Pfizer Inc.
11/04/2025 | Press release | Distributed by Public on 11/04/2025 06:04
Quarterly Report for Quarter Ending September 28, 2025 (Form 10-Q)
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
OPERATIONS
GENERAL
The following MD&A is intended to assist the reader in understanding our financial condition and results of operations, including an evaluation of the amounts and certainty of cash flows from operations and from outside sources, and is provided as a supplement to and should be read in conjunction with the condensed consolidated financial statements and related notes in Item 1. Financial Statements in this Form 10-Q.
References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates. 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.
OVERVIEW OF OUR PERFORMANCE, OPERATING ENVIRONMENT, STRATEGY AND OUTLOOK
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. Our 2025 key priorities are to:
1.Improve R&D productivity with sharpened focus
2. Expand margins and maximize operational efficiency
3, Achieve commercial excellence in our key categories
4. Optimize capital allocation.
One way we believe we will be more efficient, effective and able to execute on these strategic priorities is through digital enablement, including automation and AI.
Segments--We manage our commercial operations through a global structure consisting of three operating segments: Biopharma, PC1 and Pfizer Ignite. Biopharma is the only reportable segment. See Note 13A.
Restructuring Programs
Realigning Our Cost Base Program
•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 second quarter of 2025, we identified additional productivity opportunities to further reduce costs primarily in SI&A, driven in large part by enhanced digital enablement, including automation and AI, and simplification of business processes.
•In connection with our efforts to simplify the structure and sharpen the focus of our R&D organization, in the first quarter of 2025, we expanded this program after having identified additional opportunities to drive improvements in productivity and operational efficiencies through enhanced digital enablement, including automation and AI, and simplification of business processes.
Manufacturing Optimization Program--In the second quarter of 2024, we announced that we launched a multi-year, multi-phased program to reduce our costs of goods sold, which is expected to include primarily operational efficiencies, network structure changes, and product portfolio enhancements.
See Note 3 for the anticipated and actual costs of these programs. 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.
For additional information about our business, strategy and operating environment, see the Item 1. Businesssection and Overview of Our Performance, Operating Environment, Strategy and Outlook section within MD&A of our 2024 Form 10-K.
Our Business Development Initiatives and Other Recent Developments--We are committed to strategically capitalizing on growth opportunities, primarily by advancing our own product pipeline and maximizing the value of our existing products, but also through various business development activities. For a description of the more significant recent transactions through February 27, 2025, the filing date of our 2024 Form 10-K, see Note 2in our 2024 Form 10-K. See Note 2 and the following for significant recent business development activities and other recent developments:
Agreement with the U.S. Government-- In September 2025, we announced preliminary agreements with the Trump Administration in which we voluntarily agreed to implement measures designed to make certain drug prices for U.S. patients more comparable to those in other developed countries. We will also participate in a direct purchasing platform, TrumpRx.gov, that will allow American patients to purchase certain medicines from us at significant discounts to current retail prices, where the large majority of the Company's primary care treatments and some select specialty brands will be offered at savings that
will range as high as 85% and on average 50%. The agreements also provide a three-year grace period during which time our products under a Section 232 investigation will not face tariffs, provided the Company further invests in manufacturing in the U.S. Pfizer is now in the process of negotiating definitive agreements to implement these arrangements.
Proposed Acquisition of Metsera-- In September 2025, we and Metsera announced that the companies entered into a definitive agreement under which we will acquire Metsera, a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and cardiometabolic diseases, for $47.50 in cash per Metsera share at closing, representing an enterprise value of approximately $4.9 billion. Additionally, the agreement includes a non-transferable contingent value right entitling holders to potential additional payments of up to $22.50 per share in cash tied to the achievement of three specific milestones: $5 per share following the Phase 3 clinical trial start of Metsera's injectable GLP-1 receptor antagonist MET-097i+ amylin analog MET-233i combination, $7 per share following FDA approval of Metsera's monthly MET-097i monotherapy and $10.50 per share following FDA approval of Metsera's monthly MET-097i+MET-233i combination. We expect to finance the transaction through a combination of available cash and new debt. The transaction is subject to the satisfaction of customary closing conditions, including receipt of approval by Metsera's shareholders.
In October 2025, we announced the U.S. Federal Trade Commission granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, with respect to Pfizer's pending acquisition of Metsera. As such, all required regulatory approvals in respect of Pfizer's acquisition of Metsera have been obtained.
In October and November 2025, we announced that Pfizer has filed lawsuits against Metsera, Novo Nordisk A/S (Novo Nordisk) and several related parties and individuals in the Delaware Court of Chancery and the U.S. District Court of the District of Delaware for claims relating to a competing proposal to acquire Metsera made by Novo Nordisk on October 25, including claims for breach of contract, breach of fiduciary duty, and tortious interference in contract arising from Metsera's breach of its obligations under the merger agreement between Pfizer and Metsera, as well as various antitrust-related claims. Pfizer is requesting the Delaware Court of Chancery issue a temporary restraining order to block Metsera from terminating the merger agreement and seeks all appropriate remedies to ensure the terms of the merger agreement are fully enforced.
Our Third Quarter 2025 and First Nine Months of 2025 Performance
Total Revenues--Total revenuesdecreased $1.0 billion, or 6%, in the third quarter of 2025 to $16.7 billion from $17.7 billion in the third quarter of 2024, reflecting an operational decrease of $1.3 billion, or 7%, partially offset by a favorable impact of foreign exchange of $203 million, or 1%. The operational decrease was primarily driven by declines from Paxlovid and Comirnaty largely due to lower infection rates impacting Paxlovid demand as well as a narrower vaccine recommendation for COVID-19 in the U.S. that reduced the eligible population for Comirnaty, partially offset primarily by increases in Eliquis, the Vyndaqel family and Nurtec ODT/Vydura.
Total revenuesdecreased $842 million, or 2%, in the first nine months of 2025 to $45.0 billion from $45.9 billion in the first nine months of 2024, reflecting an operational decrease of $811 million, or 2%, as well as a de minimis impact of foreign exchange of $31 million. The operational decrease was primarily driven by a decline from Paxlovid, partially offset by increases from the Vyndaqel family, Eliquis, Padcev and Lorbrena.
See the Total Revenues by Geographyand Total Revenues--Selected Product Discussionsections for more information, including a discussion of key drivers of our revenue performance. 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, as well as additional changes in recommendation for vaccination, and Paxlovid revenues trend with infection rates. See also The Global Economic Environment--COVID-19section below for information about our COVID-19 products. For information regarding the primary indications or class as well as revenue of certain products, see Note 13C.
Income from Continuing Operations Before Provision/(Benefit)for Taxes on Income--The decrease in Income from continuing operations before provision/(benefit)for taxes on incomeof $1.4 billion to $3.3 billion in the third quarter of 2025 from $4.7 billion in the third quarter of 2024, was primarily due to an increase in Acquired in-process research and development expensesand lower revenues, partially offset by a decrease inCost of sales.
The increase in Income from continuing operations before provision/(benefit)for taxes on incomeof $1.1 billion, to $9.2 billion in the first nine months of 2025 from $8.0 billion in the first nine months of 2024, was primarily due to decreases in Cost of sales, Selling, informational and administrative expenses, Restructuring charges and certain acquisition-related costs and Research and development expenses,partially offset by an increase inAcquired in-process research and development expenses and lower revenues.
See the Analysis of the Condensed Consolidated Statements of Operationssection within MD&A and Notes 3and 4. For information on our tax provision and effective tax rate, see the Provision/(Benefit)for Taxes on Incomesection within MD&A and Note 5.
Our Operating Environment--We, like other businesses in our industry, are subject to certain industry-specific challenges. These include, among others, the topics listed below. See also the Item 1. Business--Government Regulation and Price Constraints andItem 1A. Risk Factors sections, and the Overview of Our Performance, Operating Environment, Strategy and Outlook--Our Operating Environment section of the MD&A of our 2024 Form 10-K.
Intellectual Property Rights and Collaboration/Licensing Rights--The loss, expiration or invalidation of intellectual property rights, patent litigation settlements and judgments, and the expiration of co-promotion and licensing rights can have a material adverse effect on our revenues. Certain of our products have experienced patent-based expirations or loss of regulatory exclusivity in certain markets in the last few years, and we expect certain products to face increased generic competition over the next few years. While additional patent-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. 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, including U.S., major Europe and Japan basic product patent expiration years, see the Item 1. Business--Patents and Other Intellectual Property Rights section of our 2024 Form 10-K. For a discussion of recent developments with respect to patent litigation involving certain of our products, see Note 12A1.
Regulatory Environment/Pricing and Access--Government and Other Payor Group Pressures--Governments globally, as well as 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, clawbacks and volume-based procurement. 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 and states on regulating drug pricing and access to medicine, including but not limited to, international reference pricing, including Most-Favored-Nation (MFN) drug pricing. The drug pricing provisions of the IRA are being implemented over the next several years. In August 2023, CMS published 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. Eliquis was among the first ten medicines subject to the Medicare Drug Price Negotiation Program. In August 2024, the government released the new Medicare price for Eliquis, which, effective January 1, 2026, will be required to be offered to all Medicare beneficiaries and to covered entities participating in the 340B Program that dispense Eliquis to a Medicare beneficiary if that maximum fair price is lower than the discounted price such entities are offered under the 340B Program ceiling price calculation. The Eliquis Medicare price is factored into our long-term financial planning, in accordance with our standard financial reporting and forecasting protocols. On January 17, 2025, CMS announced the selection of another 15 drugs from Medicare Part D for the maximum fair price, with prices to be set and effective on January 1, 2027. Ibrance and Xtandi were included in the list of 15 drugs selected. Another 15 drugs from Medicare Part B or Medicare Part D will be selected by February 1, 2026, for the maximum price to be set and in effect by January 1, 2028. It is possible that more of our products could be selected in future years, which could, among other things, lead to lower revenues prior to expiry of intellectual property protections. We continue to evaluate the impact of the IRA on our business, operations and financial condition and results as the full effect of the IRA on our business and the pharmaceutical industry remains uncertain. The IRA also made significant changes to the Medicare Part D benefit design (IRA Medicare Part D Redesign), which took effect beginning in 2025 and are impacting our revenues. In 2025, we expect a favorable impact from the $2,000 annual out-of-pocket cap and new Prescription Payment Plan, more than offset by an expected unfavorable impact from the sunsetting of the Coverage Gap Discount Program and the addition of new manufacturer discounts in the initial and catastrophic coverage phases, which we anticipate will have a net unfavorable impact to revenue in 2025 of approximately $1 billion, year-over-year. We expect a higher impact in the beginning of 2025, moderating through the remainder of the year, when compared to 2024. We expect these changes will more acutely impact our higher-priced medicines as they are expected to reach catastrophic coverage earlier in the year. 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 Constraintsand the Item 1A. Risk Factors--Pricing and Reimbursement sections, and the Overview of Our Performance, Operating Environment, Strategy and Outlook--Our Operating Environmentsection of the MD&A of our 2024 Form 10-K.
Policy/Regulatory Environment--New and potential policy, regulatory or other changes from the U.S. Presidential administration, Congress and states, including, among others, increased or new regulatory requirements, including heightened requirements for licensure, changes, delays or failure to receive recommendations, reimbursement and regulatory approvals and
coverage for our vaccines and medicines could have a material adverse effect on our business, earnings, cash flows, liquidity and financial guidance.
