acounting

Format of your case write-up: Use single-space and 12 point font, Times New Roman. There is no minimum required length, but the maximum allowed length is 12 pages.

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, 2023
☐
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
(State or other jurisdiction of incorporation or organization)
13-5315170
(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)
Title of each class
Common Stock, $0.05 par value
1.000% Notes due 2027
Securities registered pursuant to Section 12(b) of the Act:
Trading Symbol(s)
Name of each exchange on which registered
PFE
New York Stock Exchange
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 was approximately $207 billion. This excludes shares of common stock held by directors and executive officers. 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 15, 2024 was 5,646,778,425 shares of common stock, all of one class.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Proxy Statement for the 2024 Annual Meeting of Shareholders
Part III
TABLE OF CONTENTS
Page
Defined Terms
Available Information
Forward-Looking Information and Factors that May Affect Future Results
i
iii
1
PART I
ITEM 1. BUSINESS
3
About Pfizer
Commercial Operations
Research and Development
Collaboration and Co-Promotion Agreements
International Operations
Sales and Marketing
Patents and Other Intellectual Property Rights
Competition
Pricing Pressures and Managed Care Organizations
Raw Materials
Government Regulation and Price Constraints
Environmental Matters
Our People
ITEM 1A. RISK FACTORS
ITEM 1B. UNRESOLVED STAFF COMMENTS
ITEM 1C. CYBERSECURITY
ITEM 2. PROPERTIES
ITEM 3. LEGAL PROCEEDINGS
ITEM 4. MINE SAFETY DISCLOSURES
INFORMATION ABOUT OUR EXECUTIVE OFFICERS
3
3
4
4
5
6
6
7
10
10
11
11
14
15
16
N/A
26
27
27
N/A
28
PART II
29
ITEM 5. MARKET FOR THE COMPANY’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
29
ITEM 6. [RESERVED]
29
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
30
49
50
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
ITEM 9A. CONTROLS AND PROCEDURES
ITEM 9B. OTHER INFORMATION
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
107
107
110
N/A
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
110
110
110
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
110
110
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
ITEM 16. FORM 10-K SUMMARY
SIGNATURES
N/A = Not Applicable
110
110
110
110
110
111
114
115
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. For each
year presented, Pfizer’s fiscal year-end for subsidiaries operating outside the U.S. is as of and for the year ended November 30 and for U.S. subsidiaries is as of and for the year
ended December 31. 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, 2023
2022 Form 10-K
Our Annual Report on Form 10-K for the fiscal year ended December 31, 2022
Proxy Statement
Proxy Statement for the 2024 Annual Meeting of Shareholders, which will be filed no later than 120 days after December 31, 2023
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
ADC
Antibody-Drug Conjugate
Alexion
Alexion Pharma International Operations Limited, a subsidiary of AstraZeneca PLC
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 Limited
BioNTech
BioNTech SE
Biopharma
Global Biopharmaceuticals Business
Blackstone
Blackstone Life Sciences
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
CMS
calcitonin gene-related peptide
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), Comirnaty (COVID-19 Vaccine, mRNA, 2023-2024 Formula), the Pfizer-BioNTech
COVID-19 Vaccine (2023-2024 Formula), Comirnaty Original/Omicron BA.1, Comirnaty Original/Omicron BA.4/BA.5 and Comirnaty XBB.1.5.
Consumer Healthcare JV
GSK Consumer Healthcare JV
COVID-19
novel coronavirus disease of 2019
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 and Developed Rest of World
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, Eastern Europe, Central 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
Pfizer Inc.
2023 Form 10-K
i
GBT
Global Blood Therapeutics, Inc.
GDFV
grant-date fair value
Genmab
Genmab A/S
GPD
Global Product Development organization
GSK
GSK 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
JV
joint venture
King
King Pharmaceuticals LLC (formerly King Pharmaceuticals, Inc.)
LIBOR
London Interbank Offered Rate
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
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
NAV
net asset value
NDA
new drug application
Nimbus
NimbusTherapeutics, LLC
nmCRPC
non-metastatic castration-resistant prostate cancer
nmCSPC
non-metastatic castration-sensitive prostate cancer
NSCLC
non-small cell lung cancer
NYSE
New York Stock Exchange
ODT
oral disintegrating tablet
Ono
Ono Pharmaceutical Co., Ltd.
OPKO
OPKO Health, Inc.
ORD
Oncology Research and Development
OTC
over-the-counter
Paxlovid*
an oral COVID-19 treatment (nirmatrelvir 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 LLC (formerly Pharmacia Corporation)
PIE
Pfizer Investment Enterprises Pte. Ltd. (a wholly-owned finance subsidiary of Pfizer)
PP&E
Property, plant and equipment
PRAC
PRD
Pharmacovigilance Risk Assessment Committee
Pfizer Research and Development
Prevnar family
Includes Prevnar 20/Apexxnar (pediatric and adult) and Prevnar 13/Prevenar 13 (pediatric and adult)
PsA
psoriatic arthritis
QCE
quality consistency evaluation
RA
rheumatoid arthritis
Pfizer Inc.
2023 Form 10-K
ii
RCC
renal cell carcinoma
R&D
research and development
ReViral
ReViral Ltd.
ROU
right of use
RSV
respiratory syncytial virus
S&P
Standard & Poor’s
Seagen
Seagen Inc. and its subsidiaries
SEC
U.S. Securities and Exchange Commission
SI&A
selling, informational and administrative
SMPA
Sumitomo Pharma America, Inc.
Takeda
Takeda Pharmaceutical Company Limited
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 ULC (formerly 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
Wyeth
Wyeth LLC (formerly Wyeth)
* The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) and certain uses of Paxlovid have not been approved or licensed by the FDA. The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)
has been authorized for emergency use by the FDA under an EUA to prevent COVID-19 in individuals aged 6 months through 11 years of age. Paxlovid has been authorized for emergency use by the FDA
under an EUA for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including
hospitalization or death. 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 efficacy 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.
AVAILABLE INFORMATION
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 22, 2024. Our Proxy Statement will be available on our website on or about March 14, 2024.
Our 2023 Impact Report, which provides enhanced ESG disclosures, will be available on our website on or about March 14, 2024. 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 2023 Impact 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 page, Instagram account (@Pfizerinc), YouTube
page, LinkedIn page, and X (formerly known as Twitter) accounts (@Pfizer and @Pfizer_News)). The information contained on our website, our Facebook, Instagram, YouTube and
LinkedIn pages or our X 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
Pfizer Inc.
2023 Form 10-K
iii
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.
2023 Form 10-K
iv
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, including financial guidance and projections;
• reorganizations, business plans, strategy, goals 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, including patient demand,
market size and utilization rates; and 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 regarding the impact of or changes to existing or new government regulations or laws;
• our ability to anticipate and respond to and our expectations regarding the impact of 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 anticipated operating and financial performance; our ongoing efforts to respond to COVID-19, including our plans and
expectations regarding Comirnaty and Paxlovid, and any potential future vaccines or treatments, including anticipated revenue and expectations for the commercial market for
Comirnaty and Paxlovid; our expectations regarding the impact of COVID-19 on our business; expected patent terms; the expected impact of patent expiries and generic and
biosimilar competition; the expected pricing pressures on our products and the anticipated impact to our business; the benefits expected from our business development
transactions, including our December 2023 acquisition of Seagen; our anticipated liquidity position; the anticipated costs, savings and potential benefits from certain of our initiatives,
including our enterprise-wide Realigning our Cost Base program, which we launched in October 2023, and our Transforming to a More Focused Company program; our expectations
regarding the impact from the 2023 tornado on our manufacturing facility in Rocky Mount, NC; our greenhouse gas emission reduction goals; our planned capital spending; and our
capital allocation framework.
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, in the Item 1A. Risk Factors section or in MD&A.
