A series of label expansions for Sanofi and Regeneron’s Dupixent, including its key 2024 FDA approval to treat chronic obstructive pulmonary disorder (COPD), has given the IL-4/13 monoclonal antibody a second wind, as its growth rate increased again in the second quarter.
In the period, worldwide Dupixent sales reached $6 billion for the first time thanks to a 38% increase. It is the largest year-over-year quarterly gain for Dupixent since the fourth quarter of 2022 and a significant reversal from five quarters ago when its growth rate had dipped to 16%.
Regeneron’s cut from the Dupixent sales boom was $2.11 billion in the quarter, which topped analysts’ consensus by $358 million, according to Citi. The sales splurge fueled a 17% group-wide revenue increase, which was Regeneron’s largest for a quarter since the pandemic when its immunotherapy REGEN-COV had a sudden surge in the market.
“Demand trends across all approved indications remain robust and accounted for a majority of the year-over-year growth,” Regeneron CEO Len Schleifer said in a conference call. “We and Sanofi continue to see a long runway for Dupixent growth driven by further penetration of existing indications, expansion into additional age groups and international growth opportunities.”
Regeneron does expect Dupixent’s global sales growth to “moderate” in the second half of this year “as we annualize recent indicational launches and face stronger prior year comparisons,” chief commercial officer Marion McCourt added.
Regeneron also reported that it has repaid its Sanofi development balance of $3.1 billion. The collaboration deal was amended in 2022 as part of its transaction to acquire full rights to cancer drug Libtayo from the French company.
“That amendment accelerated repayment of the balance, which further reduced our share of collaboration profits as it was paid down,” Regeneron chief financial officer Chris Fenimore said. “The repayment lowered our reported Sanofi collaboration revenue by approximately $930 million in 2025 and $530 million in the first half of this year.”
Regeneron’s cut from the collaboration will “step up” in the future, Fenimore added, as the company now is able to collect its full share from the agreement.
Schleifer added that the company has had “productive early discussions,” with new Sanofi CEO Belen Garijo to expand their collaboration “on further assets where some of those assets might be best honed in the Dupixent portfolio.”
“What we want to capture [is] the joint, learned capabilities and experience in developing and commercializing Dupixent,” Schleifer said. “When we first partnered with Sanofi—it has to be a couple of decades ago—we were quite a different company. The rules of the game were a little bit different, so we have to get together and be open-minded.”
With Sanofi's new CEO, Schleifer said Regeneron hopes to establish a relationship that “reflects where the companies are now.”
Regeneron also reported a major gain for Eylea HD with sales reaching $596 million, for a 52% gain, topping consensus by $69 million. But Citi noted that the increase was accompanied by a 45% decline in sales of the original version of Eylea, producing a 12% sales decrease for the franchise year over year. The positive note, however, is that total Eylea sales increased sequentially from $941 million in the first quarter to $1.01 billion in the second quarter.