Product Supply--We periodically encounter supply delays, disruptions and shortages, including due to voluntary product recalls and natural or man-made disasters. In response to requests from various regulatory authorities, manufacturers across the pharmaceutical industry, including Pfizer, are evaluating their product portfolios for the potential presence or formation of nitrosamines and we are actively engaging with regulatory authorities on this topic. If nitrosamines are detected in products, this may lead to submission of comprehensive data packages to regulatory authorities to support discussions on the relevant intake limit for the product and potential impact on patient supply, and, in some instances, may lead to market action for such products. For example, in 2021, Pfizer recalled Chantix due to the presence of a nitrosamine, N-nitroso-varenicline, at or above acceptable intake limits communicated by various regulatory authorities. Following issuance of updated guidance on acceptable intake limits for N-nitroso-varenicline by regulatory authorities, Chantix has returned to market in the U.S. and in certain international markets.
We have not seen a significant disruption of our supply chain in the first nine months of 2025 and through the date of filing of this Form 10-Q, and all of our manufacturing sites globally have continued to operate at or near normal levels. We do not anticipate the availability of raw materials to have a significant impact on our operations in 2025, but are monitoring potential supply chain disruptions as a result of ongoing geopolitical and trade negotiations, which could, among other things, impact costs. 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 Riskssection of our 2024 Form 10-K.
Voluntary Withdrawal of Oxbryta--See the Product Developmentssection 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. See the Item 1A. Risk Factors-Global Operationssection of our 2024 Form 10-K, as well as the Overview of Our Performance, Operating Environment, Strategy and Outlook--The Global Economic Environment section of the MD&A of our 2024 Form 10-K.
Global Trade Environment--Issued or future executive orders or other new or changes in laws, regulations or policy regarding tariffs or other trade policy, could have a material adverse effect on our business, earnings, cash flows, liquidity and financial guidance. The actual impact of new tariffs on our business would be 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 or other retaliatory actions imposed by other countries. Strategies intended to help mitigate the potential impacts on our business in the short-term have been implemented as well as those outlined in our preliminary agreements with the Trump administration as discussed above. We are continuing to evaluate opportunities and developing plans which are intended to help mitigate the potential long-term impact of tariffs on our business and operations. See the Item 1A. Risk Factors-Global Operationssection of our 2024 Form 10-K.
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. 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. See the Product Developmentssection within MD&A.
In 2025, for Comirnaty, we expect market share in commercial markets and revenue phasing similar to 2024, primarily concentrated in the second-half of the year. However, we expect lower vaccination rates in certain markets due to changes in vaccination recommendations. For example, in September 2025, the ACIP voted to recommend "shared clinical decision making" for all FDA- approved COVID-19 vaccines consistent with the licensed ages applicable to each of the vaccines. The expected impact has been incorporated in our 2025 financial guidance. See the Item 1A. Risk Factors-U.S. Healthcare Regulation section of our 2024 Form 10-K for a description of certain risks and uncertainties that could impact revenue from our portfolio of vaccines.
In 2025, for Paxlovid, we generated most revenue through commercial channels. We have seen lower demand for Paxlovid as a result of lower infection rates. We continue to expect a higher proportion of revenue to be delivered in the second-half of the year and revenues may fluctuate based on the timing, duration and severity of COVID-19 cases. The expected impact of the lower than anticipated demand has been incorporated in our 2025 financial guidance.
For additional information on risks associated with our COVID-19 products, as well as COVID-19 intellectual property disputes, see the Overview of Our Performance, Operating Environment, Strategy and Outlook--The Global Economic Environment--COVID-19 section of the MD&A of our 2024 Form 10-K, Item 1A. Risk Factors-COVID-19, -Intellectual Property Protectionand -Third-Party Intellectual Property Claimssections of our 2024 Form 10-K, as well as Note 17Cin
our 2024 Form 10-K, and Note 12A1 and the Forward-Looking Information and Factors that May Affect Future Resultssection of this Form 10-Q. For additional information on revenues, see the Total Revenues by Geographyand Total Revenues--Selected Product Discussionsections of this Form 10-Q.
SIGNIFICANT ACCOUNTING POLICIES AND APPLICATION OF CRITICAL ACCOUNTING ESTIMATES AND ASSUMPTIONS
For a description of our significant accounting policies, see Note 1 in our 2024 Form 10-K. Of these policies, the following are considered critical to an understanding of our consolidated financial statements as they require the application of the most subjective and the most complex judgments: Acquisitions (Note 1D); Fair Value (Note 1E); Revenues (Note 1G); Long-Lived Assets (Note 1M); Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives (Note 1N); Tax Assets and Liabilities and Income Tax Contingencies (Note 1Q); Pension and Postretirement Benefit Plans (Note 1R); and Legal and Environmental Contingencies (Note 1S).
For a discussion about the critical accounting estimates and assumptions impacting our consolidated financial statements, see the Significant Accounting Policies and Application of Critical Accounting Estimates and Assumptionssection within MD&A of our 2024 Form 10-K. See also Note 1Cin our 2024 Form 10-K for a discussion about the risks associated with estimates and assumptions. For a discussion of a recently adopted accounting standard, see Note 1B.
ANALYSIS OF THE CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Total Revenues by Geography
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The following presents worldwide Total revenuesby geography:
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| Three Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | U.S. | International | World-wide | U.S. | Inter-national | |||||||||||||||||||||||||||||||||||||||||||||||||||
| (MILLIONS) | Sept. 28, 2025 | Sept. 29, 2024 | Sept. 28, 2025 | Sept. 29, 2024 | Sept. 28, 2025 | Sept. 29, 2024 | % Change | |||||||||||||||||||||||||||||||||||||||||||||||||
| Operating segments: | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Biopharma | $ | 16,310 | $ | 17,392 | $ | 10,599 | $ | 11,964 | $ | 5,711 | $ | 5,428 | (6) | (11) | 5 | |||||||||||||||||||||||||||||||||||||||||
| Pfizer CentreOne | 344 | 285 | 92 | 76 | 253 | 210 | 21 | 21 | 21 | |||||||||||||||||||||||||||||||||||||||||||||||
| Pfizer Ignite | - | 25 | - | 25 | - | - | (99) | (99) | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Total revenues | $ | 16,654 | $ | 17,702 | $ | 10,691 | $ | 12,064 | $ | 5,963 | $ | 5,638 | (6) | (11) | 6 | |||||||||||||||||||||||||||||||||||||||||
| Nine Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | U.S. | International | World-wide | U.S. | Inter-national | |||||||||||||||||||||||||||||||||||||||||||||||||||
| (MILLIONS) | Sept. 28, 2025 | Sept. 29, 2024 | Sept. 28, 2025 | Sept. 29, 2024 | Sept. 28, 2025 | Sept. 29, 2024 | % Change | |||||||||||||||||||||||||||||||||||||||||||||||||
| Operating segments: | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Biopharma | $ | 44,056 | $ | 44,987 | $ | 27,677 | $ | 29,218 | $ | 16,379 | $ | 15,769 | (2) | (5) | 4 | |||||||||||||||||||||||||||||||||||||||||
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Pfizer CentreOne
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929 | 820 | 245 | 195 | 684 | 625 | 13 | 25 | 9 | |||||||||||||||||||||||||||||||||||||||||||||||
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Pfizer Ignite
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37 | 56 | 37 | 56 | - | - | (34) | (34) | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Total revenues | $ | 45,022 | $ | 45,864 | $ | 27,959 | $ | 29,470 | $ | 17,063 | $ | 16,394 | (2) | (5) | 4 | |||||||||||||||||||||||||||||||||||||||||
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The following provides an analysis of the worldwide change in Total revenuesby geographic areas in the third quarter of 2025 compared to the third quarter of 2024:
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| (MILLIONS) | Worldwide | U.S. | International | |||||||||||||||||
| Operational growth/(decline): | ||||||||||||||||||||
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Worldwide decline from Paxlovid
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$ | (1,477) | $ | (1,192) | $ | (285) | ||||||||||||||
| Worldwide decline from Comirnaty | (280) | (294) | 14 | |||||||||||||||||
| Worldwide growth from Eliquis, the Vyndaqel family, Nurtec ODT/Vydura, Lorbrena, Padcev and Xtandi, partially offset by worldwide declines from Abrysvo, the Prevnar family, Adcetris, Ibrance and Xeljanz | 402 | 71 | 331 | |||||||||||||||||
| Other operational factors, net | 104 | 41 | 64 | |||||||||||||||||
| Operational growth/(decline), net | (1,251) | (1,373) | 123 | |||||||||||||||||
| Favorable impact of foreign exchange | 203 | - | 203 | |||||||||||||||||
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Total revenuesincrease/(decrease)
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$ | (1,048) | $ | (1,373) | $ | 326 | ||||||||||||||
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The following provides an analysis of the worldwide change in Total revenuesby geographic areas in the first nine months of 2025 compared to the first nine months of 2024:
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| (MILLIONS) | Worldwide | U.S. | International | |||||||||||||||||
| Operational growth/(decline): | ||||||||||||||||||||
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Worldwide decline from Paxlovid
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$ | (2,834) | $ | (2,385) | $ | (449) | ||||||||||||||
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Worldwide growth from the Vyndaqel family, Eliquis, Padcev, Lorbrena, Nurtec ODT/Vydura and Xtandi, partially offset by worldwide declines from Ibrance, Adcetris, the Prevnar family, Xeljanz and Abrysvo
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1,486 | 725 | 761 | |||||||||||||||||
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Worldwide growth from Comirnaty
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123 | (64) | 188 | |||||||||||||||||
| Other operational factors, net | 414 | 213 | 202 | |||||||||||||||||
| Operational growth/(decline), net | (811) | (1,511) | 701 | |||||||||||||||||
| Unfavorable impact of foreign exchange | (31) | - | (31) | |||||||||||||||||
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Total revenuesincrease/(decrease)
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$ | (842) | $ | (1,511) | $ | 669 | ||||||||||||||
See the Total Revenues--Selected Product Discussionsection within MD&A for additional analysis and Note 13C.
Product Revenue Deductions--Our gross product revenues are subject to a variety of deductions, which generally are estimated and recorded in the same period that the revenues are recognized. These deductions represent estimates of the related obligations and, as such, knowledge and judgment are required when estimating the impact of these product 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. Product-specific rebates, however, can have a significant impact on year-over-year individual product revenue growth trends.
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The following presents information about product revenue deductions:
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| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||
| (MILLIONS) |
September 28, 2025 |
September 29, 2024 |
September 28, 2025 |
September 29, 2024 |
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Medicare rebates(a)
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$ | 1,188 | $ | 1,801 | $ | 3,359 | $ | 3,278 | ||||||||||||||||||
| Medicaid and related state program rebates | 522 | 720 | 1,309 | 1,846 | ||||||||||||||||||||||
| Performance-based contract rebates | 1,948 | 1,836 | 5,222 | 4,884 | ||||||||||||||||||||||
| Chargebacks | 4,125 | 3,805 | 10,268 | 9,467 | ||||||||||||||||||||||
| Sales allowances | 1,851 | 1,569 | 5,406 | 4,654 | ||||||||||||||||||||||
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Sales returns and cash discounts(b)
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517 | 1,123 | 1,156 | 1,474 | ||||||||||||||||||||||
| Total | $ | 10,151 | $ | 10,855 | $ | 26,720 | $ | 25,603 | ||||||||||||||||||
(a)The decrease in Medicare rebates in the third quarter of 2025 is driven by lower Paxlovid revenues following transition from the U.S. government agreement, partially offset by the impact of higher manufacturer discounts as a result of IRA Medicare Part D Redesign. The increase in Medicare rebates in the first nine months of 2025 is primarily driven by the impact of higher manufacturer discounts as a result of IRA Medicare Part D Redesign, partially offset by lower Paxlovid revenues. See the Overview of Our Performance, Operating Environment, Strategy and Outlooksection within MD&A.
