GENFIT reports financial information for the first quarter of 2024

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), May 14, 2024GENFIT (Nasdaq and Euronext: GNFT)a late-stage biopharmaceutical company committed to improving the lives of patients with rare and life-threatening liver diseases, today announced its cash position as of March 31, 2024 and revenues for the first three months of 2024.1

Capital position

As of March 31, 2024, the Company’s cash and cash equivalents amounted to €74.0 million, compared to €128.6 million at March 31, 2023 and €77.8 million at December 31, 2023.

The stability in cash and cash equivalents between December 31, 2023 and March 31, 2024 takes into account changes in accounts receivable (particularly the receipt of the €13.3 million milestone invoiced to Ipsen in December 2023), offset by our ongoing research and development efforts, in particular 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 to evaluate NTZ; And
  • our non-clinical trial of SRT-015 in ACLF.

We expect that our existing cash and cash equivalents will allow us to fund our operating expenses and capital expenditures through approximately the fourth quarter of 2025. This is based on current assumptions and programs and does not include exceptional events. This estimate includes our expectations to receive future milestone revenues in 2024, subject to regulatory approvals and the US and European commercial launches of elafibranor in Primary Biliary Cholangitis (PBC) by Ipsen, totaling approximately €75.2 million represents.

Income

Sales for the first three months of 2024 amounted to €1.1 million, compared to €5.0 million for the same period in 2023.

These revenues for the first three months of 2024 were generated under the Transition Services Agreement and Part B Transition Services Agreement, signed in April 2022 and September 2023 respectively by GENFIT and Ipsen, to facilitate the transition of certain services related to the Phase 3 . ELATIVE® clinical trial until the full transfer of responsibility for the trial to Ipsen.

Of the €5.0 million of revenue for the first three months of 2023, €4.1 million of revenue was attributable to the partial recognition of the €40.0 million of deferred revenue under IFRS 15 in accordance with the collaboration and licensing agreement signed with Ipsen in 2021. €0.8 million was attributable to re-invoicing made in accordance with this agreement. €0.1 million in revenue was generated from the services GENFIT provided to Ipsen in accordance with the Transition Services Agreement signed in 2022.

ABOUT GENFIT

GENFIT is a late-stage biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and solid scientific heritage spanning more than two decades. Today, GENFIT has built a diversified and rapidly growing R&D portfolio of programs at various stages of development. The company focuses on acute-on-chronic liver failure (ACLF). The ACLF franchise includes five assets in development: VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE, based on complementary mechanisms of action using different routes of administration. Other active ingredients target other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorder (UCD), and organic acidemia (OA). GENFIT’s expertise in the development of high-potential molecules, from early to advanced stages, and in pre-commercialization, was demonstrated with the success of the 52-week Phase 3 ELATIVE® trial evaluating elafibranor in primary biliary cholangitis (PBC). In addition to therapies, GENFIT also has a diagnostic franchise, including NIS2+® for metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis) and TS-01, which targets blood ammonia levels. GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market and on the regulated market of Euronext in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of the largest shareholders of GENFIT, acquiring an 8% stake in the company’s capital. www.genfit.com

FORWARD-LOOKING STATEMENTS

This press release contains certain forward-looking statements, including statements within the meaning of the Private Securities Litigation Reform Act of 1995, regarding GENFIT, including but not limited to statements regarding the Company’s eligibility to receive future milestone payments from Ipsen related to the development and commercial launch of elafibranor in PBC, approval of elafibranor in PBC and potential commercialization in the United States and Europe as early as 2024, and expected cash runway. The use of certain words, such as ‘believe’, ‘potential’, ‘expect’, ‘goal’, ‘may’, ‘will’, ‘should’, ‘could’, ‘if’ and similar expressions are intended to identify forward-looking statements. Although the Company believes that its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including with respect to the safety of drug candidates, the costs of, the progress of and the results of our ongoing and planned clinical trials, review and approvals by regulatory authorities in the United States, Europe and globally, of our drug and diagnostic candidates, the potential commercial success of elafibranor if approved, currency fluctuations and our continued ability to raise capital to finance our development, as well as the risks and uncertainties involved discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 “Risk Factors and Internal Control” of the Company’s Universal Registration Document 2023, filed on April 5, 2024 (No. D.24-0246) to the Autorité des marchés financiers (“AMF”), which is available on the GENFIT website (www.genfit.fr) and the AMF website (www.amf.org), and which are discussed in the public documents and reports filed with the US Securities and Exchange Commission (“AMF”). SEC”), including the Company’s 2023 Annual Report on Form 20-F filed with the SEC on April 5, 2024 and subsequent filings and reports filed with the AMF or SEC or otherwise made public by the Company. Furthermore, even if the results , performance, financial position and liquidity of the company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this document. Except as required by applicable law, the Company undertakes no obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

CONTACT

GENFIT | Investors

Tel: +33 3 2016 4000 | [email protected]

PRESS RELATIONS | Media

Stephanie Boyer – Press Relations | Tel: +333 2016 4000 | [email protected]

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com


1 Unaudited financial information under IFRS

  • GENFIT reports financial information for the first quarter of 2024