Analyst Conference Summary

Biotechnology

conference date: August 1, 2025 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2025 (Q2, second quarter 2025)

Forward-looking statements

Overview:

Basic data (GAAP):

Revenue was $ billion, down % sequentially from $3.03 billion and down % from $ billion in the year-earlier quarter.

Net income was $ million, down % sequentially from $809 million, and up % from $ million year-earlier.

Diluted Earnings Per Share (EPS) was $, down % sequentially from $7.27 and up % from $ year-earlier.

Guidance:

Conference Highlights:

Leonard S. Schleifer, CEO, said ""

Declared dividend of $0.88, payable 6, of record 20, 2025.

A large number of potential milestones are possible in 2025, including FDA decisions, new submissions, and new trial starts.

In April 2025, the FDA approved Dupixent for adults and adolescents aged 12 years and older with CSU who remain symptomatic despite antihistamine treatment. For bullous pemphigoid now as a PDUFA date of June 20, 2025. In September 2024, the FDA approved Dupixent as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. Also FDA approved Dupixent as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). In November 2024 the EMA approved Dupixent for children with eosinophic esophagitis. In Q4 an sBLA for bullous pemphigoid was submitted. Also in a Phase 3 trial for lichen simplex chronicus.

Competition is increasing in the anti-VEGF eyecare space. But HD is differentiated from other products. In Q4 2024 Eylea HD pre-filled syringe submitted to FDA, but received a CRL (complete response letter) in April, 2025, related to a third-party component. The primary endpoint was met in the Phase 3 QUASAR trial of EYLEA HD for macular edema following RVO. In Q1 2025 156-week Phase 3 wet age-related macular edema positive resluts were announced.

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. PDUFA set to July 10, 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. PDUFA for FL set to July 30, 2025.

In April 2025 Regeneron reached resolution of its patent infringement litigation related to Biocon Injection 2 mg biosimilar to Eylea (aflibercept). The settlement precludes Biocon from launching its biosimilar product in the United States until the second half of 2026.

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 (includes Sanofi Dupixent sales), including Dupixent sold by Sanofi. Other income $ million.

Non-GAAP results: net income $ million, down % sequentially from $928 million and down % from $ billion year earlier. Diluted EPS was $, down % sequentially from $8.22 and down % from $ year-earlier.

See also the Regeneron Pipeline.

Cash and equivalents balance ended at $ billion, down sequentially from $17.6 billion. $ billion long-term debt. Cash from operations was $ billion, free cash flow $ million. Cap ex $ million. $ 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 $ million. Other income was $ million. Interest expense $ million. Income tax $ million.

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