(b)The decrease in Sales returns and cash discounts in the first nine months of 2025 is primarily driven by lower sales returns provision for Comirnaty, 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.
Product revenue deductions are primarily a function of product sales volume, mix of products sold, contractual or legislative discounts and rebates.
For information on our accruals for product revenue deductions, including the balance sheet classification of these accruals, see Note 1C.
Total Revenues--Selected Product Discussion
Biopharma
| (MILLIONS) | Revenue | % Change | ||||||||||||||||||||||||||||||||||||||||||||||||
| Product | Period |
Global Revenues |
Region | Sept. 28, 2025 | Sept. 29, 2024 | Total | Oper. | Operational Results Commentary | ||||||||||||||||||||||||||||||||||||||||||
| Eliquis | QTD |
$2,015
Up 22%
(operationally)
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U.S. | $ | 1,292 | $ | 1,002 | 29 |
QTD growth primarily driven by higher demand globally and favorable net price in the U.S. as a result of the expected favorable year-over-year impact of the elimination of the coverage gap as part of the IRA Medicare Part D Redesign, partially offset by generic entry and price erosion in certain international markets.
YTD growth driven by higher demand globally, partially offset by lower net price in the U.S., including the impact of higher chargebacks, generic entry and price erosion in certain international markets.
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| Int'l. | 723 | 616 | 17 | 11 | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 2,015 | $ | 1,617 | 25 | 22 | ||||||||||||||||||||||||||||||||||||||||||||
| YTD |
$5,941
Up 7%
(operationally)
|
U.S. | $ | 3,913 | $ | 3,677 | 6 | |||||||||||||||||||||||||||||||||||||||||||
| Int'l. | 2,028 | 1,857 | 9 | 8 | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 5,941 | $ | 5,534 | 7 | 7 | ||||||||||||||||||||||||||||||||||||||||||||
| (MILLIONS) | Revenue | % Change | ||||||||||||||||||||||||||||||||||||||||||||||||
| Product | Period |
Global Revenues |
Region | Sept. 28, 2025 | Sept. 29, 2024 | Total | Oper. | Operational Results Commentary | ||||||||||||||||||||||||||||||||||||||||||
| Prevnar family | QTD |
$1,742
Down 4%
(operationally)
|
U.S. | $ | 1,155 | $ | 1,308 | (12) |
QTD decline primarily driven by timing of pediatric CDC shipments in the U.S., coupled with lower demand, partially offset by higher market share and timing of shipments in the pediatric indication in certain international markets, continued uptake of the adult indication in the U.S. as a result of strong demand following the CDC's recommendation for ages 50-64 and strong uptake of the adult indication in certain international markets.
YTD decline primarily driven by worldwide lower pediatric indication sales mostly due to timing of CDC shipments in the U.S., as well as timing of shipments and competitive pressure in certain international markets, partially offset by strong uptake of the adult indication in the U.S. as a result of strong demand following the CDC's recommendation for ages 50-64, coupled with strong uptake of the adult indication in certain international developed markets as well as new launches of the pediatric indication in certain emerging markets.
|
|||||||||||||||||||||||||||||||||||||||||
| Int'l. | 587 | 495 | 18 | 17 | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 1,742 | $ | 1,803 | (3) | (4) | ||||||||||||||||||||||||||||||||||||||||||||
| YTD |
$4,786
Down 1%
(operationally)
|
U.S. | $ | 3,185 | $ | 3,289 | (3) | |||||||||||||||||||||||||||||||||||||||||||
| Int'l. | 1,601 | 1,564 | 2 | 3 | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 4,786 | $ | 4,853 | (1) | (1) | ||||||||||||||||||||||||||||||||||||||||||||
| Vyndaqel family | QTD |
$1,591
Up 7%
(operationally)
|
U.S. | $ | 948 | $ | 960 | (1) |
Growth primarily driven by strong demand with continuing uptake in patient diagnosis primarily in the U.S. and certain international developed markets, as well as improved patient affordability in the U.S., partially offset by lower net price in the U.S. mostly due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign as well as new payer contracts.
|
|||||||||||||||||||||||||||||||||||||||||
| Int'l. | 643 | 486 | 32 | 25 | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 1,591 | $ | 1,447 | 10 | 7 | ||||||||||||||||||||||||||||||||||||||||||||
| YTD |
$4,692
Up 19%
(operationally)
|
U.S. | $ | 2,924 | $ | 2,572 | 14 | |||||||||||||||||||||||||||||||||||||||||||
| Int'l. | 1,767 | 1,334 | 32 | 31 | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 4,692 | $ | 3,907 | 20 | 19 | ||||||||||||||||||||||||||||||||||||||||||||
| Ibrance | QTD |
$1,057
Down 5%
(operationally)
|
U.S. | $ | 670 | $ | 717 | (7) |
Declines primarily driven by lower net price in the U.S. largely due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign, as well as generic entry in certain international markets, partially offset by a favorable one-time adjustment of rebate accruals related to prior periods internationally recorded in the third quarter of the current year as well as improved patient affordability in the U.S.
|
|||||||||||||||||||||||||||||||||||||||||
| Int'l. | 387 | 371 | 4 | (1) | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 1,057 | $ | 1,087 | (3) | (5) | ||||||||||||||||||||||||||||||||||||||||||||
| YTD |
$3,083
Down 6%
(operationally)
|
U.S. | $ | 2,024 | $ | 2,136 | (5) | |||||||||||||||||||||||||||||||||||||||||||
| Int'l. | 1,058 | 1,135 | (7) | (8) | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 3,083 | $ | 3,272 | (6) | (6) | ||||||||||||||||||||||||||||||||||||||||||||
| Paxlovid | QTD |
$1,225
Down 55%
(operationally)
|
U.S. | $ | 1,122 | $ | 2,313 | (52) |
QTD and YTD declines primarily driven by:
• lower COVID-19 infections across U.S. and international markets and lower international government purchases; and
• the non-recurrence of a $442 million favorable U.S. government stockpile purchase in the third quarter of 2024,
partially offset by:
• favorable adjustments of rebate accruals related to prior periods, as well as higher net price in the U.S. following transition from the U.S. government agreement.
YTD decline also driven by the non-recurrence of a $771 million favorable final adjustment recorded in the first quarter of 2024 to the estimated non-cash revenue reversal of $3.5 billion recorded in the fourth quarter of 2023.
|
|||||||||||||||||||||||||||||||||||||||||
| Int'l. | 104 | 389 | (73) | (73) | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 1,225 | $ | 2,703 | (55) | (55) | ||||||||||||||||||||||||||||||||||||||||||||
| YTD |
$2,144
Down 57%
(operationally)
|
U.S. | $ | 1,796 | $ | 4,181 | (57) | |||||||||||||||||||||||||||||||||||||||||||
| Int'l. | 347 | 807 | (57) | (56) | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 2,144 | $ | 4,989 | (57) | (57) | ||||||||||||||||||||||||||||||||||||||||||||
|
Comirnaty
|
QTD |
$1,151
Down 20%
(operationally)
|
U.S. | $ | 870 | $ | 1,164 | (25) |
QTD decline mainly due to a narrower recommendation for vaccination in the U.S., as well as delayed approval of the new variant vaccine, partially offset by a lower returns provision and higher market share in the U.S., as well as higher contractual deliveries in certain international markets
YTD growth primarily driven by higher contractual deliveries in certain international markets and favorable returns reserve reversal and higher market share in the U.S., partially offset by delayed approval of the new variant vaccine as well as a narrower recommendation for vaccination in the U.S.
|
|||||||||||||||||||||||||||||||||||||||||
| Int'l. | 282 | 258 | 9 | 5 | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 1,151 | $ | 1,422 | (19) | (20) | ||||||||||||||||||||||||||||||||||||||||||||
| YTD |
$2,097
Up 6%
(operationally)
|
U.S. | $ | 1,275 | $ | 1,339 | (5) | |||||||||||||||||||||||||||||||||||||||||||
| Int'l. | 821 | 631 | 30 | 30 | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 2,097 | $ | 1,970 | 6 | 6 | ||||||||||||||||||||||||||||||||||||||||||||
| Xtandi | QTD |
$578
Up 3%
(operationally)
|
U.S. | $ | 578 | $ | 561 | 3 |
Growth mainly driven by strong demand, in part due to improved patient affordability in the U.S., partially offset by unfavorable buying patterns and lower net price partly due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign.
|
|||||||||||||||||||||||||||||||||||||||||
| Int'l. | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 578 | $ | 561 | 3 | 3 | ||||||||||||||||||||||||||||||||||||||||||||
| YTD |
$1,602
Up 9%
(operationally)
|
U.S. | $ | 1,602 | $ | 1,474 | 9 | |||||||||||||||||||||||||||||||||||||||||||
| Int'l. | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 1,602 | $ | 1,474 | 9 | 9 | ||||||||||||||||||||||||||||||||||||||||||||
| Padcev | QTD |
$464
Up 13%
(operationally)
|
U.S. | $ | 449 | $ | 407 | 10 |
QTD and YTD growth primarily driven by increased market share in first line locally advanced or metastatic urothelial cancer (la/mUC).
YTD growth also driven by a one-time favorable impact associated with transition to a wholesaler distribution model in the U.S.
|
|||||||||||||||||||||||||||||||||||||||||
| Int'l. | 16 | 2 | * | * | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 464 | $ | 409 | 13 | 13 | ||||||||||||||||||||||||||||||||||||||||||||
| YTD |
$1,432
Up 25%
(operationally)
|
U.S. | $ | 1,402 | $ | 1,128 | 24 | |||||||||||||||||||||||||||||||||||||||||||
| Int'l. | 30 | 16 | 88 | 89 | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 1,432 | $ | 1,144 | 25 | 25 | ||||||||||||||||||||||||||||||||||||||||||||
| (MILLIONS) | Revenue | % Change | ||||||||||||||||||||||||||||||||||||||||||||||||
| Product | Period |
Global Revenues |
Region | Sept. 28, 2025 | Sept. 29, 2024 | Total | Oper. | Operational Results Commentary | ||||||||||||||||||||||||||||||||||||||||||
|
Nurtec ODT/Vydura
|
QTD |
$412
Up 22%
(operationally)
|
U.S. | $ | 383 | $ | 314 | 22 |
Growth primarily driven by strong demand in the U.S. and recent launches in certain international markets, partially offset by lower net price in the U.S. mainly due to unfavorable changes in channel mix.
|
|||||||||||||||||||||||||||||||||||||||||
| Int'l. | 29 | 23 | 26 | 22 | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 412 | $ | 337 | 22 | 22 | ||||||||||||||||||||||||||||||||||||||||||||
| YTD |
$1,019
Up 17%
(operationally)
|
U.S. | $ | 945 | $ | 820 | 15 | |||||||||||||||||||||||||||||||||||||||||||
| Int'l. | 74 | 50 | 49 | 48 | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 1,019 | $ | 870 | 17 | 17 | ||||||||||||||||||||||||||||||||||||||||||||
| Xeljanz | QTD |
$313
Down 4%
(operationally)
|
U.S. | $ | 205 | $ | 203 | 1 |
Declines primarily driven by lower demand and price erosion across international developed markets, lower net price in the U.S. due to unfavorable changes in channel mix as well as the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign, partially offset by higher volumes in the U.S.
|
|||||||||||||||||||||||||||||||||||||||||
| Int'l. | 108 | 118 | (9) | (13) | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 313 | $ | 321 | (3) | (4) | ||||||||||||||||||||||||||||||||||||||||||||
| YTD |
$763
Down 7%
(operationally)
|
U.S. | $ | 431 | $ | 459 | (6) | |||||||||||||||||||||||||||||||||||||||||||
| Int'l. | 331 | 360 | (8) | (8) | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 763 | $ | 818 | (7) | (7) | ||||||||||||||||||||||||||||||||||||||||||||
| Lorbrena | QTD |
$268
Up 28%
(operationally)
|
U.S. | $ | 103 | $ | 82 | 25 |
Growth primarily driven by increased patient share in the first-line ALK+ metastatic NSCLC treatment setting in the U.S., China and certain other international markets, partially offset by lower net price in the U.S. mainly due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign.
|
|||||||||||||||||||||||||||||||||||||||||
| Int'l. | 165 | 124 | 34 | 30 | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 268 | $ | 206 | 30 | 28 | ||||||||||||||||||||||||||||||||||||||||||||
| YTD |
$741
Up 38%
(operationally)
|
U.S. | $ | 294 | $ | 211 | 39 | |||||||||||||||||||||||||||||||||||||||||||
| Int'l. | 447 | 327 | 37 | 37 | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 741 | $ | 538 | 38 | 38 | ||||||||||||||||||||||||||||||||||||||||||||
| Adcetris | QTD |
$215
Down 20%
(operationally)
|
U.S. | $ | 210 | $ | 260 | (19) |
QTD and YTD declines primarily driven by lower volume due to competitive pressures in the U.S. as a result of changes of guidelines in 2024.
