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: In slow growth mode, but high profit margin.

Basic data (GAAP):

Revenue was $3.69 billion, up 22% sequentially from $3.03 billion and up 4% from $3.55 billion in the year-earlier quarter.

Net income was $1.39 billion, up 72% sequentially from $809 million, and down 3% from $1.43 billion year-earlier.

Diluted Earnings Per Share (EPS) was $12.81, up 76% sequentially from $7.27 and up 3% from $12.41 year-earlier.

Guidance:

Updated 2025 expected R&D cost updward slightly, SG&A downward slightly, so gross margin at lower end of prior guidance.

Conference Highlights:

Leonard S. Schleifer, CEO, said "Regeneron had a strong quarter, marked by significant growth in U.S. sales of Eylea HD and global sales of Dupixent and Libtayo along with multiple regulatory approvals. We have made significant progress in our oncology portfolio, including FDA approval for Lynozyfic for relapsed or refractory multiple myeloma, exciting emerging data from the lead-in cohorts of our pivotal programs in myeloma and lymphoma, as well as positive pivotal data supporting a potential upcoming FDA approval for Libtayo in adjuvant CSCC. Dupixent continues to be the world-leading treatment for diseases driven by type 2 inflammation, adding recent FDA approvals for bullous pemphigoid and chronic spontaneous urticaria, the seventh and eighth distinct indications for this important medicine. We are confident in the near- and long-term potential of our diverse pipeline and look forward to additional data and regulatory milestones later this year. We also returned over $2.3 billion of capital to shareholders through share repurchases and dividends and committed over $7 billion to U.S. manufacturing investments, capital expenditures, and business development since the start of 2025, underscoring our commitment to deploy capital with the goal of driving long-term value creation."

Declared dividend of $0.88, payable September 6, 2025, of record August 18, 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 the U.S. District Court for the District of Delaware found that Amgen violated antitrust and tort laws by creating an anticompetitive bundling scheme designed to exclude Praluent from the market.

In Q2 2025 Regeneron acquired an FDA Rare Pediatric Disease Priority Review Voucher from a third party for $155 million.

In Q2 2025 the EU approved Eylea 8 mg with extended dosing intervals for wAMB and DME.

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.

In April 2025, the FDA approved Dupixent for adults and adolescents aged 12 years and older with CSU who remain symptomatic despite antihistamine treatment. In q2 2025 Dupixent was approved by the FDA for bullous pemphigoid. 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 pre-filled syringe 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 $1.63 billion. Collaboration revenue $1.86 billion, including Dupixent sold by Sanofi. Other income $184 million.

Non-GAAP results: net income $1.42 billion, up 53% sequentially from $928 million and up 5% from $1.35 billion year earlier. Diluted EPS was $12.89, up 45% sequentially from $8.22 and up 12% from $11.56 year-earlier.

See also the Regeneron Pipeline.

Cash and equivalents balance ended at $17.5 billion, down sequentially from $17.6 billion. $2 billion long-term debt. Cash from operations was $2.2 billion, free cash flow $1.7 million. Cap ex $448 million. $0 billion was used for shares repurchased in the quarter.

GAAP expenses of $2.60 billion consisted of: cost of goods sold $276 million; research and development $1.42 billion; acquired in-process R&D $10 million; selling, general and administrative $634 million; collaboration manufacturing costs $255 million; other operating expense $0 million. Leaving income from operations of $1.08 billion. Other income was $443 million. Interest expense $4 million. Income tax $127 million.

Q&A selective summary:

Trump, MFN? Not been to Mar-a-Lago frequently. But Regeneron's cocktail for Covid may have saved Trump's life. We are outspoken in agreeing the EU is not paying their share. American consumers should not be paying for all inovation. But no unique insite into Trump plans.

HD fills? Fix has a good chance of being done expeditiously. We believe there is nothing significant left to be done by us, expect favorable FDA decision.

Branded share erosion to Avastin? Branded share was just over 60%. Slight erosion from non-branded competition.

ROI of pipeline? We have a broad pipeline. We have considered out-licensing. In oncology we want a menu of agents that could be useful to combine. When it makes sense, we could out license.

Dupixent competition from Ox40 ligand? Data is interesting, but does not seem to offer any advantages over Dupixent. The ox40 approach is less specific in its damping of the immune system that Dupixent, which therefore has a better safety profile. Like the JAK therapies.

Can you force a higher price outside the US through partners? The Trump letter seemed to be on new products, not old ones. We do not control the pricing of Eylea outside the U.S., that is controlled by Bayer.

First line melanoma event rate slowing? Can only speculate. Powering for better effect than competitors. Delaying when we will get results. We just have to wait.

Wall Street view that your pipeline is too expensive for its likely results? Well, we got Eylea and Dupixent. We are getting very encouraging data for myeloma. We will have 8 different Phase 3 trials next year. It is a big market opportunity. Valuation is capped by view of out existing products, not really looking at the new opportunities.

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