7) $(33.1) $(57.7)
Net income attributable to Biogen Idec Inc.  $163.1  $206.6  $206.8  $206.7  $783.2 
Basic earnings per share attributable to Biogen Idec Inc.  $0.55  $0.71  $0.71  $0.71  $2.67 
Diluted earnings per share attributable to Biogen Idec Inc.  $0.54  $0.70  $0.70  $0.70  $2.65 
(a)Total costs and expenses and income tax expense for the first quarter of 2008 includes $25.0 million ofin-process research and development expense related to a milestone payment made to the former shareholders of Conforma Therapeutics Inc. pursuant to the terms of our acquisition of Conforma Therapeutics Inc. in 2006.
(b)Changes in tax law in certain state jurisdictions in which we operate during the first quarter of 2009 resulted in a $30.2 million reduction to our first quarter 2009 income tax expense.
(c)Total costs and expenses and income tax expense for the second quarter of 2009 includes the $110.0 million upfront payment made to Acorda Therapeutics, Inc. pursuant to our June 30, 2009 collaboration and license agreement to develop and commercialize products containing fampridine in markets outside the U.S.
(d)During the fourth quarter of 2009, we repurchased 8.8 million shares of our common stock at a cost of approximately $422.4 million under our $1.0 billion share repurchase program authorized in October 2009. In addition, we also purchased an additional 6.0 million shares of our common stock at a cost of approximately $271.1 million during the fourth quarter of 2009 under our 2006 share repurchase program.
(e)Resolution of federal, state and foreign tax audits, including the effective settlement of several uncertain tax positions during the fourth quarter of 2009 resulted in a $34.0 million reduction to our fourth quarter 2009 income tax expense.


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BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
23.  New Accounting Pronouncements
 
Effective January 1, 2008, we implemented Statement of Financial Accounting Standard No. 157, Fair Value Measurement,From time to time, new accounting pronouncements are issued by the FASB or SFAS 157, for our financial assets and liabilitiesother standard setting bodies that are re-measured and reported at fair value at each reporting period, and non-financial assets and liabilitiesadopted by the Company as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued standards that are re-measured and reported at fair value at least annually. In accordance with the provisions of FSPFAS 157-2, Effective Date of FASB Statement No. 157, we deferred the implementation of SFAS 157 as it relates to our non-financial assets and non-financial liabilities that are recognized and disclosed at fair value in the financial statements on a nonrecurring basis until January 1, 2009. We are evaluating the impact this standard will have on our financial statements.
On December 12, 2007,EITF 07-01,Accounting for Collaborative Arrangements Related to the Development and Commercialization of Intellectual Property, orEITF 07-01, was issued. EITF-07-01 prescribes the accounting for collaborations. It requires certain transactions between collaborators to be recorded in the income statement on either a gross or net basis within expenses when certain characteristics exist in the collaboration relationship.EITF 07-01 isnot yet effective for all of our collaborations existing after January 1, 2009. The adoption of this standard will not have a material impact on our financial statementsposition or results of operations upon adoption.
Recently Issued Accounting Standards
In October 2009, the FASB issued Accounting Standards Update (ASU)No. 2009-13,Multiple-Deliverable Revenue Arrangements(ASUNo. 2009-13). ASUNo. 2009-13, which amends existing revenue recognition accounting pronouncements and provides accounting principles and application guidance on whether multiple deliverables exist, how the arrangement should be separated, and the consideration allocated. This guidance eliminates the requirement to establish the fair value of undelivered products and services and instead provides for separate revenue recognition based upon management’s estimate of the selling price for an undelivered item when there is no other means to determine the fair value of that undelivered item. Previous accounting principles required that the fair value of the undelivered item be the price of the item either sold in a separate transaction between unrelated third parties or the price charged for each item when the item is sold separately by the vendor. This was difficult to determine when the product was not individually sold because of its unique features. If the fair value of all of the elements in the arrangement was not determinable, then revenue was deferred until all of the items were delivered or fair value was determined. This new approach is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010, which for Biogen Idec means no later than January 1, 2011. Early adoption is permitted; however, adoption of this guidance as of a date other than January 1, 2011, will require us to apply this guidance retrospectively effective as of January 1, 2010 and will require disclosure of the effect of this guidance as applied to all previously reported interim periods in the fiscal year of adoption. While we do not expect the adoption of this standard to have a material impact on our financial position and results of operations, this standard may impact us in the event we complete future transactions or modify existing collaborative relationships.
In June 2009, the FASB issued the following two new accounting standards, which were integrated into the Codification in December 2009:
• ASUNo. 2009-16,Accounting for Transfers of Financial Assets(ASUNo. 2009-16); and
• ASUNo. 2009-17,Improvements to Financial Reporting by Enterprises Involved with Variable Interest Entities(ASUNo. 2009-17).
ASUNo. 2009-16 prescribes the information that a reporting entity must provide in its financial reports about a transfer of financial assets; the effects of a transfer on its financial position, financial performance, and cash flows; and a transferor’s continuing involvement in transferred financial assets. Specifically, among other aspects, this standard amends previously issued accounting guidance, modifies the financial-components approach and removes the concept of a qualifying special purpose entity when accounting for transfers and servicing of financial assets and extinguishments of liabilities, and removes the exception from applying the general accounting principles for the consolidation of variable interest entities that are qualifying special-purpose entities. This new accounting standard is effective for transfers of financial assets occurring on or after January 1, 2010. The adoption of this standard will not have an impact on our financial position or results of operations.
 
