UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
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`FORM 10-K
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`(Mark One)
`x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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`For the fiscal year ended December 31, 2011
`¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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`For the transition period from to
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`Commission file number 1-3619
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`PFIZER INC.
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`(Exact name of registrant as specified in its charter)
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`Delaware
`(State or other jurisdiction of
`incorporation or organization)
`235 East 42nd Street
`New York, New York
`(Address of principal executive offices)
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`13-5315170
`(I.R.S. Employer
`Identification Number)
`10017-5755
`(Zip Code)
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`(212) 733-2323
`(Registrant’s telephone number, including area code)
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`Securities registered pursuant to Section 12(b) of the Act:
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`Name of each exchange
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`on which registered
`Title of each class
`Common Stock, $.05 par value
`New York Stock Exchange
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`Securities registered pursuant to Section 12(g) of the Act:
`None
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`Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x No ¨
`Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ¨ No x
`Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
`during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing
`requirements for the past 90 days. Yes x No ¨
`Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File
`required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232-405 of this chapter) during the preceding 12 months (or for such shorter
`period that the registrant was required to submit and post such files.) Yes x No ¨
`Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to
`the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to
`this Form 10-K. ¨
`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” in Rule 12b-2 of the Exchange Act.
`Smaller reporting company ¨
`Non-accelerated filer ¨
`Large accelerated filer x
`Accelerated filer ¨
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`Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
`The aggregate market value of the voting stock held by non-affiliates of the registrant, computed by reference to the closing price as of the last business
`day of the registrant’s most recently completed second fiscal quarter, July 1, 2011, was approximately $163 billion. The registrant has no non-voting
`common stock.
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1052 - Page 1
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`The number of shares outstanding of the registrant’s common stock as of February 21, 2012 was 7,538,520,276 shares of common stock, all of one
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`DOCUMENTS INCORPORATED BY REFERENCE
`Portions of the 2011 Annual Report to Shareholders
`Portions of the Proxy Statement for the 2012 Annual Meeting of Shareholders
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`Parts I, II and IV
`Part III
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1052 - Page 2
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`TABLE OF CONTENTS
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`PART I
`ITEM 1. BUSINESS
`General
`Pfizer Website
`Operating Segments
`Biopharmaceutical Products
`Other Products
`Research and Development
`International Operations
`Marketing
`Patents and Intellectual Property Rights
`Competition
`Raw Materials
`Government Regulation and Price Constraints
`Environmental Law Compliance
`Tax Matters
`Employees
`ITEM 1A. RISK FACTORS
`ITEM 1B. UNRESOLVED STAFF COMMENTS
`ITEM 2. PROPERTIES
`ITEM 3. LEGAL PROCEEDINGS
`ITEM 4. MINE SAFETY DISCLOSURES
`EXECUTIVE OFFICERS OF THE COMPANY
`PART II
`ITEM 5. MARKET FOR THE COMPANY’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
`PURCHASES OF EQUITY SECURITIES
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`ITEM 6. SELECTED FINANCIAL DATA
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`ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
`ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
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`ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
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`ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
`DISCLOSURE
`ITEM 9A. CONTROLS AND PROCEDURES
`ITEM 9B. OTHER INFORMATION
`PART III
`ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
`ITEM 11. EXECUTIVE COMPENSATION
`ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
`STOCKHOLDER MATTERS
`ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
`ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
`PART IV
`ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
`15(a)(1) Financial Statements
`15(a)(2) Financial Statement Schedules
`15(a)(3) Exhibits
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1052 - Page 3
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`ITEM 1.
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`General
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`BUSINESS
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`PART I
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`Pfizer Inc. (which may be referred to as Pfizer, the Company, we, us or our) is a research-based, global biopharmaceutical company. We apply science
`and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery,
`development and manufacturing of medicines for people and animals. Our diversified global healthcare portfolio includes human and animal biologic and
`small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer healthcare products. Every day, we
`work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. We
`also collaborate with other biopharmaceutical companies, healthcare providers, governments and local communities to support and expand access to reliable,
`affordable healthcare around the world.
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`The Company was incorporated under the laws of the State of Delaware on June 2, 1942.
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`On October 15, 2009, we completed our acquisition of Wyeth. The acquisition was a cash-and-stock transaction valued at $50.40 per share of Wyeth
`common stock, or a total of approximately $68.2 billion, based on the closing market price of Pfizer common stock on the acquisition date.
