NOT
FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY,
IN OR INTO THE UNITED STATES OF AMERICA, CANADA, AUSTRALIA, THE
REPUBLIC OF SOUTH AFRICA OR JAPAN OR ANY OTHER JURISDICTION IN
WHICH PUBLICATION, RELEASE OR DISTRIBUTION WOULD BE
UNLAWFUL.
THIS ANNOUNCEMENT IS NOT A PROSPECTUS NOR AN ADMISSION
DOCUMENT. NEITHER THIS ANNOUNCEMENT, NOR ANYTHING CONTAINED HEREIN,
SHALL FORM THE BASIS OF, OR BE RELIED UPON IN CONNECTION WITH, ANY
OFFER OR COMMITMENT WHATSOEVER IN ANY JURISDICTION. INVESTORS
SHOULD NOT SUBSCRIBE FOR OR PURCHASE ANY SECURITIES REFERRED TO IN
THIS ANNOUNCEMENT EXCEPT ON THE BASIS OF INFORMATION CONTAINED IN
THE ADMISSION DOCUMENT (THE "ADMISSION DOCUMENT") WHICH WAS
PUBLISHED BY AOTI, INC. (THE "COMPANY") ON 14 JUNE 2024 IN
CONNECTION WITH THE ADMISSION OF THE ISSUED AND TO BE ISSUED SHARES
OF COMMON STOCK (THE "SHARES") TO TRADING ON AIM
("ADMISSION"). A COPY OF ANY ADMISSION DOCUMENT PUBLISHED BY THE
COMPANY IS AVAILABLE FOR INSPECTION ON THE COMPANY'S WEBSITE AT
WWW. AOTINC.NET.
18 JUNE
2024
AOTI, INC. (the "Company" or
"Group" or "AOTI")
ADMISSION TO TRADING ON AIM
AND FIRST DAY OF DEALINGS
Realising the potential of
differentiated technologies in driving sustained healing
of
"hard-to-heal" chronic
wounds
Successfully raised £35.1m
for itself and certain selling shareholders
AOTI, INC., a medical technology
group with a mission to help all people with chronic conditions get
back to living their lives to the fullest, is pleased to announce
the admission of its shares of common stock of the Company ("Common
Shares") to trading on the AIM market of the London Stock Exchange
Group plc. The Company has successfully raised gross proceeds of
£19.5 million through a placing of 14,772,918 newly issued Common
Shares at a placing price of 132 pence per Common Share (the
"Placing Price"). In addition, gross proceeds of £15.6 million were
raised for certain selling shareholders through the placing of
11,818,336 existing Common Shares at the Placing Price.
AOTI's market capitalisation at the
placing price of 132 pence per common share on admission will be
approximately £140 million. Dealings in the common shares of the
Company will commence today at 08.00 BST, under the ticker "AOTI"
and the ISIN "US03690C1027". The Company's admission document was
published on 14 June 2024 and is available to view on its Investor
Relations website at www.aotinc.net. Peel Hunt LLP is
acting as Nominated Adviser and Broker to the Company.
AOTI, INC.
HIGHLIGHTS:
- AOTI is a
high growth medical technology business focused on the highest
growth "hard to heal" advanced wound care market segment, in
particular diabetic foot ulcers (DFUs), venous leg ulcers (VLUs)
and pressure ulcers (PUs).
o DFUs
frequently result in hospitalisations in diabetics and are the
leading cause of morbidity and lower extremity amputations in the
diabetic population. In the US, DFUs have a similar five-year
mortality risk (at 30.5 per cent) as all-cause cancer, and in the
US alone, the annual cost of diabetic foot care is c.$79 billion,
which is comparable to the c.$80 billion annual cost spent for all
cancer treatments.
- The Group
generated $43.9 million in revenue for the year ended 31 December
2023 and has seen compounded annual revenue growth of 38 per cent
(2021 - 2023), all of which came from its unique multi-modality
Topical Wound Oxygen (TWO2®) Therapy. The
Group has been profitable at the adjusted EBITDA level since
20171.
o Following a period of significant investment in the Company's
market access and commercial infrastructure over the past two
financial years, AOTI is now entering its next phase of expansion
with the foundations for sustainable growth in place.
- The
Company's patented non-invasive platform technology,
TWO2® Therapy, is a US Food and Drug
Administration (FDA) cleared and CE Marked multi-modality topical
wound oxygen therapy system that has been proven to deliver
sustained healing outcomes of chronic wounds in the at-home
setting.
