Regeneron Pharmaceuticals (NASDAQ:REGN) reported second-quarter revenue growth of 17% from a year earlier to $4.3 billion, supported by continued strength in Dupixent, EYLEA HD and Libtayo. Non-GAAP diluted earnings per share rose 11% to $14.29, while non-GAAP net income reached $1.5 billion.
Chief Executive Officer Leonard Schleifer said the company delivered its second consecutive quarter of double-digit growth in both revenue and earnings. He also noted the death of longtime Regeneron director Arthur “Art” Ryan, describing him as a trusted adviser who served on the board for more than two decades.
Commercial brands set quarterly highs
Marion McCourt, executive vice president of commercial, said more than 1.5 million patients are actively treated with Dupixent globally. The company expects global sales growth to remain strong in the second half, though growth is expected to moderate compared with the first half as the business annualizes recent indication launches and faces more difficult prior-year comparisons.
Regeneron and Sanofi have begun early discussions about potentially expanding their nearly two-decade collaboration to include additional Dupixent follow-on programs. Schleifer said any arrangement would need to reflect the companies’ current positions and combine their accumulated development and commercialization experience.
EYLEA HD U.S. net sales increased 52% year over year and 27% sequentially to $596 million. For the first time, EYLEA HD sales exceeded sales of the original Eylea, which generated $412 million in U.S. net sales, down 45% from a year earlier as patients converted to the higher-dose product and competition increased.
EYLEA HD accounted for roughly 60% of U.S. retinal-franchise sales during the quarter, compared with 34% a year earlier. Regeneron expects low-to-mid-teens sequential demand growth for EYLEA HD in both the third and fourth quarters, while original Eylea demand is expected to decline in the low-to-mid teens amid biosimilar competition.
The company continues to seek FDA approval for an EYLEA HD pre-filled syringe before year-end. Schleifer said Regeneron is working with the FDA and more than two contract manufacturers, adding that the company has had recent discussions that clarified the path forward.
Libtayo global net sales reached $489 million, up 29% on a constant-currency basis. U.S. sales grew 38% to $343 million, reflecting adoption in non-melanoma skin cancers and first-line non-small cell lung cancer. McCourt said Libtayo’s share of U.S. new patient starts in first-line lung cancer has doubled since early 2025 to 20%.
Pipeline milestones ahead
Chief Scientific Officer George Yancopoulos highlighted several expected regulatory and clinical milestones. The FDA has accepted Regeneron’s application for cemdisiran monotherapy in generalized myasthenia gravis, with a target action date in November. The company said the C5-targeting siRNA could offer quarterly subcutaneous dosing if approved.
Regeneron also expects registrational data in the fourth quarter for cemdisiran combined with pozelimab in paroxysmal nocturnal hemoglobinuria. The study compares the regimen with eculizumab using co-primary endpoints of intravascular hemolysis control and transfusion avoidance.
In rare disease, the FDA is expected to decide in August on garetosmab for fibrodysplasia ossificans progressiva. Regeneron said the activin A-blocking antibody could become the first treatment shown to reduce new abnormal bone formation lesions and clinician-assessed flare-ups in patients with the disease.
The company also reported early clinical evidence that its long-acting IL-13 antibody has a prolonged half-life. Regeneron plans to begin dosing atopic dermatitis patients later this quarter and could start registration-enabling studies by late 2027 or early 2028.
- Phase III obesity studies of olatorepatide are expected to begin later this year in obesity and obesity with type 2 diabetes.
- Regeneron plans to present data this fall from siRNA programs for metabolic dysfunction-associated steatohepatitis, or MASH, and from baloncibart in postural orthostatic tachycardia syndrome.
- Pivotal results from Factor XI studies in venous thromboembolism prevention following knee-replacement surgery are expected in the first half of 2027.
- Results from the confirmatory LINKER-MM3 study of linvoseltamab in multiple myeloma are expected next year.
Cash deployment and outlook
Sanofi collaboration revenue reached a record $2.2 billion, including $2 billion from Regeneron’s share of collaboration profits. The company said it has now fully repaid the Sanofi development balance, which had reduced reported collaboration revenue by about $930 million in 2025 and $530 million in the first half of 2026. Beginning in the third quarter, Regeneron expects to record its full share of collaboration profits.
Research and development expense was $1.5 billion, supporting a pipeline of approximately 50 product candidates. The company ended the quarter with $15.1 billion in cash and marketable securities, net of debt, and generated $1.4 billion in free cash flow during the first half.
Regeneron deployed approximately $2.5 billion during the first half on share repurchases, business development and dividends. It repurchased about $2 billion of stock in the first half, including $1.2 billion in the second quarter, and had $2.5 billion remaining under its repurchase authorization as of June 30.
Addressing potential acquisitions, Schleifer said Regeneron is not opposed to mergers and acquisitions but remains disciplined on valuation and strategic fit. “We can do small, we can do large,” he said. “We want them to make sense and make money for our shareholders over the long term.”
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.
