As Sanofi declares strong early sales for Beyfortus in its second RSV season, the French pharma is confident that it would still come out on top against potential competitor Merck because its antibody has set a “high bar to surpass.”
While the vaccine market has garnered most of the attention in RSV, infant antibodies were in the spotlight last week, when Merck said it is working toward a US approval next year armed with positive registrational data for its antibody contender, clesrovimab.
François-Xavier RogerWhile both prophylactic products are monoclonal antibodies targeting RSV, “they are actually quite different,” Sanofi CFO François-Xavier Roger said during a company earnings call with the media Friday.
With the caveat of cross-trial comparisons, AstraZeneca-partnered Beyfortus reduced medically-attended lower respiratory tract infections from RSV by almost 75% in its registrational study in healthy infants, suggesting “higher efficacy” compared with Merck’s candidate at 60.4%, Roger said. Sanofi’s product also benefits from real-world data in more than 75,000 infants, which show it matches or exceeds efficacy seen in clinical trials, establishing a “high bar to surpass” for Merck, he added.
In Q3, Beyfortus sales were almost 382% higher compared with the same time last year, reaching €645 million ($698 million) and beating analyst consensus estimates of €360 million ($389 million). This quarter’s growth was driven by “early deliveries in the US” and rollout in several new markets, including Canada, France and Germany, according to Sanofi.
Roger said the early Beyfortus orders do not necessarily indicate whether the RSV season will end earlier than usual. Even without the “favorable timing” of early shipment, “we would have stayed with a very attractive level of growth in the quarter,” he added.
In this year’s Q1, the pharma had supply constraints with extremely high demand in its first RSV season on the market. Beyfortus is closing in on blockbuster status, making €845 million ($914 million) in the year to date. Sanofi projects €1.5 million ($1.6 million) in Beyfortus sales this year.
The Q3 sales boost for Beyfortus supported Sanofi’s overall vaccine arm performance, which grew 25% from the same time last year to €3.8 billion ($4.1 billion). The drugmaker’s broader biopharma sales hit €12.2 billion ($13.2 billion), exceeding consensus estimates of €11.4 billion ($12.3 billion).
Beyfortus secured FDA approval in July 2023 and got a unanimous recommendation from the CDC’s vaccine advisory committee one month later for all infants under eight months of age ahead of their first RSV season.
Elsewhere, Sanofi reported that Dupixent did not meet the primary endpoint in a Phase 3 trial in people with uncontrolled and severe chronic itch of unknown origin, although it showed “nominal improvements” in all other endpoints. Sanofi still intends to go ahead with a second Phase 3 trial in the indication as planned.
Editor’s note: This article was updated with more context.