- Cash and cash equivalents
totaled €96.0 million as of September 30, 2024
- €59.7 million in revenues
for the nine months ended September 30, 2024, including the €48.7
million milestone invoiced in June 2024 (received in August 2024)
upon first sale of Ipsen’s Iqirvo® (elafibranor) in the U.S. for
the treatment of Primary Biliary Cholangitis
(PBC)
Lille (France), Cambridge
(Massachusetts, United States), Zurich (Switzerland); November 7,
2024 - 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, 2024 and revenue for the first nine months of 20241.
Cash Position
As of September 30, 2024, the Company’s cash and
cash equivalents amounted to €96.0 million compared with €61.6
million as of June 30, 2024 and €77.8 million as of December 31,
2023.
We expect that our existing cash and cash
equivalents will enable us to fund our operating expenses and
capital expenditure requirements until at least the start of the
fourth quarter of 2025. This is based on current assumptions and
programs and does not include exceptional events.
In the first nine months of 2024, cash
utilization is mainly the result of our research and development
efforts in our ACLF franchise (notably VS-01, NTZ, SRT-015,
CLM-022, and VS-02 HE), as well as GNS561 in cholangiocarcinoma
(CCA). Cash utilization is offset notably by the €48.7 million
milestone received in August 2024 (invoiced in June 2024) upon
first sale of Ipsen’s Iqirvo®2 (elafibranor) in the U.S. for the
treatment of PBC.
Revenue
Revenue3 for the first nine months of 2024
amounted to €59.7 million compared to €14.3 million for the same
period in 2023.
Substantially all revenue for the first nine
months is attributable to our Collaboration and License Agreement
with Ipsen and related Transition Services Agreements. Revenue
growth is due to a milestone payment invoiced to Ipsen in June 2024
(collected in August 2024) following the first commercial sale of
Iqirvo in the U.S.
Of the €59.7 million in revenues for the first
nine months of 2024, €48.7 million was attributable to a milestone
payment invoiced to Ipsen in June 2024 and €0.9 million was
attributable to royalty revenue from U.S. sales of
Iqirvo/elafibranor which commenced mid-June in application of the
Collaboration and License Agreement with Ipsen signed in December
2021. The remainder is comprised of €9.3 million attributable to
the partial recognition of deferred income of €40 million accounted
for in accordance with IFRS 15, in application of the
aforementioned licensing agreement, and €0.8 million 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®2 clinical trial until the complete transfer of the
responsibility of the trial to Ipsen.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
committed to improving the lives of patients with rare,
life-threatening liver diseases whose medical needs remain largely
unmet. GENFIT is a pioneer in liver disease research and
development with a rich history and a solid scientific heritage
spanning more than two decades. Today, GENFIT has built up a
diversified and rapidly expanding R&D portfolio of programs at
various stages of development. The Company focuses on
Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise includes
five assets under development: VS-01, NTZ, SRT-015, CLM-022 and
VS-02-HE, based on complementary mechanisms of action using
different routes of administration. Other assets target other
serious diseases, such as cholangiocarcinoma (CCA), urea cycle
disorder (UCD) and organic acidemia (OA). GENFIT's expertise in the
development of high-potential molecules from early to advanced
stages, and in pre-commercialization, was demonstrated in the
accelerated approval of Iqirvo® (elafibranor4) by the U.S. Food and
Drug Administration, the European Medicines Agency and the
Medicines and Healthcare Regulatory Agency in the UK for Primary
Biliary Cholangitis (PBC). Beyond therapies, GENFIT also has a
diagnostic franchise including NIS2+® in Metabolic
dysfunction-associated steatohepatitis (MASH, formerly known as
NASH for non-alcoholic steatohepatitis) and TS-01 focusing on blood
ammonia levels. GENFIT is headquartered in Lille, France and has
offices in Paris (France), Zurich (Switzerland) and Cambridge, MA
(USA). The Company is listed on the Nasdaq Global Select Market and
on the Euronext regulated market in Paris, Compartment B (Nasdaq
and Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest
shareholders, acquiring an 8% stake in the Company's capital.
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 Company’s
eligibility to receive future milestone payments from Ipsen
relating to the development and commercial launch of elafibranor in
PBC and expected cash runway. The use of certain words, such as
"believe", "potential", "expect", “target”, “may”, “will”,
"should", "could", "if" 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 others, 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, and 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 "Risk Factors and Internal Control" of the Company's 2023
Universal Registration Document filed on April 5, 2024 (no.
D.24-0246) with the Autorité des marchés financiers ("AMF"), which
is available on GENFIT's website (www.genfit.fr) and the AMF's
website (www.amf.org), and those discussed in the public documents
and reports filed with the U.S. Securities and Exchange Commission
("SEC"), including the Company’s 2023 Annual Report on Form 20-F
filed with the SEC on April 5, 2024 and subsequent filings and
reports filed with the AMF or SEC, including the Half-Year Business
and Financial Report at June 30, 2024 or otherwise made public, by
the Company. In addition, even if the results, performance,
financial position and liquidity of the Company 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 press release.
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.
CONTACTS
GENFIT | Investors
Tel: +33 3 2016 4000 | investors@genfit.com
GENFIT | 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 Iqirvo® and Elative® are registered trademarks of GENFIT
SA
3 Revenue recognized under IFRS 154 Elafibranor
is marketed and commercialized in the U.S by Ipsen under the
trademark Iqirvo®.
- GENFIT Reports Third Quarter 2024 Financial Information
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