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].

Core Viewpoint - GENFIT has published its 2025 Extra-Financial Performance Report, highlighting its commitment to sustainable development and corporate social responsibility (CSR) in the biopharmaceutical sector, particularly focusing on rare and life-threatening liver diseases [1][2][3] Company Commitment to ESG - The establishment of a dedicated ESG Committee in 2021 has led to a structured approach to sustainability, with an annual roadmap translating into concrete actions and monitoring of key indicators [3] - In 2024, GENFIT enhanced its social and environmental responsibility efforts, including increased patient engagement and initiatives for gender equality in the workplace [3][4] - The company is preparing a compliance plan for non-financial reporting under the CSRD framework, despite the suspension of its transition plan to ESRS standards due to regulatory developments [3] Patient and Employee Engagement - GENFIT's initiatives, such as a breast cancer prevention campaign, demonstrate its commitment to improving the quality of life and working conditions for employees [5] - Patient advocacy efforts, particularly in the area of Acute-on-Chronic Liver Failure (ACLF), reflect the company's dedication to developing treatments that significantly improve patient lives [5] Long-term Value Creation - GENFIT recognizes the correlation between long-term financial performance and extra-financial performance, emphasizing the societal impact of its R&D programs and governance practices [6][7] - The company aims to create meaningful long-term value for patients, healthcare systems, employees, and shareholders through its commitment to innovative therapeutic solutions [7] Company Overview - GENFIT is a late-stage biopharmaceutical company focused on rare liver diseases, with a diverse and expanding R&D portfolio, including five assets under development for ACLF [8] - The company has a history of successful drug approvals, including Iqirvo® (elafibranor) for Primary Biliary Cholangitis, showcasing its expertise in drug development [8]

Core Points - GENFIT, a biopharmaceutical company focused on rare and life-threatening liver diseases, announced its Combined Shareholders Meeting scheduled for June 17, 2025 [1] - The meeting will be held at the Faculty of Pharmaceutical Sciences in Lille, France, and will be accessible via live broadcast on the company's website [3] - Shareholders will have the option to vote online through the VOTACCESS platform, with a tutorial provided for guidance [4] Company Overview - GENFIT is a late-stage biopharmaceutical company with over two decades of experience in liver disease research and development [5] - The company has a diversified R&D portfolio, focusing on Acute-on-Chronic Liver Failure (ACLF) and other serious diseases, with five assets under development in its ACLF franchise [5] - GENFIT's expertise includes the accelerated approval of its drug Iqirvo® (elafibranor) for Primary Biliary Cholangitis (PBC) by major regulatory authorities [5] - The company also has a diagnostic franchise targeting metabolic dysfunction-associated steatohepatitis (MASH) and blood ammonia levels [5] - GENFIT is headquartered in Lille, France, with additional offices in Paris, Zurich, and Cambridge, MA, and is listed on both Nasdaq and Euronext [5]

