Cover and table of contents

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. Healthcare Legislation)			U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and Education 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. 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
LOE			loss of exclusivity
MCO			managed care organization
mCRC			metastatic colorectal cancer
mCRPC			metastatic castration-resistant prostate cancer
mCSPC			metastatic castration-sensitive prostate cancer
mRNA			messenger ribonucleic acid
MD&A			Management’s Discussion and Analysis of Financial Condition and Results of Operations
Medivation			Medivation LLC (formerly Medivation Inc.)
Meridian			Meridian Medical Technologies, Inc.
Moody’s			Moody’s Investors Service
Mylan			Mylan N.V.
Mylan-Japan collaboration			a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan that terminated on December 21, 2020
Myovant			Myovant Sciences Ltd.
NAV			net asset value
NDA			new drug application
nmCRPC			non-metastatic castration-resistant prostate cancer
NMPA			National Medical Product Administration in China
NYSE			New York Stock Exchange
OTC			over-the-counter
PBM			pharmacy benefit manager
PBO			Projected benefit obligation; represents the present value of the benefit obligation earned through the end of the year and factors in future compensation increases
PCPP			Pfizer Consolidated Pension Plan
PGS			Pfizer Global Supply
Pharmacia			Pharmacia Corporation
PMDA			Pharmaceuticals and Medical Device Agency in Japan
PsA			psoriatic arthritis
QCE			quality consistency evaluation
RA			rheumatoid arthritis
RCC			renal cell carcinoma
R&D			research and development
ROU			right of use
Sandoz			Sandoz, Inc., a division of Novartis AG
S&P			Standard & Poor’s
SEC			U.S. Securities and Exchange Commission
Servier			Les Laboratoires Servier SAS
Shire			Shire International GmbH
Tax Cuts and Jobs Act or TCJA			Legislation commonly referred to as the U.S. Tax Cuts and Jobs Act of 2017
Teva			Teva Pharmaceuticals USA, Inc.
Therachon			Therachon Holding AG

Pfizer Inc.			2020 Form 10-K			ii

Upjohn Business			Pfizer’s global, primarily off-patent branded and generics business, which includes a portfolio of 20 globally recognized solid oral dose brands, including Lipitor, Lyrica, Norvasc, Celebrex and Viagra, as well as a U.S.-based generics platform, Greenstone, that was spun-off on November 16, 2020 and combined with Mylan to create Viatris
UC			ulcerative colitis
U.K.			United Kingdom
U.S.			United States
VAI			Voluntary Action Indicated
Valneva			Valneva SE
VBP			volume-based procurement
Viatris			Viatris Inc.
ViiV			ViiV Healthcare Limited
WRDM			Worldwide Research, Development and Medical

This Form 10-K includes discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether.

Some amounts in this Form 10-K may not add due to rounding. All percentages have been calculated using unrounded amounts. All trademarks mentioned are the property of their owners.

FORWARD-LOOKING INFORMATION AND FACTORS THAT MAY AFFECT FUTURE RESULTS

This Form 10-K contains forward-looking statements. We also provide forward-looking statements in other materials we release to the public, as well as public oral statements. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions.

We have tried, wherever possible, to identify such statements by using words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek” and other words and terms of similar meaning or by using future dates.

We include forward-looking information in our discussion of the following, among other topics:

• our anticipated operating and financial performance, reorganizations, business plans and prospects;

• expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, post-approval clinical trial results and other developing data that become available, revenue contribution, growth, performance, timing of exclusivity and potential benefits;

• strategic reviews, capital allocation objectives, dividends and share repurchases;

• plans for and prospects of our acquisitions, dispositions and other business development activities, and our ability to successfully capitalize on these opportunities;

• sales, expenses, interest rates, foreign exchange rates and the outcome of contingencies, such as legal proceedings;

• expectations for impact of or changes to existing or new government regulations or laws;

• our ability to anticipate and respond to macroeconomic, geopolitical, health and industry trends, pandemics, acts of war and other large-scale crises; and

• manufacturing and product supply.