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 forwardlooking 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 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, 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; uncertainties regarding the ability to obtain, and the scope of,
recommendations by technical or advisory committees, and the timing of, and ability to obtain, pricing approvals and product launches, all of which could impact the
availability or commercial potential of our products and product candidates;
• 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;
Pfizer Inc.
2023 Form 10-K
1
• the success and impact of external business development activities, such as the recent acquisition of Seagen, 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 has in the past and could in the future result in increased leverage and/or a downgrade of our credit ratings and could limit our ability to obtain
future financing; challenges integrating the businesses and operations; disruption to business and operations relationships; risks related to growing revenues for certain
acquired or partnered 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 COVID-19) 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, treatments or
combinations, as well as challenges related to their manufacturing, supply and distribution, including, among others, the risk that as the market for COVID-19 products
continues to become more endemic and seasonal, demand for our COVID-19 products has and may continue to be reduced or not meet expectations, or may no longer
exist, which has and may continue to lead to reduced revenues, excess inventory on-hand and/or in the channel which, for Paxlovid and Comirnaty, resulted in
significant inventory write-offs in 2023 and could continue to result in inventory write-offs, or other unanticipated charges; challenges related to the transition to the
commercial market for our COVID-19 products; uncertainties related to the public’s adherence to vaccines, boosters, treatments or combinations; and risks related to
our ability to accurately predict or achieve our revenue forecasts for Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments;
• 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 currency devaluations and monetary policy actions in countries experiencing high
inflation or deflation rates;
• any significant issues involving our largest wholesale distributors or government customers, which account for a substantial portion of our revenues;
• the impact of the increased presence of counterfeit medicines, vaccines or other products in the pharmaceutical supply chain;
• any significant issues related to the outsourcing of certain operational and staff functions to third parties;
• any significant issues related to our JVs and other third-party business arrangements, including modifications related to supply agreements or other contracts with
customers including governments or other payors;
• 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, such
as inflation or interest rate fluctuations, and recent and possible future changes in global financial markets;
• the exposure of our operations globally to possible capital and exchange controls, economic conditions, expropriation, sanctions and/or other restrictive government
actions, changes in intellectual property legal protections and remedies, unstable governments and legal systems and inter-governmental disputes;
• the impact of disruptions related to climate change and natural disasters, including uncertainties related to the impact of the tornado at our manufacturing facility in
Rocky Mount, NC in 2023;
• any changes in business, political and economic conditions due to actual or threatened terrorist activity, geopolitical instability, political or civil unrest or military action,
including the ongoing conflicts between Russia and Ukraine and in the Middle East and the resulting economic or other consequences;
• the impact of product recalls, withdrawals and other unusual items, including uncertainties related to regulator-directed risk evaluations and assessments, including our
ongoing evaluation of our product portfolio for the potential presence or formation of nitrosamines;
• 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 growth strategies,
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,
organizational disruption, adverse effects on employee morale, retention issues or other unintended consequences;
• the ability to successfully achieve our climate goals and progress our environmental sustainability and other ESG priorities;
Risks Related to Government Regulation and Legal Proceedings:
• the impact of any U.S. healthcare reform or legislation or any significant spending reduction or cost control efforts affecting Medicare, Medicaid or other publicly funded
or subsidized health programs, including the IRA, 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
Pfizer Inc.
2023 Form 10-K
2
interactions with healthcare professionals and other industry stakeholders; as well as pricing pressures for our products as a result of highly competitive
biopharmaceutical markets;
• legislation or regulatory action in markets outside of the U.S., such as China or Europe, including, without limitation, laws related to pharmaceutical product pricing,
intellectual property, medical regulation, environmental protections, 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;
• legal defense costs, insurance expenses, settlement costs and contingencies, including without limitation, those related to actual or alleged environmental
contamination;
• the risk and impact of an adverse decision or settlement and risk related to the adequacy of reserves related to legal proceedings;
• the risk and impact of tax related litigation and investigations;
• governmental laws and regulations affecting our operations, including, without limitation, the IRA, changes in laws and regulations or their interpretation, including,
among others, changes in tax laws and regulations internationally and in the U.S., the adoption of global minimum taxation requirements outside the U.S. generally
effective in most jurisdictions since January 1, 2024 and potential changes to existing tax law by the current U.S. Presidential administration and Congress, including the
proposed “Tax Relief for American Families and Workers Act of 2024”;
Risks Related to Intellectual Property, Technology and Security:
• any significant breakdown or interruption of our IT systems and infrastructure (including cloud services);
• any business disruption, theft of confidential or proprietary information, security threats on facilities or infrastructure, extortion or integrity compromise resulting from a
cyber-attack or other malfeasance by, but not limited to, nation states, employees, business partners or others;
• risks and challenges related to the use of artificial intelligence-based software;
• 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
• risks to our products, patents and other intellectual property, such as: (i) claims of invalidity that could result in LOE; (ii) claims of patent infringement, including asserted and/or
unasserted intellectual property claims; (iii) claims we may assert against intellectual property rights held by third parties; (iv) challenges faced by our collaboration or licensing
partners to the validity of their patent rights; or (v) any pressure, or legal or regulatory action by, various stakeholders or governments that could potentially result in us not seeking
intellectual property protection or agreeing not to enforce or being restricted from enforcing intellectual property rights related to our products, including Comirnaty and Paxlovid.
PART I
ITEM 1.
BUSINESS
ABOUT PFIZER
Pfizer Inc. is a research-based, global biopharmaceutical company. We apply science and our global resources to bring therapies to people that extend and significantly improve
their lives through the discovery, development, manufacture, marketing, sale and distribution of biopharmaceutical products worldwide. We work across developed and emerging
markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. We collaborate with healthcare providers, governments and
local communities to support and expand access to reliable, affordable healthcare around the world. The Company was incorporated under the laws of the State of Delaware on
June 2, 1942.
Most of our revenues come from the manufacture and sale of biopharmaceutical products. We also sell products for the detection of certain illnesses and provide end-to-end R&D
services to select innovative biotech companies. We believe that our medicines and vaccines provide significant value for healthcare providers and patients through improved
treatment of diseases and improvements in health, wellness and productivity as well as by reducing other healthcare costs, such as emergency room visits or hospitalizations. We
seek to enhance the value of our medicines and vaccines and actively engage in dialogues about how we can best work with patients, physicians and payors to prevent and treat
disease and improve outcomes. We seek to maximize patient access and evaluate our pricing arrangements and contracting methods with payors to minimize adverse impact on
our revenues within the current legal and pricing structures.
We are committed to fulfilling our purpose: Breakthroughs that change patients’ lives. Our purpose fuels everything we do and reflects both our passion for science and our
commitment to patients. Our core business principles are:
1.
Trust is Everything
2.
Science Will Win
3.
Disruption Calls for Innovation
4.
Time is Life
5.
Execution Makes the Difference.
In addition, Pfizer’s ESG strategy, which is integrated into our corporate strategy, focuses on six areas where we see opportunities to create a meaningful impact: product innovation;
equitable access and pricing; product quality and safety; diversity, equity and inclusion; climate change; and business ethics.
We are committed to strategically capitalizing on growth opportunities, primarily by advancing our own product pipeline and maximizing the value of our existing products, but also
through various business development activities. We view our business development activity as an enabler of our strategies and seek to generate growth by pursuing opportunities
and transactions that have the potential to strengthen our business and our
Pfizer Inc.
2023 Form 10-K
3
capabilities. We assess our business, assets and scientific capabilities/portfolio as part of our regular, ongoing portfolio review process and also continue to consider business
development activities that will help advance our business strategy.
On December 14, 2023, we completed our acquisition of Seagen, a global biotechnology company that discovers, develops and commercializes transformative cancer medicines.
