o Yes o No
Pursuant to Rule 12b-23(a) of the Securities Exchange Act of 1934, as amended, the information for the 20072008 Form 20-F of AstraZeneca PLC (the “Company”) set out below is being incorporated by reference from the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated and submitted on March 12, 2008.17, 2009.
References below to major headings include all information under such major headings, including subheadings, unless such reference is part of a reference to a subheading, in which case such reference includes only the information contained under such subheading. Graphs and tabular data are not included unless specifically identified below. Photographs are also not included.
In addition to the information set out below, the information set forth under the headings “Cautionary statement regarding forward-looking statements”, “Inclusion of reported, constant exchange rate and core financial measures”, “Statements of competitive position, growth rates and sales”, “AstraZeneca websites” and “External/third party websites” on the inside front cover, the information set forth under the headingspage 1, “Trade marks”, “Use of terms”, and “Statements of dates”, “Statements of competitive position”, “Statements of growth rates, sales and market data” and “AstraZeneca websites” on the inside back cover, “Definitions and the informationInterpretation” on page 196, “Cross-Reference to Form 20-F” on page 198 and “Glossary” on pages 202199 to 204,200, in each case of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
PART I1
ITEM 1 - IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not applicable.
ITEM 2 - OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
ITEM 3 - KEY INFORMATION
A. Selected Financial Data
The information (including graphs and tabular data) set forth under the headings “Financial“AstraZeneca and our Year in Brief—Financial Highlights” on pagespage 2, and 3,“Directors’ Report—Reporting our Performance – Financial” on page 15, “Financial Statements—Notes to the Financial Statements—Note 30—20—Share Capital of Parent Company” (including tabular data) on page 176, “Financial Statements—Group129, “Group Financial Record” (including tabular data) on page 184172 and the first table that appears under “Additional Information—Shareholder Information” on page 186,190, in each case of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference. The selected financial data incorporated by reference herein is derived from audited financial statements of the Company and its consolidated entities, prepared in accordance with International Financial Reporting Standards (“IFRS”) as adopted by the European Union and IFRS as issued by the International Accounting Standards Board.Board, included in the Company’s “Annual Report and Form 20-F Information 2008” included as exhibit 15.1 to this Form 20-F dated March 17, 2009.
The following tables show certain information regarding the exchange rate for pounds sterling, for the periods and dates indicated through February 28, 2009, based on the Noon Buying Rate certified by the New York Federal Reserve Bank (the “Noon Buying Rate”) for customs purposes for pounds sterling expressed in US dollars per £1.00, and, for the periods and dates indicated from March 1, 2009 to March 6, 2009 and for the yearly average data for 2009, based on the Bloomberg Foreign Exchange Fixings Rate (the “BFIX Rate”) at noon expressed in US dollars per £1.00, unless otherwise specified.
The noon exchange rate, based on the BFIX Rate, as at March 6, 2009, the latest practicable date for which exchange rate data was available, was £1.00 = $1.41.
| | | | | | | | | | | | | | | | | | | | | |
High | | | 1.42 | | | | 1.49 | | | | 1.53 | | | | 1.55 | | | | 1.62 | | | | 1.78 | | | | 1.86 | |
Low | | | 1.41 | | | | 1.42 | | | | 1.37 | | | | 1.44 | | | | 1.48 | | | | 1.55 | | | | 1.75 | |
Monthly Average (through March 6, 2009)(1) | | | 1.41 | | | | 1.44 | | | | 1.45 | | | | 1.49 | | | | 1.53 | | | | 1.69 | | | | 1.80 | |
| | | | | | | | | | | | | | | | | | |
Yearly Average(2) | | | 1.44 | | | | 1.84 | | | | 2.01 | | | | 1.86 | | | | 1.81 | | | | 1.84 | |
(1) Average of the Noon Buying Rate (or the BFIX Rate, in the case of March, 2009), on the last available date of publication within the relevant month.