OnASUNo. 2009-17 amends previously issued accounting guidance for the consolidation of variable interest entities to require an enterprise to determine whether its variable interest or interests give it a controlling financial interest in a variable interest entity. This amended consolidation guidance for variable interest entities also replaces the existing quantitative approach for identifying which enterprise should consolidate a variable interest entity, which was based on which enterprise is exposed to a majority of the risks and rewards, with a qualitative approach, based on which enterprise has both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses of the entity that could potentially be significant to the variable interest entity or the right to


F-62


BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
receive benefits from the entity that could potentially be significant to the variable interest entity. This new standard may affect how we account for the consolidation of common structures, such as joint ventures, equity method investments, collaboration and other agreements and purchase arrangements. Under this revised guidance, more entities may meet the definition of a variable interest entity, and the determination about whether an enterprise should consolidate a variable interest entity is required to be evaluated continuously. This standard is effective for us for interim and annual periods beginning after January 1, 2010. We have completed our evaluation of the impact of adopting this standard and determined that the adoption will not have an impact on our financial position or results of operations. However, changes to existing relationships or future transactions may result in us consolidating or deconsolidating our partner(s) to collaborations and other arrangements. Refer to Note 17,Collaborationsto our Consolidated Financial Statements for information about our relationships with significant variable interest entities.
Recently Adopted Accounting Standards
In September 2009, the FASB issued ASUNo. 2009-12,Fair Value Measurements and Disclosure (ASUNo. 2009-12). This standard provides additional guidance on using the net asset value per share, provided by an investee, when estimating the fair value of an alternate investment that does not have a readily determinable fair value and enhances the disclosures concerning these investments. Examples of alternate investments, within the scope of this standard, include investments in hedge funds and private equity, real estate, and venture capital partnerships. This standard is effective for interim and annual periods ending after December 4, 2007, Statement15, 2009. As of December 31, 2009, our only investments falling within the scope of this guidance are our venture capital investments. For these investments we use the net asset value to assess fair value. Refer to Note 6,Fair Value Measurementsto our Consolidated Financial Standard No. 141(R),Business Combinations,Statements for additional disclosure related to our venture capital investments. The adoption of this standard did not have an impact on our financial position or SFAS 141(R), was issued.results of operations; however, this standard may impact us in future periods.
In April 2009, the FASB issued a new accounting standard providing guidance for the accounting of assets acquired and liabilities assumed in a business combination that arise from contingencies. This Standard will requireguidance amends and clarifies previous accounting standards to address application issues regarding the initial recognition and measurement, subsequent measurement and accounting, and disclosure of assets and liabilities arising from contingencies in a business combination. Due to the fact that this guidance is applicable to acquisitions completed after January 1, 2009 and we did not have any business combinations during 2009, the adoption of this standard did not impact our financial position or results of operations.
Effective January 1, 2009, we adopted a newly issued accounting standard for business combinations. This standard requires an acquiring company to measure all assets acquired and liabilities assumed, including contingent considerations and all contractual contingencies, at fair value as of the acquisition date. In addition, an acquiring company is required to capitalize IPR&D and either amortize it over the life of the product, or write it off if the project is abandoned or impaired. The StandardDue to the fact that this guidance is effective for transactions occurring on orapplicable to acquisitions completed after January 1, 2009. We2009 and we did not have not determined the effect thatany business combinations during 2009, the adoption of SFAS 141(R) will have onthis standard did not impact our consolidated financial statements, but the effect will generally be limited to future acquisitionsposition or results of operations. The standard also amended accounting for uncertainty in 2009, except for certain tax treatment of previous acquisitions. SFAS 141(R) amended FASB Statement No. 109, Accounting for Income Taxes (SFAS 109), and FIN 48.income taxes. Previously, SFAS 109 and FIN 48, respectively,accounting standards generally required post-acquisitionspost-acquisition adjustments related to business combination related deferred tax asset valuation allowances and liabilities related tofor uncertain tax positions to be recorded as an increase or decrease to goodwill. SFAS 141(R)This new standard does not permit this accounting and, generally, will requirerequires any such changes to be recorded in current period income tax expense. Thus, after SFAS 141(R) is adopted, all changes to valuation allowances and liabilities related tofor uncertain tax positions established in acquisition accounting, (whetherwhether the business combination was accounted for under SFAS 141 or SFAS 141(R)) mustthis guidance, will be recognized in current period income tax expense.
On December 4, 2007, Statement of Financial Standard No. 160,Noncontrolling Interests in Consolidated Financial Statements, an amendment of ARB No. 51, or SFAS 160, was issued. This Standard changes the accounting for and reporting of noncontrolling or minority interests (now called noncontrolling interest) in consolidated financial statements. This Standard is effective January 1, 2009. When implemented, prior periods will be recast for the changes required by SFAS 160. The adoption of this standard will not have a material impact on our financial statements and results of operations.
On March 19, 2008, Statement of Financial Accounting Standard No. 161, Disclosures About Derivative Instruments and Hedging Activities, or SFAS 161, was issued. This Standard enhances the disclosure requirements for derivative instruments and hedging activities. This Standard is effective January 1, 2009. Since SFAS No. 161 requires only additional disclosures concerning derivatives and hedging activities, adoption of SFAS No. 161 will not affect our financial condition, results of operations or cash flows.
On May 5, 2008, Statement of Financial Accounting Standard No. 162, The Hierarchy of Generally Accepted Accounting Principles, or SFAS 162, was issued. This Standard identifies the sources of accounting principles and the framework for selecting the principles to be used in the preparation of financial statements that are presented in conformity with generally accepted accounting principles in the U.S. The adoption of this standard will not have a material impact on our financial statements or results of operations.


