Regeneron Pharmaceuticals NASDAQ: REGN executives outlined plans for continued growth across its commercial portfolio, upcoming regulatory milestones and pipeline programs during a Wells Fargo investor conference appearance.
Ryan Crowe, senior vice president of investor relations and strategic analysis, said the company’s second-quarter financial performance featured double-digit top- and bottom-line growth, supported by commercial execution across EYLEA HD, DUPIXENT and LIBTAYO. He said each of those products reached all-time quarterly sales highs during the period.
Crowe also said Regeneron had completed repayment of its Sanofi development balance at the end of the second quarter. As a result, the company will record its full share of profits from DUPIXENT and KEVZARA within Sanofi collaboration revenue going forward.
Pipeline catalysts expected through 2026
The company highlighted several anticipated milestones for the remainder of 2026, including a November PDUFA date for cemdisiran monotherapy in generalized myasthenia gravis. Crowe described the condition as a large and growing market and said Regeneron believes its product could be differentiated. The company is also expecting pivotal data in paroxysmal nocturnal hemoglobinuria for pozelimab plus cemdisiran versus eculizumab, marketed as SOLIRIS.
In geographic atrophy, Regeneron expects an interim readout evaluating pozelimab plus cemdisiran and cemdisiran monotherapy. Crowe said the data could help determine next steps for the program, including pivotal-trial powering and whether fewer treatment arms may be needed.
Other expected developments include early data from metabolic programs in MASH and postural orthostatic tachycardia syndrome, or POTS, as well as the initiation of pivotal studies for olatorepatide in obesity and type 2 diabetes. Regeneron in-licensed olatorepatide from Hansoh in 2025 and holds global rights outside China.
Crowe said the company sees additional opportunity in its C5 franchise, its BCMA bispecific linvoseltamab, Factor XI anticoagulation programs and its genetics database. He said Regeneron has spent 12 years building a genetics database linked to electronic health records and is adding proteomics data to support target discovery and disease management.
EYLEA HD gains momentum as prefilled syringe decision nears
Marion McCourt, executive vice president and head of commercial, said EYLEA HD’s performance benefited from label enhancements that included every-four-week dosing, the retinal vein occlusion indication and durability data supporting dosing intervals of up to 20 weeks.
McCourt said physician experience with EYLEA HD has been positive, with physicians viewing the product as having strong durability across indications. She said retinal vein occlusion represents about 20% of the market and that the company has seen substantial switching from EYLEA to EYLEA HD in that segment. She added that EYLEA HD is receiving more switches than other products across the anti-VEGF category, while also gaining treatment-naive patients.
According to McCourt, EYLEA HD represented 60% of Regeneron’s total EYLEA franchise sales in the second quarter, up from about 50% in the preceding quarter. She said EYLEA HD was the fastest-growing innovative branded product in its category.
Regeneron continues to target approval of an EYLEA HD prefilled syringe by year-end. Crowe said the company is working with multiple contract manufacturers to address FDA-identified facility issues, rather than issues involving the product itself. He said approval remains possible by the end of the year at one or more manufacturing organizations.
Executives acknowledged expected competition from additional biosimilars to EYLEA 2 mg but emphasized that EYLEA HD’s durability profile differentiates it from the 2 mg aflibercept segment. Crowe said patients who move to biosimilar aflibercept could remain potential candidates for EYLEA HD over time.
DUPIXENT growth and Sanofi collaboration
McCourt said DUPIXENT has reached a $24 billion annualized revenue run rate and remains underpenetrated across its indications. She said atopic dermatitis represents roughly half of the product’s patient population, while other growth opportunities include biologic asthma, COPD, eosinophilic esophagitis, chronic spontaneous urticaria, chronic rhinosinusitis and bullous pemphigoid.
McCourt said DUPIXENT’s safety profile, use across multiple type 2 inflammatory diseases and applicability among patients with comorbidities remain key differentiators. She said more than 1.5 million patients have been treated with the drug.
On competition from longer-acting therapies, McCourt said Regeneron is preparing commercial and medical teams to discuss competing products but believes DUPIXENT benefits from its established safety record, payer coverage, ease of use and patient experience. She added that new entrants can also raise awareness and encourage patients to seek treatment.
Regeneron is also discussing a potential expansion of its collaboration with Sanofi beyond DUPIXENT. Crowe said the companies are approaching discussions with “open minds, mutual respect, and a reset of the relationship,” though he said it was too early to predict timing or terms.
The company is advancing several long-acting antibodies targeting the IL-4/IL-13 pathway. Crowe said a Regeneron-owned long-acting IL-13 antibody is being tested in healthy volunteers and could potentially enter Phase III as early as late 2027 or early 2028. He said advancing a long-acting IL-4 receptor alpha program into the clinic would require discussion with Sanofi because that receptor is covered by the existing collaboration.
Commercial preparation for new markets
McCourt said Regeneron is building a neurology business unit ahead of a potential cemdisiran launch in generalized myasthenia gravis. She said the company has added internal and external talent with neurology experience and expects its field organization to be launch-ready ahead of the November PDUFA date.
In obesity, Crowe said Regeneron is developing olatorepatide as a potential backbone therapy and is pursuing a co-formulation with PRALUENT. The company is running a study of weekly PRALUENT dosing, which would be needed for co-administration with the weekly obesity therapy. Crowe said Regeneron believes it will need to offer more than marginal weight-loss differences to compete, pointing to potential gastrointestinal tolerability benefits and LDL reduction as possible sources of differentiation.
Finally, Crowe said Regeneron remains active in evaluating business-development opportunities but will maintain its discipline on price. Internal investment remains the company’s capital-allocation priority, he said, while its balance sheet provides flexibility to pursue deals that can benefit from Regeneron’s development, commercialization, genetics and manufacturing capabilities.
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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