Genedrive Regulatory News (GDR)

genedrive plc

("genedrive" or the "Company")

Trading update

FY25 Total Income c. £1m (FY24: £0.5m)

genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, provides an unaudited trading update for the financial year ended 30 June 2025 ("FY25").

Trading update and Outlook

The Board expects to report a doubling of total income of circa. £1m for FY25 (FY24: £0.5m, FY23: £0.06m), driven by increased sales momentum in H2 FY25 which saw income of £0.65m (H1 FY25 £0.35m). The Company's overheads in FY25 remained in line with the prior year however with a strategic shift towards focussed commercial activities.

Additionally, the Company already has current visibility at month two of FY26 for around £0.6m of total income in the current financial year, which is based around:

§ The National Institute for Health and Care Clinical Excellence ("NICE") Early Value Assessment ("EVA") evidence generation completion and submission, which is expected to be a catalyst for wider UK implementation. 

§ Scotland's phased national implementation of the Genedrive® MT-RNR1 ID Kit and the CYP2C19 point of care pilot (an assessment against laboratory testing pathways) are both expected to commence in or around October 2025. 

§ The Manchester University NHS Foundation Trust commencement of the 12-month Acute Coronary Syndrome and CYP2C19 rapid genotyping programme.

FY26 revenues are also expected to increase further going forwards as our international commercial activities continue to gain pace following recent preliminary sales of both products in our key international target markets of Europe and the Middle East. The U.S. remains a significant market opportunity as we progress with FDA under the Breakthrough Device for the Genedrive® MT-RNR1 ID Kit and FDA 510(k) submission for Genedrive® CYP2C19 ID Kit, the latter of which is anticipated for early 2026 with a 3-4 month subsequent regulatory review process.

The Company's cash balances are currently c. £700k and the Board and its advisers continue to actively assess a broad range of financing options for the Company in order to provide additional working capital. Further announcements will be made as appropriate.

The healthcare political and strategic landscape is changing.

The Government's 10 Year Health Plan for England is committed to unlocking the extraordinary potential of the HealthTech and MedTech sectors. Unlike for medicines, there is currently no national pathway to prioritise and nationally fund the highest impact NICE recommended MedTech. As a Company with two CE-IVD certified, NICE recommended diagnostic products, we welcome the expansion of NICE's technology appraisal pathway, which aims to include mandated funding by the NHS, to cover medical devices, diagnostics and digital products. These changes are expected to be in place by April 2026.

Adoption of innovation will be a criterion for how providers and commissioners will be judged under a new regime and the introduction of a new 'innovator passport' will allow technology that has been robustly assessed by one NHS organisation to be easily rolled out to others.

Dr Gino Miele, CEO of genedrive plc, said: "The planned healthcare reforms at national level are significant for companies such as ours. Our best-in-class CE-IVD certified, NICE-recommended rapid near patient genetic testing platform enable (1) significantly better patient outcomes in neonatology, neurology and cardiology, (2) substantial productivity gains for pressured healthcare systems (freeing of resources) as well as (3) financial savings for healthcare systems, and represent novel solutions to clinical issues of global relevance. Our domestic revenue ramp is intrinsically linked to an increase in better patient outcomes and the realisation of cost savings to the NHS and ultimately the UK taxpayer. As the UK Government commits to a significant shift in focus by prioritising prevention over treatment, our product portfolio leaves us well positioned to build on this momentum. Of course it is important that we focus commercial efforts outside of the challenging market presented by the UK NHS, and I am pleased that our year-on-year revenue growth evidences product-market fit, both in our domestic market and international territories where we are seeing initial operational and commercial traction in European countries adopting, such as Italy, Netherlands, and Middle East countries including UAE, Bahrain, Kuwait, Saudi Arabia and Qatar, and I look forward to further growth in these and other regions as we progress."

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About genedrive plc (http://www.genedriveplc.com)

genedrive plc is a pharmacogenetic testing company developing and commercialising a low cost, rapid, versatile and simple to use point of need pharmacogenetic platform for the diagnosis of genetic variants. This helps clinicians to quickly access key genetic information that will aid them make the right choices over the right medicine or dosage to use for an effective treatment, particularly important in time-critical emergency care healthcare paradigms. Based in the UK, the Company is at the forefront of Point of Care pharmacogenetic testing in emergency healthcare. Pharmacogenetics informs on how your individual genetics impact a medicines ability to work for you. Therefore, by using pharmacogenetics, medicine choices can be personalised, made safer and more effective. The Company has launched its two flagship products, the Genedrive® MT-RNR1 ID Kit and the Genedrive® CYP2C19 ID Kit, both developed and validated in collaboration with NHS partners and deployed on its point of care thermocycler platform. Both tests are single-use disposable cartridges which are ambient temperature stable, circumventing the requirement for cold chain logistics. The Directors believe the Genedrive® MT-RNR1 ID Kit is a worlds-first and allows clinicians to make a decision on antibiotic use in neonatal intensive care units within 26 minutes, ensuring vital care is delivered, avoiding adverse effects potentially otherwise encountered and with no negative impact on the patient care pathway. Its CYP2C19 ID Kit which has no comparably positioned competitor currently allows clinicians to make a decision on the use of Clopidogrel in stroke patients in 70 minutes, ensuring that patients who are unlikely to benefit from or suffer adverse effects from Clopidogrel receive an alternative antiplatelet therapeutic in a timely manner, ultimately improving outcomes. Both tests have undergone review by the National Institute for Health and Care Clinical Excellence ("NICE") and have been recommended for use in the UK NHS. The Company has a clear commercial strategy focused on accelerating growth through maximising in-market sales, geographic and portfolio expansion and strategic M&A, and operates out of its facilities in Manchester.