Source - LSE Regulatory
RNS Number : 7740S
AOTI, Inc.
18 June 2024
 

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).

 

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.

 

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.

 

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.

 

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.

 

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.

 

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.

 

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 ACQUIRE SUCH SECURITIES WILL BE ENGAGED IN ONLY WITH, RELEVANT PERSONS. ANY PERSON WHO IS NOT A RELEVANT PERSON SHOULD NOT ACT OR RELY ON THIS ANNOUNCEMENT OR ANY OF ITS CONTENTS.

 

THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS FOR BACKGROUND PURPOSES ONLY AND DOES NOT PURPORT TO BE FULL OR COMPLETE. NO RELIANCE MAY BE PLACED FOR ANY PURPOSE ON THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT OR ITS ACCURACY, FAIRNESS OR COMPLETENESS.

 

THIS ANNOUNCEMENT DOES NOT COMPRISE AN ADMISSION DOCUMENT, LISTING PARTICULARS OR A PROSPECTUS RELATING TO THE COMPANY AND THE INFORMATION CONTAINED HEREIN DOES NOT CONSTITUTE, OR FORM PART OF, AND SHOULD NOT BE CONSTRUED AS, ANY OFFER OR INVITATION OR RECOMMENDATION TO SELL OR ISSUE, OR ANY SOLICITATION OF ANY OFFER TO PURCHASE OR SUBSCRIBE FOR ANY SHARES OR OTHER SECURITIES OF THE COMPANY IN ANY JURISDICTION, INCLUDING THE UNITED STATES, CANADA, JAPAN, SOUTH AFRICA OR AUSTRALIA OR IN ANY JURISDICTION IN WHICH SUCH OFFER OR SALE WOULD BE UNLAWFUL PRIOR TO REGISTRATION, EXEMPTION FROM REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF ANY JURISDICTION. THE DISTRIBUTION OF THIS ANNOUNCEMENT AND OTHER INFORMATION IN CONNECTION WITH ADMISSION IN CERTAIN JURISDICTIONS MAY BE RESTRICTED BY LAW AND PERSONS INTO WHOSE POSSESSION THIS ANNOUNCEMENT, ANY DOCUMENT OR OTHER INFORMATION REFERRED TO HEREIN COMES SHOULD INFORM THEMSELVES ABOUT AND OBSERVE ANY SUCH RESTRICTION. ANY FAILURE TO COMPLY WITH THESE RESTRICTIONS MAY CONSTITUTE A VIOLATION OF THE SECURITIES LAWS OF ANY SUCH JURISDICTION. NEITHER THIS ANNOUNCEMENT NOR ANY PART OF IT NOR THE FACT OF ITS DISTRIBUTION SHALL FORM THE BASIS OF OR BE RELIED ON IN 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 STATEMENTS CONTAINED IN THE ANNOUNCEMENT ARE BASED ON CURRENT EXPECTATIONS AND ARE SUBJECT TO RISKS AND UNCERTAINTIES THAT COULD 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.

 

PEEL HUNT LLP ("PEEL HUNT"), WHICH IS AUTHORISED AND REGULATED 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 RESPONSIBILITY WHATSOEVER, AND MAKES NO REPRESENTATION OR WARRANTY, 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 OR FUTURE. APART FROM THE LIABILITIES AND RESPONSIBILITIES, IF ANY, WHICH MAY BE IMPOSED ON PEEL HUNT BY THE FSMA OR THE REGULATORY REGIME ESTABLISHED THEREUNDER, PEEL HUNT ACCEPTS NO RESPONSIBILITY WHATSOEVER FOR THE CONTENTS OF THE ANNOUNCEMENT OR FOR ANY OTHER STATEMENT MADE OR PURPORTED TO BE MADE BY IT OR ON ITS BEHALF IN CONNECTION WITH ANY MATTERS REFERRED TO IN THE ANNOUNCEMENT. PEEL HUNT ACCORDINGLY DISCLAIMS ALL AND ANY LIABILITY WHETHER ARISING IN TORT, CONTRACT OR OTHERWISE (SAVE AS REFERRED TO ABOVE), WHICH IT MIGHT OTHERWISE HAVE IN RESPECT OF THE ANNOUNCEMENT OR ANY SUCH STATEMENT.

 

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.

 

FOR THE AVOIDANCE OF DOUBT, THE CONTENTS OF THE COMPANY'S WEBSITE ARE NOT INCORPORATED BY REFERENCE INTO, AND DO NOT FORM PART OF, THIS ANNOUNCEMENT.

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