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`On January 31, 2011, we completed a tender offer for the outstanding shares of common stock of King Pharmaceuticals, Inc. (King) and acquired
`approximately 92.5% of the outstanding shares for approximately $3.3 billion in cash. On February 28, 2011, we acquired the remaining outstanding shares
`of King for approximately $300 million in cash. Commencing from January 31, 2011, our financial statements include the assets, liabilities, operating results
`and cash flows of King. Therefore, in accordance with our domestic and international reporting periods, our consolidated financial statements for the fiscal
`year ended December 31, 2011 reflect approximately 11 months of King’s U.S. operations and 10 months of King’s international operations.
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`In July 2011, we announced our decision to explore strategic alternatives for our Animal Health and Nutrition businesses, which may include, among
`other things, a full or partial separation of each of these businesses from Pfizer through a spin-off, sale or other transaction. We believe these potential actions
`may create greater shareholder value, enable us to become a more focused organization and optimize capital allocation. Given the separate and distinct nature of
`Animal Health and Nutrition, we may pursue a different strategic alternative for each of these businesses. Although the timeline for each evaluation may differ,
`we expect to announce our strategic decision for each of these businesses in 2012 and to complete any separation of these businesses between July 2012 and
`July 2013. For additional information, see the Overview of Our Performance, Operating Environment, Strategy and Outlook – Our Business
`Development Initiatives section of Management’s Discussion and Analysis of Financial Condition and Results of Operations (MD&A) in our 2011
`Financial Report.
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`On August 1, 2011, we completed the sale of our Capsugel business for approximately $2.4 billion in cash. For additional information, see the Notes to
`Consolidated Financial Statements – Note 2D. Acquisitions, Divestitures, Collaborative Arrangements and Equity Method Arrangements – Divestitures
`in our 2011 Financial Report, as well as Other Products – Capsugel below.
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`Pfizer Website
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`Our Annual Report on Form 10-K for the fiscal year ended December 31, 2011 (2011 Form 10-K), Quarterly Reports on Form 10-Q, Current Reports on
`Form 8-K and amendments to those reports filed or
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1052 - Page 4
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`furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (Exchange Act), are available on our website
`(www.pfizer.com), in text format and, where applicable, in interactive data file format , as soon as reasonably practicable after we electronically file such
`material with, or furnish it to, the Securities and Exchange Commission (SEC).
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`Throughout this 2011 Form 10-K, we “incorporate by reference” certain information from other documents filed or to be filed with the SEC, including
`our Proxy Statement for the 2012 Annual Meeting of Shareholders (2012 Proxy Statement) and the 2011 Financial Report, portions of which are filed as
`Exhibit 13 to this 2011 Form 10-K, and which also will be contained in Appendix A to our 2012 Proxy Statement (2011 Financial Report). The SEC allows us
`to disclose important information by referring to it in that manner. Please refer to such information. Our 2011 Annual Report to Shareholders consists of the
`2011 Financial Report and the Corporate and Shareholder Information attached to the 2012 Proxy Statement. Our 2011 Financial Report will be available on
`our website (www.pfizer.com) on or about February 28, 2012. Our 2012 Proxy Statement will be available on our website (www.pfizer.com) on or about
`March 15, 2012.
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`Information relating to corporate governance at Pfizer, including our Corporate Governance Principles; Director Qualification Standards; Pfizer Policies
`on Business Conduct (for all of our employees, including our Chief Executive Officer, Chief Financial Officer and Principal Accounting Officer); Code of
`Business Conduct and Ethics for our Directors; information concerning our Directors; ways to communicate by e-mail with our Directors; Board
`Committees; Committee Charters; the Lead Independent Director Charter; and transactions in Pfizer securities by Directors and Officers; as well as Chief
`Executive Officer and Chief Financial Officer certifications, are available on our website (www.pfizer.com). We will provide any of the foregoing information
`without charge upon written request to Matthew Lepore, Vice President and Corporate Secretary, Chief Counsel-Corporate Governance, Pfizer Inc., 235 East
`42nd Street, New York, NY 10017-5755. Information relating to shareholder services, including our Shareholder Investment Program, book-entry share
`ownership and direct deposit of dividends, is also available on our website (www.pfizer.com).
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`The information contained in our website does not constitute a part of this 2011 Form 10-K.