(2) Average of the Noon Buying Rate on the last day of each full month during the period (or, in the case of 2009, the BFIX Rate on the last available date of publication within the relevant month).
B. Capitalization and Indebtedness
Not applicable.
C. Reason for the Offer and Use of Proceeds
Not applicable.
D. Risk Factors
The information set forth or referenced under the heading “Additional Information—Risk”“Directors’ Report—Risk—Principal Risks and Uncertainties” on pages 19376 to 19982 of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
ITEM 4 - INFORMATION ON THE COMPANY
A. History and Development of the Company
The information (including tabular data) set forth under the headings “Additional Information—Corporate Information—History and Development of the Company” on page 200,197, “Directors’ Report—Our Resources, Skills and Capabilities—Our Resources” and “—Supply and Manufacturing—Supply capability”Manufacturing” on page 34,pages 18 (third paragraph only) and 27 respectively, “Directors’ Report—Financial Review—Financial Position, Includingincluding Cash Flow and Liquidity—Liquidity – 2008—Property, plant and equipment”, and “—Cash flow”, on pages 35 and “—36, respectively, “Directors’ Report— Financial Position, including Cash Flow and Liquidity – 2007—Investments, divestments and capital expenditure” on pages 81 to 83, “Directors’ Report—Financial Review—Acquisition of MedImmune”, on pages 83 and 84,page 41, “Financial Statements—Notes to the Financial Statements—Note 8—7—Property, Plant and Equipment” on pages 131114 and 132115 and “Financial Statements—Notes to the Financial Statements—Note 24—22—Acquisitions of Business Operations” on pages 145130 to 148,133, in each case of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
B. Business Overview
The information set forth under the heading “AstraZeneca and our Year in Brief” on page 1, the information (including graphs and tabular data) set forth under the headings “AstraZeneca and our Year in Brief” on pages 2 to 3, “Directors’ Report” on pages 8 to 76,30 (excluding the “Expanding Patient Populations” graphic and the first and third paragraphs under the heading “Expanding Patient Population, on page 10) and pages 48 to 73, “Financial Statements—Notes to the Financial Statements—Note 5—Segment Information” and “—Note 6—SegmentProduct Revenue Information” on pages 128111 to 129, “Financial Statements—Notes to the Financial Statements—Note 7—Product Sales Information” on page 130113, and “Statements of competitive position”position, growth rates and sales” on the inside back cover,page 1, in each case of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
FDA Approves Symbicort for COPD
On March 2, 2009, the Company announced that the U.S. Food and Drug Administration (FDA) has approved SYMBICORT (budesonide/formoterol fumarate dihydrate) 160/4.5 mcg for the twice daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
The FDA approval is based on results from two pivotal clinical trials, SHINE (6-month) and SUN (12-month), which found SYMBICORT improved lung function within five minutes of the first dose and sustained that lung function improvement for the duration of the studies. SYMBICORT pMDI (pressurized metered-dose inhaler) has been available in the U.S. since June, 2007 for the long-term maintenance treatment of asthma in patients 12 years of age and older.
Seroquel XR – FDA Complete Response Letter and Psychopharmacologic Drugs Advisory Committee
On February 27, 2009, the Company announced that it had received a Complete Response Letter (CRL) from the FDA asking for additional information for the supplemental New Drug Application (sNDA) for SEROQUEL XR (quetiapine fumarate) Extended Release Tablets for the treatment of Generalised Anxiety Disorder (GAD) in adult patients. AstraZeneca is evaluating the contents of the CRL and the proposed labelling revisions.
On February 25, 2009, the Company announced that it had been advised by the FDA that the FDA Psychopharmacologic Drugs Advisory Committee (PDAC) is tentatively scheduled to meet on April 8, 2009, to discuss the safety and efficacy of sNDAs for SEROQUEL XR proposed for the treatment of major depressive disorder (MDD) and GAD.
