Abingdon Health plc

("Abingdon" or "the Company" or "the Group")

Interim Results for the six months ended 31 December 2024

York, U.K - 24 March 2025: Abingdon Health plc (AIM: ABDX), a leading international developer, manufacturer and distributor of high quality and effective rapid tests, announces its unaudited interim results for the six months ended 31 December 2024 ("H1 2025").

Operational Highlights (including post-period end)

·    Expansion of integrated contract development and manufacturing organisation ("CDMO") service offering with:

o  Acquisition of regulatory service provider CS Lifesciences in August 2024 for a maximum consideration of up to £3.2 million in cash and shares

o  Opening of Abingdon Analytical laboratory in Doncaster in December 2024

o  Opening of US CDMO service site, including a commercial office and laboratory, in Madison, Wisconsin, due to be fully operational by April 2025

·    Integration of Compliance Solutions (Life Sciences) well underway and recent contract wins, including one for >£500k, underpins significant growth potential in 2025 and beyond. This contract has since been extended with anticipated revenue from the contract anticipated to be >£1m over 2025 and into FY2026

·    Continued growth of contract service activities with a number of key projects contracted during H1 2025 which will impact in H2 2025 and beyond including contract win for $2m for development of sexually transmitted disease tests over calendar year 2025.

·    Product revenue growth supported by expansion (post-period-end) into Germany, Poland and Austria with distribution of own-branded version of the saliva pregnancy test Salistick™

·    Product development well underway with planned launch of sustainable pregnancy and ovulation tests in US calendar Q1 of calendar year 2026

·    Award of £800,000 (post-period-end) via UKRI alongside partners to develop lateral flow tests (LFT) for malaria.

Financial Highlights

·    Successful placing and retail offer in August 2024 raising £5.2m net of expenses

·    Revenue of £3.1m for H1 2025 (H1 2023: £2.4m) representing growth rate of 28.4%:

§ Lateral Flow CDMO revenues accounted for £1.3m (H1 2024: £1.9m)

§ Regulatory accounted for £1.3m revenues (H1 2024: £0.3m) including a four-month contribution from CS Lifesciences of £1.0m

§ Lateral Flow Products revenues accounted for the balance of £0.5m (H1 2024: £0.2m)

·    H2 2025 will be a stronger revenue performance than H1 due to the impact of a number of new contracts (outlined below); a full period contribution from CS Lifesciences; and the typical "seasonality" of the Group business

·    Investment in growth initiatives following net £5.2m fundraising in August 2024 meaning adjusted EBITDA loss of £1.9m. Second half of the year will see an improved EBITDA performance due to forecast revenue growth

·    Cash at bank and in hand of £3.7m (31 December 2023: £2.0m; 30 June 2024: £1.4m); following successful fundraising of £5.6m (£5.2m net of expenses) completed in August 2024

·    The Board is confident in meeting market expectations for revenue of £8.6m for FY2025 and is targeting a cash-flow positive situation in calendar year 2026 without the need for additional funding.

Board changes

·    Appointment of Tom Hayes as CFO in January 2025.

·    As outlined in a separate RNS released today:

o  Dr Chris Hand will continue as Executive Chairman

o  Chris Yates, CEO, will move to a new role, President, Abingdon Health USA Inc. and Group Chief Commercial Officer. He will be a director of Abingdon Health USA, Inc and stand down from the board of Abingdon Health plc with immediate effect

o  Dr Katie Brenner appointed as Non-Executive Director, effective from 1 April 2025

Chris Hand, Executive Chairman, at Abingdon Health plc, commented: "FY 2025 has started very positively for Abingdon as we continued our momentum in executing key strategic milestones such as the acquisition of CS Lifesciences, the opening of Abingdon Analytical in Doncaster, and the commencement of work on our new US site in Madison which is set to be completed in April.

"Following some temporary headwinds during H1 2025, we were pleased to see growing contract momentum towards the end of the period and into H2, including a $2m contract developing sexually transmitted disease tests. Importantly, that contract utilises each limb of our business, highlighting our ability to provide an integrated, end-to-end solution for our global customer base.

