TARRYTOWN, N.Y. — January 30, 2026 — Leads & Copy — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has announced its financial results for the fourth quarter and full year 2025, along with a business update. The company reported a 3% increase in fourth-quarter revenues, reaching $3.9 billion compared to the same period in 2024. Full-year 2025 revenues also saw a 1% rise, totaling $14.3 billion versus the previous year.
According to Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer, Regeneron performed well in 2025. He cited the company’s blockbuster medicines and late-stage clinical portfolio as key drivers of financial strength and future growth.
Global net sales of Dupixent, recorded by Sanofi, experienced a 34% increase in the fourth quarter, amounting to $4.9 billion compared to the fourth quarter of 2024. Full-year 2025 Dupixent global net sales increased 26% to $17.8 billion versus 2024.
EYLEA HD U.S. net sales increased 66% to $506 million and total EYLEA HD and EYLEA U.S. net sales decreased 28% to $1.1 billion in the fourth quarter. Full year 2025 EYLEA HD U.S. net sales increased 36% to $1.6 billion and total EYLEA HD and EYLEA U.S. net sales decreased 27% to $4.4 billion.
GAAP EPS for the fourth quarter was $7.86, while non-GAAP EPS was $11.44. The fourth quarter results include an unfavorable $0.14 impact from an acquired IPR&D charge.
Key business highlights include the FDA’s approval of EYLEA HD for treating macular edema following retinal vein occlusion (RVO) and for monthly dosing flexibility across approved indications. The FDA also approved a new manufacturer to fill vials for EYLEA HD, and a regulatory application to include a new manufacturer for EYLEA HD pre-filled syringe has been submitted to the FDA, with a decision expected in the second quarter of 2026.
Additionally, Libtayo was approved by both the FDA and EC as the first and only immunotherapy for high-risk adjuvant cutaneous squamous cell carcinoma (CSCC), and Dupixent received approval from the EC for chronic spontaneous urticaria (CSU).
Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron, stated that 2025 was a strong year for the company, with pipeline advances, commercial execution, and financial performance. He added that the company’s focus for 2026 remains on prioritizing internal investments, evaluating business development opportunities, and enhancing shareholder returns.
Key Pipeline Progress
Regeneron has approximately 45 product candidates in clinical development. In November 2025, the EC approved Dupixent for CSU in adults and adolescents aged 12 years and older who remain symptomatic despite antihistamine treatment. In December 2025, Japan approved Dupixent for bronchial asthma in children aged 6 to 11 years. In November 2025, positive results were announced from the Phase 3 trial in adults and children aged 6 years and older with allergic fungal rhinosinusitis (AFRS). The FDA accepted the sBLA for this indication, with a target action date in February 2026.
In November 2025, the FDA approved EYLEA HD for RVO, with dosing up to every 8 weeks after an initial monthly period. The FDA also approved a monthly dosing option across approved indications. In January 2026, the EC approved EYLEA 8 mg (EYLEA HD in the U.S.) for RVO.
In October and November of 2025, the FDA and EC approved Libtayo as an adjuvant treatment for adults with CSCC at high risk of recurrence after surgery and radiation.
A BLA was submitted to the FDA for DB-OTO for profound genetic hearing loss in children. An FDA decision is expected in the first half of 2026. U.S. and EU regulatory applications were submitted for garetosmab in adults with fibrodysplasia ossificans progressiva (FOP). A second Phase 3 study was initiated for REGN5713-5715 for birch allergy.
Corporate Updates
In October 2025, Dupixent was recognized as the “Best Biotechnology Product” of 2025 by the Galien Foundation. In January 2026, the collaboration agreement with Tessera Therapeutics, Inc. to develop and commercialize TSRA-196 became effective. The Company plans to invest approximately $2 billion to develop a manufacturing facility in Saratoga Springs, New York.
Select Upcoming 2026 Milestones
Upcoming milestones include an FDA decision for EYLEA HD pre-filled syringe in the second quarter of 2026, initial results from a Phase 3 study for cemdisiran in geographic atrophy in the second half of 2026, and an EC decision on a regulatory submission for Dupixent in bullous pemphigoid in the first half of 2026. The company also anticipates an FDA decision on the sBLA for Dupixent in AFRS in February 2026.
Other milestones include initiating a long-acting IL-13 antibody clinical program in atopic dermatitis in the first half of 2026, initiating a second Phase 3 study for REGN1908-1909 in cat allergy in the first half of 2026, and initiating a Phase 3 program for olatorepatide in obesity in patients with and without Type 2 diabetes in 2026.
Additionally, the company plans to initiate a clinical program for olatorepatide in combination with Praluent in 2026, report additional data from a Phase 2 study for semaglutide in combination with trevogrumab with and without garetosmab in obesity in 2026, and initiate additional Phase 3 studies for Factor XI antibodies in anticoagulation in the first half of 2026.
Finally, the company expects to report results from a Phase 3 study for fianlimab, in combination with Libtayo, versus pembrolizumab in first-line metastatic melanoma in the first half of 2026 and initiate additional Phase 3 studies for Lynozyfic in multiple myeloma and precursor conditions in 2026.
Source: Regeneron
