On September 30, 2020 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, reported its first half-year 2020 financial report, including the advances of its R&D portfolio and the new GENFIT corporate strategy (Press release, Genfit, SEP 30, 2020, https://ir.genfit.com/news-releases/news-release-details/genfit-first-half-year-2020-financial-report-and-new-corporate [SID1234567816]). The Half Year Business and Financial Report, including the new corporate strategy is available to the public and was filed with the French Autorité des marchés financiers (French Financial Markets Authority) today. The condensed consolidated financial statements are included in this press release and the complete financial statements are available on the "Investors" page of the GENFIT website.
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Conference Call in English on September 30, 2020 at 4:30pm EDT / 22:30 CEST, and in French on October 1, 2020 at 1:30am EDT / 7:30am CEST
Both the English and French conference calls will be accessible on the investor page of our website, under the events section at https://ir.genfit.com/ or by calling 877-407-9167 (toll-free U.S. and Canada), 201-493-6754 (international) or 0 800 912 848 (France) five minutes prior to the start time (no passcode needed). A replay will be available shortly after the call.
New corporate strategy and prospects
The company’s corporate strategy now focuses on two priority areas:
Phase 3 clinical trial ELATIVE evaluating elafibranor in PBC:
Patient enrolment now started, and results expected early 2023, given the current constraints due to the COVID-19 pandemic;
Following the positive Phase 2 data of elafibranor in PBC, the U.S. Food and Drug Administration (FDA) granted elafibranor Breakthrough Therapy designation. The ELATIVE study aims to confirm elafibranor’s previously successful results of efficacy, potential improvement in pruritus and safety in PBC patients;
Current market size for second line therapies in PBC is estimated at ~ $300MM in 2020 and is anticipated to experience double digit growth and estimates for 2025 are up to $1B. Elafibranor is a promising alternative therapy to the existing treatment in PBC, based on the significant unmet needs in this indication.
NIS4TM technology for (NASH) diagnosis:
NIS4TM technology data, recently published in The Lancet Gastroenterology & Hepatology, confirmed the technology’s diagnostic performance and garnered the support of leading NASH experts;
The recently announced exclusive licensing agreement with Labcorp for NIS4 TM technology will enable a large-scale commercial launch as of next year;
NIS4TM addresses patients’ and payers’ requirements as liver biopsy remains the only – although imperfect – approved diagnostic option in the clinical development field and cannot be replicated on a large scale due to its painful and invasive nature, and its cost for healthcare systems. It would be impossible to diagnose all patients with biopsies given the limited number of procedures that can be performed. The blood test commercialized by Lacorp will address these multiple challenges;
The NASH therapeutic market is potentially significant, however, the opportunity is dependent on quick, reliable and easy to execute diagnostic solutions to identify patients. NIS4TM technology represents the essential first step in managing patients with NASH and is the first step for patients to take control, even in the absence of treatments, of their disease.
GENFIT’s new strategy includes a plan, which aims to create two distinct operational subsidiaries by 2021 to enable more independent management and growth:
The first entity would be dedicated to the development of specialty indications, starting with the Phase 3 trial in PBC;
The second entity would house NASH solutions, including all programs related to the identification, evaluation and monitoring of patients with NASH. This independent structure would facilitate future partnerships for NIS4.
The two entities would remain a part of GENFIT as a listed company, who would ensure adequate decision making between both "business" entities, the goal being to best highlight each of the activities to benefit the Group’s valuation.
Concurrently, GENFIT is adopting a plan to reallocate and rationalize all capital with an objective to reduce the cash burn by more than 50% by 2022 compared to our cash burn prior to the RESOLVE-IT Phase 3 data. The program aims to reduce the current cash burn rate from €110M annually before our Phase 3 data, to approximately €45MM annually, beginning in 2022. Due to the residual expenses related to the termination of RESOLVE-IT, 2021 will be a transition year.
This plan incorporates the following key components:
The overall clinical development program for elafibranor in NASH and all activities associated with the commercial launch of elafibranor in NASH have been terminated given the low probability of success compared to required expenses. The termination includes the NASH combination therapy trials, the pediatric trials, and other trials such as the evaluation of the impact of elafibranor on liver fat composition;
A comprehensive cost-saving plan has been implemented, including the redirection of R&D activities and the termination of secondary programs (i.e. the RORgT program);
A workforce restructuring plan aims to reduce the overall workforce by 40%, encompassing both the U.S and France in order to align the company size to the new scope of activity.
Lastly, GENFIT plans to propose to the holders of its OCEANE bond (€180 million nominal amount with a maturity of October 16, 2022) and its shareholders, an adjustment of the terms of the OCEANE convertible bond. The Company’s objective is to begin this process towards the end of the year, in order to have a balance sheet which is structured in line with its new strategy.
Pascal Prigent, CEO of GENFIT, stated: "The decisions we have taken allow us to move GENFIT forward towards 2021 with a clear and precise roadmap. We are confident in the probability of success, and the potential of our two priority programs. The evolution of the company also ensures the structure adapts to our strategy, with an approach that is both organizationally and financially sound."
Key aspects of the half-year 2020 results
Key aspects of the half-year 2020 results are:
Cash and cash equivalents of €225.7 million at June 30, 2020 (€276.7 million at December 31, 2019);
Operating income of €5.9 million (€5.4 million at June 30, 2019), essentially from the Research Tax Credit, which amounted to €5.2 million for the first half 2020 (€5.3 million in the preceding half year);
Operating expenses of €55.0 million (€51.3 million at June 30, 2019) of which 67% represented R&D expenses.
The increase in operating expenses is due to increases in marketing and pre-commercialization expenses, which amounted to €9.5 million in the first half 2020 (€2.9 million in the first half 2019). Marketing and pre-commercialization expenses will significantly decrease as of the second half 2020 due to the discontinuation of the pre-commercialization work for elafibranor in NASH following the termination of this program in July 2020.
General and administrative expenses (€8,2 million in the first half 2020 compared to €9.5 million in the first half 2019) and research and development expenses (€36.9 million in the first half 2020 compared to €38.9 million in the first half 2019) have decreased slightly between 2019 and 2020. These expenses will progressively decrease as of the second half 2020 following the Company’s decision to begin the process of terminating the clinical trials for elafibranor in NASH, terminating secondary programs and to execute a comprehensive cost saving plan over 3 years. Significant expenses related to the termination of the RESOLVE-IT trial will be due in the second half 2020 and in 2021.
As a result of changes in revenues and expenses, the net loss amounted to €53.0 million at June 30, 2020 (€51.1 million at June 30, 2019). The net loss for 2019 was €65.1 million.