REGN Q3 Deep Dive: Pipeline, Regulatory Progress, and Label Expansion Take Center Stage

Biotech company Regeneron (NASDAQ:REGN) reported Q3 CY2025 results exceeding the market’s revenue expectations, but sales were flat year on year at $3.75 billion. Its non-GAAP profit of $11.83 per share was 22.7% above analysts’ consensus estimates.

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StockStory’s Take

Regeneron’s third quarter results were well received by the market, reflecting strong execution in its commercial portfolio and key products. Management attributed the positive momentum to double-digit sales growth for Dupixent, Libtayo, and EYLEA HD, despite flat overall sales. CEO Leonard Schleifer highlighted that Dupixent’s broadening indications and robust uptake across geographies remained a primary growth driver, while EYLEA HD benefited from increased physician demand, partially offset by lower net pricing. Libtayo’s continued expansion in non-melanoma skin cancers and new indications also contributed to the quarter’s performance.

Looking ahead, management emphasized the importance of upcoming regulatory milestones and product label enhancements, particularly for EYLEA HD and emerging therapies in the pipeline. Schleifer underscored the company’s plans to expand pivotal programs in areas like hematology, oncology, and metabolic diseases, stating, “Our pipeline is poised to deliver scientific breakthroughs that can potentially help treat millions of patients.” Regeneron is also preparing for increased R&D investment and ongoing manufacturing expansion, aiming to support long-term growth and market leadership.

Key Insights from Management’s Remarks

Management pointed to a combination of product innovation, successful launches, and strategic regulatory efforts as the main factors influencing third quarter performance and future expectations.

• Dupixent’s expanded reach: Dupixent saw 26% global growth driven by new approvals in diseases tied to type 2 inflammation and strong U.S. and international uptake. Management noted more than 1.3 million global patients are now being treated, with potential to address over 4 million in the U.S.
• EYLEA HD demand dynamics: EYLEA HD experienced robust physician demand and 10% sales growth, though pricing pressures and patient affordability issues limited broader anti-VEGF category expansion. Management cited the need for product enhancements, such as 4-week dosing and new indications, to fully unlock its commercial potential.
• Libtayo indication momentum: Libtayo achieved 24% growth, bolstered by its new FDA approval as the first PD-1 antibody for high-risk adjuvant cutaneous squamous cell carcinoma. The company highlighted early adoption and market share gains in both skin and lung cancer settings.
• Pipeline advancement: Regeneron reported positive late-stage data across six programs in immunology, allergy, neurology, and rare diseases. Notably, management is expanding pivotal studies in hematology/oncology, obesity, and thrombosis, presenting multiple near-term growth opportunities.
• Manufacturing and regulatory investments: The company continues to invest heavily in U.S.-based manufacturing infrastructure, including a new filling plant expected to come online next year. This is aimed at mitigating regulatory and supply chain risks highlighted by recent inspection findings and supplementing future product launches.

Drivers of Future Performance

Regeneron’s outlook is shaped by regulatory progress, expanded clinical indications, and continued investment in manufacturing and R&D.

• Key label enhancements pending: Management believes that securing FDA approval for additional EYLEA HD dosing intervals and new indications—such as treatment for retinal vein occlusion—could drive a significant uptick in demand, though regulatory timelines remain uncertain due to ongoing facility reviews.
• Pipeline-driven growth strategy: The company is prioritizing expansion in oncology, hematology, and metabolic diseases. Upcoming pivotal readouts for therapies like Lynozyfic in multiple myeloma and Factor XI antibodies in anticoagulation are expected to diversify and strengthen Regeneron’s commercial portfolio.
• Heightened R&D and manufacturing spend: Regeneron plans a mid-teens percentage increase in R&D expenses in the coming year to support late-stage pipeline development. The company is also finalizing investments in domestic manufacturing to improve control over regulatory processes and supply chain stability.

Catalysts in Upcoming Quarters

In the next few quarters, the StockStory team will be monitoring (1) regulatory decisions on EYLEA HD label enhancements and new filler approvals, (2) clinical milestones and pivotal trial readouts across the company’s hematology, oncology, and metabolic programs, and (3) the pace of commercial adoption for recently launched therapies like Lynozyfic and expanded indications for Dupixent. Effective execution on R&D investment and manufacturing scale-up will also be key.

Regeneron currently trades at $654, up from $584.78 just before the earnings. Is there an opportunity in the stock?The answer lies in our full research report (it’s free for active Edge members).

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