Pfizer Reports Strong First-Quarter Results And Reaffirms 2026 Guidance
Key Terms
phase 3 medical
progression-free survival medical
pdufa regulatory
biologics license application regulatory
committee for medicinal products for human use regulatory
hazard ratio medical
blinded independent central review medical
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Earnings Driven by Focused Execution and
22% Op Revenue Growth of Launched and Acquired Products(1) - Pipeline Momentum Builds on Positive Phase 3 and Mid-Stage Readouts
- Robust Late‑Stage R&D Pipeline, On Track to Start ~20 Key Pivotal Studies in 2026
EXECUTIVE COMMENTARY
Dr. Albert Bourla, Chairman and CEO of Pfizer:
“We're off to a strong start in 2026, and it reinforces our confidence that we will successfully navigate this defining period for Pfizer. Our R&D pipeline is advancing on multiple fronts – with positive Phase 3 readouts and encouraging mid-stage results building meaningful momentum – and I'm particularly encouraged by what we're seeing in oncology and obesity, two areas where I believe Pfizer is positioned to lead.”
David
“Our first-quarter results are attributable to our solid commercial performance globally as well as our ongoing focus on operational efficiency. This quarter, I’m particularly pleased with the
OVERALL RESULTS
-
First-Quarter 2026 Revenues of
, Representing$14.5 Billion 2% Year-over-Year Operational Growth-
Excluding Contributions from Comirnaty and Paxlovid, Revenues Grew
7% Operationally -
Revenues of Launched and Acquired Products(1) Grew
22% Operationally
-
Excluding Contributions from Comirnaty and Paxlovid, Revenues Grew
-
First-Quarter 2026 Reported(3) Diluted EPS of
, and Adjusted(4) Diluted EPS of$0.47 $0.75 -
Reaffirms All Components of Full-Year 2026 Financial Guidance(2), including Revenues in a Range of
to$59.5 and Adjusted(4) Diluted EPS in a Range of$62.5 Billion to$2.80 $3.00
Beginning in the first quarter of 2026, we made organizational changes in our commercial organization within the Global Biopharmaceuticals Business (Biopharma) to better support and optimize performance across our product portfolios. These changes include the transition of certain off-patent branded and generic sterile injectables and biosimilars primarily from the Specialty Care and Oncology product portfolios to a new Hospital and Biosimilars product portfolio and the creation of a new Global Hospital and Biosimilars Division within Biopharma. See the Item 1. Business––Commercial Operations section of Pfizer's 2025 Annual Report on Form 10-K (available at www.pfizer.com and www.sec.gov).
Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates(5).
Results for the first quarter of 2026 and 2025(6) are summarized below.
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($ in millions, except per share amounts) |
First-Quarter |
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2026 |
2025 |
% Change |
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Revenues |
$ |
14,451 |
$ |
13,715 |
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Reported(3) Net Income |
|
2,687 |
|
2,967 |
( |
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Reported(3) Diluted EPS |
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0.47 |
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0.52 |
( |
||
Adjusted(4) Income |
|
4,290 |
|
5,237 |
( |
||
Adjusted(4) Diluted EPS |
|
0.75 |
|
0.92 |
( |
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REVENUES
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($ in millions) |
First-Quarter |
||||||||
|
2026 |
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2025 |
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% Change |
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|
Total |
|
Oper. |
||||
Global Biopharmaceuticals Business (Biopharma) |
$ |
14,161 |
$ |
13,441 |
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Pfizer CentreOne |
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289 |
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273 |
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TOTAL REVENUES |
$ |
14,451 |
$ |
13,715 |
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2026 FINANCIAL GUIDANCE(2)
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Reaffirms all components of full-year 2026 Financial Guidance(2), including Revenues in a range of
to$59.5 and Adjusted(4) Diluted EPS in a Range of$62.5 billion to$2.80 .$3.00
Revenues |
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Adjusted(4) SI&A Expenses |
|
Adjusted(4) R&D Expenses |
|
Effective Tax Rate on Adjusted(4) Income |
Approximately |
Adjusted(4) Diluted EPS |
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CAPITAL ALLOCATION
During the first three months of 2026, Pfizer deployed its capital in a variety of ways, which primarily included:
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Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including:
-
invested in internal research and development projects, and$2.5 billion -
Approximately
invested in business development transactions.$110 million
-
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Returning capital directly to shareholders through
of cash dividends, or$2.4 billion per share of common stock.$0.43
Our capital allocation framework is designed to enhance long-term shareholder value, and is based on three core pillars: (i) reinvesting in the business, including maintaining the flexibility to deploy capital towards potential value-creating business development transactions, (ii) maintaining and, over the long term, growing our dividend, and (iii) in the future, the potential to resume the return of capital to shareholders through value-enhancing share repurchases after de-levering our balance sheet. The company expects to continue to de-lever over the longer term in a prudent manner in order to maintain a balanced capital allocation strategy.
