GENFIT is a French biopharmaceutical company focused on discovering and developing drug candidates and diagnostic solutions targeting liver diseases, in particular those of metabolic origin, and hepatobiliary diseases
Lille (France), Cambridge (Massachusetts, United States), March 27, 2019 – GENFIT CORP. (Euronext: 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, and hepatobiliary diseases, today announced the pricing of its global offering to specified categories of investors of an aggregate of 6,650,000 new ordinary shares, comprising an offer of 6,150,000 ordinary shares in the form of American Depositary Shares, each representing one ordinary share (“ADSs”), at an offering price of $20.32 per ADS (the “ADS Offering”) and a concurrent private placement of 500,000 ordinary shares in Europe (including France) and other countries outside of the United States at the corresponding offering price of €18.00 per ordinary share (the “European Private Placement,” and together with the ADS Offering, the “Global Offering”), for aggregate gross proceeds of approximately $135.1 million before deducting underwriting commissions and expenses payable by the Company. In addition, GENFIT has granted the underwriters for the Global Offering (the “Underwriters”) a 30-day option to purchase up to 997,500 additional ADSs and/or ordinary shares on the same terms and conditions, representing 15% of the ADSs and/or ordinary shares to be issued by the Company in the Global Offering (the “Underwriters’ Option”). All of the ADSs and ordinary shares in the Global Offering are being offered by GENFIT.
GENFIT’s ordinary shares are listed on Euronext Paris under the symbol “GNFT”. GENFIT’s ADSs have been approved for listing on the Nasdaq Global Select Market under the ticker symbol “GNFT” and are expected to begin trading on March 27, 2019.
The 6,650,000 ordinary shares issued in the Global Offering (including ordinary shares in the form of ADSs) will represent 18% of the total issued share capital of the Company of 37,833,921 ordinary shares (including ordinary shares in the form of ADSs) on a non-diluted basis following the closing of the Global Offering. In the event the Underwriters’ Option is exercised in full, the Company will issue a total of 7,647,500 new shares (including ordinary shares in the form of ADSs) in the Global Offering, which would represent 20% of the total issued share capital of the Company on a non-diluted basis.
SVB Leerink and Barclays are acting as joint global coordinators for the Global Offering and joint bookrunners for the ADS Offering. Roth Capital Partners and H.C. Wainwright & Co. are acting as co- managers of the ADS Offering. Bryan, Garnier & Co. Limited and Natixis are acting as joint bookrunners with respect to the European Private Placement.
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 ADS Offering and the European Private Placement are conditioned on each other and are expected to occur simultaneously on March 29, 2019, subject to customary closing conditions.
The Company expects to use the net proceeds from the Global Offering as follows (assuming an exchange rate of €1.00 = $1.1291, the exchange rate on March 26, 2019 as published by the European Central Bank):
- approximately €13.3 million ($15.0 million) to prepare for the potential commercialization of elafibranor in nonalcoholic steatohepatitis (“NASH”) by building out the Company’s commercial infrastructure;
- approximately €44.3 million ($50.0 million) to complete the Company’s ongoing Phase 3 clinical development of elafibranor for the treatment of NASH through to, at least, the submission of a new drug application to the U.S. Food and Drug Administration and the European Medicines Agency and the launch of the Phase 4 clinical trial;
- approximately €31.0 million ($35.0 million) to conduct and complete the Company’s 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 the Company’s in vitro diagnostic (“IVD”) test to identify NASH patients through the launch of the LDT and completion of the work required to obtain regulatory approval for its IVD kit;
- approximately €5.3 million ($6.0 million) to advance the Company’s research program on the use of elafibranor as a potential backbone for combination therapies in order to launch two proof-of-concept studies; and the remainder for working capital and for general corporate purposes.
A registration statement relating to these securities, including a prospectus, was declared effective by the U.S. Securities and Exchange Commission (“SEC”) on March 26, 2019. Copies of the final 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.
Application will be made to list the new ordinary shares to be issued in the European Private Placement and the ordinary shares underlying the ADSs in the ADS Offering on the regulated market of Euronext Paris pursuant to a listing prospectus subject to a visa application with the 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 closing of the Global Offering and GENFIT’s planned use of proceeds from the Global Offering. 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, 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 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.
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
