GENFIT Announces Revenues and Cash Position as of December 31, 2023 - Seite 2

Revenues

Revenues for 2023 amounted to €28.6 million compared to €20.2 million for the same period in 2022.

Of the €28.6 million, €13.3 million was attributable to a milestone payment invoiced to Ipsen in December 2023 in accordance with the Collaboration and Licensing agreement signed in December 2021. This milestone payment was earned following the NDA filing acceptance by the FDA and MAA filing acceptance by the EMA for accelerated approval of elafibranor. €8.7 million in revenue was attributable to the partial recognition of the €40.0 million deferred income as described below. €6.5 million in revenue was generated from the services rendered under the Transition Services Agreement and Part B Transition Services Agreement, signed in April 2022 and September 2023 respectively by GENFIT and Ipsen, in order to facilitate the transition of certain services related to the Phase 3 ELATIVE clinical trial until the complete transfer of the responsibility of the trial to Ipsen. €0.1 million was attributable to other ancillary activities.

Of the €20.2 million in revenues for 2022, €15.9 million was attributable to the partial recognition of the €40.0 million deferred income per IFRS² 15 in accordance with the Collaboration and Licensing Agreement signed with Ipsen in 2021. €1.0 million in revenue was generated from services rendered by GENFIT to Ipsen in accordance with the Transition Services Agreement signed in 2022. €3.3 million was recognized as revenue in accordance with the Inventory Purchase Agreement signed with Ipsen in 2022, under which the Company sold almost all of its remaining stock of elafibranor’s active ingredient and drug products for the ELATIVE Phase 3 clinical trial to Ipsen.

Upcoming FDA PDUFA³ Action Date for Elafibranor in PBC: June 10, 2024

Regulatory filing acceptance has been obtained in the US, Europe and the United Kingdom⁴ and a Priority Review has been granted for an NDA by the FDA for elafibranor in PBC with a PDUFA target action date of June 10, 2024.

Upcoming Financial Communications

The Company will release its full-year 2023 financial results on April 4, 2024. The 2023 Universal Registration Document, the 2023 Annual Financial Report (included in the 2023 Universal Registration Document), and the Annual Report on Form 20-F will be published by the end of April 2024.

ABOUT GENFIT

GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases characterized by high unmet medical needs. GENFIT is a pioneer in liver disease research and development with a rich history and strong scientific heritage spanning more than two decades. Today, GENFIT has a growing and diversified pipeline with programs at various development stages. The Company’s area of focus is Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise consists of five assets in development: VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE. These are all based on differentiated mechanisms of action leveraging complementary pathways. Other assets target other life-threatening disease indications such as cholangiocarcinoma (CCA) and Urea Cycle Disorders (UCD)/Organic Acidemias (OA). GENFIT’s track record in bringing early-stage assets with high potential to late development and pre-commercialization stages is highlighted in the successful 52-week Phase 3 ELATIVE trial evaluating elafibranor in PBC. Beyond therapeutics, GENFIT’s pipeline also includes a diagnostic franchise focused on Metabolic dysfunction-associated steatohepatitis (MASH) previously known as nonalcoholic steatohepatitis (NASH) and ammonia. GENFIT has facilities in Lille and Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). GENFIT is a publicly traded company listed on the Nasdaq Global Select Market and on compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT’s largest shareholders and holds 8% of the company’s share capital. For more information, visit www.genfit.com