No share repurchases have been completed to date in 2026. As of May 5, 2026, Pfizer’s remaining share repurchase authorization is
Diluted weighted-average shares outstanding of 5,731 million and 5,710 million were used to calculate Reported(3) and Adjusted(4) diluted EPS for first-quarter 2026 and 2025, respectively.
QUARTERLY FINANCIAL HIGHLIGHTS (First-Quarter 2026 vs. First-Quarter 2025)
First-quarter 2026 revenues totaled
First-quarter 2026 operational revenue growth was driven primarily by:
-
Padcev globally, up
39% operationally, driven primarily by increased market share in first-line locally advanced or metastatic urothelial cancer (la/mUC) as well as contribution from launch momentum in the cisplatin-ineligible indication for muscle-invasive bladder cancer (MIBC); -
Eliquis globally, up
8% operationally, driven primarily by higher demand globally, partially offset by declines due to generic entry and price erosion in certain international markets; -
Oncology biosimilars globally, up
52% operationally, driven primarily by favorable net price in theU.S. and supply recovery, with both drivers partially reflecting one-time impacts; -
Nurtec ODT/Vydura globally, up
41% operationally, driven primarily by strong demand and one-time net price favorability in theU.S. , as well as recent launches in certain international markets; -
Lorbrena globally, up
32% operationally, driven primarily by increased patient share in the first-line ALK-positive metastatic non-small cell lung cancer (ALK+ mNSCLC) treatment setting in theU.S. ,China , and certain other international markets; -
Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up
4% operationally. International growth was primarily driven by strong demand with continuing uptake in patient diagnosis across markets as well as improved access in certain international markets. In theU.S. , revenues declined primarily due to net price erosion as a result of new payer contracts, partially offset by continued market expansion; -
Xeljanz globally, up
34% operationally, driven primarily by favorable net price in theU.S. , partially offset by lower demand internationally; and -
Abrysvo globally, up
31% operationally.U.S. growth was primarily driven by a lower returns provision compared to the prior-year quarter, partially offset by lower vaccine rates. International growth was primarily driven by launch uptake in certain international markets, partially offset by unfavorable timing of deliveries for the maternal indication in certain international markets;
partially offset primarily by lower revenues for:
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Comirnaty globally, down
59% operationally, driven primarily by a decline in international markets from both lower contractual deliveries and a lower favorable adjustment to the returns provision, as well as lower utilization in theU.S. primarily resulting from a narrower recommendation for vaccination; and -
Paxlovid globally, down
63% operationally, driven primarily by lower COVID-19 infections acrossU.S. and international markets and lower government purchases in certain international markets.
