TIDMIRSH
This announcement contains inside information
Mainstay Medical International plc (Mainstay or the Company,
Euronext Paris: MSTY.PA and Euronext Growth of Euronext Dublin:
MSTY.IE), a medical device company focused on bringing to market
ReActiv8®, an implantable neurostimulation system to treat
disabling Chronic Low Back Pain, announces today that it has
completed financing transactions to raise gross proceeds of EUR16.9
million (US$18.9) million.
Jason Hannon, CEO of Mainstay, commented: "Our objectives for
the remainder of 2019 and 2020 are clear: file the pre-market
approval (PMA) application for ReActiv8 with the U.S. Food and Drug
Administration (FDA) this summer; advance the PMA review process
with the FDA, with an approval decision expected in late 2020; and
continue the commercial validation effort in Germany and other
select European markets by working with key physician partners who
identify appropriate ReActiv8 patients in their centres in order to
validate commercial adoption, refine patient selection strategies
and follow ongoing patient progress. We are pleased with the
outcome of this financing, which was oversubscribed. These deals
will provide the capital to expeditiously advance each of these
goals and, together with our previously-announced debt
restructuring, expands our expected cash runway into 2021."
The total cash runway extension achieved by Mainstay amounts to
approximately $28.0 million: approximately $18.9 million in gross
proceeds from the financing transactions and approximately $9.1
million in savings that resulted from the Company's restructuring
of its debt completed in April.
Specific information regarding the Financing
The financing transactions consist of the issuance of 4,649,775
new ordinary shares (New Shares) at a purchase price of EUR3.00 per
New Share and the drawdown of EUR3.0 million in additional debt
from the Company's existing lender. The investors in the equity
financing are primarily existing shareholders in the Company
(principally Sofinnova Partners, KCK Limited, Fountain Healthcare
Partners and several individual investors).
The New Shares, when issued, will represent an increase of
approximately 53.0% from the Company's existing issued ordinary
share capital. Following issuance of the New Shares, the Company's
issued share capital will consist of 13,421,504 Ordinary Shares of
EUR0.001 each (which carry voting rights) and 40,000 deferred
shares with a nominal value of EUR1.00 each (which do not carry
voting rights). Therefore, the figure that should be used by
shareholders as the denominator for the calculations by which they
will determine if they are required to notify their holdings of
voting rights, or a change to their holdings of voting rights, over
the Ordinary Shares of the Company under the Transparency
(Directive 2004/109/EC) Regulations 2007 of Ireland, as amended and
the Transparency Rules of the Central Bank of Ireland is
13,421,504.
The New Shares, when issued, will be fully paid and rank pari
passu in all respects with the existing issued Ordinary Shares,
except that the New Shares will not be admitted to trading on
Euronext Paris or the Euronext Growth market (Euronext Growth) of
Euronext Dublin (Admission) until the Company has published a
prospectus that is required to effect the admission to trading of
the New Shares on Euronext Paris in accordance with EU prospectus
law. Under the terms of the subscription agreements for the New
Shares, the Company has agreed that if Admission does not occur by
120 days after the issuance of the New Shares, then for all or part
of one or more of the consecutive 30 day periods following that
date (a Relevant Period) during which Admission does not occur the
Company shall separately pay to each investor, as liquidated
damages, a cash payment of 0.5% of the total subscription price
paid by the relevant investor for each Relevant Period (or partial
Relevant Period) during which Admission has still not occurred;
provided, however that in no event shall the Company be required to
pay to any investor an aggregate amount that exceeds 5% of the
total subscription price paid by that investor. Any such payment(s)
shall be made within five Business Days of the end of each such
Relevant Period.