"We believe we now have the foundations in place to build a sustainably profitable company. We are continuing to progress towards achieving our key goal of cashflow breakeven, which we expect to reach during calendar year 2026, without the need for further funding."

Enquiries

About Abingdon Health plc

Abingdon Health is a leading med-tech contract service provider offering its services to an international customer base.

The Group's CDMO division offers lateral flow 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's CDMO division has the internal capabilities to take lateral flow projects, in areas such as infectious disease and clinical testing, including companion diagnostics, animal health and environmental testing, from initial concept through to routine and large-scale manufacturing; from "idea to commercial success".

Abingdon's regulatory services companies, Compliance Solutions (Life Sciences) and IVDeology provide a broad range of regulatory services to the in vitro diagnostic and wider medical device industry, to support customers in bringing products to market across a range of territories including the USA, EU and the UK. Our consultancy services range from design, implementation and maintenance of quality management systems, preparation of technical files for regulatory approvals, part-time and interim management support, auditing both internally (e.g. Quality Management Systems) and externally (e.g. critical suppliers), management reviews and presentations, training and mentoring.

Abingdon Simply Test^TM range of self-tests are marketed via an e-commerce platform that offers a range of self-tests to empowers consumers to manage their own health and wellbeing. The Abingdon Simply Test^TM e-commerce 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 and other selected self-test products, such as the saliva pregnancy test, Salistick^TM, 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 with CDMO facilities in both York, UK and Madison, Wisconsin, USA. For more information visit: www.abingdonhealth.com

BUSINESS REVIEW

Strategy

Abingdon Health's mission is to improve life by making innovative healthcare products accessible to all. We seek to achieve this in three ways.

·    By providing our customers with a comprehensive lateral flow contract development and manufacturing service to bring their products to market in the most efficient and cost-effective way

·    Through the distribution of a range of lateral flow self-test products, branded Abingdon Simply Test^TM, retailer own brand or (select) private-label products

·    Through the provision of a comprehensive in vitro diagnostic (including lateral flow) and medical device/technology regulatory service to speed up market access for our customers. We provide an overview of the recent progress in each of our three service lines below.

Encouragingly, a number of Abingdon Health's customers are engaging with the Group across more than one of our service lines, and this integrated service proposition was strengthened by the acquisitions of regulatory service providers CS Lifesciences in August 2024 and IVDeology in May 2024 as well as the investment in the opening of Abingdon Analytical Ltd in December 2024. These strategic developments allow Abingdon Health to provide "all the pieces of the jigsaw" to enable customers to take an "idea through to commercial success." The clear benefit for the customer is that they have one principal service provider who is proactively co-ordinating the various work streams in a cohesive and integrated manner to ensure the overall project is being driven in a cost effective and time efficient way.

Lateral Flow CDMO services

Abingdon Health provides its customers with an integrated lateral flow Contract Research Organisation ("CRO") and Contract Development and Manufacturing Organisation ("CDMO") service (collectively "CDMO"). Abingdon Health's contract service programme covers feasibility, optimisation, scale-up, technical transfer and manufacturing. In addition, we offer a range of other complementary services such as packaging design and kitting, regulatory advice including validation and verification, documentation for regulatory submissions, and commercial support. The Group provides customers with all the services required to take their project from idea to large-scale manufacture, regulatory approval when required, and commercial success.

According to Precedence research the lateral flow market is expected to growth to $24.4 billion by 2033, with the US accounting for circa 40% of the market. Given the importance of the US market, and also given recent political changes in the US, Abingdon took a decision in 2024 to open a US CDMO site in Madison, Wisconsin, which will be fully operational in April 2025. The focus of this site initially will be on supporting customers with contract development services but it is anticipated that Abingdon Health's US presence will expand over time to include lateral flow manufacturing and kitting.

H1 2025 performance was impacted by a slowdown in market activity and decision making. We see this as a temporary headwind and have been pleased to sign a number of new contracts during H1 2025 and the early part of H2 2025 which will have a positive impact on revenues in H2 2025 and into FY 2026. We announced in January 2025 the award of approximately £800,000 as part of total project funding of €5m to develop, and transfer to manufacture, a new intervention for malaria elimination as part of a distinguished group of Institut Pasteur (and its affiliates in Madagascar and Senegal), FIND, London School of Hygiene & Tropical Medicine (LSHTM) and Walter and Eliza Hall Institute of Medical Research (WEHI). The project commenced in Q1 of calendar year 2025 and will be delivered over 24 months.

