REG - Genedrive PLC - Half-year Report
27/03/2025 15:30
For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250327:nRSa5642Ca&default-theme=true
RNS Number : 5642C Genedrive PLC 27 March 2025
genedrive plc
("genedrive" or the "Company")
Interim results to 31 December 2024
genedrive plc (LSE: GDR), the point of care pharmacogenetic testing company,
announces unaudited interim results for the six months to 31 December 2024.
OPERATING HIGHLIGHTS (including post period)
Genedrive® CYP2C19
· First UK commercial sales of the Genedrive® CYP2C19-ID Kit to
England's largest Hyperacute Stroke Centre
· North West Anglia Foundation NHS Trusts' Peterborough City Hospital
implements the Genedrive® CYP2C19-ID Kit for routine clinical use
· Growing base of initial installations for site verifications expected
to lead to subsequent routine clinical use
· Positive value assessment by the Scottish Health Technologies Group
(SHTG) following referral by the Accelerated National Adoption (ANIA) pathway
group in Scotland, leading to the Scottish Government announcement of
investment to support national pharmacogenetic testing of CYP2C19 in Stroke
patients, including genedrive's CYP2C19-ID test for rapid genetic testing in
Transient Ischaemic Attack (TIA) patients
· NICE recommendation of the Genedrive® CYP2C19-ID Kit as the rapid
genetic testing platform of choice for CYP2C19 genotyping strategies for
clopidogrel administration in ischaemic stroke (IS) and TIA, with Genedrive's
CYP2C19 ID Kit being dominant in cost effectiveness models
· Genedrive® CYP2C19-ID Kit clinical performance published in Journal of
Molecular Diagnostics (December 2024), outlining superior performance to
laboratory test and alternative available point of care (PoC) platforms with
respect to target coverage, speed, accuracy and test fails
· Inclusion in study aimed at understanding how best to deliver CYP2C19
based genotyping at scale throughout the NHS, and accepted on NHS Dynamic
Procurement System (DPS), permitting direct procurement by regional NHS trusts
· Market access routes and reimbursement strategies defined in key
initial international target countries, including the Middle East region, with
well-positioned and aligned in-country distributors, with required regulatory
certification (CE-IVD under IVDR) on track for April 2025
· 510(k) route identified for regulatory submission for US market entry,
with initial pre-submission engagement with Food and Drug Administration (FDA)
held and feedback positive and with regulatory approach confirmed as
appropriate
Genedrive® MT-RNR1
· Scottish Government announcement of £800k investment to support
national phased implementation program of pharmacogenetic testing of MT-RNR1
in newborn babies in NHS Scotland using Genedrive's MT-RNR1 ID Kit
· NIHR and OLS Funding Package of c.£500k to address NICE Real World
Evidence Generation Requirements for the Genedrive® MT-RNR1 ID Kit across 14
hospitals across the UK (PALOH-UK). Progressing as planned, with nine Group
1 sites live, with a further five Group 2 sites phased to go-live from May
2025
· 11 babies identified as positive for the MT-RNR1 DNA variant since
introduction of the test into Neonatal Intensive Care Units (NICU) in the UK
and avoiding lifelong hearing loss resulting from aminoglycoside exposure
· Distributors contracted in key international geographies, with site
installations in Italy and Saudi Arabia and additional sites expected
near-term
· Accepted on NHS Dynamic Procurement System (DPS), permitting direct
procurement by regional NHS trusts
· Breakthrough Device Designation received from the FDA. Progressing as
planned, with first-engagement with FDA under programme initiated
Genedrive
· Expansion of operational capabilities; onshoring and increased
production pipeline of instrumentation, with internalisation of MT-RNR1 and
CYP2C19 assay manufacturing to be dual-source supply and complement external
vendors scaled-up production capabilities
· Growing base of post-implementation phase "routine clinical user" sites
which in turn lead to recurring revenue source for both tests
· Expansion of sales and marketing team, in-country distributors and
in-country market access facilitation
· Product Development: focus on on-market product support of CYP2C19 and
MT-RNR1, with routine product improvements to further facilitate ease of
implementation and usability
FINANCIAL
· Revenue and other income of £0.35m (H1 2023/4: £0.24m)
· R&D spend of £2.1m (H1 2023/4: £1.9m)
· Operating loss of £2.6m (H1 2023/4: £2.4m)
· Cash of £2.1m as at 31 December 2024 (30 June 2024: £5.2m)
· Cash of £1m as at 20 March 2025
· Equity fundraise of up to £1.25m announced (see separate announcement
today)
Gino Miele, CEO of genedrive plc, commented: "Thousands of people experience
adverse reactions to drugs every year, with medicines being ineffective, or
