Analyst Conference Summary

Biotechnology

conference date: April 29, 2025 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2025 (Q1, first quarter 2025)

Forward-looking statements

Overview:

Basic data (GAAP):

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

Net income was $ billion, down % sequentially from $0.918 billion, and down % from $ billion year-earlier.

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

Guidance:

Conference Highlights:

Leonard S. Schleifer, CEO, said ""

Declared first dividend ever. $0.88, payable on March 20, 2025 to shareholders of record on February 20. Also authorized an additional $3 billion in share buyback program.

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

Dupixent sales grew 22% in full year 2024 to $14.15 billion. Q4 Sales $1.5 billion. Sales are by Sanofi. 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. But there are new entrants in the atopic dermatitis market.

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; decision expected mid-2025. The primary endpoint was met in the Phase 3 QUASAR trial of EYLEA HD for macular edema following RVO.

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.

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. Expects FDA decision in second half of 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 $ billion, down % sequentially from $1.39 billion and up % from $ billion year earlier. Diluted EPS $, down % sequentially from $12.07 and up % from $ year-earlier.

See also the Regeneron Pipeline.

Cash and equivalents balance ended at $ billion, down sequentially from $17.9 billion. $ billion long-term debt. Cash from operations was $ billion, free cash flow $ billion. 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 expense $ million. Leaving income from operations of $ million. Other expense was $ million. Income tax $ million.

Q&A selective summary:

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