PharmiWeb.com - Global Pharma News & Resources
11-May-2023

MedinCell launches a Global Offering for approximately 25 million euros

THIS PRESS RELEASE IS NOT BEING MADE IN AND COPIES OF IT MAY NOT BE DISTRIBUTED OR SENT, DIRECTLY OR INDIRECTLY, INTO THE UNITED STATES, CANADA, SOUTH AFRICA, JAPAN OR AUSTRALIA


MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:

The Global Offering of approximately 25 million euros aimed at institutional investors via a Private Placement through an accelerated book-building process, as well as retail investors via PrimaryBid platform only in France.

Funds raised will enable MedinCell to continue portfolio development and strengthen R&D activities.

U.S. FDA granted approval on April 28, 2023 for UZEDY™, the first innovative treatment formulated with MedinCell's BEPO® technology platform and now commercialized by Teva. Two other products based on the same technology platform, are already in phase 3 and several others are in development.

MedinCell, a commercial-stage pharmaceutical technology company developing a portfolio of long-acting injectable products in various therapeutic areas (the “Company”), announces today the launch of a Global Offering (as defined below) of approximately €25 million, through an offering to institutional investors via a Private Placement and to retail investors via the PrimaryBid platform.

“The FDA approval for UZEDYTM encourages us to accelerate the development of our clinical pipeline and raise funds from the capital markets. It is very important for us to allow individual shareholders to participate in this operation, with the same conditions than institutional investors” said Christophe Douat, CEO of MedinCell before adding: “Teva, which now markets UZEDYTM in the US, is an ideal partner to make it a reference treatment in schizophrenia and to harvest its full commercial potential. Beyond this first product, we have a solid portfolio of investigational treatments in several therapeutic areas, all of which are based on the same technology underpinning UZEDYTM. Two major products are already in Phase 3 with results expected in the next 18 months, and three others should enter the clinical phase in the next 12 months.”

The net proceeds from the Global Offering (as defined below), combined with the Company’s existing funds, are intended to contribute to finance:

  • preclinical and clinical activities for Company’s programs, in particular:
    • the clinical Phase 1 of mdc-GRT
    • preclinical and clinical activities of several investigational products such as mdc-TMK and mdc-DPL,
  • formulation activities of new products
  • investments to expand and improve the laboratory in Jacou,
  • research, development and industrialization of new technologies,

Terms of the Global Offering

The Global Offering will be carried out in two distinct but concomitant components:

a capital increase without shareholders' preferential subscription rights [in favor of qualified investors or a restricted circle of investors under the provisions of Article L. 411-2 1° of the French Monetary and Financial Code, meeting the following characteristics set out in the 20th resolution of the Company's combined ordinary and extraordinary general shareholders' meeting of 8 September 2022 (the “General Meeting”) (the "Private Placement"), and

- a capital increase without shareholders' preferential subscription rights in favor of retail investors via the PrimaryBid platform only in France, pursuant to Article L. 225-136 of the French Commercial Code and in accordance with the 18th resolution of the General Meeting (the “PrimaryBid Offering”, and, together with the Private Placement, the “Global Offering”).

The Private Placement will be available in accordance with the 20th resolution of the General Meeting mentioned above, to (i) qualified investors within the meaning of Article 2(e) of Regulation 2017/1129 of the European Parliament and of the Council of 14 June 2017, as amended (the “Prospectus Regulation”) or in other circumstances falling within the scope of Article 1(4) of the Prospectus Regulation in the European Union (including France) and outside the European Union with the exception of the United States, Canada, Australia, South Africa and Japan and (ii) certain institutional investors in the United States. The PrimaryBid Offering will not be made available to retail investors outside France.

