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What changed in Pfizer's 10-K — 2022 vs 2023

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Paragraph-level year-over-year comparison of Pfizer's 2022 and 2023 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2023 report.

+310 added−305 removedSource: 10-K (2024-02-22) vs 10-K (2023-02-23)

Top changes in Pfizer's 2023 10-K

310 paragraphs added · 305 removed · 223 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

57 edited+21 added−5 removed60 unchanged
Biggest changeWe also face risks and uncertainties related to our efforts to develop and commercialize our COVID-19 products, as well as challenges related to their manufacturing, supply and distribution, including, among others: • uncertainties inherent in R&D, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with pre-clinical and clinical data (including Phase 1/2/3 or Phase 4 data for Comirnaty, any monovalent, bivalent or variant-adapted vaccine candidates or any other vaccine candidate in the BNT162 program or Paxlovid or any future COVID-19 treatment) in any of our studies in pediatrics, adolescents or adults or real world evidence, including the possibility of unfavorable new pre-clinical, clinical or safety data and further analyses of existing pre-clinical, clinical or safety data or further information regarding the quality of pre-clinical, clinical or safety data, including by audit or inspection; • the ability to produce comparable clinical or other results for Comirnaty, any monovalent, bivalent or variant-adapted vaccine candidates or other vaccines that may result from the BNT162 program, Paxlovid or any future COVID-19 treatment or any other COVID-19 program, including the rate of effectiveness and/or efficacy, safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial for any such products and additional studies, in real-world data studies or in larger, more diverse populations following commercialization; • the ability of Comirnaty, any monovalent, bivalent or variant-adapted vaccine candidates or any future vaccine to prevent, or Paxlovid or any future COVID-19 treatment to be effective against, COVID-19 caused by emerging virus variants; • the risk that demand for any products may be reduced, no longer exist or not meet expectations, which may lead to excess inventory on-hand and/or in the channel or reduced revenues; • challenges related to a transition to the commercial market for any of our products; • uncertainties related to the public’s adherence to vaccines, boosters and treatments; • the risk that more widespread use of Comirnaty or Paxlovid will lead to new information about efficacy, safety or other developments, including the risk of additional adverse reactions, some of which may be serious; • the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; • whether and when additional data from the BNT162 mRNA vaccine program, Paxlovid or other COVID-19 programs will be published in scientific journal publications and, if so, when and with what modifications and interpretations; • whether regulatory authorities will be satisfied with the design of and results from existing or future pre-clinical and clinical studies; • whether and when submissions to request emergency use or conditional marketing authorizations for Comirnaty or any future vaccines in additional populations, for a potential booster dose for Comirnaty, any monovalent or bivalent vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccinations), and/or biologics license and/or EUA applications or amendments to any such applications may be filed in particular jurisdictions for Comirnaty, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a potential variant-based, higher dose, or bivalent vaccine or any other potential vaccines, and if obtained, whether or when such EUA or licenses, or existing EUAs, will expire or terminate; • whether and when submissions to request emergency use or conditional marketing authorizations for Paxlovid or any future COVID-19 treatment and/or any drug applications and/or EUA applications or amendments to any such applications for any indication for Paxlovid or any future COVID-19 treatment may be filed in particular jurisdictions, and if obtained, whether or when such EUA or licenses, or existing EUAs, will expire or terminate; • whether and when any application that may be pending or filed for Comirnaty, any monovalent, bivalent or variant-adapted vaccine candidates or other vaccines that may result from the BNT162 program, Paxlovid or any future COVID-19 treatment or any other COVID-19 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine’s or drug’s benefits outweigh its known risks and determination of the vaccine’s or drug’s efficacy and, if approved, whether it will be commercially successful; • decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine or drug, including the authorization or approval of products or therapies developed by other companies; • disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers, including our relationship with BioNTech; • the risk that other companies may produce superior or competitive products; Pfizer Inc. 2022 Form 10-K 21 • risks related to the availability of raw materials to manufacture or test any such products; • challenges related to our vaccine’s formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by us; • challenges and risks related to medication errors such as prescribing or dispensing the wrong strength, improper dosing and self-administration errors; • the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based or next generation vaccines or next generation COVID-19 treatments; • the risk that we may not be able to recoup costs associated with our R&D and manufacturing efforts; • risks associated with any changes in the way we approach or provide research funding for the BNT162 program, Paxlovid or any other COVID-19 program; • challenges and risks associated with the pace of our development programs; • the risk that we may not be able to maintain manufacturing capacity or access to logistics or supply channels commensurate with global demand for our COVID-19 products, which would negatively impact our ability to supply our COVID-19 products within the projected time periods; • risks related to our ability to achieve our revenue forecasts for Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments; • whether and when additional supply or purchase agreements will be reached or existing agreements will be completed or renegotiated; • uncertainties regarding the ability to obtain recommendations from vaccine or treatment advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; • pricing and access challenges for such products; • challenges related to public confidence in, or awareness of Comirnaty or Paxlovid, including challenges driven by misinformation or disinformation, access, concerns about clinical data integrity, or prescriber and pharmacy education; • uncertainties around future changes to applicable healthcare policies and guidelines issued by the U.S. federal government in connection with the declared termination of the federal government’s COVID-19 public health emergency as of May 11, 2023; • trade restrictions; • the risk that we may owe third-party royalties or have other claims asserted related to Comirnaty or Paxlovid; and • competitive developments.
Biggest changeWe also face risks and uncertainties related to our efforts to develop and commercialize our COVID-19 products, as well as challenges related to their manufacturing, supply and distribution, including, among others: • the risk that as the market for COVID-19 products becomes more endemic and seasonal, demand for any of our COVID-19 products has and may continue to be reduced or not meet expectations, or may no longer exist, which has and may continue to lead to reduced revenues, excess inventory on-hand and/or in the channel which, for Paxlovid and Comirnaty, has resulted in significant inventory write-offs in 2023 and could continue to result in inventory write-offs or other unanticipated charges; • challenges related to the transition to the commercial market for our COVID-19 products; • uncertainties related to the public’s demand for vaccines, boosters and COVID-19 treatments; • risks related to our ability to accurately forecast and achieve our revenue forecasts for Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments; • uncertainties inherent in R&D, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with pre-clinical and clinical data (including Phase 1/2/3 or Phase 4 data for Comirnaty or any vaccine candidate in the BNT162 program or Paxlovid or any future COVID-19 treatment) in any of our studies in pediatrics, adolescents or adults or real world evidence, including the possibility of unfavorable new pre-clinical, clinical or safety data and further analyses of existing pre-clinical, clinical or safety data or further information regarding the quality of pre-clinical, clinical or safety data, including by audit or inspection; • the ability to produce comparable clinical or other results for Comirnaty, any vaccine candidate or other vaccines that may result from the BNT162 program, Paxlovid or any future COVID-19 treatment or any other COVID-19 program, including the rate of effectiveness and/or efficacy, safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial for any such products and additional studies, in real-world data studies or in larger, more diverse populations following commercialization; • the ability of Comirnaty or any future vaccine to prevent, or Paxlovid or any future COVID-19 treatment to be effective against, COVID-19 caused by emerging virus variants; • the risk that use of Comirnaty or Paxlovid will lead to new information about efficacy, safety or other developments, including the risk of additional adverse reactions, some of which may be serious; • the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; • whether and when additional data from the BNT162 program, Paxlovid or other COVID-19 programs will be published in scientific journal publications and, if so, when and with what modifications and interpretations; • whether regulatory authorities will be satisfied with the design of and results from existing or future pre-clinical and clinical studies; • whether and when submissions to request emergency use or conditional marketing authorizations for Comirnaty or any future vaccines in additional populations, for a potential booster dose for Comirnaty, or any potential future vaccine or vaccine candidates (including potential future annual boosters or re-vaccinations), and/or biologics license and/or EUA applications or amendments to any such applications may be filed in particular jurisdictions for Comirnaty or any other potential vaccine or vaccine candidates, and if obtained, whether or when such EUA or licenses, or existing EUAs, will expire or terminate; • whether and when submissions to request emergency use or conditional marketing authorizations for Paxlovid or any future COVID-19 treatment and/or any drug applications and/or EUA applications or amendments to any such applications for any indication for Paxlovid or any future COVID-19 treatment may be filed in particular jurisdictions, and if obtained, whether or when such EUA or licenses, or existing EUAs, will expire or terminate; • whether and when any application that may be pending or filed for Comirnaty, any vaccine candidate or other vaccines that may result from the BNT162 program, Paxlovid or any future COVID-19 treatment or any other COVID-19 program may be approved by particular regulatory Pfizer Inc. 2023 Form 10-K 24 authorities, which will depend on myriad factors, including making a determination as to whether the vaccine’s or drug’s benefits outweigh its known risks and determination of the vaccine’s or drug’s efficacy and, if approved, whether it will be commercially successful; • decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any vaccine or drug, including the authorization or approval of products or therapies developed by other companies; • disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers, including our relationship with BioNTech; • the risk that other companies may produce competitive products that may be superior in terms of efficacy, safety, affordability, convenience, or a number of other competitive factors; • risks related to the availability or cost of raw materials to manufacture or test any such products; • challenges related to our vaccine’s formulation and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by us; • challenges and risks related to medication errors such as prescribing or dispensing the wrong strength, improper dosing and self-administration errors; • the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future vaccines, potential combination respiratory vaccines or next generation COVID-19 treatments; • the risk that we may not be able to recoup costs associated with our R&D and manufacturing efforts; • risks associated with any changes in the way we approach or provide research funding for the BNT162 program, Paxlovid or any other COVID-19 program; • challenges and risks associated with the pace of our development programs; • the risk that we may not be able to maintain manufacturing capacity or access to logistics or supply channels commensurate with global demand for our COVID-19 products, which would negatively impact our ability to supply our COVID-19 products within the projected time periods; • whether and when additional supply or purchase agreements will be reached or existing agreements will be modified; • uncertainties regarding the ability to obtain recommendations from vaccine or treatment advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; • pricing and access challenges for such products; • challenges related to public confidence in, or awareness of Comirnaty, Paxlovid or any future COVID-19 product candidates, including challenges driven by misinformation or disinformation, access, concerns about clinical data integrity, or prescriber and pharmacy education; • trade restrictions; and • the risk that we may owe third-party royalties or other adverse outcomes from existing litigation related to Comirnaty and Paxlovid, or have additional other claims asserted related to Comirnaty or Paxlovid.
Government investigations and actions could result in substantial criminal and civil fines and/or criminal charges, limitations on our ability to conduct business in applicable jurisdictions, corporate integrity or deferred prosecution agreements and other disciplinary actions, as well as reputational harm, including as a result of increased public interest in the matter.
Government investigations and actions have and could result in substantial criminal and civil fines and/or criminal charges, limitations on our ability to conduct business in applicable jurisdictions, corporate integrity or deferred prosecution agreements and other disciplinary actions, as well as reputational harm, including as a result of increased public interest in the matter.
Further, legal or regulatory action by various stakeholders or governments could potentially result in us not seeking intellectual property protection for or agreeing not to enforce or being restricted from enforcing intellectual property related to our products. The WTO continues to address the role of intellectual property in the context of the COVID-19 pandemic response.
Further, legal or regulatory action by various stakeholders or governments could potentially result in us not seeking intellectual property protection for or agreeing not to enforce or being restricted from enforcing intellectual property related to our products. The WTO continues to address the role of intellectual property in the context of the COVID-19 response.
Although we believe that our claims and defenses in matters in which we are a defendant are substantial, we could in the future incur judgments, enter into settlements or revise our expectations regarding the outcome of certain matters, and such developments could have a material adverse effect on our results of operations.
Although we believe that our claims and defenses in matters in which we are a defendant are substantial, we have in the past and could in the future incur judgments, enter into settlements or revise our expectations regarding the outcome of certain matters, and such developments could have a material adverse effect on our results of operations.
While we are working to develop emission reduction plans to achieve our voluntary climate goals, various factors, including the long time horizons and commercial availability of new technologies to enable the emission reductions, in the time and scale needed, may present inherent risk in our ability to meet these goals.
While we are working to develop and implement emission reduction plans to achieve our voluntary climate goals, various factors, including the long time horizons and commercial availability of new technologies to enable the emission reductions, in the time and scale needed, may present inherent risk in our ability to meet these goals.
COVID-19 may also affect our business, operations or financial condition and results in a manner that is not presently known to us or that we currently do not consider as presenting significant risks.
COVID-19 or our COVID-19 products may also affect our business, operations or financial condition and results in a manner that is not presently known to us or that we currently do not consider as presenting significant risks.
We are also party to other patent damages suits in various jurisdictions pursuant to which generic drug manufacturers, payers, governments or other parties are seeking damages from us for alleged delay of generic entry. We also are often involved in other proceedings, such as inter partes review, post-grant review, re-examination or opposition proceedings, before the U.S.
We are also party to other patent damages suits in various jurisdictions pursuant to which generic drug manufacturers, payors, governments or other parties are seeking damages from us for alleged delay of generic entry. We also are often involved in other proceedings, such as inter partes review, post-grant review, re-examination or opposition proceedings, before the U.S.
Integration of these products or businesses may result in the loss of key employees, the disruption of ongoing business, including third-party relationships, or inconsistencies in standards, controls, procedures and policies. Further, while we seek to mitigate risks and liabilities through, among other things, due diligence, we may be exposed to risks and liabilities as a result of business development transactions.
Integration of acquired products or businesses may result in the loss of key employees, the disruption of ongoing business, including third-party relationships, or inconsistencies in standards, controls, procedures and policies. Further, while we seek to mitigate risks and liabilities through, among other things, due diligence, we may be exposed to risks and liabilities as a result of business development transactions.
Like many companies in our industry, we have from time-to-time received, and may receive in the future, inquiries and subpoenas and other types of information demands from government authorities. In addition, we have been subject to claims and other actions related to our business activities, brought by governmental authorities, as well as consumers and private payers.
Like many companies in our industry, we have from time-to-time received, and may receive in the future, inquiries and subpoenas and other types of information demands from government authorities. In addition, we have been subject to claims and other actions related to our business activities, brought by governmental authorities, as well as consumers and private payors.
These risks could increase operating costs, including the cost of our electricity and energy use, or other compliance costs. Physical risks to our operations include water stress and drought; flooding and storm surge; wildfires; extreme temperatures and storms, which could impact pharmaceutical production, increase costs, or disrupt supply chains of medicines for patients.
These risks could increase operating costs, including the cost of our electricity and energy use, or otherwise increase compliance costs. Physical risks to our operations include water stress and drought; flooding and storm surge; wildfires; extreme temperatures and storms, which could impact pharmaceutical production, increase costs, or disrupt supply chains of medicines for patients.
Despite careful tracking and planning, we are unable to accurately predict the extent of the impact of COVID-19 on our business, operations and financial condition and results due to the uncertainty of future developments.
Despite careful tracking and planning, we are unable to accurately predict the extent of the impact of COVID-19 or our COVID-19 products on our business, operations and financial condition and results due to the uncertainty of future developments.
We are involved in patent-related disputes with third parties over our attempts to market pharmaceutical products, including related to Comirnaty and Paxlovid. As we expand our mRNA portfolio, such patent-related disputes may increase.
We are involved in patent-related disputes with third parties over our attempts to market pharmaceutical products, including related to Abrysvo, Comirnaty and Paxlovid. As we expand our mRNA portfolio, patent-related disputes may increase.
Any future distribution or sale of such securities will be subject to prevailing market conditions and other factors, including the size of our ownership stake, at the time of such distribution or sale and there is no assurance that such securities will ultimately be sold at an attractive price or at all.
Any future distribution or sale of such securities will be subject to prevailing market conditions and other factors, including the size of our ownership stake, at the time of such distribution or sale and there is no assurance as to the price that such securities will ultimately be sold or that such securities will be sold at all.
The outcome is inherently uncertain and involves a high degree of risk due to the following factors, among others: • The process from early discovery to design and adequate implementation of clinical trials to regulatory approval can take many years. • Product candidates can and do fail at any stage of the process, including as the result of unfavorable pre-clinical and clinical trial results, or unfavorable new pre-clinical or clinical data and further analyses of existing pre-clinical or clinical data, including results that may not support further clinical development of the product candidate or indication. • We may need to amend our clinical trial protocols or conduct additional clinical trials under certain circumstances, for example, to further assess appropriate dosage or collect additional safety data. • We may not be able to meet anticipated pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates. • We may not be able to successfully address all the comments received from regulatory authorities such as the FDA and the EMA, or be able to obtain approval for new products and indications from regulators.
The outcome is inherently uncertain and involves a high degree of risk due to the following factors, among others: • The process from early discovery to design and adequate implementation of clinical trials to regulatory approval can take many years and have high costs. • We may have difficulties recruiting and enrolling patients for clinical trials on a consistent basis. • Product candidates can and do fail at any stage of the process, including as the result of unfavorable pre-clinical and clinical trial results, or unfavorable new pre-clinical or clinical data and further analyses of existing pre-clinical or clinical data, including results that may not support further clinical development of the product candidate or indication. • We may need to amend our clinical trial protocols or conduct additional clinical trials under certain circumstances, for example, to further assess appropriate dosage or collect additional safety data. • We may not be able to meet anticipated pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates. • We may not be able to successfully address all the comments received from regulatory authorities such as the FDA and the EMA, or be able to obtain approval for new products and indications from regulators.
The required study populations include individuals specified in our December 2022 authorization letter (reissued) as well as populations of interest, such as healthcare workers, pregnant women, immunocompromised individuals and subpopulations with specific comorbidities. Additionally, in relation to the FDA approval for Comirnaty, we are required to complete certain postmarketing study requirements and commitments through 2024 and beyond.
The required study populations include individuals specified in our September 2023 authorization letter (reissued) as well as populations of interest, such as healthcare workers, pregnant women, immunocompromised individuals and subpopulations with specific comorbidities. Additionally, in relation to the FDA approval for Comirnaty, we are required to complete certain postmarketing study requirements and commitments through 2024 and beyond.
Also, the FDA may require Pfizer to assess the activity of the authorized Paxlovid against any global SARS-CoV-2 variant(s) of interest and complete certain other analyses and studies as identified in our October 2022 EUA.
Also, the FDA required Pfizer to assess the activity of the authorized Paxlovid against any global SARS-CoV-2 variant(s) of interest and complete certain other analyses and studies as identified in our October 2022 EUA.
Further, claims and concerns that may arise regarding the safety and efficacy of in-line products and product candidates can negatively impact product sales, and potentially lead to product recalls or withdrawals, including regulator-directed risk evaluations and assessments, and/or consumer fraud, product liability and other litigation and claims.
Further, claims and concerns that may arise regarding the safety and/or efficacy of in-line products and product candidates can negatively impact current or future product sales, as applicable, and potentially lead to product recalls or withdrawals, including regulator-directed risk evaluations and assessments, and/or consumer fraud, product liability and other litigation and claims.
Additionally, success may depend on the actions of governments and third parties and may require, among other things, significant capital investment; research and development; and government policies and incentives to foster innovation and reduce costs of technologies that may not currently exist or be available at scale.
Additionally, success may depend on the actions of governments and third parties and may require, among other things, significant capital investment; R&D; and government policies and incentives to foster innovation and reduce costs of technologies that may not currently exist or be available at scale.
The extent to which COVID-19 impacts our business going forward will depend on many factors, and we have made certain assumptions regarding COVID-19 for purposes of our operational planning and financial projections, including assumptions regarding the global macroeconomic impact of COVID-19, as well as the demand, revenues, supply, contracts and commercial markets for our COVID-19 products, which remain dynamic.
COVID-19 The extent to which COVID-19 impacts our business going forward will depend on many factors, and we have made certain assumptions regarding COVID-19 for purposes of our operational planning and financial projections, including assumptions regarding the global macroeconomic impact of COVID-19, as well as the demand, revenues, supply, contracts, market share and commercial markets for our current or future COVID-19 products, which remain dynamic.
The terms of our EUA for Comirnaty require that we conduct post-observational studies to evaluate the association between the Pfizer-BioNTech Covid-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and a pre-specified list of adverse events of special interest, including myocarditis and pericarditis, along with deaths and hospitalizations, and severe COVID-19.
The terms of our EUA for Comirnaty require that we conduct post-observational studies to evaluate the association between the Pfizer-BioNTech COVID-19 Vaccine (Original monovalent), Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula), and a pre-specified list of adverse events of special interest, including myocarditis and pericarditis, along with deaths and hospitalizations, and severe COVID-19.