F-63


 
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
 
To the Board of Directors and Shareholders of Biogen Idec Inc.:
 
In our opinion, the accompanying consolidated balance sheets and the related consolidated statements of income, shareholders’ equity and cash flows present fairly, in all material respects, the financial position of Biogen Idec Inc. and its subsidiaries atas of December 31, 20082009 and 2007,2008, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 20082009 in conformity with accounting principles generally accepted in the United States of America. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2008,2009 based on criteria established inInternal Control — Integrated Frameworkissued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The Company’s management is responsible for these financial statements, for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in Management’s Annual Report on Internal Control over Financial Reporting. Our responsibility is to express opinions on these financial statements and on the Company’s internal control over financial reporting based on our integrated audits. We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement and whether effective internal control over financial reporting was maintained in all material respects. Our audits of the financial statements included examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.
 
As discussed in Note 15 to the consolidated financial statements, the Company changed the manner in which it accounts for income tax contingencies in 2007.
A company’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’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) 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 (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’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.
 
/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
February 6, 20099, 2010


F-64


EXHIBIT INDEX
 
     
Exhibit No.
 
Descriptionˆ
 
 3.1 Amended and Restated Certificate of Incorporation. Filed as Exhibit 3.1 to our Annual Report onForm 10-K for the year ended December 31, 2003.
 3.2 Certificate of Amendment to the Amended and Restated Certificate of Incorporation dated May 21, 2001. Filed as Exhibit 3.2 to our Annual Report onForm 10-K for the year ended December 31, 2003.
 3.3 Certificate Increasing the Number of Authorized Shares of Series X Junior Participating Preferred Stock dated July 26, 2001. Filed as Exhibit 3.3 to our Annual Report onForm 10-K for the year ended December 31, 2003.
 3.4 Certificate of Amendment to the Amended and Restated Certificate of Incorporation dated November 12, 2003. Filed as Exhibit 3.4 to our Annual Report onForm 10-K for the year ended December 31, 2003.
 3.5 Second Amended and Restated Bylaws. Filed as Exhibit 3.1 to our Quarterly Report onForm 10-Q for the quarter ended September 30, 2008.
 4.1 Reference is made to Exhibit 3.1 for a description of the rights, preferences and privileges of our Series A Preferred Stock and Series X Junior Participating Preferred Stock
 4.2 Amended and Restated Rights Agreement between Biogen Idec and Mellon Investor Services LLC dated as of July 26, 2001. Filed as Exhibit 4.1 to an amendment to our Registration Statement onForm 8-A filed on July 27, 2001.
 4.3 Amendment No. 1 to Amended and Restated Rights Agreement between Biogen Idec and Mellon Investor Services LLC dated as of June 20, 2003. Filed as Exhibit 4.1 to our Current Report onForm 8-K filed on June 23, 2003.
 4.4+ Amendment No. 2 to Amended and Restated Rights Agreement between Biogen Idec and Mellon Investor Services LLC dated as of January 22, 2009.
 10.1 Credit Agreement among Biogen Idec, Bank of America, N.A. as administrative agent, Merrill Lynch, Pierce, Fenner & Smith Incorporated and Goldman Sachs Credit Partners L.P. as co-syndication agents, and the other lenders party thereto dated June 29, 2007. Filed as Exhibit 99.2 to our Current Report onForm 8-K filed on July 2, 2007.
 10.2 Indenture between Biogen Idec and The Bank of New York Trust Company, N.A. dated as of February 26, 2008. Filed as Exhibit 4.1 to our Registration Statement onForm S-3(File No. 333-149379).
 10.3 First Supplemental Indenture between Biogen Idec and The Bank of New York Trust Company, N.A. dated as of March 4, 2008. Filed as Exhibit 4.1 to our Current Report onForm 8-K filed on March 4, 2008.
 10.4† Expression Technology Agreement between Biogen Idec and Genentech. Inc. dated March 16, 1995. Filed as an exhibit to Biogen Idec’s Quarterly Report onForm 10-Q for the quarter ended March 31, 1995.
 10.5 Letter Agreement between Biogen Idec and Genentech, Inc. dated May 21, 1996. Filed as Exhibit 10.1 to our Current Report onForm 8-K filed on June 6, 1996.
 10.6† Amended and Restated Collaboration Agreement between Biogen Idec and Genentech, Inc. dated June 19, 2003. Filed as Exhibit 99.1 to our Current Report onForm 8-K filed on July 31, 2003.
