Pfizer Inc. operates as a research-based biopharmaceutical company.
The company discovers, develops, manufactures, markets, distributes, and sells biopharmaceutical products worldwide.
The company works across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of its time. The company collaborates with healthcare providers, governments and local communities to support and expand access to reliable, affordable healthcare around the world.
Most of the company’s revenues come from the manufacture and sale of biopharmaceutical products. The company’s medicines and vaccines provide significant value for healthcare providers and patients, through improved treatment of diseases, improvements in health, wellness, and productivity, as well as by reducing other healthcare costs, such as emergency room or hospitalization.
The company assesses its business, assets and scientific capabilities/portfolio as part of its regular, ongoing portfolio review process and also continues to consider business development activities that will help advance its business strategy.
In 2021, the company’s significant business development activities included global collaboration with Arvinas, Inc. (Arvinas) to develop and commercialize ARV-471, an investigational oral PROTAC (PROteolysis TArgeting Chimera) estrogen receptor protein degrader (the estrogen receptor is a well-known disease driver in most breast cancers); collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd., Biohaven Pharmaceutical Ireland DAC and BioShin Limited. (collectively, Biohaven) to acquire rights to commercialize rimegepant and zavegepant for the treatment and prevention of migraines outside of the United States (U.S.) upon approval; the acquisition of Trillium Therapeutics Inc. (Trillium), a clinical stage immuno-oncology company developing innovative potential therapies for the treatment of cancer; and research collaboration with Beam Therapeutics Inc. (Beam) to utilize Beam’s in vivo base editing programs, which use messenger ribonucleic acid (mRNA) and lipid nanoparticles, for three targets for rare genetic diseases of the liver, muscle and central nervous system.
At the beginning of its fiscal fourth quarter 2021, the company reorganized its commercial operations and began to manage its commercial operations through a new global structure consisting of two operating segments, each led by a single manager, Pfizer Biopharmaceuticals Group (Biopharma), its innovative science-based biopharmaceutical business; and PC1 (Pfizer CentreOne), its global contract development and manufacturing organization and a leading supplier of specialty active pharmaceutical ingredients.
The company’s Biopharma business includes the following therapeutic areas and key products:
Vaccines: Includes innovative vaccines across all ages—infants, adolescents and adults—in pneumococcal disease, meningococcal disease, tick-borne encephalitis and novel coronavirus disease of 2019 (COVID-19), with a pipeline focus on infectious diseases with significant unmet medical need. Key products include Comirnaty/BNT162b2, the Prevnar family, Nimenrix, FSME/IMMUN-TicoVac, and Trumenba.
Oncology: Includes innovative oncology brands of biologics, small molecules, immunotherapies and biosimilars across a wide range of cancers. Key products include Ibrance, Xtandi, Inlyta, Sutent, Retacrit, Lorbrena and Braftovi.
Internal Medicine: Includes innovative brands in cardiovascular metabolic and women’s health, as well as regional brands. Key products include Eliquis and the Premarin family.
Hospital: Includes the company’s global portfolio of sterile injectable and anti-infective medicines, as well as an oral COVID-19 treatment. Key products include Sulperazon, Medrol, Zavicefta, Zithromax, Vfend, Panzyga and Paxlovid.
Inflammation and Immunology: Includes innovative brands and biosimilars for chronic immune and inflammatory diseases. Key products include Xeljanz, Enbrel (outside the U.S. and Canada), Inflectra, Eucrisa/Staquis, and Cibinqo.
Rare Disease: Includes innovative brands for a number of therapeutic areas with rare diseases, including amyloidosis, hemophilia and endocrine diseases. Key products include Vyndaqel/Vyndamax, BeneFIX, and Genotropin.
