Regeneron Pharmaceuticals ((REGN)) has held its Q3 earnings call. Read on for the main highlights of the call.
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Regeneron Pharmaceuticals’ recent earnings call painted a picture of a company experiencing robust growth in key areas, yet facing some operational challenges. The sentiment was largely positive, with strong sales growth in products like Dupixent and Libtayo, and significant progress in their R&D pipeline. However, issues such as affordability challenges for EYLEA and FDA-related setbacks highlighted areas needing attention. Overall, Regeneron maintains a strong financial position and a commitment to innovation.
Dupixent Sales Growth
Dupixent continues to be a standout performer for Regeneron, with worldwide net product sales increasing by 26% compared to the third quarter of last year. In the U.S., the growth was even more pronounced at 28%, underscoring the drug’s strong market presence and demand.
Libtayo Sales and FDA Approval
Libtayo also showed impressive growth, with global net product sales reaching $365 million, marking a 24% increase on a constant currency basis. This growth was further supported by the FDA’s approval of Libtayo for high-risk adjuvant cutaneous squamous cell carcinoma, opening new avenues for market expansion.
EYLEA HD Performance
EYLEA HD achieved an all-time high in the U.S., with net product sales growing by 10% to $431 million. This performance highlights the drug’s continued relevance and acceptance in the market, despite some challenges.
R&D Pipeline Progress
Regeneron reported positive Phase III or registration-enabling data for six distinct programs across immunology, neurology, allergy, and rare diseases. This progress underscores the company’s commitment to advancing its R&D pipeline and bringing innovative treatments to market.
Regeneron’s Financial Strength
The company demonstrated strong financial health, generating $3.2 billion in free cash flow through the first nine months of 2025. With cash and marketable securities less debt of approximately $16 billion, Regeneron is well-positioned to invest in future growth opportunities.
EYLEA Affordability Issues
Despite its strong performance, EYLEA faces affordability challenges that have dampened growth in the branded anti-VEGF category. The EYLEA match program received less than $1 million in donations, highlighting the need for strategies to address these affordability issues.
FDA Complete Response Letter for EYLEA HD
Regeneron encountered a setback with the FDA issuing a complete response letter for the prefilled syringe supplemental BLA, due to unresolved inspection findings at Catalent. This highlights the operational hurdles the company needs to overcome.
EYLEA U.S. Sales Decline
EYLEA’s third-quarter U.S. net sales saw a 10% decline quarter-over-quarter, reflecting a decrease in unit demand. This decline indicates a need for strategic adjustments to regain momentum in the U.S. market.
Forward-Looking Guidance
Regeneron provided optimistic guidance for the future, indicating robust growth for several key products. Dupixent’s global net sales reached $4.9 billion, a 26% increase over the previous year. Libtayo’s sales grew by 24% worldwide, supported by its recent FDA approval. EYLEA HD’s U.S. net product sales rose by 10%, with expectations for moderate to high single-digit sequential demand growth in the fourth quarter. The company plans to invest over $7 billion in U.S. manufacturing infrastructure and anticipates a mid-teens percentage increase in R&D spending in 2026.
In conclusion, Regeneron Pharmaceuticals’ earnings call highlighted a strong performance in key areas, with significant sales growth and R&D progress. While the company faces challenges such as affordability issues and FDA-related setbacks, its financial strength and forward-looking strategies position it well for continued success. Investors and stakeholders can remain optimistic about Regeneron’s future prospects.