- Cash and cash equivalents
totaled €77.8 million as of December 31, 2023
- Revenues amounted to €28.6
million as of December 31, 2023 including a milestone payment of
€13.3 million
- Upcoming FDA PDUFA action
date for elafibranor in PBC: June 10, 2024
Lille (France), Cambridge
(Massachusetts, United States), Zurich (Switzerland), February 29,
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 December
31, 2023 and revenues for 2023.
Cash Position
As of December 31, 2023, the Company’s cash and
cash equivalents amounted to €77.8 million compared with €140.2
million as of December 31, 2022. As of September 30, 2023, cash and
cash equivalents totaled €93.9 million.
This amount does not include the receipt in
February 2024 of a €13.3 million milestone payment from Ipsen,
which was invoiced in December 2023, triggered by the acceptance of
the New Drug Application (NDA) filing by the US Food and Drug
Administration (FDA) and Marketing Authorization Application (MAA)
by the European Medicines Agency (EMA) for accelerated approval of
elafibranor in Primary Biliary Cholangitis (PBC) in December
2023.
As previously indicated in past communications1,
in 2024 GENFIT expects to receive total milestone payments of
approximately €89 million (including the €13.3 milestone already
received in February 2024), subject to the approval and
commercialization of elafibranor in PBC.
The decrease in cash and cash equivalents
between September 30, 2023, and December 31, 2023, takes into
account our continued research and development efforts, notably
for:
- UNVEIL-IT™, our Phase 2 clinical
trial evaluating VS-01 in Acute-on-Chronic Liver Failure
(ACLF);
- our cholangiocarcinoma program
evaluating GNS561;
- our ACLF program evaluating
NTZ;
- our non-clinical trial of SRT-015
in ACLF; and
- ELATIVE®, specifically the portion
of the Phase 3 clinical trial evaluating elafibranor in PBC that
has not yet been transferred to Ipsen.
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 2025. This is based on current assumptions and programs,
and does not include exceptional events. This estimation includes
our expectations to receive future milestone revenue in 2024,
subject to approval by applicable regulatory authorities and US and
European commercial launches of elafibranor in PBC by Ipsen,
representing a total of approximately €75.2 million.
Revenues
Revenues for 2023 amounted to €28.6 million
compared to €20.2 million for the same period in 2022.
Of the €28.6 million, €13.3 million was
attributable to a milestone payment invoiced to Ipsen in December
2023 in accordance with the Collaboration and Licensing agreement
signed in December 2021. This milestone payment was earned
following the NDA filing acceptance by the FDA and MAA filing
acceptance by the EMA 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 below. €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, 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. €0.1
million was attributable to other ancillary activities.
Of the €20.2 million in revenues for 2022, €15.9
million was attributable to the partial recognition of the €40.0
million deferred income per IFRS2 15 in accordance with the
Collaboration and Licensing Agreement signed with Ipsen in 2021.
€1.0 million in revenue was generated from services rendered by
GENFIT to Ipsen in accordance with the Transition Services
Agreement signed in 2022. €3.3 million was recognized as revenue in
accordance with the Inventory Purchase Agreement signed with Ipsen
in 2022, under which the Company sold almost all of its remaining
stock of elafibranor’s active ingredient and drug products for the
ELATIVE® Phase 3 clinical trial to Ipsen.
Upcoming FDA PDUFA3
Action Date for Elafibranor in PBC: June 10,
2024
Regulatory filing acceptance has been obtained
in the US, Europe and the United Kingdom4 and a Priority Review has
been granted for an NDA by the FDA for elafibranor in PBC with a
PDUFA target action date of June 10, 2024.
Upcoming Financial
Communications
The Company will release its full-year 2023
financial results on April 4, 2024. The 2023 Universal Registration
Document, the 2023 Annual Financial Report (included in the 2023
Universal Registration Document), and the Annual Report on Form
20-F will be published by the end of April 2024.
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 eligibility to receive future milestone payments from
Ipsen relating to the development and commercial launch of
elafibranor in PBC, approval of elafibranor in PBC and potential
commercialization as early as 2024, and expected 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
1 GENFIT Updates 2024 Outlook Following Acceptance of
Elafibranor Filings in Primary Biliary Cholangitis (PBC)2
International Financial Reporting Standards3 Prescription Drug User
Fee Act4 Ipsen confirms U.S. FDA grants priority review for New
Drug Application for elafibranor for the treatment of rare
cholestatic liver disease, PBCGENFIT | 885 Avenue
Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 |
www.genfit.com
- GENFIT Announces Revenues and Cash Position as of December 31,
2023
Genfit (EU:GNFT)
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