leading to unintended side effects or fatality. This costs the NHS £2.2
billion per year in England alone and it has been estimated that application
of PGx could avoid this in approximately 39% of individuals, therefore saving
£860 million per year. It is estimated that the value to the NHS of
interventional CYP2C19 testing alone if implemented nationally is £160
million per year, equating to one-third of the total savings offered recently
by the announcement of the abolishment of NHS England and the accompanying
loss of 9,000 jobs. Having expanded our UK sales team, our international
commercialisation partners and distribution network we are now seeing clear
signs of commercial traction, where following significant preceding phases
several sites are becoming routine clinical users, presenting a recurring
source of revenue to the company. We are confident that this will continue
to grow both in our domestic and international markets, with routine clinical
use and growing revenue and pipeline opportunities evidencing clinical need
and market fit for our novel products. The UK NHS has a huge opportunity to
lead the way in precision medicine and indeed, organisations such as NHS
Scotland have approached this in an integrated, forward thinking
entrepreneurial manner with the pending deployment of MT-RNR1 and CYP2C19
testing at national scale. I am proud that our company is a key part of this
and confident about our future commercial prospects in our markets."
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 (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.
CHIEF EXECUTIVE OFFICER'S AND CHAIRMAN'S REPORT
During the period genedrive maintained a strong focus on executing its
commercial strategy in rapid genetic testing, establishing a solid foundation
for continued sustainable growth. Thousands of people experience adverse
reactions to drugs every year, with medicines being ineffective, or leading to
unintended side effects or fatality. This costs the NHS £2.2 billion per
year in England alone and it has been estimated that the application of
pharmacogenetics (PGx) could avoid this in approximately 39% of individuals,
therefore saving approximately £860 million per year(1). In addition to the
avoidable costs to the NHS, there are wider costs to society such as loss of
productivity and cost of social care. With an increasing shift from
treatment to prevention, and the need for speedier diagnosis, we are well
positioned to provide solutions to this, enabling substantially improved
patient outcomes whilst at the same time offering significant financial
savings and freeing of resources to pressured healthcare systems.
Our focus on positioning the Company at the forefront of near-patient rapid
genetic testing is substantiated by recent government strategy announcements
throughout the UK, with particular traction in Scotland, where the strategic
outlook is to implement PGx within NHS Scotland at national scale, and the
genedrive products have an important role in this strategy. This is
especially the case in the avoidance of hearing loss in neonates in Neonatal
Intensive Care Units (NICU), but also in the rapid genetic testing of CYP2C19
in Transient Ischaemic Attack (TIA) stroke patients, where timely prescription
of antiplatelet drugs for pre-emptive prediction of response is critical.
Stroke has a particularly significant financial burden on healthcare
systems. The Stroke Association estimate the aggregate cost of stroke in the
UK, could reach £75 billion per annum by 2035. The estimated annual saving
is £160m for the interventional CYP2C19 testing alone(2) and equates to
one-third of the total savings offered recently by the UK government
announcement of the biggest structural reform of the NHS in over a decade. We
are encouraged by the new Government's focus on driving efficiencies within
the NHS and we envisage broader and more rapid adoption of PGx testing as a
way of helping to achieve this, both saving money and improving patient
outcomes.
There is undoubtedly a clear need for operational and strategic reform that
can contribute to mitigating these avoidable outcomes and improve efficient
use of resources to lead to "better care, smarter care" for patients, with
preventative healthcare as a core strategy essential relative to increasing
budgetary allocations to address the impact. Support for development of
innovations in the UK is high, but reimbursement routes for implementation are
poorly defined in the NHS, particularly in NHS England. A striking example
of this is seen with our MT-RNR1 interventional test, where budget for dealing
with the avoidable impact of antibiotic induced hearing loss is available to
audiology via national commissioning (bilateral cochlear implants) but the
savings enabled are not yet available at the upstream location of
intervention, with an additional budgetary pressure on Neonatology.
