FOR IMMEDIATE RELEASE
GENFIT Announces
Launch of Proposed Global Offering
and Nasdaq Listing
Lille (France),
Cambridge (Massachusetts, United States), March 14, 2019 -
GENFIT S.A. (Euronext Paris: GNFT - ISIN: FR0004163111) ("Genfit" or the "Company"), a
French biopharmaceutical company focused on discovering and
developing drug candidates and diagnostic solutions targeting liver
diseases, in particular those of metabolic origin, today announced
its intention to issue and sell, subject to market and other
conditions, 5,000,000 of its ordinary shares in a global offering
to specified categories of investors, comprised of an initial
public offering of American Depositary Shares ("ADSs"), each representing one ordinary share, in the
United States (the "U.S. Offering"), and a
concurrent private placement of ordinary shares in Europe
(including France) and other countries outside of the United States
(the "European Private Placement," and
together with the U.S. Offering, the "Global
Offering").
GENFIT intends to grant the
underwriters for the offering (the "Underwriters") a 30-day option to purchase additional
ADSs and/or ordinary shares in an aggregate amount of up to 15% of
the total number of ADSs and ordinary shares proposed to be sold in
the Global Offering.
All securities to be sold in the
Global Offering will be offered by GENFIT. GENFIT's ordinary shares
are listed on Euronext Paris under the symbol "GNFT". GENFIT has
applied to list the ADSs to be sold in the U.S. Offering on
the Nasdaq Global Market under the ticker symbol
"GNFT".
SVB Leerink and Barclays are
acting as joint global coordinators for the Global Offering and
joint bookrunners for the U.S. Offering. Roth Capital Partners and
H.C. Wainwright & Co. are acting as co-managers of the U.S.
Offering. Bryan, Garnier & Co. Limited and Natixis are
acting as joint bookrunners with respect to the European Private
Placement.
The offering price per ADS in U.S.
dollars and the corresponding offering price per ordinary share in
euros, as well as the final number of ADSs and/or ordinary shares
sold in the Global Offering, will be determined following a
bookbuilding process commencing immediately. The offering price per
ADS and per ordinary share will be at least equal to the
volume-weighted average price of the Company's ordinary shares
on Euronext Paris during a window of five to 30
consecutive trading days (as decided by the Company) within the 30
trading days preceding the date on which the final offering price
is determined, reduced by a maximum discount of 15%.
On an indicative basis, the
completion of the Global Offering, assuming the issuance of
5,000,000 ordinary shares (including in the form of ADSs), would
result in a dilution of approximately 14% of the Company's
outstanding share capital on a non-diluted basis, and approximately
16% of the Company's outstanding share capital on a non-diluted
basis in the event that the Underwriters exercise in full their
option to purchase additional ADSs and/or ordinary shares.
The ADSs and/or ordinary shares
will be issued through a capital increase without shareholders'
preferential subscription rights and for the benefit of a specified
category of persons within the meaning of Article L.225-138 of the
French Commercial Code (Code de commerce) and
pursuant to the seventeenth and eighteenth resolutions of the
Company's combined general shareholders' meeting held on June 15,
2018. Under the authority granted by the shareholders in the
seventeenth resolution, the ordinary shares and ADSs may only be
purchased initially by industrial or commercial companies in the
pharmaceutical/biotech sector or investment fund companies or fund
management companies or collective savings managing funds governed
by French or foreign law or any other legal entity (including a
trust) or natural person, investing in the pharmaceutical/biotech
sector, that is qualified to invest in a private placement. In
order to purchase ordinary shares and/or ADSs in the Global
Offering, potential investors will be required to execute and
provide to the Underwriters an investor letter representing that
they satisfy the foregoing investor criteria.
The closings of the U.S. Offering
and the European Private Placement will occur simultaneously, will
be conditioned on each other and are expected to occur on the third
trading day after the final pricing and allocation of the Global
Offering.