Core Viewpoint - GENFIT is actively participating in the EASL Annual Congress 2025, showcasing its commitment to advancing research in Acute-on-Chronic Liver Failure (ACLF) through six poster presentations and various events aimed at enhancing awareness and collaboration within the hepatology community [1][24]. Posters - Six posters accepted for presentation at the EASL Congress focus on GENFIT's assets related to ACLF, including real-world data research [2]. - Poster 1 discusses the investigational drug VS-01 and its effects on metabolite accumulation in patients with acutely decompensated liver cirrhosis [3]. - Poster 2 presents findings on the efficacy of the ASK1 inhibitor SRT-015 in disease models [4]. - Poster 3 highlights CLM-022 as a potential treatment for inflammatory liver diseases [4]. - Poster 4 examines NTZ's role in alleviating hepatocyte cell death in ACLF models [5]. - Poster 5 utilizes a machine-learning algorithm to identify at-risk subpopulations in ACLF patients [6]. - Poster 6 focuses on the development of models for detecting MASH resolution and fibrosis improvement [7]. Events - GENFIT will participate in an EASL Studio session discussing ACLF, moderated by Professor Debbie Shawcross, with industry representatives including GENFIT and Boehringer Ingelheim [8]. - A co-hosted event with EF CLIF on May 7, 2025, will explore scientific insights and updates on GENFIT's ACLF pipeline [10]. - A KOL ACLF Advisory Board meeting will facilitate discussions on collaboration opportunities and data-driven decision-making [11]. - An UNVEIL-IT® study meeting will take place on May 8, 2025, involving key opinion leaders and investigators in ACLF [13]. - A new ACLF Patient Advocacy Council session will focus on awareness and regulatory engagement from a patient perspective [14]. - GENFIT will engage in a roundtable discussion on the use of AI tools in hepatology drug development [15]. About ACLF - ACLF is characterized by hepatic and extrahepatic organ dysfunctions, with a high short-term mortality rate ranging from 23% to 74% within 28 days [18]. - The prevalence of ACLF was estimated at approximately 294,000 in the US, EU4, and UK in 2021, projected to reach around 300,000 by 2036 [18]. - The incidence of ACLF has been increasing at an epidemic rate, with a 26% rise between 2006 and 2014, attributed to factors such as an aging population and higher prevalence of liver diseases [18]. About GENFIT - GENFIT is a late-stage biopharmaceutical company focused on rare, life-threatening liver diseases, with a diverse R&D portfolio targeting ACLF [19]. - The company has five assets under development for ACLF, including VS-01, G1090N, SRT-015, CLM-022, and VS-02-HE, utilizing various mechanisms of action [19]. - GENFIT has a history of successful drug development, including the accelerated approval of elafibranor for Primary Biliary Cholangitis [21].

Financial Reporting - GENFIT filed its 2024 Universal Registration Document and Annual Report on Form 20-F for the year ended December 31, 2024[3]. - The 2024 Universal Registration Document includes the annual financial report and management report[5]. - The annual reports are available for public access on GENFIT's website and regulatory authorities' websites[4]. Research and Development - The company has a diversified R&D portfolio focusing on Acute-on-Chronic Liver Failure (ACLF) with five assets under development[6]. - Elafibranor (Iqirvo®) received accelerated approval from the FDA, EMA, and MHRA for Primary Biliary Cholangitis (PBC)[6]. - GENFIT's diagnostic franchise includes NIS2+® for Metabolic dysfunction-associated steatohepatitis (MASH) and TS-01 for blood ammonia levels[6]. Shareholder Information - Ipsen acquired an 8% stake in GENFIT, becoming one of its largest shareholders in 2021[6]. - GENFIT is listed on both Nasdaq and Euronext markets[6]. Corporate Overview - The company is headquartered in Lille, France, with additional offices in Paris, Zurich, and Cambridge, MA[6]. Risk Factors - Forward-looking statements highlight risks related to drug development, regulatory approvals, and capital raising[7].

Core Points - GENFIT, a biopharmaceutical company, focuses on improving the lives of patients with rare and life-threatening liver diseases and has filed its 2024 Universal Registration Document and Annual Report on Form 20-F [1][2] Company Overview - GENFIT is dedicated to addressing unmet medical needs in liver diseases, particularly Acute-on-Chronic Liver Failure (ACLF), with a diverse R&D portfolio that includes five assets under development: VS-01, G1090N, SRT-015, CLM-022, and VS-02-HE [2] - The company has a strong history in liver disease research, with over two decades of experience and expertise in developing high-potential molecules, evidenced by the accelerated approval of Iqirvo (elafibranor) for Primary Biliary Cholangitis (PBC) [2] - GENFIT also has a diagnostic franchise targeting Metabolic dysfunction-associated steatohepatitis (MASH) and blood ammonia levels [2] Financial Reporting - The 2024 Universal Registration Document and the Annual Report on Form 20-F are publicly available for free on GENFIT's website and the websites of the AMF and SEC [2][5] - The annual financial report includes the annual management report, Board of Directors' report on corporate governance, and Statutory Auditors' reports on financial statements [4]

