19 Nov Refer to the following three sections of PFIZER ‘s annual report: (i) Consolidated Statement of Income (also known as the income statement), (ii) the Notes to Consolidated Statements
short answer; No process required ；If the question asks for a dollar amount, you may simply reply with the dollar amount； For each of your responses below, please indicate the exact page number(s) from the annual report
1. Refer to the following three sections of PFIZER’s annual report: (i) Consolidated Statement of Income (also known as the income statement), (ii) the Notes to Consolidated Statements (also known as the “footnotes” to the financial statements), and (iii) Analysis of the Consolidated Statements of Income.
a) What are the major sources of revenue for the company?
b) What is the dollar amount of total revenues for 2022?
c) What is the dollar amount of total revenues for 2021?
$81,288 millions (pg.104)
d) In your own words, what are some of the major reasons behind the change in revenue from the previous year?
We can see that the explosive growth of the company in the past two years stems from its Comirnaty direct sales and alliance revenues, and Paxlovid. The emergence of the COVID-19 pandemic during these years has given Pfizer a significant profit increase. (pg.104)
2. Refer to PFIZER’s Notes to Consolidated Statements (also known as the “footnotes” to the financial statements). Locate the footnotes containing discussion of PFIZER’s revenue recognition policies. In your own words, please describe PFIZER’s revenue recognition policy or policies.
3. Does PFIZER prepare its income statement using the cash or accrual basis? What items on the balance sheet or income statement provide clues to answering this question?
By using accrual basis. We can find from the income statement of pg.52,
4. Which audit firm is the auditor for PFIZER? In your own words, what assurances (if any) does the auditor provide with respect to PFIZER’s annual report?
5. Please answer the following questions related to accounts receivable.
a) What is the dollar amount of accounts receivable for 2022?
b) What is the dollar amount of accounts receivable for 2021?
c) In your own words, what are some of the major reasons behind the change in accounts receivable from the previous year?
6. Please answer the following questions related to the allowance for doubtful accounts.
a) What is the dollar amount for the allowance for doubtful accounts for the year ended December 31, 2022? How does it compare to 2021?
b) Which financial statement(s) provide the dollar amount for the allowance for doubtful accounts?
c) In your own words, what does the allowance for doubtful accounts represent?
d) In your own words, please explain why the allowance could increase or decrease from one year to the next year.
e) In your own words, please describe how PFIZER determines the dollar amount to record in the allowance for doubtful accounts.
7. Answer the following questions related to inventory.
a) Inventory is generally considered a “current” asset. Why?
b) Which inventory method does PFIZER use? For example, LIFO, FIFO, average cost, or specific identification. In your own words, please provide an explanation of how the inventory method chosen by PFIZER works.
c) In your own words, please explain how inventory and cost of goods sold are related.
d) What is the dollar amount for gross profit for 2022? In your own words, what does gross profit represent? How would gross profit be different if PFIZER used a different inventory method (for example, higher or lower or stays the same)?
8. Please answer the following questions related to property, plant, and equipment (PPE).
a) What depreciation method(s) does PFIZER use? In your own words, please describe PFIZER’s depreciation method(s) (i.e., how the depreciation expense number is computed using the method).
b) What is the estimated useful life used by PFIZER for depreciating its PPE? If the company uses different useful life estimates for different categories of PPE, please identify all the major categories of PPE and indicate the useful life estimate for each category. Do you believe these estimates are reasonable? Why or why not?
c) What is the dollar amount of accumulated depreciation in 2022? What type of account is accumulated depreciation (i.e., asset, liability, owners’ equity, revenue, or expense, etc.)? In your own words, what does “accumulated depreciation” mean? Does the dollar amount of accumulated depreciation in 2022 include only depreciation related to assets that PFIZER acquired during 2022?
d) How much depreciation expense did PFIZER report for the 2022 fiscal year? Which financial statement(s) provide this dollar amount? In your own words, what is the relationship between depreciation expense and accumulated depreciation?
9. What types of intangible assets does PFIZER have? Briefly describe each type that PFIZER has.
10. Does PFIZER provide any proforma (i.e., non-GAAP) earnings numbers in the annual report? What are the major adjustments that the company makes to reported GAAP income to compute the proforma earnings number?
