It’s been eight months since Regeneron secured approval for a high-dose version of its powerhouse macular degeneration treatment Eylea in the U.S. So how much impact has souped-up Eylea had on the upward trajectory of Roche’s Vabysmo, which was approved 19 months earlier as a longer-acting challenger?
Not much, according to sales figures released by Roche on Wednesday morning.
In the first quarter of 2024, Vabysmo racked up revenue of 847 million Swiss francs ($927 million), which was up 108% year over year and demolished the analyst consensus of 750 million Swiss francs. It also was a huge leap sequentially from sales of 594 Swiss francs in the fourth quarter of last year.
Regeneron and Bayer have yet to report their first-quarter results. Bayer got high-dose Eylea approved in EU in early January. In February, Regeneron reported that Eylea U.S. sales fell from $6.3 billion in 2022 to $5.9 billion in 2023, with high-dose Eylea accounting for $166 million in sales over the last four months of the year.
Back then, Regeneron also said that it didn’t expect to see a sales surge for Eylea HD in the first quarter because its permanent J-code would not kick in until April 1. J-codes are part of an identifying system that allows pharmacies, hospitals and physicians to bill for medications, and getting it can be an important step for drug reimbursement.
In a conference call on Wednesday, Roche’s pharma CEO Teresa Graham said the company has not seen any sales impact on Vabysmo since the start of this month.
Roche pointed to a network meta-analysis comparing results from seven trials of Vabysmo and Eylea which included more than 5,000 patients and concluded that Vabysmo produced more reduction in central subfield thickness in both age-related macular degeneration (AMD) and diabetic macular edema (DME).
“This analysis adds to the growing body of evidence that Vabysmo’s unique [mechanism of action] leads to the superior anatomical outcomes in the drying of eyes, supporting Vabysmo is the preferred choice for first-line treatment in AMD and DME,” Graham said.
Graham added that real-world data studies that included more than 50,000 Vabysmo patients will validate Vabysmo’s credentials as “a standard of care,” in AMD and DME. The company will present those results next week in Seattle at the Association for Research in Vision and Ophthalmology conference.
Vabysmo continued to grow its market share in the U.S. to 25% in AMD and 18% in DME, which is an increase of 3 percentage points from the previous quarter in both indications, Roche said. Additionally, Vabysmo also has already grabbed an 8% share of the retinal vein occlusion market since the FDA signed off on the label expansion in October of last year.
Roche added that more than 40% of Vabysmo patients are new to eye treatments, compared to a 10% figure for treatment-naïve patients in the first quarter of last year.
The company is targeting Q3 to re-launch wet AMD treatment Susvimo. The medicine approved for use in Susvimo is a customized formulation of ranibizumab, but at a different concentration than what is used for eye injections with Lucentis (ranibizumab injection).
Additionally, in the second half of this year, Roche hopes to file for diabetic macular edema and diabetic retinopathy as new indications for Susvimo which was originally approved in October of 2021 but recalled by the company a year later because of a leakage issue.
Overall, for the first quarter, Roche reported sales of 14.4 billion Swiss francs ($15.8 billion), which was a 6% decline from revenue of 15.3 billion Swiss francs ($16.8 billion) in the first quarter of 2023 and a 2% drop sequentially.
Roche blamed the declines on the loss of revenue from its COVID-19 products but CEO Thomas Schinecker said that those effects will end in the second quarter, setting the company up for a return to revenue growth.
Excluding COVID products, Roche’s sales were up 7% in the quarter, supporting the company’s guidance to mid-single-digit growth in 2024, which the company confirmed on Wednesday.
Roche’s top product, multiple sclerosis treatment Ocreuvus, rang up sales of 1.66 billion Swiss francs ($1.82 billion) in the quarter, good for 8% growth year over year. With an approval expected for its injectable version of Ocrevus, Roche expects a blockbuster-sized bump in sales, “upwards of the $2 billion range,” Graham said.
Making major sales gains in the period were blood cancer treatment Polivy, which was up 70% year-over-year to 387 million Swiss francs ($424 million) and breast cancer drug Phesgo, which increased sales 81% to 249 million Swiss francs ($273 million). Polivy was approved in 2019 and Phesgo made the grade in 2020.