Analyst Conference Summary

Biotechnology

conference date: January 30, 2026 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2025 (Q4, fourth quarter 2025)

Forward-looking statements

Overview: Slow revenue growth. Raised dividend.

Basic data (GAAP):

Revenue was $3.88 billion, up 3% sequentially from $3.75 billion and up 3% from $3.79 billion in the year-earlier quarter.

Net income was $845 million, down 42% sequentially from $1.46 billion, and down 8% from $918 million year-earlier.

Diluted Earnings Per Share (EPS) was $7.86, down 42% sequentially from $13.62 and down 2.5% from $8.06 year-earlier.

Guidance:

For full year 2026 did not give revenue or profit guidance. Did give expense guidance, including GAAP R&D expense of $6.45 to $6.68 billion; SG&A $2.86 to $3.04 billion; COCM of $0.94 to $1.02 billion; cap ex of $1.1 to $1.3 billion, and an effective tax rate of 12% to 15%.

Conference Highlights:

Leonard S. Schleifer, CEO, said "Regeneron performed well in 2025, with financial strength driven by our four blockbuster medicines and future growth supported by our exciting late-stage clinical portfolio. In the fourth quarter, we secured label expansions and new filler solutions for Eylea HD, further enhancing its commercial potential. Dupixent received new approvals in Japan and Europe and is currently the most widely used innovative branded antibody medicine, with over 1.4 million active patients worldwide. Libtayo also secured additional approvals and continues to be the leading immunotherapy for non-melanoma skin cancers. Our current success is underscored by decades of investment in innovative science and technology, setting us up for exciting data read-outs and potential approvals in 2026 in a broad range of diseases" Emphasized growth of Libtayo sales. Sees Eylea 2mg sales eroding, with some compensation from HD. Also emphasized potential blockbuster drugs in development and new drugs planned to enter clinical development.

Declared dividend of $0.94, up from $0.88, payable March 5, 2026, of record February 20, 2026. On December 31, 2025, $1.5 billion remained available for share repurchases under Regeneron's share repurchase programs.

In discussion with federal agencies about reducing drug costs.

Looks forward to higher royalty tiers on sales going forward.

In Q4 2025 Libtayo received FDA approval for high-risk adjuvant cutaneous squamous cell carcinoma (CSCC). It is the only approved immunotherapy for the indication.

In Q4 Dupixent received European approval for CSU (chronic spontaneous urticaria (hives)). Japan approved for children (age 6 to 11)with bronchial asthma. Phase 3 results for allergic fungal rhinosinusitis were positive, PDUFA is February 2026.

In Q4 2025 submitted U.S. and EU applications for garetosmab (an Activin A antibody) in adults with fibrodysplasia ossificans progressiva (FOP). In September 2025, the primary endpoint was met in a Phase 3 trial of garetosmab in adults with FOP, showing a 90% or greater reduction in new bone lesions compared to placebo at 56 weeks, with a greater than 99% reduction in the total volume of new HO lesions.

Total Eylea HD and Eylea U.S. net sales decreased 28% to $1.1 billion in Q4. In Q4 2025 Eylea HD received FDA approval for macular edema following retinal vein occlusion. In Q3 2025 a CRL (complete response letter) was issued by the FDA for the pre-filled Eylea HD syringe. REGN submitted a new application for for the syringe with FDA decision expected Q2.

In Q3 2025 Libayo was approved by the FDA for adjuvent CSCC (Cutaneous Squamous Cell Carcinoma). In September Japan approved it for unresectable advanced or relapsed NSCLC. In September Phase 3 five-year follow up data in NSCLC showed a 19.4% overall survival rate, compared to 8.8% for chemo alone.

Cemdisiran for generalized myasthenia gravis met its Phase 3 endpoints in Q3 2025.

In Q4 2025 the BLA was submitted for DB-OTO. DecisionIn October 2025, updated data from the pivotal trial of DB-OTO, an AAV-based gene therapy, in children with profound genetic hearing loss due to variants of the otoferlin (OTOF) gene were published in the New England Journal of Medicine and presented at the annual American Academy of Otolaryngology-Head and Neck Surgery meeting. Showed 11 out of 12 participants experienced clinically meaningful hearing improvements.

