The new ongoing phase III study has earned Ipsen confidence and builds on broad phase II success.
A good probability of success for Genfit after a bitter failure | Photo credit: Shutterstock
Exciting meeting with Pascal Prigent, CEO of Genfit, on the occasion of the Portzamparc Conference. The failure of the Elafibranor molecule in Nash, at the end of phase III, after 15 years of work and hundreds of millions of euros in expenditure, was quite traumatic for Genfit. But the phase II results for this same molecule in another indication were excellent (for Nash, they were just positive). It is still a liver disease, but genetic this time, PBC (degradation of the channels that evacuate bile). The recruitment of 150 patients for phase III was completed this summer. The cost will be a few tens of millions of euros.
The results are expected in the second quarter of 2023, then the filing of the dossier with the FDA will follow in the third quarter. Marketing is therefore possible a year later, from the end of 2024 or the beginning of 2025. Sales could peak at 500 million dollars, based on a conservative market share of one third. You have to reckon with the current drug from Intercept (which causes side effects) and that of a Californian biotech, Cymabay, which has not yet completed the recruitment of patients for phase III.
Abundant net cash
The chances of success are high, judging by the agreements made with Ipsen. The laboratory entered the capital of Genfit to the tune of 8% by contributing 28 million euros (at 7 euros per share). He also signed an agreement including a up front (initial payment) of 120 million, milestones (milestone payments) of 390 million and royalties of up to 20%. If Genfit pays the phase III costs, Ipsen will assume the costs of an additional long-term study during marketing, ie around one hundred million euros. And, of course, Ipsen will pay the marketing costs.
Genfit now has a solid balance sheet, with 222 million in cash at the end of March and a cash burn (cash consumption) from 60 to 65 million per year in 2022 and 2023. The company, which employs 130 people, is based in Lille with an office in Cambridge (near Boston).
Jean-Luc Champetier, live from the Portzamparc Conference