With the addition of Seagen’s pipeline and its four in-line medicines (Padcev, Adcetris, Tukysa and Tivdak), Pfizer’s oncology portfolio spans multiple modalities, including ADCs,
small molecules, bispecifics and other immunotherapies. In addition to the acquisition of Seagen, our significant recent business development activities in 2023 include, among
others, the September 2023 divestiture of our early-stage rare disease gene therapy portfolio to Alexion. For a further discussion of our strategy and our business development
initiatives, see the Overview of Our Performance, Operating Environment, Strategy and Outlook section within MD&A and Note 2.
COMMERCIAL OPERATIONS
In 2023, we managed our commercial operations through a global structure consisting of two operating segments, each led by a single manager: Biopharma, our innovative sciencebased biopharmaceutical business, and Business Innovation, an operating segment established in the first quarter of 2023 that includes PC1, our contract development and
manufacturing organization and a leading supplier of specialty active pharmaceutical ingredients, and Pfizer Ignite, an offering that provides strategic guidance and end-to-end R&D
services to select innovative biotech companies that align with our R&D focus areas. In 2023, Biopharma was the only reportable segment. The commercial structure within
Biopharma included three broad customer groups in 2023: Primary Care, Specialty Care and Oncology.
At the beginning of 2024, we made changes in our commercial organization to incorporate Seagen and improve focus, speed and execution. Specifically, within our Biopharma
reportable segment we created the Pfizer Oncology Division, the Pfizer U.S. Commercial Division, and the Pfizer International Commercial Division:
Division
Pfizer Oncology Division
Pfizer U.S. Commercial
Division
Description
Combines the U.S. Oncology commercial organizations, global Oncology marketing organizations and global and U.S. Oncology medical affairs from both
Pfizer and Seagen. Includes innovative oncology product portfolio of ADCs, small molecules, bispecifics and other immunotherapies that treat a wide
range of cancers including certain types of breast cancer, genitourinary cancer and hematologic malignancies, as well as certain types of melanoma,
gastrointestinal, gynecological and thoracic cancers, which includes lung cancer.
Includes the U.S. Primary Care and U.S. Specialty Care customer groups, the Chief Marketing Office, the Global Chief Medical Affairs Office and
Global Access & Value.
U.S. Primary Care includes:
• Internal medicine product portfolio of brands in cardiovascular metabolic, bone graft for spinal fusion and women’s health, as well as post-LOE
brands.
• Migraine product portfolio.
• Vaccines product portfolio across all ages with a pipeline focus on infectious diseases with significant unmet medical need, including COVID-19.
• Treatment for COVID-19.
• Products for detection of COVID-19 and influenza.
U.S. Specialty Care includes:
• Inflammation & immunology product portfolio of brands and biosimilars for chronic immune and inflammatory diseases.
• Rare disease product portfolio of brands for a number of therapeutic areas with rare diseases, including amyloidosis, hemophilia, endocrine diseases
and sickle cell disease.
• Hospital product portfolio of sterile injectable and immunoglobulin medicines.
Pfizer International Commercial
Division
Includes the ex-U.S. commercial and medical affairs organizations covering Pfizer’s entire product portfolio in all international markets.
Select products within Oncology, Primary Care and Specialty Care include:
• Oncology: Ibrance, Xtandi, Inlyta, Bosulif, Lorbrena, Braftovi, Mektovi, Padcev, Adcetris, Talzenna, Tukysa, Elrexfio and Tivdak
• Primary Care:
◦ Internal medicine: Eliquis, the Premarin family and BMP2
◦ Migraine: Nurtec ODT/Vydura and Zavzpret
◦ Vaccines: Comirnaty, the Prevnar family, Abrysvo, FSME/IMMUN-TicoVac, Nimenrix and Trumenba
◦ Treatment for COVID-19: Paxlovid
◦ Detection of COVID-19 and influenza: Lucira by Pfizer
• Specialty Care:
◦ Inflammation & immunology: Xeljanz, Enbrel (outside the U.S. and Canada), Inflectra, Cibinqo, Litfulo and Velsipity
◦ Rare disease: the Vyndaqel family, Genotropin, BeneFIX, Oxbryta, Somavert and Ngenla
◦ Hospital: Sulperazon, Zavicefta, Zithromax, Medrol and Panzyga
For additional information on our operating segments and products, including product revenues, see Note 17, and for additional information on the key operational revenue drivers of
our business, see the Analysis of the Consolidated Statements of Income section within MD&A. For a discussion of the risks associated with our dependence on certain of our major
products, see the Item 1A. Risk Factors—Concentration section.
RESEARCH AND DEVELOPMENT
R&D is at the heart of fulfilling our purpose to deliver breakthroughs that change patients’ lives as we work to translate advanced science and technologies into the medicines and
vaccines that may be the most impactful for patients. In addition to discovering and developing new products, our R&D efforts seek to add value to our existing products by
improving their safety, efficacy and ease of dosing and by discovering potential new indications.
Pfizer Inc.
2023 Form 10-K
4
Our R&D Priorities and Strategy. Our R&D priorities include:
• delivering a pipeline of highly differentiated medicines and vaccines where we have a unique opportunity to bring the most important new therapies to patients in need;
• advancing our capabilities that can position us for long-term R&D leadership; and
• advancing new models for partnerships with creativity, flexibility and urgency to deliver innovation to patients as quickly as possible.
To that end, our R&D primarily focuses on our main therapeutic areas, which are inflammation and immunology, internal medicine, oncology, rare diseases, vaccines, and antiinfectives.
While a significant portion of our R&D is internal, we also seek promising chemical and biological lead molecules and innovative technologies developed by others to incorporate into
our discovery and development processes or projects, as well as our portfolio. We do so by entering into collaboration, alliance and license agreements with universities,
biotechnology companies and other firms as well as through acquisitions and investments. These collaboration, alliance and license agreements and investments allow us to share
knowledge, risk and cost. They also enable us to access external scientific and technological expertise, as well as provide us the opportunity to advance our own products and inlicensed or acquired products. For information on certain of these collaborations, alliances and license arrangements and investments, see Note 2.
Our R&D Operations. In 2023, we continued to strengthen our global R&D operations and pursue strategies to improve R&D productivity to achieve a sustainable pipeline that is
positioned to deliver value in the near term and over time. Our R&D activity is conducted through various platform functions that support our global operations. Beginning in July
2023, in consideration of planned future investments in oncology, including the December 2023 acquisition of Seagen, we reorganized our R&D platform operations. Discovery to
late-phase clinical development for oncology is performed by a new end-to-end Oncology Research and Development (ORD) organization and discovery to late-phase clinical
development for all remaining therapeutic areas is consolidated into the end-to-end Pfizer Research and Development (PRD) organization. ORD and PRD replace our former
WRDM and GPD organizations, where, prior to July 2023, research units within WRDM were generally responsible for research and early-stage development assets and, prior to
July 2023, GPD was generally responsible for the clinical development strategy and operational execution of clinical trials for both early- and late-stage clinical assets in Pfizer’s
pipeline. In 2023, Biopharma received R&D services from ORD, PRD and the predecessor WRDM and GPD organizations. These services included IPR&D projects for new
investigational products and additional indications for in-line products.
We manage R&D operations on a total-company basis through our PRD and ORD organizations described above. Specifically, the Portfolio Management Team, currently led by our
Chairman and Chief Executive Officer and composed of other senior executives, is accountable for aligning resources across PRD and ORD, and for helping to ensure optimal
capital allocation across the innovative R&D portfolio. We believe that this approach also serves to maximize accountability and flexibility.
We do not disaggregate total R&D expense by development phase or by therapeutic area since, as described above, we do not manage all of our R&D operations by development
phase or by therapeutic area. Further, as we are able to adjust a significant portion of our spending quickly, we believe that any prior-period information about R&D expense by
development phase or by therapeutic area would not necessarily be representative of future spending.
For additional information on our R&D operations, including R&D related costs and expenses, see the Costs and Expenses—Research and Development Expenses section within
MD&A and Note 17.
