REG - Genedrive PLC - Trading update

GenedriveAnnouncement

11/08/2025 07:00

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RNS Number : 6930U  Genedrive PLC  11 August 2025

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."

 

For further details please contact:

 

 genedrive plc                                     +44 (0)161 989 0245
 Gino Miele: CEO / Russ Shaw: CFO

 Peel Hunt LLP (Nominated Adviser and Broker)      +44 (0)20 7418 8900
 James Steel

 Walbrook PR Ltd (Media & Investor Relations)      +44 (0)20 7933 8780 or genedrive@walbrookpr.com
                                                   (mailto:genedrive@walbrookpr.com)
 Anna Dunphy                                       +44 (0)7876 741 001

 

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.

 

 

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