The gross proceeds of the Global Offering will depend exclusively on the orders received for each of the above-mentioned components without the possibility of reallocating the sums allocated from one to the other. It is specified that the PrimaryBid Offering is incidental to the Private Placement and will represent a maximum of 20 % of the total amount of the Global Offering and will be limited to a maximum of €8 million. Allocations will be proportional to demand, limited to the amount allocated to this public offer, with allocations reduced should demand exceed this limit. In any event, the PrimaryBid Offering will not be carried out if the Private Placement does not occur. The Private Placement is not conditional on the PrimaryBid Offering.

The Global Offering is subject to market and other conditions and the final aggregate amount of the Global Offering is subject to change. The Private Placement will be carried out via an accelerated book-building process, following which the number and price of the new shares to be issued will be decided by the Company’s Directoire (as defined below), in accordance with the delegations of competence granted by the Ordinary and Extraordinary General Meeting and upon prior authorization of the Conseil de Surveillance (as defined below) on the date of this press release, it being specified that the maximum number of new shares that may be issued in the Global Offering in accordance with such delegations and authorizations is 4,545,449 new shares, representing a maximum of 18% of the capital.

The subscription price of the new shares in the Private Placement shall be at least equal to the volume-weighted average of the closing prices of the Company's share of the last 3 trading sessions preceding the beginning of the Private Placement, reduced by a maximum discount of 10% in accordance with the 20th resolution. The subscription price of the new shares in the PrimaryBid Offering will be equal to the price of the new shares offered in the Private Placement, as determined by the accelerated book-building initiated with institutional investors.

The accelerated book-building process for the Private Placement will begin immediately following the publication of this press release and is expected to close before the markets open on 12 May 2023, subject to any early or extended closing. The PrimaryBid Offering will begin immediately and close at 22:00h CEST, subject to any early closing. The Company will announce the pricing and the definitive number of new shares to be issued in the Global Offering via a press release as soon as possible after the book-building ends.

Settlement-Delivery of the new ordinary shares to be issued in the Global Offering and the PrimaryBid Offering and their admission for trading on the regulated market of Euronext Paris are expected on 16 May 2023. The new ordinary shares will be of the same category and fungible with the existing shares, will be entitled to all the rights associated with the existing shares, and will be admitted to trading on the regulated market of Euronext Paris under the same ISIN FR0004065605.

Lock-up commitments

In connection with the Global Offering, the Company and the members of the management board ("Directoire") and of the supervisory boards ("Conseil de Surveillance") have signed a lock-up commitment that comes into effect on the date of the signing of the placement agreement concluded between the Company and the banks today and for a period of 90 days following the settlement/delivery of the Global Offering, subject to certain customary exceptions.

Financial Intermediaries

Jefferies, Bryan Garnier Securities SAS and Bryan, Garnier & Co are acting as Joint Global Coordinators and Joint Bookrunners in connection with the Private Placement.

Within the framework of the PrimaryBid Offering, investors may only subscribe via the PrimaryBid partners mentioned on the PrimaryBid website (www.PrimaryBid.fr). The PrimaryBid Offering is not covered by placement agreement. For further details, please go to the PrimaryBid website at www.PrimaryBid.fr.

Risk factors

The attention of the public is drawn to the risk factors associated with the Company and its activity presented in Section 2 of the universal registration document registered with the French Financial Market Authority (Autorité des Marchés Financiers) (the "AMF") under number D.22-0668 on 28 July 2022, which is available free of charge on the Company’s website (https://invest.medincell.com). The occurrence of all or part of these risks could have a negative impact on the Company’s activity, financial situation, results, development or outlook. The risk factors presented in that document are the same today.

Additionally, investors are invited to consider the following risks specific to this Global Offering: (i) the market price of the Company’s shares may fluctuate and fall below the subscription price of the shares issued as part of the Global Offering, (ii) the volatility and liquidity of the Company’s shares may fluctuate significantly, (iii) sales of the Company’s shares may take place on the market and have a negative impact on the market price of its share and (iv) the Company’s shareholders could suffer potentially significant dilution resulting from any future capital increases required to provide the Company with additional financing.

No Prospectus

The Global Offering is not subject to a prospectus requiring an approval from the AMF.

