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 October 1, 2023
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.) |
66 Hudson Boulevard East, New York, New York 10001-2192
(Address of principal executive offices) (zip code)
(212) 733-2323
(Registrant’s telephone number including area code)
| Securities registered pursuant to Section 12(b) of the Act: | ||||||||||||||
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
| Common Stock, $0.05 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 November 3, 2023, 5,646,413,292 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 nine months ended August 27, 2023 and August 28, 2022, and for U.S. subsidiaries is as of and for the three and nine months ended October 1, 2023 and October 2, 2022. 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 2022 Form 10-K. We also have used several other terms in this Form 10-Q, most of which are explained or defined below:
| 2022 Form 10-K | Annual Report on Form 10-K for the fiscal year ended December 31, 2022 | ||||
| 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. | ||||
| Arvinas | Arvinas, 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 | Global Biopharmaceuticals Business | ||||
| Blackstone | Blackstone Life Sciences | ||||
| BMS | Bristol-Myers Squibb Company | ||||
| BOD | Board of Directors | ||||
| CDC | U.S. Centers for Disease Control and Prevention | ||||
| 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 | ||||
| Developed Europe | Includes the following markets: Western Europe, Scandinavian countries and Finland | ||||
| Developed Markets | Includes the following markets: U.S., Developed Europe, Japan, Australia, Canada, South Korea and New Zealand | ||||
| Developed Rest of World | Includes the following markets: Japan, Canada, Australia, South Korea 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 | ||||
| EU | European Union | ||||
| EUA | emergency use authorization | ||||
| Exchange Act | Securities Exchange Act of 1934, as amended | ||||
| FASB | Financial Accounting Standards Board | ||||
| FDA | U.S. Food and Drug Administration | ||||
| Form 10-Q | This Quarterly Report on Form 10-Q for the quarterly period ended October 1, 2023 | ||||
| GAAP | Generally Accepted Accounting Principles | ||||
| GBT | Global Blood Therapeutics, Inc. | ||||
| GSK | GSK plc | ||||
| Haleon | Haleon plc | ||||
| 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 | ||||
| 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 | ||||
| LPS | loss per share | ||||
| 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 | ||||
| Meridian | Meridian Medical Technologies, Inc. | ||||
| Moody’s | Moody’s Investors Service | ||||
| mRNA | messenger ribonucleic acid | ||||
| MSA | Manufacturing Supply Agreement | ||||
| Mylan | Mylan N.V. | ||||
| NDA | New Drug Application | ||||
| Nimbus | Nimbus Therapeutics, LLC | ||||
| nmCRPC | non-metastatic castration-resistant prostate cancer | ||||
| NSCLC | non-small cell lung cancer | ||||
| ODT | oral disintegrating tablet | ||||
| Ono | Ono Pharmaceutical Co., Ltd. | ||||
| OPKO | OPKO Health, Inc. | ||||
| OTC | over-the-counter | ||||
| Paxlovid* | an oral COVID-19 treatment (nirmatrelvir tablets and ritonavir tablets) | ||||
| PC1 | Pfizer CentreOne | ||||
| Pharmacia | Pharmacia LLC (formerly Pharmacia Corporation) | ||||
| PIE | Pfizer Investment Enterprises Pte. Ltd. (a wholly-owned finance subsidiary of Pfizer) | ||||
| Prevnar family | Includes Prevnar 13/Prevenar 13 (pediatric and adult) and Prevnar 20/Apexxnar (pediatric and adult) | ||||
| PsA | psoriatic arthritis | ||||
| QTD | Quarter-to-date or three months ended | ||||
| RA | rheumatoid arthritis | ||||
| RCC | renal cell carcinoma | ||||
| R&D | research and development | ||||
| RSV | respiratory syncytial virus | ||||
| S&P | Standard & Poor’s | ||||
| Seagen | Seagen Inc. | ||||
| SEC | U.S. Securities and Exchange Commission | ||||
| SI&A | selling, informational and administrative | ||||
| 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 | ||||
| Vyndaqel family | Includes Vyndaqel, Vyndamax and Vynmac | ||||
| WRDM | Worldwide Research, Development and Medical | ||||
| YTD | Year-to-date or nine months ended |
*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 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 U.S. Federal Food, Drug and Cosmetic Act 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-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