Washington, D.C. 20549



PURSUANT TO RULE 13a-16 OR 15d-16


Date of report: April 8, 2020

Commission File Number: 001-38844


(Translation of registrant’s name into English)


Parc Eurasanté

885, avenue Eugène Avinée

59120 Loos, France


(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

☒ Form 20-F ☐ Form 40-F

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐









99.1   Press Release dated April 8, 2020.





Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

        GENFIT S.A.
Date: April 9, 2020       By:   /s/ Pascal PRIGENT
            Name: Pascal PRIGENT
            Title: Chief Executive Officer




GENFIT Reports Full-Year 2019 Financial Results and Corporate Update


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

Key figures (consolidated) *   
(€ thousands, except earnings per share data)  
  Dec 31, 2018 Dec 31, 2019
Revenues and other incomes 7 494 40 961
R&D expenditure (67 024) (66 170)
General and administrative expenses (9 076) (17 265)
Commercial and marketing expenses (717) (13 708) 
Other operating expenses (162) (1 649)
Operating loss (69 484) (57 832)
Financial income 728 5 221
Financial expenses (11 118) (13 110)
Financial loss (10 391) (7 889)
Net loss before tax (79 875) (65 721)
Income tax benefit 354 576
Net loss (79 521) (65 144)
Basic and diluted loss per share (€) (2.55) (1.76)
Cash and cash equivalents 207 240 276 748

* 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, 2019

Revenues 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 expenses

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 Outlook

Clinical and regulatory update

Commercial update

Financial update

      -       GENFIT does not provide guidance on expected cash burn and anticipated cash runway. Expenditures in 2020 will strongly depend on the nature of the topline results from the RESOLVE-IT Phase 3 clinical trial, which remain unknown as of today.

2019 Key Highlights

Clinical and regulatory milestones

·Investigation of elafibranor in NASH

·Investigation of elafibranor in PBC


      -       At AASLD, in November 2019, GENFIT presented new data suggesting that NIS4 was able to outperform other non-invasive diagnostics in identifying NASH with fibrosis in people with type 2 diabetes, a known risk-factor for NASH.

Commercial milestones

Governance and organizational evolution


·Corporate headcount growth

      -       In 2019, GENFIT’s global headcount increased from 148 to 194 employees, through new department creation and expansion of existing teams: market access, commercial, medical affairs, pharmacovigilance, etc.

Conference Call on April 9, 2020 at 8:00 AM EDT / 14:00 CEST

      -       GENFIT will host a Full-Year 2019 Financial Results and Corporate Update conference call on Thursday, April 9, 2020 at 8:00 AM EDT/14:00 CEST. The conference call 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.




Consolidated Statement of Financial Position*

ASSETS   As of
(in € thousands)   2018/12/31 2019/12/31
Current assets    
Cash and cash equivalents   207 240 276 748
Current trade and other receivables   8 794 12 033
Other current assets   2 078 1 968
Inventories   4 4
Total - Current assets   218 116 290 753
Non-current assets    
Intangible assets   796 920
Property, plant and equipment   7 764 16 453
Non-current trade and others receivables   1 489 0
Other non-current financial assets   1 313 1 727
Deferred tax assets   0 0
Total - Non-current assets   11 362 19 099
Total - Assets   229 478 309 853

(in € thousands)   2018/12/31 2019/12/31
Current liabilities    
Current convertible loans   1 312 1 312
Other current loans and borrowings   1 848 3 065
Current trade and other payables   35 974 36 917
Current deferred income and revenue   1 139
Current provisions   112 2 061
Total - Current liabilities   39 248 43 495
Non-current liabilities    
Non-current convertible loans   159 176 164 142
Other non-current loans and borrowings   7 255 15 100
Non-current trade and other payables   (0) 450
Non-current employee benefits   1 085 1 408
Deferred tax liabilities   1 773 1 193
Total - Non-current liabilities   169 291 182 293
Shareholders' equity    
Share capital   7 796 9 715
Share premium   251 554 377 821
Accumulated deficit   (158 897) (238 340)
Currency translation adjustment   6 14
Net loss   (79 521) (65 144)
Total shareholders' equity - Group share   20 939 84 065
Non-controlling interests   0 0
Total - Shareholders' equity   20 939 84 065
Total - Shareholders' equity & liabilities   229 478 309 853

* 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, 2019

Statement of Operations*

    Year ended
(in € thousands, except earnings per share data)   2018/12/31 2019/12/31
Revenues and other income    
Revenue   69 30 839
Other income   7 425 10 122
Revenues and other income   7 494 40 961
Operating expenses and other operating income (expenses)    
Research and development expenses   (67 024) (66 170)
General and administrative expenses   (9 076) (17 265)
Marketing and market access expenses   (717) (13 708)
Other operating income (expenses)   (162) (1 649)
Operating loss   (69 484) (57 832)
Financial income   728 5 221
Financial expenses   (11 118) (13 110)
Financial loss   (10 391) (7 889)
Net loss before tax   (79 875) (65 721)
Income tax benefit   354 576
Net loss   (79 521) (65 144)