Our R&D Pipeline. The process of drug and biological product discovery from initiation through development and to potential regulatory approval is lengthy and can take more than
ten years. As of January 30, 2024, we had the following number of projects in various stages of R&D:
Development of a single compound is often pursued as part of multiple programs. While our product candidates may or may not receive regulatory approval, new candidates
entering clinical development phases are the foundation for future products. Information concerning several of our drug and vaccine candidates in development, as well as
supplemental filings for existing products, is set forth in the Product Developments section within MD&A. The discovery and development of drugs, vaccines and biological products
are time consuming, costly and unpredictable. For information on the risks associated with R&D, see the Item 1A. Risk Factors—Research and Development section.
COLLABORATION AND CO-PROMOTION AGREEMENTS
We use collaboration and/or co-promotion arrangements to enhance our development, R&D, sales and distribution of certain biopharmaceutical products, which include, among
others, the following:
• Comirnaty is an mRNA-based coronavirus vaccine to help prevent COVID-19, which is being jointly developed and commercialized with BioNTech. Pfizer and BioNTech equally
share the costs of development for the Comirnaty program. Comirnaty has been granted an approval or an authorization in many countries around the world in populations varying
by country. We also share gross profits equally from commercialization of Comirnaty and are working jointly with BioNTech in our respective territories to commercialize the
vaccine worldwide (excluding China, Hong Kong, Macau and Taiwan), subject to regulatory authorizations or approvals market by market. For discussion on Comirnaty, see the
Overview of Our Performance, Operating Environment, Strategy and Outlook—COVID-19 section within MD&A.
• Eliquis (apixaban) is part of the Novel Oral Anticoagulant market and was jointly developed and commercialized with BMS as an alternative treatment option to warfarin in
appropriate patients. We fund between 50% and 60% of all development costs depending on the study, and profits and losses are shared equally except in certain countries
where we commercialize Eliquis and pay a percentage of net sales to BMS. In
Pfizer Inc.
2023 Form 10-K
5
certain smaller markets we have full commercialization rights and BMS supplies the product to us at cost plus a percentage of the net sales to end-customers.
• Xtandi (enzalutamide) is an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within tumor cells that is being developed and
commercialized in collaboration with Astellas. We share equally in the gross profits and losses related to U.S. net sales and also share equally all Xtandi commercialization costs
attributable to the U.S. market, subject to certain exceptions. In addition, we share certain development and other collaboration expenses. For international net sales we receive
royalties based on a tiered percentage.
• Orgovyx (relugolix) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer that is being
developed and commercialized with SMPA. The companies are also collaborating on Myfembree (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for heavy
menstrual bleeding associated with uterine fibroids in premenopausal women and the management of moderate to severe pain associated with endometriosis in premenopausal
women. The companies equally share profits and allowable expenses in the U.S. for Orgovyx, and in the U.S. and Canada for Myfembree. Pfizer does not have rights outside of
these markets. SMPA remains responsible for regulatory interactions and drug supply and continues to lead clinical development for the relugolix combination tablet.
• Padcev (enfortumab vedotin-ejfv) is a first-in-class ADC that is directed to Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer, that is being
co-developed and jointly commercialized with Astellas. In the U.S., Padcev has been approved for use with Keytruda (pembrolizumab) for adult patients with locally advanced or
metastatic urothelial cancer. Other approvals and indications for Padcev vary by market. In the U.S., the companies jointly promote, and we record net sales and are responsible
for all U.S. distribution activities for Padcev. The companies each bear the costs of their own sales organizations in the U.S., and equally share certain other costs associated with
commercializing and any profits realized in the U.S. for Padcev. Outside the U.S., we have commercialization rights in all countries in North and South America, and Astellas has
commercialization rights in the rest of the world. The agreement between us and Astellas provides that the companies will effectively equally share in profits realized in markets
outside of the U.S. through: (i) a costs-incurred and profit-sharing mechanism based on product sales and costs of commercialization in certain markets and (ii) a royalty-payment
mechanism intended to approximate an equal profit share for both parties in the remaining markets.
In addition, we have collaboration and/or co-promotion arrangements with respect to certain other biopharmaceutical products, including Adcetris and Tivdak as a result of our
acquisition of Seagen.
Revenues associated with these arrangements are included in Alliance revenues (except in certain markets where we have direct sales and except for the majority of revenues for
Comirnaty and Padcev, which are included in Product revenues). In addition, we have collaboration arrangements for the development and commercialization of certain pipeline
products that are in development stage, including, among others certain of those described in the Product Developments section within MD&A. For further discussion of collaboration
and co-promotion agreements, see the Item 1. Business—Patents and Other Intellectual Property Rights section, the Item 1A. Risk Factors—Collaborations and Other Relationships
with Third Parties section and Notes 2 and 17.
INTERNATIONAL OPERATIONS
Our operations are conducted globally, and we supply our medicines and vaccines to approximately 200 countries and territories. Emerging markets are an important component of
our strategy for global leadership, and our commercial structure recognizes that the demographics and rising economic power of the fastest-growing emerging markets are becoming
more closely aligned with the profile found within developed markets. Urbanization and the rise of the middle class in emerging markets provide potential growth opportunities for our
products.
Revenues from operations outside the U.S. of $31.4 billion accounted for 54% of Total revenues in 2023. Revenues exceeded $500 million in each of 14, 24 and 21 countries
outside the U.S. in 2023, 2022 and 2021, respectively. The decrease in the number of countries exceeding $500 million in revenues from 2022 to 2023 was primarily driven by
decreases in revenues related to Comirnaty and Paxlovid. As a percentage of Total revenues, our largest country outside the U.S. was Japan in 2023. For a geographic breakdown
of Total revenues, see the Total Revenues by Geography section within MD&A and Note 17B.
Our international operations are subject to risks inherent in carrying on business in other countries. See the Item 1A. Risk Factors—Global Operations and Item 1. Business—
Government Regulation and Price Constraints sections.
SALES AND MARKETING
Our prescription biopharmaceutical products, with the exception of Paxlovid in 2022 and 2023, are sold principally to wholesalers, but we also sell directly to retailers, hospitals,
clinics, government agencies and pharmacies. In 2022 and 2023, we principally sold Paxlovid globally to government agencies. Our vaccines in the U.S. are primarily sold directly to
the federal government (including the CDC), wholesalers, individual provider offices, retail pharmacies and integrated delivery systems. Our vaccines outside the U.S. are primarily
sold to government and non-government institutions. Certain of these government contracts may be renegotiated or terminated at the discretion of a government entity. Our
Pfizer Inc.
2023 Form 10-K
6
contracts with government and supranational organizations for the sales of Comirnaty and Paxlovid, which are binding contracts, represented a significant amount of revenues in
2022 and 2023. Sales of Comirnaty and Paxlovid in the U.S. transitioned to commercial channels in the second half of 2023. For information on our October 2023 amended
agreement with the U.S. government regarding Paxlovid, see Note 17C.
We also seek to gain access for our products on formularies, which are lists of approved medicines available to members of healthcare programs or PBMs. PBMs use various
benefit designs, such as tiered co-pays for formulary products, to drive utilization of products in preferred formulary positions. We may also work with payors on disease
management programs that help to develop tools and materials to educate patients and physicians on key disease areas. For information on our significant customers, see Note
17C.
We promote our products to healthcare providers and patients consistent with applicable laws. Through our marketing organizations, we explain the approved uses, benefits and
risks of our products to healthcare providers and patients; MCOs that provide insurance coverage, such as hospitals, integrated delivery systems, PBMs and health plans; and
employers and government agencies who hire MCOs to provide health benefits to their employees. In the U.S., we market directly to consumers through direct-to-consumer
advertising that seeks to communicate the approved uses, benefits and risks of our products while motivating people to have meaningful conversations with their doctors. In addition,
we sponsor general advertising to educate the public on disease awareness, prevention and wellness, important public health issues and our patient assistance programs.