Similarly, whilst savings of approximately £160 million annually are
estimated for implementation of CYP2C19 testing, these are effected downstream
from where the additional cost for intervention is required. Whilst these
are current challenges at national level within the NHS we remain confident
that they can be resolved, particularly given the approach by the Scottish
Government to address phased implementation centrally via provision of funding
for the ANIA pathway.
In the interim to national commissioning, Integrated Care Boards (ICBs),
trusts, Health Innovation Networks (HiNs) and clinicians are able to procure
via existing locally available budgets and we are pleased to report adoption
at several sites for both of our tests in the UK. Implementation leading to
routine clinical use is preceded by several stages in addition to securing of
finances, including verification by local Point of Care Test teams. Once
implemented as a routine clinical service, these sites become sources of
recurring revenue generation for genedrive.
The period saw significant advancement operationally, in particular with our
tests receiving positive assessments in addition to NICE by the SHTG,
ultimately leading to strategic planning for phased implementation throughout
Scotland. Funding provision to collaborators being made available by the
National Institute for Health and Care Research (NIHR) and the Office for Life
Sciences (OLS) enabling data generation across the UK nations to address
evidence gaps required by NICE to transition from the highest "conditional
recommendation" under the Early Value Assessment (EVA) programme and
permitting use in the NHS, to full recommendation. It is heartening to note
that since introduction of our test, eleven babies cared for in NICUs in the
UK have avoided lifelong deafness that might otherwise have been caused by
exposure to aminoglycoside antibiotics. Our team is working tirelessly with
our distribution network to enable this same change in paradigm of care
internationally, with traction beginning to be realised with installations in
Italy and Saudi Arabia.
We have invested significantly in development and pre-commercialisation
requirements for enabling our CYP2C19-ID test as a pre-emptive step in
management of stroke patients and prescription of the antiplatelet
clopidogrel. With NICE recommendation as the point-of-care platform of
choice, highly impactful health economic cases, clear and valuable
differentiation to current incumbent comparator technology, we are pleased to
report early traction with implementation at two Hyper Acute Stroke Centres,
one being the largest in NHS England, and look forward to reporting further as
these routine user sites grow. Unlike our MT-RNR1 test currently, there is a
private Canadian based company that offers a CYP2C19 point of care platform.
Whilst we believe, as outlined by NICE, that the valuable differentiators of
our CYP2C19 platform are significant, we intend to be mindful of balancing our
desire to rightly keep our shareholders up to date with operational progress
against seeking to maintain a competitive edge over any emerging competition.
Genedrive® MT-RNR1-ID Kit
The Genedrive® MT-RNR1 kit is the world's first rapid point-of-care test to
screen infants in an urgent care setting for a genetic variant that can cause
life-long hearing loss when carriers of the variant are given certain
antibiotics. Those infants identified by the Genedrive® MT-RNR1 ID kit as
carrying the variant can then be given alternative antibiotics. It has the
potential to save thousands of children from lifelong hearing loss, whilst
providing a net positive financial outcome case to global healthcare
systems. The test is CE-IVD certified, permitting registration and sales to
the EU and other countries that are accepting of the CE mark.
NICE developed a new Early Value Assessment (EVA) approach to assess the
technologies that are most needed and in demand, allowing rapid assessment of
digital products, devices and diagnostics for clinical effectiveness and value
for money, so that the NHS and patients can benefit from these promising
technologies sooner. NICE recommended the Genedrive® MT-RNR1 kit for use in
the NHS England and Wales through its EVA in March 2023, with the (highest)
recommendation for use in the NHS being conditional on further evidence being
generated. Subsequently, NIHR in collaboration with the OLS awarded £0.5m
of funding to the PALOH-UK program to address evidence generation requirements
of the NICE EVA.
PALOH-UK commenced in November 2024 and has a maximum duration of 18 months,
with sites phased into two groups: Group 1, consisting of the nine sites
currently using the test and Group 2, the remaining five sites, with phased
go-live from May 25.
The U.S. is a key strategic market, given the estimated number of positive
patient outcomes and the associated cost savings that our test offer, which
are substantially exemplified by the litigious nature of the U.S. FDA
Breakthrough Device Designation was received In July 2024, offering the
opportunity to interact with FDA experts and a prioritised review of our
submission. We are progressing as planned, with first-engagement with the
FDA under programme reviewing plans for evidencing test performance required.
The U.S. clinical studies are expected to take 12-18 months from first patient
recruitment and the FDA Breakthrough programme can expediate the regulatory
review, so that it takes less than 300 days. The performance data generated
during the EVA programme is also expected to contribute towards clinical
performance data requirements for FDA.
Genedrive® CYP2C19-ID Kit
The Genedrive® CYP2C19-ID Kit tests for identification of individuals
unlikely to respond to the commonly prescribed antiplatelet drug Clopidogrel,
enabling more effective management of stroke patient treatment, and which is
the only PoC test offering additional coverage of several DNA variants
enriched in certain ethnic groups. It is currently UKCA certified and the
Company remains on track for CE-IVD certification in April 2025.
NICE recommended genedrive as the PoC instrument of choice in July 2024, this
was quickly followed by the first commercial order from NHS England's largest
Hyperacute Stroke Centre in Salford. The subsequent clinical interest and
engagement has been positive, with Peterborough City Hospital being the first
hospital to adopt the test outside of the implementation study and we are
seeing a growing base of initial installations for site verifications leading
to expected routine clinical use.
The Innovate UK funded DEVOTE programme concluded the validation and
verification and in December 2024 the clinical performance was published in
Journal of Molecular Diagnostics, outlining superior performance to the
reference laboratory test with respect to target coverage, speed, accuracy and
test fails, and by definition superior to the comparator PoC platform with
respect to target coverage.
Ahead of CE-IVD certification we have invested significant resources in
defining the market access and reimbursement routes in target European &
Middle East countries, onboarding of qualified distributors and are
progressing through early stages of customer adoption sites, inclusive of
conversion of distributors and users considering using the comparator PoC test
to ours. In addition to Europe and the Middle East region, the U.S. is a key
target market, where CYP2C19 genotype-guided prescription of Clopidogrel has
been recommended by the American Heart Association for cardiovascular
indications as well as IS/TIA. We have had initial pre-submission engagement
with FDA, receiving positive feedback and confirmation of our strategy, with
the 510(k) route being identified for regulatory submission for U.S. market
entry. We look forward to updating shareholders on progress in due course.
People
Strategic changes were made to the composition of the Board and senior
leadership, with the associated cost savings beginning in H2 of FY25. We
have exceptionally talented and highly skilled people and during the period we
increased headcount from 43 to 50, to drive forward our commercial efforts and
to support our international regulatory requirements.
FINANCIAL RESULTS
Revenue and other income in the period was £0.35m (H1 2023/4: £0.24m).
Research and development costs were £2.1m (H1 2023/4: £1.9m) as the key
focus was validation and verification of CYPC219 and associated regulatory
costs. Administration costs at £862k (H1 2023/4: £721k) have increased due
to business development, marketing and support team expansion in the UK, EU
and the Middle East. The operating loss for the period was £2.6m (H1
2023/4: £2.4m) with finance income in the period of £41k (H1 2023/4: net
finance costs of £30k).
After financing costs, the loss before taxation was £2.5m (H1 2023/4:
£2.4m). The loss after taxation decreases to £2.3m (H1 2023/4: £2.0m)
after estimating the six-month taxation credit as £0.2m (H1 2023/4: £0.35m).
The basic loss per share was 0.4p (H1 2023/4: 2.0p).
Cash Resources
The operating loss for the period was £2.6m (H1 2023/4: £2.4m) and working
capital reduced by £0.6m (H1 2023/4: £0.2m). Net cash out-flow from
operations was £3.1m (H1 2023/4: £2.4m) and as the R&D tax credit was
not received in the period the net cash flow from operating activities was
also £3.1m.
Cash flows from financing activities consisted of lease liability repayments
of £19k (H1 2023/4: £112k) and there are no proceeds from the financing
activities (H1 2023/4: £1.2m).
Closing cash was £2.1m (31 December 2023: £1.2m). The cash balance on 20
March 2025 was £1m with the FY24 R&D tax credit expected in the coming
weeks. The current levels of operating expenditure is circa £0.5m per
month, revenue and grant funding when received reducing the rate of cash
burn. The Company has today announced an equity fundraise of up to £1.25m,
the net proceeds of which will provide additional working capital as the
Company actively pursues a broad range of growing commercial opportunities in
the UK and internationally at the present time.
