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What changed in Pfizer's 10-K2023 vs 2024

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Paragraph-level year-over-year comparison of Pfizer's 2023 and 2024 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 2024 report.

+298 added289 removedSource: 10-K (2025-02-27) vs 10-K (2024-02-22)

Top changes in Pfizer's 2024 10-K

298 paragraphs added · 289 removed · 222 edited across 9 sections

Item 1. Business

Business — how the company describes what it does

51 edited+7 added11 removed76 unchanged
Biggest change(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.
Biggest changeCHANGES IN LAWS AND ACCOUNTING STANDARDS Our future results could be adversely affected by changes in laws, regulations or policies, or their interpretation, including, among others, changes in accounting standards, tariffs, tax laws and regulations internationally and in the U.S., including, without limitation, the IRA, 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 laws, tariffs, competition laws, privacy laws and environmental laws or changes to other laws, regulations and policies in the U.S., including by the U.S.
LEGAL MATTERS We are and may be involved in various legal proceedings, including patent litigation, product liability and other product-related litigation, including personal injury, consumer, off-label promotion, securities, antitrust and breach of contract claims, commercial and other asserted and unasserted matters, environmental, government and tax investigations, employment, tax litigation and other legal proceedings that arise from time to time in the ordinary course of our business.
LEGAL MATTERS We are and may be involved in various legal proceedings, including patent litigation, product liability and other product-related litigation, including personal injury, consumer fraud, off-label promotion, securities, antitrust and breach of contract claims, commercial and other asserted and unasserted matters, environmental, government and tax investigations, employment litigation, tax litigation and other legal proceedings that arise from time to time in the ordinary course of our business.
For goodwill, all reporting units can confront events and circumstances that can lead to a goodwill impairment charge such as, among other things, unanticipated competition, an adverse action or assessment by a regulator, a significant adverse change in legal matters or in the business climate and/or a failure to replace the contributions of products that lose exclusivity.
For goodwill, all reporting units can confront events and circumstances that can lead to a goodwill impairment charge such as, among other things, unanticipated competition, an adverse action or assessment by a regulator, a significant adverse change in legal matters or in the business climate and/or a failure to replace the contributions of products that lose market exclusivity.
Other U.S. federal or state legislative or regulatory action and/or policy efforts could adversely affect our business, including, among others, general budget control actions, changes in patent laws, the importation of prescription drugs to the U.S. at prices that are regulated by foreign governments, revisions to reimbursement of biopharmaceuticals under government programs that could reference international prices or require new discounts, limitations on interactions with healthcare professionals and other industry stakeholders, or the use of comparative effectiveness methodologies that could be implemented in a manner that focuses primarily on cost differences and minimizes the therapeutic differences among pharmaceutical products and restricts access to innovative medicines.
Other U.S. federal or state legislative or regulatory action and/or policy efforts could adversely affect our business, including, among others, general budget control actions, changes in patent laws, the importation of prescription drugs to the U.S. at prices that are regulated by foreign governments, revisions to reimbursement of biopharmaceuticals under government programs that could reference international prices or require new discounts, limitations on interactions with healthcare professionals and other industry stakeholders, restrictions on pharmaceutical advertising, or the use of comparative effectiveness methodologies that could be implemented in a manner that focuses primarily on cost differences and minimizes the therapeutic differences among pharmaceutical products and restricts access to innovative medicines.
Further, if safety or efficacy concerns are raised about a product in the same class as one of our products, those concerns could implicate the entire class; and this, in turn, could have an adverse impact on the availability or commercial viability of our product(s) as well as other products in the class.
Further, if safety or efficacy concerns are raised about a product in the same class as one of our products, those concerns could implicate the entire class; and this, in turn, could have an adverse impact on the availability or commercial viability of our product(s) or product candidates as well as other products in the class.
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.
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 with the Office of the Inspector General of the HHS (OIG), which expired in May 2023.
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.
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 and manufacturing optimization 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.
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.
We have incurred substantial indebtedness to fund our 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 additional short-term indebtedness issued prior to the acquisition.
This focus on ESG matters may lead to new expectations or requirements that could result in increased costs associated with research, development, manufacture, or distribution of our products. Our ability to compete could also be affected by changing customer preferences and requirements, such as growing demand for companies to establish validated Net Zero targets or offer more sustainable products.
This focus may lead to new expectations or requirements that could result in increased costs associated with research, development, manufacture, or distribution of our products. Our ability to compete could also be affected by changing customer preferences and requirements, such as growing demand for companies to establish validated Net Zero targets or offer more sustainable products.
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.
Such cyber-attacks are of ever-increasing levels of sophistication, including the use of adversarial AI 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.
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.
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 post marketing study requirements and commitments through 2024 and beyond.
Transitional risks include, for example, a disorderly global transition away from fossil fuels that may result in increased energy prices; customer preference for low or no-carbon products; stakeholder pressure to decarbonize assets; or new legal or regulatory requirements that result in new or expanded carbon pricing, taxes, restrictions on greenhouse gas emissions, and increased greenhouse gas disclosure and transparency.
Transitional risks include, for example, a disorderly global transition away from fossil fuels that may result in increased energy prices; customer preference for low or no-carbon products; stakeholder pressure to decarbonize assets; or new legal or regulatory requirements that result in new or expanded carbon pricing, taxes, restrictions on GHG emissions, and increased GHG disclosure and transparency.
In addition, our issued patents may not contain claims sufficiently broad to protect us against claims regarding validity, enforceability, scope and effective term made by parties with similar technologies or products or provide us with any competitive advantage, including exclusivity in a particular product area.
In addition, our issued patents may not contain claims sufficiently broad to protect us against claims regarding validity, enforceability, scope and effective term made by parties with similar technologies or products or provide us with any competitive advantage, including patent-based exclusivity in a particular technology or product area.
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.
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 Pfizer Inc. 2024 Form 10-K 22 and the value of the acquired securities will fluctuate and may lose value.
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.
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. AI is increasingly being used in the biopharmaceutical and global healthcare industries. As with many developing technologies, AI presents risks and challenges.
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.
To the extent we incur additional indebtedness or interest rates increase, these risks could increase further. The success of our business development transactions 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.
While we monitor a broad range of ESG matters, we cannot be certain that we will manage such matters successfully, or that we will successfully meet the expectations of investors, employees, consumers, governments and other stakeholders.
While we monitor a broad range of corporate responsibility matters, we cannot be certain that we will manage such matters successfully, or that we will successfully meet the expectations of investors, employees, consumers, governments and other stakeholders.
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.
The IRA is being 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 drug cost containment efforts at both the federal and state levels.
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.
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, within expected time frames or at all, which may impact our ability to meet our growth objectives.
Such damages may be enhanced as much as three-fold if we or one of our subsidiaries is found to have willfully infringed valid patent rights of a third party. INFORMATION TECHNOLOGY AND SECURITY Significant disruptions of IT systems or breaches of information security could adversely affect our business.
Such damages may be enhanced as much as three-fold if we or one of our subsidiaries is found to have willfully infringed valid patent rights of a third party. Pfizer Inc. 2024 Form 10-K 21 INFORMATION TECHNOLOGY AND SECURITY Significant disruptions of IT systems or breaches of information security could adversely affect our business.
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.
If one of our marketed products (or a product of our 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.
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.
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.
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.
Pfizer Inc. 2024 Form 10-K 23 COST AND EXPENSE CONTROL AND UNUSUAL 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.
The potential regulatory and commercial implications of post-marketing study results typically cannot immediately be determined.
The potential regulatory, commercial or other implications of post-marketing study results typically cannot immediately be determined.
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 .
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.
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.
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 to granting approval, or increased post-approval requirements.
While we strive to improve our ESG performance and meet our voluntary goals, if we do not meet, or are perceived not to meet, our goals or other stakeholder expectations in key ESG areas, we risk negative stakeholder reaction, including from proxy advisory services, as well as damage to our brand and reputation, reduced demand for our products or other negative impacts on our business and operations.
While we are committed to responsible business growth, if we do not meet, or are perceived not to meet, our goals or other stakeholder expectations in these key areas, we risk negative stakeholder reaction, including from proxy advisory services, as well as damage to our brand and reputation, reduced demand for our products or other negative impacts on our business and operations.
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.
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.
Our sales and marketing activities, the pricing of our products and other aspects of our business are subject to extensive regulation under the FFDCA, the Medicaid Drug Rebate Program, the FCPA and other federal and state statutes, including those discussed elsewhere in this Form 10-K, as well as the Anti-Kickback Statute, anti-bribery laws, the False Claims Act, and similar laws in international jurisdictions.
Our sales and marketing activities, the pricing of our products and other aspects of our business are subject to extensive regulation under the FFDCA, the MDRP, the FCPA and other federal and state statutes, including those discussed elsewhere in this Form 10-K, as well as the AKS, anti-bribery laws, the False Claims Act, consumer protection statutes and similar laws in international jurisdictions.
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.
Any additional reduction of U.S. federal spending on entitlement programs beyond the IRA, including Medicare, Medicaid, or any other publicly funded or subsidized health programs, and the 340B Program, may affect payment for our products or services provided using our products.
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.
Pfizer Inc. 2024 Form 10-K 19 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.
For additional information on changes in tax laws or rates or accounting standards, see the Provision/(Benefit) for Taxes on Income and New Accounting Standards sections within MD&A and Note 1B .
See Government Regulation and Price Constraints for additional information regarding privacy and other laws. For additional information on changes in tax laws or rates or accounting standards, see the Provision/(Benefit) for Taxes on Income and New Accounting Standards sections within MD&A and Note 1B .
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.
Unsuccessful clinical trials, regulatory hurdles, new information and commercialization challenges, among other factors, may adversely impact revenue and income contribution from business development transactions, including from acquired products and businesses, and may lead to impairment of acquired assets.
Governmental authorities, non-governmental organizations, customers, investors, employees, and other stakeholders are increasingly sensitive to ESG matters, such as equitable access to medicines and vaccines, product quality and safety, diversity, equity and inclusion, environmental stewardship, support for local communities, value chain environmental and social due diligence, corporate governance and transparency, and addressing human capital factors in our operations.
Certain governmental authorities, non-governmental organizations, customers, investors, employees, and other stakeholders are increasingly sensitive to matters perceived to be related to responsible business growth, such as equitable access to medicines and vaccines, product quality and safety, human capital, diversity, equity and inclusion, environmental stewardship, support for local communities, value chain environmental and social due diligence, and corporate governance and transparency.
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.
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.
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.
