Genfit S.A. Q4 FY2021 earnings call

• Financial: Received €120M upfront from Ipsen, reduced convertible debt, and secured COVID-related loans. Cost control reduced expenses by €31.7M. - Development: Resolved NASH Phase 3 trial (RESOLVE-IT), ELATIVE Phase 3 trial in PBC nearing enrollment end with top-line data expected in Q2 2023. NIS4 diagnostic technology recognized by NIMBLE consortium. - Pipeline: Progress in ACLF with NTZ Phase 1 studies, and in-licensed GNS5611 for cholangiocarcinoma, aiming for Phase 1b/2 study by end of 2021 and first interim results in H1 2024.

Genfit's revenue and other operating income for 2021 amounted to €85.6 million. Revenue primarily came from a €120 million non-refundable upfront payment from Ipsen in December 2021, with €80 million recognized in 2021 and €40 million deferred. Other operating income included a research tax credit of €5.3 million from the French Tax Authorities. Operating expenses decreased to €53.8 million in 2021 from €90.7 million in 2020, resulting in consolidated operating income of €31.8 million in 2021 compared to an operating loss of €82.9 million in 2020. Net profit was €67.3 million in 2021 after a net loss of €101.2 million in 2020. Cash and cash equivalents stood at €258.8 million as of December 31, 2021, up from €171 million at the end of 2020.

• Cash used in operational activities expected to increase to €65 million in 2022. - ELATIVE Phase 3 trial in PBC targets top-line data readout in Q2 2023. - Eligible for substantial milestone payments up to €360 million from Ipsen deal, with double-digit royalties possible.

• Forward-looking statements subject to known and unknown risks and uncertainties. - COVID-19 could impact trial timelines. - Dependence on Ipsen deal milestones and royalties for future revenue.

Q: Thomas Smith asks about business development activities, specifically types of assets interested in.

A: Pascal Prigent states interest in clinical-stage assets for ACLF portfolio, looking at both early and clinical-stage assets. Dean Hum adds focus on multiple mechanisms in ACLF.

Q: Arsene Guekam asks about NIS4 launch and pipeline strategy.

A: Pascal Prigent discusses NIS4's technical progress and positioning, and interest in clinical-stage assets for diversified pipeline.

Q: Ed Arce asks about NTZ and ACLF.

A: Dean Hum explains NTZ's mechanisms, in vivo study results, and importance of immuno metabolic pathways in ACLF.