GENFIT: Reports Third Quarter 2019 Financial Information
GENFIT: Reports Third
Quarter 2019 Financial Information (Unaudited
financial information under IFRS)
- Cash and cash equivalents of €303 million at September
30, 2019
- Revenues of €31 million for the first nine months of
2019 mainly due to the upfront payment per the Terns
Pharmaceuticals licensing and collaboration agreement
Lille (France), Cambridge
(Massachusetts, United States), October 30, 2019 –
GENFIT (Nasdaq and Euronext: GNFT), a late-stage
biopharmaceutical company dedicated to the discovery and
development of innovative therapeutic and diagnostic solutions in
metabolic and liver related diseases, today announced its cash
position as of September 30, 2019 and revenues for the first nine
months of 2019.
Cash Position
As of September 30, 2019, the Company’s cash and
cash equivalents amounted to €303.0 million compared with €219.9
million one year earlier.
As of June 30, 2019, cash and cash equivalents
totaled €281.9 million.
During the third quarter GENFIT received an
up-front payment pursuant to the license and collaboration
agreement with Terns Pharmaceuticals. Under the terms of this
licensing agreement, Terns obtained the exclusive rights to
develop, register and market elafibranor in mainland China, Hong
Kong, Macau and Taiwan (“Greater China”) for both NASH and
PBC. GENFIT is eligible to receive up to an additional $193
million based on potential clinical, regulatory and commercial
milestones. Upon commercial launch of elafibranor for the
treatment of NASH in Greater China, GENFIT will be entitled to
receive mid-teen percentage royalties from Terns based on sales in
the territory.
Revenues*
Revenues* for the first nine months of 2019
amounted to €31 million compared to €0.07 million for the same
period in 2019.
Revenues for the first nine months of 2019*
result mainly from receipt of the upfront payment pursuant to the
licensing and collaboration agreement signed with Terns
Pharmaceuticals at the end of June 2019.
*Revenue recognized under IFRS 15
ABOUT ELAFIBRANOR
Elafibranor is GENFIT’s lead pipeline product
candidate. Elafibranor is an oral, once-daily, first-in-class drug
acting via dual peroxisome proliferator-activated alpha/delta
pathways developed to treat, in particular, nonalcoholic
steatohepatitis (NASH), for which it has been granted Fast Track
Designation. GENFIT believes, based on clinical results to date,
that elafibranor has the potential to address multiple facets of
NASH, including inflammation, insulin sensitivity, lipid/metabolic
profile, and liver markers. Phase 2 clinical trial results have
also shown that elafibranor may be an effective treatment for PBC,
a severe liver disease. Elafibranor was granted a Breakthrough
Therapy Designation in this indication.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
dedicated to the discovery and development of innovative
therapeutic and diagnostic solutions in metabolic and liver related
diseases where there are considerable unmet medical needs,
corresponding to a lack of approved treatments. GENFIT is a leader
in the field of nuclear receptor-based drug discovery with a rich
history and strong scientific heritage spanning almost two decades.
Its most advanced drug candidate, elafibranor, is currently being
evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a
potential treatment for NASH, and GENFIT plans to initiate a Phase
3 clinical trial in PBC at the beginning of next year following its
positive Phase 2 results. As part of GENFIT’s comprehensive
approach to clinical management of NASH patients, the company is
also developing a new, non-invasive and easy-to-access blood-based
in vitro diagnostic test to identify patients with NASH who may be
appropriate candidates for drug therapy. With facilities in Lille
and Paris, France, and Cambridge, MA, USA, the Company has
approximately 200 employees. GENFIT is a public company listed on
the Nasdaq Global Select Market and in compartment B of Euronext’s
regulated market in Paris (Nasdaq and Euronext: GNFT).
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 the potential to develop and commercialize
elafibranor in Greater China and obtain revenues therefrom.
The use of certain words, including “believe,” “potential,”
“expect” 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 related to safety,
biomarkers, progression of, and results from, its ongoing and
planned clinical trials, review and approvals by regulatory
authorities of its drug and diagnostic candidates and the Company’s
continued ability to raise capital to fund its development, as well
as those risks and uncertainties discussed or identified in the
Company’s public filings with the French Autorité des marchés
financiers (“AMF”), including those listed in Section 4 “Main Risks
and Uncertainties” of the Company’s 2018 Registration Document
filed with the AMF on February 27, 2019 under n° D.19-0078, which
is available on GENFIT’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 final prospectus dated March 26,
2019, and subsequent filings and reports filed with the AMF or SEC,
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
Naomi EICHENBAUM – Investor Relations | Tel: +1
(617) 714 5252 | investors@genfit.com
PRESS RELATIONS | Media
Hélène LAVIN – Press relations | Tel: +333 2016
4000 | helene.lavin@genfit.com
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos -
FRANCE | +333 2016 4000 |
www.genfit.com
- GENFIT: Reports Third Quarter 2019 Financial Information