UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
Date of report: September 20, 2023
Commission File Number: 001-38844
GENFIT S.A.
(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): ☐
INCORPORATION BY REFERENCE
The contents of this report on Form 6-K (including Exhibit 99.1 and Exhibits 101) are hereby incorporated by reference into the registrant’s registration statement on Form F-3 (File No. 333-271312) and registration statement on Form S-8 (File No. 333-271311) and related prospectuses, as such registration statements and prospectuses may be amended from time to time, and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished. Information contained on, or that can be accessed through, any website included in Exhibit 99.1 is expressly not incorporated by reference.
EXHIBIT LIST
| Exhibit | Description | |||||||||||||||||||||||||||||||||||||||||||||||||
| 99.1 | ||||||||||||||||||||||||||||||||||||||||||||||||||
| 101.SCH | XBRL Taxonomy Extension Schema Document | |||||||||||||||||||||||||||||||||||||||||||||||||
| 101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | |||||||||||||||||||||||||||||||||||||||||||||||||
| 101.DEF | XBRL Taxonomy Extension Definition Linkbase Documen | |||||||||||||||||||||||||||||||||||||||||||||||||
| 101.LAB | XBRL Taxonomy Extension Label Linkbase Document | |||||||||||||||||||||||||||||||||||||||||||||||||
| 101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | |||||||||||||||||||||||||||||||||||||||||||||||||
SIGNATURES
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: September 20, 2023 | By: | /s/ Pascal PRIGENT | ||||||||||||||||||
| Name: Pascal PRIGENT | ||||||||||||||||||||
| Title: Chief Executive Officer | ||||||||||||||||||||
| Half-Year Business and Financial Report | |||||
| at June 30, 2023 | |||||
 | Half-Year Business and Financial Report at June 30, 2023 | ||||
| Table of Contents | |||||||||||
| 1. | OVERVIEW OF THE GROUP AND ITS MAIN R&D PROGRAMS | ||||||||||
| 2. | HALF-YEAR MANAGEMENT REPORT | ||||||||||
2.1 | Key Events of the First Half of 2023 and Main Events after the Reporting Period | ||||||||||
2.2 | Strategy and Outlook | ||||||||||
2.3 | Operating and Financial Review | ||||||||||
2.4 | Main Transactions with Related Parties | ||||||||||
2.5 | Main Risks and Uncertainties | ||||||||||
| 3. | HALF-YEAR CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AT JUNE 30, 2023 | ||||||||||
3.1 | Consolidated Statements of Financial Position | ||||||||||
3.2 | Consolidated Statements of Operations | ||||||||||
3.3 | Consolidated Statements of Other Comprehensive Loss | ||||||||||
3.4 | Consolidated Statements of Cash Flows | ||||||||||
3.5 | Consolidated Statements of Changes in Equity | ||||||||||
3.6 | Notes to the Consolidated Financial Statements | ||||||||||
| 4. | STATUTORY AUDITORS’ LIMITED REVIEW REPORT ON 2023 HALF-YEAR CONDENSED CONSOLIDATED FINANCIAL STATEMENTS | ||||||||||
| 5. | DECLARATION BY THE PERSON RESPONSIBLE FOR THE INFORMATION | ||||||||||
Disclaimer | ||
This report contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to GENFIT, including, but not limited to statements about GENFIT’s corporate strategy and objectives, our ability to meet milestones and receive payments from Ipsen, the potential of elafibranor to receive marketing authorization and successful launch and commercialization in PBC by Ipsen, anticipated timing for study enrollment and data readouts and development plans for our pipeline programs, expected timing for potential regulatory approvals and the impact of the development of our programs and our internal organization, our ability to qualify for and obtain specific regulatory pathways, as well as our financial outlook including cash flow and cash burn projections and business activity projections for 2023 and beyond. The use of certain words, including “believe, “potential”, “expect”, “target”, “may” and “will” and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements 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 in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, potential commercial success of elafibranor if approved, exchange rate fluctuations, our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 “Main Risks and Uncertainties” of the Company’s 2022 Universal Registration Document filed with the AMF on April 18, 2023, which is available on the Company’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 2022 Annual Report on Form 20-F filed with the SEC on April 18, 2023 and subsequent filings and reports filed with the AMF or SEC, including this Half-Year Business and Financial Report at June 30, 2023 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.
 | Half-Year Business and Financial Report at June 30, 2023 | |||||||
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| 1. | OVERVIEW OF THE GROUP AND ITS MAIN R&D PROGRAMS | |||||||
About GENFIT
GENFIT is a late-stage biopharmaceutical group (the "Group” or “GENFIT” or the "Company”) dedicated to improving the lives of patients with rare and severe liver diseases characterized by high unmet medical needs. The Group includes the parent company GENFIT SA incorporated under French law and two wholly owned subsidiaries: GENFIT Corp. (American subsidiary) and Versantis AG (Swiss subsidiary) whose accounts are consolidated with those of GENFIT SA.
GENFIT is a pioneer in liver disease research and development with a rich history and strong scientific heritage spanning more than two decades. Thanks to its expertise in bringing early-stage assets with high potential to late development and pre-commercialization stages, today GENFIT boasts a growing and diversified pipeline of innovative therapeutic and diagnostic solutions.
Its R&D pipeline covers six therapeutic areas via eight programs which explore the potential of differentiated mechanisms of action, across a variety of development stages (pre-clinical, Phase 1, Phase 2, Phase 3). These diseases are acute on-chronic liver failure (ACLF), hepatic encephalopathy (HE), cholangiocarcinoma (CCA), urea cycle disorders (UCD), organic acidemias (OA) and primary biliary cholangitis (PBC). Beyond therapeutics, GENFIT’s pipeline also includes a diagnostic franchise focused on NASH1 and ACLF.
GENFIT has facilities in Lille and Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). 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). In 2021, IPSEN became one of GENFIT’s largest shareholders and holds 8% of the company’s share capital.
Overview of the main R&D programs of the Company
GENFIT remains faithful to its vocation and its specialization in hepatology, and is evolving towards having a portfolio that covers several serious and rare liver diseases that are characterized by largely unmet medical needs and their significant impact on patients’ lives.
1 At EASL Congress in June 2023, and after several years of discussion among the relevant stakeholders , it was announced that nonalcoholic steatohepatitis (NASH) would now be referred to as Metabolic dysfunction-associated steatohepatitis (MASH). In addition, Nonalcoholic fatty liver disease (NAFLD) will now be referred to as metabolic dysfunction-associated steatotic liver disease (MASLD). GENFIT is progressively transitioning its documentation over to this new nomenclature and both terms may appear in our documents during this period.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
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We are conducting eight therapeutic programs from early to late development stage with a frequent stream of clinical data expected in the coming years:
IND=Investigational New Drug
1All drugs under development are investigational compounds that have not been reviewed nor been approved by a regulatory authority in targeted indications
2Reflects management's anticipated timelines, which are subject to change | based on industry benchmark/average
3Out-licensed to Terns Pharmaceuticals and Ipsen
4In-licensed from Genoscience Pharma
5Repositioned molecule (Nitazoxanide)
6In-licensed from Seal Rock Therapeutics
7Potentially eligible for priority review voucher upon approval by the FDA
8In-licensed from Celloram
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
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| 2. | HALF-YEAR MANAGEMENT REPORT | |||||||
| 2.1 | Key Events of the First Half of 2023 and Main Events after the Reporting Period | |||||||
PBC: Positive Results from Phase 3 ELATIVE® trial | ||||||||
On June 30, 2023 Ipsen and GENFIT announced positive interim topline data from the pivotal ELATIVE® Phase 3 trial. The first part of the trial assessed the efficacy and safety of elafibranor, an investigational dual α,δ PPAR agonist, in the treatment of patients with the rare cholestatic liver disease, primary biliary cholangitis (PBC), who have an inadequate response or intolerance to the current standard of care therapy, ursodeoxycholic acid (UDCA). Results position elafibranor as a potentially important new treatment option, where there is still high unmet need.
The trial met the primary endpoint with a statistically significant higher percentage of patients achieving a clinically meaningful reduction in cholestasis compared to patients who received placebo. 51% of patients on elafibranor 80mg achieved a cholestasis response compared with 4% on placebo (p<0.0001). Cholestasis response is defined in the trial as alkaline phosphatase (ALP) <1.67 x upper limit of normal (ULN), an ALP decrease ≥ 15 percent and total bilirubin (TB) ≤ ULN at 52 weeks. ALP and bilirubin are important predictors of disease progression. Reductions in levels of both can indicate reduced cholestatic injury and improved liver function.
The first key secondary endpoint, normalization of ALP at Week 52, was also met with statistically significant improvements for investigational elafibranor compared with placebo. For the other key secondary endpoint, a trend for pruritus improvement was observed with a greater decrease from baseline in the PBC Worst Itch NRS score for patients on elafibranor compared to placebo, which did not reach statistical significance.
In the study, elafibranor was generally well tolerated with a safety profile consistent with that observed in previously reported studies.
Ipsen will assume responsibility for all additional clinical development, including completion of the long-term extension period of the ELATIVE® trial, and global commercialization (outside of Greater China, where elafibranor is licensed to Terns).
Ipsen announced that it intends to submit regulatory applications for elafibranor following discussions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
ACLF franchise1: Strengthening the R&D portfolio and advancing ongoing programs | ||||||||
GENFIT’s ACLF franchise1 now comprises five assets (VS-01, NTZ, SRT-015, CLM-022, VS-02-HE) based on differentiated mechanisms of action leveraging complementary pathways.
VS-01-ACLF: First patient randomized in the Phase 2 trial | ||
VS-01 is currently being evaluated in the international UNVEIL-IT™ Phase 2, open-label, randomized, controlled, multi-center, proof of concept study to assess its efficacy, safety, and tolerability in addition to standard of care (SOC), compared to SOC alone, in adult patients with ACLF grades 1 and 2 and ascites.
IND (Investigational New Drug) was in effect as of April 17, 2023, and the first patient was randomized in the Phase 2 trial in early July. The trial is expected to enroll approximately 60 adult patients with ACLF grades 1 and 2 Patients will be randomized in a 1:1 ratio to receive either daily intraperitoneal administration of VS-01 over 4 days on top of SOC (active treatment group) or SOC alone (control group).