 10.7† Purchase and Sale Agreement and Joint Escrow Instructions between Biogen Idec and Genentech, Inc. dated as of June 16, 2005. Filed as Exhibit 10.1 to our Quarterly Report onForm 10-Q for the quarter ended June 30, 2005.
 10.8† ANTEGREN (now TYSABRI) Development and Marketing Collaboration Agreement between Biogen Idec and Elan Pharma International Limited dated August 15, 2000. Filed as Exhibit 10.48 to Biogen, Inc.’s Annual Report onForm 10-K for the year ended December 31, 2002(File No. 0-12042) and incorporated herein by reference.
 10.9† License Agreement between Biogen Idec and Coulter Immunology (now Corixa Corporation) dated May 16, 1991. Filed as an exhibit to our Registration Statement onForm S-1 (FileNo. 33-40756).


A-1


     
Exhibit No.
 
Descriptionˆ
 
 10.10† Collaboration & License Agreement between Biogen Idec and Schering Aktiengesellschaft dated June 9, 1999. Filed as Exhibit 10.10 to our Quarterly Report onForm 10-Q for the quarter ended June 30, 1999.
 10.11 Cambridge Center Lease between Mortimer Zuckerman, Edward H. Linde and David Barrett, as Trustees of Fourteen Cambridge Center Trust, and B. Leasing, Inc. dated October 4, 1982. Filed as an exhibit to Biogen, Inc.’s Registration Statement onForm S-1 (FileNo. 2-81689) and incorporated herein by reference.
 10.12 First Amendment to Lease dated January 19, 1989, amending Cambridge Center Lease dated October 4, 1982. Filed as an exhibit to Biogen, Inc.’s Annual Report onForm 10-K for the year ended December 31, 1992 (FileNo. 0-12042) and incorporated herein by reference.
 10.13 Second Amendment to Cambridge Center Lease dated March 8, 1990. Filed as an exhibit to Biogen, Inc.’s Annual Report onForm 10-K for the year ended December 31, 1992 (FileNo. 0-12042) and incorporated herein by reference.
 10.14 Third Amendment to Cambridge Center Lease dated September 25, 1991. Filed as an exhibit to Biogen, Inc.’s Annual Report onForm 10-K for the year ended December 31, 1992 (FileNo. 0-12042) and incorporated herein by reference.
 10.15 Fourth Amendment to Cambridge Center Lease dated October 6, 1993. Filed as an exhibit to Biogen, Inc.’s Annual Report onForm 10-K for the year ended December 31, 1997 (FileNo. 0-12042) and incorporated herein by reference.
 10.16 Fifth Amendment to Cambridge Center Lease dated October 9, 1997. Filed as an exhibit to Biogen, Inc.’s Annual Report onForm 10-K for the year ended December 31, 1997 (FileNo. 0-12042) and incorporated herein by reference.
 10.17 Lease agreement between Biogen Idec BV and TUG Vastgoed B.V. dated as of September 24, 2004. Filed as Exhibit 10.1 to our Current Report onForm 8-K filed on September 29, 2004.
 10.18* Biogen Idec Inc. 2008 Omnibus Equity Plan. Filed as Appendix A to our Definitive Proxy Statement on Schedule 14A filed on May 8, 2008.
 10.19*+ Amendment to Biogen Idec Inc. 2008 Omnibus Equity Plan dated October 13, 2008.
 10.20* Form of restricted stock unit award agreement under the Biogen Idec Inc. 2008 Omnibus Equity Plan. Filed as Exhibit 10.1 to our Current Report onForm 8-K filed on August 1, 2008.
 10.21* Form of nonqualified stock option award agreement under the Biogen Idec Inc. 2008 Omnibus Equity Plan. Filed as Exhibit 10.2 to our Current Report onForm 8-K filed on August 1, 2008.
 10.22* Biogen Idec Inc. 2006 Non-Employee Directors Equity Plan. Filed as Appendix A to our Definitive Proxy Statement on Schedule 14A filed on April 14, 2006.
 10.23* Amendment to the Biogen Idec Inc. 2006 Non-Employee Directors Equity Plan dated October 11, 2006. Filed as Exhibit 10.45 to our Annual Report onForm 10-K for the year ended December 31, 2007.
 10.24* Amendment to Biogen Idec Inc. 2006 Non-Employee Directors Equity Plan dated April 18, 2008. Filed as Exhibit 10.8 to our Quarterly Report onForm 10-Q for the quarter ended June 30, 2008.
 10.25*+ Amendment to Biogen Idec Inc. 2006Non-Employee Directors Equity Plan dated October 13, 2008.
 10.26* Biogen Idec Inc. 2005 Omnibus Equity Plan. Filed as Appendix A to our Definitive Proxy Statement on Schedule 14A filed on April 15, 2005.
 10.27* Amendment No. 1 to the Biogen Idec Inc. 2005 Omnibus Equity Plan dated April 4, 2006. Filed as Exhibit 10.1 to our Quarterly Report onForm 10-Q for the quarter ended March 31, 2007.
 10.28* Amendment No. 2 to the Biogen Idec Inc. 2005 Omnibus Equity Plan dated February 12, 2007. Filed as Exhibit 10.2 to our Quarterly Report onForm 10-Q for the quarter ended March 31, 2007.
 10.29* Amendment to the Biogen Idec Inc. 2005 Omnibus Equity Plan dated April 18, 2008. Filed as Exhibit 10.7 to our Quarterly Report onForm 10-Q for the quarter ended June 30, 2008.
 10.30*+ Amendment to Biogen Idec Inc. 2005 Omnibus Equity Plan dated October 13, 2008.
 10.31* Biogen Idec Inc. 2003 Omnibus Equity Plan. Filed as Exhibit 10.73 to our Current Report onForm 8-K filed on November 12, 2003.


A-2


   
Exhibit No.
 
Descriptionˆ
 
3.110.32*Amended and Restated Certificate of Incorporation. Filed as Exhibit 3.1 to our Annual Report on Form 10-K for the year ended December 31, 2003.
3.2Certificate of Amendment to the Amended and Restated Certificate of Incorporation dated May 21, 2001. Filed as Exhibit 3.2 to our Annual Report on Form 10-K for the year ended December 31, 2003.
3.3Certificate Increasing the Number of Authorized Shares of Series X Junior Participating Preferred Stock dated July 26, 2001. Filed as Exhibit 3.3 to our Annual Report on Form 10-K for the year ended December 31, 2003.
3.4Certificate of Amendment to the Amended and Restated Certificate of Incorporation dated November 12, 2003. Filed as Exhibit 3.4 to our Annual Report on Form 10-K for the year ended December 31, 2003.
3.5Second Amended and Restated Bylaws, as amended. Filed as Exhibit 3.1 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2009.
4.1Reference is made to Exhibits 3.1 through 3.4 for a description of the rights, preferences and privileges of our Series A Preferred Stock and Series X Junior Participating Preferred Stock
4.2Amended and Restated Rights Agreement between Biogen Idec and Mellon Investor Services LLC dated as of July 26, 2001. Filed as Exhibit 4.1 to an amendment to our Registration Statement onForm 8-A filed on July 27, 2001.
4.3Amendment No. 1 to Amended and Restated Rights Agreement between Biogen Idec and Mellon Investor Services LLC dated as of June 20, 2003. Filed as Exhibit 4.1 to our Current Report onForm 8-K filed on June 23, 2003.
4.4Amendment No. 2 to Amended and Restated Rights Agreement between Biogen Idec and Mellon Investor Services LLC dated as of January 22, 2009. Filed as Exhibit 4.4 to our Annual Report onForm 10-K for the year ended December 31, 2008.
4.5Indenture between Biogen Idec and The Bank of New York Trust Company, N.A. dated as of February 26, 2008. Filed as Exhibit 4.1 to our Registration Statement on Form S-3 (File No. 333-149379).
4.6First Supplemental Indenture between Biogen Idec and The Bank of New York Trust Company, N.A. dated as of March 4, 2008. Filed as Exhibit 4.1 to our Current Report on Form 8-K filed on March 4, 2008.
10.1Credit Agreement among Biogen Idec, Bank of America, N.A. as administrative agent, Merrill Lynch, Pierce, Fenner & Smith Incorporated and Goldman Sachs Credit Partners L.P. as co-syndication agents, and the other lenders party thereto dated June 29, 2007. Filed as Exhibit 99.2 to our Current Report on Form 8-K filed on July 2, 2007.
10.2Amendment No. 1 to Credit Agreement among Biogen Idec, Bank of America, N.A. as administrative agent, and the other lenders party thereto dated as of March 5, 2009. Filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2009.
10.3†Expression Technology Agreement between Biogen Idec and Genentech. Inc. dated March 16, 1995. Filed as an exhibit to Biogen Idec’s Quarterly Report on Form 10-Q for the quarter ended March 31, 1995.
10.4Letter Agreement between Biogen Idec and Genentech, Inc. dated May 21, 1996. Filed as Exhibit 10.1 to our Current Report on Form 8-K filed on June 6, 1996.
10.5†Amended and Restated Collaboration Agreement between Biogen Idec and Genentech, Inc. dated June 19, 2003. Filed as Exhibit 99.1 to our Current Report on Form 8-K filed on July 31, 2003.
10.6†Purchase and Sale Agreement and Joint Escrow Instructions between Biogen Idec and Genentech, Inc. dated as of June 16, 2005. Filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2005.
10.7†ANTEGREN (now TYSABRI) Development and Marketing Collaboration Agreement between Biogen Idec and Elan Pharma International Limited dated August 15, 2000. Filed as Exhibit 10.48 to Biogen, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2002 (File No. 0-12042) and incorporated herein by reference.