If the outputs that AI produces or assists in producing are deficient or inaccurate, we could be subjected to competitive harm, potential legal liability and brand or reputational harm. Furthermore, use of AI may lead to the release of confidential information which may impact our ability to realize the benefits of our data, including intellectual property.
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.
Pfizer submitted its final annual report in October 2023 and the OIG officially closed the matter in January 2025. 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.
This includes the June 2022 Ministerial Decision on the Agreement on Trade-Related Aspects of Intellectual Property Rights, which seeks to make it easier for certain WTO members to issue a compulsory license on COVID-19 vaccines, and discussions continue on whether to expand that decision to COVID-19 therapeutics and diagnostics.
For example, the WTO’s June 2022 Ministerial Decision on the Agreement on Trade-Related Aspects of Intellectual Property Rights seeks to make it easier for certain WTO members to issue a compulsory license on COVID-19 vaccines.
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.
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 regulator-directed risk evaluations and assessments, asset impairments, and/or consumer fraud, product liability and other litigation and claims, as well as product recalls or withdrawals, including our voluntary withdrawal of all lots of Oxbrtya in all markets where it is approved, and any regulatory or other impact on Oxbryta or other sickle cell disease assets.
In some instances, we have incurred significant expense, civil payments, fines and other adverse consequences as a result of these claims, actions and inquiries. Such claims, actions and inquiries may relate to alleged non-compliance with laws and regulations associated with the dissemination of product (approved and unapproved) information, potentially resulting in government enforcement action and reputational damage.
Such claims, actions and inquiries may relate to alleged non-compliance with laws and regulations associated with the dissemination of product (approved and unapproved) information, potentially resulting in government enforcement action and reputational damage.
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.
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 June 2022, Pfizer established our fourth consecutive greenhouse gas reduction goal with new near- and long-term targets to achieve the Science Based Target Initiative’s voluntary Net-Zero Standard by 2040.
Our supply chain is subject to these same transitional and physical risks and would likely pass along any increased costs to us. In June 2022, Pfizer established our fourth consecutive GHG reduction goal with new near- and long-term targets to achieve the Science Based Target Initiative’s voluntary Net-Zero Standard by 2040.
Any technology service interruption or breach of our systems could adversely affect our business operations and/or result in the loss of personal data, confidential information or intellectual property. Such incidents could require disclosure to government authorities and/or regulators and could require notification to impacted individuals and any incident could result in financial, legal, business and reputational harm to us.
Any technology service interruption or breach of our systems could adversely affect our business operations and/or result in potential legal liability, the loss of personal data, confidential information or intellectual property.
We may recognize impairment charges as a result of a weak economic environment, events related to particular customers or asset types, challenging market conditions or decisions by management. Any such impairment charge of our intangible assets, goodwill and equity-method investments may be significant.
We may recognize impairment charges as a result of a weak economic environment, challenging market conditions, decisions by management, or events related to particular customers or asset types, such as the development of competing assets by us or others, regulatory actions or product recalls or withdrawals.
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.
For example, algorithms may be flawed or trained on content without the necessary intellectual property rights or other legal rights or permissions; data sets may not be appropriate for the intended use, of poor quality, contain biased information, or become corrupted during a cyber-attack; and inappropriate or controversial data practices by data scientists, engineers, and end-users could impair results.
For additional details, see the S ignificant Accounting Policies and Application of Critical Accounting Estimates and Assumptions Asset Impairments section within MD&A.
Any such impairment charge of our intangible assets, goodwill and equity-method investments may be significant. See Note 4 for a discussion of recent impairments of intangible assets. For additional details, see the S ignificant Accounting Policies and Application of Critical Accounting Estimates and Assumptions Asset Impairments section within MD&A.
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.
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.
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.
For example, our manufacturing facility in Rocky Mount, NC was damaged by a tornado in July 2023. 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.
RISKS RELATED TO INTELLECTUAL PROPERTY, TECHNOLOGY AND SECURITY: INTELLECTUAL PROPERTY PROTECTION Our success largely depends on our ability to market technologically competitive products.
For additional information, including information regarding certain legal proceedings in which we are involved in, see Note 16A . Pfizer Inc. 2024 Form 10-K 20 RISKS RELATED TO INTELLECTUAL PROPERTY, TECHNOLOGY AND SECURITY: INTELLECTUAL PROPERTY PROTECTION Our success largely depends on our ability to market technologically competitive products.
This risk may be heightened by digital marketing, including social media, mobile applications and blogger outreach.
These risks may be heightened by the use of AI in our operations as well as in our digital marketing, including social media, mobile applications and blogger outreach, as well as direct-to-consumer marketing and digital platform offerings.
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.
Risk Factors. RESPONSIBLE BUSINESS GROWTH Pfizer is subject to transitional and physical risks related to climate change.
Removed
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.
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In addition, we may face increased risks to, among other things, our business, revenue, earnings, reputation or financial guidance, as a result of potential changes to vaccine or other healthcare policy in the U.S.
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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.
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In September 2024, we made the decision to voluntarily withdraw Oxbryta in all markets where it is approved based on the totality of clinical data that indicated at that time the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population. For more information, see the Product Developments section within MD&A.
Removed
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.
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In addition, we have been and may in the future be subject to claims and other actions related to our business activities, brought by governmental authorities, as well as consumers and private payors. In some instances, we have incurred significant expense, civil payments, fines and other adverse consequences as a result of these claims, actions and inquiries.
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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 .
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Such incidents could require disclosure to government authorities and/or regulators and could require notification to impacted individuals and any incident could result in financial, legal, business and reputational harm to us.
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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.
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COVID-19 We face risks and uncertainties related to our COVID-19 products, including Comirnaty and Paxlovid or any potential future COVID-19 vaccines, treatments or combinations, including, among others, the risk that as the market for COVID-19 products remains endemic and seasonal, demand for our COVID-19 products has and may continue to be reduced or not meet expectations, which has and may continue to lead to reduced revenues, excess inventory or other unanticipated charges; risks related to our ability to develop and commercialize variant adapted vaccines, combinations and/or treatments; uncertainties related to recommendations and coverage for, and the public’s adherence to, vaccines, boosters, treatments or combinations; risks related to our ability to accurately predict revenue for Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments; whether and when EUA or biologics license applications or amendments to any such applications may be filed in particular jurisdictions for Comirnaty or any other potential vaccine or vaccine candidates, including those related to potential future annual boosters, re-vaccinations, or vaccines in additional populations, and if obtained, whether or when such EUA or licenses, or existing EUAs, will expire or terminate; whether and when additional supply or purchase agreements will be reached or existing agreements will be modified; potential third-party royalties or other claims related to Comirnaty or Paxlovid; and the other risks and uncertainties discussed throughout this Item 1A.
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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.
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Presidential administration and Congress, as well as in other countries. For example, issued or future executive orders or other new or changes in laws, regulations or policy regarding tariffs, could have a material adverse effect on our business, earnings and financial guidance.
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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.
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The actual impact of the new tariffs on our business is subject to a number of factors including, but not limited to, restrictions on trade, the effective date and duration of such tariffs, countries included in the scope of tariffs, changes to amounts of tariffs, and potential retaliatory tariffs imposed by other countries.
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We 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.
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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.
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CHANGES IN LAWS AND ACCOUNTING STANDARDS Our future results could be adversely affected by changes in laws and regulations or their interpretation, including, among others, changes in accounting standards, tax laws and regulations internationally and in the U.S.
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Presidential administration and Congress, including the proposed “Tax Relief for American Families and Workers Act of 2024”), competition laws, privacy laws and environmental laws in the U.S. and other countries.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

76 edited+40 added38 removed45 unchanged
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.
Biggest changeApproved April 2023 Approved March 2024 Approved March 2024 TicoVac (Vaccine) Active immunization to prevent tick-borne encephalitis in individuals 1 year of age and older Approved August 2021 Approved March 2024 Nurtec ODT/Vydura (rimegepant) Acute treatment of migraine with or without aura in adults Approved February 2020 Approved April 2022 Filed November 2024 Prevention of episodic migraine in adults Approved May 2021 Approved April 2022 Filed November 2024 Abrysvo (Vaccine) Active immunization for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older Approved May 2023 Approved August 2023 Approved March 2024 Active immunization for the prevention of lower respiratory tract disease caused by RSV in individuals 18-59 years of age who are at increased risk of lower respiratory tract disease caused by RSV Approved October 2024 Filed June 2024 Velsipity (etrasimod) Moderately to severely active ulcerative colitis in adults Approved October 2023 Approved February 2024 Filed June 2024 Braftovi (encorafenib) and Mektovi (binimetinib) (b) BRAF V600E -mutant metastatic non-small cell lung cancer in adult patients Approved October 2023 Approved August 2024 Braftovi (encorafenib), Erbitux (cetuximab) (c) and mFOLFOX6 First-line BRAF V600E -mutant mCRC Approved December 2024 Elrexfio (elranatamab) Triple-class relapsed/refractory multiple myeloma in adult patients Approved August 2023 Approved December 2023 Approved March 2024 Xtandi (enzalutamide) (d) nmCSPC with biochemical recurrence at high risk for metastasis (high-risk BCR) Approved November 2023 Approved April 2024 Hympavzi (marstacimab-hncq) Hemophilia A and B without inhibitors Approved October 2024 Approved November 2024 Approved December 2024 Emblaveo (aztreonam-avibactam) (e) Treatment of infections in adult patients caused by Gram-negative bacteria with limited or no treatment options Approved February 2025 Approved April 2024 Padcev (enfortumab vedotin-ejfv) (f) In combination with Keytruda ®(g) (pembrolizumab) for locally advanced or metastatic urothelial cancer in adults Approved December 2023 Approved August 2024 Approved September 2024 Tivdak (tisotumab vedotin-tftv) (h) Recurrent or metastatic cervical cancer with disease progression on or after chemotherapy Approved April 2024 Filed February 2024 Filed April 2024 Comirnaty (COVID-19 Vaccine, mRNA) 2024-2025 Formula, Omicron KP.2-adapted (i) Active immunization to prevent COVID-19 caused by SARS-CoV-2 for individuals 12 years of age and older Approved August 2024 Approved September 2024 Comirnaty (COVID-19 Vaccine, mRNA) 2024-2025 Formula, Omicron JN.1-adapted Active immunization to prevent COVID-19 caused by SARS-CoV-2 for individuals 6 months of age and older Approved July 2024 Approved August 2024 Adcetris (brentuximab vedotin) (j) Relapsed/refractory diffuse large B-cell lymphoma Approved February 2025 Paxlovid (nirmatrelvir; ritonavir) COVID-19 infection in high-risk children (6-11 years of age: >88 lbs.) Filed February 2025 Filed January 2025 ^ For the U.S., the filing date is the date on which the FDA accepted our submission.
