Regeneron Highlights EYLEA HD Momentum, Dupixent Growth and Pipeline Catalysts

Key Points

• EYLEA HD is gaining momentum, accounting for roughly 60% of EYLEA franchise sales in the second quarter. Regeneron expects low- to mid-teens sequential demand growth in the third and fourth quarters despite additional biosimilar competition.
• Dupixent and Libtayo continued to post strong growth. Dupixent is annualizing at approximately $24 billion in sales, while Libtayo sales rose more than 30% year over year and strengthened its position in U.S. lung cancer.
• Multiple pipeline catalysts are approaching, including an FDA decision for cemdisiran in generalized myasthenia gravis in November, PNH data in the fourth quarter, and additional readouts in MASH, Factor XI and melanoma. Regeneron also repurchased about $2 billion of stock in the first half of the year.

Regeneron Pharmaceuticals NASDAQ: REGN executives highlighted continued growth across key marketed products, a broad late-stage pipeline and an ongoing focus on science-driven business development during a discussion with Bernstein analyst Jeffrey Walch.

Chris Fenimore, Regeneron’s executive vice president of finance and chief financial officer, said the company delivered double-digit year-over-year growth in both revenue and earnings during the most recent quarter. He said EYLEA HD, Dupixent and Libtayo each reached all-time quarterly net sales.

Fenimore also said Regeneron paid off its Sanofi development balance during the second quarter. That balance had historically affected Regeneron’s share of profits from its collaboration with Sanofi, and its repayment is expected to lift earnings from the collaboration beginning in the third quarter.

EYLEA HD Gains Momentum

Fenimore said EYLEA HD represented roughly 60% of EYLEA franchise net sales in the second quarter. He attributed the product’s performance in part to label enhancements approved in the fourth quarter of 2025, including every-four-week dosing flexibility and an additional retinal vein occlusion indication.

According to Fenimore, the dosing flexibility provided physicians with reimbursement confidence if patients needed more frequent treatment. He added that EYLEA HD was the only innovative brand in its category to gain market share during the second quarter.

Regeneron expects sequential demand growth for EYLEA in the low- to mid-teens percentage range in both the third and fourth quarters, Fenimore said. The company faces additional biosimilar competition in the 2-milligram market, but executives said they remain constructive on EYLEA HD’s ability to grow as physicians gain more real-world experience with the therapy.

Fenimore said physicians switching patients from other products to EYLEA HD have seen treatment intervals extend by close to four weeks on average.

Dupixent and Libtayo Growth

Fenimore described Dupixent, which Regeneron markets in collaboration with Sanofi, as annualizing at roughly $24 billion in sales, including approximately $18 billion in the U.S. He said the product is approved in nine U.S. indications, four of which have achieved blockbuster status.

More than 40% of Dupixent total prescriptions and roughly half of new-brand prescriptions are now outside atopic dermatitis, according to Fenimore. He added that Dupixent is the most prescribed biologic among dermatologists, pulmonologists, allergists and ear, nose and throat specialists.

Ryan Crowe, Regeneron’s senior vice president of investor relations, said the companies hold a U.S. composition-of-matter patent for dupilumab that expires in March 2031. He said the patent expires in Europe in 2033 and Japan in 2034, while additional method-of-treatment, manufacturing and formulation patents extend into the early to mid-2040s.

Regeneron and Sanofi are also in active discussions about expanding their collaboration beyond Dupixent, Fenimore said, though he did not provide details.

For Libtayo, Crowe said sales rose more than 30% year over year in the most recent quarter. In the U.S., about 60% of sales came from cutaneous squamous cell carcinoma and basal cell carcinoma, while non-small cell lung cancer accounted for about 40%.

Crowe said Libtayo is now second in both new-to-brand and total share in U.S. lung cancer, with new-to-brand share exceeding that of Opdivo, Imfinzi and Tecentriq combined. He said Regeneron is preparing for eventual biosimilar competition to Keytruda but believes Libtayo has differentiation in squamous cell lung cancer.

Pipeline Readouts Ahead

Executives outlined several anticipated pipeline events, particularly in Regeneron’s C5 franchise. Crowe said the FDA action date for cemdisiran in generalized myasthenia gravis is in November. Regeneron believes the therapy could offer differentiated efficacy, safety and dosing that would require four administrations annually.

The company also expects registration-enabling data in paroxysmal nocturnal hemoglobinuria, or PNH, during the fourth quarter. The study is evaluating cemdisiran in combination with pozelimab against eculizumab. Crowe said disease control, as measured by lactate dehydrogenase, appears supported by earlier data, though transfusion avoidance could present risk because not all transfusions are caused by intravascular hemolysis.

In geographic atrophy, Regeneron plans an interim assessment of systemic cemdisiran alone and in combination with pozelimab. The company will evaluate whether the treatments slow the progression of geographic lesion size compared with placebo. Crowe cautioned that systemic approaches in geographic atrophy have historically been challenging and noted potential infection risks associated with extensive complement inhibition in an elderly population.

• Regeneron expects to share data later this year from siRNA programs targeting MASH-related liver disease.
• Initial Phase III data from Factor XI studies in venous thromboembolism prevention are expected next year.
• Short-duration Phase II data for its Factor XI program in atrial fibrillation are expected around the middle of next year.
• Data from an adjuvant melanoma study of fianlimab plus Libtayo are expected late this year or in early 2027.

Science, Business Development and Capital Allocation

Fenimore said Regeneron’s development strategy is rooted in its genetics, immunology and antibody-engineering capabilities. The Regeneron Genetics Center has sequenced more than 3 million exomes linked to electronic health records and is expanding into proteomics, he said.

Crowe said Regeneron expects to bring four novel targets discovered or validated by the genetics center into the clinic this year, spanning immunology, ophthalmology and oncology.

On business development, Fenimore said the company evaluates acquisitions and collaborations based primarily on scientific merit, including whether an opportunity adds technology, platforms or assets that complement internal work. He said Regeneron has walked away from opportunities because of underlying data concerns or valuations that did not support the company’s expected risk-adjusted returns.

The company’s capital-allocation priorities include funding its pipeline, pursuing external opportunities, paying dividends and repurchasing shares. Fenimore said Regeneron began a dividend program in 2025 that pays roughly $400 million annually. Crowe said the company repurchased approximately $2 billion of stock in the first half, including $1.2 billion during the second quarter.

About Regeneron Pharmaceuticals (NASDAQ:REGN)

Regeneron Pharmaceuticals, Inc is a biotechnology company that discovers, develops and commercializes medicines for serious medical conditions. The company uses technologies involving genetics, antibodies and other biologic treatments to advance therapies in areas such as eye diseases, allergic and inflammatory conditions, cancer, cardiovascular disease and rare disorders.

Regeneron's marketed medicines include EYLEA and EYLEA HD for retinal diseases, Libtayo for certain cancers, Praluent for cardiovascular disease, Evkeeza for homozygous familial hypercholesterolemia and Veopoz for a rare immune disorder.

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