GENFIT Reports Strong Revenue, Long Runway Despite Headline Loss

LILLE, FRANCE – April 02, 2026 – French biopharmaceutical company GENFIT S.A. today announced a complex but ultimately promising financial picture for its full-year 2025 results, showcasing the power of its flagship liver disease drug, Iqirvo®, while navigating the high-stakes world of clinical development. The company posted robust revenues of €65.4 million and secured a cash runway extending beyond 2028, yet reported a net loss of €86.0 million.

However, the headline loss masks a story of strategic realignment and underlying operational strength. The figure was heavily skewed by a one-time, non-cash impairment charge of €49.1 million related to a discontinued clinical program and accelerated financial expenses tied to better-than-expected royalty forecasts. When adjusted for these items, the company’s financial footing appears far more solid, reflecting a successful transition toward a commercial-stage enterprise with a sustainable future.

“Iqirvo®’s performance in its first full year of sales, together with encouraging early results from both our oncology and ACLF assets, were very promising signs for GENFIT last year,” said Pascal Prigent, CEO of GENFIT, in a statement. “2026 could be even better and significantly accelerate the Company’s trajectory.”

The Iqirvo Engine Roars to Life

The primary driver of GENFIT’s financial transformation is the stellar market performance of Iqirvo® (elafibranor), which is commercialized by its partner Ipsen for Primary Biliary Cholangitis (PBC). In its first full year on the market, Iqirvo® generated US$208 million in net sales, a figure that triggered a US$20 million commercial milestone payment to GENFIT a full year ahead of schedule.

This robust sales performance, which saw Ipsen capture significant market share in second-line PBC treatment, translated into €21.8 million in royalty revenue and €43.6 million in total milestone payments for GENFIT in 2025. The strong cash flow not only bolstered the company’s balance sheet—which showed cash and equivalents of €101.1 million at year-end—but also unlocked further non-dilutive funding. In January 2026, GENFIT drew an additional €30 million tranche from a royalty-financing agreement with HCRx, further securing its long-term financial stability without impacting shareholders.

The reported net loss of €86.0 million is largely an accounting consequence of this success and strategic prudence. A significant portion stems from a €28.8 million non-cash financial expense related to the royalty financing deal. Because Iqirvo® sales are exceeding expectations, the royalty debt is projected to be repaid faster than anticipated, forcing an acceleration of associated expenses onto the 2025 books. Another major component was a €46.2 million non-cash impairment charge following the decision to halt a clinical trial, a move that de-risks the company’s portfolio and conserves cash for more promising assets.

A Diversified Pipeline for Future Growth

While Iqirvo® in PBC is the current star, GENFIT is aggressively cultivating a deep and diversified pipeline aimed at addressing other severe liver diseases and associated conditions.

One of the most significant opportunities lies in the rapidly expanding market for metabolic dysfunction-associated steatohepatitis (MASH). As new MASH therapies gain regulatory approval and enter the market, the need for scalable, non-invasive diagnostics to identify patients has skyrocketed. GENFIT’s proprietary diagnostic technology, licensed to Labcorp as NASHnext®, is poised to capitalize on this trend. A critical step was achieved in late 2025 when pricing for the test was established by U.S. Medicare and Medicaid, paving the way for broader reimbursement and adoption.

GENFIT and Ipsen are also aiming to expand Iqirvo®’s reach into Primary Sclerosing Cholangitis (PSC), a severe liver disease with no approved therapies. In February 2026, Ipsen initiated ELASCOPE, the first and only global Phase 3 trial for a drug in PSC. Success in this indication, which represents a market opportunity comparable to PBC, would unlock additional milestones and double-digit royalties for GENFIT.

Further down the pipeline, the company is advancing several promising assets:

• Oncology: Encouraging preliminary data from a Phase 1b study is positioning GNS561 as a potential new treatment for a difficult-to-treat cholangiocarcinoma (CCA). The company expects additional data mid-year and plans to initiate a Phase 2 study in the second half of 2026.
• Acute-on-Chronic Liver Failure (ACLF): GENFIT is targeting a Phase 2 trial initiation in the second half of 2026 for its lead asset NTZ, which received Orphan Drug Designation in March 2026 for ACLF. This program targets the systemic immune dysregulation that is a critical driver of this life-threatening condition.

The Biotech Balancing Act: Pivots, Partnerships, and Purpose

GENFIT’s 2025 results also illustrate the strategic agility required to succeed in the biopharmaceutical industry. The company made the difficult but necessary decision to discontinue its VS-01 program in ACLF after a safety signal emerged in a Phase 2 trial. While this resulted in the significant non-cash write-down, the move demonstrated prudent risk management, protecting a fragile patient population and redirecting resources. The asset, however, is not lost; it has been reprioritized for development in Urea Cycle Disorders (UCD), a rare pediatric disease where it has already received a key FDA designation.

The company’s success is also a testament to its partnership model. The 2021 licensing agreement with Ipsen has proven to be a masterstroke, allowing GENFIT to leverage Ipsen’s global commercial infrastructure to maximize Iqirvo®’s market penetration while retaining significant financial upside through royalties and milestones.

Underscoring its commitment to a broader vision, GENFIT achieved B Corp certification at the end of 2025. This internationally recognized standard for social and environmental performance signals a commitment to balancing profit with purpose, a move that resonates with a growing number of investors, partners, and employees who prioritize ethical and sustainable business practices. The certification solidifies the company’s identity as it continues to develop life-changing therapies for patients with rare and life-threatening liver diseases.