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: Revenue fell y/y, possible sign competition cutting into Eylea revenue.

Basic data (GAAP):

Revenue was $3.03 billion, down 20% sequentially from $3.79 billion and down 4% from $3.15 billion in the year-earlier quarter.

Net income was $809 million, down 12% sequentially from $918 million, and up 12% from $722 million year-earlier.

Diluted Earnings Per Share (EPS) was $7.27, down 10% sequentially from $8.06 and up 16% from $6.27 year-earlier.

Guidance:

Unchanged except gross margins lowered by 1% and cap ex decreased to $850 to $950 million.

Conference Highlights:

Leonard S. Schleifer, CEO, said "Performance was mixed . . . We are laser focused on fulfilling the promise of this pipeline by advancing our clinical programs, and expect several important data readouts this year. We are also working to ensure our four blockbuster medicines reach even more patients who could benefit, with year-to-date progress including regulatory approvals for Dupixent in CSU in the U.S. and COPD in Japan" So far in 2025, received four regulatory approvals and made nine regulatory submissions. Has 45 product candidates for clinical indications. Off-label repackaged Avastin was the driver for lower VEGF therapy sales. Intends to continue to invest heavily in R&D.

Had declared first dividend ever, $0.88, payable on March 20, 2025 to shareholders of record on February 20. In Q1 2025 authorized an additional $3 billion in share buyback program and did repurchase $1.05 billion in shares. Repeated dividend of $0.88, payable June 6, of record May 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 $1.42 billion. Collaboration revenue $1.53 billion (includes Sanofi Dupixent sales), including Dupixent sold by Sanofi. Other income $82 million.

Non-GAAP results: net income $928 million, down 33% sequentially from $1.39 billion and down 17% from $1.12 billion year earlier. Diluted EPS was $8.22, down 32% sequentially from $12.07 and down 14% from $9.55 year-earlier.

See also the Regeneron Pipeline.

Cash and equivalents balance ended at $17.6 billion, down sequentially from $17.9 billion. $2 billion long-term debt. Cash from operations was $1.05 billion, free cash flow $816 million. Cap ex $229 million. $1.05 billion was used for shares repurchased in the quarter.

GAAP expenses of $1.33 billion consisted of: cost of goods sold $266 million; research and development $1.33 billion; acquired in-process R&D $12 million; selling, general and administrative $633 million; collaboration manufacturing costs $199 million; other operating expense $0 million. Leaving income from operations of $592 million. Other income was $322 million. Interest expense $9 million. Income tax $96 million.

Q&A selective summary:

CRL? New device approvals include components bought from third parties. FDA has a masterfile for each component maker. We are not allowed to be party to the FDA inquiry to the third party. We had not received the questions before the CRL was issued. Some minor clarifications in addition. Supplier says they have now given the data to the FDA. Speed of resolution is uncertain. Same component that is approved and used in EU.

Factor XI antibody timeline? The combination of indications may take a bit longer. Prioritizing the anti-coagulation profile and bleeding risk reduction. We have not disclosed all the indications, some will come in sooner than others. Phase 3 studies are beginning to enroll this year.

Eylea Foundation reopening? Explained mechanism for copay assistance. Companies can give financial assistance to charitable foundations that cover copays for those in need, as long as a specific therapy is not required. Last year we gave $400 million, others gave little. Our commercial outlook changed, so we are looking for cooperation from other companies. We are considering a matching program. We do not have a timeline, and it depends on other players.

If Itepekimab COPD results are good, we are considering moving into Asthma, where the genetic indicators are strong.

Capital expense guidance? Lowered due to timing.

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