Partnership with MAP Pharmaceuticals – Unit Dose Budesonide
On February 23, 2009, MAP Pharmaceuticals, Inc. announced that its initial Phase III clinical trial of Unit Dose Budesonide (UDB) for the potential treatment of children with asthma did not meet its co-primary endpoints: asthma control as assessed by changes from baseline in night-time and daytime composite symptom scores, in either of the doses evaluated when compared with placebo.
The Company and MAP Pharmaceuticals announced, in December, 2008, an exclusive worldwide agreement to develop and commercialise UDB, MAP Pharmaceuticals’ proprietary nebulised formulation of budesonide. This agreement is subject to review in the United States under the U.S. Hart-Scott-Rodino Act and becomes effective after the waiting period has ended. The Company intends to work with MAP Pharmaceuticals to conduct further analyses of these data to determine appropriate next steps for the programme.
Primary Endpoint for PN 400 Phase III Clinical Programmes
On January 29, 2009, the Company announced that its HORIZON III Phase II/III head-to-head study of RECENTIN (cediranib, AZD2171) with chemotherapy versus bevacizumab (Avastin) with chemotherapy in patients with first line metastatic colorectal cancer (CRC) will be progressing directly intoco-development partner for the investigational compound PN 400, POZEN Inc., has been informed that the FDA has completed its internal discussions and that there is no change to the previous agreements that gastric ulcer incidence is an acceptable primary endpoint for the PN 400 Phase III at 20mg. Patients will also continue to be recruited at 20mg intoclinical programmes. In October, the first line CRC HORIZON II study of RECENTIN with chemotherapy versus chemotherapy alone.
The HORIZON Independent Data Monitoring Committee (IDMC) conducted a planned end of Phase II (EOP II) review of efficacy and tolerability data from HORIZON I, HORIZON II and HORIZON III. Data from HORIZON I, in second line colorectal cancer, would not by itself have contributed to a positive EOP II decision. However, when combined with a review of data from HORIZON II and III by the IDMC, the IDMC confirmed the HORIZON programme in 1st line CRC could continue and HORIZON II and IIIFDA had met pre-defined EOP II criteria.
AstraZeneca also announced that they were conducting an internal review on the National Cancer Instituteacceptability of Canada Clinical Trials Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study of RECENTIN at 30mggastric ulcers as a primary endpoint in first line non-small cell lung cancer (NSCLC) will not continue into Phase III following the planned end of Phase II efficacy and tolerability analysis by the study’s Data Safety Monitoring Committee. Although evidence of clinical activity was seen, there appeared to be an imbalance in toxicity and therefore the study was considered not to have met the pre-defined criteria for automatic continuation into Phase III.
AstraZeneca is working in close collaboration with the NCIC-CTG to understand the BR24 data further.
In addition to colorectal and non-small cell lung cancer, the RECENTIN development programme includes trials in recurrent glioblastoma and a number of signal search studies in other tumours.studies.
