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
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PFIZER INC.
(Exact name of registrant as specified in its charter)
| Delaware | 13-5315170 | ||||
| (State of Incorporation) | (I.R.S. Employer Identification No.) |
235 East 42nd Street, New York, New York 10017
(Address of principal executive offices) (zip code)
(212) 733-2323
(Registrant’s telephone number)
| Securities registered pursuant to Section 12(b) of the Act: | ||||||||||||||
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
| Common Stock, $.05 par value | PFE | New York Stock Exchange | ||||||||||||
| 1.000% Notes due 2027 | PFE27 | New York Stock Exchange |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
| Yes | x | No | ☐ |
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
| Yes | x | No | ☐ |
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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 | ☐ | No | x |
At August 5, 2022, 5,612,351,809 shares of the issuer’s voting common stock were outstanding.
| TABLE OF CONTENTS |
| 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-K | Annual Report on Form 10-K for the fiscal year ended December 31, 2021 | ||||
| ACIP | Advisory Committee on Immunization Practices | ||||
| ALK | anaplastic lymphoma kinase | ||||
| Alliance revenues | Revenues from alliance agreements under which we co-promote products discovered or developed by other companies or us | ||||
| Arena | Arena Pharmaceuticals, Inc. | ||||
| Astellas | Astellas Pharma Inc., Astellas US LLC and Astellas Pharma US, Inc. | ||||
| ATTR-CM | transthyretin amyloid cardiomyopathy | ||||
| Biohaven | Biohaven Pharmaceutical Holding Company Ltd. | ||||
| BioNTech | BioNTech SE | ||||
| Biopharma | Pfizer Biopharmaceuticals Group | ||||
| BLA | Biologics License Application | ||||
| BMS | Bristol-Myers Squibb Company | ||||
| BNT162b2* | Pfizer-BioNTech COVID-19 Vaccine, also known as Comirnaty | ||||
| BOD | Board of Directors | ||||
| CDC | U.S. Centers for Disease Control and Prevention | ||||
| CGRP | calcitonin gene-related peptide | ||||
| CMA | conditional marketing authorisation | ||||
| Comirnaty* | Pfizer-BioNTech COVID-19 Vaccine, also known as BNT162b2 | ||||
| Consumer Healthcare JV | GSK Consumer Healthcare JV | ||||
| COVID-19 | novel coronavirus disease of 2019 | ||||
| Developed Europe | Includes the following markets: Western Europe, Scandinavian countries and Finland | ||||
| Developed Markets | Includes the following markets: U.S., Developed Europe, Japan, South Korea, Australia, Canada and New Zealand | ||||
| Developed Rest of World | Includes the following markets: Japan, South Korea, Australia, Canada and New Zealand | ||||
| EC | European Commission | ||||
| EMA | European Medicines Agency | ||||
| Emerging Markets | Includes, but is not limited to, the following markets: Asia (excluding Japan and South Korea), Latin America, Central Europe, Eastern Europe, the Middle East, Africa and Turkey | ||||
| EPS | earnings per share | ||||
| EU | European Union | ||||
| EUA | emergency use authorization | ||||
| Exchange Act | Securities Exchange Act of 1934, as amended | ||||
| FDA | U.S. Food and Drug Administration | ||||
| FFDCA | U.S. Federal Food, Drug and Cosmetic Act | ||||
| Form 10-Q | This Quarterly Report on Form 10-Q for the quarterly period ended July 3, 2022 | ||||
| GAAP | Generally Accepted Accounting Principles | ||||
| GIST | gastrointestinal stromal tumors | ||||
| GPD | Global Product Development organization | ||||
| GSK | GlaxoSmithKline plc | ||||
| Haleon | Haleon plc | ||||
| HIPAA | Health Insurance Portability and Accountability Act of 1996 | ||||
| Hospira | Hospira, Inc. | ||||
| IPR&D | in-process research and development | ||||
| IRS | U.S. Internal Revenue Service | ||||
| JAK | Janus kinase | ||||
| JV | joint venture | ||||
| King | King Pharmaceuticals LLC (formerly King Pharmaceuticals, Inc.) | ||||
| LIBOR | London Interbank Offered Rate | ||||
| LOE | loss of exclusivity | ||||
| 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 |
| Meridian | Meridian Medical Technologies, Inc. | ||||
| mRNA | messenger ribonucleic acid | ||||
| MSA | Manufacturing Supply Agreement | ||||
| Mylan | Mylan N.V. | ||||
| Myovant | Myovant Sciences Ltd. | ||||
| NDA | New Drug Application | ||||
| nmCRPC | non-metastatic castration-resistant prostate cancer | ||||
| NSCLC | non-small cell lung cancer | ||||
| OPKO | OPKO Health, Inc. | ||||
| OTC | over-the-counter | ||||
| Paxlovid* | an oral COVID-19 treatment (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) | ||||
| PC1 | Pfizer CentreOne | ||||
| PGS | Pfizer Global Supply | ||||
| Pharmacia | Pharmacia Corporation | ||||
| PRAC | Pharmacovigilance Risk Assessment Committee | ||||
| PsA | psoriatic arthritis | ||||
| QTD | Quarter-to-date or three months ended | ||||
| RA | rheumatoid arthritis | ||||
| RCC | renal cell carcinoma | ||||
| R&D | research and development | ||||
| ReViral | ReViral Ltd. | ||||
| Sandoz | Sandoz, Inc., a division of Novartis AG | ||||
| SEC | U.S. Securities and Exchange Commission | ||||
| sNDA | supplemental new drug application | ||||
| TSAs | transition service arrangements | ||||
| UC | ulcerative colitis | ||||
| U.K. | United Kingdom | ||||
| U.S. | United States | ||||
| 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 | ||||
| Viatris | Viatris Inc. | ||||
| ViiV | ViiV Healthcare Limited | ||||
| WRDM | Worldwide Research, Development and Medical | ||||
| YTD | Year-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