The primary objective of the study is to measure efficacy using the Chronic Liver Failure Consortium (CLIF-C) ACLF score at day 7.
1 Including HE as a therapeutic area closely associated with ACLF
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
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Interim data are expected to be available in the first half of 2024 with the objective of supporting preparation of further testing of efficacy. Given the high unmet need in this indication and the Orphan Drug Designation obtained from the US Food and Drug Administration for VS-01, it is expected that the program may qualify for some of the expedited regulatory pathways provided by health authorities.
NTZ in ACLF: Phase 1 clinical data | ||
In May 2023, GENFIT presented Phase 1 clinical data evaluating NTZ as part of its Acute-on-Chronic Liver Failure (ACLF) Program at Digestive Disease Week®.
The Phase 1, open-label clinical study was conducted to evaluate the safety, tolerability and pharmacokinetics (PK) of nitazoxanide (NTZ) in subjects with hepatic impairment (HI), as part of GENFIT’s NTZ in ACLF program. For the study, subjects between 18 and 75 years of age with HI received repeated oral dose administration of NTZ 500 mg twice a day for 7 days. NTZ was generally well tolerated, with a favorable safety profile, in subjects with moderate and severe HI. Preliminary data from a similar Phase 1 study conducted in subjects with renal impairment also support a favorable safety and tolerability profile. Taken together, safety and pharmacokinetic results, as well as exploratory pharmacodynamic data, support further clinical development of NTZ in patients with ACLF.
In addition, at the European Association for the Study of the Liver (EASL) Congress 2023 GENFIT presented preclinical data showing beneficial effects of NTZ in ACLF disease model.
Following engagement with FDA, and on the basis of the preclinical work and Phase 1 data confirming the potential of NTZ in ACLF, GENFIT has decided to pursue the development of a new nitazoxanide formulation, which will permit greater dosing flexibility. As a result of this decision, and subject to successful development of a new formulation, we have revised the expected launch date of a Phase 2 clinical trial to the first half of 2025, which would cover both clinical study scenarios (healthy volunteers or patients with ACLF).
Exclusive worldwide rights licensed from Seal Rock Therapeutics for injectable formulation of ASK1 Inhibitor SRT-015 in acute liver disease | ||
In May 2023, GENFIT licensed the exclusive worldwide rights of ASK1 Inhibitor SRT-015 (injectable formulation in acute liver disease) from Seal Rock Therapeutics, a Seattle, Washington (USA) based clinical stage company developing first-in-class and best-in-class kinase inhibitors.
Preclinical and clinical evidence support ASK1 inhibition as a relevant therapeutic strategy in multi-system disorders such as Acute-on-Chronic Liver Failure (ACLF). ASK1 inhibition has shown several potentially beneficial effects that may be relevant in ACLF, such as blocking LPS (lipopolysaccharide) associated hyperinflammatory response, reducing the ROS (Reactive Oxygen Species)-related immune response, reducing apoptosis, reducing release of the proinflammatory cytokines, reducing fibrosis, and protecting macrophage mitochondrial function. Multi-organ benefits have been observed in several animal models and clinical trials.
A First-in-Human study is planned in the second half of 2024 to support a Proof-of-Concept study in ACLF patients as early as 2025.
Under the terms of the agreement, Seal Rock Therapeutics is eligible for payments of up to 100 million euros, including regulatory, clinical and commercial milestones, as well as tiered royalties. This agreement does not have any material impact on our financial forecast included in section 2.2 of this report, insofar as virtually all of these payments would only begin to become due following positive Phase 2 results, which would not occur before 2026, according to our best estimates.
Exclusive worldwide rights licensed from Celloram Inc. for CLM-022 in liver disease | ||
In July 2023, GENFIT licensed the exclusive worldwide rights to CLM-022, a first-in-class inflammasome inhibitor, from Celloram Inc., a Cleveland-based biotechnology company. GENFIT will leverage Celloram’s acquired scientific insights on this molecule, to finalize IND enabling studies of this preclinical stage asset and secure an IND for future clinical trials. A preclinical proof-of-concept is targeted for 2024.
Under the terms of the agreement, Celloram is eligible for payments of up to 160 million euros, including regulatory, clinical and commercial milestones, as well as tiered royalties. This agreement does not have any material impact on our financial forecast included in section 2.2 of this report, insofar as virtually all of these payments would only begin to become due following positive Phase 2 results, which would not occur before 2028, according to our best estimates.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
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VS-02-HE preclinical program | ||
VS-02-HE is in preclinical stages and is being developed in Hepatic Encephalopathy (HE).
HE is one of the major complications of advanced liver disease and portal hypertension. As many as 45% of patients with cirrhosis will experience at least one episode of HE.
VS-02-HE is a urease inhibitor designed to inhibit ureases by binding to nickel atoms in their active site.
IND enabling nonclinical studies are targeted to be completed in 2025.
CCA: First patient screening in a Phase 1b/2a study evaluating GNS561 | ||||||||
The first patient is expected to be screened in the second half of 2023 in a Phase 1b/2a study evaluating GNS561 in patients with KRAS mutated cholangiocarcinoma (CCA).
In the Phase 1b, patients are enrolled to evaluate the safety and tolerability of GNS561 when given in combination with a MEK inhibitor, and to identify the recommended doses of the combination to be administered in the Phase 2a study. First biomarker data are expected to be available as early as the first half of 2024 and should support preparation of further evaluation of efficacy with the optimal doses of GNS561 and a MEK inhibitor in Phase 2a of the study.
Given the high unmet need in this indication and the Orphan Drug Designation obtained from the FDA for GNS561, it is expected that the program may qualify for some of the expedited regulatory pathways provided by health authorities.
UCD and OA: preclinical programs | ||||||||
In addition to PBC, ACLF, HE and CCA, GENFIT is also pursuing the development of preclinical programs in other indications with high unmet needs through the development of VS-01-HAC.
VS-01-HAC is a potential first-line lifesaving treatment for acute hyperammonemic crisis associated with Inborn Errors of Metabolism in Urea Cycle Disorders (UCD) and Organic Acidemias (OA).
Investigational New Drug (IND) enabling nonclinical studies are targeted to be completed in 2024.
| NASH Diagnostic: Publication of the Development and Validation of NIS2+™ in the Journal of Hepatology | ||||||||
In May 2023, GENFIT published on the development and validation of NIS2+™ in the Journal of Hepatology, which is one of the leading medical journals in the world.
NIS2+™ is a next-generation technology for the diagnosis of at-risk Non-Alcoholic Steatohepatitis (NASH)2. It is a non-invasive diagnostic technology designed as an optimization of NIS4® technology, a blood-based panel currently used to detect at-risk NASH. NIS2+™ is the only blood-based technology developed for the identification of at-risk NASH allowing it to be applied for large-scale use in clinical practice. There is currently a high unmet medical need for an In Vitro Diagnostic (IVD) in NASH.
NIS2+™ has demonstrated the robust and improved clinical performance of NIS2+™ allowing an efficient identification of at-risk NASH, irrespective of patient characteristics such as age, sex and type 2 diabetes. It was also demonstrated that NIS2+™ is an effective screening tool for the enrollment of patients with at-risk NASH in clinical trials, reducing liver biopsy failure rates and associated costs without inflating the number of patients to screen.
GENFIT continues to explore the possibility of obtaining regulatory approval and CE Certificates of Conformity, with a development and commercial partner, to release an IVD test powered by NIS2+™ technology on the US and European markets.
2 At EASL Congress in June 2023, and after several years of discussion among the relevant stakeholders , it was announced that nonalcoholic steatohepatitis (NASH) would now be referred to as Metabolic dysfunction-associated steatohepatitis (MASH). In addition, Nonalcoholic fatty liver disease (NAFLD) will now be referred to as metabolic dysfunction-associated steatotic liver disease (MASLD). GENFIT is progressively transitioning its documentation over to this new nomenclature and both NASH and MASH terms may appear in our documents during this period.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
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In addition, at the European Association for the Study of the Liver (EASL) Congress 2023 GENFIT presented NIS2+™ as an effective screening tool for optimizing patient selection in clinical trials targeting at-risk Non-Alcoholic Steatohepatitis (NASH) and NIS2+™ as the most adapted Non-Invasive Test (NIT) for an efficient identification of at-risk NASH that is not impacted by age.
Interactions with the financial community | ||||||||
During the first half of 2023, we had the opportunity to interact with many of our stakeholders, including members of the financial community.
For example, we participated in the following conferences:
•Corporate Access Events during the 41st JPMorgan Healthcare Conference in January
•Biotech Showcase: the investor conference for innovators in January
•26th ODDO BHF Forum in January
•Invest Securities Biomed Forum in January
•Degroof Petercam’s Virtual Healthcare Conference in January
•SVB Securities Global Biopharma Conference in February
•Kempen Lifesciences Conference in April
In addition, we held the following events for the financial community and shareholders:
•April: webcast and Q&A for the presentation of 2022 financial results
•May: in-person annual shareholders' meeting
•June: webcast and Q&A for the announcement of ELATIVE® trial interim topline data
Over the first part of the year, GENFIT also maintained regular contact with the financial community via non-deal roadshows and media interviews.
| Main events related to Corporate Governance | ||||||||
At the Company’s Annual Shareholders’ Meeting held on May 24, 2023, all of the resolutions endorsed by the Board of Directors were adopted by a significant majority of the votes cast; this includes the renewal of financial authorizations that would allow the Company flexibility to seize relevant market opportunities.
In June 2023, Sandra Silvestri, M.D., Ph.D., replaced Steven Hildemann M.D., Ph.D., on the Board of Directors of the Company as representative of IPSEN, the legal entity that holds the board seat.
Sandra Silvestri, M.D., Ph.D., joined Ipsen in 2023 as Executive Vice President, Chief Medical Officer and Head of Global Medical Affairs, Patient Safety and Patient Affairs.