Sofinnova Partners, KCK Limited and Fountain Healthcare Partners
(who are considered substantial shareholders under the Euronext
Growth Markets Rule Book (Euronext Growth Rules)) will subscribe
for 533,333, 654,000 and 1,333,333 New Shares, respectively. Their
participation in the financing will constitute related party
transactions under Rule 5.18 of the Euronext Growth Rules. The
Directors, with the exception of Antoine Papiernik (with respect to
Sofinnova Partners) and Nael Karim Kassar and Greg Garfield (with
respect to KCK Limited), consider, having consulted with J&E
Davy, the Company's Euronext Growth Adviser, that the terms of the
participation of Sofinnova Partners, KCK Limited and Fountain
Healthcare Partners in the financing are fair and reasonable
insofar as Mainstay shareholders are concerned.
David Brabazon, who is a Director, will also participate in the
financing, subscribing for 155,000 New Shares, so that following
completion of the financing, he will hold 212,828 Ordinary Shares,
representing 1.6% of the enlarged issued ordinary share capital of
the Company.
This announcement contains inside information for the purposes
of the Regulation (EU) No 596/2014 of the European Parliament and
of the Council of 16 April 2014 on market abuse (the "Market Abuse
Regulation" or "MAR"). Market soundings, as defined in MAR, were
taken in respect of the financing, with the result that certain
persons became aware of inside information, as permitted by MAR.
That inside information is set out in this announcement. Therefore,
those persons that received inside information in a market sounding
are no longer in possession of inside information relating to the
Company and its securities.
The person responsible for arranging release of this
announcement on behalf of Mainstay is Matt Onaitis.
- End -
About Mainstay
Mainstay is a medical device company focused on bringing to
market an innovative implantable neurostimulation system,
ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP).
The Company is headquartered in Dublin, Ireland. It has
subsidiaries operating in Ireland, the United States, Australia,
Germany and the Netherlands, and is listed on regulated market of
the Euronext Paris (MSTY.PA) and the Euronext Growth market of
Euronext Dublin (MSTY.IE).
About Chronic Low Back Pain
One of the root causes of CLBP is impaired control by the
nervous system of the muscles that dynamically stabilize the spine.
ReActiv8 is designed to electrically stimulate the nerves
responsible for contracting these muscles to improve dynamic spine
stability, allowing the body to recover from CLBP.
People with CLBP usually have a greatly reduced quality of life
and score significantly higher on scales for pain, disability,
depression, anxiety and sleep disorders. Their pain and disability
can persist despite the best available medical treatments, and only
a small percentage of cases result from an identified pathological
condition or anatomical defect that may be correctable with spine
surgery. Their ability to work or be productive is seriously
affected by the condition and the resulting days lost from work,
disability benefits and health resource utilization put a
significant burden on individuals, families, communities, industry
and governments.
Further information can be found at www.mainstay-medical.com
CAUTION - in the United States, ReActiv8 is limited by federal
law to investigational use only.
PR and IR Enquiries:
LifeSci Advisors, LLC
Brian Ritchie
Tel: + 1 (212) 915-2578
Email: britchie@lifesciadvisors.com
FTI Consulting (for Ireland)
Jonathan Neilan or Patrick Berkery
Tel. : +353 1 765 0886
Email: mainstay@fticonsulting.com
Euronext Growth Advisers:
Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie
Forward looking statements
This announcement includes statements that are, or may be deemed
to be, forward looking statements. These forward looking statements
can be identified by the use of forward looking terminology,
including the terms "anticipates", "believes", "estimates",
"expects", "intends", "may", "plans", "projects", "should", "will",
or "explore" or, in each case, their negative or other variations
or comparable terminology, or by discussions of strategy, plans,
objectives, goals, future events or intentions. These forward
looking statements include all matters that are not historical
facts. They appear throughout this announcement and include, but
are not limited to, statements regarding the Company's intentions,
beliefs or current expectations concerning, among other things, the
Company's plans to file a PMA application with the FDA for
ReActiv8, the timing of such filing and of the FDA's review of such
application, the clinical data relating to ReActiv8, the potential
for the FDA to approve ReActiv8 for marketing in the United States,
the Company's expected cash runway and the Company's results of
operations, financial position, prospects, financing strategies,
expectations for product design and development, regulatory
applications and approvals, reimbursement arrangements, costs of
sales and market penetration and other commercial performance.
