GENFIT Announces Revenues and Cash Position as of December 31, 2023

• Cash and cash equivalents totaled €77.8 million as of December 31, 2023
• Revenues amounted to €28.6 million as of December 31, 2023 including a milestone payment of €13.3 million
• Upcoming FDA PDUFA action date for elafibranor in PBC: June 10, 2024
  
  

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), February 29, 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 cash position as of December 31, 2023 and revenues for 2023.

Cash Position

As of December 31, 2023, the Company’s cash and cash equivalents amounted to €77.8 million compared with €140.2 million as of December 31, 2022. As of September 30, 2023, cash and cash equivalents totaled €93.9 million.

This amount does not include the receipt in February 2024 of a €13.3 million milestone payment from Ipsen, which was invoiced in December 2023, triggered by the acceptance of the New Drug Application (NDA) filing by the US Food and Drug Administration (FDA) and Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for accelerated approval of elafibranor in Primary Biliary Cholangitis (PBC) in December 2023.

As previously indicated in past communications¹, in 2024 GENFIT expects to receive total milestone payments of approximately €89 million (including the €13.3 milestone already received in February 2024), subject to the approval and commercialization of elafibranor in PBC.

The decrease in cash and cash equivalents between September 30, 2023, and December 31, 2023, takes into account our continued research and development efforts, notably for:

• UNVEIL-IT, our Phase 2 clinical trial evaluating VS-01 in Acute-on-Chronic Liver Failure (ACLF);
• our cholangiocarcinoma program evaluating GNS561;
• our ACLF program evaluating NTZ;
• our non-clinical trial of SRT-015 in ACLF; and
• ELATIVE, specifically the portion of the Phase 3 clinical trial evaluating elafibranor in PBC that has not yet been transferred to Ipsen.
  
  

We expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements until approximately the fourth quarter of 2025. This is based on current assumptions and programs, and does not include exceptional events. This estimation includes our expectations to receive future milestone revenue in 2024, subject to approval by applicable regulatory authorities and US and European commercial launches of elafibranor in PBC by Ipsen, representing a total of approximately €75.2 million.