The YTD decline was partially offset by a one-time favorable impact associated with transition to a wholesaler distribution model in the U.S.
|
|||||||||||||||||||||||||||||||||||||||||
| Int'l. | 5 | 8 | (37) | (37) | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 215 | $ | 268 | (20) | (20) | ||||||||||||||||||||||||||||||||||||||||||||
| YTD |
$687
Down 14%
(operationally)
|
U.S. | $ | 671 | $ | 784 | (14) | |||||||||||||||||||||||||||||||||||||||||||
| Int'l. | 16 | 20 | (21) | (18) | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 687 | $ | 804 | (15) | (14) | ||||||||||||||||||||||||||||||||||||||||||||
| Abrysvo | QTD |
$279
Down 22%
(operationally)
|
U.S. | $ | 210 | $ | 318 | (34) |
QTD decline primarily driven by lower vaccination rates for the older adult indication in the U.S. following an updated ACIP recommendation, partially offset by launch uptake for both the maternal and adult indications in certain international markets.
YTD performance primarily driven by lower vaccination rates for the older adult indication following an updated ACIP recommendation in the U.S., offset by increased market share in the adult indication, higher demand in the maternal indication -both in the U.S.- and launch uptake for both adult and maternal indications in certain international markets.
|
|||||||||||||||||||||||||||||||||||||||||
| Int'l. | 68 | 38 | 81 | 75 | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 279 | $ | 356 | (22) | (22) | ||||||||||||||||||||||||||||||||||||||||||||
| YTD |
$553
Flat
(operationally)
|
U.S. | $ | 374 | $ | 490 | (24) | |||||||||||||||||||||||||||||||||||||||||||
| Int'l. | 178 | 66 | * | * | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 553 | $ | 557 | (1) | - | ||||||||||||||||||||||||||||||||||||||||||||
Pfizer CentreOne
| (MILLIONS) | Revenue | % Change | ||||||||||||||||||||||||||||||||||||||||||||||||
| Operating Segment | Period |
Global Revenues |
Region | Sept. 28, 2025 | Sept. 29, 2024 | Total | Oper. | Operational Results Commentary | ||||||||||||||||||||||||||||||||||||||||||
| PC1 | QTD |
$344
Up 18%
(operationally)
|
U.S. | $ | 92 | $ | 76 | 21 | Growth driven by higher manufacturing of third-party products under manufacturing and supply agreements, higher manufacturing-related services and higher active pharmaceutical ingredient sales. | |||||||||||||||||||||||||||||||||||||||||
| Int'l. | 253 | 210 | 21 | 17 | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 344 | $ | 285 | 21 | 18 | ||||||||||||||||||||||||||||||||||||||||||||
| YTD |
$929
Up 13%
(operationally)
|
U.S. | $ | 245 | $ | 195 | 25 | |||||||||||||||||||||||||||||||||||||||||||
| Int'l. | 684 | 625 | 9 | 9 | ||||||||||||||||||||||||||||||||||||||||||||||
| Worldwide | $ | 929 | $ | 820 | 13 | 13 | ||||||||||||||||||||||||||||||||||||||||||||
See the Item 1. Business-Patents and Other Intellectual Property Rightssection of our 2024 Form 10-K for information regarding the expiration of various patent rights, Note 12for a discussion of recent developments concerning patent and product litigation relating to certain of the products discussed above and Note 13Cfor additional information regarding the primary indications or class of the selected products discussed above.
Costs and Expenses
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||||||||||||||
| (MILLIONS) |
September 28, 2025 |
September 29, 2024 |
% Change |
September 28, 2025 |
September 29, 2024 |
% Change |
||||||||||||||||||||||||||||||||
| Cost of sales | $ | 4,172 | $ | 5,263 | (21) | $ | 10,795 | $ | 11,942 | (10) | ||||||||||||||||||||||||||||
|
Percentage of Total revenues
|
25.0 | % | 29.7 | % | 24.0 | % | 26.0 | % | ||||||||||||||||||||||||||||||
| Selling, informational and administrative expenses | 3,186 | 3,244 | (2) | 9,632 | 10,456 | (8) | ||||||||||||||||||||||||||||||||
| Research and development expenses | 2,546 | 2,598 | (2) | 7,231 | 7,787 | (7) | ||||||||||||||||||||||||||||||||
| Acquired in-process research and development expenses | 1,390 | 13 | * | 1,401 | 20 | * | ||||||||||||||||||||||||||||||||
| Amortization of intangible assets | 1,223 | 1,312 | (7) | 3,644 | 3,927 | (7) | ||||||||||||||||||||||||||||||||
| Restructuring charges and certain acquisition-related costs | 286 | 313 | (9) | 945 | 1,669 | (43) | ||||||||||||||||||||||||||||||||
| Other (income)/deductions-net | 517 | 243 | * | 2,210 | 2,030 | 9 | ||||||||||||||||||||||||||||||||
Third Quarter of 2025 vs. Third Quarter of 2024 and First Nine Months of 2025 vs. First Nine Months of 2024
Cost of Sales
Cost of salesdecreased $1.1 billion in the third quarter of 2025, primarily due to:
•a favorable change in sales mix of $760 million, driven by lower sales of Comirnaty and Paxlovid, including the non-recurrence of a charge recorded in the third quarter of 2024 that was included in the 50% gross profit split with BioNTech and applicable royalty expenses;
•a favorable revision of our estimate of accrued royalties; and
•a decrease of $230 million due to lower amortization from the step-up of acquired inventory,
partially offset by:
•a $260 million unfavorable impact of foreign exchange.
The decrease in Cost of salesas a percentage of revenues in the third quarter of 2025 was primarily due to the factors mentioned above.
Cost of salesdecreased $1.1 billion in the first nine months of 2025, primarily due to:
•a decrease of $540 million due to lower amortization from the step-up of acquired inventory;
•the non-recurrence of charges in the first nine months of 2024 that were included in the 50% gross profit split with BioNTech and applicable royalty expenses; and
•net favorable revisions to our estimate of accrued royalties.
The decrease in Cost of salesas a percentage of revenues in the first nine months of 2025 was primarily due to all the factors discussed above, partially offset by the non-recurrence of the Paxlovid favorable final adjustment of $771 million recorded in the first quarter of 2024 to the estimated non-cash Paxlovid revenue reversal recorded in the fourth quarter of 2023 and unfavorable sales mix.
Certain of our vaccines, including Comirnaty, are subject to seasonality of demand, with a greater portion of revenues and related cost of sales anticipated in the fall and winter seasons.
See also the Overview of Our Performance, Operating Environment, Strategy and Outlook-The Global Economic Environment--COVID-19section for information about our COVID-19 products.
Selling, Informational and Administrative Expenses
Selling, informational and administrativeexpenses decreased $59 million in the third quarter and $824 million in the first nine months of 2025, primarily reflecting focused investments and ongoing productivity improvements as part of our cost realignment program that drove:
•a decrease of $260 million in the third quarter and $720 million in the first nine months in marketing and promotional spend on various products; and
•lower spending of $85 million in the third quarter and $370 million in the first nine months in corporate enabling functions,
partially offset by:
•increases of $260 million in the third quarter and $235 million in the first nine months due to a favorable adjustment of U.S. healthcare reform fees recorded in the third quarter of 2024 primarily related to Paxlovid and Comirnaty.
Research and Development Expenses
Research and development expenses decreased $52 million in the third quarter and $556 million in the first nine months of 2025 primarily driven by a net decrease in spending of $90 million in the third quarter and $590 million in the first nine months due to pipeline focus and optimization including the expansion of our digital capabilities, as well as lower compensation-related expenses.
Acquired In-Process Research and Development Expenses
Acquired in-process research and development expensesincreased $1.4 billion in the third quarter and in the first nine months of 2025 primarily driven by a $1.35 billion charge related to an in-licensing agreement with 3SBio.
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 $5.7 billion through 2027. The total net cost savings are composed of: (i) net cost savings of $4.5 billion expected to be achieved by the end of 2025, most of which was achieved by year-end 2024, and (ii) our additional anticipated net cost savings of $1.2 billion, primarily in SI&A, expected to be achieved by the end of 2027. In addition, we expect cost savings of approximately $500 million from the expansion of this program in the first quarter of 2025 related to our R&D re-organization to be fully realized by the end of 2026, with the savings expected to be reinvested in R&D programs by the end of 2026.
Manufacturing Optimization Program--The first phase of this multi phased program is on track to deliver approximately $1.5 billion in net cost savings by the end of 2027, contributing savings in the third quarter of 2025.
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 Incomesection within MD&A.
For a description of our programs, as well as the anticipated and actual costs, see Note 3. 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, especially in light of patent-based and regulatory exclusivity expiries as well as the expiration of collaborative arrangements for various products. 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 the end of 2026. The one-time costs to generate these synergies are expected to be approximately $1.7 billion, incurred primarily from 2023 through 2025.
Other (Income)/Deductions-Net
The unfavorable period-over-period change of $275 million in the third quarter of 2025 was primarily driven by (i) an intangible asset impairment charge in the third quarter of 2025, (ii) lower net gains on equity securities, (iii) the non-recurrence of equity method income in the third quarter of 2024 from our previous investment in Haleon and (iv) higher charges for certain legal matters, partially offset by (v) a non-recurrence of a charge in the third quarter of 2024 related to the expected sale of one of our facilities resulting from the discontinuation of our DMD program and (vi) lower net interest expense.
The unfavorable period-over-period change of $180 million for the first nine months of 2025 was primarily driven by (i) higher charges for certain legal matters, (ii) higher intangible asset impairments, (iii) net losses on equity securities in 2025 versus net gains on equity securities in 2024, (iv) the non-recurrence of a realized gain on the partial sale of our previous investment in Haleon recorded in the first quarter of 2024 and (v) the non-recurrence of equity method income from our previous investment in Haleon, partially offset by (vi) lower net interest expense and (vii) a non-recurrence of a charge in the third quarter of 2024 related to the expected sale of one of our facilities resulting from the discontinuation of our DMD program. See Note 4.
