Abingdon Healt. Regulatory News (ABDX)

Abingdon Health plc

("Abingdon Health" or "the Company")

Acquisition of IVDeology Holdings Limited

Strengthening Abingdon's regulatory consultancy expertise

York, U.K. 7 May 2024: Abingdon Health plc (AIM: ABDX), a leading international lateral flow contract research (CRO) and contract development and manufacturing organisation (CDMO), is pleased to announce the acquisition of IVDeology Holdings Limited, together with its subsidiaries[1] ("IVDeology"), a UK-based leading provider of regulatory consultancy support to an international customer base in the in vitro diagnostics sector for total consideration of up to £700,000.

IVDeology provides a range of regulatory services including those in support of IVDR (the In Vitro Medical Devices Regulation (EU) 2017/746) for the EU market, UKCA (UK-Conformity Assessed)-marking for the UK market, and FDA support for the US market to an international customer base. IVDeology's regulatory services include technical file build, regulatory filing support, implementation of Quality Management Systems and Quality Assurance. IVDeology also supports non-UK manufacturers registering their products for the UK market by being their UK responsible person. IVDeology was co-founded by regulatory experts Stuart Angell and Nancy Consterdine and both Stuart and Nancy will continue to lead IVDeology as part of the wider Abingdon Health group.

The acquisition strengthens Abingdon's existing regulatory service and knowledge leadership and expertise in the regulatory area. The regulatory environment for in vitro diagnostics, including lateral flow tests, is going through a period of significant change with the implementation of IVDR in Europe and the creation of UKCA marking in the UK. In addition, there have been recent changes to the classification of various categories of lateral flow products in the USA. These changes create opportunities for Abingdon Health to support existing and new customers in navigating this landscape; bringing a timely expansion to the Group's capabilities in this area.

The acquisition will be satisfied by the issue of 5 million ordinary shares of 0.0025 pence each in Abingdon Health plc ("Ordinary Shares") to the owners of IVDeology at an issue price of 10 pence per Ordinary Share, equating to £0.5m ("Initial Consideration"). The Initial Consideration shares will be subject to a 12-month lock-in agreement followed by orderly market provisions. In addition, subject to achieving certain revenue targets in the two financial years following acquisition, an earn-out of £0.2m will be payable at the time ("Earn-out"). Any consideration due under the Earn-out will be satisfied in Ordinary Shares to the current owners of IVDeology. These additional shares will be subject to a further 12-month lock-in agreement followed by orderly market provisions.

In its financial year ending 31 January 2024, IVDeology generated combined turnover across the three entities of £392k; resulting in a combined loss before tax of £30k. IVDeology Holdings Limited recorded net assets of £43k as at 31 January 2024.

Issue of Equity

Application has been made for the admission to trading on AIM for the 5 million new Initial Consideration shares ("Admission"). It is expected that Admission will become effective on 10 May 2024.

Total Voting Rights

Following the issue of the 5 million new Initial Consideration shares the Company will have a total of 126,716,822 Ordinary Shares in issue. The Company does not hold any shares in Treasury.

The above figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the Company under the FCA's Disclosure Guidance and Transparency Rules.

The above information is provided by the Company in accordance with its obligations under the FCA's Disclosure Guidance and Transparency Rules.

Chris Yates, CEO, commented:

"We're delighted to welcome Stuart, Nancy and the rest of the IVDeology team to the Abingdon Health group. The acquisition of IVDeology is in line with Abingdon's strategy of providing our customers with all the pieces of the jigsaw required to bring products from idea to commercial success. The IVDeology team will strengthen Abingdon's existing knowledge leadership and regulatory expertise. We look forward to working with the IVDeology team and supporting existing and new customers in navigating a regulatory environment going through a period of significant change."

Stuart Angell, Managing Director of IVDeology, commented:

"Nancy, the rest of the IVDeology team and I are excited to be joining the Abingdon Health Group. The in vitro diagnostics sector is undergoing a significant period of regulatory change in the UK, EU and internationally. By combining our collective skills, knowledge, and expertise, we can support our customers and the wider IVD industry with the comprehensive service that this opportunity provides".

Enquiries

About Abingdon Health plc

Abingdon Health is a leading lateral flow contract research (CRO) and contract development and manufacturing organisation (CDMO) offering its services to an international customer base across industry sectors that include clinical, animal health, plant health, and environmental testing. Abingdon Health has the internal capabilities to take projects from initial concept through to routine and large-scale manufacturing; from "idea to commercial success."

The Company's CDMO division offers product development, regulatory support, technology transfer and manufacturing services for customers looking to develop new assays or transfer existing laboratory-based assays to a lateral flow format. Abingdon Health aims to support the increase in need for rapid results across many industries and locations and produces lateral flow tests in areas such as infectious disease, clinical testing including companion diagnostics, animal health and environmental testing. Faster access to results allows for rapid decision making, targeted intervention and can support better outcomes. 

Abingdon Health's Abingdon Simply Test™ range of self-tests is an ecommerce platform that offers a range of self-tests to empowers consumers to manage their own health and wellbeing. The Abingdon Simply Test™ ecommerce site offers consumers a range of information to support them in making informed decisions on the tests available. In addition, the site provides Abingdon's contract services customers with a potential route to market for self-tests. The Abingdon Simply Test range is also sold through international distributors and through other channels in the UK and Ireland such as pharmacy chains.

Founded in 2008, Abingdon Health is headquartered in York, England.

For more information visit: www.abingdonhealth.com