- AOTI is a
market leader with over 80 per cent market share of the nascent
topical oxygen wound therapy segment.
o To
support its adoption, TWO2® Therapy has
generated an exceptional level of peer-reviewed evidence, including
a high quality randomised controlled trial (RCT) and real world
evidence (RWE) studies, demonstrating long-term outcomes that
support advancing health equity, with strong cost-saving healthcare
economics supporting reimbursement.
o The
Company has also acquired and is now rolling out its complementary
and highly differentiated disposable NEXA™ Negative Pressure Wound
Therapy system (NEXA NPWT System).
- The
Company has an experienced founder-led management team and seasoned
Board focused on scaling and growing the business through expanding
reimbursement in the US and opening up other
geographies.
o The
first phase of the Company's reimbursement strategy has
successfully been completed with reimbursement having been secured
in the Veterans Association (VA) and New York Medicaid for a number
of years.
o The
second phase of expanding wider state Medicaid payer coverage is
ongoing, with access being secured to new Medicaid states including
Arizona, New Jersey and, more recently, Tennessee, and the launch
of the NEXA NPWT System and international sales being
commenced.
o The
third phase of the Group's market access strategy is to achieve,
over time, full US national coverage and access to the Medicare
population.
- Following
recently published recommendations by leading clinical associations
for the use of topical oxygen therapy as an adjunct to the standard
care, including the American Diabetes Association, the Wound
Healing Society and the International Working Group on the Diabetic
Foot, the Board of AOTI believes the time is right to join AIM in
order to further accelerate commercial roll-out and build awareness
of its platform technology.
- The net
proceeds to the Company from the IPO of £13.5 million will be used
towards funding the continued expansion of the Group's sales team
in the US and opening up new territories in which the Group's
products can be sold whilst also repaying the Group's existing
financial debt. In addition, the Group will direct some funding
towards continuing to enhance the clinical claims attached to its
products, for instance, growing the evidence of efficacy in other
indications such as VLUs.
Dr.
Mike Griffiths, Chief Executive Officer of AOTI, INC.
commented:
"We are delighted to be admitted to trading on AIM, which is
in line with the Board's strategy to further accelerate the Group's
commercial roll-out, enabling us to reach our full potential whilst
fulfilling our mission of helping all people with chronic
conditions get back to living their lives to the fullest. The Board
believes that AOTI has all of the building blocks in place to
secure expanded market access and commercialisation of our
TWO2® Therapy and to continue the staged
roll-out of the NEXA NPWT System, the Company's independently
differentiated wound care platforms. On behalf of the Board, I
would like to thank all our new investors who have joined the AOTI
journey today and we look forward to updating them on delivering on
our scale-up strategy, underpinned by a continued trajectory of
profitable growth."
For the purposes of the Disclosure
Guidance and Transparency Rules, the total number of ordinary
shares with voting rights in the Company with effect from 18 June
2024 will be 106,359,163. This figure may be used by shareholders
as the denominator for the calculations by which they determine if
they are required to notify their interest in, or a change of their
interest in, the Company under the FCA's Disclosure Guidance and
Transparency Rules.
END
For
more information, please contact:
AOTI, INC.
Dr. Mike Griffiths, Chief Executive
Officer
Jayesh Pankhania, Chief Financial
Officer
|
+44 (0)20 3727 1000
ir@aotinc.net
|
Peel Hunt LLP (Nominated Adviser and Broker)
Dr. Christopher Golden, Patrick
Birkholm
|
+44 (0)20 7418 8900
|
FTI
Consulting (Financial PR & IR)
Ben Atwell, Simon Conway, Alex
Davis
|
+44 (0)20 3727 1000
AdvancedOxygenTherapy@fticonsulting.com
|
ABOUT AOTI, INC.
AOTI, INC. was founded in 2006 and
is based in Oceanside, California, US and Galway, Ireland,
providing innovative solutions to resolve severe and chronic wounds
worldwide. Its products reduce healthcare costs and improve the
quality of life for patients with these debilitating conditions.
The Company's patented non-invasive Topical Wound Oxygen
(TWO2®) therapy has demonstrated in
differentiating, robust, double-blinded randomised controlled
trials (RCT) and real-world evidence (RWE) studies to more-durably
reduce the recurrence of Diabetic Foot Ulcers (DFUs), resulting in
an unprecedented 88 per cent reduction in hospitalisations and 71
per cent reduction in amputations over 12 months.
TWO2® therapy can be administered by the
patient at home, improving access to care and enhancing treatment
compliance. TWO2® therapy has received
regulatory approvals from the US (FDA), Europe (CE Mark), UK
(MHRA), Health Canada, the Chinese National Medical Products
Administration, Australia (TGA) and in Saudi Arabia.
FOOTNOTES
1
- Excluding IPO-related costs.
THIS ANNOUNCEMENT HAS NOT BEEN APPROVED FOR THE PURPOSES OF
SECTION 21 OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (AS
AMENDED) OF THE UNITED KINGDOM ("FSMA").
THIS ANNOUNCEMENT IS ONLY BEING DISTRIBUTED TO AND IS ONLY
DIRECTED AT (I) INVESTMENT PROFESSIONALS FALLING WITHIN ARTICLE
19(5) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL
PROMOTION) ORDER 2005 (THE "ORDER") OR (II) HIGH NET WORTH
ENTITIES, AND OTHER PERSONS TO WHOM IT MAY LAWFULLY BE
COMMUNICATED, FALLING WITHIN ARTICLE 49(2)(A) TO (D) OF THE ORDER
OR (III) OTHER PERSONS TO WHOM IT MAY LAWFULLY BE COMMUNICATED (ALL
SUCH PERSONS TOGETHER BEING REFERRED TO AS "RELEVANT PERSONS"). THE
SECURITIES PROPOSED TO BE SOLD ARE ONLY AVAILABLE TO, AND ANY
INVITATION, OFFER OR AGREEMENT TO SUBSCRIBE, PURCHASE OR OTHERWISE
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THIS ANNOUNCEMENT DOES NOT COMPRISE AN ADMISSION DOCUMENT,
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INFORMATION CONTAINED HEREIN DOES NOT CONSTITUTE, OR FORM PART OF,
AND SHOULD NOT BE CONSTRUED AS, ANY OFFER OR INVITATION OR
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OTHER INFORMATION IN CONNECTION WITH ADMISSION IN CERTAIN
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ANY SUCH RESTRICTION. ANY FAILURE TO COMPLY WITH THESE RESTRICTIONS
MAY CONSTITUTE A VIOLATION OF THE SECURITIES LAWS OF ANY SUCH
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CONNECTION WITH OR ACT AS AN INDUCEMENT TO ENTER INTO ANY CONTRACT
OR COMMITMENT WHATSOEVER.
THIS ANNOUNCEMENT IS NOT FOR DISTRIBUTION, DIRECTLY OR
INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES
(INCLUDING ITS TERRITORIES AND POSSESSIONS, ANY STATE OF THE UNITED
STATES AND THE DISTRICT OF COLUMBIA), CANADA, JAPAN, SOUTH AFRICA
OR AUSTRALIA OR ANY OTHER JURISDICTION WHERE IT IS UNLAWFUL TO
DISTRIBUTE THIS ANNOUNCEMENT OR WOULD REQUIRE REGISTRATION UNDER
THE LAWS THEREOF. IN PARTICULAR, THIS ANNOUNCEMENT IS NOT AN OFFER
OF SECURITIES FOR SALE IN THE UNITED STATES. 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 ANY SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF
THE UNITED STATES, AND MAY NOT BE OFFERED, SOLD, TAKEN UP,
EXERCISED, RESOLD, TRANSFERRED, DELIVERED OR DISTRIBUTED, DIRECTLY
OR INDIRECTLY, IN OR INTO 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 ANY APPLICABLE SECURITIES LAWS OF ANY STATE OR OTHER
JURISDICTION OF THE UNITED STATES. THERE WILL BE NO PUBLIC OFFER OF
THE SECURITIES REFERRED TO HEREIN IN ANY JURISDICTION, INCLUDING IN
THE UNITED STATES, CANADA, JAPAN, SOUTH AFRICA OR AUSTRALIA. THE
SECURITIES REFERRED TO HEREIN HAVE NOT BEEN APPROVED OR DISAPPROVED
BY THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION OR ANY
OTHER SECURITIES COMMISSION OR REGULATORY AUTHORITY IN THE UNITED
STATES, NOR HAVE ANY OF THE FOREGOING AUTHORITIES PASSED UPON OR
ENDORSED THE MERITS OF ANY OFFERING BY THE COMPANY. ANY
REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENCE IN THE UNITED
STATES. THE SECURITIES REFERRED TO HEREIN HAVE NOT BEEN REGISTERED
UNDER THE APPLICABLE SECURITIES LAWS OF, CANADA, JAPAN, SOUTH
AFRICA OR AUSTRALIA AND, SUBJECT TO CERTAIN EXCEPTIONS, MAY NOT BE
OFFERED OR SOLD WITHIN CANADA, JAPAN, SOUTH AFRICA OR AUSTRALIA, OR
TO ANY NATIONAL, RESIDENT OR CITIZEN OF CANADA, JAPAN, SOUTH AFRICA
OR AUSTRALIA.
