firstwordpharmaMarch 15, 2019
Tag: Genfit , Announces Launch , Proposed Global Offering
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.
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.
Register as Visitor to CPhI China 2019!
-----------------------------------------------------------------------
Editor's Note:
To apply for becoming a contributor of En-CPhI.cn,
welcome to send your CV and sample works to us,
Email: Julia.Zhang@ubmsinoexpo.com.
Contact Us
Tel: (+86) 400 610 1188
WhatsApp/Telegram/Wechat: +86 13621645194
Follow Us: