GENFIT Reports First Quarter 2023 Financial Information
- Cash, cash equivalents and
current financial assets
totaled €128.6 million as of March 31,
2023
Lille (France); Cambridge,
(Massachusetts, United States); Zurich
(Switzerland); May 11, 2023 - GENFIT (Nasdaq and Euronext:
GNFT), a late-stage biopharmaceutical company dedicated to
improving the lives of patients with rare and severe liver
diseases, today announced its cash position as of March 31, 2023
and revenues for the first three months of 20231.
Cash Position
As of March 31, 2023, the Company’s cash, cash
equivalents and current financial assets amounted to €128.6 million
compared with €222.2 million as of March 31, 2022, and €140.2
million as of December 31, 2022.
The decrease in cash, cash equivalents and
current financial assets between December 31, 2022 and March 31,
2023 consists of costs arising out of the ordinary course of
business related to the progress of our research and development
pipeline.
The decrease in cash, cash equivalents and
current financial assets between March 31, 2022 and March 31, 2023
notably includes the initial consideration of CHF40.0 million
(€41.9 million) for the acquisition of Versantis AG on September
29, 2022, a payment of CHF2.4 million (€2.4 million) representing a
net cash adjustment made at year end in accordance with the
Versantis AG Share Purchase Agreement, and related acquisition
costs totaling €1.7 million.
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,
including potential milestone payments should the ELATIVE™ study be
successful. 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.
Revenues
Revenues2 for the first three months of 2023
amounted to €5.0 million compared to €3.9 million for the same
period in 2022.
Of the €5.0 million in revenues for the first
three months of 2023, €4.1 million is attributable to the partial
recognition of the €40.0 million deferred income described below.
€0.8 million is attributable to re-billings made in accordance with
the 2021 licensing and collaboration agreement with IPSEN,
referenced below. €0.1 million in revenue was generated from the
services rendered by GENFIT to Ipsen in accordance with the
Transition Services Agreement signed in 2022, in order to
facilitate the transition of certain activities related to the
Phase 3 clinical trial evaluating elafibranor in Primary Biliary
Cholangitis.
Revenues for the first three months of 2022 are
mainly attributable to the partial recognition of the €40.0 million
deferred income described below.
In 2021, GENFIT received a €120.0 million
upfront payment from Ipsen, out of which €80.0 million was
recognized as 2021 revenue, and €40.0 million was recognized as
deferred revenue. The remainder is recognized as revenue over time
and in line with the progress of the ELATIVE™ double-blind study,
in accordance with IFRS 15 and the terms of the strategic licensing
and collaboration agreement with Ipsen on December 17, 2021.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
dedicated to improving the lives of patients with rare and severe
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. 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 six 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 disorder
(UCD), organic acidemias (OA) and primary biliary cholangitis
(PBC). Beyond therapeutics, GENFIT’s pipeline also includes a
diagnostic franchise focused on NASH 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.
www.genfit.com
GENFIT FORWARD LOOKING STATEMENTS
This press release contains certain
forward-looking statements with respect to GENFIT, including those
within the meaning of the Private Securities Litigation Reform Act
of 1995 in relation to the Company’s projected cash burn. The use
of certain words, including “consider”, “contemplate”, “think”,
“aim”, “expect”, “understand”, “should”, “aspire”, “estimate”,
“targeted”, “anticipated”, “believe”, “wish”, “may”, “could”,
“allow”, “seek”, “encourage” or “have confidence” or (as the case
may be) the negative forms of such terms or any other variant of
such terms or other terms similar to them in meaning is intended to
identify forward-looking statements. Although the Company believes
its projections are based on reasonable expectations and
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, biomarkers, cost of,
progression of, and results from, its ongoing and planned clinical
trials, review and approvals by regulatory authorities in the
United States, Europe and worldwide, of our drug and diagnostic
candidates, exchange rate fluctuations, potential synergies related
to the acquisition of Versantis, our capacity to integrate its
assets, develop its programs 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 “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. 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 | InvestorsTel : + 33 3
20 16 40 00 | investors@genfit.com
PRESS RELATIONS | Media
Stephanie BOYER – Press relations | Tel : +
33 3 20 16 40 00 | 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 Revenues as recognized under IFRS 15
- GENFIT Reports First Quarter 2023 Financial Information
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