As part of our commitment to engaging our customers in a manner they prefer, we take an omnichannel approach, including both virtual and in person interactions, and see
generally positive customer response to both approaches.
PATENTS AND OTHER INTELLECTUAL PROPERTY RIGHTS
Patents. We own or have co-promotion and/or license rights related to a number of patents covering pharmaceutical and other products, their uses, formulations, and product
manufacturing processes.
Patents for individual products extend for varying periods according to the date of patent filing or grant and the legal term of patents in the various countries where patent protection
is obtained. The scope of protection afforded by a patent can vary from country to country and depends on the patent type, the scope of its patent claims and the availability of legal
remedies. Patent term extensions (PTE) may be available in some countries to compensate for a loss of patent term due to delay in a product’s approval due to the regulatory
requirements, while patent term adjustment may be available in some countries to compensate for administrative delays during prosecution of patents. One of the primary
considerations in limiting our operations in some countries outside the U.S. is the lack of effective intellectual property protection for our products, although international and U.S.
free trade agreements have included some global protection of intellectual property rights. See the Item 1. Business—Government Regulation and Price Constraints section.
In various markets, a period of regulatory exclusivity may be provided for drugs or vaccines upon approval. The scope and term of such exclusivity will vary but, in general, the
period will run concurrently with the term of any existing patent rights associated with the drug at the time of approval.
Based on current sales and other factors, and considering the competition with products sold by our competitors, the patent rights we consider most significant in relation to our
business as a whole, together with the year in which the basic product patent expires, are as follows:
Pfizer Inc.
2023 Form 10-K
7
Product
U.S. Basic Product Patent Expiration
Year(1)
Major Europe Basic Product Patent
Expiration Year(1)
Japan Basic Product Patent Expiration
Year(1)
Inlyta
2025
2025
2025
Xeljanz
2025
2028(2)
2025
Prevnar 13/Prevenar 13
2026
(3)
2029
Eliquis
2026(4)
2026(5)
2026
Ibrance
2027
2028
2028
Xtandi(6)
2027
(6)
(6)
Vyndaqel/Vyndamax/Vynmac
2024(7) (2028 pending PTE)
2026
2026/2029(8)
Adcetris(9)
2024(10)
(9)
(9)
Nurtec ODT/Vydura
2030 (2034 pending PTE)
2035
2030(11)
Braftovi(12)
2030 (2031 pending PTE)
(12)
(12)
(12)
(12)
Mektovi
(12)
2031
(13)
Talzenna
2029
(2032 pending PTE)
2034
2029
Oxbryta
2033
2037
2032(11)
Lorbrena
2033
2034
2036
Padcev(14)
2033(15)
(14)
(14)
(16)
2031
(2034 pending PTE)
2031
2026(11)
Zavzpret
2031
(2034 pending PTE)
2031(11)
2031(11)
Velsipity
2029
(2034 pending PTE)
2029
2029(11)
Prevnar 20/Apexxnar
2033 (2035 pending PTE)
2033 (2037 pending SPC)
2033(11)
Tukysa
Ngenla
(17)
Cibinqo
Tivdak
(18)
2035
(2)
2030(2)
2036
2038
2032
2034
(2036 pending PTE)
2033
(2)
(19)
2031
(11)
(18)
Litfulo
2034
(2037 pending PTE)
2034
(2038 pending SPC)
2034
(2039 pending PTE)
Abrysvo
2036
(2037 pending PTE)
(22)
2036
Elrexfio
2036
(2037 pending PTE)
2036
2036(11)
2038
(11)
2038(11)
Penbraya
2038
Pfizer-BioNTech COVID-19 Vaccine(20)
2041
(21)(23)
(22)
Paxlovid
2041
2041
2041
(22)
(22)(23)
(22)
(22)
(22)(23)
(22)
COVID-19 Products
Pfizer-BioNTech COVID-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5)/
Comirnaty Original/Omicron BA.1
Vaccine(20)
XBB.1.5-Adapted Monovalent COVID-19
vaccine(20)
(1)
(2)
(3)
(4)
Unless otherwise indicated, the years pertain to the basic product patent expiration, including granted PTEs, supplementary protection certificates (SPC) or pediatric exclusivity periods. SPCs are
included when granted in three out of five major European markets (France, Germany, Italy, Spain and the U.K.). Noted in parentheses is the projected year of expiry of the earliest pending patent term
extension in the U.S. or Japan and/or SPC application in Europe, the term of which, if granted, may be shorter than originally requested due to a number of factors. In some instances, there are laterexpiring patents relating to our products which may or may not protect our product from generic or biosimilar competition after the expiration of the basic patent.
Expiry is provided by regulatory exclusivity in this market.
The Europe patent that covers the combination of the 13 serotype conjugates of Prevenar 13 was revoked following an opposition and has now been withdrawn. There are other Europe patents and
pending applications covering the formulation, various aspects of the manufacturing process, and the combination of serotype conjugates of Prevenar 13 that remain in force.
Eliquis was developed and is being commercialized in collaboration with BMS. In the U.S., we and BMS previously settled certain patent litigations with a number of generic companies permitting their
launch of a generic version of Eliquis on April 1, 2028 (the settled generic companies). We continued to litigate against three
Pfizer Inc.
2023 Form 10-K
8
remaining generic companies and following the resolution of the litigation in our favor, the three generic companies are not permitted to launch their products until the 2031 expiration date of the
formulation patent. Both the composition of matter patent expiring in November 2026 and the formulation patent expiring in 2031 may be subject to future challenges. While we cannot predict the outcome
of any potential future litigation, there are certain potential alternatives that might occur which could potentially permit generic launch prior to April 1, 2028: (i) if the formulation patent is held invalid or not
infringed in future litigation, through appeal, the settled generic companies and any successful future litigant would be permitted to launch on November 21, 2026; or (ii) if both patents are held invalid or
not infringed in future litigation, through appeal, the settled generic companies and any successful future litigant could launch products immediately upon such an adverse decision. Refer to Note 16A1 for
more information.
(5)
On October 31, 2023, the U.K. Supreme Court refused BMS’s permission to appeal in relation to the judgment having found the apixaban basic product patent and associated SPC invalid. Additional
challenges are pending in other jurisdictions.
(6) Xtandi is being developed and commercialized in collaboration with Astellas, which has exclusive commercialization rights for Xtandi outside the U.S. Pfizer receives tiered royalties as a percentage of
international Xtandi net sales.
(7)
Interim patent term extension requests have been granted extending the expiry from December 2023 to December 2024 and Pfizer has filed applications for patent term extension to 2028.
(8)
Vyndaqel (tafamidis meglumine) basic patent expiry in Japan is August 2026 for treatment of polyneuropathy. Vynmac (tafamidis) was approved in Japan for treatment of cardiomyopathy with regulatory
exclusivity expiring in March 2029.
(9)
Adcetris is being developed and commercialized in collaboration with Takeda. Pfizer has commercialization rights for Adcetris in the U.S. and its territories and in Canada. Takeda has commercialization
rights in the rest of the world and pays Pfizer a royalty based on a percentage of Takeda’s net sales of Adcetris in its licensed territories, based on annual net sales tiers.
(10)
There are other U.S. patents covering related ADC uses, technology and manufacturing that remain in force beyond composition of matter expiry.
(11)
Product not yet approved or authorized in this market.
(12)
We have exclusive rights to Braftovi and Mektovi in the U.S., Canada and certain emerging markets. The Pierre Fabre Group has exclusive rights to commercialize both products in Europe and Ono has
exclusive rights to commercialize both products in Japan. We receive royalties from The Pierre Fabre Group and Ono on sales of Braftovi and Mektovi in a majority of markets outside the U.S.
(13) Mektovi U.S. expiry is provided by a method of use patent.
(14)
Padcev is being commercialized in collaboration with Astellas. Pfizer has co-promotion rights in the U.S. Outside the U.S., Pfizer has commercialization rights in all countries in North and South America,
and Astellas has commercialization rights in the rest of the world, including Europe, Asia, Australia and Africa.
