GENFIT Reports First Half-Year 2024 Financial Results and Provides Corporate Update
September 19, 2024
Cash and cash equivalents totaled €61.6 million as of June 30, 2024, excluding the €48.7 million milestone invoiced in June 2024 (received in August 2024) upon first sale of Ipsen’s Iqirvo® (elafibranor) in the U.S. for the treatment of Primary Biliary Cholangitis (PBC)
€59.0 million in revenues, including the €48.7 million milestone invoiced in June 2024
Positive opinion from the European Medicines Agency Committee in July 2024, with final decision on marketing authorization for Iqirvo anticipated in the second half of 2024, clearing the path to an additional €26.5 million milestone payment expected upon Iqirvo’s pricing and reimbursement approval in three European countries
Lille (France), Cambridge (Massachusetts, United States), (Zurich, Switzerland); September 19, 2024 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its first half-year 2024 financial results and provided a corporate update.
Pascal Prigent, CEO of GENFIT, commented:
“The approval of Iqirvo in the United States was a very significant milestone for the entire GENFIT team. We are proud to have developed elafibranor from its initial discovery through late-stage trials and are thrilled to now see it prescribed to U.S. patients. We believe Iqirvo can potentially address a significant unmet need for people living with PBC. Following the positive CHMP opinion in July 2024, we also anticipate a final decision on authorization in Europe by the end of the year.”
Mr. Prigent continued, “We believe the recent approval in the U.S. of Iqirvo demonstrates our robust drug development capabilities and, along with our strong financial position enabled by our partnership with Ipsen, we are well positioned to continue to develop innovative therapies for challenging and underserved liver conditions that are life-threatening.”
I. 1H24 Business highlights1
PBC
Accelerated approval of Ipsen’s Iqirvo®2 (elafibranor) was granted on June 10, 2024 by the U.S. Food and Drug Administration (U.S. FDA), as a first-in-class treatment for PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
Following Ipsen’s commercial launch in the U.S. in June 2024, first royalty invoicing began and a €48.7 million milestone payment was made.
On July 25, 2024, Ipsen announced an “encouraging early start for Iqirvo in the U.S.” and indicated that “50% of Healthcare Professionals surveyed one week post launch were very likely to prescribe Iqirvo”. Ipsen also reported “early positive coverage determinations from commercial and government payer segments”3.
On July 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) issued a positive opinion for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA.