While manufacturing and supply hitches have troubled the rollout of Sanofi’s key respiratory syncytial virus (RSV) drug, the near-term expected approval of a pair of new filling lines is giving the French pharma assurance that its AstraZeneca-partnered antibody Beyfortus can breach the billion-dollar threshold before the year is out.
“We’re confident that Beyfortus will be a blockbuster in 2024,” Thomas Triomphe, Sanofi’s executive vice president of vaccines, said on a call with analysts Thursday.
With the first Beyfortus shipment in the Northern Hemisphere expected to occur in the third quarter, Sanofi figures the last three months of the year will represent the antibody’s biggest sales season, the company’s chief financial officer, François Roger, added on the call.
That fourth-quarter sales boost is likely to come courtesy of both the seasonality of RSV and the expected approval of two new filling lines in September, Roger explained.
Beyfortus, which was approved last summer, delivered 547 million euros for all of 2023. Despite the antibody’s popularity out of the gate, the immunization quickly ran up against supply constraints, with the Centers for Disease Control and Prevention in October urging doctors to prioritize 100-mg doses for infants at the highest risk of RSV disease.
At the time, Sanofi said it was working with AstraZeneca to “accelerate additional supply” and explore “a number of actions” to beef up the partners’ manufacturing network.
Now, Sanofi is “exactly on track” with its plan to activate more filling capacity around September, Triomphe said Thursday.
“We believe that there’s reason to be confident about the accelerated approval process of those lines and the fact that we’ll be able to move forward with this update for the 2024 RSV season,” he said.
The executives’ comments came as Sanofi reported a roughly 10% overall sales increase to 10.75 billion euros (about $11.6 billion) in the second quarter.
Much of that growth was driven by immunology superstar Dupixent, which set a new quarterly record by growing sales 29% to 3.3 billion euros ($3.6 billion) over the second three months of the year. All told, Sanofi continues to expect its immunology stalwart to generate roughly 13 billion euros in 2024, according to an earnings release.
Elsewhere, Sanofi's new pharma launches grew a whopping 80.4%, bringing home total sales of 689 million euros ($746.9 million). That group includes Altuviiio in hemophilia A, Nexviazyme in Pompe disease, Rezurock in graft-versus-host disease and Sarclisa in multiple myeloma.
Meanwhile, Sanofi’s vaccines sales dipped 4.8%, though revenues were overall stable once the effects of 2023’s COVID-19 sales were removed from the equation, CEO Paul Hudson said on the company’s call.
Thanks to its strong performance so far in 2024, Sanofi is upgrading its earnings per share (EPS) guidance, which it now expects to be stable at constant currencies. The company previously expected EPS to decrease by a low single-digit percentage.