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 .
For 2022, the total adjustments 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.
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.
See the Overview of Our Performance, Operating Environment, Strategy and Outlook O ur Business and Strategy section within MD&A. Dividends —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.
(g) For 2023, the total of $238 million mainly includes $286 million in inventory losses, overhead costs related to the period in which the facility could not operate, and incremental costs resulting from tornado damage to our manufacturing facility in Rocky Mount, NC, partially offset by insurance recoveries.
(g) For 2023, the total adjustment of $238 million mainly includes $286 million in inventory losses, overhead costs related to the period in which the facility could not operate, and incremental costs resulting from tornado damage to our manufacturing facility in Rocky Mount, NC, partially offset by insurance recoveries.
The EU has approved a directive requiring member states to incorporate the OECD provisions into their respective domestic laws, and other countries outside the EU are also enacting the provisions into their domestic law. The provisions are generally effective for Pfizer in 2024, though significant details and guidance around the provisions are still pending.
The EU has approved a directive requiring member states to incorporate the OECD provisions into their respective domestic laws, and countries outside the EU are also enacting the provisions into their domestic law. The provisions are generally effective for Pfizer in 2024, though significant details and guidance around the provisions are still pending.
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.
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, 2024, the expected impact on our net income would not be significant.
(h) For 2023, the total of $246 million includes charges of (i) $474 million for certain legal matters, primarily representing certain product liability and other legal expenses related to products discontinued and/or divested by Pfizer, and to a lesser extent, legal obligations related to pre-acquisition matters, and (ii) $127 million mostly related to our equity-method accounting pro-rata share of intangible asset amortization and impairments, costs of separating from GSK and restructuring costs recorded by Haleon, partially offset by: (i) a $222 million gain on the divestiture of our early-stage rare disease gene therapy portfolio to Alexion, and (ii) dividend income of $211 million related to our investment in Nimbus resulting from Takeda’s acquisition of Nimbus’s oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor program subsidiary.
For 2023, the total adjustments of $246 million included charges of (i) $474 million for certain legal matters, primarily representing certain product liability and other legal expenses related to products discontinued and/or divested by Pfizer, and to a lesser extent, legal obligations related to pre-acquisition matters and (ii) $127 million mostly related to our equity-method accounting pro-rata share of intangible asset amortization and impairments, costs of separating from GSK and restructuring costs recorded by Haleon, partially offset by: (i) a $222 million gain on the divestiture of our early-stage rare disease gene therapy portfolio to Alexion and (ii) dividend income of $211 million from our investment in Nimbus resulting from Takeda’s acquisition of Nimbus’s oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor program subsidiary.
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.
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, 2024, the expected impact on our net income would not be significant.
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 .
Pension Plans Expected annual rate of return on plan assets 7.7 % 8.0 % 7.5 % Actual annual rate of return on plan assets 1.3 10.4 (22.4) Discount rate used to measure the plan obligations 5.7 5.4 5.4 International Pension Plans Expected annual rate of return on plan assets 4.9 5.1 4.5 Actual annual rate of return on plan assets 6.4 (4.6) (26.0) Discount rate used to measure the plan obligations 4.1 4.4 3.8 (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) : 2023 2022 2021 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) : 2024 2023 2022 U.S.
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 ).
Our significant contractual and other obligations as of December 31, 2024 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 ).
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 .
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 .
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.
Our effective tax rates for GAAP Reported income from continuing operations were: (0.4)% in 2024, (105.4)% in 2023 and 9.6% in 2022. See Note 5 . Our effective tax rates for non-GAAP Adjusted income were: 14.5% in 2024, 9.0% in 2023 and 11.7% in 2022.
ANALYSIS OF FINANCIAL CONDITION, LIQUIDITY, CAPITAL RESOURCES AND MARKET RISK Our historically robust operating cash flow, which we expect to continue over time, is a key strength of our liquidity and capital resources and our primary funding source.
ANALYSIS OF FINANCIAL CONDITION, LIQUIDITY, CAPITAL RESOURCES AND MARKET RISK Our historically robust operating cash flows, which we expect to continue over time, is a key strength of our liquidity and capital resources and our primary funding source.
(e) Includes employee termination costs, asset impairments and other exit costs related to our cost-reduction and productivity initiatives not associated with acquisitions. See Note 3 . (f) See Note 4 .
(d) Includes employee termination costs, asset impairments and other exit costs related to our cost-reduction and productivity initiatives not associated with acquisitions. See Note 3 . (e) See Note 4 .
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.
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 $ 222 $ 2,119 $ 0.37 Amortization of intangible assets 4,733 Acquisition-related items (629) (11) (28) 1,874 Discontinued operations (11) Certain significant items: Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring (d) (98) (290) 2,227 Certain asset impairments (e) (3,024) 3,024 (Gains)/losses on equity securities (e) 1,588 (1,588) Actuarial valuation and other pension and postretirement plan (gains)/losses 265 (265) Other (238) (g) (24) (246) (f) 518 Income tax provision—non-GAAP items (2,131) Non-GAAP Adjusted $ 23,988 $ 14,446 $ (1,224) $ 10,501 $ 1.84 Pfizer Inc. 2024 Form 10-K 44 Year Ended December 31, 2022 Data presented will not (in all cases) aggregate to totals.
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 ).
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 $4.1 billion, of which an estimated $1.0 billion is to be paid in the next twelve months, and $3.1 billion in periods thereafter (see Note 16C ); Purchases of PP&E (see Note 9 ).
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 table below includes 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 table includes filings with regulatory decisions pending (even if the filing occurred outside of the last twelve-month period).
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.
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, see the Analysis of the Consolidated Statements of Cash Flows section within MD&A.
(b) The short-term incentive plans for substantially all non-sales-force employees worldwide are funded from a pool based on our performance, measured in significant part versus three budgeted metrics, one of which is Adjusted diluted EPS (as defined for annual incentive compensation purposes), which is derived from Adjusted income and accounts for 40% of the bonus pool funding tied to financial performance.
(b) The short-term incentive plans for substantially all non-sales-force employees worldwide are funded from a pool based on our performance, measured in significant part versus three budgeted metrics, one of which, for the 2024 performance year, was Adjusted diluted EPS (as defined for annual incentive compensation purposes), which is derived from Adjusted income and accounted for 40% of the bonus pool funding tied to financial performance.
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.
ANALYSIS OF THE CONSOLIDATED STATEMENTS OF OPERATIONS Total Revenues by Geography The following presents worldwide Total revenues by geography: Year Ended December 31, % Change Worldwide U.S. International Worldwide U.S.
(c) For 2023, the total acquisition-related items of $1.9 billion include reconciling amounts for Restructuring charges and certain acquisition-related costs of $1.2 billion, mainly composed of $785 million of integration costs and other charges, $190 million of transaction costs and $125 million of employee termination-related charges.
For 2023, the total acquisition-related items of $1.9 billion included reconciling amounts for Restructuring charges and certain acquisition-related costs of $1.2 billion , mainly composed of $785 million of integration costs and other charges, $190 million of transaction costs and $125 million of employee termination-related charges.
For example, although major non-acquisition-related cost-reduction programs are specific to an event or goal with a defined term, we may have subsequent programs based on reorganizations of the business, cost productivity or in response to LOE or economic conditions.
For example, although major non-acquisition-related cost-reduction programs are specific to an event or goal with a defined term, we may have subsequent programs based on reorganizations of the business, cost productivity or in response to generic or biosimilar entry or economic conditions.
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 ).
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.
Additionally, the payout for performance share awards is determined in part by Adjusted net income, which is derived from Adjusted income. Beginning in the first quarter of 2022, we no longer exclude any expenses for acquired IPR&D from our non-GAAP Adjusted results but we continue to exclude certain of these expenses for our financial results for annual incentive compensation purposes.
Additionally, for the 2024 performance year, the payout for performance share awards was determined in part by Adjusted net income, which is derived from Adjusted income. Since 2022, we no longer exclude any expenses for acquired IPR&D from our non-GAAP Adjusted results but we continue to exclude certain of these expenses for our financial results for annual incentive compensation purposes.
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.
Estimated future payments related to the TCJA repatriation tax liability that will occur after December 31, 2024 total $4.7 billion, of which an estimated $2.1 billion is to be paid in the next twelve months and an estimated $2.6 billion is to be paid in periods thereafter.
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.
Business Collaboration and Co-Promotion Agreements . 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.
Income tax expense could be adversely affected as the legislation becomes effective in countries in which we do business, and such impact could be material to our results of operations. We continue to monitor pending OECD guidance and legislation enactment and implementation by individual countries. Discontinued Operations For information about our discontinued operations, see Note 2B .
Income tax expense could be adversely affected as the legislation becomes effective in countries in which we do business, and such impact could be material to our results of operations. We continue to monitor pending OECD guidance and legislation enactment and implementation by individual countries.
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.
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.
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. 2024 Form 10-K 33 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 2025 Net Periodic Benefit Costs Expected annual rate of return on plan assets (a) 50 basis point decline $86 (a) The estimate excludes any potential mark-to-market adjustments.
Changes in Tax Laws–– Many countries outside the U.S. have enacted legislation for global minimum taxation resulting from the Organization for Economic Co-operation and Development’s (OECD) Base Erosion and Profit Shifting “Pillar 2” project.
Pfizer Inc. 2024 Form 10-K 38 Changes in Tax Laws–– Many countries outside the U.S. have enacted legislation for global minimum taxation resulting from the Organization for Economic Co-operation and Development’s (OECD) Base Erosion and Profit Shifting “Pillar 2” project.
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.
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 2025 Net Periodic Benefit Costs Increase to 2024 Benefit Obligations Discount rate 10 basis point decline $5 $208 The change in the discount rates used in measuring our plan obligations as of December 31, 2024 resulted in an increase in the measurement of our aggregate plan obligations by approximately $25 million.
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.
See the Reconciliations of GAAP Reported to Non-GAAP Adjusted Information––Certain Line Items below for a non-inclusive list of certain significant items. Pfizer Inc. 2024 Form 10-K 43 Reconciliations of GAAP Reported to Non-GAAP Adjusted Information––Certain Line Items Year Ended December 31, 2024 Data presented will not (in all cases) aggregate to totals.
Each rating should be evaluated independently of any other rating. Capital Allocation Framework ––Our capital allocation framework is primarily devised to enhance shareholder value and is based on three core pillars: growing our dividend, reinvesting in the business and making share repurchases after de-levering our balance sheet.