GAAP Reported(3) Statement of Operations Highlights
SELECTED REPORTED(3) COSTS AND EXPENSES
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($ in millions) |
First-Quarter |
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2026 |
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2025 |
% Change |
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Total |
Oper. |
||||||||
Cost of Sales(3) |
$ |
3,548 |
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$ |
2,845 |
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Percent of Revenues |
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24.6 |
% |
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20.7 |
% |
N/A |
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N/A |
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SI&A Expenses(3) |
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2,961 |
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3,031 |
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( |
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( |
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R&D Expenses(3) |
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2,490 |
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2,203 |
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Acquired IPR&D Expenses(3) |
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137 |
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9 |
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* |
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* |
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Other (Income)/Deductions—net(3) |
|
861 |
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|
953 |
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( |
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( |
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Effective Tax Rate on Reported(3) Income |
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14.6 |
% |
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(6.8 |
%) |
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* Indicates calculation not meaningful or results are greater than |
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First-quarter 2026 Cost of Sales(3) as a percentage of revenues increased by 3.8 percentage points compared to the prior-year quarter, primarily driven by the non-recurrence of a favorable revision of our estimate of accrued royalties in the first quarter of 2025 as well as an unfavorable impact of foreign exchange.
First-quarter 2026 SI&A Expenses(3) decreased
First-quarter 2026 R&D Expenses(3) increased
Pfizer’s effective tax rate on Reported(3) income for the first quarter of 2026 increased compared to the prior-year quarter primarily due to an unfavorable change in the jurisdictional mix of earnings as well as the non-recurrence of favorable global income tax resolutions.
Adjusted(4) Statement of Operations Highlights
SELECTED ADJUSTED(4) COSTS AND EXPENSES
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($ in millions) |
First-Quarter |
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2026 |
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2025 |
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% Change |
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Total |
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Oper. |
||||||
Adjusted(4) Cost of Sales |
$ |
3,406 |
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$ |
2,593 |
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Percent of Revenues |
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23.6 |
% |
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18.9 |
% |
N/A |
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N/A |
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Adjusted(4) SI&A Expenses |
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2,915 |
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|
3,010 |
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( |
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( |
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Adjusted(4) R&D Expenses |
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2,434 |
|
|
2,173 |
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|
|
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Acquired IPR&D Expenses(4) |
|
137 |
|
|
9 |
|
* |
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* |
||
Adjusted(4) Other (Income)/Deductions—net |
|
388 |
|
|
246 |
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|
|
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Effective Tax Rate on Adjusted(4) Income |
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16.9 |
% |
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7.8 |
% |
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* Indicates calculation not meaningful or results are greater than |
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See the reconciliations of certain Reported(3) to non-GAAP Adjusted(4) financial measures and associated footnotes in the financial tables section of this press release located at the hyperlink below.
RECENT NOTABLE DEVELOPMENTS (Since February 3, 2026)
Product Developments
Product/Project |
Milestone |
Recent Development |
Link |
Braftovi (encorafenib) |
Regulatory |
February 2026. Announced the |
