GENFIT (Nasdaq and Euronext: GNFT) announced its first half-year 2024 financial results, highlighting significant revenue growth and advancements in its clinical programs. The company's financial upswing is largely attributed to the U.S. approval and commercial launch of Iqirvo (elafibranor), a treatment for Primary Biliary Cholangitis (PBC) developed in partnership with Ipsen.
Financial Highlights
As of June 30, 2024, GENFIT reported €61.6 million in cash and cash equivalents. This figure excludes a substantial €48.7 million milestone payment from Ipsen, invoiced in June 2024 and received in August, triggered by the first sale of Iqirvo in the U.S. Revenues for the first half of the year totaled €59.0 million, significantly higher than the €15.4 million reported in the same period last year. This increase is primarily due to the milestone payment from Ipsen.
Pascal Prigent, CEO of GENFIT, stated, "The approval of Iqirvo in the United States was a very significant milestone for the entire GENFIT team... We believe Iqirvo can potentially address a significant unmet need for people living with PBC."
Iqirvo (Elafibranor) Developments
Iqirvo (elafibranor) received accelerated approval from the U.S. FDA on June 10, 2024, as a first-in-class treatment for PBC in combination with ursodeoxycholic acid (UDCA) for adults with an inadequate response to UDCA, or as a monotherapy for those unable to tolerate UDCA. Ipsen commercially launched Iqirvo in the U.S. in June 2024, leading to the initial royalty invoicing and the €48.7 million milestone payment to GENFIT.
Ipsen reported an "encouraging early start for Iqirvo in the U.S.," noting that 50% of healthcare professionals surveyed one week post-launch were very likely to prescribe it. Positive coverage determinations from commercial and government payers were also reported.
In July 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for Iqirvo for treating PBC. A final decision on marketing authorization in Europe is expected in the second half of 2024, potentially triggering an additional €26.5 million milestone payment upon pricing and reimbursement approval in three European countries.
ACLF Program Update
GENFIT's Acute on-Chronic Liver Failure (ACLF) franchise is progressing, with the Phase 2 UNVEIL-IT trial for VS-01 expanding into the U.S. However, initial recruitment uptake was slower than expected, leading to protocol modifications to better accommodate patient logistics and comorbidities. Preliminary results from the trial are still expected before the end of the year.
Data presented at the EASL congress in June 2024 indicated that VS-01 actively captures metabolites associated with ACLF. Preclinical data also suggested that nitazoxanide (NTZ) protects against stress-induced cell death, alleviating liver damage in ACLF models. A research collaboration with the European Foundation for the Study of Chronic Liver Failure (EF CLIF) was also initiated to enhance understanding of ACLF.
MASH Diagnostics
New European Clinical Practice Guidelines recognized NIS2+ as a key tool for detecting at-risk Metabolic dysfunction-associated steatohepatitis (MASH), highlighting its potential in identifying patients who may benefit from emerging MASH treatments.
Ongoing Research and Development
GENFIT is also advancing its pipeline in other liver diseases, including cholangiocarcinoma (CCA), urea cycle disorder (UCD), and organic acidemia (OA).
