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United States Securities and Exchange Commission Washington, D.C UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 28, 2020 OR ☐ 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 of Incorporation) (I.R.S. Employer Identification No.) 235 East 42nd Street, New York, New York 10017 (Address of principal executive offices) (zip code) (212) 733-2323 (Registrant’s telephone number) 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 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 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 x No ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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 x 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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No x At August 3, 2020, 5,556,879,807 shares of the issuer’s voting common stock were outstanding. Table of Contents PART I. FINANCIAL INFORMATION Page Item 1. Financial Statements Condensed Consolidated Statements of Income for the three and six months ended June 28, 2020 and June 30, 2019 5 Condensed Consolidated Statements of Comprehensive Income for the three and six months ended June 28, 2020 and June 30, 2019 6 Condensed Consolidated Balance Sheets as of June 28, 2020 and December 31, 2019 7 Condensed Consolidated Statements of Equity for the three and six months ended June 28, 2020 and June 30, 2019 8 Condensed Consolidated Statements of Cash Flows for the six months ended June 28, 2020 and June 30, 2019 10 Notes to Condensed Consolidated Financial Statements 11 Report of Independent Registered Public Accounting Firm 45 Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 46 Item 3. Quantitative and Qualitative Disclosures About Market Risk 98 Item 4. Controls and Procedures 98 PART II. OTHER INFORMATION Item 1. Legal Proceedings 98 Item 1A. Risk Factors 98 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 100 Item 3. Defaults Upon Senior Securities 100 Item 4. Mine Safety Disclosures 100 Item 5. Other Information 100 Item 6. Exhibits 101 Signature 102 2 GLOSSARY OF DEFINED TERMS Unless the context requires otherwise, references to “Pfizer,” “the Company,” “we,” “us” or “our” in this Quarterly Report on Form 10-Q (defined below) refer to Pfizer Inc. and its subsidiaries. We also have used several other terms in this Quarterly Report on Form 10-Q, most of which are explained or defined below: 2019 Financial Report Financial Report for the fiscal year ended December 31, 2019, which was filed as Exhibit 13 to the Annual Report on Form 10- K for the fiscal year ended December 31, 2019 2019 Form 10-K Annual Report on Form 10-K for the fiscal year ended December 31, 2019 ACA (Also referred to as U.S. Healthcare U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act Legislation) ACIP Advisory Committee on Immunization Practices 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. Array Array BioPharma Inc. Astellas Astellas Pharma Inc., Astellas US LLC and Astellas Pharma US, Inc. ATTR-CM transthyretin amyloid cardiomyopathy Bamboo Bamboo Therapeutics, Inc. BioNTech BioNTech SE Biopharma Pfizer Biopharmaceuticals Group BMS Bristol-Myers Squibb Company CDC U.S. Centers for Disease Control and Prevention cGMP current Good Manufacturing Practices COVID-19 novel coronavirus disease of 2019 Developed Markets U.S., Western Europe, Japan, Canada, South Korea, Australia, Scandinavian countries, Finland 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 EU European Union Exchange Act Securities Exchange Act of 1934, as amended FASB Financial Accounting Standards Board FDA U.S. Food and Drug Administration GAAP Generally Accepted Accounting Principles GIST gastrointestinal stromal tumors GPD Global Product Development organization GSK GlaxoSmithKline plc hGH-CTP human growth hormone Hospira Hospira, Inc. IBT Income before tax ICU Medical ICU Medical, Inc. IPR&D in-process research and development IRS U.S. Internal Revenue Service IV intravenous J&J Johnson & Johnson JV Joint Venture King King Pharmaceuticals LLC (formerly King Pharmaceuticals, Inc.) LDL low density lipoprotein LIBOR London Interbank Offered Rate Lilly Eli Lilly & Company MCO managed care organization mCRC metastatic colorectal cancer MD&A Management’s Discussion and Analysis of Financial Condition and Results of Operations Medivation Medivation LLC (formerly Medivation, Inc.) 3 Meridian Meridian Medical Technologies, Inc. Moody’s Moody’s Investors Service Mylan Mylan N.V. NDA new drug application NSCLC non-small cell lung cancer OPKO OPKO Health, Inc. PARP poly ADP ribose polymerase PBM pharmacy benefit manager Pharmacia Pharmacia Corporation PP&E property, plant & equipment PsA psoriatic arthritis Quarterly Report on Form 10-Q Quarterly Report on Form 10-Q for the quarterly period ended June 28, 2020 RA rheumatoid arthritis RCC renal cell carcinoma R&D research and development Sandoz Sandoz, Inc., a division of Novartis AG SEC U.S. Securities and Exchange Commission SI&A selling, informational and administrative S&P Standard and Poor’s TCJA legislation commonly referred to as the U.S. Tax Cuts and Jobs Act of 2017 Therachon Therachon Holding AG UC ulcerative colitis U.K. United Kingdom U.S. United States Valneva Valneva SE ViiV ViiV Healthcare Limited VBP Volume-based procurement WRDM Worldwide Research, Development and Medical 4 PART I - FINANCIAL INFORMATION Item 1. Financial Statements PFIZER INC. AND SUBSIDIARY COMPANIES CONDENSED CONSOLIDATED STATEMENTS OF INCOME (UNAUDITED) Three Months Ended Six Months Ended June 28, June 30, June 28, June 30, (MILLIONS, EXCEPT PER COMMON SHARE DATA) 2020 2019 2020 2019 Revenues $ 11,801 $ 13,264 $ 23,829 $ 26,382 Costs and expenses: Cost of sales(a) 2,281 2,576 4,658 5,009 Selling, informational and administrative expenses(a) 3,030 3,511 5,903 6,850 Research and development expenses(a) 2,132 1,842 3,856 3,544 Amortization of intangible assets 905 1,184 1,790 2,367 Restructuring charges and certain acquisition-related costs 362 (115) 431 (69) (Gain) on completion of Consumer Healthcare JV transaction — — (6) — Other (income)/deductions––net (862) 126 (641) 218 Income from continuing operations before provision/(benefit) for taxes on income 3,953 4,141 7,838 8,463 Provision/(benefit) for taxes on income 519 (915) 993 (481) Income from continuing operations 3,434 5,056 6,845 8,945 Discontinued operations––net of tax — — — — Net income before allocation to noncontrolling interests 3,434 5,056 6,845 8,945 Less: Net income attributable to noncontrolling interests 8 10 17 15 Net income attributable to Pfizer Inc. $ 3,426 $ 5,046 $ 6,828 $ 8,929 Earnings per common share––basic: Income from continuing operations attributable to Pfizer Inc. common shareholders $ 0.62 $ 0.91 $ 1.23 $ 1.59 Discontinued operations––net of tax — — — — Net income attributable to Pfizer Inc. common shareholders $ 0.62 $ 0.91 $ 1.23 $ 1.59 Earnings per common share––diluted: Income from continuing operations attributable to Pfizer Inc. common shareholders $ 0.61 $ 0.89 $ 1.22 $ 1.56 Discontinued operations––net of tax — — — — Net income attributable to Pfizer Inc. common shareholders $ 0.61 $ 0.89 $ 1.22 $ 1.56 Weighted-average shares––basic 5,554 5,562 5,550 5,598 Weighted-average shares––diluted 5,619 5,672 5,616 5,711 (a) Excludes amortization of intangible
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