GENFIT LAUNCHES AN OFFERING OF BONDS CONVERTIBLE I
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This press release may not be published, forwarded or distributed, directly or indirectly in the United States of America, Canada, Australia or Japan.
This press release does not constitute or form part of any offer or solicitation to purchase or subscribe for securities in the United States of America or in any other jurisdiction in which it would be unlawful to do so.
GENFIT LAUNCHES AN OFFERING OF BONDS CONVERTIBLE INTO NEW SHARES AND/OR EXCHANGEABLE FOR EXISTING SHARES ("OCEANEs") DUE 2022 FOR AN AMOUNT OF APPROXIMATELY €150 MILLION
Lille (France), Cambridge (Massachusetts, United States), October 11 th , 2017 - GENFIT (Euronext: GNFT - ISIN: FR0004163111), a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, announces today the launch of an offering of bonds convertible into new shares and/or exchangeable for existing shares (" OCEANEs ") due October 16 th , 2022 by way of a private placement to institutional investors for a nominal amount of approximately €150 million (the " Offering ").
Purpose of the Offering:
The proceeds of the Offering will be used by the Company notably to:
- Complete the Phase 3 clinical development program for elafibranor in NASH and continue the Pediatric Investigation Plan in the same disease;
- Prepare, subject to the results of the Phase 3 pivotal study, the application for marketing approval of elafibranor in NASH;
- Prepare the potential commercialization of elafibranor in certain diseases and/or in certain territories;
- Finance the industrial development stage of a new in vitro diagnostic test as part of the continuation of the biomarker program; and
- Reinforce the Company's pipeline through in-licensing or combination therapy strategies in therapeutic areas of interest to the Company.
Jean-François Mouney, Chairman & CEO of GENFIT, commented: " With this transaction, GENFIT intends to carry out a different type of fund raise from the previous dilutive transactions and to take advantage of the leverage from 30 to 35% premium compared to the reference price included in the OCEANE price.
Th e fund raise offers a new type of institutional investor the opportunity to participate in GENFIT's development in a context where the progress made by our NASH development program brings us closer each day to important milestones, and in particular, marketing authorization for elafibranor.
The funds raised will increase the Company's resources and fund the growth of our NASH program - in particular, with the continued clinical development of elafibranor in adults and children. In this context, the strengthening of our cash position takes place in particular at a time when external factors have led to the inflation of the cost per patient in clinical trials. This is due to the growing interest in NASH demonstrated by many players in the pharmaceutical industry, as NASH is now more than ever recognized as a public health priority by regulatory authorities around the world.
The growth of the NASH program also includes the development of a simple and easy-to-access diagnostic solution which we plan to produce and market in close collaboration with a major diagnostic player, and the expansion of our work in fibrosis and cirrhosis.
Finally, these funds will be used to start preparing for the commercialization of elafibranor, with the unchanged objective of generating a double source of income, retaining both the rights of elafibranor in certain territories, and reserving a significant share of the market for future partnerships."
Main terms and conditions of the OCEANEs:
The nominal unit value of the OCEANEs will be set at a conversion/exchange premium of between 30% and 35% to GENFIT's reference share price [1] .
The OCEANEs will entitle their holders to receive new and/or existing GENFIT shares at an initial conversion/exchange ratio of one share per OCEANE, subject to any potential subsequent adjustments.
The OCEANEs will bear interest at an annual nominal rate comprised between 3.00% and 3.50% payable semi-annually in arrears on April 16 th and October 16 th of each year (or the following business day if this date is not a business day) with a first interest payment date on April 16 th , 2018. The OCEANEs will be issued at par on October 16 th , 2017, the expected date for the settlement and delivery of the OCEANEs (the " Issue Date "), and will be redeemed at par on October 16 th , 2022 (or the following business day if this date is not a business day).
Under certain conditions, the OCEANEs may be redeemed prior to maturity at the option of the Company. In particular, the OCEANEs may be redeemed early at GENFIT's option as from November 6 th , 2020 if the arithmetic average of the volume-weighted average price of GENFIT's listed share price on the regulated market of Euronext in Paris and the then prevailing conversion ratio (over a 20-consecutive trading day period among 40 trading days) exceeds 150% of the nominal value of the OCEANEs.