Balance Sheet
Balance sheet net assets at 31 December 2024 were £3.1m (30 June 2024:
£5.4m; 31 December 2023: £1.5m) and the consolidated loss of the period was
£2.3m (H1 2023/4: £2m).
PRINCIPAL RISKS AND UNCERTAINTIES
There are a number of potential risks and uncertainties which could have a
material impact on the Company's performance over the remaining six months of
the financial year and could cause actual results to differ materially from
expected and historical results. The Directors do not consider that these
principal risks and uncertainties have changed materially since publication of
the annual report for the year ended 30 June 2024; a more detailed explanation
of the risks for the Company can be found on page 30 of the annual report.
Going Concern
We have increased visibility of our sales pipeline and are beginning to see
opportunities come into fruition, we remain reasonably confident of securing
more significant revenues, but the timing of them remains unclear. As
described in the accounting policies, we continue to adopt a going concern
basis for the preparation of the accounts, but the above condition represents
a material uncertainty that may cast significant doubt on the Group and
Company's ability to continue as a going concern.
OUTLOOK
Innovation is the key focus of the NHS Long Term Plan and we are immensely
proud of the development of our tests with the NHS for the NHS. As
outlined in the recent Scottish Government announcement, approximately £0.8m
will fund a programme for testing newborn babies with genedrive's MT-RNR-ID
kit, in a phased national roll out over 18 months with first clinical testing
beginning in October 2025. Once fully implemented it is expected that over
3,000 babies per year will receive the MT-RNR1-ID test throughout Scotland.
A further £1.1m will support interventional CYP2C19 testing in recent stroke
patients and whilst primarily focused on laboratory-based testing with
substantially slower turnaround times, the Genedrive® CYP2C19-ID kit will be
included for assessment against laboratory testing pathways in Transient
Ischaemic Attack (TIA) clinics.
We are actively pursuing a broad range of growing commercial opportunities in
the UK and internationally at the present time, including both commercial
sales and potential non-dilutive grant income. CE-IVD certification for our
CYP2C19 test will also enable in-country registration and subsequently sales
of the test to commence outside of the UK and we are particularly encouraged
by opportunities presented in the Middle East region, where we have focused
significant efforts and expenditure to understand market access and
reimbursement routes as well as identification of primary target hospitals,
opinion leaders and healthcare organisations and will update further in due
course as opportunities are converted as appropriate. The additional funding
we have announced today provides the Company with an extended cash runway to
seek to close a number of the commercial and other opportunities in front of
us and further drive shareholder value. The Board continues to assess longer
term financing options in the meantime.
The U.S. remains a significant opportunity for both of our tests. Whilst we
are in the early stages of interaction with FDA under Breakthrough Device
Designation status awarded for our MT-RNR1 test, progression is as to plan and
previously reported, but with complexities to navigate that are inherent to
planning for FDA-required evidencing of safety and performance for a novel
diagnostic test such as ours, particularly in a vulnerable and challenging to
access patient group. For CYP2C19 pre-emptive testing, the American Heart
Association published clear scientific statement that this should be conducted
for Cardiovascular indications in addition to neurologic stroke, and we expect
CYP2C19 rapid genotyping to grow significantly in importance and placement in
patient healthcare pathways. Regulatory clearance for our CYP2C19-ID test in
the USA is central to our commercialisation strategy.
Our deep understanding of clinical PGx testing requirements and user needs,
and expertise in PGx in vitro diagnostic test development lends itself well to
product development offerings complementary to near-patient rapid PGx and we
look forward to updating shareholders in due course as these consolidate.
On behalf of ourselves and the board, we would like to thank our employees,
partners, collaborators and shareholders for their support and we look forward
to our growing commercial traction and patient impact.