About MedinCell

MedinCell is a commercial-stage pharmaceutical technology company developing a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology (licensed to Teva under the name SteadyTeq™) with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance (i.e. compliance with medical prescriptions) and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. MedinCell collaborates with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options. Based in Montpellier, MedinCell currently employs more than 140 people representing over 25 different nationalities.

www.medincell.com

This document and the information contained herein do not constitute either an offer to sell or purchase, or the solicitation of an offer to sell or purchase, securities of the Company in any jurisdiction.

No communication and no information in respect of the offering by the Company of its shares may be distributed to the public in any jurisdiction where registration or approval is required. No steps have been taken or will be taken in any jurisdiction where such steps would be required. The offering or subscription of shares may be subject to specific legal or regulatory restrictions in certain jurisdictions.

This announcement does not, and shall not, in any circumstances, constitute a public offering nor an invitation to the public in connection with any offer. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

Not for release, directly or indirectly, in or into the United States, Canada, South Africa, Japan or Australia. This document (and the information contained herein) does not contain or constitute an offer of securities for sale, or solicitation of an offer to purchase securities, in the United States, Canada, South Africa, Japan or Australia or any other jurisdiction where such an offer or solicitation would be unlawful. The securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), or under the securities laws of any state or other jurisdiction of the United States, and may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with the securities laws of any state or any other jurisdiction of the United States. No public offering of the securities will be made in the United States.

This document (and the information contained within) is an advertisement and not a prospectus within the meaning of the Prospectus Regulation. With respect to each member state of the European Economic Area (“Member State”), no action has been undertaken or will be undertaken that constitutes an offer of the securities referred to herein to the public in any Member State and requiring a prospectus in any Member State. The securities referred to herein may not and will not be offered in any Member State, except in accordance with the exemptions set forth in the Prospectus Regulation, including any relevant implementing measures in each Member State. For the purposes of the above, the expression an “offer to the public” in any Relevant Member State shall have the meaning ascribed to it in Article 2(d) of the Prospectus Regulation.

In France, the offer of the Company shares described above will be made in the context of (i) a capital increases in favor of qualified investors or a restricted circle of investors, pursuant to Article L. 411-2 1° of the French monetary and financial code (Code monétaire et financier) and applicable regulatory provisions and (ii) a public offering primarily intended to retail investors through the PrimaryBid platform. Pursuant to Article 211-3 of the general regulations of the AMF and Articles 1(4) and (3) of the Prospectus Regulation, the offer of the Company shares will not require the publication of a prospectus approved by the AMF.

MIFID II Product Governance/Target Market: solely for the purposes of the requirements of article 9.8 of the EU Delegated Directive 2017/593 relating to the product approval process, the target market assessment in respect of the shares of the Company has led to the conclusion in relation to the type of clients criteria only that: (i) the type of clients to whom the shares are targeted is eligible counterparties and professional clients and retail clients, each as defined in Directive 2014/65/EU, as amended (“MiFID II”); and (ii) all channels for distribution of the shares of the Company to eligible counterparties and professional clients and retail clients are appropriate. Any person subsequently offering, selling or recommending the shares of the Company (a “distributor”) should take into consideration the type of clients assessment; however, a distributor subject to MiFID II is responsible for undertaking its own target market assessment in respect of the shares of the Company and determining appropriate distribution channels.

This communication does not constitute an offer of securities to the public in the United Kingdom and is being distributed only to and is directed only at (a) persons outside the United Kingdom, (b) persons who have professional experience in matters relating to investments, i.e., investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”), and (c) high net worth entities, unincorporated associations and other bodies to whom it may otherwise lawfully be communicated in accordance with Article 49(2)(a) to (d) of the Order (all such persons together being referred to as relevant persons). The securities are available only to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be available only to and will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this communication or any of its contents.

