Analyst Conference Summary

Biotechnology

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

Forward-looking statements

Overview:

Basic data (GAAP):

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

Net income was $ billion, up % sequentially from $1.46 billion, and up % from $ billion year-earlier.

Diluted Earnings Per Share (EPS) was $, up % sequentially from $13.62 and up % from $ year-earlier.

Guidance:

Conference Highlights:

Leonard S. Schleifer, CEO, said ""

Declared dividend of $0.88, payable March , 2026, of record February , 2026.

In Q3 2025 a CRL (complete response letter) was issued by the FDA for the pre-filled Eylea HD syringe. REGN plans to submit a new application for a new manufacturer in January. Also awaiting a November FDA decision on HD for macular edema following retinal vein occlusion.

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 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. A U.S. FDA submission for DB-OTO is planned for Q4 2025. In October 2025, the FDA selected DB-OTO for a Commissioner’s National Priority Voucher, a pilot program intended to reduce the review time for certain drug and biologic applications to just one to two months.

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. The FDA submission for garetosmab is planned for Q4 2025.

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 $ billion. Collaboration revenue $ billion, including Dupixent sold by Sanofi. Other income $ million.

Non-GAAP results: net income $ billion, down % sequentially from $1.29 billion and down % from $ billion year earlier. Diluted EPS was $, down % sequentially from $11.83 and down % from $ year-earlier.

See also the Regeneron Pipeline.

Cash and equivalents balance ended at $ billion, up sequentially from $18.7 billion. $ billion long-term debt. Cash from operations was $ billion, free cash flow $ million. Cap ex $ million. $ million was used for shares repurchased in the quarter.

GAAP expenses of $ billion consisted of: cost of goods sold $ million; research and development $ billion; acquired in-process R&D $ million; selling, general and administrative $ million; collaboration manufacturing costs $ million; other operating income $ million. Leaving income from operations of $ billion. Other income was $ million. Interest expense $ million. Income tax $ million.

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