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
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230511005760/en/
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
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