In particular, forward-looking information in this Form 10-K includes statements relating to specific future actions and effects, including, among others, our efforts to respond to COVID-19, including our development of a vaccine to help prevent COVID-19, the forecasted revenue contribution of BNT162b2 and the potential number of doses that we and BioNTech believe can be delivered; our expectations regarding the impact of COVID-19 on our business; the expected impact of patent expiries and competition from generic manufacturers; the expected pricing pressures on our products and the anticipated impact to our business; the availability of raw materials for 2021; the expected charges and/or costs in connection with the spin-off of the Upjohn Business and its combination with Mylan; the benefits expected from our business development transactions; our anticipated liquidity position; the anticipated costs and savings from certain of our initiatives, including our Transforming to a More Focused Company program; our planned capital spending; the expectations for our quarterly dividend payments; and the expected benefit payments and employer contributions for our benefit plans.

Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. Actual outcomes may vary materially from past results and those anticipated, estimated, implied or projected. These forward-looking statements may be affected by underlying assumptions that may prove inaccurate or incomplete, or by known or unknown risks and uncertainties, including those described in this section and in the Item 1A. Risk Factors section in this Form 10-K.

Therefore, you are cautioned not to unduly rely on forward-looking statements, which speak only as of the date of this Form 10-K. We undertake no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. You are advised, however, to consult any further disclosures we make on related subjects.

Some of the factors that could cause actual results to differ are identified below, as well as those discussed in the Item 1A. Risk Factors section in this Form 10-K and within MD&A. We note these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. The occurrence of any of the risks identified below or in the Item 1A. Risk Factors section in this Form 10-K, or other risks currently unknown, could have a material adverse effect on our business, financial condition or results of operations, or we may be required to increase our accruals for contingencies. It is not possible to predict or identify all such factors. Consequently, you should not consider the following to be a complete discussion of all potential risks or uncertainties:

Pfizer Inc.			2020 Form 10-K			iii

Risks Related to Our Business, Industry and Operations, and Business Development:

• the outcome of R&D activities, including, the ability to meet anticipated pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or clinical trials, regulatory submission dates, and/or regulatory approval and/or launch dates, as well as the possibility of unfavorable pre-clinical and clinical trial results, including the possibility of unfavorable new pre-clinical or clinical data and further analyses of existing pre-clinical or clinical data;

• our ability to successfully address comments received from regulatory authorities such as the FDA or the EMA, or obtain approval from regulators on a timely basis or at all; regulatory decisions impacting labeling, manufacturing processes, safety and/or other matters; the impact of recommendations by technical or advisory committees; and the timing of pricing approvals and product launches;

• claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates, including claims and concerns that may arise from the outcome of post-approval clinical trials, which could impact marketing approval, product labeling, and/or availability or commercial potential, including uncertainties regarding the commercial or other impact of the results of the Xeljanz ORAL Surveillance (A3921133) study or any potential actions by regulatory authorities based on analysis of ORAL Surveillance or other data;

• the success and impact of external business development activities, including the ability to identify and execute on potential business development opportunities; the ability to satisfy the conditions to closing of announced transactions in the anticipated time frame or at all; the ability to realize the anticipated benefits of any such transactions in the anticipated time frame or at all; the potential need for and impact of additional equity or debt financing to pursue these opportunities, which could result in increased leverage and/or a downgrade of our credit ratings; challenges integrating the businesses and operations; disruption to business and operations relationships; risks related to growing revenues for certain acquired products; significant transaction costs; and unknown liabilities;

• competition, including from new product entrants, in-line branded products, generic products, private label products, biosimilars and product candidates that treat diseases and conditions similar to those treated by our in-line drugs and drug candidates;

• the ability to successfully market both new and existing products, including biosimilars;

