GENFIT Reports Full-Year 2019 Financial Results and Corporate Update
Topline interim results from Phase 3 clinical trial RESOLVE-IT expected by the end of May 2020Cash position of €277MM as of December 31, 2019 (vs €207MM as of December 31, 2018)Significant milestones achieved in 2019:Release of full dataset from the successful Phase 2 clinical trial of elafibranor in PBC, leading to “Breakthrough Therapy” and “Orphan Drug” designationsStrategic partnership with Terns Pharmaceuticals for the development and commercialization of elafibranor in Greater China, and strategic R&D agreement ($35MM upfront payment, and up to $193MM in milestones payment)Licensing agreement with LabCorp-Covance for NIS4, a non-invasive diagnostic tool for the identification of NASH patients with fibrosisGlobal offering and U.S. IPO on Nasdaq, raising gross proceeds totaling $155MMChange in governance and strengthening of US footprintConference call scheduled for April 9, 2020 at 8:00am EDT / 14:00 CEST Lille (France), Cambridge (Massachusetts, United States), April 8, 2020 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced its annual financial results for the full year ended December 31, 2019. A summary of the consolidated financial statements is included below. Pascal Prigent, CEO of GENFIT, commented: “2019 has been a year of significant progress for GENFIT and, despite the current challenges due to the COVID-19 pandemic, 2020 is starting strong with a critical milestone coming up shortly.We are targeting the end of May to communicate the interim results of RESOLVE-IT, our Phase 3 clinical trial in patients with non-alcoholic steatohepatitis (NASH). We locked the study database in February and are now adjusting the study protocol and statistical analysis plan following recent receipt of FDA insights. We are working with our CRO (Clinical Research Organization) partner to better understand the time needed to incorporate these changes, conduct the analyses, and execute thorough standard quality checks on both side – a process that could be impacted by the fast-evolving COVID-19 pandemic. We are eagerly anticipating these results and are hopeful that they will support that elafibranor is safe and efficacious for the treatment of NASH, a disease that is affecting millions of patients globally, who are currently without any approved treatments.In 2019, GENFIT also presented positive results from our Phase 2 trial in patients with primary biliary cholangitis (PBC) at major international congresses, showing that elafibranor was significantly better than placebo for both primary and composite endpoints of the study. Elafibranor was awarded “breakthrough therapy” and “orphan drug” designations from the FDA and EMA/FDA, respectively. PBC is a disease where there is still significant unmet medical need, and thus we are committed to the development of elafibranor for this indication. GENFIT also furthered the development of NIS4, our non-invasive diagnostic tool for use in identifying NASH with fibrosis patients who are at risk for progression and who may benefit from treatment. This past year, NIS4 became available for use in clinical research through our partner Labcorp-Covance and has been selected by several sponsors to assist with patient identification and recruitment for NASH clinical trials.Beyond clinical development, 2019 was a year of important commercial activity. GENFIT signed two major deals: one with LabCorp-Covance for the development of NIS4, and secondly with Terns Pharmaceuticals for both the licensing rights of elafibranor in Greater China and an ambitious R&D partnership. We also continued to strengthen our commercial team, through the hiring of new marketing talents and by partnering with leading consultancies. Together, we executed several market research and payer research studies providing valuable insight on needs and expectations of patients, healthcare professionals and payers.Earlier in the year, we solidified our foothold in the U.S. with a successful global offering and Nasdaq initial public offering (IPO) raising gross proceeds of $155MM. Our balance sheet was further bolstered with a $35MM upfront payment from Terns Pharmaceuticals and we finished 2019 with a cash position of €277MM. In September, I had the pleasure of stepping into a new role as CEO with co-founder Jean-François Mouney choosing to transition to full-time leadership as Chairman of the Board, and GENFIT expanded our Executive Committee with the recruitment of a new CMO and the promotion of our Head of Diagnostic business unit. Combined with the relocation of our COO, Dean Hum, to our Cambridge, Massachusetts office, roughly half of our leadership team is now based in the U.S.GENFIT, similar to many biotechnology companies, is affected by the COVID-19 pandemic. The RESOLVE-IT extension phase remains on-going with a few adjustments to protect our patients but, as recently communicated, the remainder of our clinical programs have been put on hold. It is still too early to accurately assess the impact these operational delays will have on our regulatory timelines for NASH, but at this stage, we estimate the timelines to shift by one to two quarters and expect to file the NDA for elafibranor in NASH in 1H21.”Financial results* Financial statements are not audited. The audit procedures by the Statutory Auditors are underway. The Group adopted IFRS 16 Leases for the first time on January 1, 2019Revenues and other incomes – The main contributor to our revenue stream was the $35MM upfront payment received from Terns Pharmaceuticals for the licensing rights of elafibranor in NASH and PBC in Greater China.Operating results and expensesR&D expenditures were stable and aligned with our sustained effort to progress both clinical trials and R&D activities in the diagnostic field.The main driver behind the increased level of expenditures is the ambitious market access, commercial and marketing plan designed to support our Launch Excellence program which is currently driven by an expanding team of internal experts and external consultants.Cash position – Cash position of €277MM, increased versus last year, thanks to the global financing and U.S. IPO on Nasdaq in March 2019, and the upfront payment received by Terns Pharmaceuticals in July 2019.2020 OutlookClinical and regulatory update