The final terms and conditions of the OCEANEs are expected to be determined today.
For illustrative purpose, when considering an offering of OCEANEs for a maximum amount of approximately €150m, a nominal value of €32.198 per OCEANE (calculated on the basis of a reference share price as of October 10 th , 2017 corresponding to €24.30 and a 32.5% issue premium corresponding to the issue premium mid-range), dilution would approximately represent 14.95% of oustanding share capital of GENFIT, if only new shares were delivered upon conversion.
The OCEANEs will be issued pursuant to the 11 th resolution approved by the shareholders' ordinary and extraordinary general meeting held on 16 June 2017 and will be offered only by way of a private placement, conducted in accordance with Article L.411-2 II of the French Monetary and Financial Code ( Code monétaire et financier ), in France and outside France (excluding the United States of America, Canada, Australia or Japan) to qualified investors.
The Offering is not subject to a prospectus approved by the French financial market authority ( Autorité des marchés financiers ) (the " AMF "). Detailed information on GENFIT, including its business, results, prospectus and related risk factors are described in the Company's reference document filed with the AMF on April 28, 2017 under number R.17-034, which is available together with all the press releases and other regulated information about the Company, on GENFIT's website ( www.genfit.fr ).
An application for the listing of the OCEANEs on Euronext Access TM (Open market of Euronext in Paris) will be made. Such listing will occur within 30 days after the Issue Date.
In the context of the Offering, GENFIT will agree to a lock-up undertaking for a period starting from the announcement of the final terms and conditions of the OCEANEs and ending 90 calendar days after the Issue Date, subject to certain exceptions or to the prior agreement of the Joint Bookrunners (as defined below).
Kepler Chevreux and Natixis act as joint bookrunners for the Offering (the " Joint Bookrunners ").
This press release does not constitute or form part of any offer or solicitation to purchase or subscribe for or to sell securities and the Offering is not an offer to the public in any jurisdiction, including France.
Third quarter 2017 financial information:
The Company has announced today the amount of cash and cash equivalents at September 30, 2017 and revenues for the first nine months of 2017:
Cash position
At September 30, 2017, the Company's cash and cash equivalents amounted to €113.8 million compared with €84.9 million one year earlier.
At June 30, 2017, cash and cash equivalents totaled €126.3 million.
Revenues
Revenues for the first nine months of 2017 amounted to €91 thousand compared to €217 thousand for the same period in 2016.
About elafibranor
Elafibranor is GENFIT's lead pipeline product. Elafibranor is an oral once-daily treatment, and a first-in-class drug acting via dual peroxisome proliferator-activated alpha/delta pathways developed to treat, in particular, nonalcoholic steatohepatitis (NASH). Elafibranor is believed to address multiple facets of NASH, including inflammation, insulin sensitivity, lipid/metabolic profile, and liver markers.
About NASH
"NASH", or nonalcoholic steatohepatitis, is a liver disease characterized by an accumulation of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. The disease is associated with long term risk of progression to cirrhosis, a state where liver function is diminished, leading to liver insufficiency, and also progression to liver cancer.