Provision/(Benefit) for Taxes on Income
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||||||||||||||
| (MILLIONS) |
September 28, 2025 |
September 29, 2024 |
% Change |
September 28, 2025 |
September 29, 2024 |
% Change |
||||||||||||||||||||||||||||||||
|
Provision/(benefit)for taxes on income
|
$ | (216) | $ | 234 | * | $ | (264) | $ | 393 | * | ||||||||||||||||||||||||||||
| Effective tax rate on continuing operations | (6.5) | % | 5.0 | % | (2.9) | % | 4.9 | % | ||||||||||||||||||||||||||||||
For information about our effective tax rate and the events and circumstances contributing to the changes between periods, as well as details about discrete elements that impacted our tax provisions, see Note 5. See Note 5A in our 2024 Form 10-K for information on our cash paid for income taxes, net of refunds.
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. The EU approved a directive requiring member states to incorporate the OECD provisions into their respective domestic laws, and countries outside the EU have also been enacting the provisions into their domestic law. The provisions are generally effective for Pfizer since 2024, though significant details and guidance around the provisions are still pending. Income tax expense could be impacted 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.
On July 4, 2025, the OBBBA was enacted into law in the U.S. The OBBBA includes significant tax provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act and modifications to the U.S. international tax framework. Among the favorable business provisions are the permanent expensing for domestic R&D costs, permanent bonus depreciation and full expensing of qualified production property. The legislation includes various effective dates, with certain provisions effective in 2025. We expect further guidance may be issued by the U.S. government with respect to certain OBBBA tax provisions.
The OBBBA also renamed the provision for taxes on foreign earnings from Global Intangible Low-Taxed Income (GILTI) to Net Controlled Foreign Corporation (CFC) Tested Income (NCTI) and established a 12.6% tax rate on such foreign earnings effective in the fiscal year 2026 (down from 13.125% in 2026 before the enactment of the OBBBA). We have elected to recognize deferred taxes for temporary differences expected to reverse as GILTI, now NCTI, in future years. As a result of the enactment of the OBBBA, in the third quarter of 2025, we remeasured our deferred tax balances related to NCTI for the changes in the tax rate and recorded a one-time tax benefit that was not material to our results of operations.
PRODUCT DEVELOPMENTS
A comprehensive update of Pfizer's development pipeline was published as of November 4, 2025 and is available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of our research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.
This section provides information as of the date of this filing about significant marketing application-related regulatory actions by, and filings pending with, the FDA and regulatory authorities in the EU and Japan.
The table below generally includes filing and approval milestones for products that have occurred in the last twelve months and does 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).
Products
| PRODUCT | INDICATION OR PROPOSED INDICATION | APPROVED/FILED^ | ||||||||||||
| U.S. | EU | JAPAN | ||||||||||||
|
Nurtec ODT/Vydura (rimegepant) |
Acute treatment of migraine with or without aura in adults |
Approved
February
2020
|
Approved
April
2022
|
Approved
September 2025
|
||||||||||
| Prevention of episodic migraine in adults |
Approved
May
2021
|
Approved
April
2022
|
ApprovedSeptember 2025
|
|||||||||||
|
Abrysvo (Vaccine) |
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
|
Approved
March
2025
|
|||||||||||
| Velsipity (etrasimod) | Moderately to severely active ulcerative colitis in adults |
Approved
October
2023
|
Approved
February
2024
|
Approved
June
2025
|
||||||||||
|
Braftovi (encorafenib),
Erbitux®(cetuximab) and mFOLFOX6(a)
|
First-line BRAFV600E-mutant mCRC
|
Approved
December 2024
|
||||||||||||
|
Hympavzi (marstacimab-hncq) |
Hemophilia A and B without inhibitors |
Approved
October
2024
|
Approved
November
2024
|
Approved
December
2024
|
||||||||||
|
Emblaveo
(aztreonam-avibactam)(b)
|
Treatment of infections in adult patients caused by Gram-negative bacteria with limited or no treatment options |
ApprovedFebruary 2025
|
Approved
April
2024
|
|||||||||||
|
Tivdak (tisotumab vedotin-tftv)(c)
|
Recurrent or mCC with disease progression on or after chemotherapy
|
Approved
April
2024
|
Approved
March
2025
|
Approved
March
2025
|
||||||||||
|
Comirnaty (COVID-19 Vaccine, mRNA) 2025-2026 Formula, LP.8.1(d)
|
Active immunization to prevent COVID-19 caused by SARS-CoV-2 for individuals 65 years of age and older
|
Approved August
2025
|
||||||||||||
|
Active immunization to prevent COVID-19 caused by SARS-CoV-2 for individuals 5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19
|
Approved
August
2025
|
|||||||||||||
|
Active immunization to prevent COVID-19 caused by SARS-CoV-2 for individuals 6 months of age and older
|
Approved
July
2025
|
Approved August
2025
|
||||||||||||
|
Adcetris
(brentuximab vedotin)(e)
|
Relapsed/refractory diffuse large B-cell lymphoma |
Approved
February
2025
|
||||||||||||
|
Hodgkin's lymphoma
|
ApprovedMarch
2018
|
ApprovedJune
2025
|
||||||||||||
| Paxlovid (nirmatrelvir; ritonavir) |
COVID-19 infection in high-risk children
|
Filed
February
2025
|
Filed
January
2025
|
Filed
April
2025
|
||||||||||
| sasanlimab (PF-06801591) | Combination with Bacillus Calmette-Guerin for high-risk non-muscle-invasive bladder cancer |
Filed
June
2025
|
Filed
June
2025
|
|||||||||||
|
vepdegestrant (PF-07850327)(f)
|
Breast cancer metastatic - 2nd line ER+/HER2- ESR1mu
|
Filed
August
2025
|
||||||||||||
| Tukysa (tucatinib) |
Treatment of adult patients with advanced or metastatic HER2+ breast cancer
|
Approved
April
2020
|
Approved
April
2020
|
Filed
March
2025
|
||||||||||
|
Padcev
(enfortumab vedotin-ejfv)(g)
|
Combination with pembrolizumab for cisplatin-ineligible/decline muscle-invasive bladder cancer
|
FiledOctober 2025
|
||||||||||||
^ For the U.S., the filing date is the date on which the FDA accepted our submission. For the EU, the filing date is the date on which the EMA validated our submission.
(a)Erbitux®is a registered trademark of ImClone LLC. We have exclusive rights to Braftovi in the U.S., Canada and certain emerging markets. Pierre Fabre has exclusive rights to commercialize Braftovi in Europe and Ono has exclusive rights to commercialize Braftovi in Japan. The December 2024 U.S. approval date reflects accelerated approval.
(b)Emblaveo is being developed in collaboration with AbbVie. 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.
(c)Tivdak is commercialized in collaboration with Genmab A/S.
(d)Comirnaty is being developed and commercialized with BioNTech. On August 27, 2025, the FDA approved the 2025-2026 formulation (i) for individuals 65 years of age and older and (ii) for individuals aged 5 to 64 years of age with at least one underlying condition that puts them at high risk for severe COVID-19. Effective as of the same date, outstanding EUAs for the COVID-19 vaccine were revoked, including those for individuals 6 months through 4 years of age. The row relating to the application for the COVID-19 vaccine for individuals 6 months through 4 years of age has been removed from the table above.
(e)Adcetris is being developed and commercialized in collaboration with Takeda. Pfizer has commercialization rights for Adcetris in the U.S. and its territories and in Canada. Takeda has commercialization rights in the rest of the world.
(f)Vepdegestrant is being developed in collaboration with Arvinas, Inc. In September 2025, Arvinas and Pfizer jointly agreed to out-license the commercialization rights to vepdegestrant to a third party. Together, the companies have begun seeking a partner with the capabilities and expertise to maximize the commercial potential of vepdegestrant, if approved, for patients with ESR1-mutant, ER+/HER2- advanced or metastatic breast cancer and potentially develop vepdegestrant in new settings.
(g)Padcev is being jointly developed and commercialized with Astellas in the U.S. Outside the U.S., we have commercialization rights in all countries in North and South America, and Astellas has commercialization rights in the rest of the world.
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 | |||||||||||
|
Padcev (enfortumab vedotin-ejfv)(b)
|
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 | |||||||||||
|
Nurtec (rimegepant)
|
Menstrually-related migraine
|
||||||||||
|
Hympavzi (marstacimab-hncq)
|
Hemophilia (pediatric) | ||||||||||
| Hemophilia (inhibitor cohort) | |||||||||||
| NEW DRUG CANDIDATES IN LATE-STAGE DEVELOPMENT |
VLA15 (PF-07307405) vaccine(c)
|
Immunization to prevent Lyme disease | |||||||||
| dazukibart (PF-06823859) | Dermatomyositis, polymyositis | ||||||||||
|
disitamab vedotin(d)
|
1st line HER2 (≥IHC1+) metastatic urothelial cancer | ||||||||||
| sigvotatug vedotin (PF-08046047) |
2nd line+ metastatic NSCLC
|
||||||||||
|
1st line metastatic NSCLC (tumor proportion score high)
|
|||||||||||
| osivelotor (PF-07940367) |
SCD
|
||||||||||
| ibuzatrelvir (PF-07817883) | COVID-19 infection | ||||||||||
| mevrometostat (PF-06821497) + enzalutamide | 1st line/2nd line metastatic castration resistant prostate cancer post-Abiraterone | ||||||||||
| 1st line metastatic castration resistant prostate cancer neoadjuvant hormonal therapy naïve | |||||||||||
|
1st line metastatic castration sensitive prostate cancer neoadjuvant hormonal therapy naïve
|
|||||||||||
| atirmociclib (PF-07220060) |
1st line HR+/HER2- metastatic breast cancer
|
||||||||||
|
PF-08046054
|
2nd line+ NSCLC
|
||||||||||
|
prifetrastat (PF-07248144)
|
2nd line/3rd line HR+/HER2- metastatic breast cancer
|
||||||||||
(a)Ibrance for ER+/HER2+ metastatic breast cancer is being developed in collaboration with Alliance Foundation Trials, LLC.
(b)Padcev is being jointly developed and commercialized with Astellas in the U.S. Outside the U.S., we have commercialization rights in all countries in North and South America, and Astellas has commercialization rights in the rest of the world.
(c)VLA15 is being developed in collaboration with Valneva SE.
(d)Disitamab vedotin is being developed in collaboration with RemeGen Co., Ltd.
In September 2024, Pfizer announced a voluntary withdrawal of all lots of Oxbryta (voxelotor) for the treatment of SCD in all markets where it was approved. Pfizer also discontinued all active voxelotor clinical trials and expanded access programs worldwide. Pfizer's decision was based on the totality of clinical data available at that time that indicated the overall benefit of Oxbryta no longer outweighed the risk in the approved sickle cell patient population. The data suggested an imbalance in vaso-occlusive crises and fatal events, which required further assessment. Pfizer notified regulatory authorities about these findings and its decision to voluntarily withdraw Oxbryta from the market and discontinue distribution and clinical studies while further reviewing the available data and investigating the findings. In July 2024, the EMA initiated a referral procedure under Article 20 of EC Regulation No 726/2004 for Oxbryta to review the product's benefits and risks. In October 2024, the EC suspended the Oxbryta marketing authorization while the EMA's review of data was ongoing. In addition, the FDA initiated an evaluation of newly identified safety signals. The FDA also placed the Oxbryta investigational new drug application on clinical hold following Pfizer's market withdrawal.
Following comprehensive review and analysis of the final data, Pfizer submitted updated data and risk management proposals to the EMA, FDA and other regulators. In the EU, the EMA's referral procedure concluded in October 2025, with the EMA adopting a negative opinion on benefit-risk for Oxbryta for the treatment of hemolytic anemia due to SCD, recommending that the marketing authorization for the product remain suspended. In the U.S., Pfizer's engagement with the FDA is ongoing. Pfizer is carefully assessing the positions of both EMA and FDA.
