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GENFIT SA (NASDAQ:GNFT) Earnings Report Highlights
Financial Modeling Prep· 2025-09-23 16:00
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]
GENFIT Reports First-Half 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-09-22 20:10
Core Insights - GENFIT announced its first half 2025 financial results and a corporate update, highlighting the discontinuation of the VS-01 program in ACLF and a shift in focus towards Urea Cycle Disorder (UCD) [1][3][4] - The company reported cash and cash equivalents of €107.5 million as of June 30, 2025, which is an increase from €81.8 million at the end of 2024, and anticipates extending its cash runway beyond 2028 [3][22][23] Business Highlights - The decision to discontinue the VS-01 program was influenced by a serious adverse event in a clinical trial, leading to a focus on UCD, which presents a significant unmet medical need [2][4] - Revenues for the first half of 2025 amounted to €35.7 million, a decrease from €61.2 million in the same period of 2024, primarily due to reduced milestone payments [25][26] - Operating expenses increased to €35.6 million in the first half of 2025 from €30.0 million in the first half of 2024, largely driven by research and development costs [27][28] Financial Performance - The net loss for the first half of 2025 was €10.0 million, compared to a net profit of €30.3 million in the first half of 2024 [30][61] - Financial income for the period resulted in a loss of €10.2 million, significantly higher than the loss of €0.9 million in the same period of 2024, attributed to increased financial charges from the Royalty Financing agreement [29][59] - The company expects to fund its operations and capital expenditures beyond 2028 based on current assumptions and anticipated revenue from collaborations [23][11] Pipeline and Future Outlook - Key milestones for the second half of 2025 include expected safety data and early efficacy markers for G1090N, with a proof-of-concept study planned for the first half of 2026 [16] - The company is also working on several other programs targeting ACLF and related conditions, with ongoing preclinical evaluations and trials expected to commence in the coming years [4][19][21] - GENFIT's acquisition of full intellectual property rights for GNS561 from Genoscience Pharma enhances its development capabilities in cholangiocarcinoma [10]
Globus Maritime, Firefly Aerospace And 3 Stocks To Watch Heading Into Monday - Firefly Aerospace (NASDAQ:FLY)
Benzinga· 2025-09-22 07:18
Company Performance - Firefly Aerospace Inc. is expected to report a quarterly loss of 46 cents per share on revenue of $17.25 million [2] - PRA Group Inc. announced a proposed offering of €300 million of senior notes due 2032, with shares falling 4.1% to close at $16.58 [2] - Genfit SA is projected to release earnings results for the first half of the year, with shares declining 1.2% to close at $4.33 [2] - Globus Maritime Ltd reported better-than-expected second-quarter results, with a quarterly loss of 9 cents per share, beating the consensus estimate of a loss of 18 cents per share, and quarterly sales of $9.538 million exceeding the estimate of $8.800 million; shares jumped 14.7% to close at $1.30 [2] - Marygold Companies Inc. posted a loss of 4 cents per share for the fourth quarter, an improvement from a loss of 5 cents per share a year ago, with sales falling to $7.200 million from $8.300 million; shares closed at $1.07 [2]
GENFIT Announces Discontinuation of its VS-01 Program in ACLF: VS-01 Development Refocused on UCD
Globenewswire· 2025-09-19 20:10
Core Viewpoint - GENFIT has decided to discontinue its VS-01 program in Acute-on-Chronic Liver Failure (ACLF) and will focus on developing VS-01 for Urea Cycle Disorder (UCD) due to safety concerns and the need for additional data [1][2][3] Company Strategy - The decision to halt the VS-01 program in ACLF was influenced by a Serious Adverse Event (SAE) reported during the UNVEIL-IT® clinical trial, leading to a review by the independent Data Monitoring Committee [2] - GENFIT will continue preclinical evaluation of VS-01 in UCD, which presents a significant unmet medical need, particularly for children [3] - The company remains committed to ACLF and related conditions, aiming to accelerate the development of four other assets in this area, which utilize different mechanisms of action [4] Financial Implications - The discontinuation of the VS-01 program is expected to