GENFIT Announces Revenues and Cash Position as of December 31, 2024
- Cash and cash equivalents
totaled €81.8 million as of December 31, 2024
- Revenues amounted to €67.0
million as of December 31, 2024 including the €48.7 million
milestone 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), February 27,
2025 - GENFIT (Nasdaq and Euronext:
GNFT), a biopharmaceutical company dedicated to improving
the lives of patients with rare and life-threatening liver
diseases, today announced its cash position as of December 31, 2024
and revenues for 2024
Cash Position
As of December 31, 2024, the Company’s cash and
cash equivalents amounted to €81.8 million compared with €77.8
million as of December 31, 2023 and €96.0 million as of September
30, 2024.
In 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®
(elafibranor) in the U.S. for the treatment of PBC, as part of our
long-term strategic partnership with Ipsen (the “Ipsen agreement”)
signed in December 2021.
As announced on January 30, 2025, Genfit has signed a royalty
financing deal providing up to €185 million non-dilutive capital,
enabling us to fund our operating expenses and capital expenditure
requirements beyond the end of 2027. This is based on current
assumptions and programs and does not include exceptional events.
This estimation assumes i) our expectation to receive significant
future milestone revenue in 2025, including the €26.55 million
milestone pending a third pricing and reimbursement approval of
Iqirvo® (elafibranor) in a major European market and Ipsen meeting
its sales-based thresholds, ii) the closing of the royalty
financing and the drawing down all instalments thereunder, and iii)
the repurchase of the OCEANEs following such closing or their
reimbursement at maturity in October 2025. Note that the closing of
the royalty financing remains subject to the approval of the OCEANE
bondholders at a bondholders general meeting convened for March 10,
2025, as announced on February 21, 2025, and the satisfaction of
other customary closing conditions.
Revenues
Revenues for 2024 amounted to €67.0 million
compared to €28.6 million for the same period in 2023.
Of the €67.0 million, €48.7 million was
attributable to a milestone payment invoiced to Ipsen in June 2024
and €2.7 million was attributable to royalty revenue from U.S.
sales of Iqirvo/elafibranor which commenced mid-June in application
of the Ipsen Agreement signed in December 2021. €15.3 million in
revenue was 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. €0.1 million
in revenue 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. €0.2
million was attributable to other ancillary activities.
Of the €28.6 million revenues in 2023, €13.3
million was attributable to a milestone payment invoiced to Ipsen
in December 2023 in accordance with the Ipsen Agreement signed in
December 2021. This milestone payment was earned following the New
Drug Application filing acceptance by the U.S. Food and Drug
Administration and Marketing Authorization Application filing
acceptance by the European Medicines Agency for accelerated
approval of elafibranor. €8.7 million in revenue was attributable
to the partial recognition of the €40.0 million deferred income as
described above. €6.5 million in revenue 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 as described above. €0.1
million was attributable to other ancillary activities.
Upcoming Financial
Communications
The Company will release its full-year 2024
financial results on April 24, 2025. The 2024 Universal
Registration Document, the 2024 Annual Financial Report (included
in the 2024 Universal Registration Document), and the Annual Report
on Form 20-F will be published by the end of April 2025.
ABOUT GENFIT
GENFIT is a 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® (elafibranor1) 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
the Company’s cash runway, the potential and management’s
expectations to receive royalties and near-term milestones under
the Ipsen Agreement, the meeting of the milestones necessary to
draw down on all instalments under the royalty financing and
approval of the royalty financing by OCEANE holders. 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, pricing, approval
and commercial success of elafibranor in the relevant
jurisdictions, 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, the Half-Year Business and
Financial Report dated September 19, 2024 and subsequent filings
and reports filed with the AMF or SEC 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.
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 Elafibranor is marketed and commercialized in the U.S by Ipsen
under the trademark Iqirvo®.
- GENFIT Announces Revenues and Cash Position as of December 31,
2024
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