In Q1 2026 the collaboration agreement with Tessera Therapeutics to develop and commercialize TSRA-196 (for the treatment of alpha-1 antitrypsin deficiency (AATD)) became effective. Tessera will lead the initial first-in-human trial, while Regeneron will lead subsequent global development and commercialization.

Hopes will report results from Phase 3 study for pozelimab (C5 antibody) in combination with cemdisiran (C5 siRNA therapy) in paroxysmal nocturnal hemoglobinuria (PNH) in Q4 2026 or Q1 2027 such that it will be best in class for PNH.

Early clinical data for the LAG3 candidate Fianlimab with Libtayo for melanoma showed very encouraging results. Phase 3 trial readout expected 2H 2025.

Itepekimab anti IL-33 for COPD in former smokers is in two Phase 3 trials with results expected 2H 2025.

Regeneron is testing several potential cancer agents, including in combo with Libtayo and 8 different bispecifics, plus one CAR-T therapy. Continues to pursue siRNA therapies generated by Alnylam.

Future growth will be fueled by the breadth and depth of the pipeline. Genetic medicines portfolio pipeline has high potential future value.

Revenue by type: product sales $1.68 billion. Collaboration revenue $1.97 billion, including Dupixent sold by Sanofi. Other income $239 million.

Non-GAAP results: net income $1.25 billion, down 3% sequentially from $1.29 billion and down 10% from $1.39 billion year earlier. Diluted EPS was $11.44, down 3% sequentially from $11.83 and down 3% from $12.07 year-earlier.

See also the Regeneron Pipeline.

Cash and equivalents balance ended at $18.9 billion, up sequentially from $18.7 billion. $2 billion long-term debt. Full year Cash from operations was $4.98 billion, free cash flow $4.08 billion. Cap ex $898 million [Q4 not given]. $671 million was used for shares repurchased in the quarter.

GAAP expenses of $3.00 billion consisted of: cost of goods sold $319 million; research and development $1.63 billion; acquired in-process R&D $19 million; selling, general and administrative $775 million; collaboration manufacturing costs $266 million; other operating income $0 million. Leaving income from operations of $880 million. Other income was $176 million. Interest expense $12 million. Income tax $199 million.

Full year 2025 revenue was $14.34 billion, up just 1% from $14.2 billion in 2024. GAAP net income was $4.51 billion, up 2% y/y. GAAP EPS was $41.48, up 8% y/y. Non-GAAP net income was $4.89 billion, down 8%, and EPS $44.31, down 3% from $45.62 y/y.

Q&A selective summary:

Libtayo plus fianlimab update? No further clarity for advanced melanoma interim readout, still estimated 1H.

Dupixent? We have a lot of follow-up opportunities in this space, including an improved version of Dupixent. It already is highly effective and has an incredible safety profile. The pathway it affects does not suppress overall imunity, unlike JAK inhibitors, so we do not see generalized increases in infections.

Metastatic melanoma data details? Powered for PFS. Two dose groups. Also hope to show an overall survival benefit. Population should represent a true first-line population.

Focus of research over 6 areas? We are disappointed with the industry just trying to duplicate Eylea and Dupixent. Our goal is to use the most innovative approaches to new drugs for new indications. Looking for the most powerful use of genetics to pick targets, like the new ones in opthemology. We are therapeutic agnostic, the focus is to use the most powerful technology for the best targets.

Improved Dupixent version? Other companies failed to make a Dupixent-like drug. Our Dupixent was a special molecule. We have generated million of versions, we believe we have found an improved version, we plan to move it into the clinic. It would be in alliance with Sanofi.

Geographic atrophy? Differentiated from approved drugs? Historically we have been able to produce more effective drugs. Better blockage of a pathway leads to better benefit. Addressing problems of the existing therapies, incluing very bad side effects, up to causing blindness. We are testing both the monotherapy and in combination with an antibody. There are many ways to deliver a better outcome to patients. VEGF is made locally, C5 systemically, so you need different approaches.

Eylea HD revenue trend? Labelling enhancements have helped in the marketplace. Prefilled syringe approval will also help.

A GLP that also reduces cholesterol, wouldn't everyone be wanting to take that? We are very excited with the clinical program. We are not competing just on weight loss. We have seen benefit in testing in China. It is about the combination, every obese patient should take this.

Bayer small molecule program? Small molecules suffer from lack of specifity. We hope our antibody may have a better, very different profile, much less overall bleeding risk, plus less frequent administration.

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