GENFIT Reports Third Quarter 2023 Financial Information
- Cash and cash equivalents
totaled €93.9 million as of September 30, 2023
Lille (France); Cambridge
(Massachusetts, United States); Zurich (Switzerland); November 9,
2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage
biopharmaceutical company dedicated to improving the lives of
patients with rare and life-threatening liver diseases, today
announced its cash position as of September 30, 2023 and revenue
for the first nine months of 20231.
Cash Position
As of September 30, 2023, the Company’s cash and
cash equivalents amounted to €93.9 million compared with €163.6
million a year earlier.
As of June 30, 2023, cash and cash equivalents
totaled €111.8 million.
The decrease in cash and cash equivalents
between June 30, 2023, and September 30, 2023, takes into account
our continued research and development efforts, notably for
ELATIVE®, our Phase 3 clinical trial evaluating elafibranor in
Primary Biliary Cholangitis (PBC); UNVEIL-IT™, our Phase 2 clinical
trial of VS-01 in Acute-on-Chronic Liver Failure (ACLF); GNS561, as
part of our cholangiocarcinoma program; and NTZ, as part of our
ACLF program.
We expect that our existing cash and cash
equivalents 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 does not
take into account milestones and royalties that the Company may
receive pursuant to the Collaboration and Licensing agreement with
Ipsen dated December 16, 2021, nor does it include exceptional
events. This agreement applies to elafibranor, which is being
evaluated in patients with Primary Biliary Cholangitis as part of
the Phase 3 ELATIVE® trial, for which positive results were
announced on June 30, 2023.
Revenue
Revenue2 for the first nine months of 2023
amounted to €14.3 million compared to €14.1 million for the same
period in 2022.
Of the €14.3 million in revenues for the first
nine months of 2023, €9.1 million are attributable to the partial
recognition of deferred income of €40 million accounted for in
accordance with IFRS 15, in application of the licensing agreement
signed with Ipsen in December 2021; and €5.2 million was generated
from the services rendered under the Transition Services Agreement
and Part B Transition Services Agreement, signed in April 2022 and
September 2023 respectively by GENFIT and Ipsen, in order to
facilitate the transition of certain services related to the Phase
3 ELATIVE® clinical trial until the complete transfer of the
responsibility of the trial to Ipsen.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
dedicated to improving the lives of patients with rare and
life-threatening liver diseases characterized by high unmet medical
needs. GENFIT is a pioneer in liver disease research and
development with a rich history and strong scientific heritage
spanning more than two decades. Today, GENFIT has a growing and
diversified pipeline with programs at various development stages.
The Company's area of focus is Acute on Chronic Liver Failure
(ACLF). Its ACLF franchise consists of five assets in development:
VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE. These are all based on
differentiated mechanisms of action leveraging complementary
pathways. Other assets target other life-threatening disease
indications such as cholangiocarcinoma (CCA) and Urea Cycle
Disorders (UCD)/Organic Acidemias (OA). GENFIT’s track record in
bringing early-stage assets with high potential to late development
and pre-commercialization stages is highlighted in the successful
52-week Phase 3 ELATIVE® trial evaluating elafibranor in PBC.
Beyond therapeutics, GENFIT’s pipeline also includes a diagnostic
franchise focused on Metabolic dysfunction-associated
steatohepatitis (MASH) (previously known as nonalcoholic
steatohepatitis – NASH) and ammonia. 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. For more information, visit www.genfit.com
FORWARD LOOKING STATEMENTS
This press release contains certain
forward-looking statements, including those within the meaning of
the Private Securities Litigation Reform Act of 1995 with respect
to GENFIT, including, but not limited to statements about the
Company’s potential future revenues and cash runway. 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
the 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.
CONTACT
GENFIT | Investors
Tel: +33 3 2016 4000 | investors@genfit.com
PRESS RELATIONS | Media
Stephanie Boyer – Press relations | Tel: +333
2016 4000 | stephanie.boyer@genfit.com
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos -
FRANCE | +333 2016 4000 | www.genfit.com
1 Unaudited financial information under IFRS
2 Revenue recognized under IFRS 15
- GENFIT Reports Third Quarter 2023 Financial Information
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