As a result of regulatory interpretations and assessments or other developments that occur during the review process, and even after a product is authorized or approved for marketing, a product’s commercial potential could be adversely affected by potential emerging concerns or regulatory decisions regarding or impacting labeling or marketing, manufacturing processes, safety and/or other matters, including decisions relating to emerging developments regarding potential product impurities.
As a result of regulatory interpretations and assessments or other developments that may occur during the review process, or even after a product is authorized or approved for marketing, a product’s commercial potential could be adversely affected by potential emerging concerns or regulatory decisions regarding or impacting the scope of indicated patient populations, labeling or marketing, manufacturing processes, safety issues and/or other matters, including decisions relating to emerging developments regarding potential product impurities.
The terms of our EUA for Paxlovid require monitoring of a genomic database(s) for the emergence of global viral variants of SARS-CoV-2 and providing reports to the FDA on a monthly basis summarizing any findings.
The terms of our Paxlovid EUA had previously required monitoring of a genomic database(s) for the emergence of global viral variants of SARS-CoV-2 and providing reports to the FDA on a monthly basis summarizing any findings.
Such cyber-attacks are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of motives (including, but not limited to, industrial espionage, extortion, property destruction and personal information theft) and expertise, including, but not limited to, organized criminal groups, “hacktivists,” nation states, employees, business partners and others.
Such cyber-attacks are of ever-increasing levels of sophistication, including the use of adversarial artificial intelligence techniques, and are made by groups and individuals with a wide range of motives (including, but not limited to, industrial espionage, extortion, property destruction and personal information theft) and expertise, including, but not limited to, organized criminal groups, “hacktivists,” nation states, employees, business partners and others.
For additional details, see the S ignificant Accounting Policies and Application of Critical Accounting Estimates and Assumptions — Asset Impa irments section within MD&A.
For additional details, see the S ignificant Accounting Policies and Application of Critical Accounting Estimates and Assumptions — Asset Impairments section within MD&A.
Where we invest in or otherwise obtain debt or equity securities of third parties in connection with business development transactions, such as our ownership interest in Haleon, we may be unable to direct or influence the management, operational decisions and policies of such companies and the value of the acquired securities will fluctuate and may lose value.
Pfizer Inc. 2023 Form 10-K 23 Where we invest in or otherwise obtain debt or equity securities of third parties in connection with business development transactions, such as our ownership interest in Haleon, we may be unable to direct or influence the management, operational decisions and policies of such companies and the value of the acquired securities will fluctuate and may lose value.
Pfizer Inc. 2022 Form 10-K 22 COST AND EXPENSE CONTROL AND NONORDINARY EVENTS Growth in costs and expenses, changes in product and geographic mix and the impact of acquisitions, divestitures, restructurings, internal reorganizations, product withdrawals, recalls and other unusual events that could result from evolving business strategies, evaluation of asset realization and organizational restructuring could adversely affect future results.
COST AND EXPENSE CONTROL AND NONORDINARY EVENTS Growth in costs and expenses, changes in product and geographic mix and the impact of acquisitions, divestitures, restructurings, internal reorganizations, product withdrawals, recalls and other unusual events that could result from evolving business strategies, evaluation of asset realization and organizational restructuring could adversely affect future results.
Pursuing, executing and consummating these transactions may require substantial investment, which may require us to obtain additional equity or debt financing, which could result in increased leverage and/or a downgrade of our credit ratings.
Pursuing, executing and consummating these transactions may require substantial investment, which may require us to obtain additional equity or debt financing, which has in the past and could in the future result in increased leverage and/or a downgrade of our credit ratings and could limit our ability to obtain future financing.
While we have invested in the protection of data and IT and develop and maintain systems and controls, our efforts may not prevent service interruptions, extortion, theft of confidential, personal or proprietary information, compromise of data integrity or unauthorized information disclosure.
While we have invested in the protection of data and IT and develop and maintain systems and controls, our efforts, like those of other similar companies, have not always and may not in the future prevent service interruptions, extortion, theft of confidential, personal or proprietary information, compromise of data integrity or unauthorized information disclosure.
Once we have final Pfizer Inc. 2022 Form 10-K 19 regulatory approval of the related products, we may decide to commercially market these products even though associated legal proceedings (including any appeals) have not been resolved (i.e., “at-risk” launch).
Once we have final regulatory approval of the related products, we may decide to commercially market these products even though associated legal proceedings (including any appeals) have not been resolved (i.e., “at-risk” launch).
The Company develops and operates digital systems to engage patients, healthcare providers, governments, payers and supply chain partners to conduct business and deliver medicines, digital diagnostics, clinical trials and digital therapies. Such systems include mobile applications, wearable devices, internet websites and other digital technologies that may be targets of attack.
We develop and operate digital systems to engage patients, healthcare providers, governments, payors and supply chain partners to conduct business and deliver medicines, digital diagnostics, clinical trials and digital therapies. Such systems include mobile applications, wearable devices, internet websites and other digital technologies that may be targets of attack.
In connection with the resolution of a U.S. government investigation concerning independent copay assistance organizations that provide financial assistance to Medicare patients, in 2018, we entered into a Corporate Integrity Agreement (CIA) with the Office of the Inspector General of the HHS, which is effective for a period of five years.
In connection with the resolution of a U.S. government investigation concerning independent copay assistance organizations that provide financial assistance to Medicare patients, in 2018, we entered into a Corporate Integrity Agreement (CIA) with the Office of the Inspector General of the HHS (OIG), which expired in May 2023.
Further regulatory agency requirements may result in a more challenging, expensive and lengthy regulatory approval process than anticipated due to requests for, among other things, additional or more extensive clinical trials prior to granting approval, or increased post-approval requirements.
Regulatory requirements may also result in a more challenging, expensive and lengthy regulatory approval process than anticipated due to requests for, among other things, additional or more extensive clinical trials prior Pfizer Inc. 2023 Form 10-K 20 to granting approval, or increased post-approval requirements.
If one of our marketed products (or a product of our collaboration/licensing partners) is found to infringe valid patent rights of a third party, such third party may be awarded significant damages or royalty payments, or we may be prevented from further sales of that product.
If one of our marketed products (or a product of our Pfizer Inc. 2023 Form 10-K 22 collaboration/licensing partners to which we have licenses or co-promotion rights) is found to infringe valid patent rights of a third party, such third party may be awarded significant damages or royalty payments, or we may be prevented from further sales of that product.
MARKET FLUCTUATIONS IN OUR EQUITY AND OTHER INVESTMENTS Changes in the fair value of certain equity investments need to be recognized in net income that may result in increased volatility of our income. For additional information, see Note 4 and the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risk section within MD&A.
Pfizer Inc. 2023 Form 10-K 25 MARKET FLUCTUATIONS IN OUR EQUITY AND OTHER INVESTMENTS Changes in the fair value of certain equity investments that are recognized in net income may result in increased volatility of our income. See Note 4 and the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risk section within MD&A.
A reduction of U.S. federal spending on entitlement programs, including Medicare and Medicaid, may affect payment for our products or services provided using our products. Any other significant spending reductions or cost controls affecting Medicare, Medicaid or other publicly funded or subsidized health programs that may be implemented could have an adverse impact on our results of operations.
Any other significant spending reductions or cost controls affecting Medicare, Medicaid or other publicly funded or subsidized health programs that may be implemented could have an adverse impact on our results of operations.
Our currently pending or future patent applications may not result in issued patents or be granted on a timely basis. Similarly, any term extensions that we seek may not be granted on a timely basis, if at all.
Our currently pending or future patent applications may not result in issued patents or be granted on a timely basis.
(including, among other things, the recently enacted IRA, changes in laws and regulations or their interpretation, including, among others, the adoption of global minimum taxation requirements outside the U.S. and potential changes to existing tax law by the current U.S. Presidential administration and Congress), competition laws, privacy laws and environmental laws in the U.S. and other countries.
(including, among other things, the IRA, changes in laws and regulations or their interpretation, including, among others, the adoption of global minimum taxation requirements outside the U.S. generally effective in most jurisdictions since January 1, 2024 and potential changes to existing tax law by the current U.S.
Item 1. Business–– Government Regulation and Price Constraints section in this Form 10-K.
Item 1. Business––Government Regulation and Price Constraints section.
Pfizer Inc. 2022 Form 10-K 18 We and certain of our subsidiaries are also subject to numerous contingencies arising in the ordinary course of business relating to legal claims and proceedings, including environmental contingencies.
Pfizer submitted its final annual report and is awaiting a response from the OIG. We and certain of our subsidiaries are also subject to numerous contingencies arising in the ordinary course of business relating to legal claims and proceedings, including environmental contingencies.
Such risks and uncertainties include, in particular, our ability to realize the projected benefits of our cost-reduction and productivity initiatives, other corporate strategic initiatives and any acquisitions, divestitures or other initiatives, as well as potential disruption of ongoing business. INTANGIBLE ASSETS, GOODWILL AND EQUITY-METHOD INVESTMENTS Our consolidated balance sheet contains significant amounts of intangible assets, including IPR&D and goodwill.
Such risks and uncertainties include, in particular, our ability to realize the projected benefits of our cost-reduction and productivity initiatives, including our enterprise-wide cost realignment program, other corporate strategic initiatives and any acquisitions, divestitures or other initiatives, as well as potential disruption of ongoing business, such as potential impacts on our ability to deliver on our pipeline as planned.
For these and other reasons discussed in this Risk Factors section, we may not obtain the approvals we expect within the timeframe we anticipate, or at all. POST-AUTHORIZATION/APPROVAL DATA As a condition to granting marketing authorization or approval of a product, the FDA may require additional clinical trials or other studies.
For these and other reasons discussed in this Risk Factors section, we may not obtain the approvals we expect within the timeframe we anticipate, or at all.
We maintain cyber liability insurance; however, this insurance may not be sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of our systems.
We maintain cyber liability insurance; however, this insurance may not be sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of our systems. Artificial intelligence-based software is increasingly being used in the biopharmaceutical and global healthcare industries. As with many developing technologies, artificial intelligence-based software presents risks and challenges.
Pfizer Inc. 2022 Form 10-K 17 We may not be able to receive or maintain favorable recommendations by technical or advisory committees, such as the ACIP or any FDA Advisory Committee that may be convened to review our applications such as EUAs, NDAs or BLAs, which may impact the potential marketing and use of our products.
We may not be able to receive or maintain favorable recommendations by technical or advisory committees, such as the ACIP or an FDA Advisory Committee, which may impact the availability or commercial potential of our products and product candidates.
For additional information, including information regarding certain legal proceedings in which we are involved in, see Note 16A . RISKS RELATED TO INTELLECTUAL PROPERTY, TECHNOLOGY AND SECURITY: INTELLECTUAL PROPERTY PROTECTION Our success largely depends on our ability to market technologically competitive products.
RISKS RELATED TO INTELLECTUAL PROPERTY, TECHNOLOGY AND SECURITY: INTELLECTUAL PROPERTY PROTECTION Our success largely depends on our ability to market technologically competitive products.
Our pension benefit obligations and postretirement benefit obligations are subject to volatility from changes in the fair value of equity investments and other investment risk in the assets funding these plans. For additional information, see the Significant Accounting Policies and Application of Critical Accounting Estimates and Assumptions — Benefit Plans section within MD&A and Note 11 .
Our pension benefit obligations and postretirement benefit obligations are subject to volatility from changes in the fair value of equity investments and other investment risk in the assets funding these plans, as well as changes in the appropriate discount rate.
Amounts recorded for legal and environmental contingencies can result from a complex series of judgments about future events and uncertainties and can rely heavily on estimates and assumptions. While we have accrued for worldwide legal liabilities, no guarantee exists that additional costs will not be incurred or additional payments will not be required beyond the amounts accrued.
Amounts recorded for legal and environmental contingencies can result from a complex series of judgments about future events and uncertainties and can rely heavily on estimates and assumptions.
GENERAL RISKS BUSINESS DEVELOPMENT ACTIVITIES One enabler of our growth strategy is to expand our in-line products and product pipeline through various forms of business development, which can include alliances, licenses, JVs, collaborations, equity- or debt-based investments, dispositions, divestments, mergers and acquisitions.
GENERAL RISKS BUSINESS DEVELOPMENT ACTIVITIES AND STRATEGIC GOALS We have established significant growth goals, which we plan to achieve, in part, by not only advancing our own product pipelines and maximizing the value of our existing products, but also through various forms of business development activities, which can include alliances, licenses, JVs, collaborations, equity- or debt-based investments, dispositions, divestments, mergers and acquisitions.
COVID-19 COVID-19 has impacted and may continue to impact our business, operations and financial condition and results.
PANDEMICS Pandemics, such as the COVID-19 pandemic, have impacted and may in the future impact our business, operations and financial condition and results.
CLIMATE CHANGE AND SUSTAINABILITY Pfizer is subject to transitional and physical risks related to climate change.
Certain of these risks and uncertainties also apply to our COVID-19 and influenza diagnostic tests. CLIMATE CHANGE AND SUSTAINABILITY Pfizer is subject to transitional and physical risks related to climate change.
For IPR&D assets, the risk of failure is significant, and there can be no certainty that these assets ultimately will yield successful products. Our ability to realize value on these significant investments is often contingent upon, among other things, regulatory approvals and market acceptance.
INTANGIBLE ASSETS, GOODWILL AND EQUITY-METHOD INVESTMENTS Our consolidated balance sheet contains significant amounts of intangible assets, including IPR&D and goodwill. For IPR&D assets, the risk of failure is significant, and there can be no certainty that these assets ultimately will yield successful products.
We may fail to generate expected revenue growth for an acquired product or business or we may fail to achieve anticipated cost savings within expected time frames or at all.
We may fail to generate expected revenue growth for our existing products, product pipeline and contribution from these transactions or from acquired products or businesses or we may fail to achieve anticipated cost savings, such as those expected with respect to Seagen, within expected time frames or at all, which may impact our ability to meet our growth objectives.
DEVELOPMENT, REGULATORY APPROVAL AND MARKETING OF PRODUCTS The discovery and development of drugs, vaccines and biological products are time consuming, costly and unpredictable.
Even if favorable coverage and reimbursement status is attained for one or more products, less favorable coverage policies and reimbursement rates may be implemented in the future. DEVELOPMENT, REGULATORY APPROVAL AND MARKETING OF PRODUCTS The discovery and development of drugs, vaccines and biological products are time consuming, costly and unpredictable.
As such, IPR&D assets may become impaired and/or be written off in the future if the associated R&D effort is abandoned or is curtailed.
Our ability to realize value on these significant investments is often contingent upon, among other things, regulatory approvals and market acceptance. As such, IPR&D assets may become impaired and/or be written off in the future if the associated R&D effort is abandoned or is curtailed. See Note 4 for a discussion of recent impairments of IPR&D assets .
The success of our business development transactions depends on our ability to realize the anticipated benefits of the transaction and is subject to numerous risks and uncertainties, many of which are outside of our control. Unsuccessful clinical trials, regulatory hurdles and commercialization challenges may adversely impact revenue and income contribution from acquired products and businesses.
Unsuccessful clinical trials, regulatory hurdles and commercialization challenges, among other factors, may adversely impact revenue and income contribution from business development transactions, including from acquired products and businesses.
The potential regulatory and commercial implications of post-marketing study results typically cannot immediately be determined. For example, in December 2021, in light of the results from the completed required postmarketing safety study of Xeljanz, ORAL Surveillance (A3921133), the U.S. label for Xeljanz was revised.
The potential regulatory and commercial implications of post-marketing study results typically cannot immediately be determined.
Our supply chain is likely subject to these same transitional and physical risks and would likely pass along any increased costs to us. We do not anticipate that these risks will have a material financial impact to the company in the near term.
For additional details on the impact of the tornado in Rocky Mount, NC, see the Overview of Our Performance, Operating Environment, Strategy and Outlook — Our Operating Environment section within MD&A. Our supply chain is subject to these same transitional and physical risks and would likely pass along any increased costs to us.
The results generated in these trials could result in the loss of marketing approval, changes in labeling, and/or new or increased concerns about the side effects, efficacy or safety. Regulatory agencies in countries outside the U.S. often have similar regulations and may impose comparable requirements.
The results generated in these trials have in the past impacted certain of our products and could impact our products in the future, such as by resulting in the loss of marketing approval, changes in labeling, and/or new or increased concerns about safety and/or efficacy, including newly discovered adverse events.
Removed
In addition, in November 2022, the EMA concluded their assessment of JAK inhibitors authorized for inflammatory diseases in the EU, including Xeljanz and Cibinqo, and recommended that risk minimization measures, including special warnings and precautions for use, should be revised and harmonized for all such JAK inhibitors.
Added
Any additional reduction of U.S. federal spending on entitlement programs beyond the IRA, including Medicare and Medicaid, may affect payment for our products or services provided using our products.
Removed
The resulting label changes are expected to be finalized in the first quarter of 2023. We continue to work with regulatory agencies worldwide to review the full results and analyses of ORAL Surveillance and their impact on product labeling.
Added
The IRA will be implemented largely through government guidance and as its effect on Medicare and commercial markets evolve, we will continue to evaluate the potential impacts to our business. We expect additional cost containment measures at both the federal and state levels as efforts to reduce drug costs continue.
Removed
In the CIA, we agreed to implement and/or maintain certain compliance program elements to promote compliance with federal healthcare program requirements. Breaches of the CIA could result in severe sanctions against us.
Added
Further, commercial payors often follow Medicare coverage policy and payment limitations when setting their own payment rates. Any reduction in cost or other containment measures may similarly be adopted by commercial plans. Coverage policies and reimbursement rates for commercial plans may change at any time.
Removed
COVID-19-related risks and challenges for our business, include, among others: decreased product demand, due to reduced new prescriptions or refills of existing prescriptions and reduced demand for products used in procedures, or as a result of unemployment or increased focus on COVID-19 vaccination; impacts due to travel limitations and mobility restrictions in some jurisdictions; manufacturing disruptions and delays; supply chain disruptions and shortages, including challenges related to reliance on third-party suppliers resulting in reduced availability of materials or components used in the development, manufacturing, distribution or administration of our products; disruptions to pipeline development and clinical trials, including challenges related to enrolling certain clinical trials and accruing a sufficient number of cases in certain clinical trials; challenges presented by reallocating resources to assist in responding to COVID-19; costs associated with COVID-19, including increased supply chain costs and additional R&D costs incurred in our efforts to develop Comirnaty and Paxlovid; challenges related to our business Pfizer Inc. 2022 Form 10-K 20 development initiatives; interruptions or delays in the operations of regulatory authorities, which may delay potential approval of new products we are developing, potential label expansions for existing products and the launch of newly-approved products; challenges operating in a virtual or hybrid work environment; increased cyber threats and attack attempts; challenges related to our intellectual property, both domestically and internationally, including in response to any pressure, or legal or regulatory action by, various stakeholders or governments that could potentially result in us not seeking intellectual property protection for or agreeing not to enforce or being restricted from enforcing intellectual property rights related to our products, including Comirnaty and Paxlovid; challenges related to conducting oversight and monitoring of regulated activities in a virtual or hybrid environment; challenges related to our human capital and talent development; challenges related to vaccine mandates; and other challenges presented by disruptions to our normal operations in response to COVID-19, as well as uncertainties regarding the impact of COVID-19, and government or regulatory actions to contain the virus or control the supply of medicines and vaccines.
Added
Also, certain of our products have received and may in the future receive approvals under accelerated approval pathways where continued approval may be contingent upon confirmatory studies demonstrating the anticipated clinical benefit and/or safety profile.
Removed
In particular, we believe the ultimate impact on our business, operations and financial condition and results will be affected by, among other things, the emergence, infectiousness and severity of the predominant strains of the SAR-CoV-2 virus, the safety, efficacy, availability and public adherence of vaccines, boosters and treatments for COVID-19, proportion of the population that receives a vaccine or treatment for COVID-19, patient demand and market share for Comirnaty and Paxlovid, timing for delivery, and potential other amendments to the terms, of contracted doses or treatment courses to certain markets, timing and effectiveness for the expected transition to the commercial market for Comirnaty and Paxlovid, the global macroeconomic impact of COVID-19 and governmental responses or regulatory actions to contain the virus or control supply of medicines and vaccines.
Added
POST-AUTHORIZATION/APPROVAL DATA As a condition to granting marketing authorization or approval of a product, the FDA may require, or the sponsor may voluntarily agree to undertake, post-marketing commitments such as additional clinical trials or other studies.