The Company expects to use the net
proceeds from the Global Offering as follows (assuming an exchange
rate of €1.00 = $1.1243, the exchange rate on March 8, 2019):
-
approximately €13.3 million ($15.0 million) to
prepare for the potential commercialization of elafibranor for the
treatment of nonalcoholic steatohepatitis ("NASH") by building out its commercial
infrastructure;
-
approximately €44.5 million ($50.0 million) to
complete its ongoing Phase 3 clinical development of elafibranor
for the treatment of NASH through to, at least, the submission of a
new drug application ("NDA") to the U.S. Food
and Drug Administration ("FDA") and European
Medicines Agency ("EMA") and the launch of the
Phase 4 clinical trial;
-
approximately €31.1 million ($35.0 million) to
conduct and complete its planned global Phase 3 clinical trial of
elafibranor for the treatment of primary biliary cholangitis
("PBC");
-
approximately €5.3 million ($6.0 million) to
advance the commercial development of an in vitro diagnostic
("IVD") test designed to identify NASH
patients, including the launch of the test as a
laboratory-developed test and completion of work required to obtain
regulatory approval for the IVD kit from the FDA;
-
approximately €5.3 million ($6.0 million) to
advance its research program on the use of elafibranor as a
potential backbone for combination therapies in order to launch two
planned proof-of-concept studies; and
-
the remainder, if any, for working capital and
general corporate purposes.
The securities referred to in this
press release will be offered only by means of a prospectus.
Copies of the preliminary prospectus relating to and describing the
terms of the Global Offering may be obtained from SVB Leerink LLC,
Attention: Syndicate Department, One Federal Street, 37th Floor,
Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6132, or
by email at syndicate@svbleerink.com; or from Barclays Capital
Inc., c/o Broadridge Financial Solutions, Attention: Prospectus
Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by
telephone at (888) 603-5847, or by email at
barclaysprospectus@broadridge.com.
A registration statement on Form
F-1 relating to these securities has been filed with the U.S.
Securities and Exchange Commission but has not yet become
effective. These securities may not be sold, nor may offers to buy
be accepted, prior to the time the registration statement becomes
effective.
Application will be made to list
the new ordinary shares to be issued pursuant to the Global
Offering on the regulated market of Euronext in
Paris pursuant to a listing prospectus subject to a visa
application with the French Autorité des marchés financiers
("AMF") and comprising the 2018 Reference
Document (Document de Référence) of the Company registered with the
AMF on February 27, 2019 under number D. 19-0078 and a
Securities Note (Note d'opération), including a summary of the
prospectus. Copies of the 2018 Reference Document are available
free of charge at the Company's head office located at Parc
Eurasanté, 885, avenue Eugène Avinée, 59120 Loos, France, on the
Company's website (www.genfit.com) and on the website of the AMF
(www.amf-france.org).
This press release does not
constitute an offer to sell or the solicitation of an offer to buy
securities, and shall not constitute an offer, solicitation or sale
in any jurisdiction in which such offer, solicitation or sale would
be unlawful prior to registration or qualification under the
securities laws of that jurisdiction.
About
GENFIT
GENFIT is a biopharmaceutical
company focused on discovering and developing drug candidates and
diagnostic solutions targeting liver diseases, in particular those
of metabolic origin, and hepatobiliary diseases. GENFIT
concentrates its R&D efforts in areas of high unmet medical
needs corresponding to a lack of approved treatments. GENFIT's lead
proprietary compound, elafibranor, is a drug candidate currently
being evaluated in one of the most advanced Phase 3 studies
worldwide (RESOLVE-IT) in NASH, considered by regulatory
authorities as a medical emergency because it is silent, with
potentially severe consequences, and with a prevalence on the rise.
Elafibranor has also obtained positive preliminary results in a
Phase 2 clinical trial in PBC, a severe chronic liver disease. As
part of its comprehensive approach to clinical management of NASH
patients, GENFIT is conducting an ambitious discovery and
development program aimed at providing patients and physicians with
a blood-based test for the diagnosis of NASH, i.e. non-invasive and
easy-to-access. With facilities in Lille and Paris, France, and
Cambridge, MA (USA), the Company has approximately 150 employees.
GENFIT is a public company listed in compartment B of Euronext's
regulated market in Paris (Euronext: GNFT - ISIN:
FR0004163111).
FORWARD LOOKING
STATEMENT/DISCLAIMER
This press release contains
certain forward-looking statements with respect to the success and
timing of the proposed Global Offering and GENFIT's planned use of
proceeds from the Global Offering, as well as GENFIT's clinical
development plans, business and regulatory strategy, and
anticipated future performance. Although the Company believes its
expectations are based on reasonable assumptions, these
forward-looking statements are subject to numerous 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,
including its RESOLVE-IT Phase 3 trial, review and approvals by
regulatory authorities, such as the FDA or the EMA, of its drug and
diagnostic candidates, the success of any in-licensing strategies,
and the Company's continued ability to raise capital to fund its
development, including as part of the proposed Global Offering, as
well as those risks and uncertainties discussed or identified in
the Company's public filings with the AMF, including those listed
in Section 4 "Main Risks and Uncertainties" of the Company's 2018
Registration Document filed with the French Autorité des marchés financiers 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). Other than as required by applicable law, the
Company does not undertake any obligation to update or revise any
forward-looking information or statements. This press release and
the information contained herein do not constitute an offer to sell
or a solicitation of an offer to buy or subscribe to shares in
GENFIT in any country. This press release has been prepared in both
French and English. In the event of any differences between the two
texts, the French language version shall supersede.