Prior to joining Ipsen, Ms. Silvestri held multiple leadership roles at Sanofi, where she was most recently SVP Chief Medical Officer for General Medicine GBU, leading a team of 1,600 medical employees worldwide. She also held several leadership positions at Eli Lilly in multiple disease areas including diabetology, endocrinology, neuroscience, immunology, dermatology, and oncology.
Sandra Silvestri is a medical doctor specialized in endocrinology and metabolic diseases. She has been an investigator in several clinical studies, published numerous book chapters as well as scientific articles in international journals, been a speaker in several national and international congresses, and from 2017 to 2023 she led the Gender Balance Board and Global Network at Sanofi. She stays active as a professor at the medical schools of the University of Florence, Italy, and Descartes University in Paris. She has lived in Italy, Denmark, USA, France, and speaks Italian, English and French.
Furthermore, in the first half of 2023, Sakina Sayah Jeanne and Tom Huijbers joined the Executive Committee, respectively as Executive Vice-President Research & Translational Science and Executive Vice-President Regulatory.
ESG commitment | ||||||||
In the first half of 2023, GENFIT's ESG commitment and performance were recognized by independent stakeholders:
•In July, GENFIT was awarded a gold medal by Ethifinance (compared to bronze in 2022) and ranked 2 out of 75 companies in the biopharmaceutical sector. This upgrade in the ratings is a testament to a company-wide effort in implementing our CSR initiatives and ensuring transparent communications in relation to our CSR approach.
•In June, GENFIT was classified by ODDO Research as "Best-in-Class" in its sector, based on two main criteria: activity impact and ESG maturity.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
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•In January 2023, GENFIT obtained a “Prime status” label by ISS ESG, upgrading its corporate rating from C to C+.
In the second half of 2023, GENFIT will continue to reaffirm its commitment to social/societal responsibility and sustainable development.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
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| 2.2 | Strategy and Outlook | |||||||
| Our approach to generate value | ||||||||
In terms of drug development, our goal is to focus our efforts in one specific area - rare and severe liver diseases - for greater operational efficiency. In order to distribute the risk across different programs, we target different but also complementary mechanisms of action, with the goal to improve our chances of success.
Our goal is also to reduce development timelines, and we therefore favor two approaches to strengthen our portfolio:
•Repurposing of molecules approved in other indications (e.g. NTZ, an antiparasitic drug, in ACLF); and
•In-licensing and/or acquisition of molecules initially developed by other companies (CCA: GNS561 from Genoscience Pharma; ACLF: VS-01-ACLF, SRT-015 and CLM-022 from respectively Versantis AG, Seal Rock Therapeutics and Celloram Inc.).
In addition, it is expected that most of the programs we pursue may qualify for some of the expedited regulatory pathways provided by health authorities, given the unmet medical needs that exist in the disease areas we target, as well as our candidates' profiles (e.g. Orphan Drug designation).
GENFIT's ambition is to develop drug candidates from the earliest stages up to the latest stages, including Phase 3. Depending on predefined criteria such as the targeted indication or competitive environment, or potential opportunities in terms of partnerships, GENFIT will then choose what we consider to be the best option to commercialize our most promising assets for which the company has not yet licensed the rights:
•Build our own marketing and sales forces to commercialize the asset on our own, or
•Leverage the existing relationship with preferred commercial partner Ipsen which provides a natural path to commercialization, or
•Commercialize via another partner.
We consider the patient journey as a whole and are also looking to continue to be present in the diagnostic field, specifically to determine which populations to treat within the therapeutic areas we are targeting with our drug candidates.
Our corporate priorities in 2023, and progress to date | ||||||||
To ensure the efficient execution of the previously described strategy in 2023, GENFIT has defined three top corporate priorities:
•to execute our ongoing programs: transition with our partner Ipsen in PBC and to progress our therapeutic programs in ACLF and CCA:
◦PBC: with the successful outcome of the first phase of the ELATIVE® trial at the end of June, the responsibility of the pursuit of this program is progressively being transferred over, country to country, to Ipsen. Furthermore, Ipsen is responsible for NDA filing, long-term study, commercialization, lifecycle management, etc.
◦ACLF: with first patients now enrolled in our trials on VS-01, execution is on track.
◦CCA: the enrollment of the first patient is expected before the end of the year.
•to capitalize on the excellence of our research, continuing to rely on our pioneering work in ACLF:
◦With three additional assets added to our ACLF franchise3 since the beginning of the year, our leadership in the field has further consolidated.
•to continue to strengthen our organization, both on the financial and human aspects:
◦We believe the success of the first phase of our Phase 3 ELATIVE® will considerably strengthen our cash position and financial visibility, if the product is approved, due to the potential revenue stream of milestone payments and royalties GENFIT is eligible for under the license agreement signed with Ipsen in December 2021;
◦We also believe that our ESG/extra-financial performance ("gold medal" by Ethifinance, "Best-in-Class" by ODDO Research and "Prime status" by ISS) demonstrates our strong commitment to a robust governance model that addresses material issues in business sustainability, social, societal and environmental challenges.
3 Including HE as a therapeutic area closely associated with ACLF
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
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| Impact on financial outlook | ||||||||
We expect that our existing cash, cash equivalents and current financial assets will enable us to fund our operating expenses and capital expenditure requirements until approximately the fourth quarter of 2024. This is based on current assumptions and without taking exceptional events into account, as well as potential milestones and royalties that the Company may receive pursuant to the licensing agreement with Ipsen. In addition, as we continue to advance our current product candidates, conduct preclinical studies and conduct clinical trials, we expect that our cash used in operational activities will amount to approximately €60 million in 2023.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
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| 2.3 | Operating and Financial Review | |||||||
| 2.3.1 | Comments on the condensed statement of net income for the periods ended June 30, 2022 and June 30, 2023 | |||||||
Revenue and other income | ||
The Company’s revenue and other income mainly comprises revenue, the research tax credit, and other operating revenue.
| Revenue and other income | Half-year ended | ||||||||||
| (in € thousands) | 2022/06/30 | 2023/06/30 | |||||||||
| Revenues | 8,790 | 11,482 | |||||||||
| CIR tax credit | 3,343 | 3,547 | |||||||||
| Government grants and subsidies | 9 | 82 | |||||||||
| Other operating income | 46 | 263 | |||||||||
| TOTAL | 12,188 | 15,374 | |||||||||
For the half-year ended June 30, 2023, total revenues and other income amounted to €15,374 (€12,188 for the same period in 2022).
Revenues
For the half-year ended June 30, 2023, Revenue amounted to €11,482 in 2023 (€8,790 for the same period in 2022).
Revenue is primarily composed of:
•Licensing Agreement (Ipsen). In December 2021, GENFIT and Ipsen entered into an exclusive licensing agreement for elafibranor, a Phase 3 asset evaluated in Primary Biliary Cholangitis (PBC), as part of a long-term global partnership ("Collaboration and License Agreement").
◦During the first six months of 2023, €8.2 million was attributable to the partial recognition of deferred revenue as noted in Note 21 - "Deferred income and revenue".
◦During the first six months of 2022, €8.2 million was attributable to the partial recognition of deferred revenue as noted in Note 21 - "Deferred income and revenue".
•Transition Services Agreement (Ipsen). In 2022, GENFIT and Ipsen entered into a Service Transition Agreement, which describes the scope of the services provided by GENFIT to Ipsen in order to facilitate the transition of certain activities related to the Phase 3 clinical trial, evaluating elafibranor in PBC.
◦During the first six months of 2023, services provided under this contract generated €3.2 million in revenue.
◦During the first six months of 2022, services provided under this contract generated €0.6 million in revenue.
CIR tax credit
For the half-year ended June 30, 2023, the research tax credit (CIR) amounted to €3,547 in 2023 (€3,343 for the same period in 2022), due to an increase in research and development activity.
The research tax credit receivable from amounted to €14,847 as of June 30, 2023, €6,017 of which relates to 2022 and €5,282 of which relates to 2021. The balance for 2021 and 2022 has not yet been reimbursed in 2023 given the ongoing tax audit.
Other operating income
During the first six months of 2023, the Group recognized €263 in “Other operating income” (€46 for the same period in 2022), mainly comprised of exchange gains on trade receivables.
Operating Expenses by destination | ||
The tables below break operating expenses down by destination, mainly into research and development expenses, general and administrative expenses, marketing and market access expenses, and restructuring and reorganization expenses.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
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| Operating expenses and other operating income (expenses) | Half-year ended | Of which : | ||||||||||||||||||||||||||||||||||||||||||
| 2022/06/30 | Raw | Contracted | Employee | Other | Depreciation, | Gain / | ||||||||||||||||||||||||||||||||||||||
| materials | research and | expenses | expenses | amortization | (loss) on | |||||||||||||||||||||||||||||||||||||||
| and | development | (maintenance, | and | disposal of | ||||||||||||||||||||||||||||||||||||||||
| consumables | activities | fees, travel, | impairment | property, | ||||||||||||||||||||||||||||||||||||||||
| used | conducted by | taxes…) | charges | plant and | ||||||||||||||||||||||||||||||||||||||||
| (in € thousands) | third parties | equipment | ||||||||||||||||||||||||||||||||||||||||||
| Research and development expenses | (17,599) | (1,052) | (8,538) | (4,889) | (2,408) | (712) | — | |||||||||||||||||||||||||||||||||||||
| General and administrative expenses | (8,229) | (133) | (38) | (3,230) | (4,580) | (248) | — | |||||||||||||||||||||||||||||||||||||
| Marketing and market access expenses | (460) | (2) | — | (272) | (182) | (3) | — | |||||||||||||||||||||||||||||||||||||
| Reorganization and restructuring income (expenses) | 179 | — | — | — | (1) | 180 | — | |||||||||||||||||||||||||||||||||||||
| Other operating expenses | (423) | — | — | — | (422) | — | (1) | |||||||||||||||||||||||||||||||||||||
| TOTAL | (26,532) | (1,187) | (8,576) | (8,391) | (7,594) | (783) | (1) | |||||||||||||||||||||||||||||||||||||
| Operating expenses and other operating income (expenses) | Half-year ended | Of which : | ||||||||||||||||||||||||||||||||||||||||||
| 2023/06/30 | Raw | Contracted | Employee | Other | Depreciation, | Gain / | ||||||||||||||||||||||||||||||||||||||
| materials | research and | expenses | expenses | amortization | (loss) on | |||||||||||||||||||||||||||||||||||||||
| and | development | (maintenance, | and | disposal of | ||||||||||||||||||||||||||||||||||||||||
| consumables | activities | fees, travel, | impairment | property, | ||||||||||||||||||||||||||||||||||||||||
| used | conducted by | taxes…) | charges | plant and | ||||||||||||||||||||||||||||||||||||||||
| (in € thousands) | third parties | equipment | ||||||||||||||||||||||||||||||||||||||||||
| Research and development income (expenses) | (25,630) | (1,040) | (14,367) | (6,299) | (3,251) | (705) | 33 | |||||||||||||||||||||||||||||||||||||
| General and administrative expenses | (9,105) | (162) | (96) | (3,919) | (4,645) | (283) | — | |||||||||||||||||||||||||||||||||||||
| Marketing and market access expenses | (520) | (2) | (1) | (275) | (236) | (6) | — | |||||||||||||||||||||||||||||||||||||
| Reorganization and restructuring income (expenses) | 633 | — | — | — | — | 633 | — | |||||||||||||||||||||||||||||||||||||
| Other operating income (expenses) | (52) | — | — | — | (75) | 3 | 20 | |||||||||||||||||||||||||||||||||||||
| TOTAL | (34,673) | (1,204) | (14,464) | (10,492) | (8,207) | (358) | 52 | |||||||||||||||||||||||||||||||||||||
For the half-year ended June 30, 2023 operating expenses amounted to €34,673 (€26,532 for the same period in 2022).
They include the following:
Research and development expenses
For the first six months of 2022, research and development expenses totaled €17.6 million, or 66.3% of our total operating expenses. These expenses were comprised of €8.5 million in contracted research and development conducted by third parties, €4.9 million in employee expenses, €2.4 million in other expenses, €0.7 million in depreciation, amortization and impairment charges and €1.1 million in raw materials and consumables.
For the first six months of 2023, research and development expenses totaled €25.6 million, or 72.8% of our total operating expenses. These expenses were comprised of €14.4 million in contracted research and development conducted by third parties, €6.3 million in employee expenses, €3.3 million in other expenses, €0.7 million in depreciation, amortization and impairment charges and €1.0 million in raw materials and consumables.
The increase of €5.8 million in contracted research and development conducted by third parties is mainly due to:
•Increasing costs related to the ELATIVE® product candidate of €2.8 million
•Increasing costs related to the VS-01 product candidate of €2.3 million,
•Increasing costs related to the GNS561 product candidate of €2.3 million,
•Increasing costs related to the NTZ product candidate €2.6 million, and
•The elafibranor project in NASH which recorded a final accrual reversal of €(1) million, which did not repeat in 2023.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
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The increase of €1.4 million in employee expenses, consisting of wages, salaries, social security, pension costs and share-based compensation paid to employees in the research and development function, relates primarily to the increase in workforce (from 82 to 96 employees at June 30, 2022 and 2023, respectively), which includes a 7 person increase due to the Versantis acquisition.
The increase of €0.8 million in other expenses is mainly due to increasing costs related to consultants of €0.7 million, increasing costs related to patent applications of €0.1 million, decreasing costs related to recruiting fees of €0.1 million and increasing costs related to rent expenses of €0.1 million.
General and administrative expenses
For the first six months of 2022, general and administrative expenses totaled €8.2 million. These expenses were mainly comprised of €3.2 million in employee expenses and €4.6 million in other expenses.
For the first six months of 2023, general and administrative expenses totaled €9.1 million. These expenses were mainly comprised of €3.9 million in employee expenses and €4.6 million in other expenses.
The increase in general and administrative employee expenses was mainly due to the increase in workforce (from 50 to 56 employees at June 30, 2022 and 2023, respectively). Other expenses remained stable period over period.
Marketing and market access expenses
For the first six months of 2022, marketing and market access expenses totaled €0.5 million. These expenses were mainly comprised of €0.3 million in employee expenses and €0.2 million in other expenses.
For the first six months of 2023, marketing and market access expenses totaled €0.5 million. These expenses were mainly comprised of €0.3 million in employee expenses and €0.2 million in other expenses.
Marketing and market access expenses remained stable period over period.
Reorganization and restructuring income (expenses)
For the first half of 2022, reorganization and restructuring income amounted to €0.2 million.
For the first half of 2023, reorganization and restructuring income amounted to €0.6 million.
During the first half of 2023, the Group reversed the entire remaining RESOLVE-IT® provision consisting of un-used building space, which are now in use.
Financial income (expenses) | ||
For the half-year ended June 30, 2023, financial income amounted to loss of €1.1 million, compared to a gain totaling €4.0 million for the same period in 2022.
For the first six months of 2022, the €4 million gain is a result of €6.0 million in realized and unrealized foreign exchange gains and €0.2 million in accrued and realized interest income, offset by interest expense of €2.2 million.
For the first six months of 2023, the €1.1 million loss is a result of €2.3 million in interest expense coupled with €0.6 million in foreign exchange losses, partially offset by €1.6 million in accrued and realized interest income.
Net income (loss) | ||
The first half of 2023 resulted in net loss of €20,854 thousand compared with a net loss of €10,399 thousand in the first half of 2022.
2.3.2 | Comments on the Group’s Cash Flows for the periods ended June 30, 2022 and June 30, 2023 | |||||||
As of June 30, 2023, cash and cash equivalents amounted to €111,826 (€136,001 as of December 31, 2022).
Over the period, changes in cash flow by type of flow were as follows:
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
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| Half-year ended | ||||||||||||||
| (in € thousands) | 2022/06/30 | 2023/06/30 | ||||||||||||
| Cash flows provided by (used in) operating activities | (47,499) | (25,074) | ||||||||||||
| Cash flows provided by (used in) investment activities | (199) | 2,682 | ||||||||||||
| Cash flows provided by (used in) financing activities | (1,943) | (1,764) | ||||||||||||
TOTAL | (49,641) | (24,156) | ||||||||||||
Cash flows provided by (used in) operating activities | ||
Cash flow used in operating activities amounted to an outflow of €25,074 thousand for the half-year ended June 30, 2023 compared with an outflow of €47,499 thousand for the half-year ended June 30, 2022.
In the first half of 2023, this amount mainly stems from our net loss of €20,854 thousand, which is largely the result of our research and development efforts; notably for ELATIVE®, our Phase 3 clinical trial of elafibranor in PBC; UNVEIL-IT™, our Phase 2 clinical trial of VS-01 in ACLF; GNS561, as part of its cholangiocarcinoma program; and NTZ, as part of its ACLF program.
In the first half of 2022, these cash flows include the disbursement of €24,000 thousand corresponding to the VAT on the upfront payment received from Ipsen under the licensing agreement entered into in December 2021, as well as the disbursement of the legally required employee participation to the profits of GENFIT SA for a total of €628 thousand.
These cash flows reflect GENFIT’s business, which requires significant research and development efforts, and generates expenses that change in line with progress on the Company’s research programs, net of its operating revenues.
Cash flows provided by (used in) investing activities | ||
Cash flow used in investing activities amounted to €2,682 thousand in the first half of 2023, compared with €(199) thousand in cash flow provided in the first half of 2022.
These cash flows include acquisitions, disposals and repayments of fixed assets and financial assets.
Cash flows provided by (used in) financing activities | ||
Cash flow used in financing activities amounted to €1,764 thousand in the first half of 2023, compared with €1,943 thousand in the first half of 2022.
In the first half of 2023, these cash flows mainly reflect financial interest received and paid, the amount of which is stable compared with first half of 2022.
Currencies | ||
GENFIT has expenses and owns bank accounts in multiple currencies, including the Euro (EUR), the US Dollar (USD) and the Swiss Franc (CHF) (given the Versantis acquisition in 2022). For further information please refer to Note 7.1 - "Foreign exchange risk" of section 3.6 - Notes to the consolidated financial statements.
| 2.4 | Main Transactions with Related Parties | |||||||
Investors are invited to refer to the information provided in Item 7.B - Related Party Transaction and note 28 to the Consolidated Annual Financial Statements for the year ended December 31, 2022 in the 2022 Annual Report on Form 20-F (the "2022 Form 20-F") for a summary of the Company's principal ongoing transactions with related parties. Transactions with related parties occurring during the first half of 2023 are described in Note 25 - "Related parties" of the half year condensed consolidated financial states for the period ended June 30, 2023 included in section 3 of this report.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
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| 2.5 | Main Risks and Uncertainties | |||||||
We encourage investors to take into consideration all of the information presented in our 2022 Form 20-F and in this Half-Year Business and Financial Report before deciding to invest in Company shares. This includes, in particular, the risk factors described in Item 3.D. “Risk Factors” of the 2022 Form 20-F (and the contents of this section), of which the realization may have (or has had in some cases) material adverse effect on the Group and its activity, financial situation, results, development or perspectives, and which are of importance in the investment decision-making process.
With the exception of the following risk factors, which are updated and replaced as below, our review of our risk factors has not prompted any modifications in the nature, quantity or categories of risk factors, nor in their ranking in terms of probability of occurrence or impact, in comparison with what was presented in Item 3.D “Risk Factors” of the 2022 Form-20-F. The risks faced by the Company and described in the 2022 Form 20-F remain essentially the same.
Our drug candidate development activities are focused primarily on the development of our drug candidate elafibranor in PBC as well as on other drug candidates for which development is less advanced. Drug development is subject to a number of risks.
In 2019, we entered into a licensing and collaboration agreement with Terns Pharmaceuticals for elafibranor in China, Hong Kong, Macau and Taiwan (Greater China), and in December 2021, the remaining worldwide rights to elafibranor in all indications were licensed to Ipsen. As part of the collaboration with Ipsen, elafibranor, our most advanced drug candidate, is currently being evaluated in a Phase 3 ELATIVE® clinical trial in primary biliary cholangitis, or PBC. We announced the positive interim topline data for this trial at the end of June 2023. Pursuant to our agreement with Ipsen and in light of the ELATIVE® trial design, we began, over the course of summer 2023, transferring the conduct of the ELATIVE® study to Ipsen in certain countries, and we expect this transfer to be completed in other countries by the beginning of 2024.
