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: Slow revenue growth on Eylea decline.

Basic data (GAAP):

Revenue was $3.75 billion, up 2% sequentially from $3.69 billion and up 1% from $3.72 billion in the year-earlier quarter.

Net income was $1.46 billion, up 5% sequentially from $1.39 million, and up 9% from $1.34 billion year-earlier.

Diluted Earnings Per Share (EPS) was $13.62, up 6% sequentially from $12.81 and up 18% from $11.54 year-earlier.

Guidance:

Updated 2025 expense guidance: R&D GAAP narrowed to $5.68 to $5.75 billion, non-GAAP $5.15 to $5.20 billion. SG&A lowered slighly. Cap ex lowered to $850 to $890 million.

Conference Highlights:

Leonard S. Schleifer, CEO, said "Regeneron had a solid financial quarter and made progress across our late-stage portfolio by securing new FDA approvals for Libtayo, Evkeeza, and Lynozyfic, receiving positive CHMP opinions for Libtayo and Dupixent, and sharing promising data across our oncology, obesity, allergy, and rare disease portfolios. We were proud to receive one of the FDA's first Commissioner's National Priority Vouchers for DB-OTO for a rare form of congenital hearing loss. We also donated our Ebola treatment, Inmazeb, to countries most at risk of outbreaks, reflecting our commitment to ensuring patients in need are able to access our novel medicines." Expects an ongoing demand decline for Eylea in Q4.

Declared dividend of $0.88, payable December 5, 2025, of record November 20, 2025.

In discussions with the Trump administration to lower drug costs. Foreign governments have not contributed their fair share to development costs. Plans to invest more in American manufacturing facilities.

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. Testing in other indications.

In Q2 2025 the EU CHMP issued a positive opinion on Dupixent for CSU (chronic spontaneous urticaria. Final decision should come soon.

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.

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 $1.59 billion. Collaboration revenue $1.97 billion, including Dupixent sold by Sanofi. Other income $198 million.

Non-GAAP results: net income $1.29 billion, down 9% sequentially from $1.42 billion and down 12% from $1.46 billion year earlier. Diluted EPS was $11.83, down 1% sequentially from $12.89 and down 5% from $12.46 year-earlier.

See also the Regeneron Pipeline.

Cash and equivalents balance ended at $18.7 billion, up sequentially from $17.4 billion. $ billion long-term debt. Cash from operations was $na billion, free cash flow $na million. Cap ex $na million. $663 million was used for shares repurchased in the quarter.

GAAP expenses of $2.73 billion consisted of: cost of goods sold $281 million; research and development $1.48 billion; acquired in-process R&D $83 million; selling, general and administrative $658 million; collaboration manufacturing costs $241 million; other operating income $10 million. Leaving income from operations of $1.03 billion. Other income was $756 million. Interest expense $19 million. Income tax $303 million.

Q&A selective summary:

Eylea pricing? We are not revealing that for competitive reasons. HD performance is due to its efficacy and convenience. We expect sequential demand growth to moderate.

Balance sheet for BD, manufacturing? We could use cash for BD if the right opportunity. We plan to invest over $7 billion in manufacturing. Our first filling plant should come online in 2026.

HD clinic inventory policy evolution? Retinal community, KOLs, look to select the right product for patients. KOLs like safety, durability, and efficacy.

IL33 for COPD new Phase 3 trial? Looking to meet with FDA to decide a strategy.

Filler approval timing is not known, hope for November or December. Believe everything is done except the filler.

CRLs? Not due to internal regulatory problems. Problem is we do not do our own filling, but hope to get that on line next year.

Factor 11 program? Phase 2 is a run into the Phase 3 program. All about benefit to risk. Bleeding risk needs to be low compared to benefits. Hope to customize this with 2 different antibodies.

Lynozyfic (linvoseltamab) launch? Pleased so far, 5th line setting, good payer and doctor feedback. Since it is best for late line patients, it is likely to be the best in earlier settings, including first line. Data is stunning and unprecedented. Multiple myeloma is a $30 billion market.

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