Added
Regulatory agencies in countries outside the U.S. often have similar regulations and may impose comparable requirements, although there are differences between the U.S., the EU and other international regulatory requirements, which may contribute to inconsistency or uncertainty in the marketability of our products across different jurisdictions.
Added
In the FDA’s revision to the EUA for Paxlovid, the FDA removed the post-authorization requirements as they were addressed as a post-marketing commitment associated with the approval of the Paxlovid NDA.
Added
While we have accrued for Pfizer Inc. 2023 Form 10-K 21 worldwide legal liabilities, no guarantee exists that additional costs will not be incurred or additional payments will not be required beyond the amounts accrued. For additional information, including information regarding certain legal proceedings in which we are involved in, see Note 16A .
Added
Similarly, any term extensions that we seek may not be granted on a timely basis, if at all, and any term adjustments related to patent office delays in obtaining a patent may be reduced or eliminated entirely due to risks associated with changes in law relating to patent terms.
Added
For example, algorithms may be flawed; data sets may be insufficient, of poor quality, or contain biased information; and inappropriate or controversial data practices by data scientists, engineers, and end-users could impair results.
Added
If the analyses that artificial intelligence-based applications assist in producing are deficient or inaccurate, we could be subjected to competitive harm, potential legal liability and brand or reputational harm. Furthermore, use of artificial intelligence-based software may lead to the release of confidential information which may impact our ability to realize the benefits of our intellectual property.
Added
Our recent acquisition of Seagen is part of that growth plan. We view our business development activity as an enabler of our strategies and seek to generate growth by pursuing opportunities and transactions that have the potential to strengthen our business and our capabilities.
Added
We have incurred substantial indebtedness to fund our recent acquisition of Seagen. We financed a portion of the transaction with the proceeds from the $31 billion of long-term debt issued in May 2023, plus $8 billion in additional short-term indebtedness issued prior to the acquisition.
Added
The amount of debt that we have incurred could have significant consequences including, among other things, reducing our operating or financial flexibility, requiring a portion of our cash flow from operations to make interest payments and reducing the cash flow available to fund capital expenditures and other corporate purposes and to grow our business.
Added
To the extent we incur additional indebtedness or interest rates increase, these risks could increase further. The success of our business development transactions, including our recent acquisition of Seagen, depends on our ability to realize the anticipated benefits of these transactions and is subject to numerous risks and uncertainties, many of which are outside of our control.
Added
Related risks and challenges for our business include, among others: uncertainty regarding the severity and duration of a pandemic; impacts to business operations; decreased demand for certain of our products; increased costs of doing business; manufacturing disruptions and delays; supply chain disruptions and shortages, including challenges related to reliance on third-party suppliers resulting in reduced availability of materials or components used in the development, manufacturing, distribution or administration of our products; evolving macroeconomic factors and conditions, including general economic uncertainty, unemployment rates and recessionary pressures; changes in labor markets, including challenges related to our human capital and talent development; unknown consequences on our business performance and initiatives stemming from the substantial investment of time and other resources to any potential pandemic response; increased difficulty and uncertainty regarding predicting or estimating future performance; pace of post-pandemic recovery, disruption and volatility within the financial or credit markets; and our financial performance in general.
Added
For example, our manufacturing facility in Rocky Mount, NC was damaged by a tornado in July 2023. While manufacturing has resumed, the supply of medicines impacted by the tornado is expected to be affected through 2024.
Added
See the Significant Accounting Policies and Application of Critical Accounting Estimates and Assumptions — Benefit Plans section within MD&A and Note 11 .

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeEU JAPAN Myfembree (relugolix, estradiol, and norethindrone acetate) (a) Heavy menstrual bleeding associated with uterine fibroids Approved May 2021 Moderate to severe pain associated with endometriosis Approved Aug. 2022 Ngenla (somatrogon) (b) Pediatric growth hormone deficiency Filed Jan. 2021 Approved Feb. 2022 Approved Jan. 2022 Prevnar 20/Apexxnar (Vaccine) (c) Active immunization to prevent invasive disease caused by Streptococcus pneumoniae serotypes (adults) Approved June 2021 Approved Feb. 2022 TicoVac (Vaccine) Active immunization to prevent tick-borne encephalitis disease Approved Aug. 2021 Paxlovid (d) (nirmatrelvir [PF-07321332]; ritonavir) COVID-19 in high-risk adults and children (12-18 years of age; >88lbs) EUA Dec. 2021 CMA Jan. 2022 Approved Feb. 2022 Nurtec ODT/Vydura (rimegepant) Acute treatment of migraine with or without aura (adults) Approved Feb. 2020 Approved Apr. 2022 Prevention of episodic migraine (adults) Approved May 2021 Approved Apr. 2022 ritlecitinib (PF-06651600) Alopecia areata Filed Sep. 2022 Filed Sep. 2022 Filed Sep. 2022 zavegepant (intranasal) Acute treatment of migraine Filed May 2022 PF-06886992 (Vaccine) Active immunization to prevent serogroups ABCWY meningococcal infections (adolescent and young adults) Filed Dec. 2022 PF-06928316 (Vaccine) Active immunization to prevent respiratory syncytial virus infection (maternal) Filed Feb. 2023 Filed Jan. 2023 Active immunization to prevent respiratory syncytial virus infection (older adults) Filed Dec. 2022 Filed Jan. 2023 etrasimod Ulcerative colitis (moderately to severely active) Filed Dec. 2022 Filed Nov. 2022 PF-06482077 (Vaccine) Active immunization to prevent invasive and non-invasive pneumococcal infections (pediatric) Filed Jan. 2023 elranatamab (PF-06863135) Multiple myeloma triple-class refractory Filed Feb. 2023 Filed Feb. 2023 * For the U.S., the filing date is the date on which the FDA accepted our submission.
Biggest changeEU JAPAN Ngenla (somatrogon) (a) Pediatric growth hormone deficiency Approved June 2023 Approved February 2022 Approved January 2022 Prevnar 20/Apexxnar (Vaccine) Active immunization to prevent pneumonia, invasive disease and otitis media caused by Streptococcus pneumoniae (adults) Approved June 2021 Approved February 2022 Filed September 2023 Active immunization to prevent pneumonia, invasive disease and otitis media caused by Streptococcus pneumoniae (pediatric) Approved April 2023 Filed November 2022 Filed March 2023 TicoVac (Vaccine) Active immunization to prevent tick-borne encephalitis disease Approved August 2021 Filed March 2023 Paxlovid (b ) (nirmatrelvir and ritonavir) COVID-19 in high-risk adults Approved May 2023 Approved February 2023 Approved July 2023 Nurtec ODT/Vydura (rimegepant) Acute treatment of migraine with or without aura (adults) Approved February 2020 Approved April 2022 Prevention of episodic migraine (adults) Approved May 2021 Approved April 2022 Litfulo/Ritfulo (ritlecitinib) Alopecia areata Approved June 2023 Approved September 2023 Approved June 2023 Zavzpret (zavegepant) (intranasal) Acute treatment of migraine with or without aura (adults) Approved March 2023 Penbraya (PF-06886992) (Vaccine) Active immunization to prevent serogroups ABCWY meningococcal infections (adolescent and young adults) Approved October 2023 Filed June 2023 Abrysvo (Vaccine) Active immunization to prevent RSV infection (maternal) Approved August 2023 Approved August 2023 Approved January 2024 Active immunization to prevent RSV infection (older adults) Approved May 2023 Approved August 2023 Filed May 2023 Velsipity (etrasimod) Ulcerative colitis (moderately to severely active) Approved October 2023 Approved February 2024 Braftovi (encorafenib) and Mektovi (binimetinib) BRAF V600E -mutant metastatic non-small cell lung cancer Approved October 2023 Filed October 2023 (c) Elrexfio (elranatamab) Multiple myeloma triple-class relapsed/refractory Approved August 2023 Approved December 2023 Filed June 2023 Talzenna (talazoparib) Combination with Xtandi (enzalutamide) for adult patients with homologous recombination repair (HRR) gene-mutated mCRPC (d) Approved June 2023 Approved January 2024 Approved January 2024 Treatment of BRCA gene-mutated, HER2-negative, inoperable or recurrent breast cancer who have been treated with cancer chemotherapy Approved October 2018 Approved June 2019 Approved January 2024 fidanacogene elaparvovec (PF-06838435) (e) Hemophilia B (adults) Filed June 2023 Filed May 2023 Xtandi (enzalutamide) (f) nmCSPC with biochemical recurrence at high risk for metastasis (high-risk BCR) Approved November 2023 Filed September 2023 marstacimab (PF-06741086) Hemophilia A and B Filed December 2023 Filed October 2023 aztreonam-avibactam (g) (PF-06947387) Treatment of infections caused by Gram-negative bacteria with limited or no treatment options Filed September 2023 Padcev (enfortumab vedotin-ejfv) (h) In combination with Keytruda (i) (pembrolizumab) for locally advanced or metastatic urothelial cancer (adults) Approved December 2023 Filed January 2024 Filed January 2024 Tivdak (tisotumab vedotin-tftv) (j) Recurrent or metastatic cervical cancer with disease progression on or after first-line therapy Filed (k) January 2024 Filed February 2024 Tukysa (tucatinib) In combination with trastuzumab for HER2-positive metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy Approved January 2023 Pfizer Inc. 2023 Form 10-K 42 * For the U.S., the filing date is the date on which the FDA accepted our submission.
The discount rate used to measure the plan obligations for our international plans is determined at least annually by reference to investment grade corporate bonds, rated AA/Aa or better, including, when there is sufficient data, a yield-curve approach. These discount rate determinations are made in consideration of local requirements.
The discount rate used to measure the plan obligations for our significant international plans is determined at least annually by reference to investment grade corporate bonds, rated AA/Aa or better, including, when there is sufficient data, a yield-curve approach. These discount rate determinations are made in consideration of local requirements.
Gains and losses on equity securities, and pension and postretirement actuarial remeasurement gains and losses have a very high degree of inherent market volatility, which we do not control and cannot predict with any level of certainty and because we do not believe including these gains and losses assists investors in understanding our business or is reflective of our core operations and business.
Gains and losses on equity securities and pension and postretirement actuarial remeasurement gains and losses have a very high degree of inherent market volatility, which we do not control and cannot predict with any level of certainty, and we do not believe including these gains and losses assists investors in understanding our business or is reflective of our core operations and business.
MILLIONS, EXCEPT PER SHARE DATA Cost of sales (a) Selling, informational and administrative expenses (a) Other (income)/deductions––net (a) Net income attributable to Pfizer Inc. common shareholders (a), (b), (c) Earnings per common share attributable to Pfizer Inc. common shareholders––diluted GAAP Reported $ 34,344 $ 13,677 $ 217 $ 31,372 $ 5.47 Amortization of intangible assets — — — 3,609 Acquisition-related items (119) (7) (74) 832 Discontinued operations (d) — — — (21) Certain significant items: Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring (e) (88) (562) — 1,396 Certain asset impairments (f) — — (421) 421 (Gains)/losses on equity securities (f) — — (1,270) 1,270 Actuarial valuation and other pension and postretirement plan (gains)/losses — — 230 (230) Other (40) (59) (636) (g) 752 Income tax provision—Non-GAAP items (1,683) Non-GAAP Adjusted $ 34,096 $ 13,049 $ (1,954) $ 37,717 $ 6.58 Pfizer Inc. 2022 Form 10-K 40 Year Ended December 31, 2021 Data presented will not (in all cases) aggregate to totals.
MILLIONS, EXCEPT PER SHARE DATA Cost of sales (a) Selling, informational and administrative expenses (a) Other (income)/deductions––net (a) Net income attributable to Pfizer Inc. common shareholders (a), (b), (c) Earnings per common share attributable to Pfizer Inc. common shareholders––diluted GAAP Reported $ 34,344 $ 13,677 $ 217 $ 31,372 $ 5.47 Amortization of intangible assets — — — 3,609 Acquisition-related items (119) (7) (74) 832 Discontinued operations (d) — — — (21) Certain significant items: Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring (e) (88) (562) — 1,396 Certain asset impairments (f) — — (421) 421 (Gains)/losses on equity securities (f) — — (1,270) 1,270 Actuarial valuation and other pension and postretirement plan (gains)/losses — — 230 (230) Other (40) (59) (636) (h) 752 Income tax provision—Non-GAAP items (1,683) Non-GAAP Adjusted $ 34,096 $ 13,049 $ (1,954) $ 37,717 $ 6.58 Pfizer Inc. 2023 Form 10-K 45 Year Ended December 31, 2021 Data presented will not (in all cases) aggregate to totals.
Pension Plans Expected annual rate of return on plan assets 7.5 % 6.3 % 6.8 % Actual annual rate of return on plan assets (22.4) 9.2 14.1 Discount rate used to measure the plan obligations 5.4 2.9 2.6 International Pension Plans Expected annual rate of return on plan assets 4.5 3.1 3.4 Actual annual rate of return on plan assets (26.0) 11.4 9.7 Discount rate used to measure the plan obligations 3.8 1.6 1.5 (a) For detailed assumptions associated with our benefit plans, see Note 11B .
Pension Plans Expected annual rate of return on plan assets 8.0 % 7.5 % 6.3 % Actual annual rate of return on plan assets 10.4 (22.4) 9.2 Discount rate used to measure the plan obligations 5.4 5.4 2.9 International Pension Plans Expected annual rate of return on plan assets 5.1 4.5 3.1 Actual annual rate of return on plan assets (4.6) (26.0) 11.4 Discount rate used to measure the plan obligations 4.4 3.8 1.6 (a) For detailed assumptions associated with our benefit plans, see Note 11B .
The following provides (i) at the end of each year, the expected annual rate of return on plan assets for the following year, (ii) the actual annual rate of return on plan assets achieved in each year, and (iii) the weighted-average discount rate used to measure the benefit obligations at the end of each year for our U.S. pension plans and our international pension plans (a) : 2022 2021 2020 U.S.
The following provides (i) at the end of each year, the expected annual rate of return on plan assets for the following year, (ii) the actual annual rate of return on plan assets achieved in each year, and (iii) the weighted-average discount rate used to measure the benefit obligations at the end of each year for our U.S. pension plans and our international pension plans (a) : 2023 2022 2021 U.S.
Diverse sources of funds: Related disclosure presented in this Form 10-K Internal sources: • Operating cash flows Consolidated Statements of Cash Flows – Operating Activities and the Analysis of the Consolidated Statements of Cash Flows within MD&A • Cash and cash equivalents Consolidated Balance Sheets • Money market funds Note 7A • Available-for-sale debt securities Note 7A , 7B External sources: Short-term funding: • Commercial paper Note 7C • Revolving credit facilities Note 7C • Lines of credit Note 7C Long-term funding: • Long-term debt Note 7D • Equity Consolidated Statements of Equity and Note 12 For additional information about the sources and uses of our funds and capital resources for the years ended December 31, 2022 and 2021, see the Analysis of the Consolidated Statements of Cash Flows in this MD&A.
Diverse sources of funds: Related disclosure presented in this Form 10-K Internal sources: • Operating cash flows Consolidated Statements of Cash Flows – Operating Activities and the Analysis of the Consolidated Statements of Cash Flows section within MD&A • Cash and cash equivalents Consolidated Balance Sheets • Money market funds Note 7A • Available-for-sale debt securities Note 7A , 7B • Equity investments Note 7A , 7B External sources: Short-term funding: • Commercial paper Note 7C • Revolving credit facilities Note 7C • Lines of credit Note 7C Long-term funding: • Long-term debt Note 7D • Equity Consolidated Statements of Equity and Note 12 For additional information about the sources and uses of our funds and capital resources for the years ended December 31, 2023 and 2022, see the Analysis of the Consolidated Statements of Cash Flows section within MD&A.
Income Tax Assets and Liabilities Income tax assets and liabilities include income tax valuation allowances and accruals for uncertain tax positions. For additional information, see Notes 1Q and 5 , as well as the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risk section within MD&A .
Income Tax Assets and Liabilities Income tax assets and liabilities include income tax valuation allowances and accruals for uncertain tax positions. See Notes 1Q and 5 , as well as the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risk section within MD&A .
See the Reconciliations of GAAP Reported to Non-GAAP Adjusted Information––Certain Line Items below for a non-inclusive list of certain significant items. Reconciliations of GAAP Reported to Non-GAAP Adjusted Information––Certain Line Items Year Ended December 31, 2022 Data presented will not (in all cases) aggregate to totals.
See the Reconciliations of GAAP Reported to Non-GAAP Adjusted Information––Certain Line Items below for a non-inclusive list of certain significant items. Reconciliations of GAAP Reported to Non-GAAP Adjusted Information––Certain Line Items Year Ended December 31, 2023 Data presented will not (in all cases) aggregate to totals.
Our significant contractual and other obligations as of December 31, 2022 consisted of: • Long-term debt, including current portion (see Note 7D ) and related interest payments; • Estimated cash payments related to the TCJA repatriation estimated tax liability (see Note 5 ).
Our significant contractual and other obligations as of December 31, 2023 consisted of: • Long-term debt, including current portion (see Note 7D ) and related interest payments; • Estimated cash payments related to the TCJA repatriation estimated tax liability (see Note 5 ).
In connection with transforming our commercial go-to market strategy, we expect net cost savings of $1.4 billion, to be achieved primarily from 2022 through 2024. In connection with manufacturing network optimization, we expect net cost savings of $550 million to be achieved primarily from 2020 through 2023.
In connection with transforming our commercial go-to market strategy, we expect net cost savings of $1.4 billion, to be achieved primarily from 2022 through 2024. In connection with manufacturing network optimization, we achieved net cost savings of $550 million.
Restatements due to discontinued operations do not impact compensation or change the Adjusted income measure for the compensation in respect of the restated periods, but are presented for consistency across all periods. Certain Significant Items –– Adjusted income continues to exclude certain significant items representing substantive and/or unusual items that are evaluated individually on a quantitative and qualitative basis.
Restatements due to discontinued operations do not impact compensation or change the Adjusted income measure for the compensation in respect of the restated periods, but are presented for consistency across all periods. Certain Significant Items –– Adjusted income excludes certain significant items representing substantive and/or unusual items that are evaluated individually on a quantitative and qualitative basis.
For 2021, the total of $334 million primarily included (i) charges of $185 million mostly representing our equity-method accounting pro rata share of restructuring charges and costs of preparing for separation from GSK recorded by the Consumer Healthcare JV, and (ii) charges of $162 million for certain legal matters, primarily for c ertain product liability expenses related to products discontinued and/or divested by Pfizer, and to a lesser extent, legal obligations related to pre-acquisition commitments .
For 2021, the total of $334 million included charges of (i) $185 million mostly representing our equity-method accounting pro rata share of restructuring charges and costs of separating from GSK recorded by the Consumer Healthcare JV, and (ii) $162 million for certain legal matters, primarily for c ertain product liability expenses related to products discontinued and/or divested by Pfizer, and to a lesser extent, legal obligations related to pre-acquisition matters .
(g) For 2022, the total of $636 million primarily includes (i) charges of $307 million mostly representing our equity-method accounting pro rata share of restructuring charges and costs of preparing for separation from GSK recorded by Haleon/the Consumer Healthcare JV, and adjustments to our equity-method basis differences which are also related to the separation of Haleon/the Consumer Healthcare JV from GSK, and (ii) charges of $230 million for certain legal matters, primarily for c ertain product liability and other expenses related to products discontinued and/or divested by Pfizer .
For 2022, the total of $636 million included charges of (i) $307 million mostly representing our equity-method accounting pro rata share of restructuring charges and costs of separating from GSK recorded by Haleon/the Consumer Healthcare JV, and adjustments to our equity-method basis differences which are also related to the separation of Haleon/the Consumer Healthcare JV from GSK, and (ii) $230 million for certain legal matters, primarily representing c ertain product liability and other legal expenses related to products discontinued and/or divested by Pfizer .
Item 1A. Risk Factors sections in this Form 10-K. Benefit Plans For a description of our different benefit plans, see Note 11 . Our assumptions reflect our historical experiences and our judgment regarding future expectations that have been deemed reasonable by management. The judgments made in determining the costs of our benefit plans can materially impact our results of operations.
Item 1A. Risk Factors sections. Benefit Plans For a description of our different benefit plans, see Note 11 . Our assumptions reflect our historical experiences and our judgment regarding future expectations that have been deemed reasonable by management. The judgments made in determining the costs of our benefit plans can materially impact our results of operations.