Only two treatments are currently approved and marketed in this indication, UDCA, approved by the FDA to treat PBC in 1997, and Ocaliva, approved by the FDA and European Commission for the treatment of PBC in combination with UDCA in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA, and these treatments do not meet the medical needs of all patients. A limited number of treatments are therefore approved for the management of this disease and we have little experience with drug development in this disease area. The development and approval of drug candidates to treat PBC may therefore present an even higher level of risk than in other indications.
Although the topline data from the Phase 3 ELATIVE® clinical trial that we announced at the end of June 2023 were positive, it is possible that this clinical trial, and our other ongoing or future clinical trials in general, could fail to meet their primary endpoints, as was the case with our Phase 3 RESOLVE-IT® trial evaluating elafibranor in non-alcoholic steatohepatitis, or NASH, in 2020, or are delayed, additional development is necessary. Despite a favorable outcome in clinical trials, the regulatory authorities may also consider that the clinical results of these trials are insufficient to grant or maintain a marketing authorization. These different risks are further described below.
Our other development programs (VS-02-HE, SRT-015 and CLM-022) are at a much earlier stage of development, while others (VS-01-ACLF and GNS561) are in Phase 2 clinical trial (see section 2.1 - Key Events of the First Half of 2023 and Main Events after the Reporting Period). Clinical development of these product candidates faces similar risks and challenges as our development of elafibranor in PBC.
A failure of the clinical program for elafibranor in PBC, or a delay or the failure to receive related marketing authorization for the product would therefore have a negative impact, even more so since it would impact our most advanced product candidate in our portfolio of drug candidates, and because represents the most significant source of potential revenues for the Group in the short term. As a result, our ability to fund our other programs could be severely impacted which could significantly affect the future of our Group.
Clinical failure can occur at any stage of clinical development, as was the case with our Phase 3 RESOLVE-IT® trial of elafibranor in NASH4. The results of earlier clinical trials and interim data are not necessarily predictive of future results and elafibranor in PBC or any other product candidate (NTZ or GNS561 or VS-01 or any other current or future drug candidates) that we or our collaborators advance through clinical trials may not have favorable results in later clinical trials, which may delay, limit or prevent our ability to receive regulatory approval or marketing authorization.
Clinical failure can occur at any stage of our clinical development or those of our current partner or a future partner. Clinical trials may produce negative or inconclusive results, and we or our collaborators may decide, or regulators may require us, to conduct additional clinical trials or preclinical studies. In addition, interim data or other data obtained from trials and studies are subject to varying interpretations, and regulators may not interpret our data as favorably as we or our collaborators do, which may delay, limit or prevent regulatory approval or marketing authorization.
4 At EASL Congress in June 2023, and after several years of discussion among the relevant stakeholders , it was announced that nonalcoholic steatohepatitis (NASH) would now be referred to as Metabolic dysfunction-associated steatohepatitis (MASH). In addition, Nonalcoholic fatty liver disease (NAFLD) will now be referred to as metabolic dysfunction-associated steatotic liver disease (MASLD). GENFIT is progressively transitioning its documentation over to this new nomenclature and both NASH and MASH terms may appear in our documents during this period.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
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Success in preclinical studies and early clinical trials or interim positive data cannot guarantee that the final results or subsequent clinical trials will generate the same or similar results or otherwise provide adequate data to demonstrate or confirm the efficacy and safety of a product candidate. A number of companies in the pharmaceutical industry, including those with greater resources and experience than us or our current and potential future collaborators, have suffered significant setbacks in Phase 3 clinical trials and at other stages of clinical development, in particular in NASH and PBC, even after seeing promising results in earlier clinical trials.
For example, in May 2020, we published the topline results of the interim analysis of our Phase 3 RESOLVE-IT® trial of elafibranor in NASH. Elafibranor did not demonstrate a statistically significant effect on the primary surrogate efficacy endpoint of NASH resolution without worsening of fibrosis nor on the key secondary endpoints. These results led us to stop development of elafibranor in NASH in 2020 due to lack of efficacy but not due to safety reasons.
In addition, the design of a clinical trial can determine whether its results will support approval of a product and flaws in the design of a clinical trial may not become apparent until the clinical trial is well-advanced. We or our collaborators may be unable to design and execute a clinical trial to support regulatory approval. Further, clinical trials of potential products often reveal that it is not practical or feasible to continue development efforts. If elafibranor or our other drug candidates are found to be unsafe or lack efficacy for any indication, we or our collaborators will not be able to obtain regulatory approval for them, and our prospects and business may be materially and adversely affected.
In some instances, there can be significant variability in safety and/or efficacy results between different trials of the same product candidate due to numerous factors, including changes or differences in trial protocols, patient distribution by clinical investigator site, standards of care across sites, differences in composition of the patient populations, adherence to the dosing regimen and other trial protocols and the rate of dropout among clinical trial participants. We do not know whether any Phase 2, Phase 3 or other clinical trials we or any of our collaborators may conduct will demonstrate consistent or adequate efficacy and safety to obtain regulatory approval to market our product candidates. If we or our collaborators are unable to bring any of our current or future product candidates to market, or to acquire any marketed, previously approved products, our ability to create long-term shareholder value will be limited.
Delays in the commencement, enrollment and completion of clinical trials, including our Phase 3 ELATIVE® trial of elafibranor in PBC, could result in increased costs to us and delay or limit our ability and that of Terns Pharmaceuticals or Ipsen, our current partners for elafibranor and that of any future partners, to obtain regulatory approval for elafibranor and our other drug candidates.
We are currently conducting our Phase 3 ELATIVE® trial of elafibranor in PBC after having announced the topline positive interim results at the end of June 2023. In addition, we have two clinical studies that are currently underway, including a Phase 1/2a study for GNS561 in cholangiocarcinoma, or CCA, and a Phase 2 study in VS-01 in acute on chronic liver failure, or ACLF. Delays in the commencement, enrollment and completion of our clinical trials or those of our partners, Terns Pharmaceuticals or Ipsen or any future collaborator, could increase our product development costs or limit our ability to obtain regulatory approval of our drug candidates. In the past, we have experienced some delays in enrollment in our clinical trials, including in our RESOLVE-IT® clinical trial in NASH. We have also experienced, and may continue to experience delays and challenges in enrollment in clinical trials due to the COVID-19 pandemic, for example with patients postponing site visits due to developing COVID, or having to be re-screened because they fell out of the screening window. COVID also led to administrative backlogs at sites and with regulatory authorities due to continued high volumes of trials and staffing shortages.
The results from these trials, be they final or interim, may not be available when we expect or we or our collaborators may be required to conduct additional clinical trials or preclinical studies not currently planned to receive approval for our product candidates, including elafibranor. In addition, our clinical programs and those of our partners Ipsen and Terns Pharmaceuticals are subject to a number of variables and contingencies, such as the results of other trials, patient enrollments or regulatory interactions that may result in a change in timing. As such, we do not know whether any future trials or studies in elafibranor or our other product candidates will begin on time or will be completed on schedule, if at all.
The commencement, enrollment and completion of clinical trials can be delayed or suspended for a variety of reasons, including:
•inability to demonstrate sufficient safety and efficacy to obtain regulatory approval to commence a clinical trial;
•inability to validate test methods to support quality testing of the drug substance and drug product;
•inability to determine dosing and clinical trial design;
•inability to obtain sufficient funds required for a clinical trial or lack of adequate funding to continue the clinical trial due to unforeseen costs or other business decisions made by the Group, its current partners or any future partners;
•our inability to enter into collaborations relating to the development and commercialization of our product candidates;
•inability to reach agreements on acceptable terms with prospective contract research organizations, or CROs, trial sites and contract manufacturing organizations or CMOs, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs, trial sites and CMOs;
•clinical holds, other regulatory objections to commencing or continuing a clinical trial or the inability to obtain regulatory approval to commence a clinical trial in countries that require such approvals;
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
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•discussions with the FDA, European Medicines Agency or EMA, the competent authorities of European Economic Area, or EEA, countries or other non-U.S. regulators regarding the scope or design of our clinical trials, which may occur at various times, including subsequent to the initiation of the clinical trial;
•governmental or regulatory delays and changes in regulatory requirements, policy and guidelines, including mandated changes in the scope or design of clinical trials or requests for supplemental information with respect to clinical trial results;
•varying interpretations of our data, and regulatory commitments and requirements by the FDA, EMA, European Commission and similar foreign regulatory authorities;
•inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged in our other programs or clinical trials, including some that may be for the same indications targeted by our product candidates;
•the delay in receiving results from or the failure to achieve the necessary results in other clinical trials;
•inability to obtain approval from institutional review boards, or IRBs, or positive opinions from Ethics Committees, to conduct a clinical trial at their respective sites;
•lack of effectiveness of product candidates during clinical trials;
•suspension or termination by a data and safety monitoring board, or DSMB, that is overseeing the clinical trial;
•changes in the standard of care on which a clinical development plan was based, which may require new or additional trials;
•failure to conduct clinical trials in accordance with regulatory requirements;
•severe or unexpected drug-related adverse effects experienced by patients, death of a patient during a trial or any determination that a clinical trial presents unacceptable health risks;
•a breach of the terms of any agreement with, or termination for any other reason by, current or future collaborators that have responsibility for the clinical development of any of our product candidates, or investigators leading clinical trials on our product candidates;
•inability to timely manufacture or deliver sufficient quantities of the product candidate, or other consumables required for preclinical studies or clinical trials;
•difficulty identifying, recruiting and enrolling patients to participate in clinical trials for a variety of reasons, including meeting the enrollment criteria for our trial, the rarity of the disease or condition, the rarity of the characteristics of the population being studied (for example PBC, ACLF and CCA), the nature of the protocol, the risks of procedures that may be required as part of our trials, such as such as a liver biopsy, the availability of effective treatments for the relevant disease and the eligibility criteria for the clinical trial, and competition from other clinical trial programs for the same indications or with products with the same mechanism of action as our product candidates;
•global health pandemics such as COVID-19, armed conflicts, war or natural disasters; and
•inability to retain enrolled patients after a clinical trial is underway.
