GENFIT to Receive $20M Milestone as Iqirvo 2025 Sales Top $200M

GENFIT will receive a $20 million commercial milestone payment after Ipsen reported $208 million in full-year 2025 net sales of Iqirvo in primary biliary cholangitis, surpassing the $200 million threshold set out in the companies’ 2021 licensing agreement. GENFIT said the sales performance also unlocked a €30 million instalment under its separate royalty-financing deal with HealthCare Royalty, a non-dilutive arrangement backed by a portion of the royalties it is entitled to receive on Iqirvo sales.

Iqirvo, the brand name for elafibranor, is a once-daily oral treatment for primary biliary cholangitis, a rare autoimmune liver disease. The drug was developed by GENFIT, which granted Ipsen global development and commercialization rights in 2021. Ipsen now manufactures and markets the product worldwide, while GENFIT remains eligible for milestone payments and royalties tied to its sales performance.

In return for the worldwide right to develop, manufacture and commercialize elafibranor, GENFIT is eligible for a package of payments that includes upfront cash, €120 million when the deal closed, regulatory and commercial milestones, and tiered royalties that can reach up to 20% of net sales. Since its deal with HealthCare Royalty in January 2025, the royalties have been partially encumbered under a royalty financing agreement through which the company raised up to €185 million in non-dilutive capital, including €130 million upfront and up to €55 million in two additional instalments tied to near-term sales thresholds for Iqirvo, including the €30 million GENFIT announced.

Rather than paying interest, GENFIT agreed that HealthCare Royalty would receive a defined portion of the royalties it earns from Ipsen on global Iqirvo sales. Those royalty payments began accruing from October 2024 and are subject to a capped return structure. HealthCare Royalty will continue receiving its share of royalties until it reaches a predefined return, initially set at 155% of the total subscribed amount, with step-ups if that return is not achieved by specified dates, and a final long-stop date of March 2045 applies regardless of performance.

Milestone payments from Ipsen, including the $20 million triggered this week, are not part of the pledged royalty stream and remain fully payable to GENFIT. GENFIT positioned the deal as a way to extend its cash runway and fund its liver-disease pipeline while avoiding an equity raise, and also linked it to resolving its convertible debt overhang.

As Iqirvo was approved in June 2024, 2025 was the first full commercial year for the treatment, after Ipsen launched it in primary biliary cholangitis following FDA accelerated approval and subsequent European authorisation later that year. GENFIT said Ipsen has confirmed plans to launch a global phase 3 trial in primary sclerosing cholangitis, an indication where no approved drug therapies currently exist, and liver transplantation remains the only option that clearly changes prognosis.

GENFIT has been repositioning around acute-on-chronic liver failure and related complications. Within that pipeline, GENFIT’s lead programme is G1090N, a reformulated version of nitazoxanide, and the company has said it expects the first acute-on-chronic liver failure patients to be enrolled in a phase 2 study in the second half of 2026. The company’s broader acute-on-chronic liver failure portfolio also includes SRT-015, CLM-022, and VS-02-HE.