Pfizer Inc. 2022 Form 10-K 42 Credit Ratings ––The cost and availability of financing are influenced by credit ratings, and an increase or decrease in our credit rating could have a beneficial or adverse effect on financing. Our long-term debt is rated high-quality by both S&P and Moody’s.
Pfizer Inc. 2023 Form 10-K 47 Credit Ratings ––The cost and availability of financing are influenced by credit ratings, and an increase or decrease in our credit rating could have a beneficial or adverse effect on financing. Our long-term debt is rated high-quality by both S&P and Moody’s.
In this analysis, holding all other assumptions constant and assuming that a change in one currency’s rate relative to the U.S. dollar would not have any effect on another currency’s rates relative to the U.S. dollar, if the dollar were to appreciate against all other currencies by 10%, as of December 31, 2022, the expected adverse impact on our net income would not be significant.
In this analysis, holding all other assumptions constant and assuming that a change in one currency’s rate relative to the U.S. dollar would not have any effect on another currency’s rates relative to the U.S. dollar, if the dollar were to move against all other currencies by 10%, as of December 31, 2023, the expected impact on our net income would not be significant.
Contingencies We and certain of our subsidiaries are subject to numerous contingencies arising in the ordinary course of business, including tax, legal contingencies and guarantees and indemnifications. For additional information, see Notes 1Q , 1S , 5D and 16 .
Contingencies We and certain of our subsidiaries are subject to numerous contingencies arising in the ordinary course of business, including tax and legal contingencies, guarantees and indemnifications. See Notes 1Q , 1S , 5D and 16 .
For information about our effective tax rate and the events and circumstances contributing to the changes between periods, as well as details about discrete elements that impacted our tax provisions, see Note 5 . Discontinued Operations For information about our discontinued operations, see Note 2B .
For information about our effective tax rate and the events and circumstances contributing to the changes between periods, as well as details about discrete elements that impacted our tax provisions, see Note 5 .
See the Overview of Our Performance, Operating Environment, Strategy and Outlook — Our Business and Strategy section of this MD&A. Our current and projected dividends provide a return to shareholders while maintaining sufficient capital to invest in growing our business. Our dividends are not restricted by debt covenants.
See the Overview of Our Performance, Operating Environment, Strategy and Outlook — O ur Business and Strategy section within MD&A. Our current and projected dividends provide a return to shareholders while maintaining sufficient capital to invest in growing our business. Our dividends are not restricted by debt covenants.
In this analysis, holding all other assumptions constant and assuming a parallel shift in the interest rate curve for all maturities and for all instruments, if there were a one hundred basis point decrease in interest rates as of December 31, 2022, the expected adverse impact on our net income would not be significant.
In this analysis, holding all other assumptions constant and assuming a parallel shift in the interest rate curve for all maturities and for all instruments, if there were a one hundred basis point change in interest rates as of December 31, 2023, the expected impact on our net income would not be significant.
Pfizer Inc. 2022 Form 10-K 41 ANALYSIS OF THE CONSOLIDATED STATEMENTS OF CASH FLOWS For a discussion of the drivers of change for 2021 versus 2020 as well as cash flows from discontinued operations in 2020, see the Analysis of the Consolidated Statements of Cash Flows section within MD&A in our 2021 Form 10-K.
Pfizer Inc. 2023 Form 10-K 46 ANALYSIS OF THE CONSOLIDATED STATEMENTS OF CASH FLOWS For a discussion of the drivers of change for 2022 versus 2021 as well as cash flows from discontinued operations in 2021, see the Analysis of the Consolidated Statements of Cash Flows section within MD&A in our 2022 Form 10-K.
Estimated future payments related to the TCJA repatriation tax liability that will occur after December 31, 2022 total $7.0 billion, of which an estimated $1.0 billion is to be paid in the next twelve months and an estimated $6.0 billion is to be paid in periods thereafter.
Estimated future payments related to the TCJA repatriation tax liability that will occur after December 31, 2023 total $6.0 billion, of which an estimated $1.5 billion is to be paid in the next twelve months and an estimated $4.5 billion is to be paid in periods thereafter.
For more information on how we manage our foreign exchange and interest rate risks, see Notes 1 F and 7E , as well as the Item 1A. Risk Factors—Global Operations section in this Form 10-K for key currencies in which we operate. Our sensitivity analyses of such risks are discussed below.
For more information on how we manage our foreign exchange and interest rate risks, see Notes 1F and 7E , as well as the Item 1A. Risk Factors—Global Operations section for key currencies in which we operate. Our sensitivity analyses of such risks are discussed below.
Pfizer Inc. 2022 Form 10-K 35 The tables below include filing and approval milestones for products that have occurred in the last twelve months and generally do not include approvals that may have occurred prior to that time. The tables include filings with regulatory decisions pending (even if the filing occurred outside of the last twelve-month period).
The tables below include filing and approval milestones for products that have occurred in the last twelve months and generally do not include approvals that may have occurred prior to that time. The tables include filings with regulatory decisions pending (even if the filing occurred outside of the last twelve-month period).
Our obligations may vary as a result of changes in our uncertain tax positions and/or availability of attributes such as foreign tax and other credit carryforwards; • Certain commitments totaling $4.4 billion, of which an estimated $1.4 billion is to be paid in the next twelve months, and $3.0 billion in periods thereafter (see Note 16C ); • Purchases of property plant and equipment (see Note 9 ).
Our obligations may vary as a result of changes in our uncertain tax positions and/or availability of attributes such as foreign tax and other credit carryforwards; • Certain commitments totaling $5.2 billion, of which an estimated $1.3 billion is to be paid in the next twelve months, and $3.9 billion in periods thereafter (see Note 16C ); • Purchases of PP&E (see Note 9 ).
It does not include revenues for certain Comirnaty-related manufacturing activities performed on behalf of BioNTech, which are included in PC1. See Note 17C . * Indicates calculation not meaningful. See the Item 1.
It does not include revenues for certain Comirnaty-related manufacturing activities performed on behalf of BioNTech, which are included in PC1, which is part of the Business Innovation operating segment. See Note 17C . * Indicates calculation not meaningful. See the Item 1.
MILLIONS, EXCEPT PER SHARE DATA Cost of sales (a) Selling, informational and administrative expenses (a) Other (income)/deductions––net (a) Net income attributable to Pfizer Inc. common shareholders (a), (b) Earnings per common share attributable to Pfizer Inc. common shareholders––diluted GAAP Reported $ 30,821 $ 12,703 $ (4,878) $ 21,979 $ 3.85 Amortization of intangible assets — (38) (2) 3,746 Acquisition-related items 25 (3) (114) 139 Discontinued operations (d) — — — 585 Certain significant items: Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring (e) (108) (450) — 1,309 Certain asset impairments — — (86) 86 (Gains)/losses on equity securities (f) — — 1,338 (1,338) Actuarial valuation and other pension and postretirement plan (gains)/losses — — 1,601 (1,601) Other (52) (141) (h) (334) (g) 542 Income tax provision—Non-GAAP items (2,250) Non-GAAP Adjusted $ 30,685 $ 12,071 $ (2,475) $ 23,196 $ 4.06 Year Ended December 31, 2020 Data presented will not (in all cases) aggregate to totals.
MILLIONS, EXCEPT PER SHARE DATA Cost of sales (a) Selling, informational and administrative expenses (a) Other (income)/deductions––net (a) Net income attributable to Pfizer Inc. common shareholders (a), (b) Earnings per common share attributable to Pfizer Inc. common shareholders––diluted GAAP Reported $ 30,821 $ 12,703 $ (4,878) $ 21,979 $ 3.85 Amortization of intangible assets — (38) (2) 3,746 Acquisition-related items 25 (3) (114) 139 Discontinued operations (d) — — — 585 Certain significant items: Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring (e) (108) (450) — 1,309 Certain asset impairments — — (86) 86 (Gains)/losses on equity securities (f) — — 1,338 (1,338) Actuarial valuation and other pension and postretirement plan (gains)/losses — — 1,601 (1,601) Other (52) (141) (i) (334) (h) 542 Income tax provision—Non-GAAP items (2,250) Non-GAAP Adjusted $ 30,685 $ 12,071 $ (2,475) $ 23,196 $ 4.06 (a) Items that reconcile GAAP Reported to non-GAAP Adjusted balances are shown pre-tax.
(c) For 2022, the total acquisition-related items of $832 million include reconciling amounts for Restructuring charges and certain acquisition-related costs of $631 million , composed of $348 million of integration costs and other charges, $144 million of transaction costs and $138 million of employee termination-related charges. See Note 3 . (d) For information about discontinued operations, see Note 2B .
For 2022, the total acquisition-related items of $832 million included reconciling amounts for Restructuring charges and certain acquisition-related costs of $631 million , composed of $348 million of integration costs and other charges, $144 million of transaction costs and $138 million of employee termination-related charges. See Note 3 . (d) See Note 2B .
Business — Patents and Other Intellectual Property Rights section in this Form 10-K for information regarding the expiration of various patent rights, Note 16 for a discussion of recent developments concerning patent and product litigation relating to certain of the products discussed above and Note 17 C for additional information regarding the primary indications or class of the selected products discussed above.
Business — Patents and Other Intellectual Property Rights section for information regarding the expiration of various patent rights, Note 16 for a discussion of recent developments concerning patent and product litigation relating to certain of the products discussed above and Note 17C for the primary indications or class of the selected products discussed above.
Provision/(Benefit) for Taxes on Income Year Ended December 31, % Change (MILLIONS) 2022 2021 2020 22/21 21/20 Provision/(benefit) for taxes on income $ 3,328 $ 1,852 $ 370 80 * Effective tax rate on continuing operations 9.6 % 7.6 % 5.3 % * Indicates calculation not meaningful.
Provision/(Benefit) for Taxes on Income Year Ended December 31, % Change (MILLIONS) 2023 2022 2021 23/22 22/21 Provision/(benefit) for taxes on income $ (1,115) $ 3,328 $ 1,852 * 80 Effective tax rate on continuing operations (105.4) % 9.6 % 7.6 % * Indicates calculation not meaningful.
We have made no adjustments for resulting synergies. The significant costs incurred in connection with a business combination result primarily from the need to eliminate duplicate assets, activities or employees––a natural result of acquiring a fully integrated set of activities.
The significant costs incurred in connection with a business combination result primarily from the need to eliminate duplicate assets, activities or employees––a natural result of acquiring a fully integrated set of activities.
The following illustrates the sensitivity of net periodic benefit costs and benefit obligations to a 10 basis point decline in our assumption for the discount rate, holding all other assumptions constant (in millions, pre-tax): Assumption Change Decrease in 2023 Net Periodic Benefit Costs Increase to 2022 Benefit Obligations Discount rate 10 basis point decline $6 $248 The change in the discount rates used in measuring our plan obligations as of December 31, 2022 resulted in a decrease in the measurement of our aggregate plan obligations by approximately $6.6 billion.
Pfizer Inc. 2023 Form 10-K 35 The following illustrates the sensitivity of net periodic benefit costs and benefit obligations to a 10 basis point decline in our assumption for the discount rate, holding all other assumptions constant (in millions, pre-tax): Assumption Change Decrease in 2024 Net Periodic Benefit Costs Increase to 2023 Benefit Obligations Discount rate 10 basis point decline $5 $210 The change in the discount rates used in measuring our plan obligations as of December 31, 2023 resulted in a decrease in the measurement of our aggregate plan obligations by approximately $616 million.
In addition, total shareholder return, both on an absolute basis and relative to a publicly traded pharmaceutical index, plays a significant role in determining payouts under certain of our incentive compensation plans.
In addition, total shareholder return, both on an absolute basis and relative to a publicly traded pharmaceutical index, plays a significant role in determining payouts under certain of our incentive compensation plans. Adjusted Income and Adjusted Diluted EPS Amortization of Intangible Assets —Adjusted income excludes all amortization of intangible assets.
(h) For 2021 and 2020, the totals of $141 million and $292 million, respectively, primarily included costs for consulting, legal, tax and advisory services associated with a non-recurring internal reorganization of legal entities.
(i) For 2021, the total of $141 million primarily included costs for consulting, legal, tax and advisory services associated with a non-recurring internal reorganization of legal entities.
PRODUCT DEVELOPMENTS A comprehensive update of Pfizer’s development pipeline was published as of January 31, 2023 and is available at www.pfizer.com/science/drug-product-pipeline.
Pfizer Inc. 2023 Form 10-K 40 PRODUCT DEVELOPMENTS A comprehensive update of Pfizer’s development pipeline was published as of January 30, 2024 and is available at www.pfizer.com/science/drug-product-pipeline.
Pfizer Inc. 2022 Form 10-K 31 ANALYSIS OF THE CONSOLIDATED STATEMENTS OF INCOME Revenues by Geography The following presents worldwide revenues by geography: Year Ended December 31, % Change Worldwide U.S. International Worldwide U.S.
ANALYSIS OF THE CONSOLIDATED STATEMENTS OF INCOME Total Revenues by Geography The following presents worldwide Total revenues by geography: Year Ended December 31, % Change Worldwide U.S. International Worldwide U.S.
The following provides information about significant marketing application-related regulatory actions by, and filings pending with, the FDA and regulatory authorities in the EU and Japan.
This section provides information as of the date of this filing about significant marketing application-related regulatory actions by, and filings pending with, the FDA and regulatory authorities in the EU and Japan.
Investing activities from continuing operations $ (15,783) $ (22,534) $ (4,162) The change was driven mainly by a $17.4 billion increase in proceeds from redemptions of short-term investments with original maturities of greater than three months, a $7.6 billion decrease in net purchases of short-term investments with original maturities of three months or less and a $4.0 billion dividend received from the Consumer Healthcare JV in 2022 that was allocated to investing activities (see Note 2C ), partially offset by cash paid for acquisitions in 2022 of $23.0 billion (Biohaven, $11.5 billion, Arena, $6.2 billion and GBT, $5.2 billion), net of cash acquired (see Note 2A ).
Investing activities from continuing operations $ (32,278) $ (15,783) $ (22,534) The change was driven mainly by $43.4 billion cash paid in 2023 for the acquisition of Seagen, net of cash acquired, compared with $23.0 billion cash paid in 2022 for acquisitions (Biohaven, $11.5 billion, Arena, $6.2 billion and GBT, $5.2 billion), net of cash acquired (see Note 2A ), as well as a $4.0 billion dividend received from the Consumer Healthcare JV in 2022 that was allocated to investing activities (see Note 2C ), partially offset by a $5.5 billion increase in net redemptions of short-term investments in 2023 and a $1.7 billion decrease in purchases of long-term investments.
Int’l. 1,751 2,019 (13) (4) Worldwide $ 5,120 $ 5,437 (6) (2) Vyndaqel family $2,447 Up 29% (operationally) U.S. $ 1,245 $ 909 37 Growth largely driven by continued strong uptake of the ATTR-CM indication, primarily in developed Europe and the U.S., partially offset by a planned price decrease that went into effect in Japan in the second quarter of 2022.
Int’l. 1,602 1,751 (8) (6) Worldwide $ 4,753 $ 5,120 (7) (6) Vyndaqel family $3,321 Up 36% (operationally) U.S. $ 1,863 $ 1,245 50 Growth largely driven by continued strong uptake of the ATTR-CM indication, primarily in the U.S. and developed Europe, partially offset by a planned price decrease that went into effect in Japan in the second quarter of 2022.
Costs and Expenses Costs and expenses follow: Year Ended December 31, % Change (MILLIONS) 2022 2021 2020 22/21 21/20 Cost of sales (a) $ 34,344 $ 30,821 $ 8,484 11 * Percentage of Revenues 34.2 % 37.9 % 20.4 % Selling, informational and administrative expenses (a) 13,677 12,703 11,597 8 10 Research and development expenses 11,428 10,360 8,709 10 19 Acquired in-process research and development expenses 953 3,469 684 (73) * Amortization of intangible assets (a) 3,609 3,700 3,348 (2) 11 Restructuring charges and certain acquisition-related costs (a) 1,375 802 579 71 38 Other (income)/deductions—net (a) 217 (4,878) 1,213 * * * Indicates calculation not meaningful.
Costs and Expenses Costs and expenses follow: Year Ended December 31, % Change (MILLIONS) 2023 2022 2021 23/22 22/21 Cost of sales $ 24,954 $ 34,344 $ 30,821 (27) 11 Percentage of Total revenues 42.7 % 34.2 % 37.9 % Selling, informational and administrative expenses 14,771 13,677 12,703 8 8 Research and development expenses 10,679 11,428 10,360 (7) 10 Acquired in-process research and development expenses 194 953 3,469 (80) (73) Amortization of intangible assets 4,733 3,609 3,700 31 (2) Restructuring charges and certain acquisition-related costs 2,943 1,375 802 * 71 Other (income)/deductions—net (a) (835) 217 (4,878) * * * Indicates calculation not meaningful.
While we are holding such securities, we are subject to equity price risk, and this may increase the volatility of our income in future periods due to changes in the fair value of equity investments. From time to time, we will sell such equity securities based on our business considerations, which may include limiting our price risk.
While we are holding such securities, we are subject to equity price risk, and this may increase the volatility of our income in future periods due to changes in the fair value of equity investments.
In connection with restructuring our corporate enabling functions, we achieved gross cost savings of $1.0 billion, or net cost savings, excluding merit and inflation growth and certain real estate cost increases, of $700 million, in the two year period from 2021 through 2022.
Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives Transforming to a More Focused Company Program –– In connection with restructuring our corporate enabling functions, we achieved gross cost savings of $1.0 billion, or net cost savings, excluding merit and inflation growth and certain real estate cost increases, of $700 million, in the two year period from 2021 through 2022.
The current ratings assigned to our commercial paper and senior unsecured long-term debt: NAME OF RATING AGENCY Pfizer Short-Term Rating Pfizer Long-Term Rating Outlook/Watch Moody’s P-1 A1 Stable S&P A-1+ A+ Stable A security rating is not a recommendation to buy, sell or hold securities and the rating is subject to revision or withdrawal at any time by the rating organization.
As of the date of the filing of this Form 10-K, the following ratings have been assigned to our commercial paper and senior unsecured long-term debt: NAME OF RATING AGENCY Pfizer Short-Term Rating Pfizer Long-Term Rating Outlook/Watch Moody’s P-1 A2 Stable Outlook S&P A-1 A Stable Outlook These ratings are not a recommendation to buy, sell or hold securities and the ratings are subject to revision or withdrawal at any time by the rating organization.
The measurement of the plan obligations at the end of the year will affect the amount of service cost, interest cost and amortization expense reflected in our net periodic benefit costs in the following year.
The measurement of plan obligations at the end of the year will affect (i) the actuarial (gains)/losses recognized in our net periodic benefit cost for that year and (ii) the amount of service cost and interest cost reflected in our net periodic benefit costs in the following year.
Int’l. — — — — Worldwide $ 1,198 $ 1,185 1 1 Inlyta $1,003 Up 4% (operationally) U.S. $ 618 $ 599 3 Growth primarily reflects continued strong performance in emerging markets and the U.S. driven by the adoption of combinations of certain immune checkpoint inhibitors and Inlyta for the first-line treatment of patients with advanced RCC.
Int’l. — — — — Worldwide $ 1,191 $ 1,198 (1) (1) Inlyta $1,036 Up 5% (operationally) U.S. $ 642 $ 618 4 Growth primarily reflects continued growth in emerging markets and the U.S. driven by the adoption of combinations of certain immune checkpoint inhibitors and Inlyta for the first-line treatment of patients with advanced RCC, partially offset by lower volumes and lower net price in certain European markets.
Revenue Deductions –– Our gross product revenues are subject to a variety of deductions, which generally are estimated and recorded in the same period that the revenues are recognized. These deductions represent estimates of the related obligations and, as such, knowledge and judgment are required when estimating the impact of these revenue deductions on gross sales for a reporting period.
These deductions represent estimates of the related obligations and, as such, knowledge and judgment are required when estimating the impact of these product revenue deductions on gross sales for a reporting period.
Int’l. 952 1,206 (21) (16) Worldwide $ 1,342 $ 1,731 (22) (19) Pfizer Inc. 2022 Form 10-K 33 (a) Comirnaty includes direct sales and Alliance revenues related to sales of the Pfizer-BioNTech COVID-19 vaccine, which are recorded within our Primary Care customer group.
Int’l. 920 952 (3) (3) Worldwide $ 1,310 $ 1,342 (2) (2) (a) Comirnaty includes direct sales and Alliance revenues related to sales of the Pfizer-BioNTech COVID-19 vaccine, which are recorded within our Primary Care customer group.
