Encorafenib

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 NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) reported financial results for the first quarter of 2026 and reaffirmed its full-year 2026 financial guidance (2) . 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 Denton, CFO and EVP of Pfizer: “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 22% year-over-year operational revenue growth from our launched and acquired products (1) . Today, we are reaffirming our full-year 2026 financial guidance.” OVERALL RESULTS First-Quarter 2026 Revenues of $14.5 Billion, Representing 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 First-Quarter 2026 Reported (3) Diluted EPS of $0.47, and Adjusted (4) Diluted EPS of $0.75 Reaffirms All Components of Full-Year 2026 Financial Guidance (2) , including Revenues in a Range of $59.5 to $62.5 Billion and Adjusted (4) Diluted EPS in a Range of $2.80 to $3.00 Beginning in the first quarter of 2026, we made organizational changes in our commercial organization within the Global Biopharmaceuticals Business (Biopharma) to better support and optimize performance across our product portfolios. These changes include the transition of certain off-patent branded and generic sterile injectables and biosimilars primarily from the Specialty Care and Oncology product portfolios to a new Hospital and Biosimilars product portfolio and the creation of a new Global Hospital and Biosimilars Division within Biopharma. See the Item 1. Business––Commercial Operations section of Pfizer's 2025 Annual Report on Form 10-K (available at and ). Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates (5) . Results for the first quarter of 2026 and 2025 (6) are summarized below. ($ in millions, except per share amounts) First-Quarter 2026 2025 % Change Revenues $ 14,451 $ 13,715 5% Reported (3) Net Income 2,687 2,967 (9%) Reported (3) Diluted EPS 0.47 0.52 (10%) Adjusted (4) Income 4,290 5,237 (18%) Adjusted (4) Diluted EPS 0.75 0.92 (18%) REVENUES ($ in millions) First-Quarter 2026 2025 % Change Total Oper. Global Biopharmaceuticals Business (Biopharma) $ 14,161 $ 13,441 5% 2% Pfizer CentreOne 289 273 6% 1% TOTAL REVENUES $ 14,451 $ 13,715 5% 2% 2026 FINANCIAL GUIDANCE (2) Reaffirms all components of full-year 2026 Financial Guidance (2) , including Revenues in a range of $59.5 to $62.5 billion and Adjusted (4) Diluted EPS in a Range of $2.80 to $3.00. Revenues $59.5 to $62.5 billion Adjusted (4) SI&A Expenses $12.5 to $13.5 billion Adjusted (4) R&D Expenses $10.5 to $11.5 billion Effective Tax Rate on Adjusted (4) Income Approximately 15.0% Adjusted (4) Diluted EPS $2.80 to $3.00 CAPITAL ALLOCATION During the first three months of 2026, Pfizer deployed its capital in a variety of ways, which primarily included: Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including: $2.5 billion invested in internal research and development projects, and Approximately $110 million invested in business development transactions. Returning capital directly to shareholders through $2.4 billion of cash dividends, or $0.43 per share of common stock. 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 $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2026. 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 $14.5 billion, an increase of $736 million, or 5%, compared to the prior-year quarter, reflecting an operational increase of $304 million, or 2%, and a favorable impact of foreign exchange of $431 million. The operational increase was primarily driven by an increase in revenues for Padcev, Eliquis, Oncology biosimilars, Nurtec and several other products across categories, partially offset primarily by a year-over-year decline in COVID-19 product revenues. Excluding contributions from Comirnaty and Paxlovid, revenues for the first quarter grew 7% operationally. Additionally, first-quarter revenues of our Launched and Acquired Products (1) grew 22% operationally. 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 the U.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 the U.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 the U.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 the U.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 the U.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: 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 the U.S. primarily resulting from a narrower recommendation for vaccination; and Paxlovid globally, down 63% operationally, driven primarily by lower COVID-19 infections across U.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 ($ in millions) First-Quarter 2026 2025 % Change Total Oper. Cost of Sales (3) $ 3,548 $ 2,845 25% 15% Percent of Revenues 24.6 % 20.7 % N/A N/A SI&A Expenses (3) 2,961 3,031 (2%) (4%) R&D Expenses (3) 2,490 2,203 13% 12% Acquired IPR&D Expenses (3) 137 9 * * Other (Income)/Deductions—net (3) 861 953 (10%) (13%) Effective Tax Rate on Reported (3) Income 14.6 % (6.8 %) * Indicates calculation not meaningful or results are greater than 100%. 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 4% operationally compared to the prior-year quarter, primarily reflecting lower marketing and promotional spending on various products from more targeted investments and ongoing productivity improvements, as well as lower spending in corporate enabling functions; partially offset by an unfavorable impact of foreign exchange. First-quarter 2026 R&D Expenses (3) increased 12% operationally compared to the prior-year quarter, driven primarily by an increase in spending in certain oncology and obesity product candidates. 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 ($ in millions) First-Quarter 2026 2025 % Change Total Oper. Adjusted (4) Cost of Sales $ 3,406 $ 2,593 31% 20% Percent of Revenues 23.6 % 18.9 % N/A N/A Adjusted (4) SI&A Expenses 2,915 3,010 (3%) (5%) Adjusted (4) R&D Expenses 2,434 2,173 12% 11% Acquired IPR&D Expenses (4) 137 9 * * Adjusted (4) Other (Income)/Deductions—net 388 246 58% 45% Effective Tax Rate on Adjusted (4) Income 16.9 % 7.8 % * Indicates calculation not meaningful or results are greater than 100%. 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 U.S. Food and Drug Administration (FDA) granted full approval to Braftovi in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation based on results from the global Phase 3 BREAKWATER trial (NCT04607421). The Braftovi combination regimen is the only approved targeted regimen for first-line BRAF V600E -mutant metastatic colorectal cancer. Full Release 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 pro Braftovi in combination with cetuximab and FOLFIRI was consistent with the known pro each regimen component and no new safety signals were identified. Full Release 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. Full Release 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. Full Release 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. Full Release Padcev (enfortumab vedotin) 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. Full Release 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 47% reduction in the risk of tumor recurrence, progression or death compared to patients treated with standard of care neoadjuvant (before surgery) gemcitabine and cisplatin (Hazard Ratio (HR) of 0.53; 95% Confidence Interval (CI), 0.41–0.70; 1-sided p20) was not met in the first pre-specified analysis (primary endpoint). The vaccine candidate was well tolerated with no safety concerns identified at time of analysis. Pfizer is planning submissions to regulatory authorities. Full Release 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 (≥ 75% reduction in the Eczema Area and Severity Index) at Week 16 across all doses tested, compared to placebo. Tilrekimig was well-tolerated with a favorable safety pro no dose dependent safety signals; adverse event rates were comparable to placebo. Phase 3 planning for atopic dermatitis is ongoing, with a pivotal study on track to start this year. Full Release 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 $495M in upfront, regulatory and sales milestone payments. Ecnoglutide Injection (Xianweiying (7) ) was approved in China on March 6 for long-term weight management in adults with overweight or obesity, as an adjunct to a reduced calorie diet and increased physical activity, and was subsequently launched in China on April 27, 2026. Full Release 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 U.S. government enabling patients to pay lower prices for their prescription medicines, while strengthening America’s role as a global leader in pharmaceutical innovation. Full Release ViiV Healthcare Limited March 2026. Pfizer completed the exit of its 11.7% investment in ViiV Healthcare Limited and received $1.875 billion in proceeds (or approximately $1.65 billion in cash, net of associated taxes and fees). This transaction will be accounted for in the second quarter of 2026. 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 U.S. District Court for the District of Delaware for infringement of patents relating to Vyndamax. These settlements extend the effective U.S. patent expiry date for Vyndamax to June 1, 2031, subject to the outcome of other litigation. Pfizer had previously anticipated a significant decline in U.S. revenues for Vyndamax beginning in 2029 upon patent expiry. As a result of this settlement, revenues are now expected to remain relatively stable from 2028 through mid-2031. Full Release 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 inform Contacts Media PfizerMediaRelations@Pfizer.com 212.733.1226 Investors IR@Pfizer.com Read full story here