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`Operating Segments
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`We manage our operations through five operating segments—Primary Care; Specialty Care and Oncology; Established Products and Emerging
`Markets; Animal Health and Consumer Healthcare; and Nutrition. Each operating segment has responsibility for its commercial activities and for certain
`research and development activities related to in-line products and in-process research and development (IPR&D) projects that generally have achieved proof-of-
`concept. Previously, we managed our operations through two operating segments—Biopharmaceutical and Diversified.
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`We regularly review our segments and the approach used by management to evaluate performance and allocate resources.
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`A description of each of our five operating segments follows:
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` Primary Care operating segment—includes revenues from human pharmaceutical products primarily prescribed by primary-care physicians, and
`may include products in the following therapeutic and disease areas: Alzheimer’s disease, cardiovascular (excluding pulmonary arterial
`hypertension), erectile dysfunction, genitourinary, major depressive disorder, pain, respiratory and smoking cessation. Examples of products in
`this segment include Celebrex, Chantix/Champix, Lipitor, Lyrica, Premarin, Pristiq and Viagra. All revenues for such products are allocated
`to the Primary Care business unit, except those generated in emerging markets and those that are managed by the Established Products business
`unit.
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`Through the end of 2011, sales of Lipitor in the U.S. are reported in our Primary Care business unit. Beginning in 2012, sales of Lipitor in the
`U.S. will be reported in our Established Products business unit.
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1052 - Page 5
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` Specialty Care and Oncology operating segment—comprises the Specialty Care business unit and the Oncology business unit.
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` Specialty Care—includes revenues from most human pharmaceutical products primarily prescribed by physicians who are specialists,
`and may include products in the following therapeutic and disease areas: anti-infectives, endocrine disorders, hemophilia, inflammation,
`multiple sclerosis, ophthalmology, pulmonary arterial hypertension, specialty neuroscience and vaccines. Examples of products in this
`business unit include BeneFIX, Enbrel, Genotropin, Geodon, the Prevnar/Prevenar franchise, Rebif, ReFacto AF, Revatio, Xalatan,
`Xyntha and Zyvox. All revenues for such products are allocated to the Specialty Care business unit, except those generated in emerging
`markets and those that are managed by the Established Products business unit.
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` Oncology—includes revenues from human prescription pharmaceutical products addressing oncology and oncology-related illnesses.
`Examples of products in this business unit include Aromasin, Sutent, Torisel and Xalkori. All revenues for such products are allocated
`to the Oncology business unit, except those generated in emerging markets and those that are managed by the Established Products
`business unit.
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` Established Products and Emerging Markets operating segment—comprises the Established Products business unit and the Emerging Markets
`business unit.
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` Established Products—generally includes revenues from human prescription pharmaceutical products that have lost patent protection or
`marketing exclusivity in certain countries and/or regions. Typically, products are transferred to this business unit in the beginning of the
`fiscal year following loss of patent protection or marketing exclusivity. In certain situations, products may be transferred to this business
`unit at a different point than the beginning of the fiscal year following loss of patent protection or marketing exclusivity in order to
`maximize their value. This business unit also excludes revenues generated in emerging markets. Examples of products in this business
`unit include Arthrotec, Effexor, Medrol, Norvasc, Protonix, Relpax and Zosyn/Tazocin.
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` Emerging Markets––includes revenues from all human prescription pharmaceutical products sold in emerging markets, including Asia
`(excluding Japan and South Korea), Latin America, Middle East, Africa, Central and Eastern Europe and Turkey.
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` Animal Health and Consumer Healthcare operating segment—comprises the Animal Health business unit and the Consumer Healthcare business
`unit.
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` Animal Health––includes worldwide revenues from products and services to prevent and treat disease in livestock and companion
`animals, including vaccines, parasiticides and anti-infectives.
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` Consumer Healthcare––generally includes worldwide revenues from non-prescription products in the following therapeutic categories:
`dietary supplements, pain management, respiratory and personal care. Products marketed by Consumer Healthcare include Advil,
`Caltrate, Centrum, ChapStick, Preparation H and Robitussin.
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` Nutrition operating segment––generally includes revenues from a full line of infant and toddler nutritional products sold outside the U.S. and
`Canada. Examples of products in this segment include the S-26 and SMA product lines, as well as formula for infants with special nutritional
`needs.