Other larger contract wins, which will run through calendar year 2025, include a $2m contract with Find Out From Home, Inc. ("FOFH") for the continued development and regulatory approval of lateral flow tests for four sexually transmitted disease ("STD") tests.

Lateral Flow Self-Test Products

The Abingdon Simply Test™ and branded range of self-tests includes 16 products. H1 2025 revenues were £0.5m (H1 2024: £0.2m). The timing of orders means that H2 2025 will see an improved revenue performance compared to H1 2025 with further Boots Salistick™, Vitamin D and Ferritin orders being delivered coupled with the launch of an own-branded version of Salistick™ in Germany and other territories. We were pleased to see recent coverage of Boots' Vitamin D and Ferritin tests on ITV's This Morning show which highlighted the usability and growing recognition of these self-tests.

As announced on 17 March 2025, Abingdon Health has extended its distribution agreement with Salignostics to several key European markets, including the German market on an exclusive basis. Abingdon Health, along with its long-standing distribution partner NeutraPharma, expects to launch an own-branded version Salistick™ with major German retailers, including DM, Rossman and Mueller, in calendar year Q2 2025.  Abingdon Health has received an initial purchase order for 70,000 tests, with further purchase orders anticipated during the calendar year 2025 on a quarterly basis.

We see further opportunities for self-test expansion and continue to work with our strategic partner Find Out From Home, on the regulatory approval of their first four Sexually Transmitted Disease ("STD") self-tests and the development of a further three STD tests.

We continue to work on the development of developing sustainable product design solutions reducing the use of plastic for the lateral flow market. The first products to market in this area are planned to be a sustainable pregnancy and ovulation test which we are targeting for launch in the US market by calendar Q1 2026. We are excited about the opportunity to bring innovative solutions for the lateral flow market using this proprietary technology.   

In addition, the use of smartphone technology, such as Abingdon's patented AI driven AppDx® (which will be available for commercial use in H2 FY2025), further adds to the development of use cases for lateral flow technology.

Regulatory Services

Abingdon Health's regulatory service provision covers both the diagnostics market (including lateral flow and the wider medical device and medical technology market.  Our regulatory services division recorded H1 2025 revenues of £1.3m (H1 2024: £0.3m), including six months' contribution from IVDeology (£0.2m) and four months' contribution from CS Lifesciences (£1.0m).

We were delighted to acquire CS Lifesciences for a consideration of up to £3.2m in cash and shares in August 2024. The acquisition comprised Compliance Solutions (Life Sciences) Ltd, CS Lifesciences Europe Ltd and CS Lifesciences USA Inc. and employs 37 staff with offices in Dublin, Glasgow and Florida. This deepens Abingdon Health's in vitro diagnostic regulatory expertise and broadens our offering into the medical device and medical technology markets. The Board has been pleased with the progress since the acquisition, which was illustrated the announcement on 8 January 2025 of a contract worth over £500k with a major global diagnostics company to work on quality management systems and regulatory approvals. The contract commenced in March 2025 and will run for an initial 12 months. The contract has since been expanded and is now anticipated to be worth over double the initial estimates.

Our regulatory service proposition was further strengthened by the investment in opening Abingdon Analytical Ltd in Doncaster in December 2024. The Group has been providing analytical laboratory services since 2023 as part of its strategy to offer a comprehensive CDMO service that supports its customers in bringing products to market. The services of an analytical laboratory, including product stability testing, specificity, sensitivity, assessment of detection limits, interference, cross-reactivity testing, and method comparisons, make a significant contribution to a product's regulatory technical file, a key requirement for regulatory approval by FDA, EU IVDR, UKCA and other regulatory authorities. The inclusion of analytical laboratory services as part of our $2m contract with FOFH underlines the significant benefit of having development, manufacturing, regulatory, clinical trial support and performance evaluation "under one roof" within the Abingdon Health group.