C. Organizational Structure
The information set forth under the headings “Directors’ Report—Corporate GovernanceOther Matters—Other Company Disclosures and Managing Risk—Corporate Governance: Other Matters—Information—Subsidiaries and principal activities” on page 4594 and “Financial Statements—Principal Subsidiaries” on page 177,164, in each case of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
D. Property, Plants and Equipment
The information (including tabular data) set forth under the headings “Directors’ Report—Research and Development—Our Resources, SkillsResources” on pages 17 and Capabilities—Main Facilities” on page 37,18, “Directors’ Report—Financial Review—Financial Position,
including Cash Flow and Liquidity – 2008 —Property, plant and equipment” and “—Financial Position, including Cash Flow and Liquidity—Liquidity – 2007—Property, plant and equipment”, on page 81, “Additional Information—pages 35 and 40, respectively, “Directors’ Report—Risk—Principal Risks and Uncertainties—Industry/Economic Environment Risks—Environmental/occupational occupational/health and safety liabilities” on page 196,79, “Financial Statements—Notes to the Financial Statements—Note 27—25—Commitments and contingent liabilities—Environmental costs and liabilities” on pages 160146 to 161147 and “Financial Statements—Notes to the Financial Statements—Note 8—7—Property, Plant and Equipment” on pages 131114 to 132,115, in each case of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
ITEM 4A - UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 5 - OPERATING AND FINANCIAL REVIEW AND PROSPECTS
The information (including graphs and tabular data) set forth under the headings “Directors’ Report—Geographical Review—North America—US—Medicare Part D prescription drug benefit”World Pharmaceutical Markets” (comprising first table only) on page 70,9, “Directors’ Report—Our Resources, Skills and Capabilities—Sales and Marketing—Price regulation”Financial Review” on pages 31 to 32,47, “Directors Report—Geographical Review” on pages 6948 to 72,52, “Directors’ Report—Therapy Area Review—Sales by Therapy Area” (comprising final tabular data only) on page 53, “Directors’ Report—Therapy Area Review—Our Financial Review”Performance” (comprising tabular data only) on pages 77 to 96,55, 58, 60, 62, 65 and 68, “Directors’ Report—Our Therapy Area Review—Financial Performance 2008/2007” on pages 56, 58, 60, 63, 66 and 69, “Directors’ Report—Resources, Skills and Capabilities—Research and Development” on pages 23 to 26,17-21, “Financial Statements—Notes to the Financial Statements—Note 15—14—Interest Bearing Loans and Borrowings” on page 135,119, “Financial Statements—Notes to the Financial Statements—Note 16—Financial Risk Management Objectives and Policies”Instruments” on pages 136122 to 137,126, “Financial Statements—Notes to the Financial Statements—Note 17—Financial Instruments” on pages 138 to 141, “Financial Statements—Notes to the Financial Statements—Note 21—Reserves—Nature19—Capital and purpose of otherReserves—Other reserves” on page 145128 and “Financial Statements—Notes to the Financial Statements—Note 27—25—Commitments and Contingent Liabilities” on pages 158144 to 174,162, in each case of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
On February 28, 2008, the Company announced that, under the provisions of the agreements relating to the restructuring of the AstraZeneca and Merck & Co. joint venture in the United States, AstraZeneca has been informed that Merck has elected not to exercise the First Option related to the relinquishment of Merck’s rights over the products not covered by the Partial Retirement, other than Nexium and Prilosec. As a result of this decision, contingent payments will continue on the products Atacand, Lexxel, Plendil and Entocort until at least 2010, at which time AstraZeneca may exercise this option at the 2008 Appraised Value of approximately $650 million. The Appraised Value also includes rights to certain products that are still in clinical development (AZD6140, AZD3355, AZD0328 and AZD2327). AstraZeneca made contingent payments in respect of the products included in the First Option of $69 million in 2007.
Other aspects of the scheduled termination arrangements will proceed as follows:
| · | The Partial Retirement of Merck’s limited partnership interest, under which Merck’s rights in respect of certain products will end. The products covered by the Partial Retirement include Toprol-XL, Pulmicort, Rhinocort and Symbicort. AstraZeneca made contingent payments in respect of these products amounting to $182 million in 2007. AstraZeneca will pay Merck approximately $4.27 billion in respect of the Partial Retirement. |
| · | A true-up of the Advance Payment, which was triggered at the time of the merger between Astra and Zeneca, under which Merck relinquished all rights, including contingent payment on future sales, to potential Astra products with no existing or pending US patents at the time of the merger, amounting to a payment by Merck to AstraZeneca of approximately $0.24 billion, inclusive of interest. |
| · | Settlement of the loan note receivable by AstraZeneca from Merck, in the amount of $1.4 billion inclusive of accrued interest. |
The combined effects of these three items will be a net cash outflow from AstraZeneca to Merck of approximately $2.63 billion upon settlement during the first quarter 2008.
Further details on the accounting treatment of these events from the Company’s perspective will be provided in conjunction with the Q1 2008 earnings announcement on April 24, 2008.