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`For a further discussion of our operating segments, including certain costs that are not allocated to our operating segment results, as well as comparative
`segment information for 2011, 2010 and 2009, see the Notes to Consolidated Financial Statements – Note 18. Segment, Geographic and Other Revenue
`Information – Segment
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1052 - Page 6
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`Information, including the tables therein captioned Selected Income Statement Information, Geographic Information and Significant Product Revenues in
`our 2011 Financial Report and the table captioned Revenues by Segment and Geographic Area in the MD&A in our 2011 Financial Report. The information
`from those tables in our 2011 Financial Report is incorporated by reference into this 2011 Form 10-K.
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`Our businesses are heavily regulated in most of the countries in which we operate. In the U.S., the principal authority regulating our operations is the
`U.S. Food and Drug Administration (FDA). The FDA regulates the safety and efficacy of the products we offer and our research quality, manufacturing
`processes, product promotion, advertising and product labeling. Similar regulations exist in most other countries, and in many countries the government also
`regulates our prices. See Government Regulation and Price Constraints below.
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`Biopharmaceutical Products
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`Revenues from biopharmaceutical products contributed approximately 86% of our total revenues in 2011, 87% of our total revenues in 2010 and 92%
`of our total revenues in 2009.
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`We recorded direct product sales of more than $1 billion for each of 12 biopharmaceutical products in 2011, each of 15 biopharmaceutical products in
`2010 and each of nine legacy Pfizer biopharmaceutical products in 2009. These products represented 56% of our revenues from biopharmaceutical products
`in 2011, 60% of our revenues from biopharmaceutical products in 2010, and 56% of our revenues from biopharmaceutical products in 2009. See Item 1A.
`Risk Factors – Dependence on Key In-Line Products below.
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`Worldwide revenues from biopharmaceutical products in 2011 were $57.7 billion, a decrease of 1% compared to 2010, primarily due to the decrease of
`$4.7 billion in operational revenues from Lipitor, Effexor, Protonix, Xalatan, Caduet, Vfend, Aromasin and Zosyn, and lower Alliance revenues for
`Aricept, all due to loss of exclusivity in certain markets, and a reduction in revenues of $359 million due to the Patient Protection and Affordable Care Act, as
`amended by the Health Care and Education Reconciliation Act (commonly referred to as the Affordable Care Act, or ACA). This decrease was partially offset
`by the solid performance of Lyrica, the Prevnar/Prevenar franchise and Enbrel, the inclusion of operational revenues from legacy King products of
`approximately $950 million, which favorably impacted biopharmaceutical revenues by 2%, and the favorable impact of foreign exchange of $1.7 billion, or
`3%.
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`Geographically, in the U.S., revenues from biopharmaceutical products decreased 9% in 2011, compared to 2010, reflecting lower revenues from
`Lipitor, Protonix, Effexor, Zosyn, Xalatan, Vfend, Caduet and Aromasin, all due to loss of exclusivity, lower Alliance revenues due to loss of exclusivity
`of Aricept 5mg and 10mg tablets in November 2010 and lower revenues from Detrol/Detrol LA, as well as the reduction in revenues of $359 million in 2011
`due to the ACA. The impact of these adverse factors was partially offset by the strong performance of certain other biopharmaceutical products and the
`addition of U.S. revenues from legacy King products of approximately $904 million in 2011.
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`For additional information regarding the impact of the ACA on our revenues, see the Overview of our Performance, Operating Environment, Strategy
`and Outlook – Our Operating Environment – U.S. Healthcare Legislation section of the MD&A in our 2011 Financial Report.
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`In our international markets, revenues from biopharmaceutical products increased 5% in 2011, compared to 2010, reflecting the favorable impact of
`foreign exchange of 6% in 2011, partially offset by a net operational decrease. Operationally, revenues were favorably impacted by increases in the Prevenar
`franchise, Lyrica, Enbrel, Celebrex and Alliance revenues and unfavorably impacted by declines in Lipitor, Effexor, Norvasc and Xalatan/Xalacom.
`International revenues from legacy King products were not significant to our international revenues in 2011. During 2011, international revenues from
`biopharmaceutical products represented 59% of total revenues from biopharmaceutical products, compared to 56% in 2010.
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`For additional information, see the Analysis of the Consolidated Statements of Income – Biopharmaceutical Revenues section of the MD&A in our
`2011 Financial Report.
