Cover and table of contents

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Cover and table of contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended July 3, 2022

OR

☐ TRANSITION REPORT PURSUANT TO SECTION 13

OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _______ to _______

COMMISSION FILE NUMBER 1-3619

----

PFIZER INC.

(Exact name of registrant as specified in its charter)

Delaware13-5315170
(State of Incorporation)(I.R.S. Employer Identification No.)

235 East 42nd Street, New York, New York 10017

(Address of principal executive offices) (zip code)

(212) 733-2323

(Registrant’s telephone number)

Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $.05 par valuePFENew York Stock Exchange
1.000% Notes due 2027PFE27New York Stock Exchange

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

YesxNo☐

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).

YesxNo☐

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 x Accelerated filer ☐ Non-accelerated filer ☐ Smaller reporting company ☐ Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes☐Nox

At August 5, 2022, 5,612,351,809 shares of the issuer’s voting common stock were outstanding.

TABLE OF CONTENTS
PART I. FINANCIAL INFORMATIONPage
Item 1.
Financial Statements
Condensed Consolidated Statements of Income5
Condensed Consolidated Statements of Comprehensive Income6
Condensed Consolidated Balance Sheets7
Condensed Consolidated Statements of Equity8
Condensed Consolidated Statements of Cash Flows9
Notes to Condensed Consolidated Financial Statements10
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations37
Item 3.
Quantitative and Qualitative Disclosures About Market Risk59
Item 4.
Controls and Procedures59
PART II. OTHER INFORMATION
Item 1.
Legal Proceedings59
Item 1A.
Risk Factors59
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds59
Item 3.
Defaults Upon Senior SecuritiesN/A
Item 4.
Mine Safety DisclosuresN/A
Item 5.
Other InformationN/A
Item 6.
Exhibits60
Signature60
N/A = Not Applicable
DEFINED TERMS

Unless the context requires otherwise, references to “Pfizer,” “the Company,” “we,” “us” or “our” in this Form 10-Q (defined below) refer to Pfizer Inc. and its subsidiaries. Pfizer’s fiscal quarter-end for subsidiaries operating outside the U.S. is as of and for the three and six months ended May 29, 2022 and May 30, 2021, and for U.S. subsidiaries is as of and for the three and six months ended July 3, 2022 and July 4, 2021. References to “Notes” in this Form 10-Q are to the Notes to the Condensed or Consolidated Financial Statements in this Form 10-Q or in our 2021 Form 10-K. We also have used several other terms in this Form 10-Q, most of which are explained or defined below:

