Regeneron Highlights Dupixent Growth, Cemdisiran Catalysts and EYLEA HD Momentum

Key Points

• Dupixent continues to offer significant growth potential, with low U.S. penetration in atopic dermatitis and expanding demand across nine approved indications, including COPD and chronic spontaneous urticaria. Regeneron and Sanofi are targeting broader global access after Sanofi raised its 2030 sales forecast to €25 billion.
• Cemdisiran has several key catalysts ahead: an FDA decision for myasthenia gravis in November, a Phase III PNH readout in the fourth quarter and an interim geographic atrophy analysis. Regeneron is preparing its neurology commercial infrastructure in case of approval.
• EYLEA HD represented about 60% of combined EYLEA franchise sales in the second quarter, up from 50% in the first, supported by expanded labeling and longer dosing durability. The company expects growing competition from EYLEA biosimilars and continues to monitor patent litigation involving potential 8 mg aflibercept rivals.

Regeneron Pharmaceuticals NASDAQ: REGN outlined growth opportunities for Dupixent, pipeline catalysts for cemdisiran and continued commercial momentum for EYLEA HD during the Morgan Stanley Global Healthcare Conference.

Marion McCourt, Regeneron’s EVP and head of commercial, said Dupixent’s growth opportunity is supported by patient demand across nine approved U.S. indications. While Sanofi independently raised its 2030 Dupixent sales guidance to EUR 25 billion from EUR 22 billion, McCourt said Regeneron shares the ambition to expand access to the therapy globally.

Dupixent Growth Across Indications

Atopic dermatitis remains Dupixent’s largest indication, accounting for about half of total Dupixent net sales, according to McCourt. However, she said the U.S. market has reached only “high teens, maybe 20%” penetration, leaving substantial unmet need.

McCourt said patient adherence has remained high because patients can experience returning symptoms, including itch and lesions, when treatment is interrupted. She also pointed to Dupixent’s potential benefits for patients with multiple type 2 inflammatory diseases, such as atopic dermatitis alongside asthma or chronic rhinosinusitis with nasal polyps.

Beyond atopic dermatitis, McCourt identified COPD as Dupixent’s most successful respiratory launch and said chronic spontaneous urticaria, or CSU, has shown what she described as the company’s second-best trajectory among dermatologists. She also cited eosinophilic esophagitis, bullous pemphigoid and prurigo nodularis as important indications serving patients with previously limited treatment options.

Ryan Crowe, SVP of investor relations and portfolio strategy and intelligence, said Regeneron aims to sustain leadership in immunology and inflammation through a pipeline that includes a long-acting IL-13 antibody, a longer-acting antibody targeting the same receptor as Dupixent, an IL-4 ligand program and an IL-4/IL-13 bispecific candidate. The company also has an undisclosed-target antibody in early development for genetically linked diseases that may include primary biliary cholangitis, systemic lupus, ulcerative colitis and Sjögren’s disease.

Chris Fenimore, Regeneron’s EVP of finance and CFO, said the company continues discussions with Sanofi regarding the future structure of their collaboration. He said both companies are seeking to leverage the value created by Dupixent, though he did not provide timing for a potential update.

Capital Allocation and Business Development

Fenimore said Regeneron remains active in business development and is not limited to platform or early-stage transactions. While the company sees advantages in platforms capable of producing multiple products, it has also evaluated later-stage opportunities, he said.

The company’s decision-making is driven by scientific potential, commercial opportunity, development cost and the speed with which an asset could reach the market, Fenimore said. He added that Regeneron remains disciplined on valuations and is willing to deploy capital when an opportunity meets its criteria.

On shareholder returns, Fenimore said the company does not view its dividend as a major capital-return mechanism or a near- to medium-term dividend-growth story. Regeneron began its dividend program at $0.88 per share in 2025 and increased it to $0.94 per share in 2026, representing annual payouts of roughly $400 million.

The company repurchased approximately $2 billion of shares in the first half of the year, including $1.2 billion in the second quarter, and had $2.5 billion remaining under its authorization. Fenimore said buybacks are valuation-sensitive, with purchases increasing when the stock trades at lower levels.

Cemdisiran Readouts and Launch Planning

Regeneron expects an FDA decision on cemdisiran for myasthenia gravis in November. McCourt said the company has established a neurology business unit and expects to be launch-ready if the product is approved. She highlighted cemdisiran’s every-three-month dosing schedule, as well as its clinical profile, safety and mechanism of action.

Crowe said a Phase III readout in paroxysmal nocturnal hemoglobinuria, or PNH, is expected in the fourth quarter. The study evaluates cemdisiran combined with pozelimab against eculizumab over 26 weeks, with co-primary endpoints of disease control measured by LDH and transfusion avoidance. Both endpoints must be met for the study to be positive.

Also in the fourth quarter, Regeneron expects an interim analysis from its geographic atrophy program. The study is evaluating systemic cemdisiran alone and in combination with pozelimab against placebo. Crowe said the 26-week analysis of the first 225 patients will assess the slope of geographic atrophy lesion size, safety and other endpoints. The results are intended to guide the ongoing 750-patient registrational cohort.

EYLEA HD Uptake and Competition

McCourt said EYLEA HD represented about 60% of combined EYLEA and EYLEA HD franchise net sales in the second quarter, up from roughly 50% in the first quarter. She attributed uptake to label enhancements, including dosing options for retinal vein occlusion and longer durability, which she said provide the broadest label in the anti-VEGF category.

Regeneron expects additional competition and potential pricing pressure from 2 mg EYLEA biosimilars over time. Fenimore said the company continues to expect approval of a prefilled syringe from one or more contract manufacturing organizations by year-end.

Crowe said the timing of potential biosimilars for 8 mg aflibercept is difficult to predict. He noted that patent proceedings involving Alvotech are ongoing, with oral arguments scheduled for Dec. 4 and a Patent Trial and Appeal Board decision expected in early March. Regeneron believes its broader intellectual-property estate will be relevant to any biosimilar launch timing.

McCourt also said linvoseltamab has received encouraging early feedback in heavily pretreated, fourth-line-plus multiple myeloma patients. She said physicians have cited its efficacy, safety, ease of use and lower hospitalization requirements, while emphasizing that additional clinical studies will be important to support potential expansion into earlier treatment lines.

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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