VEGF (NIH)

Regeneron's U.S. sales for macular degeneration treatment Eylea fell from $6.3 billion in 2022 to $5.9 billion in 2023, as Roche's Vabysmo has quickly become a powerhouse in the indication. One day after Roche said it was starting to establish Vabysmo as the new standard of care in age-related macular degeneration (AMD) and diabetic macular edema (DME), Regeneron clapped back with the same claim about its new treatment—high-dose Eylea.   “We continue to see physicians prescribe Eylea HD in both treatment experienced and treatment naïve settings as Eylea HD is increasingly recognized as the new standard of care,” Marion McCourt, Regeneron’s commercial chief, said as the company presented its fourth-quarter and 2023 earnings. Eylea HD is Regeneron’s response to Vabysmo, which hit the market in the first quarter of 2022 as a game-changing, longer-acting treatment. Vabysmo allowed many patients to reduce dosing from six times a year—with Regeneron’s original version of Eylea—to three times a year. Vabysmo has been an immediate hit as illustrated by Roche’s sales figures, which were presented on Thursday. In its first full year on the market, the VEGF and Ang-2 inhibitor generated sales of 2.36 billion Swiss francs ($2.7 billion). Meanwhile, U.S. sales of Regeneron’s Eylea franchise have taken a hit, falling from $6.3 billion in 2022 to $5.9 billion last year. Eylea HD—which matches the duration of Vabysmo and was approved in August—accounted for $166 million in sales over the last four months of 2023. On Friday, McCourt said that more than two-thirds of eligible patients are covered to receive Eylea HD, but the company doesn’t expect a significant sales surge in the first quarter of this year because its recently approved permanent J-code will not kick in until April 1, allowing for more ready access to the treatment. J-codes are part of an identifying system that allows pharmacies, hospitals and physicians to bill for medications. Roche’s numbers indicate that Eylea HD has not slowed the momentum for Vabysmo. On Thursday, the Swiss company said it now has a 22% market share in AMD and a 15% share in DME, both up three percentage points since August. Additionally, nearly half of all patients who are starting on Vabysmo are new to any treatment, which is up from a percentage range in the teens at the beginning of 2023. This statistic backs Roche’s claim that Vabysmo is becoming the new standard of care, according to the company’s new pharma chief Teresa Graham. Regeneron is answering with clinical results, which indicate Eylea HD can extend the dosing interval for many patients beyond every four months, and from strong early reports from physicians.   “The experience in the market to date with Eylea HD has been very favorable for physicians and that is probably the most important differentiating characteristic of the product,” McCourt said. Regeneron has no such concerns with its bell cow Sanofi-partnered Dupixent, which saw sales up 31% to $3.22 billion in the fourth quarter and up 33% over the year to $11.6 billion. The company anxiously awaits an FDA decision on Dupixent to expand its label to treat COPD. “Dupixent led in new-to-brand prescription share in the United States across all five of its approved indications,” said Regeneron CEO Len Schleifer. The metric is a key indicator pointing to future growth. Regeneron’s revenue for the fourth quarter came in at $3.43 billion, which topped consensus estimates comfortably and was a 1% bump sequentially. Excluding sales of its COVID-19 antibody cocktail REGEN-COV, it was a 14% increase year over year. For the full year, Regeneron scored $13.1 billion in revenue, up 8%. The company did not provide a revenue estimate for 2024. Cancer drug Libtayo routed consensus estimates with a $244 million haul in the fourth quarter, which was up 44%. For the year, Libtayo was up 50% to $869 million.