Acquisition-Related Items –– Adjusted income continues to exclude certain acquisition-related items, which are comprised of transaction, integration, restructuring charges and additional depreciation costs for business combinations because these costs are unique to each Pfizer Inc. 2022 Form 10-K 39 transaction and represent costs that were incurred to restructure and integrate businesses as a result of an acquisition.
Acquisition-Related Items –– Adjusted income excludes certain acquisition-related items, which are composed of transaction, integration, restructuring charges and additional depreciation costs for business combinations because these costs are unique to each transaction and represent costs that were incurred to restructure and integrate businesses as a result of an acquisition. We have made no adjustments for resulting synergies.
See the Non-GAAP Financial Measure: Adjusted Income section of this MD&A. In addition to this program, we continuously monitor our operations for cost reduction and/or productivity opportunities, especially in light of the losses of exclusivity and the expiration of collaborative arrangements for various products.
In addition to these programs, we continuously monitor our operations for cost reduction and/or productivity opportunities, especially in light of the losses of exclusivity and the expiration of collaborative arrangements for various products.
Acquisition-related items may now include purchase accounting impacts that previously would have been included as part of a reconciling line entitled “Purchase accounting adjustments” that we no longer separately present, such as: (i) the incremental charge to cost of sales from the sale of acquired inventory that was written up to fair value; (ii) depreciation related to the increase/decrease in fair value of acquired fixed assets; (iii) amortization related to the increase in fair value of acquired debt and (iv) the fair value changes for contingent consideration.
Acquisition-related items may include purchase accounting impacts such as the incremental charge to cost of sales from the sale of acquired inventory that was written up to fair value, depreciation related to the increase/decrease in fair value of acquired fixed assets, amortization related to the increase in fair value of acquired debt, and the fair value changes for contingent consideration.
Cash Flows from Continuing Operations Year Ended December 31, (MILLIONS) 2022 2021 2020 Drivers of change 2022 v. 2021 Cash provided by/(used in): Operating activities from continuing operations $ 29,267 $ 32,922 $ 10,540 The change was driven primarily by a net increase in payments to BioNTech for the gross profit split for Comirnaty (see Note 8B ) and an increase in noncurrent inventories primarily driven by a strategic build for Paxlovid (see Note 8A ), partially offset by higher net income adjusted for non-cash items and the timing of receipts and payments in the ordinary course of business.
Cash Flows from Continuing Operations Year Ended December 31, (MILLIONS) 2023 2022 2021 Drivers of change 2023 v. 2022 Cash provided by/(used in): Operating activities from continuing operations $ 8,700 $ 29,267 $ 32,922 The change was driven primarily by a decrease in net income adjusted for non-cash items and the timing of receipts and payments in the ordinary course of business, partially offset by net changes in inventory greater than one year (see Note 8A ).
The following illustrates the sensitivity of net periodic benefit costs to a 50 basis point decline in our assumption for the expected annual rate of return on plan assets, holding all other assumptions constant (in millions, pre-tax): Assumption Change Increase in 2023 Net Periodic Benefit Costs Expected annual rate of return on plan assets 50 basis point decline $92 The actual return on plan assets resulted in a net loss on our plan assets of approximately $6.3 billion during 2022 .
The following illustrates the sensitivity of net periodic benefit costs to a 50 basis point decline in our assumption for the expected annual rate of return on plan assets, holding all other assumptions constant (in millions, pre-tax): Assumption Change Increase in 2024 Net Periodic Benefit Costs Expected annual rate of return on plan assets (a) 50 basis point decline $84 (a) The estimate excludes any potential mark-to-market adjustments.
Pfizer Inc. 2022 Form 10-K 43 Equity Price Risk ––We hold equity securities with readily determinable fair values in life science companies as a result of certain business development transactions.
Equity Price Risk ––We hold long-term investments in equity securities with readily determinable fair values in life science companies as a result of certain business development transactions (see Note 7B ).
Other (Income)/Deductions––Net 2022 v. 2021 The period-over-period change of $5.1 billion resulting in net other deductions in 2022 compared to net other income in 2021 was primarily driven by net losses recognized on equity securities in 2022 versus net gains recognized in 2021, lower net periodic benefit credits, and higher asset impairment charges. See Note 4 for additional information .
Other (Income)/Deductions––Net The favorable period-over-period change of $1.1 billion was primarily driven by net gains on equity securities in 2023 versus net losses recognized on equity securities in 2022 and lower net interest expense, partially offset by higher intangible asset impairment charges. See Note 4 .
ANALYSIS OF FINANCIAL CONDITION, LIQUIDITY, CAPITAL RESOURCES AND MARKET RISK Due to our significant operating cash flows, which is a key strength of our liquidity and capital resources and our primary funding source, as well as our financial assets, access to capital markets, revolving credit agreements, and available lines of credit, we believe that we have, and will maintain, the ability to meet our liquidity needs to support ongoing operations, our capital allocation objectives, and our contractual and other obligations for the foreseeable future.
We believe as a result of this, together with our financial assets, access to capital markets, revolving credit agreements, and available lines of credit, we have and will maintain the ability to meet our liquidity needs to support ongoing operations, our capital allocation objectives, and our contractual and other obligations for the foreseeable future.
In December 2022, our BOD declared a first-quarter dividend of $0.41 per share, payable on March 3, 2023, to shareholders of record at the close of business on January 27, 2023. The first-quarter 2023 cash dividend will be our 337th consecutive quarterly dividend.
On December 14, 2023, our BOD declared a first-quarter dividend of $0.42 per share, payable on March 1, 2024, to shareholders of record at the close of business on January 26, 2024. The first-quarter 2024 cash dividend will be our 341st consecutive quarterly dividend. As of December 31, 2023, our remaining share-purchase authorization was approximately $3.3 billion.
International (MILLIONS) 2022 2021 2020 2022 2021 2020 2022 2021 2020 22/21 21/20 22/21 21/20 22/21 21/20 Operating segments: Biopharma $ 98,988 $ 79,557 $ 40,724 $ 42,083 $ 29,221 $ 21,055 $ 56,905 $ 50,336 $ 19,670 24 95 44 39 13 156 Pfizer CentreOne 1,342 1,731 926 390 524 400 952 1,206 526 (22) 87 (26) 31 (21) 129 Total revenues $ 100,330 $ 81,288 $ 41,651 $ 42,473 $ 29,746 $ 21,455 $ 57,857 $ 51,542 $ 20,196 23 95 43 39 12 155 2022 v. 2021 The following provides an analysis of the change in worldwide revenues by geographic areas from 2021 to 2022 (a) : (MILLIONS) Worldwide U.S.
International (MILLIONS) 2023 2022 2021 2023 2022 2021 2023 2022 2021 23/22 22/21 23/22 22/21 23/22 22/21 Operating segments: Biopharma $ 57,186 $ 98,988 $ 79,557 $ 26,698 $ 42,083 $ 29,221 $ 30,488 $ 56,905 $ 50,336 (42) 24 (37) 44 (46) 13 Business Innovation 1,310 1,342 1,731 390 390 524 920 952 1,206 (2) (22) — (26) (3) (21) Total revenues $ 58,496 $ 100,330 $ 81,288 $ 27,088 $ 42,473 $ 29,746 $ 31,408 $ 57,857 $ 51,542 (42) 23 (36) 43 (46) 12 2023 v. 2022 The following provides an analysis of the worldwide change in Total revenues by geographic areas from 2022 to 2023: (MILLIONS) Worldwide U.S.
Discontinued Operations –– Adjusted income continues to exclude the results of discontinued operations, as well as any related gains or losses on the disposal of such operations.
Pfizer Inc. 2023 Form 10-K 44 Discontinued Operations –– Adjusted income excludes the results of discontinued operations, as well as any related gains or losses on the disposal of such operations.
Int’l. 1,202 1,106 9 22 Worldwide $ 2,447 $ 2,015 21 29 Xeljanz $1,796 Down 24% (operationally) U.S. $ 1,129 $ 1,647 (31) Global declines driven primarily by decreased prescription volumes globally resulting from ongoing shifts in prescribing patterns related to label changes, as well as declines in net price due to unfavorable changes in channel mix in the U.S.
Int’l. 1,458 1,202 21 22 Worldwide $ 3,321 $ 2,447 36 36 Xeljanz $1,703 Down 4% (operationally) U.S. $ 1,154 $ 1,129 2 Decline driven primarily by decreased prescription volumes globally resulting from ongoing shifts in prescribing patterns related to label changes, partially offset by higher net price in the U.S. due to favorable changes in channel mix.
We do not expect this new guidance to have a material impact on our consolidated financial statements. In June 2022, the FASB issued final guidance to clarify that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered when measuring fair value.
Recently Issued Accounting Standards, Not Adopted as of December 31, 2023 Standard/Description Effective Date Effect on the Financial Statements In June 2022, the FASB issued final guidance to clarify that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered when measuring fair value.
Our effective tax rates for GAAP Reported income from continuing operations were: 9.6% in 2022, 7.6% in 2021 and 5.3% in 2020. See Note 5 . Our effective tax rates for non-GAAP Adjusted income were: 11.7% in 2022, 14.5% in 2021 and 13.5% in 2020. (b) Includes reconciling amounts for Research and development expenses that are not material.
Our effective tax rates for GAAP Reported income from continuing operations were: (105.4)% in 2023, 9.6% in 2022 and 7.6% in 2021. See Note 5 . Our effective tax rates for non-GAAP Adjusted income were: 9.0% in 2023, 11.7% in 2022 and 14.5% in 2021.
Selling, Informational and Administrative Expenses 2022 v. 2021 Selling, informational and administrative expenses increased $974 million, mostly due to: • an increase of $1.3 billion for Paxlovid and Comirnaty marketing and promotional expenses and a higher provision for U.S. healthcare reform fees based on sales of Paxlovid; and • an increase of $540 million for marketing and promotional expenses for recently acquired and launched products, partially offset by: • a $414 million favorable impact of foreign exchange; • a $320 million decrease in spending across multiple customer groups; and • a decrease of $270 million in our liability to be paid to participants of our supplemental savings plan.
Selling, Informational and Administrative Expenses Selling, informational and administrative expenses increased $1.1 billion, mostly due to: • an increase of $1.1 billion in marketing and promotional expenses for recently acquired and launched products; • an increase of $280 million for the expected Paxlovid commercial launch; • an increase of $210 million in our liability to be paid to participants of our supplemental savings plan; and • an increase of $170 million in marketing and promotional expenses for rare disease products, partially offset by: • a decrease of $690 million due to a lower provision for U.S. healthcare reform fees related to Comirnaty and Paxlovid.
Pfizer Inc. 2022 Form 10-K 37 The following provides information about additional indications and new drug candidates in late-stage development: PRODUCT/CANDIDATE PROPOSED INDICATION LATE-STAGE CLINICAL PROGRAMS FOR ADDITIONAL USES AND DOSAGE FORMS FOR IN-LINE AND IN-REGISTRATION PRODUCTS Ibrance (palbociclib) (a) ER+/HER2+ metastatic breast cancer Xtandi (enzalutamide) (b) Non-metastatic high-risk castration sensitive prostate cancer Talzenna (talazoparib) Combination with Xtandi (enzalutamide) for first-line mCRPC Combination with Xtandi (enzalutamide) for DNA Damage Repair (DDR)-deficient mCSPC PF-06482077 (Vaccine) Immunization to prevent invasive and non-invasive pneumococcal infections (pediatric) somatrogon (PF-06836922) (c) Adult growth hormone deficiency Braftovi (encorafenib) and Erbitux ® (cetuximab) (d) First-line BRAF V600E -mutant mCRC Braftovi (encorafenib) and Mektovi (binimetinib) and Keytruda ® (pembrolizumab) (e) BRAF V600E/K -mutant metastatic or unresectable locally advanced melanoma Braftovi (encorafenib) and Mektovi (binimetinib) BRAF V600E -mutant non-small cell lung cancer Paxlovid (nirmatrelvir [PF-07321332]; ritonavir) COVID-19 in high-risk children (6-11 years of age; >88lbs) zavegepant (oral) Prevention of acute migraine (adults) ritlecitinib (PF-06651600) Vitiligo elranatamab (PF-06863135) Multiple myeloma double-class exposed Newly diagnosed multiple myeloma post-transplant maintenance Eliquis (apixaban) Venous thromboembolism (pediatric) NEW DRUG CANDIDATES IN LATE-STAGE DEVELOPMENT aztreonam-avibactam (PF-06947387) Treatment of infections caused by Gram-negative bacteria with limited or no treatment options fidanacogene elaparvovec (PF-06838435) (f) Hemophilia B giroctocogene fitelparvovec (PF-07055480) (g) Hemophilia A PF-06425090 (Vaccine) Immunization to prevent primary clostridioides difficile infection sasanlimab (PF-06801591) Combination with Bacillus Calmette-Guerin for non-muscle-invasive bladder cancer fordadistrogene movaparvovec (PF-06939926) Duchenne muscular dystrophy (ambulatory) marstacimab (PF-06741086) Hemophilia Omicron-based mRNA vaccine (h) Immunization to prevent COVID-19 (adults) VLA15 (PF-07307405) vaccine (i) Immunization to prevent Lyme Disease PF-07252220 (quadrivalent mRNA-based vaccine) Immunization to prevent influenza inclacumab (PF-07940370) Sickle Cell Disease (a) Being developed in collaboration with The Alliance Foundation Trials, LLC.
The following provides information about additional indications and new drug candidates in late-stage development: PRODUCT/CANDIDATE PROPOSED DISEASE AREA LATE-STAGE CLINICAL PROGRAMS FOR ADDITIONAL USES AND DOSAGE FORMS FOR IN-LINE AND IN-REGISTRATION PRODUCTS Ibrance (palbociclib) (a) ER+/HER2+ metastatic breast cancer Talzenna (talazoparib) Combination with Xtandi (enzalutamide) for DNA Damage Repair-deficient mCSPC Ngenla (somatrogon) (b) Adult growth hormone deficiency Braftovi (encorafenib) and Erbitux® (cetuximab) (c) First-line BRAF V600E -mutant mCRC Paxlovid (nirmatrelvir; ritonavir) COVID-19 in high-risk children (6-11 years of age; >88lbs) Litfulo (ritlecitinib) Vitiligo Elrexfio (elranatamab) Multiple myeloma double-class exposed Newly diagnosed multiple myeloma post-transplant maintenance Newly diagnosed multiple myeloma transplant-ineligible Oxbryta (voxelotor) Sickle cell disease (pediatric) Eliquis (apixaban) (d) Venous thromboembolism (pediatric) Abrysvo (vaccine) Active immunization to prevent RSV infection in adults (18-59) Padcev (enfortumab vedotin) (e) Cisplatin-ineligible/decline muscle-invasive bladder cancer Cisplatin-eligible muscle-invasive bladder cancer Tukysa (tucatinib) HER2+ adjuvant breast cancer 2nd line/3rd line HER2+ metastatic breast cancer 1st line HER2+ metastatic colorectal cancer NEW DRUG CANDIDATES IN LATE-STAGE DEVELOPMENT giroctocogene fitelparvovec (PF-07055480) (f) Hemophilia A PF-06425090 (Vaccine) Immunization to prevent primary clostridioides difficile infection sasanlimab (PF-06801591) Combination with Bacillus Calmette-Guerin for non-muscle-invasive bladder cancer fordadistrogene movaparvovec (PF-06939926) Duchenne muscular dystrophy (ambulatory) VLA15 (PF-07307405) vaccine (g) Immunization to prevent Lyme disease PF-07252220 (quadrivalent mRNA-based vaccine) Immunization to prevent influenza Vepdegestrant (PF-07850327) (h) Breast cancer metastatic - 2 nd line ER+/HER2- inclacumab (PF-07940370) Sickle cell disease Ibrance + vepdegestrant (h) ER+/HER2- metastatic breast cancer Dazukibart (PF-06823859) Dermatomyositis, polymyositis Disitamab vedotin (i) 1st line HER2 (≥IHC1+) metastatic urothelial cancer PF-07926307 (COVID/flu combo vaccine) (j) Immunization to prevent COVID infection and influenza sisunatovir (PF-07923568) Respiratory syncytial virus infection (adults) Note: Braftovi/Mektovi/Keytruda previously listed as a late-stage clinical candidate is no longer considered registrational and has been removed.
January 1, 2023, except for the amendment on rollforward information, which is effective January 1, 2024. Early adoption is permitted. This new guidance will result in increased disclosures in the notes to our financial statements.
January 1, 2024 for annual reports and January 1, 2025 for interim reports. Early adoption is permitted. This new guidance will result in increased disclosures in the notes to our financial statements. In December 2023, the FASB issued final guidance to improve income tax disclosures .
Recognizing a contractual sale restriction as a separate unit of account is not permitted. January 1, 2024, with early adoption permitted. We are assessing the impact, but currently do not expect this new guidance to have a material impact on our consolidated financial statements.
Recognizing a contractual sale restriction as a separate unit of account is not permitted. January 1, 2024, with early adoption permitted. The new guidance is consistent with our current policy, and it will not have an impact on our consolidated financial statements. In November 2023, the FASB issued final guidance to improve transparency of segment disclosures .
For information on our accruals for revenue deductions, including the balance sheet classification of these accruals, see Note 1G . Pfizer Inc. 2022 Form 10-K 32 Revenues—Selected Product Discussion Biopharma Revenue (MILLIONS) Year Ended Dec. 31, % Change Product Global Revenues Region 2022 2021 Total Oper.
Pfizer Inc. 2023 Form 10-K 37 Total Revenues—Selected Product Discussion Biopharma Revenue (MILLIONS) Year Ended Dec. 31, % Change Product Global Revenues Region 2023 2022 Total Oper.
In the EU, we are developing in collaboration with the Pierre Fabre Group. In Japan, we are developing in collaboration with Ono. (f) Being developed in collaboration with Spark Therapeutics, Inc. (g) Being developed in collaboration with Sangamo Therapeutics, Inc. (h) Being developed in collaboration with BioNTech. (i) Being developed in collaboration with Valneva.
In Japan, we are developing in collaboration with Ono. (d) Being developed in collaboration with BMS. (e) Being developed in collaboration with Astellas. (f) Being developed in collaboration with Sangamo Therapeutics, Inc. (g) Being developed in collaboration with Valneva. (h) Vepdegestrant is being developed in collaboration with Arvinas. (i) Being developed in collaboration with RemeGen Co., Ltd.
Financing activities from continuing operations $ (14,834) $ (9,816) $ (21,640) The change was driven mostly by $2.0 billion of purchases of the Company’s common stock in 2022, a $1.3 billion increase in repayments of long-term debt, and a $997 million decrease in proceeds from the issuance of long-term debt.
Financing activities from continuing operations $ 26,066 $ (14,834) $ (9,816) The change was driven mostly by $30.8 billion of proceeds from the issuance of long-term debt in May of 2023 and a $7.9 billion increase in net proceeds from the issuance of short-term borrowings.
As such, we believe that investors’ understanding of our performance is enhanced by disclosing this measure.
NON-GAAP FINANCIAL MEASURE: ADJUSTED INCOME Adjusted income is an alternative measure of performance used by management to evaluate our overall performance as a supplement to our GAAP Reported performance measures. As such, we believe that investors’ understanding of our performance is enhanced by disclosing this measure.
MILLIONS, EXCEPT PER SHARE DATA Cost of sales (a) Selling, informational and administrative expenses (a) Other (income)/deductions––net (a) Net income attributable to Pfizer Inc. common shareholders (a), (b) Earnings per common share attributable to Pfizer Inc. common shareholders––diluted GAAP Reported $ 8,484 $ 11,597 $ 1,213 $ 9,159 $ 1.63 Amortization of intangible assets — (38) (3) 3,395 Acquisition-related items 18 (1) (75) 98 Discontinued operations (d) — — — (2,879) Certain significant items: Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring (e) (61) (197) — 791 Certain asset impairments (f) — — (1,691) 1,691 (Gains)/losses on equity securities (f) — — 557 (557) Actuarial valuation and other pension and postretirement plan (gains)/losses — — (1,092) 1,092 Other (56) (292) (h) (691) (g) 1,063 Income tax provision—Non-GAAP items (1,251) Non-GAAP Adjusted $ 8,386 $ 11,068 $ (1,781) $ 12,601 $ 2.24 (a) Items that reconcile GAAP Reported to non-GAAP Adjusted balances are shown pre-tax.