(15)
There is a U.S. patent covering related ADC manufacturing that will remain in force beyond the composition of matter expiry.
(16)
In September 2020, Seagen and Merck began a collaboration to commercialize Tukysa. As of December 31, 2023, this collaboration ended and all commercialization rights were returned to Seagen
(Pfizer).
(17) Ngenla is being developed in collaboration with OPKO.
(18)
Tivdak is developed and commercialized in collaboration with Genmab. Pfizer and Genmab have co-promotion rights in the U.S. Outside the U.S., Pfizer has commercialization rights in the rest of the
world except for Japan, where Genmab has commercialization rights, and certain territories where Zai Lab Limited (Zai Lab) has commercialization rights (mainland China, Hong Kong, Macau, and
Taiwan). Pfizer and Genmab equally share all costs and profits for Tivdak in the U.S., Europe, China (including the payments from Zai Lab described below) and Japan. In markets outside the U.S. other
than Europe, China, and Japan, Pfizer will pay Genmab a royalty based on a percentage of aggregate net sales. Further, pursuant to the agreement with Zai Lab, Pfizer is entitled to receive potential
development, regulatory and commercial milestone payments, and tiered royalties on net sales of Tivdak in the Zai Lab territories, which will be shared equally with Genmab.
(19)
Expiry is provided by regulatory exclusivity in this market. In addition to regulatory exclusivity, there are U.S. patents covering related ADC manufacturing and technology that remain in force beyond the
regulatory exclusivity expiry.
(20)
Product is being commercialized in collaboration with BioNTech.
(21)
The basic product patent has been granted in the U.K. and expires in 2041. In the other major markets, a patent application has been filed. If granted, a full term is expected.
(22) The basic product patent application has been filed in this market. If granted, a full term is expected in this market.
(23)
Pfizer does not have co-promotion rights for this product in Germany.
For information regarding profit sharing and royalty arrangements for certain of these products, see Item 1. Business—Collaboration and Co-Promotion Agreements.
Loss of Intellectual Property Rights. The loss, expiration or invalidation of intellectual property rights, patent litigation settlements and judgments and the expiration of co-promotion
and licensing rights can have a material adverse effect on our revenues. Once patent protection has expired or has been lost prior to the expiration date as a result of a legal
challenge, we typically lose exclusivity on these products, and generic and biosimilar pharmaceutical manufacturers generally produce identical or highly similar products and sell
them for a lower price. The date at which generic or biosimilar competition commences may be different from the date that the patent or regulatory exclusivity expires. However,
when generic or biosimilar competition does commence, the resulting price competition can substantially decrease our revenues for the impacted products, often in a very short
period of time. Also, if one of our product-related patents is found to be invalid by judicial, court or regulatory or administrative proceedings, generic or biosimilar products could be
introduced, resulting in the erosion of sales of our existing products. Additionally, we could be subject to claims that our intellectual property rights infringe third party patents.
Certain of our products have experienced patent-based expirations or loss of regulatory exclusivity in certain markets in the last few years, and we expect certain products to face
increased generic competition over the next few years. While additional patent expiries will continue, we expect a moderate impact of reduced revenues due to patent expiries from
2024 through 2025. We anticipate a more significant impact of reduced revenues from patent expiries in 2026 through 2030 as several of our in-line products experience patentbased expirations. There is no assurance that a particular product will maintain market exclusivity for the full time period that appears in the estimates included in this Form 10-K or
that we assume when we provide our financial guidance. For additional information on the impact of LOEs on our revenues, see the Overview of Our Performance, Operating
Environment, Strategy and Outlook—Our 2023 Performance section within MD&A.
We continue to vigorously defend our patent rights against infringement, and we will continue to support efforts that strengthen worldwide recognition of patent rights while taking
necessary steps to help ensure appropriate patient access. See the Item 1A. Risk Factors—Competitive Products, —Intellectual Property Protection and —Third-Party Intellectual
Property Claims sections and Note 16A1.
Trademarks. Our products are sold under brand-name and logo trademarks and trade dress. Registrations generally are for fixed, but renewable, terms and protection is provided in
some countries for as long as the mark is used while in others, for as long as it is registered. Protecting our trademarks is of material importance to us.
Pfizer Inc.
2023 Form 10-K
9
COMPETITION
Our business is conducted in intensely competitive and highly regulated markets. Many of our products face competition in the form of branded or generic drugs or biosimilars that
treat similar diseases or indications. The principal forms of competition include efficacy, safety, ease of use and cost. Though the means of competition vary among our products,
demonstrating the value of our products is a critical factor for success.
We compete with other companies that manufacture and sell products that treat or prevent diseases or indications similar to those treated or prevented by our major products. These
competitors include other worldwide research-based biopharmaceutical companies, smaller research companies with more limited therapeutic focus and generic drug and biosimilar
manufacturers. Our competitors also may devote substantial funds and resources to R&D and their successful R&D could result in erosion of the sales of our existing products and
potential sales of our products in development, as well as product obsolescence. In addition, several of our competitors operate without large R&D expenses and make a regular
practice of challenging our product patents before their expiration.
To help address competitive trends we continually emphasize innovation, which is underscored by our multi-billion-dollar investment in R&D, as well as our business development
transactions, both designed to result in a strong and differentiated product pipeline. Our investment in research continues even after drug or vaccine approval as we seek to further
demonstrate the value of our products for the conditions they treat or prevent, as well as investigating potential new applications. We educate patients, physicians, payors and global
health authorities on the benefits and risks of our medicines and vaccines, and seek to continually enhance the organizational effectiveness of our biopharmaceutical functions,
including our efforts to effectively launch and market our products to our customers.
Operating conditions have also shifted as a result of increased global competitive pressures, industry regulation and cost containment. We continue to evaluate, adapt and improve
our organization and business practices in an effort to better meet customer and public needs. We believe that we have taken an industry-leading role in evolving our ethical
approaches to U.S. direct-to-consumer advertising, interactions with, and payments to, healthcare professionals and medical education grants. We also continue to support
programs to address patient affordability and access barriers, as we strive to advance fundamental health system change through our support for better healthcare solutions. For
example, in May 2022, we launched An Accord for a Healthier World, which aims to provide our full portfolio of patented and off-patent medicines and vaccines for which Pfizer holds
global rights on a not-for-profit basis to 1.2 billion people living in 45 lower-income countries around the world.
Our vaccines have and may continue to face competition, including from the introduction of alternative vaccines or “next-generation” vaccines prior to or after the expiration of their
patents, which may adversely affect our future results.
Our biosimilars, which include biosimilars of certain inflammation & immunology and oncology biologic medicines, compete with branded products from competitors, as well as other
generics and biosimilars manufacturers. We seek to maximize the opportunity to establish a “first-to-market” or early market position for our biosimilars to provide customers a lowercost alternative immediately when available and also to potentially provide us with higher levels of sales and profitability until other competitors enter the market.
Generic Products. Generic pharmaceutical manufacturers pose one of the biggest competitive challenges to our branded small molecule products because they can market a
competing version of our product after the expiration or loss of our patent protection and often charge much less. Several competitors regularly challenge our product patents before
their expiration. Generic competitors often operate without large R&D expenses, as well as without costs of conveying medical information about products to the medical community.
In addition, the approval process in the U.S. and in the EU exempts generics from costly and time-consuming clinical trials to demonstrate their safety and efficacy, allowing generic
manufacturers to rely on the safety and efficacy data of the innovator product. In China, for example, given the expansion of the QCE process and continuation of the VBP program,
we expect to continue to face intensified competition by certain generic manufacturers in 2024 and beyond, which has and may continue to result in price cuts and volume loss of
some of our products. In addition, generic versions of competitors’ branded products have and may continue to compete with our products.