By their nature, forward looking statements involve risk and
uncertainty because they relate to future events and circumstances.
Forward looking statements are not guarantees of future
performance, and the actual results of the Company's operations,
the development of its main product, and the markets and the
industry in which the Company operates may differ materially from
those described in, or suggested by, the forward looking statements
contained in this announcement. In addition, even if the Company's
results of operations, financial position and growth, and the
development of its main product and the markets and the industry in
which the Company operates are consistent with the forward looking
statements contained in this announcement, those results or
developments may not be indicative of results or developments in
subsequent periods. A number of factors could cause results and
developments of the Company to differ materially from those
expressed or implied by the forward looking statements, including,
without limitation, the final outcome of the Company's ReActiv8-B
clinical study, the outcome of the Company's interactions with the
FDA on a PMA application for ReActiv8, the successful launch and
commercialization of ReActiv8, general economic and business
conditions, global medical device market conditions, industry
trends, competition, changes in law or regulation, changes in
taxation regimes, the availability and cost of capital, the time
required to commence and complete clinical trials, the time and
process required to obtain regulatory approvals, currency
fluctuations, changes in its business strategy, and political and
economic uncertainty. The forward-looking statements herein speak
only at the date of this announcement.
Disclaimers
This announcement and the information it contains does not
constitute and shall not be considered as constituting a public
offer, an offer to subscribe or an intention to solicit the
interest of the public for a public offering of Mainstay's
securities in Ireland, France, the United Kingdom, the United
States or any other jurisdiction.
In Ireland, the offer of New Shares described above is being
made solely to persons who are "qualified investors" within the
meaning of article 2 (e) of the Regulation (EU) 2017/1129 of 14
June 2017 (the "Prospectus Regulation") and "professional clients"
as defined in schedule 2, or "eligible counterparties" as defined
in Regulation 38, of the European Union (Markets in Financial
Instruments) Regulations 2017 and, to a small number of other
individual investors in accordance with other applicable exemptions
under Irish prospectus law.
In France, the offer of New Shares described above is being made
solely as a private placement, in accordance with Article L. 411-2
of the Code monétaire et financier and applicable regulations. The
offering does not constitute a public offering in France, as
defined in Article L. 411-1 of the Code monétaire et financier and
no prospectus reviewed or approved by the Autorité des marchés
financiers will be published. A listing prospectus will be prepared
for approval by the Central Bank of Ireland, passported into France
and published as part of the application for listing of the New
Shares.
This announcement does not constitute an offer to the public in
the United Kingdom. No prospectus has been or will be approved in
the United Kingdom in respect of the New Shares. Consequently, this
announcement is only directed at persons who (i) are located
outside the United Kingdom, or (ii) are in the United Kingdom and
are "qualified investors" as defined in section 86(7) of FSMA,
being persons falling within the meaning of Article 2 (e) of the
Prospectus Regulation, and (a) who have professional experience in
matters relating to investments and who falls within the definition
of "investment professionals" in Article 19(5) of the Financial
Services and Markets Act 2000 (Financial Promotion) Order 2005 (as
amended) (the "Order"), (b) fall within Article 49(2)(a) to (d) of
the Order, or (c) are persons to whom it may lawfully be
communicated under an exemption contained in the Order, (all such
persons together being referred to as "Relevant Persons"). Any
investment or investment activity to which this announcement
relates is available only to Relevant Persons and will be engaged
in only with such persons. Any person in the United Kingdom who is
not a Relevant Person should not act or rely on this document or
any of its contents. For the purpose of this paragraph, the
expression "Prospectus Regulation" means Regulation (EU) 2017/1129
of 14 June 2017 on the prospectus to be published when securities
are offered to the public or admitted to trading on a regulated
market as amended and implemented in the United Kingdom.