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Phase 3 Results |
February 2026. Announced positive topline progression-free survival (PFS) results from Cohort 3, a separate, randomized cohort of the pivotal BREAKWATER trial, evaluating Braftovi in combination with cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) in patients with previously untreated metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. The Braftovi regimen demonstrated a statistically significant and clinically meaningful improvement in PFS, a key secondary endpoint, as assessed by blinded independent central review (BICR) compared to treatment with FOLFIRI with or without bevacizumab. Overall survival (OS), a descriptive secondary endpoint, also showed clinically meaningful prolonged improvement with the Braftovi regimen. At the time of the PFS analysis, the safety profile of Braftovi in combination with cetuximab and FOLFIRI was consistent with the known profile of each regimen component and no new safety signals were identified. |
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Elrexfio (elranatamab) |
Phase 3 Results |
April 2026. Announced positive topline results from the Phase 3 MagnetisMM-5 study evaluating Elrexfio as monotherapy in adults with relapsed or refractory multiple myeloma (RRMM) who received at least one prior line of treatment. The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS, as assessed by BICR, versus standard-of-care daratumumab plus pomalidomide and dexamethasone. The safety and tolerability of Elrexfio was consistent with its known safety profile. |
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Hympavzi (marstacimab) |
Regulatory |
March 2026. Announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Hympavzi to expand the approved indication to include patients 12 years of age and older weighing at least 35 kg with hemophilia A (congenital factor VIII [FVIII] deficiency) with FVIII inhibitors, or hemophilia B (congenital factor IX [FIX] deficiency) with FIX inhibitors. The European Commission will review the CHMP recommendation and is expected to make a final decision in the coming months. |
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Regulatory |
February 2026. Announced the FDA accepted and granted priority review for the supplemental Biologics License Application (sBLA) for Hympavzi to expand the approved indication to include the treatment of hemophilia A or B patients 6 years and older with inhibitors, and pediatric patients (ages 6 to 11) with hemophilia A or B without inhibitors. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in the second quarter of 2026. |
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Padcev
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Regulatory |
April 2026. Pfizer and Astellas Pharma Inc. announced the FDA accepted for priority review a sBLA for perioperative (before and after surgery) Padcev in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph as treatment for patients with muscle-invasive bladder cancer (MIBC). This regimen was FDA-approved in November 2025 for use as perioperative treatment in cisplatin-ineligible patients with MIBC. This filing seeks to expand the indication to patients with MIBC regardless of cisplatin eligibility. The FDA has set a PDUFA target action date of August 17, 2026. |
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Phase 3 Results |
February 2026. Pfizer and Astellas announced positive results from the investigational Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15) for Padcev in combination with pembrolizumab in patients with MIBC eligible for cisplatin-based chemotherapy. Perioperative (before and after surgery) Padcev plus pembrolizumab demonstrated a |
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Talzenna (talazoparib) |
Phase 3 Results |
March 2026. Announced positive topline results from the investigational Phase 3 TALAPRO-3 study of Talzenna in combination with Xtandi in people with homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC). The study met its primary endpoint, with Talzenna plus Xtandi demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS), compared to placebo plus Xtandi. The results markedly exceeded the pre-specified target hazard ratio of 0.63, with the majority of patients remaining progression-free at the time of analysis. Consistent efficacy benefit was also observed in patients whose tumors harbored BRCA and non-BRCA HRR gene alterations. The safety of Talzenna plus Xtandi was consistent with the known safety profile of each medicine, and no new safety signals were identified. |
Pipeline Developments
A comprehensive update of Pfizer’s development pipeline was published today and is now available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of Pfizer’s 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.
Product/Project |
Milestone |
Recent Development |
Link |
atirmociclib |
Phase 2 Results |
March 2026. Announced positive topline results from the randomized Phase 2 FOURLIGHT-1 study evaluating atirmociclib in combination with fulvestrant, versus fulvestrant or everolimus plus exemestane, in people with hormone receptor (HR)-positive, human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC) who had received prior cyclin-dependent kinase (CDK) 4/6 inhibitor-based treatment. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS, as assessed by the investigator [HR: 0.60 ( |
