Regeneron Pharmaceuticals Q1 Earnings Call Highlights

Regeneron Pharmaceuticals NASDAQ: REGN reported what management described as a strong start to 2026, driven by growth in key commercial products, continued pipeline progress, and an updated capital return plan. On the company’s first-quarter earnings call, executives also addressed regulatory timing for EYLEA HD’s prefilled syringe, highlighted clinical and regulatory milestones across multiple programs, and discussed a newly announced Most-Favored-Nation pricing agreement with the U.S. government.

First-quarter performance and key product trends

Board Co-Chair, Co-Founder, President, and CEO Dr. Leonard Schleifer said Regeneron delivered “double-digit growth across both revenues and earnings,” with total revenues up 19% versus the first quarter of 2025 and non-GAAP earnings per share up 15%.

Commercial performance was led by Dupixent, EYLEA HD, and Libtayo:

• Dupixent: Dr. Schleifer reported global Dupixent net sales increased 31% on a constant currency basis to $4.9 billion. Executive Vice President of Commercial Marion McCourt added that Dupixent is now used by “more than 1.4 million patients worldwide” and said growth was seen “across all nine indications,” including newer launches such as COPD, chronic spontaneous urticaria, bullous pemphigoid, and allergic fungal rhinosinusitis.
• EYLEA HD: Dr. Schleifer said U.S. net product sales rose 52% year-over-year to $468 million. McCourt noted combined U.S. net sales for EYLEA HD and EYLEA were $942 million, with EYLEA HD demand rising sequentially by 10% despite typical first-quarter seasonality.
• Libtayo: Dr. Schleifer said global Libtayo net product sales grew 54% to $438 million, driven by uptake in advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer, with “early contributions” from adjuvant CSCC following FDA approval in the fourth quarter of 2025. McCourt characterized the quarter as strong but noted the year-over-year comparison included a prior-year quarter with “some movement in the inventory.”

McCourt also pointed to pressure on the legacy EYLEA franchise, with EYLEA U.S. net sales down 36% year-over-year to $473 million, citing conversion to EYLEA HD, competitive pressures, and affordability issues. She said continued inventory absorption is expected to negatively impact second-quarter net product sales by approximately $20 million.

EYLEA HD prefilled syringe regulatory status

Executives spent part of the call addressing the status of EYLEA HD’s prefilled syringe (PFS) manufacturing applications. Dr. Schleifer said the company resubmitted an application seeking FDA approval for filling of the EYLEA HD PFS at Catalent’s Indiana site, where the FDA has conducted a re-inspection.

He added that the FDA did not act by the April 2026 PDUFA date for a separate application for a second contract manufacturer for the PFS, leaving that application pending. “Regeneron and both third-party filling manufacturers are working closely with the FDA to resolve all outstanding issues,” he said, adding the company anticipates “a regulatory decision on one or both applications during this quarter.”

In response to an analyst question on why the FDA missed the April date, Dr. Schleifer said Regeneron had shared what it knew and reiterated expectations for action “on one or both of these during this quarter.”

Pipeline updates: complement, immunology, oncology, and obesity

Board Co-Chair, Co-Founder, President, and Chief Scientific Officer Dr. George Yancopoulos reviewed R&D progress across several programs, with a notable focus on Regeneron’s complement strategy.

Cemdisiran in generalized myasthenia gravis (gMG): Yancopoulos highlighted phase III NIMBLE trial results presented at the American Academy of Neurology and published in The Lancet. Cemdisiran (a C5 siRNA) met the primary and all key secondary endpoints with subcutaneous dosing every 12 weeks, including a 2.3 placebo-adjusted improvement in MG-ADL at week 24. He said efficacy was shown by week two and sustained through week 24, with mostly mild-to-moderate adverse events. The data have been submitted to the FDA, and Regeneron expects “a regulatory decision in the fourth quarter of this year.”

PNH combination approach: In paroxysmal nocturnal hemoglobinuria (PNH), Yancopoulos said phase III lead-in results support combining cemdisiran with pozelimab (Regeneron’s C5 antibody) for complete blockade, and noted enrollment is complete in the registrational-enabling cohort, with results expected “late in the fourth quarter of this year.” He also said Regeneron initiated a first-in-human study of an siRNA targeting complement factor B, aimed initially at patients who remain anemic due to extravascular hemolysis despite optimal C5 therapy.

Geographic atrophy strategy: Yancopoulos said Regeneron expects interim data from an exploratory cohort in its phase III geographic atrophy (GA) program in the fourth quarter of this year, evaluating systemic cemdisiran with or without pozelimab to slow GA lesion growth while aiming to avoid ocular safety issues seen with some approved intravitreal therapies. He also said the company has begun clinical development of an intravitreal pozelimab formulation and plans to follow with a co-formulation of pozelimab with aflibercept.

Dupixent label expansions and next-generation programs: Yancopoulos said Dupixent was approved in the U.S. as the first and only medicine for allergic fungal rhinosinusitis (AFRS) in adults and children six and older, and was approved in the U.S. and Europe for children ages 2–11 with chronic spontaneous urticaria. He also said Regeneron is on track to initiate a first-in-human trial for a long-acting IL-13 antibody by mid-year in healthy volunteers and atopic dermatitis patients, with plans for an expedited path to regulatory approvals.

Oncology programs: Yancopoulos said the phase III fianlimab (LAG-3) plus Libtayo study in metastatic melanoma remains on track, with results expected later in the second quarter. Asked about what would be needed for broad adoption, he said it depends on the progression-free survival results and that the “hope” is to see both PFS and overall survival benefit. He also said Regeneron did not view fianlimab as a potential “game changer” in lung cancer and indicated there is “no negative read-through” from new or unanticipated side effects, according to Dr. Schleifer.

Olatorepatide in obesity and combination with Praluent: Yancopoulos discussed positive phase III results reported by Hansoh in China for olatorepatide, an in-licensed GLP-1/GIP agonist, in a 604-patient trial, citing up to 19% mean weight loss at week 48 and what he described as encouraging gastrointestinal tolerability. He said Regeneron’s phase II obesity study is enrolling rapidly, with plans to initiate two global phase III programs later this year—one in obesity and one in obesity with type 2 diabetes. He also said work continues on an olatorepatide/Praluent combination, with a first clinical study of weekly Praluent “initiating shortly.”

Rare disease milestones and research collaborations

Regeneron highlighted several rare disease developments. Dr. Schleifer said the company recently received FDA approval for Otarmeni for genetic hearing loss and has committed to offering the product for free in the U.S. Yancopoulos described Otarmeni as Regeneron’s first gene therapy approval and referenced The New England Journal of Medicine publication data indicating that nearly half of treated children born profoundly deaf regained hearing at normal levels within one year.

Yancopoulos also said the FDA accepted for priority review the biologics license application for garetosmab, an activin A-blocking antibody for fibrodysplasia ossificans progressiva (FOP), with a PDUFA date in August 2026.

On research infrastructure, Yancopoulos highlighted a collaboration between the Regeneron Genetics Center and TriNetX to access de-identified electronic health record data representing 300 million patients, as well as a strategic collaboration with Telix to co-develop and co-commercialize radiopharmaceutical therapies.

Financial details, capital allocation, and updated guidance

Executive Vice President and CFO Christopher Fenimore said total revenues rose 19% year-over-year to $3.6 billion, while first-quarter diluted net income per share grew 15% to $9.47 on net income of $1.0 billion (non-GAAP measures unless otherwise noted).

Fenimore said Sanofi collaboration revenue totaled $1.6 billion in the quarter, including $1.5 billion tied to Regeneron’s share of collaboration profits, which grew 42% driven by Dupixent sales growth and improved margins. He said Regeneron expects the Sanofi development balance to be fully repaid by the end of the second quarter, which would cause collaboration revenue to “step up” starting in the third quarter as Regeneron receives its full share of profits.

He also said Regeneron generated $848 million in free cash flow and ended the quarter with $15.8 billion in cash and marketable securities less debt. The company repurchased $800 million of shares during the quarter and announced a new $3 billion share repurchase authorization, leaving approximately $3.4 billion available for repurchases as of the call.

On manufacturing, Fenimore said GAAP gross margin was 76%, negatively impacted by costs incurred from a temporary interruption in bulk manufacturing at the company’s Limerick, Ireland site. He said production has resumed initially and is expected to return to full production by the end of the second quarter; the interruption has not impacted and is not expected to impact product availability.

Fenimore said Regeneron made “minor changes” to 2026 guidance, including updating GAAP gross margin guidance to 77%–78% due to the manufacturing interruption.

Separately, Dr. Schleifer said Regeneron recently entered into a Most-Favored-Nation pricing agreement with the U.S. government, describing it as aligned with goals including “timely and affordable access” while “preserving innovation.”

About Regeneron Pharmaceuticals NASDAQ: REGN

Regeneron Pharmaceuticals, Inc NASDAQ: REGN is a U.S.-based biotechnology company founded in 1988 and headquartered in Tarrytown, New York. It focuses on discovering, developing, manufacturing and commercializing medicines for serious medical conditions. The company combines laboratory research, clinical development and in-house manufacturing to advance a pipeline of biologic therapies across multiple therapeutic areas.

Regeneron is known for its proprietary drug discovery technologies, including its VelocImmune platform, which is used to generate fully human monoclonal antibodies.

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