MILLIONS, EXCEPT PER SHARE DATA Cost of sales (a) Selling, informational and administrative expenses (a) Other (income)/deductions––net (a) Net income attributable to Pfizer Inc. common shareholders (a), (b), (c) Earnings per common share attributable to Pfizer Inc. common shareholders––diluted GAAP Reported $ 24,954 $ 14,771 $ (835) $ 2,119 $ 0.37 Amortization of intangible assets — — — 4,733 Acquisition-related items (629) (11) (28) 1,874 Discontinued operations (d) — — — (11) Certain significant items: Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring (e) (98) (290) — 2,227 Certain asset impairments (f) — — (3,024) 3,024 (Gains)/losses on equity securities (f) — — 1,588 (1,588) Actuarial valuation and other pension and postretirement plan (gains)/losses — — 265 (265) Other (238) (g) (24) (246) (h) 518 Income tax provision—Non-GAAP items (2,131) Non-GAAP Adjusted $ 23,988 $ 14,446 $ (2,281) $ 10,501 $ 1.84 Year Ended December 31, 2022 Data presented will not (in all cases) aggregate to totals.
The following presents information about revenue deductions: Year Ended December 31, (MILLIONS) 2022 2021 2020 Medicare rebates $ 838 $ 726 $ 647 Medicaid and related state program rebates 973 1,214 1,136 Performance-based contract rebates 3,575 3,253 2,660 Chargebacks 7,560 6,122 4,531 Sales allowances 5,460 4,809 3,835 Sales returns and cash discounts 1,290 1,054 924 Total $ 19,697 $ 17,178 $ 13,733 Revenue deductions are primarily a function of product sales volume, mix of products sold, contractual or legislative discounts and rebates.
Pfizer Inc. 2023 Form 10-K 36 The following presents information about product revenue deductions: Year Ended December 31, (MILLIONS) 2023 2022 2021 Medicare rebates $ 997 $ 838 $ 726 Medicaid and related state program rebates 1,655 973 1,214 Performance-based contract rebates 5,159 3,575 3,253 Chargebacks 9,828 7,560 6,122 Sales allowances 6,790 5,460 4,809 Sales returns and cash discounts (a) 5,619 1,290 1,054 Total $ 30,048 $ 19,697 $ 17,178 (a) The increase in sales returns and cash discounts in 2023 was primarily due to the revenue reversal of $3.5 billion in the fourth quarter of 2023, related to the expected return of an estimated 6.5 million treatment courses of EUA-labeled U.S. government Paxlovid inventory (see Note 17C ).
In connection with optimizing our end-to-end R&D operations, we expect net cost savings of $2.3 billion to be achieved primarily from 2023 through 2025. Certain qualifying costs for this program were recorded in 2022, 2021 and 2020, and are reflected as Certain Significant Items and excluded from our non-GAAP measure of Adjusted Income.
In connection with optimizing our end-to-end R&D operations, we expect net cost savings of $2.3 billion to be achieved primarily from 2023 through 2025. Realigning our Cost Base Program –– This program is expected to deliver net cost savings of at least $4 billion, to be achieved primarily from 2023 through 2024.
Int’l. 385 403 (5) 5 Worldwide $ 1,003 $ 1,002 — 4 Pfizer CentreOne Revenue (MILLIONS) Year Ended Dec. 31, % Change Operating Segment Global Revenues Region 2022 2021 Total Oper.
Int’l. 20 2 * * Worldwide $ 928 $ 213 * * Pfizer Inc. 2023 Form 10-K 38 Business Innovation Revenue (MILLIONS) Year Ended Dec. 31, % Change Operating Segment Global Revenues Region 2023 2022 Total Oper.
In November 2022, Moody’s increased the rating on our long-term debt from A2 to A1 as well as the outlook on our long-term debt to Stable; S&P continues to rate the outlook of our long-term debt as Stable since November 2020.
In December 2023, following the release of 2024 guidance (i) Moody’s downgraded our long-term rating from A1 to A2 and changed its outlook on our long-term debt to Stable and (ii) S&P downgraded our long-term rating from A+ to A and changed its outlook on our long-term debt to Stable.
Int’l. 2,305 2,571 (10) (4) Worldwide $ 6,337 $ 5,272 20 23 Ibrance $5,120 Down 2% (operationally) U.S. $ 3,370 $ 3,418 (1) Global declines primarily driven by prior-year clinical trial purchases internationally, planned price decreases that recently went into effect in international developed markets, and continued increase in the proportion of patients accessing Ibrance through the U.S.
Int’l. 2,236 2,305 (3) — Worldwide $ 6,440 $ 6,337 2 3 Ibrance $4,753 Down 6% (operationally) U.S. $ 3,151 $ 3,370 (6) Declines primarily driven by lower demand globally due to competitive pressure, lower clinical trial purchases internationally, and planned price decreases in certain international developed markets.
(h) The third dose of the primary series 6 months through 4 years of age in the U.S. has been replaced by the 3-µg booster of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). Pfizer Inc. 2022 Form 10-K 36 Other Products PRODUCT INDICATION OR PROPOSED INDICATION APPROVED/FILED* U.S.
The FDA also granted EUA for the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)). Pfizer Inc. 2023 Form 10-K 41 Other Products PRODUCT INDICATION OR PROPOSED INDICATION APPROVED/FILED* U.S.
(b) Being developed in collaboration with Astellas. (c) Being developed in collaboration with OPKO. (d) Erbitux ® is a registered trademark of ImClone LLC. In the EU, we are developing in collaboration with the Pierre Fabre Group. In Japan, we are developing in collaboration with Ono. (e) Keytruda ® is a registered trademark of Merck Sharp & Dohme Corp.
Note: Zavzpret oral for the prevention of chronic migraine previously listed as a late-stage clinical candidate has been removed. (a) Being developed in collaboration with The Alliance Foundation Trials, LLC. (b) Being developed in collaboration with OPKO. (c) Erbitux is a registered trademark of ImClone LLC. In the EU, we are developing in collaboration with the Pierre Fabre Group.
Global Economic Conditions ––Venezuela and Argentina operations, and beginning in our second quarter of 2022, our operations in Turkey function in a hyperinflationary economy. The impact to Pfizer is not considered material. For additional information on the global economic environment, see the Item 1A. Risk Factors––Global Operations section in this Form 10-K.
In 2024, we expect to spend approximately $3.7 billion on PP&E; and • Future minimum rental commitments under non-cancelable operating leases (see Note 15 ). Global Economic Conditions ––Venezuela, Argentina and Turkey operations function in a hyperinflationary economy. The impact to Pfizer is not considered material. See the Item 1A. Risk Factors––Global Operations section.
Int’l. 2,658 2,810 (5) 5 Worldwide $ 6,480 $ 5,970 9 14 Prevnar family $6,337 Up 23% (operationally) U.S. $ 4,032 $ 2,701 49 Growth primarily driven by the adult indications in the U.S. due to strong patient demand following the launch of Prevnar 20 for the eligible adult population, partially offset by a reduction in revenues due to a one-time CDC inventory return program for the pediatric indication, the revenue impact of which is expected to be reversed in 2023 upon replenishment, as well as unfavorable timing of purchases for the adult indication internationally.
Int’l. 2,519 2,658 (5) (3) Worldwide $ 6,747 $ 6,480 4 5 Prevnar family $6,440 Up 3% (operationally) U.S. $ 4,204 $ 4,032 4 Growth primarily driven by the adult indications in the U.S. due to strong patient demand for Prevnar 20 for the eligible adult population, partially offset by the Prevnar pediatric indication in the U.S. driven by lower market share due to competitor entry.

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Item 2. Properties

Properties — owned and leased real estate

3 edited+0 added−0 removed2 unchanged
Biggest changeIn February 2023, we relocated our global headquarters to the Spiral, an office building in the Hudson Yards neighborhood of New York City. We continue to advance our global workplace strategy to provide workplaces that enable collaboration and foster innovation. As of December 31, 2022, we had 301 owned and leased properties, amounting to approximately 40 million square feet.
Biggest changeWe continue to advance our global workplace strategy to provide workplaces that enable collaboration and foster innovation. As of December 31, 2023, we had 284 owned and leased properties (including properties acquired in the Seagen acquisition), amounting to approximately 38 million square feet.
Our PGS division expects to exit the Perth, Australia site in early 2023. PGS also operate s multiple distribution facilities around the world. In general, we believe that our properties, including the principal properties described above, are well-maintained, adequate and suitable for their current requirements and for our operations in the foreseeable future.
The leadership team for PGS is primarily located in New York City. PGS also operates multiple distribution facilities around the world. In general, we believe that our properties, including the principal properties described above, are well-maintained, adequate and suitable for their current requirements and for our operations in the foreseeable future.
Our PGS division is headquartered in various locations, with leadership teams primarily in New York City and in Peapack, New Jersey. As of December 31, 2022, PGS had responsibility for 36 plants around the world, which manufacture products for our commercial divisions, including in Belgium, Germany, India, Ireland, Italy, Japan, S ingapore and the U.S.
The recent Seagen acquisition has increased our real estate portfolio by 14 sites totaling 1 million square feet. As of December 31, 2023, of the 284 properties, PGS had responsibility for 37 plants around the world, which manufacture products for our commercial divisions, including in Belgium, Germany, India, Ireland, Italy, Japan, Singapore and the U.S.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

13 edited+3 added−4 removed0 unchanged
Biggest changeChief Information Officer and Senior Vice President of Quest Diagnostics Incorporated from 2014 to 2018. Senior Vice President of Laboratory Corporation of America Holdings from 2008 until March 2013. Director of Tegna, Inc. and Medtronic plc. Angela Hwang 57 Chief Commercial Officer since October 2022 and President, Global Biopharmaceuticals Group since January 2019.
Biggest changeDirector of Agilent Technologies, Inc, and Vimian Group AB. Lidia Fonseca 55 Chief Digital and Technology Officer, Executive Vice President since January 2019. Chief Information Officer and Senior Vice President of Quest Diagnostics Incorporated from 2014 to 2018. Senior Vice President of Laboratory Corporation of America Holdings from 2008 until March 2013. Director of Tegna, Inc. from 2014 to 2023.
Various U.S. geographic leadership roles with McKinsey & Company from 2019 to 2021; previously co-led McKinsey & Company’s Global Pharmaceuticals & Medical Products practice from 2015 to 2018. Michael McDermott 57 Chief Global Supply Officer, Executive Vice President since January 2022. President of Pfizer Global Supply from 2018 until 2021. Vice President of Pfizer Global Supply from 2014 until 2018.
Various U.S. geographic leadership roles with McKinsey & Company from 2019 to 2021; previously co-led McKinsey & Company’s Global Pharmaceuticals & Medical Products practice from 2015 to 2018. Michael McDermott 58 Chief Global Supply Officer, Executive Vice President since January 2022. President of Pfizer Global Supply from 2018 until 2021. Vice President of Pfizer Global Supply from 2014 until 2018.
Each holds the office or offices indicated until his or her successor is chosen and qualified at the regular meeting of the BOD to be held on the date of the 2023 Annual Meeting of Shareholders, or until his or her earlier death, resignation or removal. Each of the executive officers is a member of the Pfizer Executive Leadership Team.
Each holds the office or offices indicated until his or her successor is chosen and qualified at the regular meeting of the BOD to be held on the date of the 2024 Annual Meeting of Shareholders, or until his or her earlier death, resignation or removal. Each of the executive officers is a member of the Pfizer Executive Leadership Team.
Name Age Position Albert Bourla 61 Chairman of the Board since January 2020 and Chief Executive Officer since January 2019. Chief Operating Officer from January 2018 until December 2018. Group President, Pfizer Innovative Health from June 2016 until December 2017.
Name Age Position Albert Bourla 62 Chairman of the Board since January 2020 and Chief Executive Officer since January 2019. Chief Operating Officer from January 2018 until December 2018. Group President, Pfizer Innovative Health from June 2016 until December 2017.
Executive Vice President, Chief Financial Officer, Lowe’s Companies, Inc., from November 2018 until April 2022; Executive Vice President and Chief Financial Officer, CVS Health Corporation (a diversified health solutions company), from January 2010 until November 2018. Director of Tapestry, Inc. Effective March 1, 2023, Director of Haleon plc.
Executive Vice President, Chief Financial Officer, Lowe’s Companies, Inc., from November 2018 until April 2022; Executive Vice President and Chief Financial Officer, CVS Health Corporation (a diversified health solutions company), from January 2010 until November 2018. Director of Tapestry, Inc. from 2014 to 2023. Director of Haleon plc.
Corporate Secretary from January 2014 until February 2014. Executive Vice President, Chief Compliance and Risk Officer from February 2011 until December 2013. Executive Vice President, Chief Compliance Officer from December 2010 until February 2011. Aamir Malik 47 Chief Business Innovation Officer, Executive Vice President since August 2021.
Corporate Secretary from January 2014 until February 2014. Executive Vice President, Chief Compliance and Risk Officer from February 2011 until December 2013. Aamir Malik 48 Chief U.S. Commercial Officer, Executive Vice President since December 2023. Chief Business Innovation Officer, Executive Vice President from August 2021 until December 2023.
Group President, Global Innovative Pharma Business (responsible for Vaccines, Oncology and Consumer Healthcare since 2014) from February 2016 until June 2016. President and General Manager of Established Products Business Unit from December 2010 until December 2013. Our Director since February 2018. David M. Denton 57 Chief Financial Officer, Executive Vice President since May 2022.
Group President, Global Innovative Pharma Business (responsible for Vaccines, Oncology and Consumer Healthcare since 2014) from February 2016 until June 2016. President and General Manager of Established Products Business Unit from December 2010 until December 2013. Our Director since February 2018. Chris Boshoff 60 Chief Oncology Officer, Executive Vice President since December 2023.
Johnson 61 Chief Compliance, Quality and Risk Officer, Executive Vice President since January 2019. Executive Vice President, Chief Compliance and Risk Officer from December 2013 until December 2018. Senior Vice President and Associate General Counsel from October 2006 until December 2013. Douglas M. Lankler 57 General Counsel, Executive Vice President since December 2013.
Director of Medtronic plc. Rady A. Johnson 62 Chief Compliance, Quality and Risk Officer, Executive Vice President since January 2019. Executive Vice President, Chief Compliance and Risk Officer from December 2013 until December 2018. Senior Vice President and Associate General Counsel from October 2006 until December 2013. Douglas M. Lankler 58 General Counsel, Executive Vice President since December 2013.
Payal Sahni 48 Chief People Experience Officer, Executive Vice President since January 2022. Chief Human Resources Officer, Executive Vice President from June 2020 to December 2021. From May 2016 until June 2020 served as Senior Vice President of Human Resources for multiple operating units. Vice President of Human Resources, Vaccines, Oncology & Consumer from 2015 until 2016. Ms.
Vice President of the Biotechnology Unit from 2012 until 2014. Payal Sahni 49 Chief People Experience Officer, Executive Vice President since January 2022. Chief Human Resources Officer, Executive Vice President from June 2020 to December 2021. From May 2016 until June 2020 served as Senior Vice President of Human Resources for multiple operating units.
ITEM 3. LEGAL PROCEEDINGS Certain legal proceedings in which we are involved are discussed in Note 16 A . INFORMATION ABOUT OUR EXECUTIVE OFFICERS The executive officers of the Company are set forth in this table.
ITEM 3. LEGAL PROCEEDINGS Certain legal proceedings in which we are involved are discussed in Note 16A . Pfizer Inc. 2023 Form 10-K 27 INFORMATION ABOUT OUR EXECUTIVE OFFICERS The executive officers of the Company are set forth in this table.
Sahni has served in a number of positions in the Human Resources organization with increasing responsibility since joining Pfizer in 1997. Sally Susman 61 Chief Corporate Affairs Officer, Executive Vice President since January 2019. Executive Vice President, Corporate Affairs (formerly Policy, External Affairs and Communications) from December 2010 until December 2018.
Vice President of Human Resources, Vaccines, Oncology & Consumer from 2015 until 2016. Ms. Sahni has served in a number of positions in the Human Resources organization with increasing responsibility since joining Pfizer in 1997. Sally Susman 62 Chief Corporate Affairs Officer, Executive Vice President since January 2019.
Pfizer Inc. 2022 Form 10-K 23 Name Age Position Mikael Dolsten 64 Chief Scientific Officer and President, Worldwide Research, Development and Medical since January 2019. President of Worldwide Research and Development from December 2010 until December 2018. Senior Vice President; President of Worldwide Research and Development from May 2010 until December 2010.
Chief Scientific Officer and President, Worldwide Research, Development and Medical from January 2019 until July 2023. President of Worldwide Research and Development from December 2010 until December 2018. Senior Vice President; President of Worldwide Research and Development from May 2010 until December 2010. Senior Vice President; President of Pfizer BioTherapeutics Research & Development Group from October 2009 until May 2010.
Senior Vice President, Policy, External Affairs and Communications from December 2009 until December 2010. Director of WPP plc from 2013 to 2022. PART II
Executive Vice President, Corporate Affairs (formerly Policy, External Affairs and Communications) from December 2010 until December 2018. Senior Vice President, Policy, External Affairs and Communications from December 2009 until December 2010. Pfizer Inc. 2023 Form 10-K 28 PART II
Removed
Senior Vice President; President of Pfizer BioTherapeutics Research & Development Group from October 2009 until May 2010. Director of Agilent Technologies, Inc, and Vimian Group AB. Director of Karyopharm Therapeutics Inc. from 2015 to 2021. Lidia Fonseca 54 Chief Digital and Technology Officer, Executive Vice President since January 2019.
Added
Chief Oncology Research and Development Officer and Executive Vice President from July 2023 until December 2023. Senior Vice President, Oncology, from 2017 until 2023. David M. Denton 58 Chief Financial Officer, Executive Vice President since May 2022.
Removed
Group President, Pfizer Essential Health from January 2018 until December 2018. Global President, Pfizer Inflammation and Immunology from January 2016 until December 2017. Regional Head, U.S. Vaccines from January 2014 until December 2015. Vice President, Emerging Markets for Primary Care from September 2011 until December 2013. Director of United Parcel Service, Inc. Rady A.
Added
Alexandre de Germay 56 Chief International Commercial Officer, Executive Vice President since December 2023. Chief Executive Officer, Laboratoires Majorelle (a specialty pharma company based in France dedicated to women’s health and urology) from 2021 until January 2024 (assisting with transition matters after December 15, 2023).
Removed
Vice President of the Biotechnology Unit from 2012 until 2014. William Pao 56 Chief Development Officer, Executive Vice President since March 2022.
Added
From 2020 until 2021 was Senior Vice President; Global Franchise Head of Cardiology, Transplant and Established Products, and from 2016 until 2020 was Head of Mature Markets General Medicines of Sanofi. Regional President of Asia-Pacific of Pfizer Inc. from 2013 until 2016. Mikael Dolsten 65 Chief Scientific Officer, President, Pfizer Research and Development since July 2023.
Removed
Head of Roche Pharma Research & Early Development (pRED) and member of Roche’s Enlarged Corporate Executive Committee from 2018 until March 2022; Senior Vice President, Global Head Oncology Discovery and Translational Area at Roche pRED from 2014 until 2018. Vanderbilt University Medical Center Adjunct Professor from 2014 to present.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

5 edited+0 added−0 removed0 unchanged
Biggest changeFive Year Performance 2017 2018 2019 2020 2021 2022 PFIZER $100.0 $124.8 $116.2 $120.2 $200.4 $179.5 PEER GROUP $100.0 $108.0 $131.3 $136.7 $159.3 $184.3 S&P 500 $100.0 $95.6 $125.7 $148.8 $191.5 $156.8 DRG Index $100.0 $107.5 $127.3 $138.4 $170.7 $183.9 ITEM 6. [RESERVED]
Biggest changeFive Year Performance 2018 2019 2020 2021 2022 2023 PFIZER $100.0 $93.1 $96.3 $160.5 $143.8 $84.5 PEER GROUP $100.0 $122.0 $128.7 $154.4 $179.9 $207.8 S&P 500 $100.0 $131.5 $155.6 $200.3 $164.0 $207.0 DRG Index $100.0 $118.4 $128.7 $158.8 $171.1 $184.3
PEER GROUP PERFORMANCE GRAPH The following graph assumes a $100 investment on December 31, 2017, and reinvestment of all dividends, in each of the Company’s Common Stock, a composite peer group of the major U.S. and European-based pharmaceutical companies, which are: AbbVie Inc., Amgen Inc., AstraZeneca PLC, Bristol-Myers Squibb Company, Eli Lilly and Company, GlaxoSmithKline plc, Johnson & Johnson, Merck & Co., Inc., Novartis AG, Roche Holding AG and Sanofi SA, the S&P 500 Index and the NYSE Arca Pharmaceutical Index (DRG index).
