Analyst Conference Summary

Biotechnology

conference date: October 28, 2025 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2025 (Q3, third quarter 2025)

Forward-looking statements

Overview:

Basic data (GAAP):

Revenue was $ billion, up % sequentially from $3.69 billion and up % from $ billion in the year-earlier quarter.

Net income was $ billion, up % sequentially from $1.39 million, and down % from $ billion year-earlier.

Diluted Earnings Per Share (EPS) was $, up % sequentially from $12.81 and up % from $ year-earlier.

Guidance:

Conference Highlights:

Leonard S. Schleifer, CEO, said ""

Declared dividend of $0.88, payable December , 2025, of record November , 2025.

In July 2025, Regeneron's license agreement with Hansoh Pharmaceuticals, to acquire development and commercial rights outside of mainland China, Hong Kong, and Macau for HS-20094, a dual GLP-1/GIP receptor agonist, currently in Phase 3 in China, became effective.

In Q2 2025 Lynozyfic (linvoseltamab) gained FDA accelerated approval for 5th line multiple myeloma. In Europe the approval was for 4th line.

Itepekimab, an IL-33 antibody, had one Phase 3 trial succeed, but a second did not, for COPD. Working with Sanofi.

Competition is increasing in the anti-VEGF eyecare space. But HD is differentiated from other products.

In January 2025, resubmitted to the FDA the BLA for linvoseltamab, a bispecific antibody targeting BCMA and CD3, in relapsed/refractory (R/R) multiple myeloma. That followed resolution of third-party manufacturing issues. FDA approved on July 2, 2025. Already approved in EU. Also in Q1 2025 completed R/R multiple myeloma Phase 3 enrollment.

In January 2025, resubmitted to the FDA the BLA for odronextamab, a bispecific antibody targeting CD20 and CD3, in R/R follicular lymphoma. Presented new and updated data for odronextamab spanning several B-cell non-Hodgkin lymphoma (B-NHL) subtypes, across earlier lines of treatment, at ASH. The FDA issued a CRL for FL on July 30, 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.

Phase 2 obesity trial underway combining semaglutide with and without garetosmab is underway, hoping for better weight loss with muscle retention.

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, up % sequentially from $1.42 billion and up % from $ billion year earlier. Diluted EPS was $, up % sequentially from $12.89 and up % from $ year-earlier.

See also the Regeneron Pipeline.

Cash and equivalents balance ended at $ billion, down sequentially from $17.4 billion. $ billion long-term debt. Cash from operations was $ billion, free cash flow $ million. Cap ex $ million. $0 billion 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 expense $0 million. Leaving income from operations of $ billion. Other income was $ million. Interest expense $ million. Income tax $ million.

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