Typically, at major pharmaceutical companies’ earnings conferences, executives talk enthusiastically about new products and tout expectations for blockbusters. But patent defense took center stage during Sanofi’s first quarter presentation.
A big question for the French company is how to overcome Dupixent’s loss of exclusivity (LOE) when the immunology superstar’s intellectual property expires in the United States.
Instead of pointing to pipeline candidates that could fill the void, Sanofi emphasized that it has a “robust defense plan” to extend Dupixent’s exclusivity beyond March 2031, when the U.S. patents protecting Dupixent’s compound expire (PDF).
Sanofi said in an investor presentation that issued patents and pending applications for new formulations could extend Dupixent’s protection until 2045. The FDA first approved the treatment in partnership with Regeneron in 2017.
During the Q&A session, TD Cowen analyst Steve Scala addressed the elephant in the room, asking whether the sudden emphasis on Dupixent’s patent protection had anything to do with increased confidence in the company’s ability to extend the LOE, the timing of the LOE, uncertainty in Sanofi’s pipeline, or changes in the company’s communications strategy related to the start of incoming CEO Belen Garijo’s tenure.
“There is very strong interest from the investor community to understand what will happen with the Dupixent LOE,” said Olivier Charmeil, Sanofi’s acting CEO. “By the way, this was also done in full coordination with our partners. Regeneron also had some communication with JPMorgan on this matter.”
One way Sanofi is seeking to extend Dupixent’s patent protection is by developing a new formulation called Q4 that can extend the time between doses from two weeks to four weeks. A study examining the fourth quarter is expected to begin later this year.
“Right now, we’re focused on the fourth quarter and we’re delivering on that in multiple signals,” Homan Ashrafian, Sanofi’s head of research and development, said on a conference call. “Then we will move forward towards further innovation, but at this point you cannot expect us to actively engage in further innovation.”
The focus on Dupixent’s LOE extension comes after a series of clinical trial setbacks and the departure of CEO Paul Hudson after seven years.
Notable candidates that failed in 2025 included the anti-OX40L ligand antibody amritelimab, which failed in a phase 2 asthma trial. The oral TNF inhibitor valinatunfib was lacking in the mid-stages of psoriasis research. Itepekimab, the IL-33 candidate partnered with Regeneron, failed in one of two Phase 3 trials in COPD.
Sanofi’s first-quarter results highlighted its dependence on Dupixent, with sales (PDF) of 4.17 billion euros ($4.9 billion), up 31% year over year. The figure represented 40% of Sanofi’s sales of 10.51 billion euros ($12.3 billion) in the quarter, and was up 14% from a year earlier.
Dupixent’s sales increased by €690 million ($808 million), while the company’s overall sales increased by €614 million ($719 million).
One positive was the performance of rare disease drugs Aivakit and Artuvio, which generated combined sales of 1.75 billion euros ($2.05 billion). Vaccine sales, on the other hand, rose slightly in constant currency terms, reaching 1.3 billion euros in the same period.
