Core Insights - GENFIT announced a strong commercial performance of Iqirvo® in its first full year, achieving net sales of US$208M, which triggered a US$20M milestone payment from Ipsen ahead of schedule [2][8] - The partnership with Ipsen is highlighted as a key factor in the commercial success, reinforcing GENFIT's financial position and leading to an additional €30M tranche under a royalty-financing agreement with HCRx [2][3] - Ipsen has initiated a Phase 3 clinical trial for Iqirvo® in primary sclerosing cholangitis (PSC), representing a significant market opportunity, with potential for additional milestone payments and royalties for GENFIT [3][8] Financial Performance - Iqirvo® net sales reached US$208M in 2025, with US$88M reported in Q4 2025 [2][8] - The early achievement of the milestone payment is expected to enhance GENFIT's financial flexibility [2] - The company anticipates a landmark year in 2026, with ongoing clinical programs and new data expected [5] Clinical Development - GENFIT is advancing its oncology program, specifically the Phase 1b study of GNS561 in cholangiocarcinoma (CCA), which is progressing as planned with no dose-limiting toxicities reported [4][8] - Recruitment for the next dose-escalation cohort has been completed, with multi-cohort readouts expected by the end of the first half of 2026 [4][8] - The company is also preparing for a Phase 2 study evaluating G1090N in acute on-chronic liver failure (ACLF) patients [5] Company Overview - GENFIT is focused on rare and life-threatening liver diseases, with a strong history in liver disease research and development [7] - The company has a diverse R&D portfolio, including therapies for cholangiocarcinoma, urea cycle disorders, and organic acidemias [9] - GENFIT is headquartered in Lille, France, and is listed on the Euronext regulated market [9]

Core Insights - GENFIT announced a US$20 million milestone payment from Ipsen due to the strong commercial performance of Iqirvo® in its first full year, with net sales reaching US$208 million in 2025, exceeding initial expectations [2][3][8] Financial Performance - Iqirvo® achieved first-year net sales of US$208 million, leading to a milestone payment from Ipsen ahead of schedule, which strengthens GENFIT's financial position [2][8] - An additional €30 million tranche was received under GENFIT's royalty-financing agreement with HCRx, enhancing financial flexibility without dilution [2] Clinical Developments - Ipsen initiated the first global Phase 3 clinical trial for primary sclerosing cholangitis (PSC), addressing a significant unmet medical need, with potential for additional milestone payments and double-digit royalties for GENFIT if approved [3][8] - GENFIT's ongoing Phase 1b study in cholangiocarcinoma (CCA) is progressing as planned, with a new dose-escalation cohort fully enrolled and no dose-limiting toxicities reported [4][8] Future Outlook - The CEO of GENFIT expressed optimism about the commercial trajectory of Iqirvo® and the progress of the GNS561 program, anticipating significant developments in 2026 [5] - GENFIT plans to publish its 4Q25 revenue and cash position on February 26, 2026, indicating a commitment to transparency and ongoing communication with stakeholders [5]

Core Insights - Ipsen has reported strong sales growth for the year-to-date and third quarter of 2025, with total sales reaching €2,734.8 million, a 9.6% increase compared to the same period in 2024 [2][7] - The company has upgraded its full-year financial guidance, anticipating total sales growth of around 10.0% at constant exchange rates (CER), up from previous guidance of greater than 7.0% [4][8] Sales Performance - Oncology sales increased by 4.5% year-to-date, reaching €1,912.0 million, while third-quarter sales were €624.0 million, up 3.3% [2] - Rare Disease sales saw a significant rise of 97.0% year-to-date, totaling €255.4 million, with third-quarter sales of €102.0 million, reflecting a 100.8% increase [2] - Neuroscience sales grew by 5.8% year-to-date to €567.3 million, with third-quarter sales of €188.9 million, up 3.9% [2] Pipeline and Acquisitions - Ipsen announced positive data from the Phase II LANTIC trial for IPN10200, a long-acting molecule in aesthetics, and plans to present this data at a scientific conference in H1 2026 [3][5] - The company has proposed the acquisition of ImCheck Therapeutics, which will enhance its oncology pipeline with a first-in-class asset [9][10] Regulatory Approvals - Ipsen received regulatory approval for Bylvay® in Japan for treating pruritus associated with progressive familial intrahepatic cholestasis (PFIC) [6] - The company also obtained European Commission approval for Cabometyx® in advanced neuroendocrine tumors [6] Financial Guidance - The updated financial guidance includes a core operating margin of around 35.0% of total sales, an increase from prior guidance of greater than 32.0% [8] - The company expects an adverse impact of around 3% on total sales from currency fluctuations based on September 2025 exchange rates [8][18]