A-1


Exhibit No.
Descriptionˆ
10.8*Biogen Idec Inc. 2008 Omnibus Equity Plan. Filed as Appendix A to our Definitive Proxy Statement on Schedule 14A filed on May 8, 2008.
10.9*Amendment to Biogen Idec Inc. 2008 Omnibus Equity Plan dated October 13, 2008. Filed as Exhibit 10.19 to our Annual Report on Form 10-K for the year ended December 31, 2008.
10.10*Form of restricted stock unit award agreement under the Biogen Idec Inc. 2008 Omnibus Equity Plan. Filed as Exhibit 10.1 to our Current Report on Form 8-K filed on August 1, 2008.
10.11*Form of nonqualified stock option award agreement under the Biogen Idec Inc. 2008 Omnibus Equity Plan. Filed as Exhibit 10.2 to our Current Report on Form 8-K filed on August 1, 2008.
10.12*Biogen Idec Inc. 2006 Non-Employee Directors Equity Plan. Filed as Appendix A to our Definitive Proxy Statement on Schedule 14A filed on April 14, 2006.
10.13*Amendment to the Biogen Idec Inc. 2006 Non-Employee Directors Equity Plan dated October 11, 2006. Filed as Exhibit 10.45 to our Annual Report on Form 10-K for the year ended December 31, 2007.
10.14*Amendment to Biogen Idec Inc. 2006 Non-Employee Directors Equity Plan dated April 18, 2008. Filed as Exhibit 10.8 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2008.
10.15*Amendment to Biogen Idec Inc. 2006 Non-Employee Directors Equity Plan dated October 13, 2008. Filed as Exhibit 10.25 to our Annual Report on Form 10-K for the year ended December 31, 2008.
10.16*Biogen Idec Inc. 2005 Omnibus Equity Plan. Filed as Appendix A to our Definitive Proxy Statement on Schedule 14A filed on April 15, 2005.
10.17*Amendment No. 1 to the Biogen Idec Inc. 2005 Omnibus Equity Plan dated April 4, 2006. Filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2007.
10.18*Amendment No. 2 to the Biogen Idec Inc. 2005 Omnibus Equity Plan dated February 12, 2007. Filed as Exhibit 10.2 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2007.
10.19*Amendment to the Biogen Idec Inc. 2005 Omnibus Equity Plan dated April 18, 2008. Filed as Exhibit 10.7 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2008.
10.20*Amendment to Biogen Idec Inc. 2005 Omnibus Equity Plan dated October 13, 2008. Filed as Exhibit 10.30 to our Annual Report on Form 10-K for the year ended December 31, 2008.
10.21*Biogen Idec Inc. 2003 Omnibus Equity Plan. Filed as Exhibit 10.73 to our Current Report on Form 8-K filed on November 12, 2003.
1022* Amendment to Biogen Idec Inc. 2003 Omnibus Equity Plan. Filed as Exhibit 10.1 to our Quarterly Report onForm 10-Q for the quarter ended March 31, 2005.
10.33*10.23* Amendment to Biogen Idec Inc. 2003 Omnibus Equity Plan dated April 18, 2008. Filed as Exhibit 10.6 to our Quarterly Report onForm 10-Q for the quarter ended June 30, 2008.
10.34*+10.24* Amendment to Biogen Idec Inc. 2003 Omnibus Equity Plan dated October 13, 2008. Filed as Exhibit 10.34 to our Annual Report on Form 10-K for the year ended December 31, 2008.
10.35*10.25* Biogen Idec Inc. 1995 Employee Stock Purchase Plan as amended and restated effective April 6, 2005. Filed as Appendix B to our Definitive Proxy Statement on Schedule 14A filed on April 15, 2005.
10.36*10.26* IDEC Pharmaceuticals Corporation 1993 Non-Employee Directors Stock Option Plan, as amended and restated through February 19, 2003. Filed as Appendix B to our Definitive Proxy Statement on Schedule 14A filed on April 11, 2003.
10.37*10.27* Amendment to IDEC Pharmaceuticals Corporation 1993 Non-Employee Directors Stock Option Plan dated April 18, 2008. Filed as Exhibit 10.5 to our Quarterly Report onForm 10-Q for the quarter ended June 30, 2008.
10.38*10.28* IDEC Pharmaceuticals Corporation 1988 Stock Option Plan, as amended and restated through February 19, 2003. Filed as Appendix A to our Definitive Proxy Statement on Schedule 14A filed on April 11, 2003.
10.39*10.29* Amendment to the IDEC Pharmaceuticals Corporation 1988 Stock Option Plan dated April 16, 2004. Filed as Exhibit 10.1 to our Quarterly Report onForm 10-Q for the quarter ended June 30, 2004.
10.40*10.30* Amendment to IDEC Pharmaceuticals Corporation 1988 Stock Option Plan dated April 18, 2008. Filed as Exhibit 10.4 to our Quarterly Report onForm 10-Q for the quarter ended June 30, 2008.