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1052 - Page 7
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`Biopharmaceutical—Selected Product Descriptions:
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` Lipitor, for the treatment of elevated LDL-cholesterol levels in the blood, lost U.S. exclusivity on November 30, 2011, and faces generic competition in
`the U.S. Lipitor lost exclusivity in Australia in February 2012; in Japan in 2011; and in Brazil, Canada, Spain and Mexico in 2010; and it has lost
`exclusivity in nearly all emerging market countries. We do not expect that Lipitor revenues in emerging markets will be materially impacted over the next
`several years by the loss of exclusivity. Lipitor will have lost exclusivity in the majority of European markets by May 2012. See Patents and
`Intellectual Property Rights below for further information on Lipitor.
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` Lyrica is indicated for the management of post-herpetic neuralgia, neuropathic pain associated with diabetic peripheral neuropathy, the management of
`fibromyalgia, and as adjunctive therapy for adult patients with partial onset seizures in the U.S., and for neuropathic pain (peripheral and central),
`adjunctive treatment of epilepsy and general anxiety disorder in certain countries outside the U.S.
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` Prevnar 13/Prevenar 13 is our 13-valent pneumococcal conjugate vaccine for the prevention of various syndromes of pneumococcal disease in infants
`and young children and in adults 50 years of age and older. Prevnar 13/Prevenar 13 for use in infants and young children has been launched in the
`U.S. for the prevention of invasive pneumococcal disease caused by the 13 serotypes in Prevnar 13 and otitis media caused by the seven serotypes in
`Prevnar, and in the European Union (EU) and many other international markets for the prevention of invasive pneumococcal disease, otitis media and
`pneumococcal pneumonia caused by the vaccine serotypes. The launch of the Prevnar 13/Prevenar 13 pediatric indication has reduced our
`Prevnar/Prevenar (7-valent) revenues (see discussion below), and we expect this trend to continue. In addition, in 2011, we received approval of
`Prevnar 13/Prevenar 13 for use in adults 50 years of age and older in the U.S. for the prevention of pneumococcal pneumonia and invasive
`pneumococcal disease caused by the 13 serotypes in Prevnar 13, and in the EU for the prevention of invasive pneumococcal disease caused by the
`vaccine serotypes. Prevenar 13 for use in adults 50 years of age and older also has been approved in many other international markets. We expect to
`commence commercial launches for the adult indication in 2012.
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`We currently are conducting the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) to fulfill requirements in connection with the
`FDA’s approval of the Prevnar 13 adult indication under its accelerated approval program. CAPiTA is an efficacy trial involving subjects 65 years of
`age and older that is designed to evaluate whether Prevnar 13 is effective in preventing the first episode of community-acquired pneumonia caused by
`the serotypes contained in the vaccine. We estimate that this event-driven trial will be completed in 2013. At its regular meeting held on February 22,
`2012, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) indicated that it will defer voting
`on a recommendation for the routine use of Prevnar 13 in adults 50 years of age and older until the results of CAPiTA, as well as data on the impact of
`pediatric use of Prevnar 13 on the disease burden and serotype distribution among adults, are available. We expect that the rate of uptake for the use of
`Prevnar 13 in adults 50 years of age and older will be impacted by ACIP’s decision to defer voting on a recommendation for the routine use of Prevnar
`13 by that population.
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` Enbrel is our treatment for moderate-to-severe rheumatoid arthritis, polyarticular juvenile rheumatoid arthritis, psoriatic arthritis, plaque psoriasis and
`ankylosing spondylitis, a type of arthritis affecting the spine. Under our co-promotion agreement with Amgen Inc. (Amgen), we and Amgen co-promote
`Enbrel in the U.S. and Canada and share in the profits from Enbrel sales in those countries, which we include in Alliance revenues. Our co-promotion
`agreement with Amgen will expire in October 2013, and, subject to the terms of the agreement, we are entitled to a royalty stream for 36 months
`thereafter, which we expect will be significantly less than our current share of Enbrel profits from U.S. and Canadian sales. Following the end of the
`royalty period, we will not be entitled to any further revenues from Enbrel sales in the U.S. and Canada. Our exclusive rights to Enbrel outside the U.S.
`and Canada will not be affected by the expiration of the co-promotion agreement with Amgen.
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1052 - Page 8
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` Celebrex is for the treatment of the signs and symptoms of osteoarthritis and rheumatoid arthritis worldwide and for the management of acute pain in
`adults in the U.S. and certain markets in the EU. Celebrex is supported by continued educational and promotional efforts highlighting its efficacy and
`safety profile for appropriate patients.
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` Viagra remains the leading treatment for erectile dysfunction and one of the world’s most recognized pharmaceutical brands after more than a decade.