ITEM 6 - DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A. Directors and Senior Management
The information set forth under the headings “Directors’ Report — Report—Business Organisation and Corporate Governance—Board of Directors at 31 December 2007”2008” on pages 1884 and 1985, “—Chief Executive Officer, Delegation of Authority and Senior Executive Team—Senior Executive Team” on page 86 and “Remuneration Report—Directors’ Remuneration report—Executive Directors’ and Senior Executive Team’s Remuneration and Terms of Employment—Report—Variable Remuneration—Policy on external appointments and retention of fees” on page 105,181, in each case of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
On February 18, 2008,27, 2009, the Company announced that Håkan Mogren, Non-Executive Deputy Chairman, will retire from the appointment of Jean-Philippe Courtois to theCompany’s Board of Directors as a Non-Executive Director with immediate effect. Jean-Philippe Courtois, age 47, is Presidentat the close of Microsoft International and a Senior Vice-President of Microsoft Corporation, having joined Microsoft in 1984. He has previously served as Chief Executive Officer and President of Microsoft Europe, Middle East and Africa.the Company’s AGM on April 30, 2009.
B. Compensation
The information (including graphs and tabular data) set forth under the headings “Remuneration Report—Directors’ Remuneration Report” on pages 98174 to 114,188, “Financial Statements—Notes to the Financial Statements—Note 25—23—Post-Retirement Benefits” on pages 148 to 153, “Financial Statements—Notes to the Financial Statements—, “—Note 26—24—Employee Costs and Share Option Plans for Employees” on pages 153 to 158 and “Financial Statements—Notes to the Financial Statements—“—Note 29—27—Statutory and Other Information—Key management personnel compensation”, on page 175,pages 133 to 138, 138 to 143, and 163, respectively, in each case of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
C. Board Practices
The information set forth under the headings “Directors’ Report—Business Organisation—Organisation and Corporate Governance—Board of Directors at 31 December 2007”2008” and “—Chief Executive Officer, Delegation of Authority
and Senior Executive Team—Senior Executive Team”, on pages 1884 to 19, “Directors’ Report—Corporate Governance and Managing Risk—Corporate Governance: 86, “—Operation of the Board of Directors” and “—Corporate Governance and Managing Risk—Corporate Governance: Operation of Board Committees” on pages 3887 to 42,91, “—Corporate Governance and Managing Risk—Corporate Governance: Principal UK and US Governance Requirements—The US Sarbanes-Oxley Act of 2002”UK Corporate Governance Requirements” and “—The New York Stock Exchange” eachUS Corporate Governance Requirements” on page 43, “Business Report—Business Organisation—Chief Executive Officer and Delegation of Authority” and “—Senior Executive Team” each on page 20,pages 91 to 93, and “Directors’ Remuneration Report—Executive Director’sDirectors’ and Senior Executive Team’s Remuneration and Terms of Employment—Details of Executive Directors’ service contractsService Contracts at 31 December 2007”2008” (consisting of tabular data), “—Service contracts” and “—Non-Executive Directors”, each on page 105,181, in each case of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
D. Employees
The information set forth under the headings “Directors’ Report—Our Resources, Skills and Capabilities—People—People” (comprising the graphical data and first paragraph only) on page 28, “—Communication and dialogue” and “—Employee relations”, eachDialogue” on page 36pages 28 to 29 and “Financial Statements—Notes to the Financial Statements—Note 26—24—Employee Costs and Share Option Plans for Employees” (including the tabular data) on pages 153138 to 158,143, in each case of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
E. Share Ownership
The information (including graphs and tabular data) set forth under the headings “Financial Statements—Notes to the Financial Statements—Note 26—24—Employee Costs and Share Option Plans for Employees” on pages 153138 to 158,143, “Remuneration Report—Directors’ Remuneration Report—Variable Remuneration” (including tabular data) on pages 102 to 105, “Remuneration Report—Directors’ Remuneration Report—Directors’Report —Directors’ Interests in Shares” on pages 110185 to 112, “Remuneration Report—Directors’ Remuneration Report—Share Options” on page 113, “—Directors’ Remuneration Report—Gains by Directors on Exercise of Share Options” on page 114,188, and “Additional Information—Shareholder Information—Major Shareholdings—Title of class” and “—Shareholder Information—Options to Purchase Securities from Registrant or Subsidiaries” (consisting of tabular data and related text), both on page 188,192, in each case of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
ITEM 7 - MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. Major Shareholders
The information set forth under the heading “Additional Information—Shareholder Information—Major Shareholdings” on pages 187191 to 188192 of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
B. Related Party Transactions
The information set forth under the headings “Financial Statements—Notes to the Financial Statements—Note 29—27—Statutory and Other Information—Related party transactions”Party Transactions” on page 175163 and “Additional Information—Shareholder Information—Related Party Transactions” on page 188,192, in each case of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
C. Interests of Experts and Counsel
Not applicable.