Regulatory Approvals and Market Authorization - Iqirvo® (elafibranor) received accelerated approval from the FDA in June 2024, conditional market approval from the European Commission in September 2024, and approval from the MHRA in October 2024[46]. - The marketing authorizations obtained for Iqirvo® (elafibranor) in PBC may not guarantee similar authorizations in other territories or for other indications[49]. - Regulatory approval does not guarantee marketing authorization in other countries or for different indications[54]. - The approval process for drug candidates in the US and EEA requires extensive preclinical and clinical data, which can be long and costly[50]. - Regulatory authorities may impose limitations on the indicated uses for approved products, affecting marketing strategies[71]. - Regulatory approvals may carry conditions that limit the market for products or impose warnings, making effective marketing more challenging[103]. - The company must comply with ongoing regulatory requirements, including safety reporting and quality control, which could impact operational efficiency[104]. Financial Performance and Revenue Generation - The company's future revenues and financial situation mainly depend on the commercial success of Iqirvo® (elafibranor) in PBC in the countries where it has marketing authorization[47]. - The company recorded a net loss of €28,894 thousand for the year ended December 31, 2023, compared to a net loss of €23,719 thousand for the year ended December 31, 2022[214]. - The company has never generated any direct profits from the sale of approved products and does not expect to become profitable from such sales in the foreseeable future[215]. - Significant revenue has come from one-time upfront payments received in 2019 under a license agreement with Terns Pharmaceuticals and milestone payments under a license agreement with Ipsen since 2021[216]. - Revenues from agreements with Labcorp/Covance for the use of NIS4® diagnostic technology have been insignificant, with future growth dependent on external factors[217]. - The collaboration and license agreement with Ipsen provides for additional regulatory and commercial milestones and significant royalties on net sales of Iqirvo® (elafibranor), but there is no assurance of timely achievement[215]. - The company’s ability to sustainably reduce losses and maintain shareholder equity is unproven and may never be achieved[213]. - Indirect revenues from royalty payments under licensing agreements depend on the success of development and marketing by partners[213]. Development Risks and Challenges - A significant part of the development pipeline results from the acquisition of licensing rights or intellectual property from other companies, which increases the risk associated with these programs[30]. - The company is currently developing drug candidates for ACLF, a condition with no approved treatments, which poses additional risks in patient recruitment for clinical trials[29]. - The company has limited experience in recruiting patients for clinical trials in ACLF, which may delay the development process[29]. - Development failure can occur at any stage of preclinical or clinical development, impacting the ability to receive regulatory approval[31]. - Delays in clinical trials could significantly increase product development costs, impairing financing capacity and limiting regulatory approvals[44]. - The company faces risks related to combination treatments, including potential withdrawal of approval for existing treatments used in combination[57]. - The company faces significant risks if it cannot establish its own sales, marketing, and distribution capabilities, which could lead to lower revenue and profitability[102]. - The company relies heavily on third-party contractors for clinical trials and manufacturing, which may lead to increased costs and delays if these parties fail to meet obligations[127]. Intellectual Property and Patent Challenges - The company invests significant resources in obtaining and maintaining patent protection, which is essential for its competitive advantage and profitability[167]. - Patent applications are costly and time-consuming, and failure to secure adequate patent protection could harm the company's ability to commercialize its product candidates[169]. - Changes in patent law, such as the transition to a "first-to-file" system, may negatively impact the company's ability to obtain and enforce patents[174]. - The company may face challenges in patent litigation, including the risk of patents being found invalid or unenforceable, which could harm its business[172]. - The company expects to seek extensions of patent terms under the Hatch-Waxman Amendments, which could be critical for its product candidates[177]. - The company relies on trade secret protection for proprietary technology, but such protection is difficult to enforce, and breaches could harm its competitive position[179]. - The company faces challenges in enforcing intellectual property rights globally, as legal protections vary significantly by jurisdiction, particularly in developing countries[185]. Market Acceptance and Competitive Landscape - The competitive landscape includes drugs like Gilead's Livdelzi® for PBC, which could significantly influence the market acceptance of elafibranor and other candidates[97]. - Market acceptance of Iqirvo® (elafibranor) and other products will depend on their acceptance among the medical community and healthcare payors[98]. - The company may face challenges in establishing sales, marketing, and distribution capabilities for elafibranor and other product candidates if they are approved[99]. - Government pricing restrictions and reimbursement policies may negatively affect the company's revenue generation capabilities[115]. - Coverage and adequate reimbursement from third-party payors are critical for the acceptance of new products, and variability in these factors can significantly impact demand[116]. - Legislative changes, such as the Inflation Reduction Act of 2022, may impose additional pricing pressures and affect the company's ability to raise prices[119]. Cybersecurity and Data Privacy Risks - The company’s internal IT systems and those of its collaborators may be vulnerable to security breaches, potentially disrupting product development and commercialization[160]. - The company collects and stores sensitive data, including legally protected patient health information and personally identifiable information, which poses risks of data breaches and cybersecurity incidents[161]. - The complexity and number of cybersecurity threats are increasing, potentially harming market perception and leading to regulatory actions or private litigation related to data privacy[163]. - The company faces risks related to the misappropriation and leakage of critical data maintained in its information systems and those of its vendors[162]. - Compliance with data privacy laws in the U.S. and EU, and breaches could negatively impact its operations[197]. Strategic Collaborations and Partnerships - The company may need to collaborate with third parties to advance product candidates due to limited access to capital[75]. - The company has exclusive licensing agreements with Ipsen for elafibranor and with Labcorp and Q2 for NIS4® technology, which may not guarantee revenue generation[140]. - The company faces risks related to collaborations, including potential failure to achieve widespread clinical or commercial use of products developed with partners like Labcorp, Ipsen, and Terns Pharmaceuticals[144]. - Future collaborations may require additional expenditures and could dilute existing shareholders[142]. - The company has entered into a licensing agreement with Seal Rock Therapeutics for exclusive worldwide rights to the ASK1 inhibitor SRT-015, aimed at developing an injectable formulation for acute liver disease and ACLF[158]. - In May 2023, the company also entered into a licensing agreement with Celloram for worldwide rights to the inflammasome inhibitor CLM-022, targeting liver diseases and ACLF, with potential milestone payments and royalties[158]. Operational and Compliance Challenges - The company must invest significant resources in regulatory compliance to maintain approvals for its product candidates[114]. - The company faces penalties and enforcement actions if it fails to comply with regulatory obligations, which could adversely affect its business[113]. - The company faces risks related to compliance with various data protection laws, which could increase operational costs and complexity[206]. - Compliance with healthcare laws and regulations is costly and non-compliance could lead to severe penalties, including exclusion from government-funded healthcare programs[196]. - The company may face challenges in attracting and retaining qualified personnel, which is critical for its success in new therapeutic areas[153].

