PFE-2020-Form-10K-FINAL.Pdf
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 1-3619 PFIZER INC. (Exact name of registrant as specified in its charter) Delaware 13-5315170 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification Number) 235 East 42nd Street, New York, New York 10017 (Address of principal executive offices) (zip code) (212) 733-2323 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $.05 par value PFE New York Stock Exchange 0.250% Notes due 2022 PFE22 New York Stock Exchange 1.000% Notes due 2027 PFE27 New York Stock Exchange 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 ☒ 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 ☒ 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 ☒ No ☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files.) Yes ☒ No ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large Accelerated filer ☒ Accelerated filer ☐ Non-accelerated filer ☐ Smaller reporting company ☐ Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒ 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, June 28, 2020, was approximately $169 billion. This excludes shares of common stock held by directors and executive officers at June 28, 2020. Exclusion of shares held by any person should not be construed to indicate that such person possesses the power, directly or indirectly, to direct or cause the direction of the management or policies of the registrant, or that such person is controlled by or under common control with the registrant. The registrant has no non-voting common stock. The number of shares outstanding of the registrant’s common stock as of February 23, 2021 was 5,577,629,491 shares of common stock, all of one class. DOCUMENTS INCORPORATED BY REFERENCE Portions of the Proxy Statement for the 2021 Annual Meeting of Shareholders Part III TABLE OF CONTENTS Page Defined Terms i Forward-Looking Information and Factors that May Affect Future Results iii PART I 1 ITEM 1. BUSINESS 1 About Pfizer 1 Commercial Operations 1 Collaboration and Co-Promotion Agreements 2 Research and Development 3 International Operations 4 Sales and Marketing 4 Patents and Other Intellectual Property Rights 5 Competition 6 Pricing Pressures and Managed Care Organizations 7 Raw Materials 8 Government Regulation and Price Constraints 8 Environmental Matters 10 Human Capital 10 Available Information 11 ITEM 1A. RISK FACTORS 11 ITEM 1B. UNRESOLVED STAFF COMMENTS N/A ITEM 2. PROPERTIES 20 ITEM 3. LEGAL PROCEEDINGS 20 ITEM 4. MINE SAFETY DISCLOSURES N/A INFORMATION ABOUT OUR EXECUTIVE OFFICERS 20 PART II 21 ITEM 5. MARKET FOR THE COMPANY’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 21 ITEM 6. SELECTED FINANCIAL DATA 23 ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 23 ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 48 ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 49 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 109 ITEM 9A. CONTROLS AND PROCEDURES 109 ITEM 9B. OTHER INFORMATION N/A PART III 112 ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 112 ITEM 11. EXECUTIVE COMPENSATION 112 ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 112 ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 112 ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES 112 PART IV 113 ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES 113 15(a)(1) Financial Statements 113 15(a)(2) Financial Statement Schedules 113 15(a)(3) Exhibits 113 ITEM 16. FORM 10-K SUMMARY 116 N/A = Not Applicable DEFINED TERMS Unless the context requires otherwise, references to “Pfizer,” “the Company,” “we,” “us” or “our” in this Form 10-K (defined below) refer to Pfizer Inc. and its subsidiaries. The financial information included in our consolidated financial statements for our subsidiaries operating outside the U.S. is as of and for the year ended November 30 for each year presented. Pfizer's fiscal year-end for U.S. subsidiaries is as of and for the year ended December 31 for each year presented. References to “Notes” in this Form 10-K are to the Notes to the consolidated financial statements in Item 8. Financial Statements and Supplementary Data in this Form 10-K. We also have used several other terms in this Form 10-K, most of which are explained or defined below. 2018 Financial Report Exhibit 13 to the Annual Report on Form 10-K for the fiscal year ended December 31, 2018 Form 10-K This Annual Report on Form 10-K for the fiscal year ended December 31, 2020 Proxy Statement Proxy Statement for the 2021 Annual Meeting of Shareholders, which will be filed no later than 120 days after December 31, 2020 AbbVie AbbVie Inc. ABO Accumulated benefit obligation represents the present value of the benefit obligation earned through the end of the year but does not factor in future compensation increases ACA (also referred to as U.S. U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and Education Healthcare Legislation) Reconciliation Act ACIP Advisory Committee on Immunization Practices Akcea Akcea Therapeutics, Inc. ALK anaplastic lymphoma kinase Alliance revenues Revenues from alliance agreements under which we co-promote products discovered or developed by other companies or us Allogene Allogene Therapeutics, Inc. AML Acute Myeloid Leukemia Anacor Anacor Pharmaceuticals, Inc. AOCI Accumulated Other Comprehensive Income Array Array BioPharma Inc. Astellas Astellas Pharma Inc., Astellas US LLC and Astellas Pharma US, Inc. ATTR-CM transthyretin amyloid cardiomyopathy Bain Capital Bain Capital Private Equity and Bain Capital Life Sciences Biogen Biogen Inc. BioNTech BioNTech SE Biopharma Pfizer Biopharmaceuticals Group BMS Bristol-Myers Squibb Company BNT162b2 Pfizer-BioNTech COVID-19 Vaccine BOD Board of Directors BRCA BReast CAncer susceptibility gene CAR T chimeric antigen receptor T cell CDC U.S. Centers for Disease Control and Prevention Cellectis Cellectis S.A. Cerevel Cerevel Therapeutics, LLC cGMPs current Good Manufacturing Practices CIAS cognitive impairment associated with schizophrenia Consumer Healthcare JV GSK Consumer Healthcare JV COVID-19 novel coronavirus disease of 2019 CMA conditional marketing authorization CStone CStone Pharmaceuticals DEA U.S. Drug Enforcement Agency Developed Europe Includes the following markets: Western Europe, Scandinavian countries and Finland Developed Markets Includes the following markets: U.S., Developed Europe, Japan, Canada, Australia, South Korea and New Zealand Developed Rest of World Includes the following markets: Japan, Canada, Australia, South Korea and New Zealand EMA European Medicines Agency Emerging Markets Includes, but is not limited to, the following markets: Asia (excluding Japan and South Korea), Latin America, Eastern Europe, Africa, the Middle East, Central Europe and Turkey EPS earnings per share ESOP employee stock ownership plan EU European Union EUA emergency use authorization Exchange Act Securities Exchange Act of 1934, as amended FASB Financial Accounting Standards Board FCPA U.S. Foreign Corrupt Practices Act FDA U.S. Food and Drug Administration Pfizer Inc. 2020 Form 10-K i FFDCA U.S. Federal Food, Drug and Cosmetic Act GAAP Generally Accepted Accounting Principles GDFV grant-date fair value GIST gastrointestinal stromal tumors GPD Global Product Development organization GSK GlaxoSmithKline plc Hospira Hospira, Inc. Ionis Ionis Pharmaceuticals, Inc. IPR&D in-process research and development IRC Internal Revenue Code IRS U.S.