In December 2024, the FDA issued a partial clinical hold for osivelotor, which prohibited Pfizer from enrolling new participants into osivelotor clinical studies. The FDA recently concluded that initiation of osivelotor studies and enrollment may proceed outside of sub-Saharan Africa and for participants who have not relocated from sub-Saharan Africa.
In August 2025, Pfizer announced results from the Phase 3 THRIVE-131 study evaluating inclacumab, an investigational P-selectin inhibitor, in patients 16 years of age and older with SCD. The study did not meet its primary endpoint of significant reduction in the rate of vaso-occlusive crises (VOCs) in participants receiving inclacumab versus placebo every 12 weeks over 48 weeks. Inclacumab was generally well tolerated in THRIVE-131. Inclacumab has been removed from the table above.
For additional information about our R&D organization, see Note 13and the Item 1. Business-Research and Developmentsection of our 2024 Form 10-K. For additional information regarding certain collaboration arrangements see the Item 1. Business-Collaboration and Co-Promotion Agreements section of our 2024 Form 10-K.
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. We use Adjusted income, certain components of Adjusted income and Adjusted diluted EPS to present the results of our major operations--the discovery, development, manufacture, marketing, sale and distribution of biopharmaceutical products worldwide--prior to considering certain income statement elements as follows:
| Measure | Definition | Relevance of Metrics to Our Business Performance | ||||||||||||
|
Adjusted income
|
Net income attributable to Pfizer Inc. common shareholders(a) before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items
|
•Provides investors useful information to:
◦evaluate the normal recurring operational activities, and their components, on a comparable year-over-year basis
◦assist in modeling expected future performance on a normalized basis
•Provides investors insight into the way we manage our budgeting and forecasting, how we evaluate and manage our recurring operations and how we reward and compensate our senior management(b)
|
||||||||||||
|
Adjusted cost of sales, Adjusted selling, informational and administrative expenses, Adjusted research and development expenses and Adjusted other (income)/deductions--net
|
Cost of sales, Selling, informational and administrative expenses, Research and development expensesandOther (income)/deductions--net(a), each before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items, which are components of the Adjusted income measure
|
|||||||||||||
|
Adjusted diluted EPS
|
EPS attributable to Pfizer Inc. common shareholders--diluted(a)before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items
|
|||||||||||||
(a)Most directly comparable GAAP measure.
(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 financial metrics, as well as performance against certain of our non-financial pipeline metrics, and may be further modified by our Compensation Committee's assessment of other factors. One of the three financial metrics, beginning with the 2025 performance year, is Adjusted income (as defined for annual incentive compensation purposes), which accounts for 40% of the bonus pool funding tied to financial performance. Any expenses for acquired IPR&D are included in our non-GAAP Adjusted results but we exclude certain of these expenses for our financial results for annual incentive compensation purposes. Additionally, beginning with the 2025 performance year, the payout for performance share awards is determined in part by Adjusted diluted EPS, which is derived from Adjusted income.
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. Because of their non-standardized definitions, they may not be comparable to the calculation of similar measures of other companies and are presented to permit investors to more fully understand how management assesses performance. A limitation of these measures is that they provide a view of our operations without including all events during a period, and do not provide a comparable view of our performance to peers. These measures are not, and should not be viewed as, substitutes for their most directly comparable GAAP measures ofNet income attributable to Pfizer Inc. common shareholders, components of Net income attributable to Pfizer Inc. common shareholdersand EPS attributable to Pfizer Inc. common shareholders-diluted, respectively.
We also recognize that, as internal measures of performance, these measures have limitations, and we do not restrict our performance-management process solely to these measures. We also use other tools designed to achieve the highest levels of performance. For example, our R&D organization has productivity targets, upon which its effectiveness is measured. In addition, total shareholder return, both on an absolute basis and relative to a publicly traded pharmaceutical index, plays a significant role in determining payouts under certain of our incentive compensation plans.
Adjusted Income and Adjusted Diluted EPS
Amortization of Intangible Assets-Adjusted income excludes all amortization of intangible assets.
Acquisition-Related Items-Adjusted income excludes certain acquisition-related items, which are composed of transaction, integration, restructuring charges and additional depreciation costs for business combinations because these costs are unique to each transaction and represent costs that were incurred to restructure and integrate businesses as a result of an acquisition. We have made no adjustments for resulting synergies. Acquisition-related items may include purchase accounting impacts such as the incremental charge to cost of sales from the sale of acquired inventory that was written up to fair value, depreciation related to the increase/decrease in fair value of acquired fixed assets, amortization related to the increase in fair value of acquired debt, and the fair value changes for contingent consideration.
Discontinued Operations-Adjusted income excludes the results of discontinued operations, as well as any related gains or losses on the disposal of such operations. We believe that this presentation is meaningful to investors because, while we review our product portfolio for strategic fit with our operations, we do not build or run our business with the intent to discontinue parts of our business. Restatements due to discontinued operations do not impact compensation or change the Adjusted income measure for the compensation in respect of the restated periods, but are presented for consistency across all periods.
Certain Significant Items-Adjusted income excludes certain significant items representing substantive and/or unusual items that are evaluated individually on a quantitative and qualitative basis. Certain significant items may be highly variable and difficult to predict. Furthermore, in some cases it is reasonably possible that they could reoccur in future periods. 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. Legal charges to resolve litigation are also related to specific cases, which are facts and circumstances specific and, in some cases, may also be the result of litigation matters at acquired companies that were inestimable, not probable or unresolved at the date of acquisition, or legal matters generally related to divested products or businesses. Gains and losses on equity securities and pension and postretirement actuarial remeasurement gains and losses have a very high degree of inherent market volatility, which we do not control and cannot predict with any level of certainty, and we do not believe including these gains and losses assists investors in understanding our business or is reflective of our core operations and business. Unusual items represent items that are not part of our ongoing business; items that, either as a result of their nature or size, we would not expect to occur as part of our normal business on a regular basis; items that would be non-recurring; or items that relate to products we no longer sell. See the Reconciliations of GAAP Reported to Non-GAAP Adjusted information-Certain Line Itemsbelow for a non-inclusive list of certain significant items and the Non-GAAP Financial Measure: Adjusted Incomesection within MD&A of our 2024 Form 10-K.
Reconciliations of GAAP Reported to Non-GAAP Adjusted Information--Certain Line Items
| Three Months Ended September 28, 2025 | ||||||||||||||||||||||||||||||||
|
Data presented will not (in all cases) aggregate to totals.
(MILLIONS, EXCEPT PER SHARE DATA)
|
Cost of sales(a)
|
Selling, informational and administrative expenses(a)
|
Other (income)/deductions--net(a)
|
Net income attributable to Pfizer Inc. common shareholders(a), (b)
|
Earnings per common share attributable to Pfizer Inc. common shareholders--diluted
|
|||||||||||||||||||||||||||
| GAAP Reported | $ | 4,172 | $ | 3,186 | $ | 517 | $ | 3,541 | $ | 0.62 | ||||||||||||||||||||||
| Amortization of intangible assets | - | - | - | 1,223 | ||||||||||||||||||||||||||||
| Acquisition-related items | (128) | (1) | (13) | 194 | ||||||||||||||||||||||||||||
| Discontinued operations | - | - | - | - | ||||||||||||||||||||||||||||
| Certain significant items: | ||||||||||||||||||||||||||||||||
|
Restructuring charges/(credits), inventory write-offs, implementation costs and additional depreciation-asset restructuring(c)
|
(62) | (26) | - | 379 | ||||||||||||||||||||||||||||
|
Certain asset impairments(d)
|
- | - | (260) | 260 | ||||||||||||||||||||||||||||
|
(Gains)/losses on equity securities
|
- | - | 201 | (201) | ||||||||||||||||||||||||||||
| Actuarial valuation and other pension and postretirement plan (gains)/losses | - | - | (11) | 11 | ||||||||||||||||||||||||||||
|
Other(e)
|
(3) | (1) | (177) | 184 | ||||||||||||||||||||||||||||
| Income tax provision-non-GAAP items | (643) | |||||||||||||||||||||||||||||||
| Non-GAAP Adjusted | $ | 3,979 | $ | 3,158 | $ | 257 | $ | 4,949 | $ | 0.87 | ||||||||||||||||||||||
| Nine Months Ended September 28, 2025 | ||||||||||||||||||||||||||||||||
|
Data presented will not (in all cases)aggregate to totals.
(MILLIONS, EXCEPT PER SHARE DATA)
|
Cost of sales(a)
|
Selling, informational and administrative expenses(a)
|
Other (income)/deductions--net(a)
|
Net income attributable to Pfizer Inc. common shareholders(a), (b)
|
Earnings per common share attributable to Pfizer Inc. common shareholders--diluted
|
|||||||||||||||||||||||||||
| GAAP Reported | $ | 10,795 | $ | 9,632 | $ | 2,210 | $ | 9,419 | $ | 1.65 | ||||||||||||||||||||||
| Amortization of intangible assets | - | - | - | 3,644 | ||||||||||||||||||||||||||||
| Acquisition-related items | (576) | (2) | (52) | 814 | ||||||||||||||||||||||||||||
|
Discontinued operations
|
- | - | - | (25) | ||||||||||||||||||||||||||||
| Certain significant items: | ||||||||||||||||||||||||||||||||
|
Restructuring charges/(credits), inventory write-offs, implementation costs and additional depreciation-asset restructuring(c)
|
(115) | (46) | - | 1,050 | ||||||||||||||||||||||||||||
|
Certain asset impairments(d)
|
- | - | (577) | 577 | ||||||||||||||||||||||||||||
|
(Gains)/losses on equity securities(d)
|
- | - | (94) | 94 | ||||||||||||||||||||||||||||
| Actuarial valuation and other pension and postretirement plan (gains)/losses | - | - | 57 | (57) | ||||||||||||||||||||||||||||
|
Other(e)
|
(29) | (22) | (855) | 914 | ||||||||||||||||||||||||||||
|
Income tax provision-non-GAAP items
|
(1,810) | |||||||||||||||||||||||||||||||
| Non-GAAP Adjusted | $ | 10,075 | $ | 9,562 | $ | 688 | $ | 14,620 | $ | 2.56 | ||||||||||||||||||||||
| Three Months Ended September 29, 2024 | ||||||||||||||||||||||||||||||||
|
Data presented will not (in all cases) aggregate to totals.
(MILLIONS, EXCEPT PER SHARE DATA)
|
Cost of sales(a)
|
Selling, informational and administrative expenses(a)
|
Other (income)/deductions--net(a)
|
Net income attributable to Pfizer Inc. common shareholders(a), (b)
|
Earnings per common share attributable to Pfizer Inc. common shareholders--diluted
|
|||||||||||||||||||||||||||
| GAAP Reported | $ | 5,263 | $ | 3,244 | $ | 243 | $ | 4,465 | $ | 0.78 | ||||||||||||||||||||||
| Amortization of intangible assets | - | - | - | 1,312 | ||||||||||||||||||||||||||||
| Acquisition-related items | (355) | (9) | (11) | 465 | ||||||||||||||||||||||||||||
|
Discontinued operations
|
- | - | - | 6 | ||||||||||||||||||||||||||||
| Certain significant items: | ||||||||||||||||||||||||||||||||
|
Restructuring charges/(credits) and implementation costs and additional depreciation-asset restructuring(c)
|
(36) | (13) | - | 304 | ||||||||||||||||||||||||||||
|
(Gains)/losses on equity securities
|
- | - | 446 | (446) | ||||||||||||||||||||||||||||
| Actuarial valuation and other pension and postretirement plan (gains)/losses | - | - | (4) | 4 | ||||||||||||||||||||||||||||
|
Other(e)
|
1 | (4) | (430) | 437 | ||||||||||||||||||||||||||||
| Income tax provision-non-GAAP items | (498) | |||||||||||||||||||||||||||||||
| Non-GAAP Adjusted | $ | 4,874 | $ | 3,219 | $ | 243 | $ | 6,050 | $ | 1.06 | ||||||||||||||||||||||
| Nine Months Ended September 29, 2024 | ||||||||||||||||||||||||||||||||
|
Data presented will not (in all cases)aggregate to totals.