Dr Gino Miele
Chief Executive Officer
Dr Ian Gilham
Chairman
27 March 2025
(1) Osanlou R, Walker L, Hughes DA, et al BMJ
Open 2022;12:e055551. doi: 10.1136/bmjopen-2021-055551
(2) Manchester leads implementation of lifesaving genetic bedside stroke test
- Manchester University NHS Foundation Trust
(https://mft.nhs.uk/2024/07/31/manchester-leads-implementation-of-lifesaving-genetic-bedside-stroke-test/)
UNAUDITED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
For the six months ended 31 December 2024
Six months ended Six months ended Year ended
31 December 2024 31 December 2023 30 June 2024
Unaudited Unaudited Audited
Note £000 £000 £000
Revenue and other income (3) 350 238 501
Research and development costs (2,058) (1,876) (4,175)
Administrative costs (862) (721) (1,638)
Operating loss (4) (2,570) (2,359) (5,312)
Finance costs (5) - (48) (2,468)
Finance income (5) 41 18 30
Loss on ordinary activities before taxation (2,529) (2,389) (7,750)
Taxation 200 350 675
Loss for the financial period (2,329) (2,039) (7,075)
Total comprehensive expense for the period (2,329) (2,039) (7,075)
Loss per share (pence)
-Basic (0.4)p (2.4)p (4.7)p
-Diluted (0.4)p (2.4)p (4.7)p
UNAUDITED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
For the six months ended 31 December 2024
Share Capital Other Reserves Accumulated Total
(unaudited) (unaudited) Losses (unaudited)
£000 £000 (unaudited) £000
£000
At 30 June 2023 1,485 52,777 (52,221) 2,041
Investment funding arrangement, net of costs 351 1,113 - 1,464
Equity -settled share-based payments - 40 - 40
Transactions settled directly in equity 351 1,153 - 1,504
Total comprehensive loss for the period - - (2,039) (2,039)
At 31 December 2023 1,836 53,930 (54,260) 1,506
Share issue: January 2024 4 13 - 17
Share issue: June 2024 6,000 - - 6,000
Investment funding arrangement, net of costs 307 711 - 1,018
Equity -settled share-based payments - 2 - 2
Transactions settled directly in equity 6,311 726 - 7,037
Total comprehensive loss for the period - - (5,036) (5,036)
Settlement of Financial Derivative Liability - - 1,852 1,852
At 30 June 2024 8,147 54,656 (57,444) 5,359
Equity -settled share-based payments - 40 - 40
Transactions settled directly in equity - 40 - 40
Total comprehensive loss for the period - - (2,329) (2,329)
At 31 December 2024 8,147 54,696 (59,773) 3,070
UNAUDITED CONSOLIDATED BALANCE SHEET
As at 31 December 2024
31 December 31 December 30 June
2024 2023 2024
(unaudited) (unaudited) (audited)
£000 £000 £000
Note
Non-current assets
Property, plant and equipment 145 279 174
145 279 174
Current assets
Inventories 366 539 381
Trade and other receivables 522 214 382
Current tax 875 1,181 675
asset
(6)
Cash and cash equivalents 2,098 1,226 5,188
3,861 3,160 6,626
Total assets 4,006 3,439 6,800
Liabilities
Current liabilities
Trade and other payables (936) (788) (1,422)
Lease liabilities - (129) (19)
Derivative financial instruments - (1,016) -
(936) (1,933) (1,441)
Non-current liabilities
Lease liabilities - - -
Total liabilities (936) (1,933) (1,441)
Net assets 3,070 1,506 5,359
Capital and reserves
Called-up equity share 8,147 1,836 8,147
capital
(8)
Other 54,696 53,930 54,656
reserves
(9)
Accumulated losses (59,773) (54,260) (57,444)
Total shareholder equity 3,070 1,506 5,359
UNAUDITED CONSOLIDATED CASH FLOW STATEMENT
For the six months ended 31 December 2024
31 December 2024 31 December 2023 30 June
(unaudited) (unaudited) 2024
(audited)
£000 £000 £000
Cash flows from operating activities
Operating loss for the period (2,570) (2,359) (5,312)
Depreciation and amortisation on non-leased assets 26 28 54
Depreciation on right-of-use assets 17 90 193
Share - based payment 40 40 59
Operating loss before changes in working capital and provisions (2,487) (2,201) (5,006)
Decrease/ (increase) in inventories 15 (14) 144
Increase in trade and other receivables (140) (56) (224)
(Decrease)/ increase in trade and other payables (486) (147) 487
Net cash outflow from operations (3,098) (2,418) (4,599)
Tax received - - 831
Net cash outflow from operating activities (3,098) (2,418) (3,768)
Cash flows from investing activities
Finance income 41 18 30
Finance costs - (10) -
Acquisition of plant and equipment (14) (5) (29)
Net cash inflow from investing activities 27 3 1
Cash flows from financing activities
Proceeds from the investment placing agreement - 1,200 1,200
Transaction costs relating to investment placing agreement - (48) (48)
Proceeds from share issue - - 6,000
Transaction costs relating to share issue - - (566)
Repayment of lease liabilities (19) (112) (222)
Net (outflow)/ inflow from financing activities (19) 1,040 6,364
Net (decrease) /increase in cash equivalents (3,090) (1,375) 2,597
Effects of exchange rate changes on cash and cash equivalents - - (10)
Cash and cash equivalents at beginning of period 5,188 2,601 2,601
Cash and cash equivalents at end of period 2,098 1,226 5,188
Analysis of net funds
Cash at bank and in hand 2,098 1,226 5,188
NOTES TO THE UNAUDITED INTERIM FINANCIAL STATEMENTS
1. General information
genedrive plc ('the Company') and its subsidiaries (together 'the Group') is a
pharmacogenetic testing company developing and commercialising a low cost,
rapid, versatile, simple to use and robust point of need pharmacogenetic
platform for the diagnosis of genetic variations. The Company is a public
limited company incorporated and domiciled in the UK. The address of its
registered office is 48 Grafton Street, Manchester, M13 9XX. The Company has
its listing on the London Stock Exchange Alternative Investment Market
(AIM).