Each rating should be evaluated independently of any other rating. Pfizer Inc. 2024 Form 10-K 46 Capital Allocation Framework ––Our capital allocation framework is primarily devised to enhance shareholder value and is based on three core pillars: maintaining and growing our dividend over time, reinvesting in the business and making share repurchases after de-levering our balance sheet.
Adjusted income and its components and Adjusted diluted EPS are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, are limited in their usefulness to investors.
Pfizer Inc. 2024 Form 10-K 42 Adjusted income and its components and Adjusted diluted EPS are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, are limited in their usefulness to investors.
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.
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 $ 1,062 $ 31,372 $ 5.47 Amortization of intangible assets 3,609 Acquisition-related items (119) (7) (74) 832 Discontinued operations (21) Certain significant items: Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring (d) (88) (562) 1,396 Certain asset impairments (e) (421) 421 (Gains)/losses on equity securities (e) (1,270) 1,270 Actuarial valuation and other pension and postretirement plan (gains)/losses 230 (230) Other (40) (59) (636) (f) 752 Income tax provision—non-GAAP items (1,683) Non-GAAP Adjusted $ 34,096 $ 13,049 $ (1,109) $ 37,717 $ 6.58 (a) Items that reconcile GAAP Reported to non-GAAP Adjusted balances are shown pre-tax.
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.
We continue to believe that with our ongoing operating cash flows, together with our financial assets, access to capital markets, revolving credit agreement, 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.
The bonus pool funding, which is largely based on financial performance, is adjusted by our R&D pipeline performance, as measured by four metrics, and performance against certain of our ESG metrics, and may be further modified by our Compensation Committee’s assessment of other factors.
The bonus pool funding is largely based on financial performance, as measured by three metrics, modified by performance against certain of our non-financial metrics, and may be further modified by our Compensation Committee’s assessment of other factors.
(g) Being developed in collaboration with AbbVie. AbbVie has the exclusive commercialization rights to this investigative therapy in the U.S. and Canada; Pfizer leads the joint development program and has commercialization rights in all other countries. (h) Being developed in collaboration with Astellas. (i) Keytruda is a registered trademark of Merck Sharp & Dohme Corp.
AbbVie has the exclusive commercialization rights in the U.S. and Canada; Pfizer leads the joint development program and has commercialization rights in all other countries. (f) Being jointly developed and commercialized with Astellas. (g) Keytruda ® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
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.
Discontinued Operations –– Adjusted income excludes the results of discontinued operations, as well as any related gains or losses on the disposal of such operations.
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.
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.
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.
In 2025, we expect to spend approximately $2.8 billion on PP&E; and Future minimum rental commitments under non-cancelable operating leases (see Note 15 ). Global Economic Conditions ––We have operations in countries that have hyperinflationary economies. The impact to Pfizer is not considered material. See the Item 1A. Risk Factors––Global Operations section.
In connection with our acquisition of Seagen, we are focusing our efforts on achieving an appropriate cost structure for the combined company. We expect to generate approximately $1 billion of annual cost synergies, to be achieved by 2026.
Long-term improvement in gross margin will remain a key focus for the Company over the next few years. Seagen acquisition –– In connection with our acquisition of Seagen, we are focusing our efforts on achieving an appropriate cost structure for the combined company. We expect to generate approximately $1 billion of annual cost synergies, to be achieved by 2026.
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 ).
Pfizer Inc. 2024 Form 10-K 45 ANALYSIS OF THE CONSOLIDATED STATEMENTS OF CASH FLOWS Year Ended December 31, (MILLIONS) 2024 2023 2022 Drivers of change 2024 v. 2023 Cash provided by/(used in): Operating activities $ 12,744 $ 8,700 $ 29,267 The change was driven primarily by an increase in net income adjusted for non-cash items partially offset by the timing of receipts and payments in the ordinary course of business, including a decrease in advance payments for Comirnaty and Paxlovid and net changes in inventory greater than one year (see Note 8A ).
Certain qualifying costs for these programs were recorded in 2023, 2022 and 2021, and are reflected as Certain Significant Items and excluded from our non-GAAP measure of Adjusted Income. See the Non-GAAP Financial Measure: Adjusted Income section within MD&A.
Certain qualifying costs for these programs in all periods since inception were recorded and reflected as Certain Significant Items and excluded from our non-GAAP measure of Adjusted Income. See the Non-GAAP Financial Measure: Adjusted Income section within MD&A. For a description of our programs, as well as the anticipated and actual costs, see Note 3A .
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.
Total Revenues—Selected Product Discussion Biopharma Revenue (MILLIONS) Year Ended Dec. 31, % Change Product Global Revenues Region 2024 2023 Total Oper.
International Operational growth/(decline): Worldwide declines from Comirnaty $ (26,423) $ (6,370) $ (20,053) Worldwide declines from Paxlovid (17,506) (11,803) (5,703) Worldwide growth from the Vyndaqel family, Eliquis, the Prevnar family and Inlyta, partially offset by worldwide declines from Ibrance, Xeljanz and Xtandi 1,016 1,018 (2) Increase in revenues from Nurtec ODT/Vydura and Oxbryta, which were acquired in the fourth quarter of 2022 972 949 23 Revenues from Abrysvo, primarily driven by launch of the older adult indication in the U.S. in July 2023 890 888 2 Revenues from legacy Seagen products subsequent to the acquisition on December 14, 2023 120 120 Other operational factors, net 120 (185) 305 Operational growth/(decline), net (40,812) (15,385) (25,428) Unfavorable impact of foreign exchange (1,022) (1,022) Total revenues increase/(decrease) $ (41,834) $ (15,385) $ (26,449) Emerging markets revenues decreased $8.1 billion, or 40%, in 2023 to $12.0 billion from $20.1 billion in 2022, reflecting an operational decrease of $7.4 billion, or 37%, and an unfavorable impact from foreign exchange of 3%.
International Operational growth/(decline): Worldwide declines from Comirnaty $ (26,427) $ (6,374) $ (20,053) Worldwide declines from Paxlovid (17,506) (11,803) (5,703) Worldwide growth from the Vyndaqel family, Eliquis, the Prevnar family and Inlyta, partially offset by worldwide declines from Ibrance and Xeljanz 1,079 1,081 (2) Increase in revenues from Nurtec ODT/Vydura and Oxbryta, which were acquired in the fourth quarter of 2022 972 949 23 Revenues from Abrysvo, primarily driven by launch of the older adult indication in the U.S. in July 2023 890 888 2 Revenues from legacy Seagen products subsequent to the acquisition on December 14, 2023 132 132 Other operational factors, net 260 (45) 305 Operational growth/(decline), net (40,600) (15,172) (25,428) Unfavorable impact of foreign exchange (1,022) (1,022) Total revenues increase/(decrease) $ (41,621) $ (15,172) $ (26,450) See the Total Revenues––Selected Product Discussion section within MD&A for additional analysis and Note 17C .
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.
PRODUCT DEVELOPMENTS A comprehensive update of Pfizer’s development pipeline was published as of February 4, 2025 and is available at www.pfizer.com/science/drug-product-pipeline.
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.
Financing activities $ (17,140) $ 26,066 $ (14,834) The change was driven mostly by $30.8 billion of proceeds from the issuance of long-term debt in May of 2023 for the acquisition of Seagen and $12.6 billion greater net repayments of short-term borrowings in 2024.
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.
The program savings discussed above may be rounded and represent approximations. In addition to these programs, we continuously monitor our operations for cost reduction and/or productivity opportunities in light of patent-based and regulatory exclusivity expiries as well as the expiration of collaborative arrangements for various products.
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.
On December 12, 2024, our BOD declared a first-quarter dividend of $0.43 per share, payable on March 7, 2025, to shareholders of record at the close of business on January 24, 2025. The first-quarter 2025 cash dividend will be our 345th consecutive quarterly dividend.
Int’l. 8,816 29,032 (70) (69) Worldwide $ 11,220 $ 37,806 (70) (70) Eliquis $6,747 Up 5% (operationally) U.S. $ 4,228 $ 3,822 11 Growth driven primarily by continued oral anti-coagulant adoption and market share gains in the non-valvular atrial fibrillation indication in the U.S. and certain markets in Europe, partially offset by declines due to LOE and generic competition in certain international markets.
Operational Results Commentary Eliquis $7,366 Up 10% (operationally) U.S. $ 4,803 $ 4,228 14 Growth driven primarily by continued oral anti-coagulant adoption and market share gains in the non-valvular atrial fibrillation indication in the U.S. and certain markets in Europe, partially offset by declines due to loss of patent-based exclusivity and generic competition in certain international markets.
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 ).
The following presents information about product revenue deductions: Year Ended December 31, (MILLIONS) 2024 2023 2022 Medicare rebates $ 4,145 $ 997 $ 838 Medicaid and related state program rebates 2,252 1,655 973 Performance-based contract rebates 6,497 5,159 3,575 Chargebacks 12,698 9,828 7,560 Sales allowances 6,444 6,790 5,460 Sales returns and cash discounts 1,852 5,619 1,290 Total (a) $ 33,888 $ 30,048 $ 19,697 (a) The increase in revenue deductions in 2024 was primarily driven by the transition of Paxlovid and Comirnaty to commercial markets, an increase in sales from legacy Seagen products acquired in December 2023, sales growth from the Vyndaqel family, and higher sales of acquired products, partially offset by a $771 million favorable final adjustment recorded in the first quarter of 2024 to the estimated non-cash Paxlovid revenue reversal of $3.5 billion recorded in the fourth quarter of 2023 (see Note 17C ).
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.
Int’l. 30 * * Worldwide $ 1,089 $ 56 * * Pfizer Inc. 2024 Form 10-K 36 Revenue (MILLIONS) Year Ended Dec. 31, % Change Product Global Revenues Region 2024 2023 Total Oper.
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.