Commercial and government payors typically encourage the use of generics as alternatives to brand-name drugs in their healthcare programs, including Medicaid in the U.S., and
U.S. laws generally allow, and in some cases require, pharmacists to substitute generic drugs for brand-name drugs. In a small subset of states, prescribing physicians are able to
expressly prevent such substitution. Similar rules also apply in several EU member states, where national authorities typically encourage and incentivize the use of generic products.
Biosimilars. Certain of our biologic products, including Enbrel (we market Enbrel outside the U.S. and Canada), already face, or may face in the
future, competition from biosimilars (also referred to as follow-on biologics). Biosimilars are versions of biologic medicines that have been developed and proven to be highly similar
to the original biologic in terms of safety and efficacy and that have no clinically meaningful differences in safety, purity or potency. Biosimilars have the potential to offer high-quality,
lower-cost alternatives to innovative biologic medicines. In the U.S., biosimilars referencing innovative biologic products are approved by the FDA under the U.S. Public Health
Service Act, whereas in the EU the EMA is responsible for evaluating the majority of applications for biosimilars through the centralized procedure.
PRICING PRESSURES AND MANAGED CARE ORGANIZATIONS
Commercial Pricing Pressures. Pricing and access pressures in the commercial sector continue to be significant. Overall, there is increasing pressure on U.S. providers to deliver
healthcare at a lower cost and to ensure that those expenditures deliver demonstrated value in terms of health outcomes. Many employers have adopted or make available high
deductible health plans, which can increase out-of-pocket costs for medicines. This trend is likely to continue. Private third-party payors, such as health plans, increasingly challenge
pharmaceutical product pricing, which could result in lower prices, lower reimbursement rates for payors and a reduction in demand for our products, including denial of coverage of
our products, if lower cost alternatives are available. Payors often require significant discounts, or rebates, from our prices in exchange for more favorable formulary placement.
Pricing pressures also may occur as a result of highly competitive biopharmaceutical markets and increasing concentration of insurers and PBMs. Healthcare provider purchasers,
directly or through group purchasing organizations, are seeking enhanced discounts or implementing more rigorous bidding or purchasing review processes.
Longer term, we foresee a shift in focus among payors and their PBMs away from fee-for-service reimbursement towards outcomes-based payments and risk-sharing arrangements
that reward providers and pharmaceutical manufacturers for cost reductions and improved patient outcomes. These new payment models can, at times, lead to lower prices for, and
restricted access to, new medicines. At the same time, these models can also promote utilization of drugs by encouraging physicians to screen and diagnose and consider drugs as
a means of forestalling more costly medical interventions. Further, these models may also encourage payors and their PBMs to cover higher cost drugs where coverage is tied to
patient outcomes and other quality incentives.
Pfizer Inc.
2023 Form 10-K
10
The impact of large-scale healthcare disruptions, like the COVID-19 pandemic, on the pace of adoption of value-based payment models remains unclear. Both payors and providers
may resist adopting such models or choose to adopt such models at a slower pace if the incentives available do not outweigh the financial risk involved. Adoption of such models, in
particular models that involve downside risk, may depend on revenue predictability for hospitals and other institutional providers, many of which are still struggling to recover
financially following the COVID-19 pandemic. Providers in more advanced value-based payment models, such as full capitation, a fixed amount paid in advance per-patient per-unit
of time-period, generally found their revenues remained steady during the COVID-19 pandemic, which may ultimately encourage the growth of such models. Going forward, we
expect continued focus on value-based payment models that support financial resiliency and advance healthcare equity by incorporating features intended to reduce disparities in
healthcare quality and access experienced by underrepresented and underserved populations.
We believe medicines and vaccines are the most efficient and effective use of healthcare dollars based on the value they deliver to the overall healthcare system. We work with law
makers and advocate for solutions that effectively improve patient health outcomes, lower costs to the healthcare system, and help ensure access to medicines and vaccines within
an efficient and affordable healthcare system. This includes assessing our go-to market model to help address patient affordability challenges. We have engaged with major payors
and the U.S. government to explore opportunities to improve access and reimbursement in an effort to drive pro-patient policies. In addition, in response to the evolving U.S. and
global healthcare spending landscape, we work with health authorities, health technology assessment and quality measurement bodies and major U.S. payors throughout the
product-development process to better understand how these entities value our compounds and products. Further, we are developing stronger support designed to demonstrate the
net value of the medicines and vaccines that we discover or develop, register and manufacture.
For information on government pricing pressures, see the Item 1. Business—Government Regulation and Price Constraints and Item 1A. Risk Factors—Pricing and Reimbursement
sections.
Managed Care Organizations. The evolution of managed care in the U.S. has been a major factor in the competitiveness of the healthcare marketplace. Approximately 318 million
people in the U.S. now have some form of health insurance coverage, and the marketing of prescription drugs and vaccines to both consumers and the entities that manage
coverage in the U.S. continues to grow in importance. In particular, the influence of MCOs has increased in recent years due to the growing number of patients receiving coverage
through MCOs. At the same time, consolidation in the MCO industry has resulted in fewer, even larger MCOs, which enhances those MCOs’ ability to negotiate lower pricing and
further increases their importance to our business. Since MCOs seek to contain and reduce healthcare expenditures, their growing influence has increased downward pressure on
drug prices, as well as negatively impacted revenues.
MCOs and their PBMs typically negotiate prices with pharmaceutical providers by using formularies (which are lists of approved medicines available to MCO members), clinical
protocols (which require prior authorization for a branded product if a generic product is available or require the patient to first fail on one or more generic products before permitting
access to a branded medicine), long-term contracts and their ability to influence volume and market share of prescription drugs. In addition, by placing branded medicines on highertier or non-preferred status in their formularies, MCOs transfer to the patient higher patient out-of-pocket expenses. This financial disincentive is a tool for MCOs to manage drug
costs and channel patients to medicines preferred by the MCOs. We expect payment reforms for MCOs will continue to evolve with increased emphasis on expanded participation
and on removing barriers to equitable healthcare.
The breadth of the products covered by formularies can vary considerably from one MCO to another, and many formularies include alternative and competitive products for
treatment of particular medical problems. MCOs emphasize primary and preventive care, out-patient treatment and procedures performed at doctors’ offices and clinics as ways to
manage costs. Hospitalization and surgery, typically the most expensive forms of treatment, are carefully managed, and drugs that can help in chronic care management and reduce
the need for hospitalization, professional therapy or surgery may become favored first-line treatments for certain diseases. At the same time, MCOs may seek to exclude high-cost
drugs from formularies in their efforts to manage and lower their costs.
Exclusion of a product from a formulary or other MCO-implemented restrictions can significantly impact drug usage in the MCO patient population and beyond. Consequently,
pharmaceutical companies compete to gain access to formularies for their products, typically on the basis of unique product features, such as greater efficacy, better patient ease of
use, or fewer side effects, as well as the overall cost of the therapy. We continue to seek to ensure that our major products are included on MCO formularies. However, our branded
products are increasingly being placed on the higher tiers or in a non-preferred status. Continuing efforts by managed care entities to contain or reduce costs of healthcare and/or
impose price controls may adversely affect demand for our products and our financial performance. See the Item 1A. Risk Factors—Managed Care Trends section.
RAW MATERIALS
We procure raw materials essential to our business from numerous suppliers worldwide. In general, these materials have been available in sufficient quantities to support our
demand and in many cases are available from multiple suppliers. No significant impact to our operations due to the availability of raw materials is currently anticipated in 2024.
However, we continue to see heightened demand in the industry for certain components and raw materials, which could potentially result in constraining available supply leading to a
possible future impact on our business. We are continuing to monitor and implement mitigation strategies to reduce any potential risk or impact including active supplier
management, qualification of additional suppliers and advanced purchasing to the extent possible.