People

As at 31 December 2024, the Group's headcount was 113, compared with 85 at 1 July 2024. This followed the acquisition of CS Lifesciences in August 2024 which added 37 talented regulatory professionals to the Abingdon group.

The Board were delighted to appoint Tom Hayes as CFO in January 2025. Tom has over 25 years' experience, particularly with AIM-listed companies, having worked as Group Finance Director at Northern Bear plc and prior to this in advisory roles; and Tom's role will be invaluable as the Group integrates its recent acquisitions and continues to grow its revenues.

As announced in a separate RNS statement today, Chris Hand will continue as Executive Chairman, having been appointed into the expanded role on 15 October 2024. Chris Yates will step down from the board with immediate effect and will be appointed into a new role of President, Abingdon Health USA Inc. and Group Chief Commercial Officer. Given the expanding nature of the Group's operations the Board is pleased that Chris has agreed to focus his efforts on driving the Group's revenues across all its different service lines.

We are also pleased to announce the strengthening of the Board today with the planned appointment of a new Non-Executive Director. Dr Katie Brenner founded bluDiagnostics, a company specialising in lateral flow testing with an associated app to allow at home monitoring of female fertility using saliva samples. She sold bluDiagnostics to Amazon in 2020 and remained there until 2024. Katie will be joining the Board from 1 April 2025.

Max Duckworth, an early investor and previous Board member (pre-IPO), sits as a Board Observer.

Financial Performance

Revenues in H1 2025 were £3.1m (H1 2024: £2.4m) which represented a growth rate of 28.4%. As with previous financial years, we expect revenues to be weighted towards the second half of the financial year, and with a number of customer agreements announced recently which will record revenue in H2 2025.

The gross profit margin for the period was 38.3% (H1 2024: 53.0%) primarily as a result of our regulatory consultants, including those who joined as part of the CS Lifesciences acquisition, being classified as part of cost of sales.  We note that CS Lifesciences operates with limited overheads and generated a positive EBITDA contribution in the period. 

Operating costs in H1 2025 were £3.2m (H1 2024: £2.7m) following the significant investment in operations, including the opening of a new analytical and performance evaluation laboratory in Doncaster, and a new commercial office and laboratory in Madison, Wisconsin, USA.  

Adjusted EBITDA loss was £1.9m in H1 2025 (£1.2m in H1 2024) as a result of increased investment in the Group as detailed above.

The Company's cash balance at 31 December 2024 was £3.7m (30 June 2024: £1.4m). The cash movement reflects both the investment in operations above and payments of £1.2m made for the CS Lifesciences acquisition, offset by net placing proceeds of £5.2m received in August 2024.

The earnings per share figure below includes in the denominator deferred shares. Technically this is correct. However, it should be noted that the deferred shares are non-voting shares, with no rights to dividends, but holders of deferred shares are entitled to receive the nominal value of that share (0.0025 pence sterling) once on a return of capital, a repurchase of those shares by the Company or in connection with a sale of those shares. As set out in note 3 below, the total nominal value of all the deferred shares is £45k.

Current Trading and Outlook

Abingdon Health's comprehensive lateral flow CDMO service proposition has been strengthened by the investment in Abingdon Analytical, the new US lateral flow CDMO site and our two regulatory service acquisitions, CS Lifesciences and IVDeology. Our service proposition leaves us uniquely placed to support the needs of our customers and offer speed to market for their products.   

The Board remains confident of achieving market revenue expectations of £8.6m for FY 2025.

The Group's key focus remains on continued revenue growth, proactive cost control, progression towards profitability and a cashflow positive position. Our strategic initiatives have left us well placed to achieve this, and we currently forecast to reach a cashflow positive position in 2026, without the need for further financing.

Chris Hand

Executive Chairman

24 March 2025

Abingdon Health PLC

Consolidated Statement of Total Comprehensive Income

For the period ended 31 December 2024

All results are in respect of continuing activities.

Adjusted EBITDA defined as Earnings before interest, tax, depreciation, amortisation and one-off costs as outlined above, is a non-GAAP measure used by management and is not an IFRS disclosure.

Abingdon Health PLC

Consolidated Statement of Financial Position

As at 31 December 2024