About GENFIT
GENFIT is a biopharmaceutical company focused on the discovery and development of drug candidates in areas of high unmet medical needs corresponding to a lack of suitable treatment and an increasing number of patients worldwide. GENFIT's R&D efforts are focused on bringing new medicines to market for patients with metabolic, inflammatory, autoimmune and fibrotic diseases, that affect the liver (such as NASH - Nonalcoholic steatohepatitis) and more generally the gastro-intestinal arena. GENFIT's approach combines novel treatments and biomarkers. Its lead proprietary compound, elafibranor, is currently in a Phase 3 study. With facilities in Lille and Paris, France, and Cambridge, MA (USA), the Company has approximately 130 employees. GENFIT is a public company listed in compartment B of Euronext's regulated market in Paris (Euronext: GNFT - ISIN: FR0004163111). www.genfit.com
Forward Looking Statement / Disclaimer This press release contains certain forward-looking statements. 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 biomarkers, progression of, and results of clinical data from, the RESOLVE-IT trial and the trial of elafibranor in PBC, review and approvals by regulatory authorities, such as the FDA or the EMA, regarding in particular, elafibranor in NASH and PBC, as well as other drug candidates in other indications and biomarkers candidates, the success of any inlicensing strategies, the Company's continued ability to raise capital to fund its development, as well as those discussed or identified in the Company's public filings with the AMF, including those listed in Chapter 7 of the 2017 Half Year Business and Financial Report and under Section 4 "Main Risks and Uncertainties" of the Company's 2016 Registration Document registered with the French Autorité des marchés financiers on April 28, 2017 under n° R.17-034, 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.
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Disclaimer
This press release may not be published, distributed or released directly or indirectly in the United States of America, Canada, Australia or Japan.
No communication or information relating to the issuance by GENFIT of bonds convertible into and/or exchangeable for new and/or existing shares (the " Bonds ") may be transmitted to the public in a country where there is a registration obligation or where an approval is required. No action has been or will be taken in any country in which such registration or approval would be required. The issuance or the subscription of the Bonds may be subject to legal and regulatory restrictions in certain jurisdictions; none of GENFIT and the Joint Bookrunners 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, 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 Bonds will be offered only by way of a private placement in France and/or outside France (excluding the United States of America, Canada, Australia or Japan) to persons referred to in Article L.411-2-II of the French monetary and financial code (code monétaire et financier), without an offer to the public in any country (including France).
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 Bonds requiring a publication of a prospectus in any Relevant Member State. As a result, the Bonds 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 Bonds " 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 Bonds to be offered, thereby enabling an investor to decide to purchase or subscribe for the Bonds, 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 Bonds have not been and 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 Bonds and distribution of any offering material relating to the Bonds 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 (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 Bonds and, if applicable, the shares of GENFIT to be delivered upon exercise of the conversion rights (the " Financial Instruments ") are intended only for Relevant Persons and any invitation, offer of contract related to the subscription, tender, or acquisition of the Financial Instruments 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.
Each institution in charge of the placement has represented and agreed that:
(i) it has only communicated or caused to be communicated and will only communicate or cause to be communicated invitations or inducements to engage in investment activity (within the meaning of Section 21 of the Financial Services and Markets Act 2000), received by it in connection with the Bonds, in circumstances in which Section 21(1) of the Financial Services and Markets Act 2000 does not apply to the issuer; and
(ii) it has complied and will comply with all applicable provisions of the Financial Services and Market Act 2000 with respect to anything that it has done or will do in relation to the Bonds in the United Kingdom, from the United Kingdom or otherwise involving the United Kingdom.
United States of America
This press release shall not be published, distributed or transmitted in the United States.
This press release does not constitute or form a part of any offer or solicitation to purchase or subscribe for securities nor of any offer or solicitation to sell securities in the United States. The securities mentioned herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the " U.S. Securities Act "), and may not be offered or sold, directly or indirectly, within the United States of America except pursuant to an exemption from or in a transaction not subject to, the registration requirements of the Securities Act. GENFIT does not intend to register any portion of the proposed offering in the United States of America or conduct a public offering of securities in the United States of America.
Canada, Australia and Japan
The Bonds may not and will not be offered, sold or purchased in Canada, Australia or Japan.
The distribution of this press release in certain countries may constitute a breach of applicable law. The information contained in this press release does not constitute an offer of securities for sale in Canada, Australia or Japan.
CONTACT
GENFIT | Jean-François Mouney - Chairman & CEO | +333 2016 4000
PRESS RELATIONS | Bruno Arabian | +336 8788 4726
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com
[1] The reference share price will be equal to the volume-weighted average price of the Company's share recorded on the regulated market of Euronext in Paris from the launch of the Offering today until the determination of the final terms and conditions (pricing) of the OCEANEs on the same day.
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