For example, our RESOLVE-IT® trial was a large and complex Phase 3 clinical trial in a disease without any approved therapies and the diagnosis of which generally involves invasive procedures such as liver biopsies. These specificities led us to face significant competition for patient enrollment, and to delay the publication date of our topline interim analysis.
As we engage in other large and complicated trials and trials in advanced disease populations, including our ongoing Phase 3 ELATIVE® trial evaluating elafibranor in PBC, we may experience a number of the aforementioned complications that may negatively affect our plans or our development programs. The ELATIVE® trial was in particular made complex by the fact that it is an orphan disease with a small number of patients and the fact that one of our competitor’s product is the only one to have recently received market approval in this indication, and another Phase 3 trial in PBC was enrolling patients at the same time as ours which may compromise our ability to retain or recruit patients or complete the trial on time. Potential discussions with the FDA, the EMA, competent authorities of EEA countries or other regulatory authorities outside the United States or EEA regarding the scope or design of our clinical trials may also happen at any time.
More broadly, changes in the treatment of PBC, such as the approval of a drug therapy for the treatment of PBC by one of our competitors, could result in difficulties retaining or enrolling patients in our clinical trials and those of our current or future partners. Any difficulty retaining patients may delay or produce negative or inconclusive results from our clinical trials, and we or our collaborators may decide, or regulators may require us, to conduct additional clinical trials or preclinical studies. Any delay or compromises with respect to our clinical trials may have a material adverse effect on our business or diminish our competitive position relative to other biotechnology or pharmaceutical companies.
We cannot be certain that elafibranor or any of our other product candidates, even if they meet clinical and regulatory requirements, will receive regulatory approval or certification, as applicable, and without regulatory approval or certification, we or our partners will not be able to market our product candidates.
We currently have no products approved for sale and we cannot guarantee that we or any of our current or future collaborators will ever have marketable products. Our business and financial situation currently depends substantially on the successful development and potential successful commercialization of elafibranor in PBC. Our ability to generate short-term revenue derived from product sales will depend on the successful development and regulatory approval of elafibranor in PBC by our partners, and in particular, Ipsen, in the United States, the EEA and other countries.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
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The development of drug candidates and NIS4® technology and issues relating to their approval, CE marking, and marketing are subject to extensive regulation by the FDA in the United States, and EMA, European Commission (EC) and competent authorities of EEA countries in the EEA and comparable foreign regulatory authorities in other countries, with regulations differing from country to country.
We or our current or future collaborators will not be permitted to market our drug candidates in the United States or the EEA until we receive approval of a New Drug Application, or NDA, from the FDA or a marketing authorization, or MA, from the European Commission (based on the positive opinion of the EMA), as applicable. The same is true for other countries, including the United Kingdom since Brexit. We have not submitted at this time any marketing applications for any of our product candidates and neither have Ipsen nor Terns Pharmaceuticals, our development partners for elafibranor, for its products. NDAs, marketing authorization applications or MAAs and MAs in other countries must include extensive preclinical and clinical data and supporting information to establish the drug candidate’s safety and effectiveness for each desired indication. These marketing applications must also include significant information and data regarding the chemistry, manufacturing and controls for the drug.
We cannot predict whether our ongoing or planned future trials and studies will be successful or whether regulators will agree with our conclusions regarding the preclinical studies and clinical trials, including Phase 3 trials, we have conducted to date, or for ongoing trials, with our interim results. These regulators may also consider the data insufficient, in light of data produced by other drug candidates or already approved drugs and require future studies or data prior to approval.
Obtaining approval of a NDA, MA or other marketing authorization is a lengthy, expensive and uncertain process, and we may not be successful in obtaining approval.
Regulatory authorities in countries outside of the United States and EEA also have requirements for approval of drug candidates and diagnostics, or certification, with which we and our collaborators must comply prior to marketing in those countries. Obtaining regulatory approval or certification for marketing of a drug candidate or diagnostic in one country does not ensure that we will be able to obtain regulatory approval or certification in any other country. In addition, delays in approvals or certifications or rejections of marketing or certification applications in the United States, EEA or other countries may be based upon many factors, including regulatory requests for additional analyses, reports, data, preclinical studies and clinical trials, regulatory questions regarding different interpretations of data and results, changes in regulatory policy during the period of product development and the emergence of new information regarding our product candidates or other products, as applicable. Also, regulatory approval or certification for any of our product candidates may be withdrawn.
If we, our partners Ipsen and Terns Pharmaceuticals or a future partner are unable to obtain approval from the FDA, the EC or other comparable foreign regulatory authorities for elafibranor and our other product candidates, or approval or certification of an IVD using NIS4® technology or its improvements, or if, subsequent to approval or certification, we, our partners Ipsen or Terns Pharmaceuticals or a future partner are unable to successfully commercialize elafibranor, an IVD using NIS4® technology or our other product candidates, we will not be able to generate sufficient revenue to become profitable or to continue our operations.
Our future capital resources depend in large part on the successful continuation of development of elafibranor in PBC, as well as its potential regulatory approval and the success of future commercialization in this indication, if approved. Because our access to alternative financing is limited, failure in PBC could impact our strategic decisions with respect to the development of our other product candidates and may affect the development or timing of our business prospects.
Our future capital resources depend in large part on the successful continuation of development of elafibranor in PBC, as well as its potential regulatory approval and the success of future commercialization in this indication, if approved. We expect Ipsen to file for conditional marketing authorization for elafibranor in PBC by end of 2023, although it is possible that this application will not be approved. Because we have limited access to capital to fund our operations, failure of the PBC program, a delay or the refusal of marketing authorization in this indication could significantly negatively affect our resources available to allocate to research, collaboration, management and financial resources toward particular compounds, programs, product candidates or therapeutic areas. We may be restricted in the opportunities we can pursue, and we may be required to collaborate with third parties to advance a particular product candidate at terms that are less than optimal to us. Because of our limited resources, we may also have to decline to pursue opportunities that may otherwise prove to be profitable.
Furthermore, any failure (or in certain cases a delay) of the development program, regulatory authorization or possible marketing of elafibranor in the PBC would result in the non-payment of milestones negotiated within the framework of our partnership agreements concluded with Ipsen and Terns Pharmaceuticals.
We have entered, and may in the future enter into, collaboration, licensing or co-marketing agreements with third parties for the development and eventual commercialization of our product candidates and NIS4® diagnostic technology or its variations, and may not generate revenues from these agreements.
We have limited experience in product development and marketing and may seek to enter into collaborations with third parties for the development and potential commercialization of our product candidates including those at an early and preclinical stage, particularly those candidates outside of our main therapeutic areas of interest. We have entered into an exclusive licensing and collaboration agreement with Ipsen to develop and commercialize elafibranor for the treatment of PBC and other indications worldwide, with the exception of Greater China which is licensed to Terns Pharmaceuticals. Our NIS4® technology is licensed to two partners, both to Labcorp to allow them to deploy an LDT powered by NIS4® technology in the clinical research and clinical diagnostics spaces and also to Q2 in the clinical research space.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
18 | ||||||||
We have also entered into licensing agreements with Genoscience to develop and use GNS561 in CCA, with Seal Rock Therapeutics to develop and use an injectable formulation of SRT-015 in acute liver diseases and with Celloram to develop and use CLM-022 in the treatment of liver diseases.
Should we seek to collaborate with additional third parties with respect to our development programs or to market or co-market our product candidates, those that we in-license or our NIS4® technology and its updates, we may not be able to locate a suitable partner and may not be able to enter into an agreement on commercially reasonable terms or at all.
Any new collaboration may require additional expenditures, increase our short and long term investments, require us to issue new shares and dilute our existing shareholders or disrupt our management team or activities. With our current agreements, or even if we succeed in securing collaborators for the development and commercialization of elafibranor, our NIS4® technology, the NASHnext® LDT or our other product candidates, we have limited control over the amount and timing that our collaborators may dedicate to the development or commercialization of our product candidates.
These collaborations and licensing agreements pose a number of risks, including:
•the means and resources used within the framework of these agreements remain, for the most part, at the discretion of the partner;
•the partner might not fulfill its contractual obligations;
•the partner might interrupt the development or commercialization or decide to interrupt or not renew the development or commercialization programs due to a change in strategic orientation, a lack of financing or external factors such as an acquisition that would reallocate resources or induce different priorities;
•the partner might develop, independently or with the assistance of third parties, products, in the case of pharmaceuticals or in-vitro tests, in the case of diagnostic technologies that are in direct or indirect competition with our product candidates or future IVD powered by NIS4® or its variations if it believes that it is easier to successfully commercialize competing products under more attractive economic conditions than ours;
•the partner, as holder of the commercialization and distribution rights on a product candidate or technology for a set time period or a specific territory or territories, might not allocate sufficient resources to these activities;
•the partner might not protect or defend our intellectual property rights in an appropriate manner or might use exclusive information that belongs to us in a manner resulting in disputes that may compromise or discredit our exclusive information or expose us to potential disputes;
•the partner might not respect the property rights of third parties, which might expose us to litigation and potentially involve our liability;
•disputes might arise between us and the partner, which could result in delays or suspension of the commercialization of the product candidate, or legal action or costly procedures that would monopolize resources as well as divert management’s attention;
•we might lose certain important rights obtained through these partnerships, notably in the case of change of control of our company;
•the collaboration might be terminated and, in such case, require additional financing to further develop or market the product candidate licensed to it;
•the partner has access to our discoveries and might use this information to develop future competing products;
•there may be conflicts between different partners that could negatively affect those partnerships and potentially others;
•the collaboration, due to its nature, might have a negative impact on our attractiveness for collaborators or potential acquirers;
•the collaboration might not result in the development and commercialization of the product candidate(s) in an optimal fashion or never fulfill its objectives;
•if the partner were to take part in a merger, the continuity of advancement and the central nature of our commercialization program might be delayed, reduced or suspended by it; and
•the partner may be unable to obtain the necessary marketing approvals.