• difficulties or delays in manufacturing, sales or marketing; supply disruptions, shortages or stock-outs at our facilities; and legal or regulatory actions;

• the impact of public health outbreaks, epidemics or pandemics (such as the COVID-19 pandemic) on our business, operations and financial condition and results;

• risks and uncertainties related to our efforts to develop a vaccine to help prevent COVID-19 and potential treatments for COVID-19, as well as challenges related to their manufacturing, supply and distribution;

• trends toward managed care and healthcare cost containment, and our ability to obtain or maintain timely or adequate pricing or favorable formulary placement for our products;

• interest rate and foreign currency exchange rate fluctuations, including the impact of possible currency devaluations in countries experiencing high inflation rates;

• any significant issues involving our largest wholesale distributors, which account for a substantial portion of our revenues;

• the impact of the increased presence of counterfeit medicines in the pharmaceutical supply chain;

• any significant issues related to the outsourcing of certain operational and staff functions to third parties; and any significant issues related to our JVs and other third-party business arrangements;

• uncertainties related to general economic, political, business, industry, regulatory and market conditions including, without limitation, uncertainties related to the impact on us, our customers, suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions and recent and possible future changes in global financial markets;

• any changes in business, political and economic conditions due to actual or threatened terrorist activity, civil unrest or military action;

• the impact of product recalls, withdrawals and other unusual items;

• trade buying patterns;

• the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments;

• the impact of, and risks and uncertainties related to, restructurings and internal reorganizations, as well as any other corporate strategic initiatives, and cost-reduction and productivity initiatives, each of which requires upfront costs but may fail to yield anticipated benefits and may result in unexpected costs or organizational disruption;

Risks Related to Government Regulation and Legal Proceedings:

• the impact of any U.S. healthcare reform or legislation or any significant spending reductions or cost controls affecting Medicare, Medicaid or other publicly funded or subsidized health programs or changes in the tax treatment of employer-sponsored health insurance that may be implemented;

• U.S. federal or state legislation or regulatory action and/or policy efforts affecting, among other things, pharmaceutical product pricing, intellectual property, reimbursement or access or restrictions on U.S. direct-to-consumer advertising; limitations on interactions with healthcare professionals and other industry stakeholders; as well as pricing pressures for our products as a result of highly competitive insurance markets;

• legislation or regulatory action in markets outside of the U.S., including China, affecting pharmaceutical product pricing, intellectual property, reimbursement or access, including, in particular, continued government-mandated reductions in prices and access restrictions for certain biopharmaceutical products to control costs in those markets;

• the exposure of our operations outside of the U.S. to possible capital and exchange controls, economic conditions, expropriation and other restrictive government actions, changes in intellectual property legal protections and remedies, as well as political unrest, unstable governments and legal systems and inter-governmental disputes;

Pfizer Inc.			2020 Form 10-K			iv

• legal defense costs, insurance expenses, settlement costs and contingencies, including those related to actual or alleged environmental contamination;

• the risk and impact of an adverse decision or settlement and the adequacy of reserves related to legal proceedings;

• the risk and impact of tax related litigation;

• governmental laws and regulations affecting our operations, including, without limitation, changes in laws and regulations or their interpretation, including, among others, changes in taxation requirements;

Risks Related to Intellectual Property, Technology and Security:

• any significant breakdown, infiltration or interruption of our information technology systems and infrastructure;

• the risk that our currently pending or future patent applications may not be granted on a timely basis or at all, or any patent-term extensions that we seek may not be granted on a timely basis, if at all; and

• our ability to protect our patents and other intellectual property, including against claims of invalidity that could result in LOE and in response to any pressure, or legal or regulatory action by, various stakeholders or governments that could potentially result in us not seeking intellectual property protection for or agreeing not to enforce intellectual property related to our products, including our vaccine to help prevent COVID-19 and potential treatments for COVID-19.

Pfizer Inc.			2020 Form 10-K			v

PART I