A-2


 10.41*
Exhibit No.
Descriptionˆ
10.31* Biogen, Inc. 1987 Scientific Board Stock Option Plan (as amended and restated through February 7, 2003). Filed as Exhibit 10.22 to Biogen, Inc.’s Annual Report onForm 10-K for the year ended December 31, 2002 (FileNo. 0-12042) and incorporated herein by reference.
10.42*10.32* Amendment to Biogen, Inc. 1987 Scientific Board Stock Option Plan dated April 18, 2008. Filed as Exhibit 10.3 to our Quarterly Report onForm 10-Q for the quarter ended June 30, 2008.
10.43*10.33* Biogen, Inc. 1985 Non-Qualified Stock Option Plan, as amended and restated through April 11, 2003. Filed as Exhibit 10.22 to our Annual Report onForm 10-K for the year ended December 31, 2007.
10.44*10.34* Amendment to Biogen, Inc. 1985 Non-Qualified Stock Option Plan dated April 18, 2008. Filed as Exhibit 10.2 to our Quarterly Report onForm 10-Q for the quarter ended June 30, 2008.
10.45*+10.35* Amendment to Biogen, Inc. 1985Non-Qualified Stock Option Plan dated October 13, 2008. Filed as Exhibit 10.45 to our Annual Report on Form 10-K for the year ended December 31, 2008.
10.46*10.36* Biogen Idec Inc. 2008 Performance-Based Management Incentive Plan. Filed as Appendix B to Biogen Idec’s Definitive Proxy Statement on Schedule 14A filed on May 8, 2008.
10.47*10.37* Biogen Idec Inc. 2003 Performance-Based Management Incentive Plan. Filed as Exhibit 10.74 to our Current Report onForm 8-K filed on November 12, 2003.
10.48*10.38* Voluntary Executive Supplemental Savings Plan, as amended and restated effective January 1, 2004. Filed as Exhibit 10.13 to our Annual Report onForm 10-K for the year ended December 31, 2003.
10.49*10.39* Supplemental Savings Plan, as amended and restated effective January 1, 2008. Filed as Exhibit 10.55 to our Annual Report onForm 10-K for the year ended December 31, 2007.
10.50*10.40* Voluntary Board of Directors Savings Plan, as amended and restated effective January 1, 2008. Filed as Exhibit 10.56 to our Annual Report onForm 10-K for the year ended December 31, 2007.
10.51*+10.41* Biogen Idec Inc. Executive Severance Policy -- U.S. Executive Vice President, as amended effective October 13, 2008. Filed as Exhibit 10.51 to our Annual Report on Form 10-K for the year ended December 31, 2008.
10.52*+10.42* Biogen Idec Inc. Executive Severance Policy -- International Executive Vice President, as amended effective October 13, 2008. Filed as Exhibit 10.52 to our Annual Report on Form 10-K for the year ended December 31, 2008.
10.53*+10.43* Biogen Idec Inc. Executive Severance Policy -- U.S. Senior Vice President, as amended effective October 13, 2008. Filed as Exhibit 10.53 to our Annual Report on Form 10-K for the year ended December 31, 2008.
10.54*+10.44* Biogen Idec Inc. Executive Severance Policy -- International Senior Vice President, as amended effective October 13, 2008. Filed as Exhibit 10.54 to our Annual Report on Form 10-K for the year ended December 31, 2008.
10.55*10.45* Annual Retainer Summary for Board of Directors. Filed as Exhibit 10.110.3 to our Quarterly Report onForm 10-Q for the quarter ended SeptemberJune 30, 2008.