|
Lyme Disease Vaccine Candidate (LB6V / VLA15) |
Phase 3 Results |
March 2026. Pfizer and Valneva SE announced topline results from the Phase 3 VALOR “Vaccine Against Lyme for Outdoor Recreationists” clinical trial (NCT05477524) of its investigational 6-valent OspA-based Lyme disease vaccine candidate PF-07307405 (LB6V, formerly known as VLA15). Results from pre-specified analyses demonstrated efficacy of |
|
tilrekimig |
Phase 2 Results |
March 2026. Announced positive topline results from a Phase 2 study investigating tilrekimig (PF-07275315), a potential first-in-class, investigational trispecific antibody that simultaneously targets interleukin-4 (IL-4), interleukin-13 (IL-13) and thymic stromal lymphopoietin (TSLP), in adults with moderate to severe atopic dermatitis. The study met its primary efficacy endpoint, demonstrating a statistically significant increase in the percentage of participants achieving EASI-75 (≥ |
Corporate Developments
Topic |
Recent Development |
Link |
Business Development |
February 2026. Pfizer and Hangzhou Sciwind Biosciences Co., Ltd. (Sciwind Biosciences) announced a strategic commercialization collaboration in which Pfizer obtained exclusive commercialization rights for Sciwind Biosciences’ glucagon-like peptide 1 (GLP-1) receptor agonist ecnoglutide in Mainland China. Sciwind Biosciences remains the Marketing Authorization Holder and is responsible for research and development, registration, manufacturing and supply of the product. Sciwind Biosciences is eligible to receive an aggregate of up to
Ecnoglutide Injection (Xianweiying(7)) was approved in
|
|
TrumpRx |
February 2026. Announced the launch of Pfizer’s participation on TrumpRx.gov providing Americans a wide range of more than 30 medicines at a significant discount off list prices. This effort is part of Pfizer’s broader Most Favored Nation (MFN) agreement with the |
|
ViiV Healthcare Limited |
March 2026. Pfizer completed the exit of its |
N/A |
Vyndamax Patent Settlements |
April 2026. Pfizer entered into settlement agreements with generic drug manufacturers Dexcel Pharma, Hikma Pharmaceuticals and Cipla Ltd, regarding lawsuits filed in the |
PFIZER TO HOST CONFERENCE CALL
Please find Pfizer’s press release and associated financial tables, including reconciliations of certain GAAP reported to non-GAAP adjusted information, at the following hyperlink:
https://investors.pfizer.com/Q1-2026-PFE-Earnings-Release
(Note: If clicking on the above link does not open a new webpage, you may need to cut and paste the above URL into your browser's address bar.)
Pfizer will host a live conference call and webcast today, May 5, 2026, at 10:00 AM EDT. To access the live conference call, the first-quarter 2026 earnings presentation, and the accompanying prepared remarks from management, visit our website at pfizer.com/investors.
You can also listen to the conference call by dialing either 800-456-4352 in the
The transcript and webcast replay of the call will be made available on our website at pfizer.com/investors within 24 hours after the end of the live conference call and will be accessible for at least 90 days.
For additional details, see the financial schedules and product revenue tables within the press release located at the hyperlink above, and the attached disclosure notice.
(1) |
‘Launched and Acquired Products’ represent select recently launched and acquired products, including new indications. Launched products primarily include Prevnar 20 (Pediatrics), Abrysvo (Older Adult / Maternal), Elrexfio, Cibinqo, Talzenna, Litfulo, Ngenla, Hympavzi, Penbraya Adolescent, and Lorbrena (added Q1-26); and acquired products primarily include Padcev, Adcetris, Tukysa, Tivdak, Nurtec ODT/Vydura, and Velsipity. |
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(2) |
Pfizer does not provide guidance for |
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Financial guidance for full-year 2026 reflects the following: |
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(3) |
Revenues is defined as revenues in accordance with |
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(4) |
Adjusted income and Adjusted diluted earnings per share (EPS) are defined as |
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(5) |
References to operational (Op) variances in this press release pertain to period-over-period changes that exclude the impact of foreign exchange rates. Although foreign exchange rate changes are part of Pfizer’s business, they are not within Pfizer’s control and because they can mask positive or negative trends in the business, Pfizer believes presenting operational variances excluding these foreign exchange changes provides useful information to evaluate Pfizer’s results. |
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(6) |
Pfizer’s fiscal year-end for international subsidiaries is November 30 while Pfizer’s fiscal year-end for |
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(7) |
Xianweiying® is a registered trademark of Hangzhou Sciwind Biosciences Co., Ltd. |
DISCLOSURE NOTICE: Except where otherwise noted, the information contained in this earnings release and the related attachments is as of May 5, 2026. We assume no obligation to update any forward-looking statements contained in this earnings release and the related attachments as a result of new information or future events or developments.