Core Insights - GENFIT announced that Ipsen will present late-breaking data on elafibranor, demonstrating a favorable safety profile and significant efficacy in treating Primary Sclerosing Cholangitis (PSC) at the EASL Congress on May 10, 2025 [1][4] Efficacy Results - The Phase 2 ELMWOOD trial results showed that patients on elafibranor experienced significant dose-dependent reductions in alkaline phosphatase (ALP) levels, with reductions of −103.2 U/L and −171.1 U/L for the 80 mg and 120 mg doses respectively, compared to a placebo increase of +32.1 U/L (p < 0.0001) [2] - Improvements in other liver biochemical parameters, including alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT), were also observed, indicating a positive impact on disease progression [2] - Patients on elafibranor showed stabilization in Enhanced Liver Fibrosis (ELF) at week 12 compared to placebo [2] - The 120 mg dose of elafibranor led to significant improvements in pruritus, as measured by the Worst Itch Numeric Rating Scale (WI NRS), with scores of -0.96 versus -0.28 for placebo (p < 0.05) [2] Product Information - Elafibranor is a first-in-class oral peroxisome proliferator-activated receptor (PPAR) agonist, which has been marketed in the U.S., EU, and UK under the trademark Iqirvo® since June 2024 for Primary Biliary Cholangitis (PBC) [3][6] - The drug was developed by GENFIT and licensed to Ipsen in 2021, with exclusive worldwide rights except for certain regions in Asia [3][6] Company Overview - GENFIT is a biopharmaceutical company focused on rare and life-threatening liver diseases, with a strong emphasis on research and development [7] - The company has a diversified R&D portfolio, including assets targeting Acute-on-Chronic Liver Failure (ACLF) and other serious diseases [8] - GENFIT has established a diagnostic franchise, demonstrating its commitment to addressing unmet medical needs in liver disease [8]