`Viagra began facing generic competition in certain markets, including Spain and Finland, in December 2009.
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` Norvasc, for treating hypertension, lost exclusivity in the U.S. and other major markets in 2007 and in Canada in 2009.
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` Zyvox is the world’s best selling agent among those used to treat serious Gram-positive pathogens, including methicillin-resistant staphylococcus-aureus.
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` Xalabrands consists of Xalatan, a prostaglandin, which is a branded agent used to reduce elevated eye pressure in patients with open-angle glaucoma or
`ocular hypertension, and Xalacom, a fixed combination of prostaglandin (Xalatan) and beta blocker (timolol), available outside the U.S. Xalatan lost
`exclusivity in the U.S. in March 2011. Xalatan and Xalacom lost exclusivity in 15 major European markets in January 2012.
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` Sutent is for the treatment of advanced renal cell carcinoma, including metastatic renal cell carcinoma (mRCC) and gastrointestinal stromal tumors
`(GIST) after disease progression on, or intolerance to, imatinib mesylate. In May 2011, the FDA approved Sutent for the treatment of progressive, well-
`differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease. In the U.S., Sutent is the
`most prescribed oral mRCC therapy, and more than 100,000 patients have been treated with Sutent worldwide.
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` Geodon/Zeldox, an atypical antipsychotic, is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or
`mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. Geodon/Zeldox is expected to lose
`exclusivity in the U.S. in March 2012.
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` Our Premarin family of products remains the leading therapy to help women address moderate to severe menopausal symptoms.
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` Genotropin, one of the world’s leading human growth hormones, is used in children for the treatment of short stature with growth hormone deficiency,
`Prader-Willi Syndrome, Turner Syndrome, Small for Gestational Age Syndrome, Idiopathic Short Stature (in the U.S. only) and Chronic Renal
`Insufficiency (outside the U.S. only), as well as in adults with growth hormone deficiency. Genotropin is supported by a broad platform of innovative
`injection-delivery devices and patient support programs.
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` Detrol/Detrol LA, a muscarinic receptor antagonist, is one of the most prescribed branded medicines worldwide for overactive bladder . Detrol LA is an
`extended-release formulation taken once a day. Detrol immediate release (Detrol IR) will lose exclusivity in the U.S. in September 2012.
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` Vfend is a broad-spectrum agent for treating yeast and molds. Vfend tablets lost exclusivity in the U.S. in February 2011.
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` Chantix/Champix is an aid to smoking-cessation treatment in adults 18 years of age and older. We are continuing our educational and promotional
`efforts, which are focused on addressing the significant health consequences of smoking, highlighting the Chantix benefit-risk proposition and
`emphasizing the importance of the physician-patient dialogue in helping patients quit smoking.
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`6
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1052 - Page 9
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`In July 2011, the U.S. prescribing information was revised to include clinical data showing that Chantix is an effective aid to smoking-cessation
`treatment for smokers with stable cardiovascular disease (CVD) and mild-to-moderate chronic obstructive pulmonary disease (COPD). The revised label
`also includes a warning/precaution advising smokers with CVD to inform their physician of any new or worsening symptoms of cardiovascular
`disease, and to seek emergency medical help if they experience any symptoms of a heart attack. This safety information was added at the FDA’s request
`following an observation of a small numeric increase in certain cardiovascular events in patients treated with Chantix versus those taking a placebo in a
`study of 700 smokers with stable cardiovascular disease. Approval of the EU labeling, revised at the European Medicines Agency’s (EMA’s) request to
`include a similar cardiovascular-related warning/precaution, was received in late December 2011, with regulators reaffirming the positive benefit/risk
`profile of the medication. Approval of the Japan labeling, which includes a similar precaution, occurred in late October 2011. In December 2011, Pfizer
`received a positive opinion from the EMA’s Committee for Medical Products for Human Use for changes to the Champix EU label regarding
`schizophrenia data.
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` BeneFIX and ReFacto AF/Xyntha are hemophilia products using state of the art manufacturing that assist patients with a lifelong bleeding disorder.
`BeneFIX is the only available recombinant factor IX product for the treatment of hemophilia B, while ReFacto AF/Xyntha are recombinant factor VIII
`products for the treatment of hemophilia A. Both products are indicated for the control and prevention of bleeding in patients with these disorders and in
`some countries also are indicated for prophylaxis in certain situations, such as s