(MILLIONS, EXCEPT PER SHARE DATA)
|
Cost of sales(a)
|
Selling, informational and administrative expenses(a)
|
Other (income)/deductions--net(a)
|
Net income attributable to Pfizer Inc. common shareholders(a), (b)
|
Earnings per common share attributable to Pfizer Inc. common shareholders--diluted
|
|||||||||||||||||||||||||||
| GAAP Reported | $ | 11,942 | $ | 10,456 | $ | 2,030 | $ | 7,621 | $ | 1.34 | ||||||||||||||||||||||
| Amortization of intangible assets | - | - | - | 3,927 | ||||||||||||||||||||||||||||
| Acquisition-related items | (1,117) | (25) | (32) | 1,590 | ||||||||||||||||||||||||||||
|
Discontinued operations
|
- | - | - | (14) | ||||||||||||||||||||||||||||
| Certain significant items: | ||||||||||||||||||||||||||||||||
|
Restructuring charges/(credits) and implementation costs and additional depreciation-asset restructuring(c)
|
(106) | (77) | - | 1,502 | ||||||||||||||||||||||||||||
|
Certain asset impairments(d)
|
- | - | (349) | 349 | ||||||||||||||||||||||||||||
|
(Gains)/losses on equity securities
|
- | - | 129 | (129) | ||||||||||||||||||||||||||||
| Actuarial valuation and other pension and postretirement plan (gains)/losses | - | - | (9) | 9 | ||||||||||||||||||||||||||||
|
Other(e)
|
(41) | (11) | (971) | 1,036 | ||||||||||||||||||||||||||||
|
Income tax provision-non-GAAP items
|
(1,769) | |||||||||||||||||||||||||||||||
| Non-GAAP Adjusted | $ | 10,678 | $ | 10,342 | $ | 797 | $ | 14,124 | $ | 2.48 | ||||||||||||||||||||||
(a)Items that reconcile GAAP Reported to non-GAAP Adjusted balances are shown pre-tax. Our effective tax rates for GAAP Reported income from continuing operations were (6.5)% and (2.9)% for the three and nine months ended September 28, 2025, respectively, and 5.0% and 4.9% for the three and
nine months ended September 29, 2024, respectively. See Note 5. Our effective tax rates for non-GAAP Adjusted income were 7.9% and 9.5% for the three and nine months ended September 28, 2025, respectively, and 10.8% and 13.3% for the three and nine months ended September 29, 2024, respectively.
(b)The amounts for the three and nine months ended September 28, 2025 and September 29, 2024 include reconciling amounts for Research and development expensesthat are not material to our non-GAAP consolidated results of operations.
(c)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.
(d)See Note 4.
(e)For the third quarter and first nine months of 2025, the total Other (income)/deductions--net adjustments of $177 million and $855 million, respectively, primarily include charges of $191 million for the third quarter for certain legal matters, primarily representing certain product liability expenses and $755 million for the first nine months for certain legal matters, primarily representing certain product liability and other legal expenses. For the third quarter and first nine months of 2024, the total Other(income)/deductions--net adjustments of $430 million and $971 million, respectively, included charges of (i) $420 million related to the expected sale of one of our facilities resulting from the discontinuation of our DMD program and (ii) $45 million for the third quarter and $422 million for the first nine months for certain legal matters, primarily representing certain product liability expenses related to products discontinued and/or divested by Pfizer. For the first nine months of 2024, the total Other (income)/deductions--net adjustment of $971 million also included charges of (i) $312 million mostly related to (a) our equity-method accounting pro-rata share of intangible asset amortization, impairments and restructuring costs recorded by Haleon, as well as (b) adjustments to our equity-method basis differences and (c) Pfizer's share of investee capital transactions recognized by Haleon, partially offset by (ii) a $150 million realized gain on the partial sale of our previous investment in Haleon recorded in the first quarter of 2024.
ANALYSIS OF THE CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| Nine Months Ended | ||||||||||||||||||||
| (MILLIONS) |
September 28, 2025 |
September 29, 2024 |
Drivers of change | |||||||||||||||||
| Cash provided by/(used in): | ||||||||||||||||||||
| Operating activities | $ | 6,356 | $ | 6,023 |
The change was driven mainly by an increase in net income, which includes the offset of a $1.35 billion cash outflow in connection with the in-license arrangement with 3SBio, adjusted for non-cash items and the timing of receipts and payments in the ordinary course of business.
|
|||||||||||||||
| Investing activities | $ | 4,795 | $ | 4,275 |
The change was driven mainly by a $2.8 billion increase in proceeds from the sale of the remaining portion of our previous investment in Haleon, partially offset by a $1.6 billion decrease in net proceeds from short-term investments and a $1.0 billion decrease in proceeds from sales of long-term investments.
|
|||||||||||||||
| Financing activities | $ | (10,900) | $ | (12,026) |
The change was driven mainly by $3.7 billion proceeds received from the issuance of long-term Euro debt, partially offset by a $1.5 billion increase in repayments of long-term debt, and a $907 million increase in net repayments of short-term borrowings.
|
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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. 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. For information about the sources and uses of our funds and capital resources, as well as our operating cash flows, see our Condensed Consolidated Statements of Cash Flows, Condensed Consolidated Balance Sheets, Condensed Consolidated Statements of Equity, and the Analysis of the Condensed Consolidated Statements of Cash Flowssection within MD&A. For information on our money market funds, available-for sale-debt securities and long-term debt, see Note 7.
For information about our diverse sources of funds, off-balance sheet arrangements, contractual and other obligations, global economic conditions and market risk, see the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risksection within MD&A of our 2024 Form 10-K. For more information on guarantees and indemnifications, see Note 12B.
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.
|
As of the date of the filing of this Form 10-Q, the following ratings have been assigned to our commercial paper and senior unsecured long-term debt:
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| NAME OF RATING AGENCY | Pfizer Short-Term Rating | Pfizer Long-Term Rating | Outlook/Watch | |||||||||||||||||
| Moody's | P-1 |
A2
|
Stable Outlook
|
|||||||||||||||||
| S&P | A-1 |
A
|
Stable Outlook
|
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These ratings are not recommendations to buy, sell or hold securities and the ratings are subject to revision or withdrawal at any time by the rating organizations. Each rating should be evaluated independently of any other rating.
Debt Capacity--Lines of Credit--As of the date of the filing of this Form 10-Q, we had access to a $7.0 billion committed U.S. revolving credit facility maturing in October 2030, which may be used for general corporate purposes including to support our global commercial paper borrowings. In addition to the U.S. revolving credit facility, our lenders have provided us an additional $242 million in lines of credit, which expire within one year. Essentially all lines of credit were unused as of the date of the filing of this Form 10-Q.
Capital Allocation Framework--Our capital allocation framework is designed to enhance long-term 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. Over time, we expect to continue to de-lever in a prudent manner in order to maintain a balanced capital allocation strategy.
Dividends--In October 2025, our BOD declared a dividend of $0.43 per share, payable on December 1, 2025, to shareholders of record at the close of business on November 7, 2025.
Common Stock Purchases-As of September 28, 2025, our remaining share-purchase authorization was $3.3 billion, with no repurchases in the first nine months of 2025. See Note 12in our 2024 Form 10-K for more information on our publicly announced share-purchase plans.
Haleon- In the first quarter of 2025, we sold the remaining portion of our investment in Haleon for $6.3 billion and the proceeds are being used to support capital allocation priorities.
NEW ACCOUNTING STANDARDS
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Recently Issued Accounting Standards, Not Adopted as of September 28, 2025
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| Standard/Description | Effective Date |
Effect on the Financial Statements |
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|
In December 2023, the FASB issued final guidance to improveincome tax disclosures. The final guidance requires enhanced disclosures primarily related to existing rate reconciliation and income taxes paid information. The guidance may be applied on a prospective or a retrospective basis; we intend to elect a prospective adoption.
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2025 for annual reports. Early adoption is permitted.
|
This new guidance will result in increased disclosures in the notes to our financial statements.
|
||||||||||||
|
In November 2024, the FASB issued final guidance which requires disaggregated disclosures of certain categories of expenses that are included in expense line items on the face of the income statement. The disclosures are required on an annual and interim basis. The guidance also requires the total amount of selling expenses to be disclosed and, on an annual basis, the definition of selling expenses. The guidance may be applied on a prospective or a retrospective basis.
|
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. | ||||||||||||
|
In September 2025, the FASB issued final guidance to modernize the accounting for internal use software costs. The guidance requires entities to start capitalizing eligible costs when (1) management has authorized and committed to funding the software project, and (2) it is probable that the project will be completed and the software will be used to perform the function intended. The guidance can be applied on a prospective basis, a modified basis for in-process projects, or a retrospective basis.
|
January 1, 2028, with early adoption permitted.
|
We are assessing the impact but currently do not expect this new guidance to have a material impact on our consolidated financial statements.
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FORWARD-LOOKING INFORMATION AND FACTORS THAT MAY AFFECT FUTURE RESULTS
This Form 10-Q contains forward-looking statements. We also provide forward-looking statements in other materials we release to the public, as well as public oral statements. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions.
We have tried, wherever possible, to identify such statements by using words such as "will," "may," "could," "likely," "ongoing," "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," "assume," "target," "forecast," "guidance," "goal," "objective," "aim," "seek," "potential," "hope" and other words and terms of similar meaning or by using future dates.
We include forward-looking information in our discussion of the following, among other topics:
•our anticipated operating and financial performance, including financial guidance and projections;
•reorganizations, business plans, strategy, goals and prospects;
•expectations for our product pipeline (including products from completed or anticipated acquisitions), in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches,
discontinuations, clinical trial results and other developing data; revenue contribution and projections; potential pricing and reimbursement; potential market dynamics, including demand, market size and utilization rates; and growth, performance, timing of exclusivity and potential benefits;
•strategic reviews, leverage and capital allocation objectives, dividends and share repurchases;
•plans for and prospects of our acquisitions, dispositions and other business development activities, and our ability to successfully capitalize on growth opportunities and prospects;
•sales, expenses, interest rates, foreign exchange rates and the outcome of contingencies, such as legal proceedings;
•expectations regarding the impact of or changes to existing or new government regulations, laws or policies;
•our ability to anticipate and respond to and our expectations regarding the impact of macroeconomic, geopolitical, health and industry trends, pandemics, acts of war and other large-scale crises; and
•manufacturing and product supply.
In particular, forward-looking information in this Form 10-Q includes statements relating to specific future actions, performance and effects, including, among others, the expected benefits of the organizational changes to our operations; our anticipated operating and financial performance; our ongoing efforts to respond to COVID-19; our expectations regarding the impact of COVID-19 on our business, operations and financial results; the expected revenue, seasonality of demand and phasing for certain of our products; expected patent terms; the expected impact of patent expiries and generic and biosimilar competition; the expected pricing pressures on our products and the anticipated impact to our business; the expected impact of the IRA Medicare Part D Redesign; the benefits expected from our business development transactions, including our acquisition of Seagen, our proposed acquisition of Metsera and our licensing agreement with 3SBio; the availability of raw materials; our efforts to develop plans to help mitigate the impact, and potential impact, of tariffs on our business and operations; our anticipated cash flows and liquidity position; the anticipated costs, savings and potential benefits from certain of our initiatives, including our enterprise-wide Realigning Our Cost Base Program and our Manufacturing Optimization Program to reduce our cost of goods sold; our voluntary agreement with the U.S. Government designed to lower drug costs for U.S. patients and to include Pfizer products in a direct purchasing platform, and Pfizer's plans to further invest in U.S. manufacturing; our expectations regarding product supply; our planned capital spending; and our capital allocation framework.