ITEM 8 - FINANCIAL INFORMATION
A. Consolidated Statements and Other Financial Information
The information (including graphs and tabular data) set forth under the headings “Directors’ Report—Financial Review—Capitalisation and Shareholder Return—Dividend and share re-purchases”Share Re-Purchases” on page 84,37, “Directors’ Report—Business Organisation and Corporate Governance and Managing Risk—Corporate Governance: Governance—Other Matters—ReturnsDistributions to shareholders” on pages 45 to 46,page 95, “Financial Statements” on pages 118100 to 176163 (including the information set forth under the subheading “Notes to
the Financial Statements”), “Financial Statements—Principal Subsidiaries” on page 177, “Financial Statements—Group164, “Group Financial Record” on page 184,172, and “Additional Information—Shareholder Information” on pages 186190 to 192,195, in each case of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
B. Significant Changes
Since the publicationdate of the Company’s Annual Report and Form 20-F Information 2007, the Company has become aware of certain developments with respect to currently pending litigation involving the Company and/or its affiliates, as describedannual consolidated financial statements included in more detail below.
Average Wholesale Price Class Action Litigation
A verdict was reached in February, 2008 in the Montgomery County Circuit Court awarding $40 million in compensatory damages and $175 million in punitive damages for alleged false and misleading reporting of prices for drugs reimbursed by the Alabama State Medicaid Agency in the US.
The Company was among 73 pharmaceutical manufacturers named in a lawsuit filed in 2005 by the Alabama Attorney General, alleging that misleading and false reported prices had caused Alabama Medicaid to reimburse pharmacists too much money on prescriptions filed for Medicaid patients.
The Company considers the lawsuit to be legally and factually unfounded, and believes that serious errors occurred during the proceedings and that the verdict should not be upheld. The Company believes that it has fully complied with the law, government guidelines and contracts that govern Medicaid pricing.
The Company announced on February 22, 2008 that it intends to seek reconsideration or reversal of the verdict through appeal, in which it is confident that it will prevail and so no provision has been made for these awards.
The information set forth under the heading “Financial Statements—Notes to the Financial Statements—Commitments and Contingent Liabilities—Average Wholesale Price Class Action Litigation” at page 171 of the Company’s “Annual Report and Form 20-F Information 2007” included as exhibit 15.1 to this Form 20-F dated March 12, 2008 is incorporated by reference.17, 2009, no significant change has occurred, except as otherwise disclosed herein.
Patent Litigation (Seroquel)
On March 12, 2008, the Company announced that a trial date has been set for patent litigation in the US District Court for the District of New Jersey against Teva Pharmaceutical Industries Ltd. (‘Teva’) and Sandoz, Inc. (‘Sandoz’) alleging infringement of AstraZeneca’s patent as a result of Teva’s and Sandoz’s filings of Abbreviated New Drug Applications (‘ANDAs’). The ANDAs seek approval to market generic versions of Seroquel (quetiapine fumarate tablets) in the US before Seroquel’s patent expires in 2011. The US District Court for the District of New Jersey has set a date for trial beginning on 11 August 2008.