Thus, collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all. For example, although we have entered into a license agreement with Labcorp to enable them to develop and commercialize an LDT powered by NIS4® or its variations for clinical research and clinical diagnostic purposes, there is no guarantee that our collaboration with Labcorp will result in widespread clinical or commercial use of NASHnext®, an LDT powered by NIS4® technology for clinical care. Commercial launch of NASHnext® in 2021 was slowed by COVID-19 and also impacted by the lack of approved treatment for NASH. Similarly, although we have entered into a collaboration and license agreement with Ipsen for the treatment of PBC and other indications worldwide, with the exception of Greater China which is licensed to Terns Pharmaceuticals, there is no guarantee that our partnership with Ipsen or Terns Pharmaceuticals will successfully result in a generalized clinical or commercial use of elafibranor for these indications and in those jurisdictions.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
19 | ||||||||
In addition, in-licensing agreements such as those we have signed with Genoscience, Seal Rock Therapeutics and Celloram, which contain obligations to pay milestones in the event the partner meets clinical, regulatory and commercial milestones and royalties in the event of commercialization, could also impact our ability to generate profits if we are unable to obtain commercial benefit from these drug candidates.
Finally, some collaboration agreements may be terminated without cause on short notice. Once a collaboration agreement is signed, it may not lead to commercialization of a product candidate. We also face competition in seeking out collaborators. If we are unable to secure new collaborations that achieve the collaborator’s objectives and meet our expectations, we may be unable to advance our product candidates and may not generate meaningful revenues.
Developments in patent law in the United States and in other jurisdictions could have a negative impact on our business.
From time to time, the U.S. Supreme Court, other federal courts, the U.S. Congress, the USPTO or similar foreign authorities may change the standards of patentability and any such changes could have a negative impact on our business. In addition, the Leahy-Smith America Invents Act, or the America Invents Act, which was signed into law in 2011, includes a number of significant changes to U.S. patent law. These changes include a transition from a “first-to-invent” system to a “first-to-file” system, changes to the way issued patents are challenged, and changes to the way patent applications are disputed during the examination process. In certain areas, these changes may favor larger and more established companies that have greater resources to devote to patent application filing and prosecution. The USPTO has developed new regulations and procedures to govern the full implementation of the America Invents Act, and many of the substantive changes to patent law associated with the America Invents Act, and, in particular, the first-to-file provisions, became effective on March 16, 2013. Substantive changes to patent law associated with the America Invents Act, or any subsequent U.S. legislation regarding patents, may affect our ability to obtain patents, and if obtained, to enforce or defend them.
Furthermore, recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances for diagnostic method claims and gene patents.
In view of these and other U.S. federal appellate cases, we cannot guarantee that our efforts to seek patent protection for our tools and biomarkers will be successful.
In May 2023, the European Commission proposed the creation of a unitary Supplementary Protection Certificate (SPC) that is valid in all EU countries. If this project is accepted in the future, it would allow third parties to only bring one legal proceeding in an attempt to obtain an invalidity decision by SPC that is valid in all EU countries.
The European Commission also proposed revisions to pharmaceutical legislation which aim to reduce the duration of regulatory data protection and the duration of market exclusivity granted to orphan drugs.
If these proposals are accepted, the duration of the regulatory protection of our products could be reduced.
We have recently acquired and may in the future acquire, products or businesses or form new strategic alliances, and we may not realize the benefits of such partnerships or acquisitions.
As part of our growth strategy, we have sought and intend to seek opportunities to in-license rights to drug candidates in clinical development. This could also include the acquisition of companies or technologies facilitating or enabling us to access to new medicines, new research projects, or new geographical areas, or enabling us to express synergies with our existing operations. If such acquisitions occur in the future, we may not be able to identify appropriate targets or make acquisitions under satisfactory conditions, in particular, satisfactory price conditions. In addition, we may be unable to obtain the financing for these acquisitions on favorable terms, which could require us to finance these acquisitions using our existing cash resources that could have been allocated to other purposes. If we acquire businesses with promising markets or technologies, we may not be able to realize the benefit of acquiring such businesses or the expected synergies if we are unable to successfully integrate them with our existing operations and company culture.
In December 2021, we licensed the exclusive rights from Genoscience Pharma to develop and commercialize the investigational treatment GNS561 in CCA in the United States, Canada and Europe, including the United Kingdom and Switzerland. As CCA is a new therapeutic area for us, and despite our due diligence, or in the event we are unable to collaborate efficiently, we may not be successful in realizing the full potential of the GNS561 program.
We also acquired Versantis AG in September 2022 to strengthen our product candidate pipeline, including the drug candidates VS-01-ACLF, VS-01-HAC and VS-02 that we are developing respectively in ACLF, UCD and OA, and HE. As these three therapeutic areas are relatively or totally new to us, despite our due diligence and our evaluation of the potential of these programs, we may be unsuccessful in integrating the company or realizing the full potential of these programs and potential synergies. The anticipated benefits and synergies of this acquisition are based on projections and assumptions, not actual experience, and assume a successful integration.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
20 | ||||||||
Finally, in May 2023, we announced the licensing deal made with Seal Rock Therapeutics for the exclusive worldwide rights for the ASK-1 inhibitor SRT-015 to develop an injectable formulation for use in the treatment of acute liver diseases, particularly in ACLF. In July 2023, we entered into a licensing agreement with Celloram for the exclusive worldwide rights to develop and use CLM-022, an inflammasome inhibitor, in the treatment of liver diseases, particularly in ACLF. In return, these two companies are eligible for clinical, regulatory and commercial milestone payments and royalties if the products are commercialized. Given that ACLF is a new therapeutic area for the Company, it is possible that, despite prior audits and evaluation procedures being carried out, or if the partnership with both companies is less effective than expected, we may not be able to achieve the full potential of these two programs.
We may require substantial additional funding to develop and commercialize our products, if approved, as well as to reinforce our pipeline, which may not be available to us, or to our current or future partners on acceptable terms, or at all, and, if not so available, may require us or them to delay, limit, reduce or cease our operations.
We are currently advancing elafibranor through clinical development in PBC and our other drug candidates through clinical or preclinical development. Additionally, we are also considering formal validation studies of an IVD powered by NIS4® technology in preparation for submitting the test for marketing authorization for clinical care. Developing pharmaceutical and diagnostic products, including conducting preclinical studies and clinical trials, along with obtaining necessary validation, is expensive.
Subject to obtaining regulatory approval of any of our drug candidates or an IVD powered by NIS4® or its improvements, we or our current or future partners also expect to incur significant commercialization expenses for product sales, marketing, manufacturing and distribution. We anticipate incurring significant expenses in connection with our planned commercialization of an IVD powered by NIS4® or its improvements, along with an increase in our product development, scientific, commercial and administrative personnel and expansion of our facilities and infrastructure in the United States, France and other countries. We also expect to incur additional costs associated with operating as a public company in the United States and further plan on expanding our operations in the United States, Europe and in other territories. We could continue to require substantial additional capital in connection with our continuing operations, in particular if the revenue that we plan on receiving as part of our licensing-out contracts is less substantial than expected or we do not receive this revenue at all, and/or to further expand our pipeline, and to continue our clinical development and pre-commercialization activities.
However, access, in particular under acceptable conditions, to necessary financing is subject to contextual factors affecting the financial markets, investors and potential lenders. In addition, our convertible bond contract initially issued on October 16, 2017 contains customary restrictive covenants, some of which limit, but generally do not exclude, the creation of new guarantees on our assets and the incurring of additional indebtedness.
Because successful development of our drug candidates and diagnostic program is uncertain, we are unable to estimate the actual funds required to complete the research and development and commercialization of our products under development.
