- A long-standing partnership between Sanofi and Regeneron is for the first time profitable, thanks to the market success of the companies' anti-inflammation drug Dupixent.
- Global net sales for Dupixent reached $557 million in the second quarter, up 166% from the same period a year prior and about $100 million more than what analysts expected. The drug initially gained U.S. approval in March 2017 as a treatment for eczema, but has since racked up three label expansions that pushed into markets like asthma.
- Along with an earnings presentation, Regeneron announced Tuesday that European regulators approved Dupixent to treat moderate-to-severe eczema in adolescents aged 12 to 17. The big biotech also disclosed that Dupixent achieved the main and secondary goals of a Phase 3 study testing it in children aged 6 to 11 with severe eczema.
Dupixent (dupilumab) hasn't always wowed Wall Street. A little over a year ago, quarterly sales came in lower than analysts' estimates due in part to de-stocking and the effects of patient assistance programs.
Sanofi and Regeneron are seeing greater Dupixent growth now, however, because of a few recent regulatory and clinical victories.
Perhaps most notable: U.S. and European regulators approved the drug as a treatment for certain asthma patients, a valuable indication by analyst forecasts. Investment bank Raymond James modeled $8.4 billion in end-user revenue for Dupixent by 2026, with around 30% coming from asthma patients.
Additionally, the Food and Drug Administration in March approved Dupixent for adolescents 12 to 17 years old with moderate-to-severe eczema who either shouldn't use topical therapies or aren't getting enough disease control from them. Sanofi and Regeneron said the approval expanded Dupixent's eligible patient population by more than 150,000.
That eligible population is poised to grow larger still, with the European approval of Dupixent for adolescent eczema patients and the Phase 3 data supporting a potential approval in children aged 6 to 11.
All told, Dupixent brought in sales of $931 million across the first six months of 2019 and is on its way to annualizing around $2 billion.
Its performance was particularly strong from April through June, which was the first time on a quarterly basis that the antibody collaboration between Sanofi and Regeneron yielded profits. Sanofi didn't expect the partnership, which has spanned 12 years and also generated the cholesterol drug Praluent (alirocumab) and rheumatoid arthritis drug Kevzara (sarilumab), to hit such a milestone until the second half of this year.
The two companies also have a collaboration in immuno-oncology that resulted in the approved drug Libtayo (cemiplimab).
For the second quarter, Regeneron recorded $1.9 billion worth of revenue representing a 20% year-over-year increase. Double-digit growth from its eye medicine Eylea (aflibercept) and triple-digit growth from Dupixent helped to prop up revenue amid stagnant Praluent sales.
As for the Phase 3 data that Regeneron released, 70% of children aged 6 to 11 with severe eczema who received Dupixent every four weeks experienced skin improvement of 75% or greater, compared to 27% for patients in the placebo group. Safety was consistent with previous Dupixent studies of older patients, according to Regeneron.
Shares in the biotech were up 1.6% at market's open Tuesday, though they dipped down to trade at $298 apiece in late-morning trading.