The information set forth under the heading “Financial Statements—Notes to the Financial Statements—Commitments and Contingent Liabilities—Seroquel (quetiapine fumarate)—Patent Litigation” at pages 168 and 169 of the Company’s “Annual Report and Form 20-F Information 2007” included as exhibit 15.1 to this Form 20-F dated March 12, 2008 is incorporated by reference.
ITEM 9 - THE OFFER AND LISTING
A. Offer and Listing Details
The information (including graphs and tabular data) set forth under the heading “Additional Information—Shareholder Information” on page 186190 of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
In addition, the table below sets forth, for the periods indicated, the reported high and low share prices of AstraZeneca PLC, on the following bases:
| · | for shares listed on the London Stock Exchange (‘LSE’)(LSE) the reported high and low middle market closing quotations are derived from The Daily Official List; |
| · | for shares listed on the Stockholm Stock Exchange (‘SSE’)(SSE) the high and low closing sales prices are as stated in the Official List; |
| · | for American Depositary Shares (‘ADS’)(ADS) listed on the New York Stock Exchange the reported high and low sales are as reported by Dow Jones (ADR quotations). |
| | AstraZeneca | | | AstraZeneca | |
| | | | | | | | | | | | | | | | | | |
| | High | | | Low | | | High | | | Low | | | High | | | Low | | | High | | | Low | | | High | | | Low | | | High | | | Low | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | |
2009 – February | | | 2,767 | | | 2,238 | | | 40.16 | | | 31.33 | | | 330.0 | | | 287.5 | |
2009 – January | | | 2,947 | | | 2,671 | | | 41.60 | | | 38.36 | | | 331.0 | | | 309.5 | |
2008 – December | | | 2,807 | | | 2,420 | | | 41.12 | | | 35.24 | | | 326.0 | | | 300.0 | |
2008 – November | | | 2,888 | | | 2,245 | | | 44.38 | | | 34.10 | | | 340.5 | | | 280.5 | |
2008 – October | | | 2,630 | | | 2,075 | | | 44.76 | | | 36.50 | | | 320.0 | | | 253.5 | |
2008 – September | | | 2,766 | | | 2,415 | | | 48.95 | | | 43.53 | | | 321.5 | | | 292.5 | |
2008 | | | 2,888 | | | 1,748 | | | 49.85 | | | 34.10 | | | 340.5 | | | 211.5 | |
2008 – Quarter 4 | | | 2,888 | | | 2,075 | | | 44.76 | | | 34.10 | | | 340.5 | | | 253.5 | |
2008 – Quarter 3 | | | 2,766 | | | 2,130 | | | 49.85 | | | 43.42 | | | 321.5 | | | 255.5 | |
2008 – Quarter 2 | | | 2,289 | | | 1,981 | | | 44.57 | | | 39.36 | | | 268.0 | | | 235.5 | |
2008 – Quarter 1 | | | 2,345 | | | 1,748 | | | 45.70 | | | 35.50 | | | 296.5 | | | 211.5 | |
2007 | | | 2,984 | | | 2,093 | | | 59.04 | | | 42.82 | | | 414.0 | | | 272.0 | |
2007 – Quarter 4 | | 2,606 | | | 2,090 | | | 52.97 | | | 42.21 | | | 343.5 | | | 271.0 | | | 2,589 | | | 2,093 | | | 52.47 | | | 42.82 | | | 343.5 | | | 272.0 | |
2007 – Quarter 3 | | 2,793 | | | 2,200 | | | 56.60 | | | 44.62 | | | 379.5 | | | 310.5 | | | 2,770 | | | 2,278 | | | 56.16 | | | 45.56 | | | 374.5 | | | 315.0 | |
2007 | | 2,991 | | | 2,090 | | | 59.47 | | | 42.21 | | | 415.5 | | | 271.0 | | |
2007 – Quarter 2 | | | 2,953 | | | 2,567 | | | 59.04 | | | 51.00 | | | 401.0 | | | 354.5 | |
2007 – Quarter 1 | | | 2,984 | | | 2,734 | | | 58.78 | | | 53.53 | | | 414.0 | | | 367.5 | |
2006 | | 3,529 | | | 2,574 | | | 66.37 | | | 45.12 | | | 484.0 | | | 352.5 | | | 3,529 | | | 2,574 | | | 66.37 | | | 45.12 | | | 484.0 | | | 352.5 | |
2005 | | 2,837 | | | 1,861 | | | 49.50 | | | 34.72 | | | 392.0 | | | 243.0 | | | 2,837 | | | 1,861 | | | 49.50 | | | 34.72 | | | 392.0 | | | 243.0 | |