11. Using total revenues as the common deflator, prepare a common size income statement for each year: 2020, 2021, and 2022. Provide analysis and discussion of noteworthy patterns and trends.
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549
(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, 2022
☐ 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)
66 Hudson Boulevard East, New York, New York 10001-2192 (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 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. ☒ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐ 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, July 3, 2022, was approximately $294 billion. This excludes shares of common stock held by directors and executive officers at July 3, 2022. 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 21, 2023 was 5,619,074,621 shares of common stock, all of one class.
DOCUMENTS INCORPORATED BY REFERENCE Portions of the Proxy Statement for the 2023 Annual Meeting of Shareholders Part III
TABLE OF CONTENTS
Page Defined Terms i Available Information iii Forward-Looking Information and Factors that May Affect Future Results 1
PART I 3 ITEM 1. BUSINESS 3
About Pfizer 3 Commercial Operations 3 Research and Development 4 Collaboration and Co-Promotion Agreements 5 International Operations 5 Sales and Marketing 6 Patents and Other Intellectual Property Rights 6 Competition 8 Pricing Pressures and Managed Care Organizations 9 Raw Materials 9 Government Regulation and Price Constraints 10 Environmental Matters 12 Human Capital 12
ITEM 1A. RISK FACTORS 14 ITEM 1B. UNRESOLVED STAFF COMMENTS N/A ITEM 2. PROPERTIES 23 ITEM 3. LEGAL PROCEEDINGS 23 ITEM 4. MINE SAFETY DISCLOSURES N/A INFORMATION ABOUT OUR EXECUTIVE OFFICERS 23
PART II 24 ITEM 5. MARKET FOR THE COMPANY’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 24 ITEM 6. [RESERVED] 25 ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 25 ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 44 ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 45 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 101 ITEM 9A. CONTROLS AND PROCEDURES 101 ITEM 9B. OTHER INFORMATION N/A ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS N/A
PART III 104 ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 104 ITEM 11. EXECUTIVE COMPENSATION 104 ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 104 ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 104 ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES 104
PART IV 104 ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES 104
15(a)(1) Financial Statements 104 15(a)(2) Financial Statement Schedules 104 15(a)(3) Exhibits 104
ITEM 16. FORM 10-K SUMMARY 108 SIGNATURES 109 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. Pfizer’s fiscal year-end for 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: Form 10-K This Annual Report on Form 10-K for the fiscal year ended December 31, 2022 2021 Form 10-K Our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 Proxy Statement Proxy Statement for the 2023 Annual Meeting of Shareholders, which will be filed no later than 120 days after
December 31, 2022 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 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 Arena Arena Pharmaceuticals, Inc. Array Array BioPharma Inc. Arvinas Arvinas, Inc. Astellas Astellas Pharma Inc., Astellas US LLC and Astellas Pharma US, Inc. ATTR-CM transthyretin amyloid cardiomyopathy Beam Beam Therapeutics Inc. Biohaven Biohaven Pharmaceutical Holding Company Ltd. BioNTech BioNTech SE Biopharma Global Biopharmaceuticals Business BLA Biologics License Application BMS Bristol-Myers Squibb Company BOD Board of Directors CDC U.S. Centers for Disease Control and Prevention cGMP current Good Manufacturing Practices CGRP calcitonin gene-related peptide CMA conditional marketing authorisation CMS Centers for Medicare & Medicaid Services Comirnaty* Unless otherwise noted, refers to, as applicable, and as authorized or approved, the Pfizer-BioNTech
COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), the Comirnaty Original/Omicron BA.1 Vaccine, and Comirnaty Original/Omicron BA.4/BA.5 Vaccine
Cond. J-NDA Conditional Japan New Drug Application Consumer Healthcare JV GSK Consumer Healthcare JV COVID-19 novel coronavirus disease of 2019 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, South Korea, Australia and New