lead to a substantial reduction in operating expenses, providing strategic flexibility and extending the projected cash runway by at least one year [6][11] - GENFIT anticipates sharing Phase 1b data for cholangiocarcinoma (CCA) by year-end, indicating ongoing investment in other life-threatening indications [5] Research and Development Focus - GENFIT has a diversified R&D portfolio targeting various liver diseases, including ACLF, Acute Decompensation (AD), Hepatic Encephalopathy (HE), UCD, and CCA [7] - The company has engaged with key opinion leaders (KOLs) and received positive feedback on its clinical strategy for ACLF, reinforcing confidence in its development plans [4]
Genfit: Half-Year Report of Liquidity Contract with Crédit Industriel et Commercial
Globenewswire· 2025-07-08 20:10
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]
GENFIT: June 17, 2025 Combined Shareholders Meeting Results
Globenewswire· 2025-06-17 18:30
Core Viewpoint - GENFIT, a biopharmaceutical company focused on rare and life-threatening liver diseases, successfully held its Combined Shareholders Meeting on June 17, 2025, where all resolutions were approved except for one [1]. Company Overview - GENFIT is dedicated to improving the lives of patients with unmet medical needs related to rare liver diseases, with over two decades of experience in liver disease research and development [3]. - The company has a diversified and expanding R&D portfolio, particularly focusing on Acute-on-Chronic Liver Failure (ACLF) with five assets under development: VS-01, G1090N, SRT-015, CLM-022, and VS-02-HE [3]. - GENFIT also targets other serious diseases, including cholangiocarcinoma (CCA), urea cycle disorder (UCD), and organic acidemia (OA) [3]. - The company has demonstrated its expertise in drug development with the accelerated approval of Iqirvo (elafibranor) for Primary Biliary Cholangitis (PBC) by major regulatory agencies [3]. - In addition to therapies, GENFIT has a diagnostic franchise focusing on metabolic dysfunction-associated steatohepatitis (MASH) and blood ammonia levels [3]. Shareholder Meeting Results - The quorum for the meeting was 27.21%, and all resolutions were approved except for resolution n°28, which was rejected based on the Board of Directors' recommendations [1]. - Detailed voting results for each resolution are available on the company's website [2].
GENFIT Reports First Quarter 2025 Financial Information
Globenewswire· 2025-05-22 20:10
Core Viewpoint - GENFIT reported a significant increase in cash position and revenues for the first quarter of 2025, driven by a non-dilutive royalty financing agreement and royalties from Iqirvo® sales, indicating a strong financial outlook for the company. Cash Position - As of March 31, 2025, the company's cash and cash equivalents were €129.5 million, up from €74.0 million on March 31, 2024, and €81.8 million on December 31, 2024 [2][3] - The increase in cash is attributed to a €130.0 million first installment from a royalty financing agreement with HCRx, offset by the repurchase of OCEANEs totaling €61.7 million [3] Revenues - Revenues for the first three months of 2025 were €2.8 million, compared to €1.1 million for the same period in 2024, reflecting a substantial growth [4] - The revenue increase is primarily due to royalties from Iqirvo® (elafibranor) sales from Ipsen [4] Corporate Governance Update - Chief Medical Officer Carol Addy will retire effective June 30, 2025, with a replacement to be announced later [6] - CEO Pascal Prigent expressed gratitude for Addy's contributions to the company [6] Company Overview - GENFIT is focused on developing treatments for rare and life-threatening liver diseases, with a strong emphasis on Acute-on-Chronic Liver Failure (ACLF) [7] - The company has a diversified R&D portfolio, including multiple assets under development targeting various liver diseases and related conditions [8][9]
GENFIT to receive a €26.5 million milestone payment following the approval of pricing and reimbursement of Ipsen’s Iqirvo® in Italy
Globenewswire· 2025-05-20 20:10
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].
GENFIT: Publication of the 2025 Extra-Financial Performance Report (fiscal year 2024)
Globenewswire· 2025-05-14 20:10
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]
GENFIT Annual Combined General Meeting of June 17, 2025 — Availability of Preparatory Documents
GlobeNewswire News Room· 2025-05-07 20:10
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]