2004 | | 2,749 | | | 1,863 | | | 50.85 | | | 35.88 | | | 374.0 | | | 237.5 | | | 2,749 | | | 1,863 | | | 50.85 | | | 35.88 | | | 374.0 | | | 237.5 | |
2003 | | 2,868 | | | 1,820 | | | 49.47 | | | 29.98 | | | 382.0 | | | 245.0 | | |
B. Plan of Distribution
Not applicable.
C. Markets
The information set forth under the heading “Additional Information—Shareholder Information” on page 186190 of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
D. Selling Shareholders
Not applicable.
E. Dilution
Not applicable.
F. Expenses of the Issue
Not applicable.
A. Share Capital
Not applicable.
B. Memorandum and Articles of Association
The information set forth under the heading “Additional Information—Corporate Information—Memorandum and Articles of Association” on page 200197 of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
C. Material Contracts
Not applicable.
D. Exchange Controls
The information set forth under the headings “Additional Information—Shareholder Information—Exchange Controls and Other Limitations Affecting Security Holders” on page 190194 of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
E. Taxation
The information set forth under the headings “Additional Information—Shareholder Information—Taxation for US Residents”, “—UK and US Income Taxation of Dividends”, “—Taxation on Capital Gains”, “—Passive Foreign Investment Company Rules”, “—UK Inheritance Tax” and “—UK Stamp Duty Reserve Tax and Stamp Duty” on pages 189193 to 190194 of the Company’s “Annual���Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
F. Dividends and Paying Agents
Not applicable.
G. Statement by Experts
Not applicable.
H. Documents on Display
The information set forth under the heading “Additional Information—Shareholder Information—Documents on Display” on page 189193 of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
In addition, we file reports and other information with the United States Securities and Exchange Commission (the “SEC”). You can read and copy these reports and other information at the SEC’s Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549. You can call the SEC at 1-800-SEC-0330 for further information on the Public Reference Room. The SEC also maintains a website at www.sec.gov which contains in electronic form each of the reports and other information that we have filed electronically with the SEC.
I. Subsidiary Information
Not applicable.
The information (including graphs and tabular data) set forth under the headings “Directors’ Report—Financial Review—Financial Risk Management Policies”Management” on pages 8541 to 86, “—42, and “Financial Statements—Note 15—Financial Review—CapitalisationRisk Management Objectives and Shareholder Return—Sensitivity analysis—31 December 2007”Policies” and “—Note 16—Financial Review—Capitalisation and Shareholder Return—Instruments—Sensitivity analysis—31 December 2006”, bothAnalysis” on page 85,pages 120 to 126, in each case of the Company’s “Annual Report and Form 20-F Information 2007”2008” included as exhibit 15.1 to this Form 20-F dated March 12, 200817, 2009 is incorporated by reference.
Not applicable.
(a) There has been no material default in payment of principal, interest, a sinking or purchase fund installment, or any other material default with respect to any indebtedness of the Company or any of its significant subsidiaries.
(b) There have been no arrears in the payment of dividends on, and no material delinquency with respect to, any class of preferred stock of any significant subsidiary of the Company.
ITEM 14 - MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
Not applicable.