GENFIT to receive $20M milestone from Ipsen as Iqirvo tops $200M in first full year
French biotech 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 (HCRx), 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 (PBC), 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.
The complex economics behind Iqirvo
The $20 million that GENFIT announced it will receive from Ipsen is only one side of Iqirvo’s economic ties. 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.
However, since its deal with HCRx in January 2025, the royalties have been partially encumbered. Indeed, GENFIT’s separate €30 million instalment is part of a royalty financing agreement with HCRx, under which the company raised up to €185 million in non-dilutive capital. The transaction included €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 today.
Rather than paying interest, GENFIT agreed that HCRx 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. HCRx will continue receiving its share of royalties until it reaches a predefined return, initially set at 155% of the total subscribed amount (approximately €277.5 million), with step-ups if that return is not achieved by specified dates. A final long-stop date of March 2045 applies regardless of performance.
Importantly, 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.
A solid first year for Iqirvo
As Iqirvo was approved in June 2024, 2025 was the first full commercial year for the treatment, after Ipsen launched it in PBC following FDA accelerated approval and subsequent European authorisation later that year. At $208 million in 2025 net sales, the first-year trajectory looks solid for a rare liver disease market.
For context, Intercept’s Ocaliva, another second-line PBC drug, generated $129.2 million in worldwide net sales in 2017, which the company described as its first full year on the U.S. market following FDA approval in 2016. The comparison isn’t perfect, as the different launch periods imply different pricing dynamics and landscape, but it gives a rough sense that Iqirvo’s early uptake is at least in the range of what a successful PBC launch can look like.
And Ipsen is now looking to extend that trajectory beyond PBC. GENFIT said Ipsen has confirmed plans to launch a global phase 3 trial in primary sclerosing cholangitis (PSC), an indication where no approved drug therapies currently exist, and liver transplantation remains the only option that clearly changes prognosis. If the PSC programme ultimately supports approval, GENFIT would be in position to benefit from higher royalty flows but also from additional milestones under the Ipsen agreement.
Where GENFIT is putting the funds
GENFIT has been repositioning around acute-on-chronic liver failure (ACLF) and related complications, and the company has framed both the HCRx royalty financing and the additional liquidity unlocked by Iqirvo’s commercial performance as a way to fund that strategy while extending runway.
Within that ACLF-focused pipeline, GENFIT’s lead programme is G1090N, a reformulated version of nitazoxanide. GENFIT has said it expects the first ACLF patients to be enrolled in a phase 2 study in the second half of 2026, following earlier clinical work that has been generating safety and early signal readouts. The company’s broader ACLF portfolio also includes SRT-015, CLM-022, and VS-02-HE. Notably, in September 2025, GENFIT discontinued its VS-01 programme in ACLF following a serious peritonitis adverse event in the UNVEIL-IT study and redirected development toward urea cycle disorder.
Outside of liver failure, GENFIT continues to advance GNS561 in cholangiocarcinoma, where it is running a phase 1b dose-escalation study combining the compound with a MEK inhibitor. The company said multi-cohort safety/activity readouts and a recommended phase 2 dose remain expected in the first half of 2026.