2021 Form 10-KAnnual Report on Form 10-K for the fiscal year ended December 31, 2021
ACIPAdvisory Committee on Immunization Practices
ALKanaplastic lymphoma kinase
Alliance revenuesRevenues from alliance agreements under which we co-promote products discovered or developed by other companies or us
ArenaArena Pharmaceuticals, Inc.
AstellasAstellas Pharma Inc., Astellas US LLC and Astellas Pharma US, Inc.
ATTR-CMtransthyretin amyloid cardiomyopathy
BiohavenBiohaven Pharmaceutical Holding Company Ltd.
BioNTechBioNTech SE
BiopharmaPfizer Biopharmaceuticals Group
BLABiologics License Application
BMSBristol-Myers Squibb Company
BNT162b2*Pfizer-BioNTech COVID-19 Vaccine, also known as Comirnaty
BODBoard of Directors
CDCU.S. Centers for Disease Control and Prevention
CGRPcalcitonin gene-related peptide
CMAconditional marketing authorisation
Comirnaty*Pfizer-BioNTech COVID-19 Vaccine, also known as BNT162b2
Consumer Healthcare JVGSK Consumer Healthcare JV
COVID-19novel coronavirus disease of 2019
Developed EuropeIncludes the following markets: Western Europe, Scandinavian countries and Finland
Developed MarketsIncludes the following markets: U.S., Developed Europe, Japan, South Korea, Australia, Canada and New Zealand
Developed Rest of WorldIncludes the following markets: Japan, South Korea, Australia, Canada and New Zealand
ECEuropean Commission
EMAEuropean Medicines Agency
Emerging MarketsIncludes, but is not limited to, the following markets: Asia (excluding Japan and South Korea), Latin America, Central Europe, Eastern Europe, the Middle East, Africa and Turkey
EPSearnings per share
EUEuropean Union
EUAemergency use authorization
Exchange ActSecurities Exchange Act of 1934, as amended
FDAU.S. Food and Drug Administration
FFDCAU.S. Federal Food, Drug and Cosmetic Act
Form 10-QThis Quarterly Report on Form 10-Q for the quarterly period ended July 3, 2022
GAAPGenerally Accepted Accounting Principles
GISTgastrointestinal stromal tumors
GPDGlobal Product Development organization
GSKGlaxoSmithKline plc
HaleonHaleon plc
HIPAAHealth Insurance Portability and Accountability Act of 1996
HospiraHospira, Inc.
IPR&Din-process research and development
IRSU.S. Internal Revenue Service
JAKJanus kinase
JVjoint venture
KingKing Pharmaceuticals LLC (formerly King Pharmaceuticals, Inc.)
LIBORLondon Interbank Offered Rate
LOEloss of exclusivity
mCRCmetastatic colorectal cancer
mCRPCmetastatic castration-resistant prostate cancer
mCSPCmetastatic castration-sensitive prostate cancer
MD&AManagement’s Discussion and Analysis of Financial Condition and Results of Operations
MeridianMeridian Medical Technologies, Inc.
mRNAmessenger ribonucleic acid
MSAManufacturing Supply Agreement
MylanMylan N.V.
MyovantMyovant Sciences Ltd.
NDANew Drug Application
nmCRPCnon-metastatic castration-resistant prostate cancer
NSCLCnon-small cell lung cancer
OPKOOPKO Health, Inc.
OTCover-the-counter
Paxlovid*an oral COVID-19 treatment (nirmatrelvir [PF-07321332] tablets and ritonavir tablets)
PC1Pfizer CentreOne
PGSPfizer Global Supply
PharmaciaPharmacia Corporation
PRACPharmacovigilance Risk Assessment Committee
PsApsoriatic arthritis
QTDQuarter-to-date or three months ended
RArheumatoid arthritis
RCCrenal cell carcinoma
R&Dresearch and development
ReViralReViral Ltd.
SandozSandoz, Inc., a division of Novartis AG
SECU.S. Securities and Exchange Commission
sNDAsupplemental new drug application
TSAstransition service arrangements
UCulcerative colitis
U.K.United Kingdom
U.S.United States
Upjohn BusinessPfizer’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
ViatrisViatris Inc.
ViiVViiV Healthcare Limited
WRDMWorldwide Research, Development and Medical
YTDYear-to-date or six months ended

*This Form 10-Q includes discussion of the COVID-19 vaccine that Pfizer has co-developed with BioNTech (BNT162b2) and our oral COVID-19 treatment (Paxlovid). The vaccine may be referred to by its brand name, Comirnaty (approved under a BLA in the U.S.), or as BNT162b2 (authorized under EUA in the U.S.). The vaccine is FDA-approved to prevent COVID-19 in individuals 12 years of age and older. In addition, Comirnaty/BNT162b2 is authorized for emergency use by the FDA for individuals 6 months of age and older, as a third dose for certain immunocompromised individuals 5 years of age and older, as a booster dose for individuals 5 years of age and older and as a second booster dose for individuals 50 years of age and older and for certain immunocompromised individuals 12 years of age and older. Paxlovid is authorized for emergency use by the FDA under an EUA for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS CoV-2 viral testing, and 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 under Section 564(b)(1) of the FFDCA unless the declaration is terminated or authorization revoked sooner. The FDA has issued EUAs to certain other companies for products intended for the prevention or treatment of COVID-19 and may continue to do so during the duration of the Declaration. See the EUA Fact Sheets at www.cvdvaccine-us.com and www.covid19oralrx.com.

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

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

The information contained on our website, our Facebook, Instagram, YouTube and LinkedIn pages or our Twitter accounts, or any third-party website, is not incorporated by reference into this Form 10-Q.

PART I. FINANCIAL INFORMATION

Next: Item 1. FINANCIAL STATEMENTS