Collaboration and Co-Promotion
The company uses collaboration and/or co-promotion arrangements to enhance its development, research and development, sales and distribution of certain biopharmaceutical products, which include among others, the following:
Comirnaty/BNT162b2 is an mRNA-based coronavirus vaccine to help prevent COVID-19, which is being jointly developed and commercialized with BioNTech. The company and BioNTech equally share the costs of development for the Comirnaty program. Comirnaty/BNT162b2 has been granted an approval or an authorization in many countries around the world in populations varying by country. The company also shares gross profits equally from the commercialization of Comirnaty/BNT162b2; and is working jointly with BioNTech in its respective territories to commercialize the vaccine worldwide (excluding China, Hong Kong, Macau, and Taiwan), subject to regulatory authorizations or approvals market by market.
Eliquis (apixaban) is part of the Novel Oral Anticoagulant market and was jointly developed and commercialized with Bristol-Myers Squibb Company as an alternative treatment option to warfarin in appropriate patients.
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 (Astellas Pharma Inc., Astellas US LLC, and Astellas Pharma US, Inc.). For international net sales, the company receives royalties based on a tiered percentage.
Bavencio (avelumab) is a human anti-programmed death ligand-1 (PD-L1) antibody that is being developed and commercialized in collaboration with Merck KGaA.
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 Myovant Sciences Ltd. 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.
Revenues associated with these arrangements are included in Alliance revenues (except in certain markets where the company has direct sales and except for the majority of revenues for Pfizer-BioNTech COVID-19 Vaccine, also known as BNT162b2 (Comirnaty)/Pfizer-BioNTech COVID-19 Vaccine, also known as Comirnaty (BNT162b2), which are included as direct product revenues). In addition, the company has collaboration arrangements for the development and commercialization of certain pipeline products that are in development stage, including among others with BioNTech SE (BioNTech) to develop a modified mRNA-based vaccine for the prevention of varicella zoster (Shingles); and with Valneva SE (Valneva) to co-develop and commercialize Valneva’s Lyme disease vaccine candidate, VLA15.
The company’s operations are conducted globally. The company sells its products in over 125 countries.
Sales and Marketing
The company’s prescription biopharmaceutical products are sold principally to wholesalers, but it also sells directly to retailers, hospitals, clinics, government agencies and pharmacies. In the U.S., the company primarily sells its vaccines directly to the federal government, the U.S. Centers for Disease Control and Prevention (CDC), wholesalers, individual provider offices, retail pharmacies and integrated delivery systems. Outside the U.S., the company primarily sells its vaccines to government and non-government institutions. Certain of these government contracts may be renegotiated or terminated at the discretion of a government entity. In addition, the company’s contracts with government and supranational organizations for the sale of Comirnaty/BNT162b2 and Paxlovid (an oral COVID-19 treatment (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), which are on a committed basis, represented a significant amount of revenues in 2021. The company promotes its products to healthcare providers and patients. In the U.S., the company markets directly to consumers through direct-to-consumer advertising that seeks to communicate the approved uses, benefits and risks of its products while motivating people to have meaningful conversations with their doctors.
The U.S. Food and Drug Administration (FDA), pursuant to the U.S. Federal Food, Drug and Cosmetic Act (FFDCA), the Public Health Service Act and other federal statutes and regulations, extensively regulates pre- and post-marketing activities related to the company’s biopharmaceutical products. Other the U.S. federal agencies, including the U.S. Drug Enforcement Agency (DEA), also regulate certain of the company’s products and activities.
The company is also required to report adverse events and comply with current Good Manufacturing Practices (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, repackagers and dispensers to facilitate the tracing of product through the pharmaceutical distribution supply chain), as well as advertising and promotion regulations.
The company’s marketing practices are subject to state laws, as well as federal laws, such as the Anti-Kickback Statute and False Claims Act, intended to prevent fraud and abuse in the healthcare industry. In the European Union (EU), the European Medicines Agency (EMA) conducts the scientific evaluation, supervision and safety monitoring of the company’s innovative medicinal products; and employs a centralized procedure for approval for the EU and the European Economic Area (EEA) countries.
Pfizer Inc. was founded in 1849. The company was incorporated under the laws of the state of Delaware in 1942.