PEER GROUP PERFORMANCE GRAPH The following graph assumes a $100 investment on December 31, 2018, and reinvestment of all dividends, in each of the Company’s Common Stock, a composite peer group of the major U.S. and European-based pharmaceutical companies, which are: AbbVie Inc., Amgen Inc., AstraZeneca PLC, Bristol-Myers Squibb Company, Eli Lilly and Company, GSK plc, Johnson & Johnson, Merck & Co., Inc., Novartis AG, Novo Nordisk, Roche Holding AG and Sanofi SA, the S&P 500 Index and the NYSE Arca Pharmaceutical Index (DRG index).
ITEM 5. MARKET FOR THE COMPANY’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES The principal market for our common stock is the NYSE. Our common stock currently trades on the NYSE under the symbol “PFE”. As of February 21, 2023, there were 128,767 holders of record of our common stock.
ITEM 5. MARKET FOR THE COMPANY’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES The principal market for our common stock is the NYSE. Our common stock currently trades on the NYSE under the symbol “PFE”. As of February 15, 2024, there were 123,387 holders of record of our common stock.
Pfizer Inc. 2022 Form 10-K 24 (b) Represents (i) 473,126 shares of common stock surrendered to the Company to satisfy tax withholding obligations in connection with the vesting of awards under our long-term incentive programs and (ii) the open market purchase by the trustee of 2,064 shares of common stock in connection with the reinvestment of dividends paid on common stock held in trust for employees who deferred receipt of performance share awards.
(b) Represents (i) 49,685 shares of common stock surrendered to the Company to satisfy tax withholding obligations in connection with the vesting of awards under our long-term incentive programs and (ii) the open market purchase by the trustee of 2,811 shares of common stock in connection with the reinvestment of dividends paid on common stock held in trust for employees who deferred receipt of performance share awards.
The following summarizes purchases of our common stock during the fourth quarter of 2022 (a) : Period Total Number of Shares Purchased (b) Average Price Paid per Share (b) Total Number of Shares Purchased as Part of Publicly Announced Plan Approximate Value of Shares that May Yet Be Purchased Under the Plan (a) October 3 through October 30, 2022 19,483 $ 43.68 — $ 3,292,882,444 October 31 through November 30, 2022 39,821 $ 47.85 — $ 3,292,882,444 December 1 through December 31, 2022 415,886 $ 51.29 — $ 3,292,882,444 Total 475,190 $ 50.69 — (a) See Note 12 .
The following summarizes purchases of our common stock during the fourth quarter of 2023 (a) : Period Total Number of Shares Purchased (b) Average Price Paid per Share (b) Total Number of Shares Purchased as Part of Publicly Announced Plan Approximate Value of Shares that May Yet Be Purchased Under the Plan (a) October 2 through October 29, 2023 12,222 $ 32.93 — $ 3,292,882,444 October 30 through November 30, 2023 25,825 $ 29.95 — $ 3,292,882,444 December 1 through December 31, 2023 14,449 $ 28.58 — $ 3,292,882,444 Total 52,496 $ 30.26 — (a) See Note 12 .

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

54 edited+26 added−28 removed28 unchanged
Biggest changeIncome from Continuing Operations Before Provision/(Benefit) for Taxes on Income –– The increase in Income from continuing operations before provision/(benefit) for taxes on income of $10.4 billion, to $34.7 billion in 2022 from $24.3 billion in 2021, was primarily attributable to higher revenues and lower Acquired in-process research and development expenses , partially offset by (i) an increase in Cost of sales, (ii) net losses on equity securities in 2022 versus net gains on equity securities in 2021, (iii) lower net periodic benefit credits associated with pension and other postretirement plans, and (iv) increases in Research and development expenses, Selling, informational and administrative expenses, and Restructuring charges and certain acquisition-related costs.
Biggest changeIncome from Continuing Operations Before Provision/(Benefit) for Taxes on Income –– The decrease in Income from continuing operations before provision/(benefit) for taxes on income of $33.7 billion, to $1.1 billion in 2023 from $34.7 billion in 2022, was primarily attributable to (i) lower revenues, (ii) higher intangible asset impairment charges, and (iii) increases in Restructuring charges and certain acquisition-related costs , Amortization of intangible assets , and Selling, informational and administrative expenses, partially offset by (iv) a decrease in Cost of sales and (v) net gains on equity securities in 2023 versus net losses on equity securities in 2022 .
Clinical trials are conducted to determine, among other things, whether an investigational drug or device is safe and effective for a particular patient population. After a product has been approved or authorized and launched, we continue to monitor its safety as long as it is available to patients, including conducting postmarketing trials, voluntarily or pursuant to a regulatory request.
Clinical trials are conducted to determine, among other things, whether an investigational drug, vaccine or device is safe and effective for a particular patient population. After a product has been approved or authorized and launched, we continue to monitor its safety as long as it is available to patients, including conducting postmarketing trials, voluntarily or pursuant to a regulatory request.
While as of now, we do not anticipate any significant negative impacts on our business from this conflict, continued regional instability, geopolitical shifts, potential additional sanctions and other restrictive measures against Russia, neighboring countries or allies of Russia, any retaliatory measures taken by Russia, neighboring countries or allies of Russia, and actions by our customers or suppliers in response to such measures could adversely affect the global macroeconomic environment, our operations, currency exchange rates and financial markets, which could in turn adversely impact our business and results of operations.
While as of now, we do not anticipate any significant negative impacts on our global operations from this conflict, continued regional instability, geopolitical shifts, potential additional sanctions and other restrictive measures against Russia, neighboring countries or allies of Russia, any retaliatory measures taken by Russia, neighboring countries or allies of Russia, and actions by our customers or suppliers, including financial institutions, in response to such measures could adversely affect the global macroeconomic environment, our operations, currency exchange rates and financial markets, which could in turn adversely impact our business and results of operations.
Intellectual Property Rights and Collaboration/Licensing Rights –– The loss, expiration or invalidation of intellectual property rights, patent litigation settlements and the expiration of co-promotion and licensing rights can have a material adverse effect on our revenues.
Intellectual Property Rights and Collaboration/Licensing Rights –– The loss, expiration or invalidation of intellectual property rights, patent litigation settlements and judgments, and the expiration of co-promotion and licensing rights can have a material adverse effect on our revenues.
Certain of our products have experienced patent-based expirations or loss of regulatory exclusivity in certain markets in the last few years, and we expect certain products to face increased generic competition over the next few years. While additional patent expiries will continue, we expect a moderate impact of reduced revenues due to patent expiries from 2023 through 2025.
Certain of our products have experienced patent-based expirations or loss of regulatory exclusivity in certain markets in the last few years, and we expect certain products to face increased generic competition over the next few years. While additional patent expiries will continue, we expect a moderate impact of reduced revenues due to patent expiries from 2024 through 2025.
In addition, we continually seek to expand and broaden our product portfolio offerings through prioritized development of our pipeline and acquisitions targeted at critical unmet patient needs. As a result, our commercial organizational structure and R&D operations are critical to the successful execution of our business strategy.
In addition, we continually seek to expand and broaden our product portfolio offerings through prioritized development of our pipeline and business development opportunities targeted at critical unmet patient needs. As a result, our commercial organizational structure and R&D operations are critical to the successful execution of our business strategy.
This could result, for example, from a change in a government reimbursement program that results in an inability to sustain projected product revenues and profitability. This also could result from the introduction of a competitor’s product that impacts projected revenue growth, as well as the lack of acceptance of a product by patients, physicians and payers.
This could result, for example, from a change in a government reimbursement program that results in an inability to sustain projected product revenues and profitability. This also could result from the introduction of a competitor’s product that impacts projected revenue growth, as well as the lack of acceptance of a product by patients, physicians and payors.
For the years ended December 31, 2022 and 2021, the business of our Russia and Ukraine subsidiaries represented less than 1% of our consolidated revenues and assets, and while we are monitoring the effects of the armed conflict between Russia and Ukraine, the situation continues to evolve and the long-term implications, including the broader economic consequences of the conflict, are difficult to predict at this time.
For the years ended December 31, 2023 and 2022, the business of our Russia and Ukraine subsidiaries represented less than 1% of our consolidated revenues and assets, and while we are monitoring the effects of the conflict between Russia and Ukraine, the situation continues to evolve and the long-term implications, including the broader economic consequences of the conflict, are difficult to predict at this time.
Financial Statements and Supplementary Data in this Form 10-K. Discussions of 2020 items and year-to-year comparisons between 2021 and 2020 that are not included in this Form 10-K can be found within MD&A in our 2021 Form 10-K.
Financial Statements and Supplementary Data in this Form 10-K. Discussions of 2021 items and year-to-year comparisons between 2022 and 2021 that are not included in this Form 10-K can be found within MD&A in our 2022 Form 10-K.
R&D is at the heart of fulfilling our purpose to deliver breakthroughs that change patients’ lives as we work to translate advanced science and technologies into the therapies that may be the most impactful for patients. Innovation, drug discovery and development are critical to our success.
R&D is at the heart of fulfilling our purpose to deliver breakthroughs that change patients’ lives as we work to translate advanced science and technologies into the medicines and vaccines that may be the most impactful for patients. Innovation, drug discovery and development are critical to our success.
Certain factors in the global economic environment that may impact our global operations include, among other things, currency fluctuations, capital and exchange controls, local and global economic conditions including inflation, recession, volatility and/or lack of liquidity in capital markets, expropriation and other restrictive government actions, changes in intellectual property, legal protections and remedies, trade regulations, tax laws and regulations and procedures and actions affecting approval, production, pricing, and marketing of, reimbursement for and access to our products, as well as impacts of political or civil unrest or military action, including the ongoing conflict between Russia and Ukraine and its economic consequences, geopolitical instability, terrorist activity, unstable governments and legal systems, inter-governmental disputes, public health outbreaks, epidemics, pandemics, natural disasters or disruptions related to climate change.
Certain factors in the global economic environment that may impact our global operations include, among other things, currency and interest rate fluctuations, capital and exchange controls, local and global economic conditions including inflation, recession, volatility and/or lack of liquidity in capital markets, expropriation and other restrictive government actions, changes in intellectual property, legal protections and remedies, trade regulations, tax laws and regulations and procedures and actions affecting approval, production, pricing, and marketing of, reimbursement for and access to our products, as well as impacts of political or civil unrest or military action, including the ongoing conflicts between Russia and Ukraine and in the Middle East and their economic consequences, geopolitical instability, terrorist activity, unstable governments and legal systems, inter-governmental disputes, public health outbreaks, epidemics, pandemics, natural disasters or disruptions related to climate change.
Government pressures can lead to negative pricing pressure in various markets where governments take an active role in setting prices, access criteria or other means of cost control. For additional information on risks related to our global operations, see the Item 1A. Risk Factors — Global Operations section in this Form 10-K.
Government pressures can lead to negative pricing pressure in various markets where governments take an active role in setting prices, access criteria or other means of cost control. For additional information on risks related to our global operations, see the Item 1A. Risk Factors—Global Operations section.
In addition to discovering and developing new products, our R&D efforts seek to add value to our existing products by improving their effectiveness and ease of dosing and by discovering potential new indications. See the Item 1. Business — Research and Development section in this Form 10-K for our R&D priorities and strategy.
In addition to discovering and developing new products, our R&D efforts seek to add value to our existing products by improving their effectiveness and ease of dosing and by discovering potential new indications. See the Item 1. Business — Research and Development section for our R&D priorities and strategy.
We assess our business, assets and scientific capabilities/portfolio as part of our regular, ongoing portfolio review process and also continue to consider business development activities that will help advance our business strategy. For additional information, including discussion of recent significant business development activities, see Note 2 .
We assess our business, assets and scientific capabilities/portfolio as part of our regular, ongoing portfolio review process and also continue to consider business development activities that will help advance our business strategy. For a discussion of recent significant business development activities, see Note 2 .
Regulatory Environment/Pricing and Access––Government and Other Payer Group Pressures –– The pricing of medicines and vaccines by pharmaceutical manufacturers and the cost of healthcare, which includes medicines, vaccines, medical services and hospital services, continues to be important to payers, governments, patients, and other stakeholders.
Regulatory Environment/Pricing and Access––Government and Other Payor Group Pressures –– The pricing of medicines and vaccines by pharmaceutical manufacturers and the cost of healthcare, which includes medicines, vaccines, medical services and hospital services, continues to be important to payors, governments, patients, and other stakeholders.
While all intangible assets other than goodwill can face events and circumstances that can lead to impairment, those that are most at risk of impairment include IPR&D assets (approximately $11.4 billion as of December 31, 2022) and newly acquired or recently impaired indefinite-lived brand assets. IPR&D assets are high-risk assets, given the uncertain nature of R&D.
While all intangible assets other than goodwill can face events and circumstances that can lead to impairment, those that are most at risk of impairment include IPR&D assets (approximately $23.2 billion as of December 31, 2023) and newly acquired or recently impaired indefinite-lived brand assets. IPR&D assets are high-risk assets, given the uncertain nature of R&D.
We are continuing to monitor and implement mitigation strategies in an effort to reduce any potential risk or impact including active supplier management, qualification of additional suppliers and advanced purchasing to the extent possible. For information on risks related to product manufacturing, see the Item 1A. Risk Factors––Product Manufacturing, Sales and Marketing Risks section in this Form 10-K.
We continue to monitor and implement mitigation strategies in an effort to reduce any potential risk or impact including active supplier management, qualification of additional suppliers and advanced purchasing to the extent possible. For information on risks related to product manufacturing, see the Item 1A. Risk Factors––Product Manufacturing, Sales and Marketing Risks section.
Goodwill ––Our goodwill impairment review work as of December 31, 2022 concluded that none of our goodwill was impaired and we do not believe the risk of impairment is significant at this time, as the fair value of each of our reporting units is significantly higher than their respective net book values.
Pfizer Inc. 2023 Form 10-K 34 Goodwill ––Our goodwill impairment review work as of December 31, 2023 concluded that none of our goodwill was impaired and we do not believe the risk of impairment is significant at this time, as the fair value of each of our reporting units is significantly higher than their respective net book values.
Internationally, we expect sales of Comirnaty in international developed markets to generally be under government contracts in 2023, and in emerging markets, under a combination of private channels and government contracts; in both cases, we expect to generally transition to commercial markets starting in 2024.
Internationally, sales of Comirnaty in international developed markets were generally under government contracts in 2023, and in emerging markets, under a combination of private channels and government contracts; in both cases, we expect to start transitioning to commercial markets in 2024.
For a discussion of a recently adopted accounting standard, see Note 1B . Acquisitions We account for acquired businesses using the acquisition method of accounting, which requires, among other things, that most assets acquired and liabilities assumed be recognized at their estimated fair value as of the acquisition date.
For a discussion of recently adopted accounting standards, see Note 1B . Pfizer Inc. 2023 Form 10-K 33 Acquisitions We account for acquired businesses using the acquisition method of accounting, which requires, among other things, that most assets acquired and liabilities assumed be recognized at their estimated fair value as of the acquisition date.
Governments globally, as well as private third-party payers in the U.S., may use a variety of measures to control costs, including, among others, proposing pricing reform or legislation, employing formularies to control costs, cross country collaboration and procurement, price cuts, mandatory rebates, health technology assessments, forced localization as a condition of market access, “international reference pricing” (i.e., the practice of a country linking its regulated medicine prices to those of other countries), QCE processes and VBP.
Governments globally, as well as private third-party payors in the U.S., may use a variety of measures to control costs, including, among others, legislative or regulatory pricing reforms, drug formularies (including tiering and utilization management tools), cross country collaboration and procurement, price cuts, mandatory rebates, health technology assessments, forced localization as a condition of market access, “international reference pricing” (i.e., the practice of a country linking its regulated medicine prices to those of other countries), QCE processes and VBP.
For additional information on patent rights we consider most significant to our business as a whole, see the Item 1. Business––Patents and Other Intellectual Property Rights section in this Form 10-K. For a discussion of recent developments with respect to patent litigation, see Note 16 A1 .
For additional information on patent rights we consider most significant to our business as a whole, see the Item 1. Business––Patents and Other Intellectual Property Rights section. For a discussion of recent developments with respect to patent litigation, see Note 16A1 .
Our ability to fulfill our purpose, Breakthroughs that change patients’ lives , remains a core focus and underscores our commitment to addressing the needs of society to help sustain long-term value creation for all stakeholders. Most of our revenues come from the manufacture and sale of biopharmaceutical products.
Our ability to fulfill our purpose, Breakthroughs that change patients’ lives , remains a core focus and underscores our commitment to addressing the needs of society to help sustain long-term value creation for all stakeholders.
We believe that our medicines and vaccines provide significant value for healthcare providers and patients and seek to enhance their value by continuously evaluating how we can best collaborate with patients, physicians and payers to support and expand patient access to reliable, affordable healthcare around the world.
We believe that our medicines and vaccines provide significant value for healthcare providers and patients and continuously evaluate how we can best collaborate with patients, physicians and payors to support and expand patient access to reliable, affordable healthcare around the world.
As a science-driven global biopharmaceutical company, we remain focused on advancing our pipeline, supporting our marketed brands and deploying capital responsibly, with a focus on initiatives that can help contribute to our long-term revenue and future growth.
As a science-driven global biopharmaceutical company, we remain focused on advancing our pipeline, supporting our marketed brands and deploying capital responsibly, with a focus on initiatives that can help contribute to our long-term revenue and future growth. Most of our revenues come from the manufacture and sale of biopharmaceutical products.
Examples of events or circumstances that may be indicative of impairment include: • A significant adverse change in legal factors or in the business climate that could affect the value of the asset.
Our impairment review processes are described in Note 1M . Examples of events or circumstances that may be indicative of impairment include: • A significant adverse change in legal factors or in the business climate that could affect the value of the asset.
See the Revenues by Geography and Revenues –– Selected Product Discussion sections within MD&A for more information, including a discussion of key drivers of our revenue performance. See also The Global Economic Environment––COVID-19 section below for information about our COVID-19 products, including expectations for 2023.
The following chart outlines the components of the net change in Total revenues : See the Total Revenues by Geography and Total Revenues––Selected Product Discussion sections within MD&A for more information, including a discussion of key drivers of our revenue performance. See also The Global Economic Environment––COVID-19 section below for information about our COVID-19 products.
Regulatory Environment––Pipeline Productivity –– Our product lines must be replenished over time to offset revenue losses when products lose exclusivity or market share or to respond to healthcare and innovation trends, as well as to provide for earnings growth.
Regulatory Environment––Pipeline Productivity –– Our product lines must be replenished over time to offset revenue losses when products lose exclusivity or market share or to respond to healthcare and innovation trends, as well as to provide for earnings growth, primarily through internal R&D or through collaborations, acquisitions, JVs, licensing or other arrangements.
Of these policies, the following are considered critical to an understanding of our consolidated financial statements as they require the application of the most subjective and the most complex judgments: Acquisitions ( Note 1 D ); Fair Value ( Note 1 E ); Revenues ( Note 1 G ); Asset Impairments ( Note 1 M ); Tax Assets and Liabilities and Income Tax Contingencies ( Note 1 Q ); Pension and Postretirement Benefit Plans ( Note 1 R ); and Legal and Environmental Contingencies ( Note 1 S ).
Of these policies, the following are considered critical to an understanding of our consolidated financial statements as they require the application of the most subjective and the most complex judgments: Acquisitions ( Note 1D ); Fair Value ( Note 1E ); Revenues ( Note 1G ); Asset Impairments ( Note 1M ); Tax Assets and Liabilities and Income Tax Contingencies ( Note 1Q ); Pension and Postretirement Benefit Plans ( Note 1R ); and Legal and Environmental Contingencies ( Note 1S ).
See Note 3 for additional information. For a description of savings related to this Pfizer Inc. 2022 Form 10-K 26 program, see the Costs and Expenses––Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives section of this MD&A . R&D: We believe we have a strong pipeline and are well-positioned for future growth.
See Note 3 . For a description of savings related to these programs, see the Costs and Expenses––Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives section within MD&A . R&D: We believe we have a strong pipeline and are well-positioned for future growth.
In addition, changes to the Medicaid program or the federal 340B drug pricing program, including legal or legislative developments at the federal or state level with respect to the 340B program, could have a material impact on our business. For additional information, see the Item 1.
In addition, changes to the Medicaid Drug Rebate program or the 340B Program, including legal or legislative developments at the federal or state level with respect to the 340B program, could have a material impact on our business. See the Item 1. Business –– Pricing Pressures and Managed Care Organizations and ––Government Regulation and Price Constraints and the Item 1A.
Pfizer Inc. 2022 Form 10-K 25 OVERVIEW OF OUR PERFORMANCE, OPERATING ENVIRONMENT, STRATEGY AND OUTLOOK Financial Highlights –– The following is a summary of certain financial performance metrics (in billions, except per share data): 2022 Total Revenues––$100.3 billion 2022 Net Cash Flow from Operations––$29.3 billion An increase of 23% compared to 2021 A decrease of 10% compared to 2021 2022 Reported Diluted EPS––$5.47 2022 Adjusted Diluted EPS (Non-GAAP)––$6.58* An increase of 42% compared to 2021 An increase of 62% compared to 2021 * For additional information regarding Adjusted diluted EPS (which is a non-GAAP financial measure), including reconciliations of certain GAAP Reported to non-GAAP Adjusted information, see the Non-GAAP Financial Measure: Adjusted Income section within MD&A.
OVERVIEW OF OUR PERFORMANCE, OPERATING ENVIRONMENT, STRATEGY AND OUTLOOK Financial Highlights –– The following is a summary of certain financial performance metrics (in billions, except per share data): 2023 Total Revenues––$58.5 billion 2023 Net Cash Flow from Operations––$8.7 billion A decrease of 42% compared to 2022 A decrease of 70% compared to 2022 2023 Reported Diluted EPS––$0.37 2023 Adjusted Diluted EPS (Non-GAAP)––$1.84* A decrease of 93% compared to 2022 A decrease of 72% compared to 2022 * For additional information regarding Adjusted diluted EPS (which is a non-GAAP financial measure), including reconciliations of certain GAAP Reported to non-GAAP Adjusted information, see the Non-GAAP Financial Measure: Adjusted Income section within MD&A.
COVID-19 ––In response to COVID-19, we have developed Paxlovid and collaborated with BioNTech to jointly develop Comirnaty, including booster doses of an Omicron-adapted bivalent vaccine. As part of our strategy for COVID-19, we are continuing to make significant additional Pfizer Inc. 2022 Form 10-K 28 investments in breakthrough science and global manufacturing.
COVID-19 ––In response to COVID-19, we developed Paxlovid and collaborated with BioNTech to jointly develop Comirnaty, including an Omicron XBB.1.5-adapted monovalent vaccine. As part of our strategy for COVID-19, we are continuing to make significant investments in breakthrough science and global manufacturing.
Product-specific rebates, however, can have a significant impact on year-over-year individual product revenue growth trends. If any of our ratios, factors, assessments, experiences or judgments are not indicative or accurate estimates of our future experience, our results could be materially affected. The potential of our estimates to vary (sensitivity) differs by program, product, type of customer and geographic location.
If any of our ratios, factors, assessments, experiences or judgments are not indicative or accurate estimates of our future experience, our results could be materially affected. The potential of our estimates to vary (sensitivity) differs by program, product, type of customer and geographic location. However, estimates associated with U.S.
However, estimates associated with U.S. Medicare, Medicaid and performance-based contract rebates are most at risk for material adjustment because of the extensive time delay between the recording of the accrual and its ultimate settlement, an interval that can generally range up to one year.
Medicare, Medicaid and performance-based contract rebates are most at risk for material adjustment because of the extensive time delay between the recording of the accrual and its ultimate settlement, an interval that can generally range up to one year. Because of this lag, our recording of adjustments to reflect actual amounts can incorporate revisions of several prior quarters.
Regarding our supply chain generally, in 2022 and to date, we have not seen a significant disruption, and all of our manufacturing sites globally have continued to operate at or near normal levels; however, we are seeing an increase in overall demand in the industry for certain components and raw materials, which could potentially result in constraining available supply leading to a possible future impact on our business.
Except for the tornado in Rocky Mount, NC discussed above, we have not seen a significant disruption of our supply chain in 2023 and through the date of filing of this Form 10-K, and all of our manufacturing sites globally have continued to operate at or near normal levels; however, we continue to see heightened demand in the industry for certain components and raw materials, which could potentially result in constraining available supply leading to a possible future impact on our business.
Pfizer Inc. 2022 Form 10-K 30 For all of our reporting units, there are a number of future events and factors that may impact future results and that could potentially have an impact on the outcome of subsequent goodwill impairment testing.
For all of our reporting units, there are a number of future events and factors that may impact future results and that could potentially have an impact on the outcome of subsequent goodwill impairment testing. For a list of these factors, see the Forward-Looking Information and Factors That May Affect Future Result s and the
To estimate fair value, we utilize an exit price approach from the perspective of a market participant. For further detail on acquisition accounting, see Note 1 D . For further detail on the techniques and methodologies that we use to estimate fair value, see Note 1 E .
To estimate fair value, we utilize an exit price approach from the perspective of a market participant. For further detail on acquisition accounting, see Note 1D . For further detail on the techniques and methodologies that we use to estimate fair value, see Note 1E . Historically, intangible assets have been the most significant fair values within our business combinations.
In the third quarter of 2022, we made several organizational changes to further transform our operations to better leverage our expertise in certain areas and in anticipation of potential future new product or indication launches, and in the fourth quarter of 2022, we began taking steps to optimize our end-to-end R&D operations to reduce costs and cycle times as well as to further prioritize our internal R&D portfolio in areas where our capabilities are differentiated while increasing external innovation efforts to leverage an expanding and productive biotech sector.
In the fourth quarter of 2022, we began taking steps through our Transforming to a More Focused Company restructuring program to optimize our end-to-end R&D operations to reduce costs and cycle times as well as to further prioritize our internal R&D portfolio in areas where our capabilities are differentiated while increasing external innovation efforts to leverage an expanding and productive biotech sector.
This includes continuing to evaluate Comirnaty and Paxlovid, including against new variants of concern, developing monovalent, bivalent and variant adapted vaccine candidates and booster doses and developing potential combination respiratory vaccines and potential next generation vaccines and therapies. We are also evaluating Paxlovid for additional populations.
This includes continuing to evaluate Comirnaty and Paxlovid, including against new variants of concern, developing variant adapted vaccine candidates and developing potential combination respiratory vaccines and potential next generation vaccines and therapies. We are also evaluating Paxlovid for additional populations. See the Product Developments section within MD&A. In 2023, we principally sold Comirnaty globally under government contracts.
We anticipate that these and similar initiatives will continue to increase pricing and access pressures globally. In the U.S., we expect to see continued focus by Congress and the Biden Administration on regulating pricing, which could result in legislative and regulatory changes designed to control costs, such as the IRA that was signed into law in August 2022.
We anticipate that these and similar initiatives will continue to increase pricing and access pressures globally. In the U.S., we expect to see continued focus by Congress and the Biden Administration on regulating pricing.
We apply science and our global resources to bring therapies to people that extend and significantly improve their lives. See the Item 1 . Business –– About Pfizer section in this Form 10-K. Pfizer is committed to working towards equitable and affordable access to our medicines and vaccines for people around the world.
We apply science and our global resources to bring therapies to people that extend and significantly improve their lives. See the Item 1. Business ––About Pfizer section.
Federal and state governments and private third-party payers in the U.S. continue to take action to manage the utilization of drugs and cost of drugs, including increasingly employing formularies to control costs by taking into account discounts in connection with decisions about formulary inclusion or favorable formulary placement.
Federal and state governments and private third-party payors in the U.S. continue to take action to manage the utilization and cost of drugs, including increasingly employing formularies to control costs and encourage utilization of certain drugs, including through the use of deductibles, utilization management tools, cost sharing or formulary placement.
We expect sales of Comirnaty in the U.S. will transition to traditional commercial market sales in the second half of 2023, triggered by the expiration of current contracts and the vaccines purchased through them becoming either depleted or not usable against new variants.
In September 2023, Comirnaty transitioned to traditional commercial market sales in the U.S., triggered by the expiration of current contracts and the COVID-19 vaccines from Pfizer and BioNTech purchased through them becoming either depleted or not used following the introduction of a new variant vaccine.
When necessary, we record charges for impairments of long-lived assets for the amount by which the fair value is less than the carrying value of these assets. Our impairment review processes are described in Note 1M .
We perform impairment testing for indefinite-lived intangible assets and goodwill at least annually and for all other long-lived assets whenever impairment indicators are present. When necessary, we record charges for impairments of long-lived assets for the amount by which the fair value is less than the carrying value of these assets.
See the Analysis of the Consolidated Statements of Income within MD&A and Note 4 for additional information. See also The Global Economic Environment––COVID-19 section below for information about our COVID-19 products, including expectations for 2023. For information on our tax provision and effective tax rate, see the Provision/(Benefit) for Taxes on Income section within MD&A and Note 5 .
See the Analysis of the Consolidated Statements of Income section within MD&A and Note 4 . For information on our tax provision and effective tax rate, see the Provision/(Benefit) for Taxes on Income section within MD&A and Note 5 . Our Operating Environment ––We, like other businesses in our industry, are subject to certain industry-specific challenges.
Some of Pfizer Inc. 2022 Form 10-K 29 the more significant estimates and assumptions inherent in this approach include the amount and timing of projected net cash flows, the discount rate and the tax rate. For further information on our process to estimate the fair value of intangible assets, see Asset Impairments below.
We utilize an income approach to estimate the acquisition date fair value of each identifiable intangible asset. Some of the more significant estimates and assumptions inherent in this approach include the amount and timing of projected net cash flows, the discount rate, the tax rate, and, for IPR&D assets, the probability of technical and regulatory success (PTRS).
These deductions represent estimates of the related obligations and, as such, knowledge and judgment are required when estimating the impact of these revenue deductions on gross sales for a reporting period. Historically, adjustments to these estimates to reflect actual results or updated expectations, have not been material to our overall business and generally have been less than 1% of revenues.
Historically, adjustments to these estimates to reflect actual results or updated expectations, have not been material to our overall business and generally have been less than 1% of revenues. Product-specific rebates, however, can have a significant impact on year-over-year individual product revenue growth trends.
Pfizer Inc. 2022 Form 10-K 27 Our Operating Environment ––We, like other businesses in our industry, are subject to certain industry-specific challenges. These include, among others, the topics listed below. See also the Item 1. Business––Government Regulation and Price Constraints and Item 1A. Risk Factors sections in this Form 10-K.
These include, among others, the topics listed below. See also the Item 1. Business––Government Regulation and Price Constraints and Item 1A. Risk Factors sections.
For further information, see the Revenue Deductions section within MD&A and Note 1 G . Asset Impairments We review all of our long-lived assets for impairment indicators throughout the year. We perform impairment testing for indefinite-lived intangible assets and goodwill at least annually and for all other long-lived assets whenever impairment indicators are present.
Rebate accruals are product specific and, therefore for any period, are impacted by the mix of products sold as well as the forecasted channel mix for each individual product. For further information, see the Product Revenue Deductions section within MD&A and Note 1G . Asset Impairments We review all of our long-lived assets for impairment indicators throughout the year.
Our 2022 Performance Revenues ––Revenues increased $19.0 billion, or 23%, to $100.3 billion in 2022 from $81.3 billion in 2021, reflecting an operational increase of $24.6 billion, or 30%, as well as an unfavorable impact of foreign exchange of $5.5 billion, or 7%. The operational increase was primarily driven by growth from Paxlovid and Comirnaty.
Our 2023 Performance Total Revenues ––Total revenues decreased $41.8 billion, or 42%, to $58.5 billion in 2023 from $100.3 billion in 2022, reflecting an operational decrease of $40.8 billion, or 41%, as well as an unfavorable impact of foreign exchange of $1.0 billion, or 1%.
Revenues Our gross product revenues are subject to a variety of deductions, which generally are estimated and recorded in the same period that the revenues are recognized. Such variable consideration represents chargebacks, rebates, sales allowances and sales returns.
We expect to finalize the amounts of assets acquired and liabilities assumed as soon as possible but no later than one year from the acquisition date. Revenues Our gross product revenues are subject to a variety of deductions, which generally are estimated and recorded in the same period that the revenues are recognized.
Future developments could result in additional favorable or unfavorable impacts on our business, operations or financial condition and results. For information on risks associated with COVID-19 and our COVID-19 products, as well as COVID-19 intellectual property disputes, see the Item 1A.
For information on risks associated with our COVID-19 products, including certain assumptions made for purposes of our operational planning and financial projections and the uncertainty of future developments, as well as COVID-19 intellectual property disputes, see the Item 1A. Risk Factors — COVID-19 , — Intellectual Property Protection and –– Third-Party Intellectual Property Claims sections and Note 16A1 .
Excluding the impact of Paxlovid and Comirnaty, revenues increased 2% operationally, reflecting strong growth in the Prevnar family, Eliquis and the Vyndaqel family, as well as revenue from recently acquired products, Nurtec ODT/Vydura and Oxbryta, partially offset by declines in Xeljanz, Chantix/Champix, Sutent, certain Comirnaty-related manufacturing activities performed on behalf of BioNTech (which are included in the PC1 contract development and manufacturing organization) and Ibrance.
Excluding contributions from Comirnaty and Paxlovid, Total revenues increased 7% operationally, reflecting an increase in revenues from Nurtec ODT/Vydura and Oxbryta; revenues from Abrysvo, primarily driven by the launch of the older adult indication in the U.S.; as well as continued growth from the Vyndaqel family and Eliquis; partially offset by a decline in Ibrance.
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In 2023, we are making additional investments in both R&D and SI&A to support Pfizer’s near- and longer-term growth plans, including to support anticipated new launches, commercial launch of COVID-19 products, potential high-value pipeline programs and recently acquired assets.
Added
Our 2024 key priorities are: • Achieve world-class oncology leadership • Deliver next wave of pipeline innovation • Maximize performance of our new products • Expand margins by realigning our cost base • Allocate capital to enhance shareholder value Pfizer Inc. 2023 Form 10-K 30 In 2023, we managed our commercial operations through a global structure consisting of two operating segments: Biopharma and Business Innovation.
Removed
With the formation of the Consumer Healthcare JV in 2019, the spin-off of our former Upjohn Business in the fourth quarter of 2020 and the sale of our Meridian subsidiary in the fourth quarter of 2021, Pfizer transformed into a more focused, global leader in science-based innovative medicines and vaccines engaged in the discovery, development, manufacture, marketing, sale and distribution of biopharmaceutical products worldwide.
Added
Biopharma was the only reportable segment. See Note 1A and the Item 1. Business––Commercial Operations section. In December 2023, we completed our acquisition of Seagen. At the beginning of 2024, we made changes in our commercial organization that went into effect on January 1, 2024 to incorporate Seagen and improve focus, speed and execution.
Removed
In the fourth quarter of 2021, we began managing our commercial operations through a global structure consisting of two operating segments: Biopharma and PC1. Biopharma is the only reportable segment. See Note 1A and Item 1. Business––Commercial Operations in this Form 10-K for additional information.
Added
Specifically, within our Biopharma reportable segment we created: • the Pfizer Oncology Division, which brings together U.S. oncology commercial operations from both Pfizer and Seagen and is led by the Chief Oncology Officer, Executive Vice President, who also leads Pfizer’s newly combined global oncology R&D operations; • the Pfizer U.S.
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We expect to incur costs of approximately $700 million in connection with separating Upjohn, of which approximately 85% has been incurred since inception and through December 31, 2022. These charges include costs and expenses related to separation of legal entities and transaction costs.
Added
Commercial Division, which focuses on the commercialization of non-oncology products in the U.S. and is led by the Chief U.S. Commercial Officer, Executive Vice President; and • the Pfizer International Commercial Division, which focuses on the commercialization of Pfizer’s entire product portfolio outside the U.S. and is led by the Chief International Commercial Officer, Executive Vice President.
Removed
Beginning in 2019, we took action through our Transforming to a More Focused Company restructuring program to ensure our cost base and support model aligned appropriately with our operating structure.
Added
Beginning in July 2023, in consideration of planned future investments in oncology, including the acquisition of Seagen on December 14, 2023, we reorganized our R&D platform operations. See Note 17A . In the fourth quarter of 2023, we announced that we launched a multi-year, enterprise-wide cost realignment program that aims to realign our costs with our longer-term revenue expectations.
Removed
The following outlines the components of the net change in revenues: As of January 31, 2023, on a total company basis, we forecasted revenues in 2023 of $67 billion to $71 billion, reflecting an operational decline of 31% at the midpoint from 2022 results, which we expect will also have an unfavorable impact on Income from continuing operations before provision/(benefit) for taxes on income .
Added
The operational decrease was primarily driven by significant declines in revenues from Comirnaty and Paxlovid, including a $3.5 billion non-cash revenue reversal for Paxlovid recorded in the fourth quarter of 2023.
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The total company expected revenue declines in 2023 are driven by an expected reduction in sales of our COVID-19 products, partially offset by expected operational growth from our non-COVID-19 in-line portfolio, anticipated new product launches, and recently acquired products.
Added
For information regarding the primary indications or class of certain products, see Note 17C . Pfizer Inc. 2023 Form 10-K 31 While royalty income through December 31, 2023 has been recorded in Other Income/(Deductions)—net , we will begin reporting such royalty income in Total revenues beginning in 2024 and will restate prior periods for consistency with our 2024 presentation.
Removed
For information regarding the primary indications or class of certain products, see Note 17 C .
Added
Additionally, we will no longer record royalties from U.S. sales of Bavencio, as we have irrevocably chosen to donate the right to such royalties to the American Association for Cancer Research.
Removed
Business –– Pricing Pressures and Managed Care Organizations and ––Government Regulation and Price Constraints and the Item 1A. Risk Factors –– Pricing and Reimbursement sections in this Form 10-K. Product Supply –– We periodically encounter supply delays, disruptions and shortages, including due to voluntary product recalls.
Added
The drug pricing provisions of the IRA, which was signed into law in August 2022, began to be implemented in 2022 and implementation efforts will continue over the next several years.
Removed
In response to requests from various regulatory authorities, manufacturers across the pharmaceutical industry, including Pfizer, are evaluating their product portfolios for the potential presence or formation of nitrosamines.
Added
In August 2023, the Biden Administration unveiled the first ten medicines subject to the “Medicare Drug Price Negotiation Program,” which requires manufacturers of select drugs to engage in a process with the federal government to set new Medicare prices which would go into effect in 2026. Among the first ten medicines subject to the Program included Eliquis.
Removed
This has led to recalls, including our voluntary recall of Chantix in 2021 and additional voluntary recalls initiated for other products in 2022 due to the presence of nitrosamines above the FDA interim acceptable intake limit, and may lead to additional recalls or other market actions for Pfizer products.
Added
Risk Factors –– Pricing and Reimbursement sections. Impact of the July 2023 Tornado in Rocky Mount, North Carolina (NC) –– Our manufacturing facility in Rocky Mount, NC was damaged by a tornado in July 2023.
Removed
For additional information, including our continuing late-stage development efforts for Paxlovid, see the Product Developments section within MD&A. In 2022 and to date, we principally sold Comirnaty and Paxlovid globally under government contracts.
Added
The facility is a key producer of sterile injectables and is responsible for manufacturing nearly 25 percent of all our sterile injectables—including anesthesia, analgesia, and micronutrients—which is nearly eight percent of all the sterile injectables used in U.S. hospitals. While manufacturing has resumed, the supply of medicines impacted by the tornado is expected to be affected through 2024.
Removed
For Paxlovid, we expect 2023 to be a transitional year as we expect to start selling Paxlovid through the commercial channels in the second half of 2023 rather than significant government purchases. We also remain committed to helping ensure broad and equitable access to our COVID-19 products to eligible patients around the world.
Added
In 2023, we recorded $286 million to Cost of sales for inventory losses, overhead costs related to the period in which the facility could not operate, and incremental costs resulting from the tornado damage. Losses incurred in 2023 were partially offset by insurance recoveries received in the fourth quarter of 2023.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK The information required by this Item is incorporated by reference to the discussion in the Analysis of Financial Condition , Liquidity, Capital Resources and Market Risk section within MD&A. Pfizer Inc. 2022 Form 10-K 44
Biggest changeITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK The information required by this Item is incorporated by reference to the discussion in the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risk section within MD&A. Pfizer Inc. 2023 Form 10-K 49

Other PFE 10-K year-over-year comparisons