Sanofi expects RSV antibody to ⁠breach blockbuster status in 2024, even as supply hitch drags on

As Sanofi strives to become a global immunology leader, it's also busy making the most of a crucial immunization rollout with partner AstraZeneca. On both fronts, Sanofi expects to see dividends in 2024.

Last year represented a "pivotal" stretch for the drugmaker, one in which the French pharma largely proved its thesis that it can become a global immunology powerhouse, CEO Paul Hudson said on a call with investors Thursday.

Separately, Sanofi's AZ-partnered respiratory syncytial virus (RSV) antibody Beyfortus pulled down 547 million euros (about $592 million) during its first year on the market, a figure Sanofi expects to roughly double this year.

The partners have been hamstrung on Beyfortus supply since last fall, and it will take plenty more manufacturing work before the antibody is available fully unfettered, execs explained.

“Clearly, Sanofi and AstraZeneca are working very hard to extend [Beyfortus’] manufacturing network,” which includes packaging and filling sites, Sanofi’s vaccine chief Thomas Triomphe explained on the company’s earnings call.

Many of those production lines still need to be cleared by regulatory authorities around the world, he added.

“That’s the work that is ongoing right now in order to be able to completely ‘de-bottleneck’ the supply and have the full supply for season 2025,” Triomphe said.

Supply should increase in 2024, Triomphe stressed, and Sanofi still expects Beyfortus to breach the blockbuster threshold ($1 billion) this year. While Sanofi expects some RSV sales in the first half of 2024, the third and fourth quarters will be “key” for Beyfortus revenues this year, Triomphe said.

So far, Beyfortus' uptake in the U.S. has surpassed previous childhood immunization benchmarks, such as those for rotavirus and pneumococcal disease, according to the company. Sanofi has successfully delivered its antibody to a “broad infant population,” reaching some 35% of young patients in the U.S. and France and a whopping 90% in Spain, Triomphe said.

On the flip side, Sanofi’s influenza vaccine business was down 4%, clocking 741 million euros ($802 million) last year, courtesy of dropping immunization rates and increased competition in the U.S., Triomphe explained.

All told, the immunization arm of Sanofi snared 2 billion euros ($2.2 billion) for the latest 12-month period, an 8.3% increase.

Elsewhere, Sanofi's Regeneron-partnered immunology superstar Dupixent was no slouch last year, either. The drug generated around 10.7 billion euros ($11.6 billion) in 2023, growing 34% across the globe.

For 2024, Sanofi expects Dupixent to bring home roughly 13 billion euros in sales, with much of that boost being driven by an expected approval and launch in chronic obstructive pulmonary disease during the second half of the year.

Sanofi is becoming a “launch engine,” Hudson said. In fact, Sanofi’s new roster of drugs Beyfortus, Altuviiio and Tzield reeled in an impressive 731 million euros for all of last year, which “exceeded” the company’s expectations, according to the CEO.

Besides its launch efforts, Sanofi is rolling out a series of savings initiatives in a bid to save upward of 2 billion euros from 2024 to the end of 2025. The company will implement measures such as pipeline reallocation, "smart spending" and changes to country setups.

Beyond Dupixent’s 13 billion euro sales goal, Sanofi expects vaccine sales writ large to grow in the mid single digits this year. In contrast, the company is expecting to take a hit in the first half of 2024 thanks to Aubagio’s loss of exclusivity. That drug’s plunge off the patent cliff represents Sanofi’s “last major [loss of exclusivity]” for the rest of the decade, Hudson said.

Overall, Sanofi’s full-year sales for 2024 clocked in at 43.07 billion euros, growing 5.3% over the sum the company generated in 2023.