Sanofi's Dupixent puts on another stellar show, and it's still 'at the beginning' of its journey: exec

Five years after its first FDA approval in eczema, Sanofi’s Dupixent is still blazing a trail in inflammatory diseases.

That’s the evaluation of Bill Sibold, Sanofi’s global head of specialty care, after the Regeneron-partnered drug posted a 46% revenue increase in the first quarter to 1.61 billion euros ($1.79 billion), ahead of industry watchers’ expectations.

“We’re still only at the beginning of our journey, with approximately 8% [Dupixent] market penetration in adults” in atopic dermatitis, Sibold said during an investor call Thursday.

Dupixent’s 46% revenue growth at constant currencies marks the largest of a first quarter for the med so far. Sales outside of the U.S. jumped 69%. And the drug’s 38% U.S. increase is “even more impressive,” Sibold said, because less than 90% of physicians’ offices have reopened since the beginning of the pandemic.

Amid competition, there may be some “downward pressure” on Dupixent’s net price in the U.S., but Sibold said, “there is nothing out of the ordinary here.”

Sanofi recently raised Dupixent’s peak sales target to at least 13 billion euros. More than 430,000 patients are now on the IL-4/13 inhibitor across inflammatory disease indications, Sibold said, and the French pharma is planning to add at least 1.5 million eligible patients worldwide by 2025 with new label expansions.

On that front, the FDA recently put Dupixent’s application for eosinophilic esophagitis under priority review, potentially making it the first approved drug for the disorder. Sanofi and Regeneron have also filed the drug for the itch condition prurigo nodularis with U.S. and European regulators.

Meanwhile, competitors are piling into the market. Leo Pharma in December won an FDA go-ahead for IL-13-specific injection Adbry in moderate to severe atopic dermatitis. Eli Lilly just posted what Jefferies analysts called “compelling” phase 3 data for its own IL-13 antibody lebrikizumab, with skin clearance at least on par with Dupixent or better by absolute numbers. In less direct threats to Dupixent, oral JAK inhibitors such as AbbVie’s Rinvoq and Pfizer’s Cibinqo are also entering the ring. But Sanofi is undeterred.

“We believe that the additional treatment options for patients contribute to unlocking significant incremental growth potential for Dupixent through market expansion as well as improved physician and patient awareness,” Sibold said.

“We’ve seen it around the world where competitors have come into the market, it helps to accelerate growth,” he added. “As the product with the best profile, guess who wins?”

In addition to Dupixent as “the foundation and the cornerstone” in type 2 inflammatory diseases, CEO Paul Hudson noted Sanofi currently has 10 molecules in development in the area, including injectables, oral drugs and a topical candidate. Those programs could start to enter the market as early as 2025.

Outside of immunology, Sanofi is trying to catch up in oncology under Hudson’s leadership. The company’s CD38 drug Sarclisa reeled in 65 million euros. In its head-to-head competition against Johnson & Johnson’s Darzalex, Sarclisa expects a delayed key readout in the second half of the year in newly diagnosed multiple myeloma.

Under generic pressure to its top-selling cancer drug Jevtana in Europe, Sanofi’s entire oncology portfolio brought in 244 million euros sales in the first quarter, up 6.8% at unchanged exchange rates.

Overall, Sanofi’s first-quarter haul came in at 9.67 million euros, representing an 8.6% increase at constant currencies.