Amid a push to win back investor confidence in its R&D trajectory, Sanofi still has significant commercial powder to burn with Dupixent, as illustrated in a third-quarter showing that looked strong by the numbers and lifted the French drugmaker’s share price nearly 4% Friday morning.
The receptivity to the report likely comes as a boon for new CEO Belén Garijo and her fresh pick for R&D chief in Paulo Fontoura, M.D., Ph.D., of Roche, who also made his mark this week with the announcement that the company will wind down wider development on BTK inhibitor tolebrutinib following a limited launch of the multiple sclerosis drug in Germany.
On the whole, Sanofi drove net sales up 14.3% at constant currencies for the third-quarter period to 14.44 billion euros (around $16 billion). Over that same span, Sanofi’s new pharma launches grew revenue more than 41% to hit 1.4 billion euros (nearly $1.6 billion), propped up primarily by hemophilia A med Altuviiio, Ayvakit in gastrointestinal stromal tumors and mastocytosis, and Rezurock, cleared to treat chronic graft-versus-host disease.
Cash cow Dupixent continued to deliver, too, bringing home 5.7 billion euros ($6.4 billion) in sales at close to 35% growth year over year. Though the immunology juggernaut continues to reap billions for Sanofi and its partner Regeneron, the clock is ticking on the drug’s branded exclusivity, and investors have become increasingly restless about Sanofi’s plans to pad the anti-IL-4/13 drug’s eventual tumble over the patent cliff with fresh innovative assets.
Following a string of R&D misses meant to map out Sanofi’s future, CEO Paul Hudson was shown to the exit earlier this year as Sanofi tapped Merck KGaA leader Garijo to helm the ship. Shortly after her arrival, Garijo hired Roche’s Fontoura to replace Hudson-appointed Houman Ashrafian, Ph.D., as head of the French pharma’s R&D wing.
In his opening remarks on Sanofi’s Q3 earnings call, Fontoura compared correcting Sanofi’s R&D engine to treating a chronic disease, with both requiring that attention be paid to “multiple interconnected factors.” At the same time, “there’s no one simple solution,” the new research head admitted.
Amid plans to close its pipeline “gap” with its peers, Fountoura noted that, when it comes to development, “when the evidence supports advancing a program, we invest.” Conversely, “when it doesn’t, we reallocated resources.”
While most of that recent cleanout work has focused on clinical-stage programs, the drive for R&D efficiency has appeared to touch at least one commercial product as well in Cenrifki (tolebrutinib), the BTK inhibitor Sanofi acquired via its 2020 purchase of Principia, back when its R&D arm was still managed by John Reed, M.D., Ph.D.
“Cenrifki has had a limited launch in Germany under a strict risk management program, with encouraging initial feedback,” Fontoura explained on Friday’s call. “But we do not plan to expand this development program.”
The drug won sign-off from European regulators to treat certain patients with secondary progressive multiple sclerosis (SPMS) last summer, and has also picked up clearance in places like Australia and the United Arab Emirates, though tolebrutinib has faced a more checkered regulatory path in the United States.
Sanofi has reported several MS setbacks in the drug’s development program and the FDA ultimately issued a complete response letter to the company in late 2025, citing benefit and safety questions.
A Sanofi spokesperson clarified over email that the company does “not plan to pursue additional regulatory engagement with the FDA on tolebrutinib at this time.”
“However,” the spokesperson said, “the scientific insights and learnings gained from our post-CRL FDA discussions will continue to inform our approach to ongoing and future development programs, including our frexalimab program in MS.”
The Sanofi representative noted the drug is available in Germany as of Oct. 1 under a risk management program and patient support program.
“We will take a measured approach in introducing this innovative, first-in-class medicine for people living with SPMS without relapses,” the spokesperson said, adding that, based on learnings in Germany, “we will decide on the next steps.”
Even as the pressure is no doubt on Sanofi and its leadership to pave the way for a post-Dupixent future, several analysts pointed to the fact that sales momentum doesn’t exactly show signs of stopping soon, flagging the potential for Sanofi to upgrade its expectations for the brand’s last hurrah.
Pointing to the guidance lift on peak Dupixent sales to 25 billion euros that Sanofi telegraphed in its second-quarter report, the pharma’s finance chief François Roger reiterated Friday that “we are very confident about it.”
On whether that estimate is lowballing the med’s potential, Roger told analysts on the call to “be assured that if we can go to beyond that, we are working on it on a daily basis,” but he seemed to suggest that “this is not the right time” to pin even bigger hopes on Dupixent.
“We are conservative,” he said of Sanofi’s projections, noting that the company tries not to over-promise with its financial forecasts.
Across the rest of Sanofi’s business, the company reported a 6.6% jump in vaccine sales to 3.2 billion euros (around $3.6 billion), while R&D expenses reached 1.8 billion euros ($2 billion) for the third quarter, which the company described as “broadly stable.”
On a call with media earlier Friday, Roger elaborated further on Sanofi’s hunger for external innovation, citing an “increased interest in late-stage and commercial medicines in our core disease areas.” Those types of deals, he said, will be complemented with “disciplined built-in acquisitions of early-stage projects.”
While teasing that more details are still to come on Sanofi’s strategy in 2026, Roger signaled a particular interest in “what we call white spaces or moonshots with unmet medical needs.”
Meanwhile, as Sanofi’s commercial engine continues to churn, the French drugmaker is raising its overall guidance for the remainder of the year. The company now expects to grow sales by a low-teen percentage at constant currencies in 2026 versus a previous 10% target for the year.