Core Viewpoint - GENFIT has successfully completed a royalty financing transaction with HealthCare Royalty (HCRx), providing significant financial resources to support its development programs and reduce convertible debt burden without dilution for shareholders [1][2][3]. Financial Transaction Details - The royalty financing includes an upfront payment of €130 million, with the potential for an additional €55 million contingent on achieving near-term milestones [3][7]. - GENFIT will repurchase 1,882,891 of its 2025 OCEANEs at a price of €32.75 per bond, totaling approximately €61.66 million, which represents 99% of the outstanding OCEANEs [6][7]. - The repurchase is expected to reduce GENFIT's convertible debt to €586 thousand [7]. Future Financial Outlook - The financing arrangement extends GENFIT's cash runway beyond 2027, allowing the company to fund its operating expenses and capital expenditures [4][7]. - The company anticipates receiving significant milestone revenue in 2025, including a €26.55 million milestone pending regulatory approval for Iqirvo® (elafibranor) [4][5]. Pipeline Development - With the new financial backing, GENFIT is positioned to advance its Acute-on-Chronic Liver Failure (ACLF) pipeline, which includes several promising assets at various stages of development [5][7]. - The company retains rights to receive regulatory, commercial, and sales-based milestone payments under its agreement with Ipsen [3][4]. Repurchase Implementation - The settlement of the repurchase is scheduled for March 26, 2025, and the repurchased OCEANEs will be canceled [8]. - A consent fee of €0.90 per bond will be paid on April 14, 2025, to bondholders who participated in the repurchase [9].

Core Viewpoint - GENFIT successfully obtained unanimous approval from bondholders for all proposed resolutions regarding the 2025 OCEANEs, enabling the company to proceed with the Royalty Financing and related transactions [1][3]. Bondholder Meeting Results - The bondholders' meeting for the 2025 OCEANEs was held on March 10, 2025, with a quorum of 95.79% and 100% of votes cast in favor of the resolutions [3]. - The approval allows GENFIT to amend the negative pledge clause, facilitating the Royalty Financing with HCRx [2][3]. Royalty Financing and Repurchase Agreement - The Royalty Financing, signed on January 30, 2025, is contingent upon the bondholders' approval of the amendment to the negative pledge clause [2]. - GENFIT proposed a Put Option Agreement to bondholders, offering to repurchase the 2025 OCEANEs at EUR 32.75 per bond, with a deadline for exercising this option set for March 19, 2025 [4][8]. - The settlement for the repurchase is expected on March 26, 2025, and the repurchased bonds will be canceled [5]. Consent Fee Payment - A consent fee of EUR 0.90 will be paid to holders of the outstanding 2025 OCEANEs after the repurchase, with payment expected on April 14, 2025 [6][7]. Upcoming Events Timeline - Key dates include: - March 19, 2025: Deadline for exercising the put option - March 26, 2025: Repurchase settlement date - April 14, 2025: Payment of the consent fee [8]. Company Overview - GENFIT is a biopharmaceutical company focused on rare and life-threatening liver diseases, with a diverse R&D portfolio including five assets under development for Acute-on-Chronic Liver Failure (ACLF) [9]. - The company has a strong history in liver disease research and has achieved accelerated approval for its drug Iqirvo® (elafibranor) for Primary Biliary Cholangitis (PBC) [9].