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 Litfulo (ritlecitinib) Vitiligo Elrexfio (elranatamab) Multiple myeloma double-class exposed Newly diagnosed multiple myeloma post-transplant maintenance Newly diagnosed multiple myeloma transplant-ineligible 2nd line + relapsed refractory multiple myeloma Eliquis (apixaban) (b) Venous thromboembolism (pediatric) Padcev (enfortumab vedotin) (c) 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+ maintenance metastatic breast cancer 1st line HER2+ metastatic colorectal cancer Hympavzi (marstacimab-hncq) Hemophilia (pediatric) Hemophilia (inhibitor cohort) NEW DRUG CANDIDATES IN LATE-STAGE DEVELOPMENT PF-06425090 (vaccine) Immunization to prevent primary clostridioides difficile infection sasanlimab (PF-06801591) Combination with Bacillus Calmette-Guerin for non-muscle-invasive bladder cancer VLA15 (PF-07307405) vaccine (d) Immunization to prevent Lyme disease vepdegestrant (PF-07850327) (e) Breast cancer metastatic - 2nd line ER+/HER2- inclacumab (PF-07940370) Sickle cell disease Ibrance + vepdegestrant (e) ER+/HER2- metastatic breast cancer dazukibart (PF-06823859) Dermatomyositis, polymyositis disitamab vedotin (f) 1st line HER2 (≥IHC1+) metastatic urothelial cancer sigvotatug vedotin (PF-08046047) 2nd line+ metastatic non-small cell lung cancer osivelotor (PF-07940367) Sickle cell disease atirmociclib (PF-07220060) 2nd line metastatic breast cancer ibuzatrelvir (PF-07817883) COVID-19 infection mevrometostat (PF-06821497) + enzalutamide 1st line/2nd line metastatic castration resistant prostate cancer post-Abiraterone mevrometostat (PF-06821497) + enzalutamide 1st line metastatic castration resistant prostate cancer neoadjuvant hormonal therapy naïve atirmociclib (PF-07220060) 1st line metastatic breast cancer (a) Ibrance for ER+/HER2+ metastatic breast cancer is being developed in collaboration with Alliance Foundation Trials, LLC.
(b) Includes reconciling amounts for Research and development expenses that are not material to our non-GAAP consolidated results of operations.
(b) Includes reconciling amounts for Research and development expenses that are not material to our non-GAAP consolidated results of operations. (c) For 2024, the total acquisition-related items of $1.9 billion include reconciling amounts for Restructuring charges and certain acquisition-related costs of $514 million, mainly composed of $427 million of integration costs and other charges.
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.
Costs and Expenses Costs and expenses follow: Year Ended December 31, % Change (MILLIONS) 2024 2023 2022 24/23 23/22 Cost of sales $ 17,851 $ 24,954 $ 34,344 (28) (27) Percentage of Total revenues 28.1 % 41.9 % 33.9 % Selling, informational and administrative expenses 14,730 14,771 13,677 8 Research and development expenses 10,822 10,679 11,428 1 (7) Acquired in-process research and development expenses 108 194 953 (44) (80) Amortization of intangible assets 5,286 4,733 3,609 12 31 Restructuring charges and certain acquisition-related costs 2,419 2,943 1,375 (18) * Other (income)/deductions—net 4,388 222 1,062 * (79) 2024 v. 2023 Cost of Sales Cost of sales decreased $7.1 billion, primarily due to: the non-recurrence of a non-cash charge of $6.2 billion in 2023 related to Paxlovid and Comirnaty recorded for inventory write-offs and related charges ($5.0 billion for Paxlovid and $1.2 billion for Comirnaty); and a favorable change in sales mix of $2.6 billion, primarily driven by lower sales of Comirnaty, partially offset by: an impact of $1.9 billion from our Seagen acquisition, inclusive of the amortization of the fair value step-up of inventory.
In this sensitivity analysis, the expected impact on our net income would not be significant. NEW ACCOUNTING STANDARDS Recently Adopted Accounting Standards See Note 1B .
Our equity securities with readily determinable fair values are analyzed at year-end to determine their sensitivity to equity price rate changes. In this sensitivity analysis, the expected impact on our net income would not be significant. Pfizer Inc. 2024 Form 10-K 47 NEW ACCOUNTING STANDARDS Recently Adopted Accounting Standards See Note 1B .
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.
Investing activities $ 2,652 $ (32,278) $ (15,783) The change was driven mainly by $43.4 billion cash paid in 2023 for the acquisition of Seagen, net of cash acquired (see Note 2A ) and $7.0 billion of proceeds from the partial sales of our investment in Haleon in 2024, partially offset by $16.3 billion greater net purchases of short-term investments in 2024.
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 .
The guidance also requires the total amount of selling expenses to be disclosed and, on an annual basis, the definition of selling expenses. 2027 for annual reports and 2028 for interim reports. Early adoption is permitted. This new guidance will result in increased disclosures in the notes to our financial statements.
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.
Int’l. 3,349 8,816 (62) (62) Worldwide $ 5,353 $ 11,220 (52) (53) Ibrance $4,367 Down 8% (operationally) U.S. $ 2,849 $ 3,151 (10) Declines primarily driven by lower demand due to competitive pressures mainly in the U.S., price decreases in certain international developed markets and generic penetration in certain emerging markets.
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.
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 $ 17,851 $ 14,730 $ 4,388 $ 8,031 $ 1.41 Amortization of intangible assets 5,286 Acquisition-related items (1,341) (10) (45) 1,938 Discontinued operations (14) Certain significant items: Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring (d) (134) (90) 2,213 Certain asset impairments (e) (3,295) 3,295 (Gains)/losses on equity securities (e) 1,008 (1,008) Actuarial valuation and other pension and postretirement plan (gains)/losses (579) 579 Other 44 (13) (445) (f) 430 Income tax provision—non-GAAP items (3,035) Non-GAAP Adjusted $ 16,420 $ 14,617 $ 1,031 $ 17,716 $ 3.11 Year Ended December 31, 2023 Data presented will not (in all cases) aggregate to totals.
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 .
Provision/(Benefit) for Taxes on Income Year Ended December 31, % Change (MILLIONS) 2024 2023 2022 24/23 23/22 Provision/(benefit) for taxes on income $ (28) $ (1,115) $ 3,328 (97) * Effective tax rate on continuing operations (0.4) % * 9.6 % 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, and cash paid for income taxes, net of refunds, see Note 5 .
(j) Being developed in collaboration with BioNTech. Pfizer Inc. 2023 Form 10-K 43 For additional information about our R&D organization, see Note 17 and the Item 1. Business Research and Development section. For additional information regarding certain collaboration arrangements, see Item 1. Business Collaboration and Co-Promotion Agreements .
In October 2024, Pfizer stopped two clinical trials with sisunatovir (PF-07923568) following observed drug-drug interactions. Since then Pfizer has decided to terminate development of sisunatovir. For additional information about our R&D organization, see Note 17 and the Item 1. Business Research and Development section. For additional information regarding certain collaboration arrangements, see Item 1.
(a) EU JAPAN Comirnaty (COVID-19 Vaccine, mRNA, 2023-2024 Formula) Active immunization to prevent COVID-19 caused by SARS-CoV-2 for individuals 6 months through 4 years of age Authorized September 2023 Approved August 2023 Approved September 2023 Active immunization to prevent COVID-19 caused by SARS-CoV-2 for individuals 5 through 11 years of age Authorized September 2023 Approved August 2023 Approved September 2023 Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older Approved September 2023 Approved August 2023 Approved September 2023 (a) In September 2023, Pfizer and BioNTech announced the FDA approved a regulatory application for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 12 years of age and older (Comirnaty (COVID-19 Vaccine, mRNA, 2023-2024 Formula)).
(h) Being developed in collaboration with Genmab A/S. The April 2024 approval date in the U.S. refers to the conversion of a prior accelerated approval to full approval. (i) In September 2024, the EC approved the Pfizer/BioNTech Omicron KP.2-adapted monovalent COVID-19 vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.
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.
(b) Eliquis is being developed in collaboration with BMS. (c) Padcev is being jointly developed and commercialized with Astellas. (d) VLA15 is being developed in collaboration with Valneva SE. (e) Vepdegestrant is being developed in collaboration with Arvinas. (f) Disitamab vedotin is being developed in collaboration with RemeGen Co., Ltd .
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.
International (MILLIONS) 2024 2023 2022 2024 2023 2022 2024 2023 2022 24/23 23/22 24/23 23/22 24/23 23/22 Operating segments: Biopharma $ 62,400 $ 58,237 $ 99,826 $ 38,332 $ 27,749 $ 42,920 $ 24,068 $ 30,488 $ 56,905 7 (42) 38 (35) (21) (46) Pfizer CentreOne 1,146 1,272 1,342 278 352 390 868 920 952 (10) (5) (21) (10) (6) (3) Pfizer Ignite 82 44 7 82 44 7 85 * 85 * Total revenues $ 63,627 $ 59,553 $ 101,175 $ 38,691 $ 28,145 $ 43,317 $ 24,936 $ 31,408 $ 57,858 7 (41) 37 (35) (21) (46) 2024 v. 2023 The following provides an analysis of the worldwide change in Total revenues by geographic areas from 2023 to 2024: (MILLIONS) Worldwide U.S.
The final guidance requires enhanced disclosures primarily related to existing rate reconciliation and income taxes paid information. January 1, 2025, with early adoption permitted. This new guidance will result in increased disclosures in the notes to our financial statements.
Recently Issued Accounting Standards, Not Adopted as of December 31, 2024 Standard/Description Effective Date Effect on the Financial Statements In December 2023, the FASB issued final guidance to improve income tax disclosures . The final guidance requires enhanced disclosures primarily related to existing rate reconciliation and income taxes paid information. 2025 for annual reports. Early adoption is permitted.
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 .
Other (Income)/Deductions––Net 2024 v. 2023 The unfavorable period-over-period change of $4.2 billion was primarily driven by (i) higher net interest expense of $2.0 billion, (ii) an unfavorable impact of $760 million due to net periodic benefit costs associated with pension and postretirement plans in 2024 versus net periodic benefit credits in 2023, (iii) lower net gains on equity securities of $580 million, (iv) a charge of $420 million in 2024 related to the expected sale of one of our facilities resulting from the discontinuation of our DMD program and (v) lower Haleon equity method income of $400 million, partially offset by (vi) gains of $945 million in 2024 on the partial sales of our investment in Haleon. 2023 v. 2022 The favorable period-over period change of $840 million was mainly driven by a favorable impact of $2.9 billion due to net gains on equity securities in 2023 versus net losses recognized on equity securities in 2022 and lower net interest expense of $400 million, partially offset by higher intangible asset impairment charges of $2.6 billion.
Amortization of Intangible Assets Amortization of intangible assets increased $1.1 billion, primarily as a result of 2023 reflecting a full year of amortization of intangible assets from our acquisitions of Biohaven and GBT, higher amortization of intangible assets related to Prevnar, as well as reclassifications of IPR&D to developed technology rights, partially offset by fully amortized assets.
Amortization of Intangible Assets Amortization of intangible assets increased $553 million, primarily due to: an increase of $570 million from our December 2023 acquisition of Seagen; and an increase of $470 million related to assets reclassified in 2023 from IPR&D to developed technology rights and from indefinite-lived to finite-lived brands, partially offset by: a decrease of $570 million related to changes in asset lives and fully amortized assets.
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.
