Core Insights - GENFIT SA reported an EPS of -$0.24, significantly below the expected $1.19, indicating financial challenges [1][6] - The company's revenue was approximately $40.3 million, falling short of the estimated $114.7 million, reflecting difficulties in meeting market expectations [1][6] Financial Position - As of June 30, 2025, GENFIT had cash and cash equivalents of €107.5 million, excluding a €26.5 million milestone payment received in July 2025 [2] - The revenues for the first half of 2025 were €33.5 million, supported by the milestone payment, with strong sales of Iqirvo noted in the primary biliary cholangitis (PBC) market [3] Strategic Decisions - The company has discontinued the VS-01 program, extending its cash runway beyond 2028, which provides flexibility for future business initiatives [4] - GENFIT is advancing its pipeline, with Phase 1b data for GNS561 in cholangiocarcinoma expected by the end of 2025, alongside safety data for G1090N in ACLF [4] Valuation Metrics - The price-to-sales ratio is 2.53, and the enterprise value to sales ratio is 2.25, reflecting the company's market valuation [5] - A debt-to-equity ratio of 0.90 indicates a balanced use of debt and equity, while a current ratio of 1.23 suggests reasonable liquidity [5]

Cash and cash equivalents totaled €107.5 million as of June 30, 2025, excluding the €26.5 million milestone invoiced in May 2025 (received in July 2025) upon pricing and reimbursement approval of Iqirvo® (elafibranor) in three major European countries€33.5 million in revenues, including the €26.5 million milestone invoiced in May 2025Strong 1H25 sales trajectory reported by Ipsen for Iqirvo® in PBC in July, followed by U.S. market exit of key competitor in SeptemberFollowing discontinuation of the VS-01 pro ...

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), September 19, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its decision to discontinue its VS-01 program in ACLF (Acute-on-Chronic Liver Failure), and reprioritize the development of VS-01 on UCD (Urea Cycle Disorder). GENFIT’s decision follows the occurrence of a peritonitis case reported as Seri ...

Company Overview - GENFIT is a biopharmaceutical company focused on improving the lives of patients with rare and life-threatening liver diseases, with a strong emphasis on unmet medical needs [2] - The company has a diversified and rapidly expanding R&D portfolio, particularly targeting Acute-on-Chronic Liver Failure (ACLF) with five assets under development [2] - GENFIT has expertise in developing high-potential molecules and has achieved accelerated approval for its drug Iqirvo® (elafibranor) for Primary Biliary Cholangitis (PBC) [2] Financial Summary - As of June 30, 2025, the liquidity contract with Crédit Industriel et Commercial reported total trading of €398,484.67 [4] - The buy side recorded 1,412,901 shares traded for a total amount of €5,016,550.43, while the sell side recorded 1,419,301 shares for €5,061,074.96 [4] - The total number of trades during the first half of 2025 was 2,673 on the buy side and 1,894 on the sell side [4] Research and Development Focus - GENFIT's ACLF franchise includes five assets: VS-01, G1090N, SRT-015, CLM-022, and VS-02-HE, which utilize different mechanisms of action [2] - The company also targets other serious diseases such as cholangiocarcinoma (CCA), urea cycle disorder (UCD), and organic acidemia (OA) [2] - GENFIT has a diagnostic franchise that includes NIS2+® for Metabolic dysfunction-associated steatohepatitis (MASH) and TS-01 focusing on blood ammonia levels [2] Market Position - GENFIT is headquartered in Lille, France, with additional offices in Paris, Zurich, and Cambridge, MA [2] - The company is listed on the Nasdaq Global Select Market and Euronext regulated market in Paris [2] - In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the company [2]

Core Viewpoint - GENFIT has announced that Ipsen's Iqirvo® has received pricing and reimbursement approval in Italy for Primary Biliary Cholangitis (PBC), marking a significant milestone for the company [1][2]. Group 1: Financial Impact - The approval in Italy triggers a milestone payment of €26.5 million under the Licensing and Collaboration Agreement with Ipsen, which is due upon pricing and reimbursement in three major European markets [2]. - This payment will support the advancement of GENFIT's pipeline focused on Acute On-Chronic Liver Failure (ACLF) and other serious diseases [2]. Group 2: Company Overview - GENFIT is a biopharmaceutical company dedicated to addressing unmet medical needs in patients with rare and life-threatening liver diseases, with over two decades of research and development experience [3]. - The company has a diversified R&D portfolio, including five assets under development for ACLF and other serious diseases such as cholangiocarcinoma, urea cycle disorder, and organic acidemia [3]. - GENFIT has successfully achieved accelerated approval for Iqirvo® (elafibranor) from major regulatory agencies, including the U.S. FDA and the European Medicines Agency [3]. Group 3: Strategic Partnerships - Ipsen became one of GENFIT's largest shareholders in 2021, acquiring an 8% stake in the company, indicating a strong partnership and commitment to the collaboration [3].