* 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, 2019

Statement of Cash Flows*

    Year ended Year ended
(in € thousands)   31/12/2018 31/12/2019
Cash flows from operating activities    
 + Net loss   (79 521) (65 144)
 + Non-controlling interests   0 0
Reconciliation of net loss to net cash used in operating activities    
Adjustments for:    
 + Amortization   1 819 3 263
 + Depreciation and impairment charges   (208) 2 143
 + Expenses related to share-based compensation   787 1 657
 - Gain on disposal of property, plant and equipment   (2) (19)
 + Net finance expenses   10 971 11 437
 + Income tax expense   (354) (576)
 + Other non-cash items   0 (83)
Operating cash flows before change in working capital   (66 507) (47 324)
Change in:    
Decrease / (increase) in inventories   (0) 0
Increase in trade receivables and other assets   (724) (1 640)
Increase in trade payables and other liabilities   11 056 1 284
Change in working capital   10 332 (356)
Income tax paid   93 0
Net cash flows used in operating activities   (56 081) (47 680)
Cash flows from investment activities    
 - Acquisition of property, plant and equipment   (2 938) (2 030)
 + Proceeds from disposal of property, plant and equipment   3 2 517
 - Acquisition of financial instruments   (1 050) (160)
 + Proceeds from sale of financial instruments   0 0
 - Acquisition of subsidiary, net of cash acquired   0 0
Net cash flows provided by / (used in ) investment activities   (3 986) 327
Cash flows from financing activities    
 + Proceeds from issue of share capital (net)   0 126 486
 + Proceeds from subscription / exercise of share warrants   37 43
 + Proceeds from new loans and borrowings net of issue costs   1 800 0
 - Repayments of loans and borrowings   (2 000) (1 884)
 - Financial interests paid (including finance lease)   (6 351) (7 785)
Net cash flows provided by / (used in ) financing activities   (6 514) 116 860
Increase / (decrease) in cash and cash equivalents   (66 580) 69 508
Cash and cash equivalents at the beginning of the period   273 820 207 240
Cash and cash equivalents at the end of the period   207 240 276 748

* 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, 2019


GENFIT is a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases where there are considerable unmet medical needs, corresponding to a lack of approved treatments. GENFIT is a leader in the field of nuclear receptor-based drug discovery, with a rich history and strong scientific heritage spanning more than two decades. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH and GENFIT plans to initiate a Phase 3 clinical trial of elafibranor in patients with PBC. As part of GENFIT’s comprehensive approach to clinical management of patients with NASH, the company is also developing a new, non-invasive blood-based diagnostic test, NIS4, which could enable easier identification of patients with NASH. With facilities in Lille and Paris, France, and Cambridge, MA, USA, the Company has approximately 200 employees. 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). www.genfit.com


This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995, with respect to GENFIT, including timing of publication of the top-line interim results of our Phase 3 RESOLVE-IT clinical trial,  timing of our NDA submission regarding elafibranor in NASH, the impacts of the COVID-19 pandemic on our business, timing of clinical and regulatory milestones and our financial perspective, regulatory and development timelines for our NIS4 technology and its availability as an LDT beyond the clinical research environment,   and our ability to continue supporting activities and to minimize potential delays once the COVID-19 pandemic subsides. The use of certain words, including “believe,” “potential,” “expect” and “will”, “provisional” and similar expressions, is intended to identify forward-looking statements. These forward-looking statements are based on assumptions and estimates by our management, which, although believed to be reasonable, are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, biomarkers, progression of, and results from, its ongoing and planned clinical trials, review and approvals by regulatory authorities of its drug and diagnostic candidates and the Company’s continued ability to raise capital to fund its development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the French Autorité des marchés financiers (“AMF”), including those listed in Section 4 “Main Risks and Uncertainties” of the Company’s 2018 Registration Document filed with the AMF on February 27, 2019 under n° D.19-0078, which is available on GENFIT’s website (www.genfit.com) and on the website of the AMF (www.amf-france.org) and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s final prospectus dated March 26, 2019, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company. In addition, even if the Company’s results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods.  These forward-looking statements speak only as of the date of publication of this document. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.


GENFIT | Investors

Naomi EICHENBAUM – Investor Relations | Tel: +1 (617) 714 5252 | investors@genfit.com


Hélène LAVIN – Press relations | Tel: +333 2016 4000 | helene.lavin@genfit.com

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com