Regeneron hauled in $3.6 billion during the first quarter of 2026, as analysts homed in on a slight Eylea HD miss and key upcoming readouts, including for LAG3 candidate fianlimab in metastatic melanoma.
It was mostly upside in the first quarter for Regeneron, which brought in $3.6 billion in revenue—a 19% increase over Q1 last year—driven largely by blockbusters Dupixent and Eylea. The company’s earnings report also comes less than a week after the groundbreaking approval of hearing loss gene therapy Otarmeni.
“This was an incredibly meaningful moment for the company,” Regeneron Chief Scientific Officer George Yancopoulos said during a call with investors Wednesday morning, “as it is not only our first gene therapy approval, [it is] one of the most striking successes with gene therapy in history, restoring for the first time a sensory function in humans.”
Regeneron surprised many across biopharma when it announced that Otarmeni would be made available to U.S. patients free of charge.
“While this may seem like an unconventional decision, we believe it’s the right one for Regeneron, and it reflects the ethos that we live by, pushing the boundaries of science to benefit humanity,” CEO Leonard Schleifer said during the investor call.
Also on the rare disease front, Regeneron executives highlighted the FDA’s February acceptance of a biologics license application (BLA) for garetosmab in fibrodysplasia ossificans progressiva (FOP). The FDA has assigned a target action date in August 2026.
“If approved, garatocymed would become the first and only available treatment shown to prevent abnormal bone formation in FOP patients,” Yancopoulos told investors.
A regulatory application is also under review in the EU.
Elsewhere in the development pipeline, analysts homed in on LAG3 candidate fianlimab. Regeneron continues to expect results from a Phase 3 study of the candidate combined with Libtayo vs. Merck’s Keytruda in first-line metastatic melanoma in the second quarter of this year, according to its earnings press release.
RBC Capital Markets analysts, in a Wednesday morning note, said they “believe results should show indications of a differentiated or superior profile vs. [Bristol Myers Squibb’s] Opdualag,” though they added that the addressable opportunity is “relatively modest in our view.” Opdualag—which comprises BMS’s PD-1 blockbuster Opdivo and anti-LAG3 relatlimab—won FDA approval in March 2022 in metastatic melanoma as the first LAG-3-blocking antibody combination.
Regeneron had also been studying fianlimab in combination with Libtayo in a Phase 2 trial for non-small cell lung cancer (NSCLC). However, data from this trial did not support the combo’s advancement to Phase 3, Regeneron reported Wednesday. This is not surprising, Leerink Partners said in a morning note, “given historically disappointing LAG3 results in NSCLC.”
RBC agreed that “expectations were low . . . and impact to shares should be limited.”
The blockbusters
As for the moneymakers, inflammation and immunology superstar Dupixent and retinal blockbuster Eylea led Regeneron’s first quarter haul. Global sales of Sanofi-partnered Dupixent, which recently snagged another approval for children aged 2 to 11 years with chronic spontaneous urticaria, increased 33% year-over-year to $4.9 billion, while U.S. sales of Eylea were up 52% to $468 million.
Meanwhile, sales of Eylea HD, the high-dose version of the retinal disease drug, disappointed with $468 million for Q1, coming in just under Wall Street’s estimate of $476 million, according to RBC, and further off the firm’s more generous estimate of $502 million. Total sales of the franchise—made up of Eylea and Eylea HD—decreased 10% to $941 million.
RBC analysts attributed Eylea HD’s miss to slightly higher sequential physician demand for the therapy than expected. Regeneron reiterated this theory in its press release, saying that sales of Eylea HD were “negatively impacted by lower wholesaler inventory levels at the end of the first quarter of 2026 compared to the end of the fourth quarter of 2025.”
Addressing a question about life-cycle expansion efforts within the Sanofi collaboration, Schleifer took the opportunity to welcome his new counterpart Belén Garijo, who took over as CEO of Sanofi this week after Paul Hudson was let go in February. Schleifer said he looks forward to conversations in the coming weeks and months regarding further opportunities for Dupixent.
Schleifer also thanked Hudson “for all the work he did on Dupixent since 2019” and wished him luck in his next chapter.