Int’l. 69 20 * * Worldwide $ 1,263 $ 928 36 36 Xeljanz $1,168 Down 31% (operationally) U.S. $ 680 $ 1,154 (41) Declines primarily driven by lower demand globally resulting from ongoing shifts in prescribing patterns related to label changes, as well as lower net price in the U.S. and the impact of regulatory exclusivity expiry in Canada.
The actual return on plan assets resulted in a net gain on our plan assets of approximately $835 million during 2023 .
The actual return on plan assets was $652 million during 2024 .
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.
Int’l. 2,563 2,519 2 3 Worldwide $ 7,366 $ 6,747 9 10 Prevnar family $6,411 Down 1% (operationally) U.S. $ 4,233 $ 4,265 (1) Declines driven by fewer adult vaccinations in the U.S. and lower pediatric indication sales in most international developed markets and certain emerging markets, partially offset by growth in the pediatric indication in the U.S. reflecting recovered market share as a result of the Prevnar 20 launch in 2023, as well as strong uptake of the adult indication in certain international markets.
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.
Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives Realigning our Cost Base Program –– This program is expected to deliver total net cost savings of approximately $4.5 billion by the end of 2025, most of which was achieved by year-end 2024.
Research and Development Expenses Research and development expenses decreased $749 million, primarily due to: lower spending of $870 million mainly for lower compensation-related expenses, and ongoing vaccine and hospital programs, as well as a decrease of $260 million in the value of the portfolio performance share grants reflecting the decrease in the price of Pfizer’s common stock, Pfizer Inc. 2023 Form 10-K 39 partially offset by: increased investments of $345 million, mainly to develop certain acquired assets, as well as activities to support upcoming product launches.
Research and Development Expenses Research and development expenses increased $143 million, primarily due to: a net increase in spending of $1.1 billion mainly to develop certain product candidates acquired from Seagen; and an increase of $680 million in compensation-related expenses, partially offset by: lower spending of $1.6 billion as a result of our cost realignment program and on various product candidates, primarily ongoing vaccine programs.
Int’l. 394 385 3 7 Worldwide $ 1,036 $ 1,003 3 5 Nurtec ODT/Vydura $928 * U.S. $ 908 $ 211 * Growth primarily driven by timing of the acquisition of Biohaven (fourth quarter of 2022) as well as strong patient demand in the U.S. See Note 2A .
Int’l. Worldwide $ 2,039 $ 1,659 23 23 Padcev $1,588 Up * (operationally) U.S. $ 1,561 $ 53 * Growth driven by the acquisition of Seagen in the fourth quarter of 2023 as well as strong demand.
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The operational decrease in emerging markets revenues was primarily driven by declines from Comirnaty and Paxlovid, partially offset by growth from Lorbrena, Zavicefta and Eliquis. See the Total R evenues––Selected Product Discussion section within MD&A for additional analysis.
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International Operational growth/(decline): Worldwide growth from Paxlovid $ 4,452 $ 5,905 $ (1,453) Increase in revenues from legacy Seagen, which was acquired in December 2023 3,223 3,071 153 Worldwide growth from the Vyndaqel family, Eliquis, Xtandi and Nurtec ODT/Vydura, partially offset by declines from Xeljanz, Ibrance, Abrysvo, Inlyta and the Prevnar family 2,403 1,770 633 Worldwide declines from Comirnaty (5,907) (400) (5,507) Decline in oncology biosimilars, largely due to lower net price in the U.S.
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Operational Results Commentary Comirnaty (a) $11,220 Down 70% (operationally) U.S. $ 2,404 $ 8,775 (73) Declines largely driven by lower contracted deliveries and demand in international markets and lower U.S. government contracted deliveries, due to transition to new variant vaccines in most markets and the transition to traditional U.S. commercial market sales which began in September 2023.
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(362) (338) (24) Other operational factors, net 614 538 76 Operational growth/(decline), net 4,423 10,546 (6,123) Unfavorable impact of foreign exchange (349) — (349) Total revenues increase/(decrease) $ 4,074 $ 10,546 $ (6,472) Pfizer Inc. 2024 Form 10-K 34 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.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThe CISO works in coordination with other members of the management team, including, among others, the Chief Digital Officer, the Chief Financial Officer, the Chief Compliance and Risk Officer and the General Counsel and their designees. We believe our business leaders have the appropriate expertise, background and depth of experience to manage risks arising from cybersecurity threats.
Biggest changeThe CISO works in coordination with other members of the management team, including, among others, the Chief Digital Officer, the Chief Financial Officer and the Chief Legal Officer and their designees.
The impacts of attacks, abuse and misuse of Pfizer’s systems and information include, without limitation, loss of assets, operational disruption and damage to Pfizer’s reputation.
The impacts of attacks, abuse and misuse of Pfizer’s systems and information could include, without limitation, loss of assets, operational disruption and damage to Pfizer’s reputation.
Our policies require all workers to report any real or suspected cybersecurity events. Supplier Ecosystem Management : We extend our cybersecurity management control expectations to our supply chain ecosystem, as applicable.
Our policies require all workers to report any real or suspected cybersecurity events. Supplier Ecosystem Management : We extend our cybersecurity management control expectations to our supply chain ecosystem, as appropriate.
The Audit Committee receives regular briefings on cybersecurity risks and risk management practices, including, for example, recent developments in the external cybersecurity threat landscape, evolving standards, vulnerability assessments, third-party and independent reviews, technological trends and considerations arising from our supplier ecosystem.
The Audit Committee receives periodic briefings on, and discusses with our CISO, cybersecurity risks and risk management practices, including, for example, recent developments in the external cybersecurity threat landscape, evolving standards, vulnerability assessments, third-party and independent reviews, technological trends and considerations arising from our supplier ecosystem.
Certain results of such assessments and reviews are reported to the Audit Committee and the BOD, as appropriate, and we make adjustments to our cybersecurity processes and practices as necessary based on the information provided by the third-party assessments and reviews.
Certain results of such assessments and reviews are reported by the Chief Information Security Officer (CISO) to certain senior leaders, the Audit Committee and the BOD, as appropriate, and we make adjustments to our cybersecurity processes and practices as necessary based on the information provided by the third-party assessments and reviews.
As of the date of this Form 10-K, we are not aware of any cybersecurity incidents that have materially affected or are reasonably likely to materially affect the Company, including our business strategy, results of operations, or financial condition at this time. For further discussion of the risks associated with cybersecurity incidents, see the Item 1A.
For the fiscal year ended December 31, 2024 , we are not aware of any cybersecurity incidents that have materially affected or are reasonably likely to materially affect the Company, including our business strategy, results of operations, or financial condition. For further discussion of the risks associated with cybersecurity incidents, see the Item 1A.
ITEM 1C. CYBERSECURITY Managing cybersecurity risk is a crucial part of our overall strategy for safely operating our business. We incorporate cybersecurity practices into our Enterprise Risk Management (ERM) approach, which is subject to oversight by our BOD. Our cybersecurity policies and practices are aligned with relevant industry standards.
ITEM 1C. CYBERSECURITY Managing cybersecurity risk is a crucial part of our overall strategy for safely operating our business. We incorporate cybersecurity practices into our Enterprise Risk Management (ERM) program. Management is responsible for assessing and managing risk, including through the ERM program, subject to oversight by our BOD.
Such plans include the protocol by which material incidents would be communicated to executive management, our BOD, external regulators and shareholders. Enterprise-Wide Coordination : We engage experts from across the Company to identify emerging risks and respond to cybersecurity threats. This cross-functional approach includes personnel from our R&D, manufacturing, commercial, technology, legal, compliance, internal audit and other business functions.
Such plans include the protocol by which certain significant or potentially material incidents would be communicated to executive management, our BOD, external regulators and shareholders, as appropriate. Enterprise-Wide Coordination : We engage relevant stakeholders from across the Company to identify emerging risks and respond to cybersecurity threats.
Our CISO is a member of our management team who is principally responsible for overseeing our cybersecurity risk management program, in partnership with other business leaders across the Company.
The Audit Committee may also promptly receive information regarding certain significant or potentially material cybersecurity incidents that may occur, including any ongoing updates regarding the same. Our CISO is a member of our management team who is principally responsible for overseeing our cybersecurity risk management program, in partnership with other business leaders across the Company.
Pfizer Inc. 2023 Form 10-K 26 Governance : Our BOD’s oversight of cybersecurity risk management is led by the Audit Committee, which oversees our ERM program. Cybersecurity threats, risks and mitigation are periodically reviewed by the Audit Committee and such reviews include both internal and independent assessment of risks, controls and effectiveness.
Cybersecurity threats, risks and mitigation are periodically reviewed by the Audit Committee and such reviews include both internal and independent assessment of risks, controls and effectiveness.
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The Audit Committee may also promptly receive information regarding any material cybersecurity incident that may occur, including any ongoing updates regarding the same. The Audit Committee periodically discusses our approach to cybersecurity risk management with our Chief Information Security Officer (CISO).
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Our cybersecurity policies and practices are aligned with NIST (National Institute of Standards and Technology) industry standards.
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This cross-functional approach includes personnel from our R&D, manufacturing, commercial, technology, legal, compliance, internal audit and other business functions. Pfizer Inc. 2024 Form 10-K 24 • Governance : Our BOD’s oversight of cybersecurity risk management is led by the Audit Committee, which oversees our ERM program.
Added
We believe our CISO and the information security organization have the appropriate expertise, background and depth of experience relating to monitoring the prevention, mitigation, detection and remediation of cybersecurity incidents to manage risks arising from cybersecurity threats.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeThe 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.
Biggest changeAs of December 31, 2024, 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. The leadership team for PGS is primarily located in New York City. PGS also operates multiple distribution facilities around the world.
ITEM 2. PROPERTIES We own and lease space globally for sales and marketing, customer service, regulatory compliance, R&D, manufacturing and distribution and corporate enabling functions. In many locations, our business and operations are co-located to achieve synergy and operational efficiencies. Our global headquarters are located in New York City.
ITEM 2. PROPERTIES Our global headquarters are located in New York City. We own and lease space globally for sales and marketing, customer service, regulatory compliance, R&D, manufacturing and distribution and corporate enabling functions. In many locations, our business and operations are co-located to achieve synergy and operational efficiencies.
We 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.
We continue to advance our global workplace strategy to provide workplaces that promote our forward-thinking and highly inclusive culture. As of December 31, 2024, we had 251 owned and leased properties worldwide, amounting to approximately 37 million square feet.
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.
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. See Note 9 for amounts invested in land, buildings and equipment.
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See Note 9 for amounts invested in land, buildings and equipment.