No communication or information
relating to the Global Offering by GENFIT may be transmitted to the
public in a country where there is a registration obligation or
where an approval is required. The issuance or the subscription of
the shares of the Company may be subject to legal and regulatory
restrictions in certain jurisdictions; none of GENFIT and the banks
involved in the Global Offering assumes any liability in connection
with the breach by any person of such restrictions.
This press release is an
advertisement and not a prospectus within the meaning of Directive
2003/71/EC of the European Parliament and the Council of 4 November
2003 as amended or superseded, as implemented in each member state
of the European Economic Area (the Prospectus Directive).
This press release is not an offer
to the public, an offer to subscribe or designed to solicit
interest for purposes of an offer to the public in any
jurisdiction, including France.
The shares of the Company will be
offered only by way of a private placement in France and/or outside
France (excluding the United States of America) to persons referred
to in Article L.411-2-II of the French monetary and financial code
(code monétaire et financier).
European Economic
Area
With respect to the Member States
of the European Economic Area which have implemented the Prospectus
Directive (the Relevant Member States), no action has been
undertaken or will be undertaken to make an offer to the public of
the shares of the Company requiring a publication of a prospectus
in any Relevant Member State. As a result, the shares of the
Company may only be offered in Relevant Member States:
a) to any legal entity which is a
qualified investor as defined in the Prospectus Directive;
b) to fewer than 150 natural or
legal persons (other than qualified investors as defined in the
Prospectus Directive); or
c) in any other circumstances
falling within Article 3(2) of the Prospectus Directive.
For the purposes of this
paragraph, (i) the expression "offer to the public of shares of the
Company" in any Relevant Member States, means any communication, to
individuals or legal entities, in any form and by any means, of
sufficient information on the terms and conditions of the offering
and on the shares of the Company to be offered, thereby enabling an
investor to decide to purchase or subscribe for the shares of the
Company, as the same may be varied in that Member State.
These selling restrictions with
respect to Relevant Member States apply in addition to any other
selling restrictions which may be applicable in the Relevant Member
States who have implemented the Prospectus Directive.
France
The shares of the Company in the
context of the Global Offering will not be offered or sold or cause
to be offered or sold, directly or indirectly, to the public in
France. Any offer or sale of the shares of the Company and
distribution of any offering material relating to the shares of the
Company have been and will be made in France only to (a) persons
providing investment services relating to portfolio management for
the account of third parties (personnes
fournissant le service d'investissement de gestion de portefeuille
pour compte de tiers), and/or (b) qualified investors
(investisseurs qualifiés) and/or a restricted
circle of investors acting for their own account, as defined in,
and in accordance with, Articles L.411-1, L.411-2 and D.411-1 of
the French monetary and financial code (code
monétaire et financier).
United
Kingdom
This press release is addressed
only (i) to persons located outside the United Kingdom, (ii) to
investment professionals as defined in Article 19(5) of the
Financial Services and Markets Act 2000 (Financial Promotion) Order
2005, as amended (the Order), (iii) to people designated by Article
49(2) (a) to (d) of the Order or (iv) to any other person to whom
this press release could be addressed pursuant to applicable law
(the persons mentioned in paragraphs (i), (ii), (iii) and (iv) all
deemed relevant persons (Relevant Persons). The shares of the
Company sold in the context of the Global Offering are intended
only for Relevant Persons and any invitation, offer of contract
related to the subscription, tender, or acquisition of the shares
of the Company in the context of the Global Offering may be
addressed and/or concluded only with Relevant Persons. All persons
other than Relevant Persons must abstain from using or relying on
this document and all information contained therein.
This press release is not a
prospectus which has been approved by the Financial Services
Authority or any other United Kingdom regulatory authority for the
purposes of Section 85 of the Order.
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
2019.03.14 - GENFIT PR - IPO
launch
This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: GENFIT via Globenewswire
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