Given their nature, we cannot assure you that any outcome expressed in these forward-looking statements will be realized in whole or in part. Actual outcomes may vary materially from past results and those anticipated, estimated, implied or projected. These forward-looking statements may be affected by underlying assumptions that may prove inaccurate or incomplete, or by known or unknown risks and uncertainties, including those described in this section and in the Item 1A. Risk Factorssection in our 2024 Form 10-K.
Therefore, you are cautioned not to unduly rely on forward-looking statements, which speak only as of the date of this Form
10-Q. We undertake no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. You are advised, however, to consult any further disclosures we make on related subjects.
10-Q. We undertake no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. You are advised, however, to consult any further disclosures we make on related subjects.
Some of the factors that could cause actual results to differ are identified below, as well as those discussed in the Item 1A. Risk Factorssection in our 2024 Form 10-K and within MD&A. We note these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. The occurrence of any of the risks identified below, in the Item 1A. Risk Factorssection in our 2024 Form 10-K or within MD&A, or other risks currently unknown, could have a material adverse effect on our business, financial condition or results of operations, or we may be required to increase our accruals for contingencies. It is not possible to predict or identify all such factors. Consequently, you should not consider the following to be a complete discussion of all potential risks or uncertainties:
Risks Related to Our Business, Industry and Operations, and Business Development
•the outcome of R&D activities, including the ability to meet anticipated pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or clinical trials, regulatory submission dates, and/or regulatory approval and/or launch dates; the possibility of unfavorable pre-clinical and clinical trial results, including the possibility of unfavorable new pre-clinical or clinical data and further analyses of existing pre-clinical or clinical data; risks associated with preliminary, early stage or interim data; 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 our pipeline programs will be published in scientific journal publications, and if so, when and with what modifications and interpretations; and uncertainties regarding the future development of our product candidates, including whether or when our product candidates will advance to future studies or phases of development or whether or when regulatory applications may be filed for any of our product candidates, including as a result of clinical trial data or regulatory feedback that could impact the future development of our product candidates, including our vaccine candidates such as our next generation pneumococcal conjugate vaccine candidate;
•our ability to successfully address comments received from regulatory authorities such as the FDA or the EMA, or obtain approval for new products and indications from regulators on a timely basis or at all;
•regulatory decisions impacting labeling, approval or authorization, including the scope of indicated patient populations, product dosage, manufacturing processes, safety and/or other matters, including decisions relating to emerging developments regarding potential product impurities; uncertainties regarding the ability to obtain or maintain, and the scope of, recommendations by technical or advisory committees, and the timing of, and ability to obtain, pricing approvals and product launches, all of which could impact the availability or commercial potential of our products and product candidates;
•claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates, including claims and concerns that may arise from the conduct or outcome of post-approval clinical trials, pharmacovigilance or Risk Evaluation and Mitigation Strategies, which could impact marketing approval, product labeling, and/or availability or commercial potential;
•the success and impact of external business development activities, such as risks and uncertainties related to our proposed acquisition of Metsera and the impact of Novo Nordisk's competing proposal on the proposed acquisition; the ability to identify and execute on potential business development opportunities; the ability to satisfy the conditions to closing of announced transactions in the anticipated time frame or at all, including the possibility that such transactions do not close; the ability to realize the anticipated benefits of any such transactions in the anticipated time frame or at all; the potential need for and impact of additional equity or debt financing to pursue these opportunities, which has in the past and could in the future result in increased leverage and/or a downgrade of our credit ratings and could limit our ability to obtain future financing; challenges integrating the businesses and operations; disruption to business or operations relationships; risks related to growing revenues for certain acquired or partnered products; significant transaction costs; and unknown liabilities;
•competition, including from new product entrants, in-line branded products, generic products, private label products, biosimilars and product candidates that treat or prevent diseases and conditions similar to those treated or intended to be prevented by our in-line products and product candidates;
•the ability to successfully market both new and existing products, including biosimilars;
•difficulties or delays in manufacturing, sales or marketing; supply disruptions, shortages or stock-outs at our facilities or third-party facilities that we rely on; and legal or regulatory actions;
•the impact of public health outbreaks, epidemics or pandemics (such as COVID-19) on our business, operations and financial condition and results, including impacts on our employees, manufacturing, supply chain, sales and marketing, R&D and clinical trials;
•risks and uncertainties related to 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 and/or COVID-19 infection rates do not follow prior patterns, demand for our COVID-19 products has and may continue to be reduced or not meet expectations, which has in the past 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, including uncertainties related to the potential impact of narrowing recommended patient populations; whether or when our EUAs or biologics licenses will expire, terminate or be revoked; and potential third-party royalties or other claims related to Comirnaty and Paxlovid;
•trends toward managed care and healthcare cost containment, and our ability to obtain or maintain timely or adequate pricing or favorable formulary placement for our products;
•interest rate and foreign currency exchange rate fluctuations, including the impact of global trade tensions, as well as currency devaluations and monetary policy actions in countries experiencing high inflation or deflation rates;
•any significant issues involving our largest wholesale distributors or government customers, which account for a substantial portion of our revenues;
•the impact of the increased presence of counterfeit medicines, vaccines or other products in the pharmaceutical supply chain;
•any significant issues related to the outsourcing of certain operational and staff functions to third parties;
•any significant issues related to our JVs and other third-party business arrangements, including modifications or disputes related to supply agreements or other contracts with customers including governments or other payors;
•uncertainties related to general economic, political, business, industry, regulatory and market conditions including, without limitation, uncertainties related to the impact on us, our customers, suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions, such as inflation or interest rate fluctuations, and recent and possible future changes in global financial markets;
•the exposure of our operations globally to possible capital and exchange controls, economic conditions, expropriation, sanctions, tariffs and/or other restrictive government actions, changes in intellectual property legal protections and remedies, unstable governments and legal systems and inter-governmental disputes;
•risks and uncertainties related to issued or future executive orders or other new, or changes in, laws, regulations or policy regarding tariffs or other trade policy and/or the impact of any U.S. Governmental shutdowns, including impacts on governmental agencies due to the shutdown;
•the risk and impact of tariffs on our business, which 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 or other retaliatory actions imposed by other countries;
•the impact of disruptions related to climate change and natural disasters;
•any changes in business, political and economic conditions due to actual or threatened terrorist activity, geopolitical instability, political or civil unrest or military action, including the ongoing conflicts between Russia and Ukraine and in the Middle East and the resulting economic or other consequences;
•the impact of product recalls, withdrawals and other unusual items, including uncertainties related to regulator-directed risk evaluations and assessments, such as our ongoing evaluation of our product portfolio for the potential presence or formation of nitrosamines, and our voluntary withdrawal of all lots of Oxbryta in all markets where it is approved and any regulatory or other impact on Oxbryta and other SCD assets;
•trade buying patterns;
•the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments;
•the impact of, and risks and uncertainties related to, restructurings and internal reorganizations, as well as any other corporate strategic initiatives and growth strategies, and cost-reduction and productivity initiatives, including any potential future phases, each of which requires upfront costs but may fail to yield anticipated benefits and may result in unexpected costs, organizational disruption, adverse effects on employee morale, retention issues or other unintended consequences;
•the ability to successfully achieve our climate-related goals and progress our environmental sustainability and other priorities;
Risks Related to Government Regulation and Legal Proceedings
•the impact of any U.S. healthcare reform or legislation, including executive orders or other change in laws, regulations or policy, or any significant spending reduction or cost control efforts affecting Medicare, Medicaid, the 340B Program or other publicly funded or subsidized health programs, including the IRA and the IRA Medicare Part D Redesign, or changes in the tax treatment of employer-sponsored health insurance that may be implemented;
•risks and uncertainties related to the impact of Pfizer's voluntary agreement with the U.S. Government designed to lower drug costs for U.S. patients and to include Pfizer products in a direct purchasing platform, and Pfizer's plans to further invest in U.S. manufacturing, including risks relating to entering into definitive agreements with the U.S. Government and the initiation of new tariffs not subject to Pfizer's grace period;
•U.S. federal or state legislation or regulatory action and/or policy efforts affecting, among other things, pharmaceutical product pricing, including international reference pricing, including Most-Favored-Nation drug pricing, intellectual property, reimbursement or access to or recommendations for our medicines and vaccines, tax changes or other restrictions on U.S. direct-to-consumer advertising; limitations on interactions with healthcare professionals and other industry stakeholders; as well as pricing pressures for our products as a result of highly competitive biopharmaceutical markets;
•risks and uncertainties related to changes to vaccine or other healthcare policy in the U.S., including the FDA's recently adopted policy of disclosing Complete Response Letters for unapproved drug candidates and the attendant risk of disclosure of trade secrets or confidential commercial information;
•legislation or regulatory action in markets outside of the U.S., such as China or Europe, including, without limitation, laws related to pharmaceutical product pricing, intellectual property, medical regulation, environmental protections, data protection and cybersecurity, reimbursement or access, including, in particular, continued government-mandated reductions in prices and access restrictions for certain products to control costs in those markets;
•legal defense costs, insurance expenses, settlement costs and contingencies, including without limitation, those related to legal proceedings and actual or alleged environmental contamination;
•the risk and impact of an adverse decision or settlement and risk related to the adequacy of reserves related to legal proceedings;
•the risk and impact of tax related litigation and investigations;
•governmental laws, regulations and policies affecting our operations, including, without limitation, the IRA, as well as changes in such laws, regulations or policies or their interpretation, including, among others, new or changes in tariffs, tax laws and regulations internationally and in the U.S., including the OBBBA, which was enacted on July 4, 2025, and is still subject to further guidance; the adoption of global minimum taxation requirements outside the U.S. generally effective in most jurisdictions since January 1, 2024, government cost-cutting measures and related impacts on, among other matters, government staffing, resources and ability to timely review and process regulatory or other submissions; restrictions related to certain data transfers and transactions involving certain countries; and potential changes to existing tax laws, tariffs, or changes to other laws, regulations or policies in the U.S., including by the U.S. Presidential administration and Congress, as well as in other countries;
Risks Related to Intellectual Property, Technology and Cybersecurity
•the risk that our currently pending or future patent applications may not be granted on a timely basis or at all, or any patent-term extensions that we seek may not be granted on a timely basis, if at all;
•risks to our products, patents and other intellectual property, such as: (i) claims of invalidity that could result in loss of patent coverage; (ii) claims of patent infringement, including asserted and/or unasserted intellectual property claims; (iii) claims we may assert against intellectual property rights held by third parties; (iv) challenges faced by our collaboration or licensing partners to the validity of their patent rights; or (v) any pressure from, or legal or regulatory action by, various stakeholders or governments that could potentially result in us not seeking intellectual property protection or agreeing not to enforce or being restricted from enforcing intellectual property rights related to our products;
•any significant breakdown or interruption of our information technology systems and infrastructure (including cloud services);
•any business disruption, theft of confidential or proprietary information, security threats on facilities or infrastructure, extortion or integrity compromise resulting from a cyber-attack, which may include those using adversarial AI techniques, or other malfeasance by, but not limited to, nation states, employees, business partners or others; and
•risks and challenges related to the use of software and services that include AI-based functionality and other emerging technologies.
Pfizer Inc. published this content on November 04, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on November 04, 2025 at 12:05 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]