This earnings release and the related attachments contain forward-looking statements about, 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, clinical development plans, discontinuations, clinical trial results and other developing data, revenue contribution and projections, pricing and reimbursement, market dynamics, including demand, market size and utilization rates and growth, performance, timing and duration of exclusivity and potential benefits; the impact and potential impact of tariffs and pricing dynamics; strategic reviews; leverage and capital allocation objectives; an enterprise-wide cost realignment program (including anticipated costs, savings and potential benefits); a Manufacturing Optimization Program to reduce our cost of goods sold (including anticipated costs, savings and potential benefits); dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities, including our acquisitions of Metsera and Seagen and our in-licensing agreements with 3SBio and YaoPharma, and our ability to successfully capitalize on growth opportunities and prospects; our voluntary agreement with the
Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following:
Risks Related to Our Business, Industry and Operations, and Business Development:
- the outcome of research and development (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 decisions or 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 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/reimbursement, 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, as well as risks and uncertainties related to the ability to identify and execute on potential business development opportunities; the ability to satisfy the conditions to closing of any 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 achieving or 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 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, receive regulatory approval for, 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; risks related to our ability to accurately predict or achieve our revenue forecasts for Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments; 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, 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 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;
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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 or foreign policy and/or the impact of any potential
U.S. Governmental shutdowns, including impacts on governmental agencies due to a 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 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 sickle cell disease 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 and other sustainability 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 Drug Pricing Program or other publicly funded or subsidized health programs, including the Inflation Reduction Act of 2022 (IRA) and the IRA Medicare Part D Redesign, government cuts to Affordable Care Act (ACA) subsidies, 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 forU.S. patients and to include certain Pfizer products on the TrumpRx.gov platform, Pfizer’s plans to further invest inU.S. manufacturing and potential tariff impacts, including risks relating to entering into binding final agreements with theU.S. Government and its impact on the applicability of Section 232 tariffs; -
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, product approval processes and pathways, reimbursement or access to or recommendations for our medicines and vaccines, tax changes or other restrictions onU.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: (i) risks and uncertainties relating to the evolving vaccine landscape; and (ii) 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 and/or policy efforts in markets outside of the
U.S. , such asChina orEurope , 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 One Big Beautiful Bill Act, which was enacted on July 4, 2025, and is still subject to further guidance; the adoption of global minimum taxation requirements outside theU.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, including data security, data localization and cross border data transfer regulations, and transactions involving certain countries; and potential changes to existing tax laws, tariffs, or changes to other laws, regulations or policies in theU.S. , including by theU.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 artificial intelligence 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 proprietary or third-party software, systems and services (including cloud services) that include artificial intelligence-based functionality and other emerging technologies, such as the risk of inaccurate, biased or otherwise flawed outputs of AI tools and models; risks related to the protection of proprietary data and confidential information used in or generated by AI systems; reputational risks related to the use of AI in drug discovery, clinical development, manufacturing, commercial operations or patient-facing applications; and the risk that anticipated cost savings from AI, automation and digital enablement efforts may not be realized in the expected amounts or within expected timeframes.
Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q, in each case including in the sections thereof captioned “Forward-Looking Information and Factors That May Affect Future Results” and “Item 1A. Risk Factors,” and in our subsequent reports on Form 8-K.
This earnings release may include discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether.
The information contained on our website or any third-party website is not incorporated by reference into this earnings release. All trademarks mentioned are the property of their owners.
Certain of the products and product candidates discussed in this earnings release are being co-researched, co-developed and/or co-promoted in collaboration with other companies for which Pfizer’s rights vary by market or are the subject of agreements pursuant to which Pfizer has commercialization rights in certain markets.
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Source: Pfizer Inc.