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PGS continuously evaluates it network and capacity to meet Pfizer's ever changing needs and help inform future decisions. In the U.S., our R&D facilities contain an aggregate of approximately 9 million square feet, with the majority of that area owned by Pfizer. Outside of the U.S., we lease R&D labs in the U.K., India and Belgium.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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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.
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 Medtronic plc. Douglas M. Lankler 59 Chief Legal Officer, Executive Vice President since January 2025. General Counsel, Executive Vice President from December 2013 until December 2024.
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).
Alexandre de Germay 57 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).
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.
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 2025 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.
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.
Corporate Secretary from January 2014 until February 2014. Executive Vice President, Chief Compliance and Risk Officer from February 2011 until December 2013. Aamir Malik 49 Chief U.S. Commercial Officer, Executive Vice President since December 2023. Chief Business Innovation Officer, Executive Vice President from August 2021 until December 2023.
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.
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 59 Chief Financial Officer, Executive Vice President since May 2022.
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.
ITEM 3. LEGAL PROCEEDINGS Certain legal proceedings in which we are involved are discussed in Note 16A . Pfizer Inc. 2024 Form 10-K 25 INFORMATION ABOUT OUR EXECUTIVE OFFICERS The executive officers of the Company are set forth in this table.
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.
Name Age Position Albert Bourla, DVM, Ph.D. 63 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. from 2014 to 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. Served as Director of Haleon plc from March 2023 to December 2024.
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.
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 59 Chief Global Supply and Quality Officer, Executive Vice President since January 2025. Chief Global Supply Officer, Executive Vice President from 2022 until December 2024.
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.
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. Andrew Baum, MA, BM ChB 55 Chief Strategy and Innovation Officer and Executive Vice President since 2024.
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.
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. Lidia Fonseca 56 Chief Digital and Technology Officer, Executive Vice President since January 2019.
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.
President of Pfizer Global Supply from 2018 until 2021. Vice President of Pfizer Global Supply from 2014 until 2018. Vice President of the Biotechnology Unit from 2012 until 2014. Payal Sahni 50 Chief People Experience Officer, Executive Vice President since January 2022. Chief Human Resources Officer, Executive Vice President from June 2020 to December 2021.
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.
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. Sahni has served in a number of positions in the Human Resources organization with increasing responsibility since joining Pfizer in 1997.
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
Sally Susman 63 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. Senior Vice President, Policy, External Affairs and Communications from December 2009 until December 2010. Director of UL Solutions Inc. Pfizer Inc. 2024 Form 10-K 26 PART II
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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.
Added
Prior to joining Pfizer, he was Head of Global Healthcare - Managing Director Equity Research at Citigroup from 2011 until 2024. Chris Boshoff, MD, FRCP, FMedSci, Ph.D. 61 Chief Scientific Officer and President, Research & Development, since January 2025. Chief Oncology Officer, Executive Vice President from December 2023 until December 2024.
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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.

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeITEM 4. MINE SAFETY DISCLOSURES N/A INFORMATION ABOUT OUR EXECUTIVE OFFICERS 28 PART II 29 ITEM 5. MARKET FOR THE COMPANY’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 29 ITEM 6. [RESERVED] 29 ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 30 ITEM 7A.
Biggest changeITEM 4. MINE SAFETY DISCLOSURES N/A INFORMATION ABOUT OUR EXECUTIVE OFFICERS 26 PART II 27 ITEM 5. MARKET FOR THE COMPANY’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 27 ITEM 6. [RESERVED] 27 ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 28 ITEM 7A.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 49 ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 50
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 48 ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 49

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest change(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.
Biggest changeThe following summarizes purchases of our common stock during the fourth quarter of 2024: Period Total Number of Shares Purchased (a) Average Price Paid per Share (a) Total Number of Shares Purchased as Part of Publicly Announced Plan Approximate Value of Shares that May Yet Be Purchased Under the Plan (b) September 30 through October 27, 2024 33,110 $ 29.04 $ 3,292,882,444 October 28 through November 30, 2024 34,233 $ 27.85 $ 3,292,882,444 December 1 through December 31, 2024 63,672 $ 26.21 $ 3,292,882,444 Total 131,015 $ 27.36 (a) Represents (i) 127,726 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 3,289 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.
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).
PEER GROUP PERFORMANCE GRAPH The following graph assumes a $100 investment on December 31, 2019, 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, 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 15, 2024, there were 123,387 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 20, 2025, there were 113,116 holders of record of our common stock.
Five 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
Five Year Performance 2019 2020 2021 2022 2023 2024 PFIZER $100.0 $103.4 $172.5 $154.5 $90.8 $88.8 PEER GROUP $100.0 $105.5 $126.6 $147.5 $170.1 $177.4 S&P 500 $100.0 $118.4 $152.3 $124.7 $157.5 $196.8 DRG Index $100.0 $108.7 $134.2 $144.5 $155.7 $163.6
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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

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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 .
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 $7.0 billion, to $8.0 billion in 2024 from $1.1 billion in 2023, was primarily attributable to (i) a decrease in Cost of Sales, (ii) higher revenues and (iii) a decrease in Restructuring charges and certain acquisition-related costs, partially offset by (iv) higher net interest expense, (v) net periodic benefit costs associated with pension and other postretirement plans incurred in 2024 versus net periodic benefit credits in 2023, (vi) lower net gains on equity securities and (vii) an increase in Amortization of intangible assets.
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.
We believe that our medicines and vaccines provide significant value for healthcare providers and patients, and we 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.
On October 13, 2023, we announced an amended agreement with the U.S. government, which facilitated the transition of Paxlovid to traditional commercial markets in November 2023, with minimal uptake of NDA-labeled commercial product before January 1, 2024. See Note 17C .
On October 13, 2023, we announced an amended agreement with the U.S. government, which facilitated the transition of Paxlovid to traditional commercial markets in the U.S. in November 2023, with minimal uptake of NDA-labeled commercial product before January 1, 2024 (see Note 17C ).
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.
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, tariffs, 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.
We seek to leverage a strong pipeline, organize around expected operational growth drivers and capitalize on trends creating long-term growth opportunities, including: an aging global population that is generating increased demand for innovative medicines and vaccines that address patients’ unmet needs; and advances in both biological science and platform technologies that are enhancing the delivery of breakthrough new medicines and vaccines.
We seek to leverage a strong pipeline, organize around expected operational growth drivers and capitalize on trends creating long-term growth opportunities, including: an aging global population that is generating increased demand for innovative medicines and vaccines that address patients’ unmet needs; and advances in both biological science and platform technologies that are enhancing the delivery of potential breakthrough new medicines and vaccines.
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.
In September 2023, Comirnaty transitioned to traditional commercial market sales in the U.S., triggered by the expiration of 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.
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.
See the Analysis of the Consolidated Statements of Operations 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.
Israel/Hamas Conflict ––Our local operations have been impacted by the armed conflict between Israel and Hamas that began on October 7, 2023. For the years ended December 31, 2023 and 2022, the business of our Israeli subsidiary represented less than 1% of our consolidated revenues and assets.
Israel/Hamas Conflict ––Our local operations have been impacted by the armed conflict between Israel and Hamas that began on October 7, 2023. For the years ended December 31, 2024 and 2023, the business of our Israeli subsidiary represented less than 1% of our consolidated revenues and assets.
For example, a successful challenge of our patent rights would likely result in generic competition earlier than expected. A significant adverse change in the extent or manner in which an asset is used such as a restriction imposed by the FDA or other regulatory authorities that could affect our ability to manufacture or sell a product. An expectation of losses or reduced profits associated with an asset.
For example, a successful challenge of our patent rights would likely result in generic competition earlier than expected. A significant adverse change in the extent or manner in which an asset is used such as a restriction imposed by the FDA or other regulatory authorities, withdrawals or other unusual items that could affect our ability to manufacture or sell a product. An expectation of losses or reduced profits associated with an asset.
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 .
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. See Note 2 for significant recent activities.
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.
For a description of anticipated 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.
We are closely monitoring developments in this conflict, including evaluating potential impacts to our business, customers, suppliers, employees, and operations in Israel and elsewhere in the Middle East that may impact global operations. At this time, longer term impacts to the Company are uncertain and subject to change.
We are closely monitoring developments in this conflict, including evaluating potential impacts to our business, customers, suppliers, employees, and operations in Israel and elsewhere in the Middle East that may impact global operations. At this time, longer term impacts from these events to the Company are uncertain and subject to change.
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.
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), quality consistency evaluation processes and volume-based procurement.
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.
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 certain pediatric patients. See the Product Developments section within MD&A. In 2023, we principally sold Comirnaty globally under government contracts.
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.
Internationally, sales of Comirnaty in international developed markets were generally under government contracts in 2023 and 2024, and in emerging markets, under a combination of private channels and government contracts; in both cases, we started transitioning to commercial markets in 2024.
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.
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 $18.9 billion as of December 31, 2024) and newly acquired or recently impaired indefinite-lived brand assets. IPR&D assets are high-risk assets, given the uncertain nature of R&D.
The price that patients pay in the U.S. for prescribed medicines and vaccines is ultimately set by healthcare providers and insurers.
The price that patients pay in the U.S. for prescribed medicines and vaccines is ultimately set by healthcare providers and insurers, including government healthcare programs.
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.
We are continuing to monitor and implement mitigation strategies 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.
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.
For a discussion of recently adopted accounting standards, 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.
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.
Goodwill ––Our goodwill impairment review work as of December 31, 2024 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.
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.
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.
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.
Our Business and Strategy –– Pfizer Inc. is a research-based, global biopharmaceutical company. 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.
Although foreign exchange rate changes are part of our business, they are not within our control and since they can mask positive or negative trends in the business, we believe presenting operational variances excluding these foreign exchange changes provides useful information to evaluate our results. Our Business and Strategy –– Pfizer Inc. is a research-based, global biopharmaceutical company.
Although foreign exchange rate changes are part of our business, they are not within our control and because they can mask positive or negative trends in the business, we believe presenting operational variances excluding these foreign exchange changes provides useful information to evaluate our results.
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.
COVID-19 ––In response to COVID-19, we developed Paxlovid and collaborated with BioNTech to jointly develop Comirnaty. As part of our strategy for COVID-19, we are continuing to make significant investments in breakthrough science.
The Global Economic Environment ––In addition to the industry-specific factors discussed above, we, like other businesses of our size and global extent of activities, are exposed to economic cycles.
Voluntary Withdrawal of Oxbryta –– See the Product Developments section within MD&A. The Global Economic Environment ––In addition to the industry-specific factors discussed above, we, like other businesses of our size and global extent of activities, are exposed to economic cycles.
In 2021, Pfizer recalled all lots of Chantix in the U.S. due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. Regulatory authorities outside the U.S. have issued updated guidance on nitrosamine acceptable intake levels.
