PFIZER INC
For the period ended Dec 31, 2023. Filed Feb 22, 2024.
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FY2023 · Filed Feb 22, 2024
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Defined Termsi
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:
| 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 | calcitonin gene-related peptide |
| CMS | Centers for Medicare & Medicaid Services |
| Comirnaty* | Unless otherwise noted, refers to, as applicable, and as authorized or approved, the Pfizer-BioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), 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 |
| 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 | Pharmacovigilance Risk Assessment Committee |
| PRD | 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 |
| 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 atwww.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.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.