Jefferies GmbH is authorised and regulated in Germany by the Bundesanstalt für Finanzdienstleistungsaufsicht. Each of Bryan, Garnier & Co, Bryan Garnier Securities SAS and Jefferies GmbH (together, the "Banks") is acting exclusively for the Company and for no one else in connection with the Private Placement and will not regard any other person (whether or not a recipient of this document) as a client in relation to the Private Placement or any other matter referred to in this document and will not be responsible to anyone other than the Company for providing the protections afforded to its clients or for giving advice in relation to the Private Placement or any other matter referred to in this Document. None of the Banks is acting for the Company with respect to the PrimaryBid Offering.

This document is being issued by and is the sole responsibility of the Company. No representation or warranty, express or implied, is or will be made as to, or in relation to, and no responsibility or liability is or will be accepted by or on behalf of the Banks or by their respective affiliates or any of their respective directors, officers, partners, employees, advisers or agents (collectively, "Representatives") as to, or in relation to, the accuracy, adequacy, fairness or completeness of this document or any other written or oral information made available to or publicly available to any interested party or its advisers or any other statement made or purported to be made by or on behalf of the Banks or any of their respective affiliates or any of their respective Representatives in connection with the Company, the securities being offered or the Global Offering and any responsibility and liability whether arising in tort, contract or otherwise therefor is expressly disclaimed. No representation or warranty, express or implied, is made by the Banks or any of their respective affiliates or any of their respective Representatives as to the accuracy, fairness, verification, completeness or sufficiency of the information or opinions contained in this Announcement or any other written or oral information made available to or publicly available to any interested party or its advisers, and any liability therefor is expressly disclaimed.

This press release contains forward-looking statements, including statements regarding Company’s expectations for (i) the timing, progress and outcome of its clinical trials; (ii) the clinical benefits and competitive positioning of its product candidates; (iii) its ability to obtain regulatory approvals, commence commercial production and achieve market penetration and sales; (iv) its future product portfolio; (v) its future partnering arrangements; (vi) its future capital needs, capital expenditure plans and ability to obtain funding; and (vii) prospective financial matters regarding our business. Although the Company believes that its expectations are based on reasonable assumptions, any statements other than statements of historical facts that may be contained in this press release relating to future events are forward-looking statements and subject to change without notice, factors beyond the Company's control and the Company's financial capabilities.

These statements may include, but are not limited to, any statement beginning with, followed by or including words or phrases such as "objective", "believe", "anticipate", “expect”, "foresee", "aim", "intend", "may", "anticipate", "estimate", "plan", "project", "will", "may", "probably", “potential”, "should", "could" and other words and phrases of the same meaning or used in negative form. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that may, if any, cause actual results, performance, or achievements to differ materially from those anticipated or expressed explicitly or implicitly by such forward-looking statements. A list and description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the AMF pursuant to its regulatory obligations, including the Company's universal registration document, filed with the AMF on July 28, 2022, (the "Universal Registration Document"), as well as in the documents and reports to be published subsequently by the Company. In particular, readers' attention is drawn to section 2 entitled "Facteurs de Risques" on page 24 of the Universal Registration Document.

Any forward-looking statements made by or on behalf of the Company speak only as of the date they are made. Except as required by law, the Company does not undertake any obligation to publicly update these forward-looking statements or to update the reasons why actual results could differ materially from those anticipated by the forward-looking statements, including in the event that new information becomes available. The Company's update of one or more forward-looking statements does not imply that the Company will make any further updates to such forward-looking statements or other forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements.


Contacts

MedinCell
David Heuzé
Head of Communications
david.heuze@medincell.com
+33 (0)6 83 25 21 86

NewCap
Louis-Victor Delouvrier/Alban Dufumier
Investor Relations
medincell@newcap.eu
+33 (0)1 44 71 94 94

NewCap
Nicolas Merigeau
Media Relations
medincell@newcap.eu
+33 (0)1 44 71 94 94

Editor Details

  • Company:
    • Businesswire
Last Updated: 11-May-2023