For example, in 2021, Pfizer recalled all lots of Chantix due to the presence of a nitrosamine, N-nitroso-varenicline, at or above acceptable intake limits communicated by various regulatory authorities. Regulatory authorities have since issued updated guidance on nitrosamine acceptable intake levels.
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.
In August 2023, CMS published the first ten medicines subject to the MDPNP, 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. Eliquis was among the first ten medicines subject to MDPNP.
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.
Business –– Pricing Pressures and Managed Care Organizations and ––Government Regulation and Price Constraints and the Item 1A. 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.
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.
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): 2024 Total Revenues––$63.6 billion 2024 Net Cash Flow from Operations––$12.7 billion An increase of 7% compared to 2023 An increase of 46% compared to 2023 2024 Reported Diluted EPS––$1.41 2024 Adjusted Diluted EPS (Non-GAAP)––$3.11** An increase of over 100% compared to 2023 An increase of 69% compared to 2023 ** 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.
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.
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.
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.
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.
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.
Financial Statements and Supplementary Data in this Form 10-K. Discussions of 2022 items and year-to-year comparisons between 2023 and 2022 that are not included in this Form 10-K can be found within MD&A in our 2023 Form 10-K. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates.
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.
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.
SIGNIFICANT ACCOUNTING POLICIES AND APPLICATION OF CRITICAL ACCOUNTING ESTIMATES AND ASSUMPTIONS Following is a discussion about the critical accounting estimates and assumptions impacting our consolidated financial statements. Also, see Note 1C . For a description of our significant accounting policies, see Note 1 .
For information on risks associated with these conflicts, see the Item 1A. Risk Factors—Global Operations section. SIGNIFICANT ACCOUNTING POLICIES AND APPLICATION OF CRITICAL ACCOUNTING ESTIMATES AND ASSUMPTIONS Following is a discussion about the critical accounting estimates and assumptions impacting our consolidated financial statements. Also, see Note 1C . For a description of our significant accounting policies, see Note 1 .
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.
Except for the impact of the tornado in Rocky Mount, NC discussed above, we have not seen a significant disruption of our supply chain in 2024 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.
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.
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.
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.
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. Our 2025 key priorities are: 1. Improve R&D productivity with sharpened focus 2. Expand margins and maximize operational efficiency 3.
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 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 the U.S. government on regulating drug pricing and access to medicine. The drug pricing provisions of the IRA are being implemented over the next several years.
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 .
Business––Patents and Other Intellectual Property Rights section. For a discussion of recent developments with respect to patent litigation involving certain of our products, see Note 16A1 .
With this recently issued guidance, which included an updated intake level for N-nitroso-varenicline, we expect to make regulatory submissions in 2024 to potentially enable Chantix to return to market outside the U.S., and our related discussions with FDA are ongoing.
With this guidance, which included an updated intake level for N-nitroso-varenicline, we have started making regulatory submissions to potentially enable Chantix to return to market in the U.S. and in certain international markets.
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.
SNS. See Note 17C . Excluding contributions from Comirnaty and Paxlovid, Total revenues increased 12% operationally. 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.
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 .
For information on risks associated with our COVID-19 products, as well as COVID-19 intellectual property disputes, see the Item 1A. Risk Factors COVID-19 , Intellectual Property Protectio n and –– Third-Party Intellectual Property Claims sections as well as Notes 16A1 and 17C .
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.
Oncology commercial organization and the global Oncology marketing organization, which were part of the former Pfizer Oncology Division, into the Pfizer U.S. Commercial Division, which now focuses on the commercialization of Pfizer’s entire product portfolio in the U.S. and is led by the Chief U.S.
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.
In addition, changes to the MDRP or the 340B Program, including legal or legislative developments at the federal or state level with respect to the 340B Program, could Pfizer Inc. 2024 Form 10-K 30 have a material impact on our business. See the Item 1.
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.
In the fourth quarter of 2023, we announced that we launched a multi-year, enterprise-wide cost realignment program (Realigning Our Cost Base Program) that aims to realign our costs with our longer-term revenue expectations.
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.
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 .
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.
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, potential additional sanctions, and actions by our customers or suppliers (including financial institutions) are difficult to predict at this time.
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.
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. 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.
We anticipate a more significant impact of reduced revenues from patent expiries in 2026 through 2030 as several of our in-line products experience patent-based expirations. We continue to vigorously defend our patent rights against infringement, and we will continue to support efforts that strengthen worldwide recognition of patent rights while taking necessary steps to help ensure appropriate patient access.
We continue to vigorously defend our patent rights against infringement, and we will continue to support efforts that strengthen worldwide recognition of patent rights while taking necessary steps to help ensure appropriate patient access. For additional information on patent rights we consider most significant to our business as a whole, see the Item 1.
For IPR&D projects, this could result from, among other things, a change in outlook based on clinical trial data, a delay in the projected launch date or additional expenditures to commercialize the product. Identifiable Intangible Assets ––We use an income approach, specifically the discounted cash flow method to determine the fair value of intangible assets, other than goodwill.
For IPR&D projects, this could result from, among other things, a change in outlook based on clinical trial data, a delay in the projected launch date or additional expenditures to commercialize the product. Pfizer Inc. 2024 Form 10-K 32 Changes in development plans and/or de-prioritization of certain assets.
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.
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. Supply of medicines has recovered from the impact of the tornado. We incurred losses in 2023 and 2024 that were partially offset by insurance recoveries received.
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.
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.
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.
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. In addition, issued or future executive orders or other new or changes in laws, regulations or policy regarding tariffs, could have a material adverse effect on our business, earnings and financial guidance.
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.
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.
Due to the commercial market transition as well as the anticipated seasonal nature of COVID vaccination, we expect more than 80% of our 2024 global revenues for Comirnaty to be recorded in the second half of the year. In 2023, we principally sold Paxlovid globally to government agencies.
Due to the commercial market transition as well as the seasonality of demand for COVID-19 vaccinations, the majority of our global revenues for Comirnaty were recorded in the fourth quarter of 2024. In 2025, for Comirnaty we expect vaccination rates and market share in commercial markets and revenue phasing similar to 2024, primarily concentrated in the second-half of the year.
We may record additional losses and/or costs and/or insurance recoveries in future periods, but we are unable to predict them with certainty at this time. Pfizer Inc. 2023 Form 10-K 32 Product Supply –– We periodically encounter supply delays, disruptions and shortages, including due to voluntary product recalls and natural or man-made disasters.
Product Supply –– We periodically encounter supply delays, disruptions and shortages, including due to voluntary product recalls and natural or man-made disasters.
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%.
Our 2024 Performance Total Revenues ––Total revenues increased $4.1 billion, or 7%, to $63.6 billion in 2024 from $59.6 billion in 2023, reflecting an operational increase of $4.4 billion, or 7%, partially offset by an unfavorable impact of foreign exchange of $349 million, or approximately 1%.
Internationally, for Paxlovid, we are continuing the transition to commercial markets and are expecting most revenue for Paxlovid to be generated through commercial channels in 2024.
Internationally, for Paxlovid, most markets have now transitioned to commercial markets, and we are expecting most revenue for Paxlovid to be generated through commercial channels. In 2025, we expect utilization for Paxlovid to follow infection rates and stable market share, and revenues may fluctuate based on the timing, duration and severity of COVID-19 cases.
Russia/Ukraine Conflict ––Our local operations have been impacted by the armed conflict between Russia and Ukraine.
Pfizer Inc. 2024 Form 10-K 31 Russia/Ukraine Conflict ––Our local operations have been impacted by the armed conflict between Russia and Ukraine. For the years ended December 31, 2024 and 2023, the business of our Russia and Ukraine subsidiaries represented less than 1% of our consolidated revenues and assets.
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.
At the beginning of 2025, we made the following changes within our Biopharma reportable segment that went into effect on January 1, 2025 to support our continued focus on commercial execution and to further strengthen Pfizer’s capabilities and leadership in discovering and developing breakthrough medicines and vaccines: transitioned the Pfizer U.S.
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References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates.
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In the first quarter of 2024, we reclassified royalty income (substantially all of which is related to our Biopharma segment) from Other (income)/deductions––net and began presenting Royalty revenues as a separate line item within Total revenues in our consolidated statements of operations. Prior-period amounts have been recast to conform to the current presentation.
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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.
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Achieve commercial excellence in our key categories 4. Optimize capital allocation. Pfizer Inc. 2024 Form 10-K 28 One way we believe we will be more efficient, effective and able to execute on these strategic priorities is through technology, including AI.
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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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In 2024, we managed our commercial operations through a global structure consisting of three operating segments: Biopharma, PC1 and Pfizer Ignite. Biopharma was the only reportable segment. See Note 1 7 A and the Item 1. Business––Commercial Operations section.
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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.
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Commercial Officer, Executive Vice President; and • combined our global ORD and PRD organizations to form a single Pfizer R&D organization that is responsible for all R&D activities across all therapeutic areas.
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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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In the second quarter of 2024, we announced that we launched a multi-year, multi-phased program to reduce our costs of goods sold (Manufacturing Optimization Program), which is expected to include operational efficiencies, network structure changes, and product portfolio enhancements. See Note 3 .
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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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The operational increase was primarily driven by Paxlovid, the addition of legacy Seagen revenues in full-year 2024 following the acquisition in December 2023, and growth from the Vyndaqel family and Eliquis, partially offset by declines in Comirnaty.
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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.
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The operational increase for Paxlovid was primarily due to: (i) a non-cash revenue reversal of $3.5 billion recorded 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 inventory and (ii) revenue in 2024 of $1.2 billion from two one-time items: a $771 million favorable final adjustment recorded in the first quarter of 2024 to the aforementioned $3.5 billion revenue reversal; and $442 million from the one-time contractual delivery of treatment courses to the U.S.
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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.
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Certain of our vaccines, including Comirnaty, are subject to seasonality of demand, with a greater portion of revenues anticipated in the fall and winter seasons, and Paxlovid revenues trend with infection rates. See also The Global Pfizer Inc. 2024 Form 10-K 29 Economic Environment––COVID-19 section below for information about our COVID-19 products.
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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.
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For information regarding the primary indications or class of certain products, see Note 17C .
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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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While additional patent-based or regulatory exclusivity expiries will continue, we expect a moderate impact of reduced revenues due to patent expiries in 2025 and anticipate a more significant impact of reduced revenues from patent-based or regulatory exclusivity expiries in 2026 through 2030 as several of our in-line products experience these expirations.

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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. 2023 Form 10-K 49
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. 2024 Form 10-K 48

Other PFE 10-K year-over-year comparisons