GENFIT, a late-stage biopharmaceutical company focused on rare and life-threatening liver diseases, has announced positive financial results for the full year 2024, marking its transition from a pure R&D organization to a company generating commercial revenues.
The company reported a net profit of €1.5 million for the year ended December 31, 2024, compared to a net loss of €28.9 million in 2023. This significant improvement was driven by revenues of €67.0 million, primarily from a €48.7 million milestone payment following the first commercial sale of Iqirvo® (elafibranor) in the United States and €2.7 million in royalty revenue from subsequent sales.
Commercial Success with Iqirvo® in Primary Biliary Cholangitis
Iqirvo® (elafibranor), GENFIT's first-in-class treatment for Primary Biliary Cholangitis (PBC), received accelerated approval from the U.S. Food and Drug Administration in June 2024. The drug was subsequently approved by the European Commission in September 2024 and the UK's Medicines and Healthcare products Regulatory Agency in October 2024.
Commercialized by GENFIT's partner Ipsen, Iqirvo® is indicated for use in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults who cannot tolerate UDCA. According to Ipsen's reports, the drug is experiencing "accelerated sales growth in the U.S. based on increasing patient uptake from new patients."
Pascal Prigent, CEO of GENFIT, commented: "In 2024 the commercial launch of Iqirvo® by Ipsen marked a major milestone in GENFIT's history as we evolved from a pure R&D company into a company with commercial revenues. This enabled us to considerably strengthen our financial visibility and eliminate our convertible debt overhang, as we pivot decisively towards the advancement of our innovative pipeline in ACLF."
Strengthened Financial Position
GENFIT ended 2024 with cash and cash equivalents of €81.8 million, up from €77.8 million at the end of 2023. In early 2025, the company further strengthened its financial position by completing a non-dilutive royalty financing agreement with HealthCare Royalty (HCRx) for up to €185 million, including an initial payment of €130 million.
The company also successfully repurchased 99% of its outstanding convertible debt, effectively eliminating this financial burden without diluting shareholders. These strategic financial moves have extended GENFIT's cash runway beyond the end of 2027, providing substantial resources to advance its pipeline.
Focus on Acute-on-Chronic Liver Failure (ACLF)
GENFIT has positioned itself as a key player in addressing Acute-on-Chronic Liver Failure (ACLF), a deadly condition with no currently approved treatments. The company is advancing five complementary programs targeting different aspects of this disease:
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VS-01-ACLF: The UNVEIL-IT® Phase 2 trial continued to progress with expanded geographic reach. Data readout is expected in the second half of 2025. A proof-of-concept study was also initiated in Q1 2025 targeting patients with Acute Decompensation (AD) or ACLF grade 1 with hepatic encephalopathy and ascites.
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G1090N (nitazoxanide): New data presented at scientific conferences demonstrated NTZ's ability to protect from stress-induced cell death and alleviate liver damage in preclinical models of ACLF. A proof-of-concept study with a new formulation was initiated in Q1 2025.
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SRT-015: Preclinical analyses showed that intravenous administration of SRT-015 alleviates liver injury and systemic inflammation in disease models of liver failure. The company is working on an improved formulation with a potential first-in-human trial targeted for the second half of 2026.
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CLM-022: New data positioned CLM-022 as a potent inhibitor of NLRP3 inflammasome-mediated pyroptosis with potential for treating acute and inflammatory liver diseases. First in-vivo data showed that one oral administration decreases inflammation and protects against liver injury in mice.
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VS-02-HE: Development continues on this oral formulation designed to act where ammonia is primarily produced, with IND-enabling studies expected to complete in 2025.
Other Pipeline Developments
Beyond ACLF, GENFIT is advancing several other programs:
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GNS561 in Cholangiocarcinoma (CCA): The Phase 1b/2a clinical trial is ongoing with results from Phase 1b expected by the end of 2025. In early 2025, GENFIT completed the acquisition of full intellectual property rights for GNS561 from Genoscience Pharma.
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VS-01-HAC (pediatric indication): Following regulatory feedback, GENFIT is preparing to start a pivotal juvenile toxicology study potentially as early as the second half of 2025.
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Diagnostics: NIS2+® was included in the European clinical practice guidelines for the management of metabolic dysfunction-associated steatotic liver disease (MASLD) as a key tool for detecting at-risk MASH.
Sustainability Commitment
In parallel with its clinical and commercial progress, GENFIT has maintained a strong commitment to sustainability. The company was ranked among the top 5 companies in its sector by Ethifinance (out of 222), retained its Gold Medal status while increasing its score from 74 to 82 in 2024, and maintained its "Prime status" with ISS.
In its recently published 2025 Extra-Financial Performance Report, GENFIT highlighted initiatives including increased engagement with patients through awareness campaigns, accelerated production of educational content on ACLF, and a comprehensive assessment of gender equality in the workplace.
Outlook for 2025
GENFIT expects several key developments in 2025, including:
- Data readouts from the UNVEIL-IT® Phase 2 trial and a proof-of-concept study for VS-01 in the second half of 2025
- Results from studies evaluating the new formulation of nitazoxanide (G1090N) by the end of the year
- Continued advancement of SRT-015, CLM-022, and VS-02-HE programs
- Results from Phase 1b of the GNS561 trial in cholangiocarcinoma by the end of 2025
- Potential receipt of a €26.55 million milestone payment pending a third pricing and reimbursement approval of Iqirvo® in a major European market
With its strengthened financial position and advancing pipeline, GENFIT is well-positioned to continue its transformation from a research-focused organization to a commercial-stage biopharmaceutical company delivering innovative treatments for patients with rare and severe liver diseases.