Zealand Developed Rest of World Includes the following markets: Japan, Canada, South Korea, Australia and New Zealand EC European Commission EMA European Medicines Agency Emerging Markets Includes, but is not limited to, the following markets: Asia (excluding Japan and South Korea), Latin America,
Central Europe, Eastern Europe, the Middle East, Africa and Turkey EPS earnings per share ESG Environmental, Social and Governance 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 FFDCA U.S. Federal Food, Drug and Cosmetic Act GAAP Generally Accepted Accounting Principles GBT Global Blood Therapeutics, Inc. GDFV grant-date fair value
Pfizer Inc. 2022 Form 10-K i
GPD Global Product Development organization GSK GlaxoSmithKline plc Haleon Haleon plc HHS U.S. Department of Health and Human Services HIPAA Health Insurance Portability and Accountability Act of 1996 Hospira Hospira, Inc. IPR&D in-process research and development IRA Inflation Reduction Act of 2022 IRC Internal Revenue Code IRS U.S. Internal Revenue Service IT information technology JAK Janus kinase JV joint venture King King Pharmaceuticals LLC (formerly King Pharmaceuticals, Inc.) LIBOR London Interbank Offered Rate Lilly Eli Lilly and 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 MD&A Management’s Discussion and Analysis of Financial Condition and Results of Operations MDL Multi-District Litigation Medivation Medivation LLC (formerly Medivation, Inc.) Meridian Meridian Medical Technologies, Inc. Moody’s Moody’s Investors Service mRNA messenger ribonucleic acid MSA Manufacturing Supply Agreement MTM mark-to-market MTM change in accounting principle
In the first quarter of 2021, we adopted a change in accounting principle to a more preferable policy under U.S. GAAP to immediately recognize actuarial gains and losses arising from the remeasurement of our pension and postretirement plans (MTM Accounting).
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 NSCLC non-small cell lung cancer NYSE New York Stock Exchange Ono Ono Pharmaceutical Co., Ltd. OPKO OPKO Health, Inc. OTC over-the-counter Paxlovid* an oral COVID-19 treatment (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) 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 PC1 Pfizer CentreOne PGS Pfizer Global Supply Pharmacia Pharmacia Corporation PRAC Pharmacovigilance Risk Assessment Committee Prevnar family Includes Prevnar 13/Prevenar 13 (pediatric and adult) and Prevnar 20 (adult) PsA psoriatic arthritis QCE quality consistency evaluation RA rheumatoid arthritis RCC renal cell carcinoma R&D research and development ReViral ReViral Ltd. ROU right of use S&P Standard & Poor’s SEC U.S. Securities and Exchange Commission SI&A selling, informational and administrative
Pfizer Inc. 2022 Form 10-K ii
sNDA supplemental new drug application Tax Cuts and Jobs Act or TCJA
Legislation commonly referred to as the U.S. Tax Cuts and Jobs Act of 2017
Trillium Trillium Therapeutics Inc. TSAs transition service arrangements UC ulcerative colitis U.K. United Kingdom Upjohn Business Pfizer’s former global, primarily off-patent branded and generics business, which included 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
U.S. United States Valneva Valneva SE VBP volume-based procurement Viatris Viatris Inc. ViiV ViiV Healthcare Limited Vyndaqel family Includes Vyndaqel, Vyndamax and Vynmac WRDM Worldwide Research, Development and Medical WTO World Trade Organization
* Paxlovid and emergency uses of the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), have not been approved or licensed by the FDA. Paxlovid has been authorized for emergency use by the FDA under an EUA, for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with a current diagnosis of mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death. Emergency uses of the Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent have been authorized by the FDA under an EUA to prevent COVID-19 in individuals aged 6 months and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product during the COVID-19 pandemic under Section 564(b)(1) of the FFDCA, unless the declaration is terminated or authorization revoked sooner. Please see the EUA Fact Sheets at www.covid19oralrx.com and www.cvdvaccine-us.com.
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.