With respect to Member States of the European Economic Area, no
action has been taken or will be taken to permit a public offering
of the securities referred to in this announcement which would
require the publication of a prospectus in any Member State. There
will be no offer to the public of Ordinary Shares in any Member
State of the European Economic Area and no prospectus or other
offering document has been or will be prepared in connection with
the sale of the New Shares by Mainstay. In Member States of the
European Economic Area other than Ireland or the United Kingdom,
the New Shares are only being offered and sold to "qualified
investors" as defined in the Prospectus Regulation or in other
circumstances falling within Article 2(e) of the Prospectus
Regulation and to "professional clients" or "eligible
counterparties" within the meaning of Directive 2014/65/EU on
markets in financial instruments, as amended ("MiFID II").
This announcement does not constitute or form part of any offer
or solicitation to purchase or subscribe for, nor does it
constitute an offer to sell, or the solicitation of an offer to buy
Ordinary Shares in the United States or in any jurisdiction in
which such offer, solicitation or sale would be unlawful prior to
its registration or qualification under the laws of such
jurisdiction. The New Shares mentioned herein have not been, and
will not be, registered under the U.S. Securities Act of 1933 (the
"Securities Act"). The New Shares may not be offered or sold in the
United States except pursuant to an effective registration
statement under, or an exemption from the registration requirements
of, the Securities Act. There will be no public offer of securities
in the United States.
J&E Davy, trading as Davy, which is authorised and regulated
in Ireland by the Central Bank of Ireland, is acting exclusively
for the Company and no one else in connection with the financing
and will not be responsible to anyone other than the Company for
providing the protections afforded to its clients or for providing
any advice in relation to the Financing or any matter referred to
herein.
Information to distributors
Solely for the purposes of the product governance requirements
contained within: (a) MiFID II; (b) Articles 9 and 10 of Commission
Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c)
local implementing measures (together, the "MiFID II Product
Governance Requirements"), and disclaiming all and any liability,
whether arising in tort, contract or otherwise, which any
"manufacturer" (for the purposes of the MiFID II Product Governance
Requirements) may otherwise have with respect thereto, the New
Shares have been subject to a product approval process, which has
determined that such New Shares are: (i) compatible with an end
target market of retail investors and investors who meet the
criteria of professional clients and eligible counterparties, each
as defined in MiFID II; and (ii) eligible for distribution through
all distribution channels as are permitted by MiFID II (the "Target
Market Assessment"). Notwithstanding the Target Market Assessment,
distributors should note that: the price of the New Shares may
decline and investors could lose all or part of their investment;
the New Shares offer no guaranteed income and no capital
protection; and an investment in the New Shares is compatible only
with investors who do not need a guaranteed income or capital
protection, who (either alone or in conjunction with an appropriate
financial or other adviser) are capable of evaluating the merits
and risks of such an investment and who have sufficient resources
to be able to bear any losses that may result therefrom. The Target
Market Assessment is without prejudice to the requirements of any
contractual, legal or regulatory selling restrictions in relation
to the offer of the New Shares. Furthermore, it is noted that,
notwithstanding the Target Market Assessment, the Company will only
procure investors who meet the criteria of professional clients and
eligible counterparties. For the avoidance of doubt, the Target
Market Assessment does not constitute: (a) an assessment of
suitability or appropriateness for the purposes of MiFID II; or (b)
a recommendation to any investor or group of investors to invest
in, or purchase, or take any other action whatsoever with respect
to the New Shares. Each distributor is responsible for undertaking
its own target market assessment in respect of the New Shares and
determining appropriate distribution channels.
The distribution of this announcement may be subject to legal or
regulatory restrictions in certain jurisdictions. Any person who
comes into possession of this announcement must inform him or
herself of and comply with any such restrictions.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20190729005514/en/
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(END) Dow Jones Newswires
July 29, 2019 11:33 ET (15:33 GMT)
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