A-3


2009.
Exhibit No.
Descriptionˆ
10.56*10.46* Form of indemnification agreement for directors. Filed as Exhibit 10.1 to our Current Report onForm 8-K filed on October 17, 2008.
10.57*10.47* Employment Agreement between Biogen Idec and James C Mullen dated as of June 20, 2003. Filed as Exhibit 10.2 to our Registration Statement onForm S-4 (FileNo. 333-107098).
10.58*10.48* First Amendment to Employment Agreement between Biogen Idec and James C. Mullen dated February 7, 2006. Filed as Exhibit 10.1 to our Current Report onForm 8-K filed on February 10, 2006.
10.59*+10.49* Second Amendment to Employment Agreement between Biogen Idec and James C. Mullen dated as of December 4, 2008. Filed as Exhibit 10.59 to our Annual Report on Form 10-K for the year ended December 31, 2008.
10.50*+10.60*Transition Agreement between Biogen Idec and James C. Mullen dated as of January 4, 2010.
10.51* Letter regarding employment arrangement of Paul J. Clancy dated August 17, 2007. Filed as Exhibit 10.49 to our Annual Report onForm 10-K for the year ended December 31, 2007.
10.61*10.52*+Employment Agreement between Biogen Idec Management Services GmbH and Hans Peter Hasler dated October 15, 2008.
10.62* Letter regarding employment arrangement of Cecil B. PickettRobert Hamm dated June 21, 2006. Filed as April 1, 2009.


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Exhibit 10.1 to our Quarterly Report onForm 10-Q for the quarter ended September 30, 2006.No.
Descriptionˆ
 10.63*+First Amendment to Employment Agreement between Biogen Idec and Cecil B. Pickett dated October 28, 2008.
10.64*Letter agreement regarding employment arrangement of Robert Hamm dated October 15, 2007. Filed as Exhibit 10.50 to our Annual Report onForm 10-K for the year ended December 31, 2007.
10.65*10.53* Letter regarding employment arrangement of Craig E. Schneier dated October 8, 2001. Filed as Exhibit 10.53 to our Annual Report onForm 10-K for the year ended December 31, 2005.
10.66*+10.54* First Amendment to Employment Agreement between Biogen Idec and Craig E. Schneier dated October 8, 2008. Filed as Exhibit 10.66 to our Annual Report on Form 10-K for the year ended December 31, 2008.
10.55*21Employment Agreement between Biogen Idec Management Services GmbH and Hans Peter Hasler dated October 15, 2008. Filed as Exhibit 10.61 to our Annual Report onForm 10-K for the year ended December 31, 2008.
10.56*Consulting Agreement between Eidetica Biopharma GmBH and Hans Peter Hasler dated April 30, 2009. Filed as Exhibit 10.1 to our Quarterly Report onForm 10-Q for the quarter ended June 30, 2009.
10.57*Director Agreement between Biogen Idec International B.V. and Hans Peter Hasler dated April 30, 2009. Filed as Exhibit 10.2 to our Quarterly Report onForm 10-Q for the quarter ended June 30, 2009.
10.58*+ SubsidiariesLetter regarding employment arrangement of Susan Alexander dated December 13, 2005.
21+23.1+Subsidiaries.
23+ Consent of PricewaterhouseCoopers LLP, an Independent Registered Public Accounting FirmFirm.
31.1+31.1+ Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 20022002.
31.2+31.2+ Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 20022002.
32.1+32.1++ Certification of the Chief Executive Officer and the Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 20022002.
101++The following materials from Biogen Idec Inc.’s Annual Report on Form 10-K for the year ended December 31, 2009, formatted in XBRL (Extensible Business Reporting Language): (i) the Consolidated Statements of Income, (ii) the Consolidated Balance Sheets, (iii) the Consolidated Statements of Cash Flows, (iv) the Consolidated Statement of Shareholders’ Equity and (v) Notes to Consolidated Financial Statements, tagged as blocks of text.
 
 
ˆReference to “our” filings mean filings made by Biogen Idec Inc. and filings made by IDEC Pharmaceuticals Corporation prior to the merger with Biogen, Inc. Unless otherwise indicated, exhibits were previously filed with the Securities and Exchange Commission under Commission File Number 0-19311 and are incorporated herein by reference.
 
*Management contract or compensatory plan or arrangement.
 
Confidential Treatment has been granted with respect to portions of this agreement.
 
+Filed herewith.
 
++Furnished herewith.


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