THE
ANNOUNCEMENT CONTAINS FORWARD-LOOKING STATEMENTS. THESE STATEMENTS
RELATE, INTER ALIA, TO THE COMPANY'S PROPOSED STRATEGY, PLANS AND
OBJECTIVES. FORWARD-LOOKING STATEMENTS ARE IDENTIFIED BY THE USE OF
SUCH TERMS AS "BELIEVE", "COULD", "ENVISAGE", "ESTIMATE",
"POTENTIAL", "INTEND", "MAY", "PLAN", "WILL" OR VARIATIONS OR
SIMILAR EXPRESSIONS, OR THE NEGATIVE THEREOF. THE FORWARD-LOOKING
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CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE EXPRESSED OR
IMPLIED BY THOSE STATEMENTS. IF ONE OR MORE OF THESE RISKS OR
UNCERTAINTIES MATERIALISE, OR IF ANY UNDERLYING ASSUMPTIONS PROVE
INCORRECT, THE COMPANY'S ACTUAL RESULTS MAY VARY MATERIALLY FROM
THOSE EXPECTED, ESTIMATED OR PROJECTED. GIVEN THESE RISKS AND
UNCERTAINTIES, CERTAIN OF WHICH ARE BEYOND THE COMPANY'S CONTROL,
POTENTIAL INVESTORS SHOULD NOT PLACE ANY RELIANCE ON
FORWARD-LOOKING STATEMENTS. THESE FORWARD-LOOKING STATEMENTS SPEAK
ONLY AS AT THE DATE OF THIS ANNOUNCEMENT. EXCEPT AS REQUIRED BY
LAW, THE COMPANY UNDERTAKES NO OBLIGATION TO PUBLICLY RELEASE ANY
UPDATE OR REVISIONS TO THE FORWARD-LOOKING STATEMENTS CONTAINED IN
THIS ANNOUNCEMENT TO REFLECT ANY CHANGE IN EVENTS, CONDITIONS OR
CIRCUMSTANCES ON WHICH ANY SUCH STATEMENTS ARE BASED AFTER THE TIME
THEY ARE MADE. IN PARTICULAR, NO REPRESENTATION OR WARRANTY IS
GIVEN AS TO THE ACHIEVEMENT OR REASONABLENESS OF ANY FUTURE
PROJECTIONS, MANAGEMENT ESTIMATES, PROSPECTS OR
RETURNS.
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IN THE UNITED KINGDOM BY THE FINANCIAL CONDUCT AUTHORITY (THE
"FCA"), IS EXCLUSIVELY ACTING AS SOLE NOMINATED ADVISER TO THE
COMPANY IN CONNECTION WITH THE MATTERS REFERRED TO HEREIN, AND NO
ONE ELSE. PEEL HUNT WILL NOT BE RESPONSIBLE TO ANYONE OTHER THAN
THE COMPANY FOR PROVIDING THE PROTECTIONS AFFORDED TO ITS CLIENTS,
NOR FOR PROVIDING ADVICE IN RELATION TO THE CONTENTS OF THE
ANNOUNCEMENT OR ANY TRANSACTION OR ARRANGEMENT REFERRED TO
HEREIN.
APART FROM THE RESPONSIBILITIES AND LIABILITIES, IF ANY, WHICH
MAY BE IMPOSED ON PEEL HUNT BY THE FSMA OR THE REGULATORY REGIME
ESTABLISHED THEREUNDER, PEEL HUNT DOES NOT ACCEPT ANY
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EXPRESS OR IMPLIED, IN RELATION TO THE CONTENTS OF THE
ANNOUNCEMENT, INCLUDING ITS ACCURACY, COMPLETENESS OR VERIFICATION
OR FOR ANY OTHER STATEMENT MADE OR PURPORTED TO BE MADE BY IT, OR
ON BEHALF OF IT, THE COMPANY, THE DIRECTORS, THE COMPANY'S
INVESTMENT ADVISER OR ANY OTHER PERSON IN CONNECTION WITH THE
COMPANY, ADMISSION, THE SHARES OR THE MATTERS REFERRED TO HEREIN,
AND NOTHING IN THIS ANNOUNCEMENT IS OR SHALL BE RELIED UPON AS A
PROMISE OR REPRESENTATION IN THIS RESPECT, WHETHER AS TO THE PAST
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CERTAIN FIGURES CONTAINED IN THIS ANNOUNCEMENT, INCLUDING
FINANCIAL INFORMATION, HAVE BEEN SUBJECT TO ROUNDING ADJUSTMENTS.
ACCORDINGLY, IN CERTAIN INSTANCES, THE SUM OR PERCENTAGE CHANGE OF
THE NUMBERS CONTAINED IN THIS ANNOUNCEMENT MAY NOT CONFORM EXACTLY
WITH THE TOTAL FIGURE GIVEN.
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ANNOUNCEMENT.