Our website is www.pfizer.com. This Form 10-K, our Quarterly Reports on Form 10-Q, our Current Reports on Form 8-K and our proxy statements, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, are, or will be, available (free of charge) on our website, in text format and, where applicable, in interactive data file format, as soon as reasonably practicable after we electronically file this material with, or furnish it to, the SEC. Throughout this Form 10-K, we “incorporate by reference” certain information from other documents filed or to be filed with the SEC, including our Proxy Statement. Please refer to this information. This Form 10-K will be available on our website on or about February 23, 2023. Our Proxy Statement will be available on our website on or about March 16, 2023. Our 2022 ESG Report, which provides enhanced ESG disclosures, will be available on our website on or about March 16, 2023. We also have a Pfizer Investor Insights website, which includes articles on the company, its products and its pipeline, located at insights.pfizer.com. Information in our ESG Report and on the Pfizer Investor Insights website are not incorporated by reference into this Form 10-K. We may use our website as a means of disclosing material information and for complying with our disclosure obligations under Regulation Fair Disclosure promulgated by the SEC. These disclosures are included on our website in the “About—Investors” or “Newsroom” sections. Accordingly, investors should monitor these portions of our website, in addition to following our press releases, SEC filings, public conference calls and webcasts, as well as our social media channels (our Facebook, Instagram (@Pfizerinc), YouTube and LinkedIn pages and Twitter accounts (@Pfizer and @Pfizer_News)). The information contained on our website, our Facebook, Instagram, YouTube and LinkedIn pages or our Twitter accounts, or any third-party website, is not incorporated by reference into this Form 10-K. 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 Members of the Board of Directors; information concerning our Directors; ways to communicate by e-mail with our Directors; information concerning our Board Committees; Committee Charters; Charter of the Lead Independent Director; and transactions in Pfizer securities by Directors and Officers are available on our website. We will provide any of the foregoing information without charge upon written request to our Corporate Secretary, Pfizer Inc., 66 Hudson Boulevard East, New York, NY 10001-2192. We will disclose any future amendments to, or waivers from, provisions of the Pfizer Policies on Business Conduct affecting our Chief Executive Officer, Chief Financial Officer, Principal Accounting Officer and executive officers on our website as promptly as practicable, as may be required under applicable SEC and NYSE rules. Information relating to shareholder services, including the Computershare Investment Program, book- entry share ownership and direct deposit of dividends, is also available on our website.
Pfizer Inc. 2022 Form 10-K iii
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,” “potential,” “hope” 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, strategy and prospects; • expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs,
study starts, approvals, launches, clinical trial results and other developing data; revenue contribution and projections; potential pricing and reimbursement; potential market dynamics and size; 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
growth opportunities and prospects; • 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, performance and effects, including, among others, the expected benefits of the organizational changes to our operations; our 2023 revenue expectations; our ongoing efforts to respond to COVID-19, including our plans and expectations regarding Comirnaty and Paxlovid, and any potential future vaccines or treatments; the forecasted revenue, demand, manufacturing and supply of Comirnaty and Paxlovid, including expectations for the commercial market for Comirnaty and Paxlovid; our expectations regarding the impact of COVID-19 on our business; the expected patent term for Comirnaty; the expectations for ongoing revenue streams from Comirnaty and Paxlovid; the expected impact of patent expiries and generic competition; the expected pricing pressures on our products and the anticipated impact to our business; the availability of raw materials for 2023; 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; and the expected benefit payments from and employer contributions to 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, in the Item 1A. Risk Factors section in this Form 10-K, or within MD&A, 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:
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; 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; risks associated with preliminary, early stage or interim data; the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/ publication process, in the scientific community generally, and by regulatory authorities; and whether and when additional data from our pipeline programs will be published in scientific journal publications, and if so, when and with what modifications and interpretations;
• our ability to successfully address comments received from regulatory authorities such as the FDA or the EMA, or obtain approval for new products and indications from regulators on a timely basis or at all; regulatory decisions impacting labeling, including the scope of indicated patient populations, product dosage, manufacturing processes, safety and/or other matters, including decisions relating to emerging developments regarding potential product impurities; the impact of, or uncertainties regarding the ability to obtain, 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 actions by regulatory authorities based on analysis of ORAL Surveillance or other data, including on other JAK inhibitors in our portfolio;
• 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
Pfizer Inc. 2022 Form 10-K 1
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 or prevent diseases and conditions similar to those treated or intended to be prevented by our in-line products and product 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 or third-party
facilities that we rely on; 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, including impacts on our employees, manufacturing, supply chain, sales and marketing, R&D and clinical trials;
• risks and uncertainties related to our efforts to continue to develop and commercialize Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments, as well as challenges related to their manufacturing, supply and distribution;
• risks related to our ability to achieve our revenue forecasts for Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments, including, among other things, whether and when additional supply or purchase agreements will be reached and the risk that demand for any products may be reduced, no longer exist or not meet expectations, which may lead to excess inventory on- hand and/or in the channel or reduced revenues;
• 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 and monetary policy actions in countries experiencing high inflation rates;
• any significant issues involving our largest wholesale distributors or