As we operate in multiple currencies including the US Dollar, the Swiss Franc and the Euro, we invite investors to read Note 7.1 - "Foreign Exchange Risk" of the notes to the 2023 half year condensed consolidated financial statements and its sensitivity tables included herein.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
21 | ||||||||
3. | HALF-YEAR CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AT JUNE 30, 2023 | |||||||
| 3.1 | Consolidated Statements of Financial Position | |||||||||||||
| 3.2 | Consolidated Statements of Operations | |||||||||||||
| 3.3 | Consolidated Statements of Other Comprehensive Loss | |||||||||||||
| 3.4 | Consolidated Statements of Cash Flows | |||||||||||||
| 3.5 | Consolidated Statements of Changes in Equity | |||||||||||||
| 3.6 | Notes to the Consolidated Financial Statements | |||||||||||||
| Note 1 | The Company | |||||||||||||
| Note 2 | Major Events in the Period and Events after the Period | |||||||||||||
| Note 3 | Basis of Presentation | |||||||||||||
| Note 4 | Summary of Significant Accounting Policies | |||||||||||||
| Note 5 | Acquisitions | |||||||||||||
| Note 6 | Segment Information | |||||||||||||
| Note 7 | Financial Risks Management | |||||||||||||
| Note 8 | Revenues and Other Income | |||||||||||||
| Note 9 | Operating Expenses | |||||||||||||
| Note 10 | Financial Income and Expenses | |||||||||||||
| Note 11 | Income Tax | |||||||||||||
| Note 12 | Earnings (loss) Per Share | |||||||||||||
| Note 13 | Cash and Cash Equivalents | |||||||||||||
| Note 14 | Goodwill and Intangible Assets | |||||||||||||
| Note 15 | Trade and Other Receivables | |||||||||||||
| Note 16 | Other Financial Assets | |||||||||||||
| Note 17 | Other Assets | |||||||||||||
| Note 18 | Loans and Borrowings | |||||||||||||
| Note 19 | Fair Value of Financial Instruments | |||||||||||||
| Note 20 | Trade and Other Payables | |||||||||||||
| Note 21 | Deferred Income and Revenue | |||||||||||||
| Note 22 | Provisions | |||||||||||||
| Note 23 | Equity | |||||||||||||
| Note 24 | Litigation and Contingent Liabilities | |||||||||||||
| Note 25 | Related Parties | |||||||||||||
| Note 26 | Commitments | |||||||||||||
| Note 27 | Supplemental Cash Flow Information | |||||||||||||
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
22 | ||||||||
3.1 | Consolidated statements of financial position | |||||||
| ASSETS | Notes | As of | ||||||||||||||||||
| (in € thousands) | 2022/12/31 | 2023/06/30 | ||||||||||||||||||
| Current assets | ||||||||||||||||||||
| Cash and cash equivalents | 13 | |||||||||||||||||||
| Current trade and others receivables | 15 | |||||||||||||||||||
| Other current financial assets | 16 | |||||||||||||||||||
| Other current assets | 17 | |||||||||||||||||||
| Inventories | — | |||||||||||||||||||
| Total - Current assets | ||||||||||||||||||||
| Non-current assets | ||||||||||||||||||||
| Intangible assets | 14 | |||||||||||||||||||
| Property, plant and equipment | — | |||||||||||||||||||
| Other non-current financial assets | 16 | |||||||||||||||||||
| Deferred tax assets | 11 | |||||||||||||||||||
| Total - Non-current assets | ||||||||||||||||||||
| Total - Assets | ||||||||||||||||||||
| SHAREHOLDERS' EQUITY AND LIABILITIES | Notes | As of | ||||||||||||||||||
| (in € thousands) | 2022/12/31 | 2023/06/30 | ||||||||||||||||||
| Current liabilities | ||||||||||||||||||||
| Current convertible loans | 18 | |||||||||||||||||||
| Other current loans and borrowings | 18 | |||||||||||||||||||
| Current trade and other payables | 20 | |||||||||||||||||||
| Current deferred income and revenue | 21 | |||||||||||||||||||
| Current provisions | 22 | |||||||||||||||||||
| Other current tax liabilities | 11 | |||||||||||||||||||
| Total - Current liabilities | ||||||||||||||||||||
| Non-current liabilities | ||||||||||||||||||||
| Non-current convertible loans | 18 | |||||||||||||||||||
| Other non-current loans and borrowings | 18 | |||||||||||||||||||
| Non-current trade and other payables | 20 | |||||||||||||||||||
| Non-current deferred income and revenue | 21 | |||||||||||||||||||
| Non-current employee benefits | — | |||||||||||||||||||
| Deferred tax liabilities | 11 | |||||||||||||||||||
| Total - Non-current liabilities | ||||||||||||||||||||
| Shareholders' equity | ||||||||||||||||||||
| Share capital | 23 | |||||||||||||||||||
| Share premium | — | |||||||||||||||||||
| Retained earnings (accumulated deficit) | — | ( | ( | |||||||||||||||||
| Currency translation adjustment | — | ( | ( | |||||||||||||||||
| Net profit (loss) | — | ( | ( | |||||||||||||||||
| Total - Shareholders' equity | ||||||||||||||||||||
| Total - Shareholders' equity & liabilities | ||||||||||||||||||||
The accompanying notes form an integral part of these consolidated financial statements.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
23 | ||||||||
3.2 | Consolidated statements of operations | |||||||
| Notes | Half-year ended | |||||||||||||||||||
| (in € thousands, except earnings per share data) | 2022/06/30 | 2023/06/30 | ||||||||||||||||||
| Revenues and other income | ||||||||||||||||||||
| Revenue | 8 | |||||||||||||||||||
| Other income | 8 | |||||||||||||||||||
| Revenues and other income | ||||||||||||||||||||
| Operating expenses and other operating income (expenses) | ||||||||||||||||||||
| Research and development expenses | 9 | ( | ( | |||||||||||||||||
| General and administrative expenses | 9 | ( | ( | |||||||||||||||||
| Marketing and market access expenses | 9 | ( | ( | |||||||||||||||||
| Reorganization and restructuring income (expenses) | 9 | |||||||||||||||||||
| Other operating expenses | 9 | ( | ( | |||||||||||||||||
| Operating income (loss) | ( | ( | ||||||||||||||||||
| Financial income | 10 | |||||||||||||||||||
| Financial expenses | 10 | ( | ( | |||||||||||||||||
| Financial profit (loss) | ( | |||||||||||||||||||
| Net profit (loss) before tax | ( | ( | ||||||||||||||||||
| Income tax benefit (expense) | 11 | ( | ( | |||||||||||||||||
| Net profit (loss) | ( | ( | ||||||||||||||||||
| Basic and diluted earnings (loss) per share | ||||||||||||||||||||
| Basic earnings (loss) per share (€/share) | 12 | ( | ( | |||||||||||||||||
| Diluted earnings (loss) per share (€/share) | 12 | ( | ( | |||||||||||||||||
The accompanying notes form an integral part of these consolidated financial statements.
3.3 | Consolidated statements of other comprehensive income (loss) | |||||||
| Notes | Half-year ended | |||||||||||||||||||
| (in € thousands) | 2022/06/30 | 2023/06/30 | ||||||||||||||||||
| Net profit (loss) | ( | ( | ||||||||||||||||||
| Actuarial gains and losses net of tax | 0 | |||||||||||||||||||
| Other comprehensive income (loss) | ||||||||||||||||||||
| that will never be reclassified to profit or loss | ||||||||||||||||||||
| Exchange differences on translation of foreign operations | ||||||||||||||||||||
| Other comprehensive income (loss) | ||||||||||||||||||||
| that are or may be reclassified to profit or loss | ||||||||||||||||||||
| Total comprehensive income (loss) | ( | ( | ||||||||||||||||||
| Attributable to owners of the Company | ( | ( | ||||||||||||||||||
The accompanying notes form an integral part of these consolidated financial statements.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
24 | ||||||||
3.4 | Consolidated statements of cash flows | |||||||
| Notes | Half-year ended | Half-year ended | ||||||||||||||||||
| (in € thousands) | 2022/06/30 | 2023/06/30 | ||||||||||||||||||
| Cash flows from operating activities | ||||||||||||||||||||
| + Net profit (loss) | ( | ( | ||||||||||||||||||
| Reconciliation of net loss to net cash used in operating activities | ||||||||||||||||||||
| Adjustments for: | ||||||||||||||||||||
| + Depreciation and amortization on tangible and intangible assets | ||||||||||||||||||||
| + Impairment and provision for litigation | 22 | ( | ( | |||||||||||||||||
| + Expenses related to share-based compensation | — | |||||||||||||||||||
| - Gain on disposal of property, plant and equipment | ( | |||||||||||||||||||
| + Net finance expenses (revenue) | ||||||||||||||||||||
| + Income tax expense (benefit) | 11 | |||||||||||||||||||
| + Other non-cash items | 10 | |||||||||||||||||||
| Operating cash flows before change in working capital | ( | ( | ||||||||||||||||||
| Decrease (increase) in trade receivables and other assets | 15 | ( | ( | |||||||||||||||||
| (Decrease) increase in trade payables and other liabilities | 20 | ( | ( | |||||||||||||||||
| Change in working capital | ( | ( | ||||||||||||||||||
| Income tax paid | ||||||||||||||||||||
| Net cash flows provided by (used in) in operating activities | ( | ( | ||||||||||||||||||
| Cash flows from investment activities | ||||||||||||||||||||
| - Acquisition of intangible assets | 14 | ( | ( | |||||||||||||||||
| - Acquisition of property, plant and equipment | — | 265 | 61 | |||||||||||||||||
| + Proceeds from disposal of / reimbursement of property, plant and equipment | 14 | |||||||||||||||||||
| - Acquisition of financial instruments | 16 | ( | ||||||||||||||||||
| + Proceeds from disposal of financial instruments | 16 | |||||||||||||||||||
| Net cash flows provided by (used in ) investment activities | ( | |||||||||||||||||||
| Cash flows from financing activities | ||||||||||||||||||||
| - Repayments of loans and borrowings | 18 | ( | ( | |||||||||||||||||
| - Payments on lease debts | 18 | ( | ( | |||||||||||||||||
| - Financial interests paid (including finance lease) | ( | ( | ||||||||||||||||||
| + Financial interests received | ||||||||||||||||||||
| Net cash flows provided by (used in ) financing activities | ( | ( | ||||||||||||||||||
| Increase (decrease) in cash and cash equivalents | ( | ( | ||||||||||||||||||
| Cash and cash equivalents at the beginning of the period | 13 | |||||||||||||||||||
| Effects of exchange rate changes on cash | ( | |||||||||||||||||||
| Cash and cash equivalents at the end of the period | ||||||||||||||||||||
The accompanying notes form an integral part of these consolidated financial statements.
| Half-Year Business and Financial Report at June 30, 2023 | |||||||
25 | ||||||||
3.5 | Consolidated statements of changes in equity | |||||||
(Amounts in thousands of euros, except for number of shares)
| Share capital | Share | Treasury | Retained | Currency | Net | Total | ||||||||||||||||||||||||||||||||||||||||||||
| Number | Share | premium | shares | earnings | translation | profit | shareholders' | |||||||||||||||||||||||||||||||||||||||||||
| of shares | capital | (accumulated | adjustment | (loss) | equity | |||||||||||||||||||||||||||||||||||||||||||||
| (in € thousands) | deficit) | |||||||||||||||||||||||||||||||||||||||||||||||||
| As of January 01, 2022 | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||
| Net profit (loss) | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Total comprehensive income (loss) | — | — | — | — | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
| Allocation of prior period profit (loss) | ( | |||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based compensation | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Treasury shares | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||
| Other movements | — | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||
| As of June 30, 2022 | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||
| Net profit (loss) | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||
| Total comprehensive income (loss) | — | — | — | — | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||||
| Allocation of prior period profit (loss) | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Capital increase | — | ( | ||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based compensation | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Treasury shares | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Other movements | — | |||||||||||||||||||||||||||||||||||||||||||||||||
| As of December 31, 2022 | ( | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||
| Net profit (loss) | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Total comprehensive income (loss) | — | — | — | — | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
| Allocation of prior period profit (loss) | ( | |||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based compensation | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Treasury shares | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Other movements | ||||||||||||||||||||||||||||||||||||||||||||||||||
| As of June 30, 2023 | ( | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||
The accompanying notes form an integral part of these consolidated financial statements.