REGN Q2 Deep Dive: New Indications and Pipeline Progress Offset EYLEA Challenges

Biotech company Regeneron (NASDAQ:REGN) reported revenue ahead of Wall Street’s expectations in Q2 CY2025, with sales up 3.6% year on year to $3.68 billion. Its non-GAAP profit of $12.89 per share was 52.9% above analysts’ consensus estimates.

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StockStory’s Take

Regeneron’s second quarter was marked by robust growth in key products, which the company attributed to the strong commercial performance of Dupixent, Libtayo, and the launch of EYLEA HD. CEO Leonard Schleifer highlighted that worldwide net product sales for Dupixent increased by 21% and Libtayo by 25% at constant exchange rates, while EYLEA HD saw a 29% rise in the U.S. compared to the prior year. Management pointed to broad-based demand across new indications and geographies, as well as positive physician uptake for EYLEA HD, as primary drivers of the quarter’s outperformance. However, Schleifer also acknowledged ongoing pressures in the standard EYLEA franchise due to competitive dynamics and affordability issues.

Looking ahead, Regeneron’s outlook is anchored by the expansion of its pipeline and the expectation of further regulatory milestones. Management emphasized anticipated Phase III data readouts for several programs, including myasthenia gravis and advanced melanoma, and upcoming FDA decisions for EYLEA HD label enhancements and Libtayo in high-risk adjuvant use. CFO Christopher Fenimore noted that the company is investing heavily in U.S. manufacturing and R&D, “including a brand-new state-of-the-art fill/finish manufacturing facility,” to support future growth. Management also highlighted the potential for new launches to offset challenges in established products and reiterated a focus on capital returns through share repurchases and dividends.

Key Insights from Management’s Remarks

Management credited the quarter’s performance to Dupixent’s growth across new indications, strong demand for EYLEA HD, and the launch of new oncology and hematology products, while also addressing manufacturing and competition headwinds.

• Dupixent multi-indication strength: Dupixent continued to grow across eight approved diseases, with recent launches in chronic spontaneous urticaria and bullous pemphigoid contributing to expanded addressable markets. Management highlighted positive uptake in these newer indications and the potential to treat over 4 million patients in the U.S.
• EYLEA HD momentum, standard EYLEA decline: EYLEA HD achieved significant physician demand growth, attributed to its clinical profile and dosing convenience. However, standard EYLEA faced declining U.S. sales due to patient affordability issues and increased competition from branded and biosimilar products.
• Libtayo market expansion: Libtayo remained the market leader in advanced non-melanoma skin cancers and gained traction in lung cancer. Management noted preparations for potential FDA approval in high-risk adjuvant cutaneous squamous cell carcinoma, which could expand its use to more than 10,000 patients in the U.S. and EU.
• Lynozyfic launch in hematology: The early launch of Lynozyfic, a BCMA bispecific antibody for relapsed/refractory multiple myeloma, was described as a strategic milestone. Management expects modest near-term revenue with a long-term goal of establishing Lynozyfic as a backbone therapy in a $30 billion global myeloma market.
• Manufacturing and regulatory challenges: The FDA’s inspection of a third-party manufacturing site delayed label enhancements for EYLEA HD and impacted odronextamab’s approval. Management expressed confidence that these were process-related, not structural, and anticipated resolution but recognized short-term uncertainties.

Drivers of Future Performance

Regeneron’s future performance will be shaped by progress in regulatory approvals, new product launches, and the ongoing shift in its commercial portfolio.

• Pipeline milestones and regulatory decisions: Management expects important Phase III data for myasthenia gravis, advanced melanoma, and allergy programs in the coming quarters. The outcome of FDA reviews for EYLEA HD label enhancements and Libtayo’s expanded indication will be key inflection points for future growth.
• Adoption of new launches: The company is prioritizing the launch and market penetration of Lynozyfic and new Dupixent indications. Management believes that rapid uptake in these markets can help offset competitive pressures in established products, particularly EYLEA.
• Manufacturing, pricing, and policy risks: Delays from third-party manufacturing inspections, evolving tariff and pricing policies, and ongoing affordability issues for EYLEA patients are noted as risks. Management stated that current tariff changes are not expected to materially impact 2025 results but could become more relevant in 2026 and beyond.

Catalysts in Upcoming Quarters

In the quarters ahead, the StockStory team will be watching (1) the resolution of FDA review timelines for EYLEA HD and odronextamab, (2) the pace of patient uptake for newly launched indications of Dupixent and Lynozyfic, and (3) progress on pivotal Phase III data for key pipeline programs like myasthenia gravis and advanced melanoma. Continued updates on manufacturing expansion and regulatory developments will also be important factors for monitoring Regeneron’s execution against its growth strategy.

Regeneron currently trades at $555.10, up from $545.34 just before the earnings. In the wake of this quarter, is it a buy or sell? Find out in our full research report (it’s free).

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