GOVERNMENT REGULATION AND PRICE CONSTRAINTS
We are subject to extensive regulation by government authorities in the countries in which we do business. This includes laws and regulations governing the operations of
biopharmaceutical companies, such as the approval, manufacturing and marketing of products, pricing (including discounts and rebates) and price reporting, interactions with
healthcare professionals, institutions, and referral sources, reporting of remuneration provided to healthcare providers and academic medical centers, financial assistance provided
to patients, clinical research, data privacy and information security, among others. These laws and regulations may require administrative guidance for implementation, and a failure
to comply could subject us to legal and/or administrative actions. Enforcement measures may include substantial fines and/or penalties, orders to stop non-compliant activities,
criminal charges, warning letters, product recalls or seizures, delays in product approvals, exclusion from participation in government programs or contracts as well as limitations on
conducting business in applicable jurisdictions, and could result in harm to our reputation and business. See Note 16A. Compliance with these laws and regulations may be costly,
and may require significant technical expertise and capital investment to ensure compliance. While capital expenditures or operating costs for compliance with government
regulations
Pfizer Inc.
2023 Form 10-K
11
cannot be predicted with certainty, we do not currently anticipate they will have a material effect on our capital expenditures or competitive position.
In the U.S.
Drug and Biologic Regulation. The FDA, pursuant to the FFDCA, the Public Health Service Act and other federal statutes and regulations, extensively regulates pre- and postmarketing activities related to our biopharmaceutical products and devices. The regulations govern areas such as safety and efficacy, clinical trials, advertising and promotion, quality
control, manufacturing, labeling, distribution, post-marketing safety surveillance and reporting, and record keeping. Other U.S. federal agencies, including the DEA, also regulate
certain of our products and activities.
For a biopharmaceutical company to market a drug or a biologic product, including vaccines, the FDA must evaluate whether the product is safe and effective for its intended use. If
the FDA determines that the drug or biologic is safe and effective, the FDA will approve the product’s NDA or BLA (or supplemental NDA or supplemental BLA), as appropriate.
A drug or biologic may be subject to postmarketing commitments, which are studies or clinical trials that the product sponsor agrees to conduct, or postmarketing requirements,
which are studies or clinical trials that are required as a condition of approval. In addition, we are also required to report adverse events and comply with cGMPs (the FDA
regulations that govern all aspects of manufacturing quality for pharmaceuticals) and the Drug Supply Chain Security Act (the law that, among other things, sets forth requirements
related to product tracing, product identifiers and verification for manufacturers, wholesale distributors, re-packagers and dispensers to facilitate the tracing of product through the
pharmaceutical distribution supply chain), as well as advertising and promotion regulations. See the Item 1A. Risk Factors—Development, Regulatory Approval and Marketing of
Products and —Post-Authorization/Approval Data sections.
In the context of public health emergencies, like the COVID-19 pandemic, we may apply to the FDA for an EUA which, if granted, allows for the distribution and use of our products
during the declared emergency, in accordance with the conditions set forth in the EUA, unless the EUA is terminated by the government. Although the criteria for an EUA differ from
the criteria for approval of an NDA or BLA, EUAs nevertheless require the development and submission of data to satisfy the relevant FDA standards, and a number of ongoing
obligations. The FDA generally expects EUA holders to work toward submission of full applications, such as a BLA or an NDA, as soon as possible.
Biosimilar Regulation. The FDA is responsible for approval of biosimilars. Innovator biologics, or reference products, are entitled to 12 years exclusivity. Applications for biosimilars
may not be submitted until four years after the date on which the reference product was first licensed and may not be approved until 12 years after the reference product was first
licensed.
Sales and Marketing Regulations. Our marketing practices are subject to federal and state laws, such as the Anti-Kickback Statute (AKS), Civil Monetary Penalties Law and False
Claims Act, intended to prevent fraud and abuse in the healthcare industry. The AKS prohibits soliciting, offering, receiving, or paying anything of value to generate business that may
be paid for, in whole or in part, by a federal healthcare program. The Civil Monetary Penalties Law covers a variety of conduct, often violations under other laws, and includes
penalties for AKS violations as well as causing the submission of false claims. The False Claims Act generally prohibits anyone from knowingly and willingly presenting, or causing to
be presented, any claims for payment for goods or services, including to government payors, such as Medicare and Medicaid, that are false or fraudulent including false certifications
of compliance with applicable law. The federal government and states also regulate sales and marketing activities and financial interactions between manufacturers and healthcare
providers, requiring disclosure to government authorities and the public of such interactions, and the adoption of compliance standards or programs. State attorneys general have
also taken action to regulate the marketing of prescription drugs under state consumer protection and false advertising laws.
Pricing, Reimbursement and Access Regulations. Pricing and reimbursement for our products depend in part on government regulation. Any significant efforts at the federal or state
levels to reform the healthcare system by changing the way healthcare is provided or funded or to expand controls on drug pricing, government reimbursement, and access to
medicines and vaccines on public and private insurance plans could have a material impact on us.
We must offer discounts or rebates on purchases of pharmaceutical products under various government programs including Medicare, Medicaid, the Veterans Administration and the
340B Drug Pricing Program (340B Program). We also must report specific prices to government agencies. The calculations necessary to determine the prices reported are complex
and the failure to do so accurately may expose us to enforcement measures. See the discussion regarding rebates in the Product Revenue Deductions section within MD&A and
Note 1G.
The drug pricing provisions of the IRA, which was signed into law in August 2022, began to be implemented in 2022 and implementation will continue over the next several years.
The IRA includes several provisions to lower prescription drug costs for Medicare patients and to reduce drug spending by the federal government. Among other things, the IRA
enhances the Medicare Part D benefit by eliminating the coverage gap (“donut hole”) beginning in 2025, adds a maximum out-of-pocket cap for Medicare beneficiaries (set at $2,000
for 2025), and creates a new program that allows patients to pay their cost-sharing over time. The law also requires manufacturers to provide a 10% discount on branded
prescriptions in the initial coverage phase and a 20% discount in the catastrophic phase, imposes rebates under Medicare Part B and Medicare Part D on drug price increases that
outpace inflation, and directs HHS to set the prices of certain high-expenditure, single-source drugs and biologics covered under Medicare (known as the “Medicare Drug Price
Negotiation Program”). In August 2023, the Biden Administration published the first ten medicines subject to the Medicare Drug Price Negotiation Program, which included Eliquis.
As a selected drug, CMS will establish a “maximum fair price” for Eliquis and that price will be published by September 1, 2024. The price will be in effect in 2026. The maximum fair
price established by CMS is required to be offered to all Medicare beneficiaries and to covered entities participating in the 340B Program if that maximum fair price is lower than the
discounted price such entities are offered under the 340B Program ceiling price calculation. In addition, there will be a new Medicare manufacturer discount program agreement
expected to be signed in March 2024 that will change our discounting obligations for all medicines in Medicare, with few exceptions, beginning in 2025. The Medicare Drug Price
Negotiation Program is currently subject to legal challenges and therefore, the outcome of the Program remains uncertain. We continue to evaluate the impact of the IRA on our
business, operations and financial condition and results as the full effect of the IRA on our business and the pharmaceutical industry remains uncertain.
Changes to the Medicaid Drug Rebate Program or the 340B Program could have a material impact on our business. For example, certain changes finalized by CMS in a December
2020 final rule, including which products qualify as so-called “line extension” drugs subject to increased rebate liability, may have a material impact on our business. Additionally, in
May 2023, CMS proposed new rules that could, if finalized, have a material impact on our business. Those proposals include, for example, new rules regarding how manufacturers
would be required to aggregate discounts for purposes of determining their Medicaid Best Price. Additionally, various potential changes to the 340B Program are undergoing
Pfizer Inc.
2023 Form 10-K
12
review or are the subject of current regulatory activity and/or litigation, and their status is unclear. In 2022, we implemented a policy that will help improve contract pharmacy integrity.
The HHS Health Resources and Services Administration (HRSA), which administers the 340B Program, has sent letters to numerous manufacture…