The financial information for the period ended 31 December 2024 and similarly
the period ended 31 December 2023 has been neither audited nor reviewed by the
auditor. The financial information for the year ended 30 June 2024 has been
based on information in the audited financial statements for that period. The
interim financial statements for the period ended 31 December 2024 do not
constitute statutory accounts as defined in section 434 of the Companies Act
2006. A copy of the statutory accounts for the year ended 30 June 2024 has
been delivered to the Registrar of Companies, the accounts had an unqualified
audit opinion and did not contain a statement under section 498(2) or (3) of
the Companies Act 2006 but did include a reference to a material uncertainty
that might cast significant doubt over the Group's ability to continue as a
going concern, to which the auditor drew attention by way of emphasis.
These interim financial statements were approved by the Board of Directors on
27 March 2025.
The accounting policies set out below have, unless otherwise stated, been
applied consistently to all periods represented in these consolidated
financial statements.
2. Significant accounting policies
Basis of accounting
The consolidated interim financial statements consolidate those of the Company
and its subsidiaries (together referred to as the "Group"). They are presented
in pounds sterling and all values are rounded to the nearest one thousand
pounds (£k) except where otherwise indicated.
Subsidiaries are entities controlled by the Group. The financial statements of
subsidiaries are included in the consolidated financial statements from the
date that control commences until the date that control ceases. Transactions
between Group companies are eliminated on consolidation.
The accounting policies used in the preparation of the financial information
for the six months ended 31 December 2024 are in accordance with the
recognition and measurement criteria of UK adopted international accounting
standards and are consistent with those which will be adopted in the annual
financial statements for the year ending 30 June 2025. Whilst the financial
information included has been prepared in accordance with the recognition and
measurement criteria of international accounting standards, the financial
information does not contain sufficient information to comply with
international accounting standards. The Group has not applied IAS 34, Interim
Financial Reporting, which is not mandatory for UK AIM listed Groups, in the
preparation of this interim financial report.
Going concern
The Directors have concluded that it is necessary to draw attention to the
revenue and cost forecasts in the business plans for the period to June
2026. In order for the Company to continue as a going concern, there is a
requirement to achieve a certain level of sales. If an adequate sales level
cannot be achieved to support the Group and Company, the Directors have the
options to reduce ongoing spend and seek additional financing from investors
or debt providers.
The Company is confident that given the health benefits and economics that
MT-RNR1 will be a commercial success. The NICE EVA (Early Value Assessment)
recommendation is testimony to it and the funding for the EVA evidence
generation, which commenced in November 2024, will see over £0.5m of revenue.
The huge success of our CYP2C19 product development, offers the NHS an
intervention that is estimated to save the NHS £160m every year and improve
patient outcomes. This paves the way to a much larger global market than
MT-RNR1 with a far less complex route to adoption. The NICE DAP (Diagnostics
Assessment Programme) recommendation and the initial sales demonstrates
significant progress.
The Company recognises the uncertainty regarding the timing of the associated
revenue generation, given we are at the forefront of the emerging
pharmacogenetic field and the funding complexities within the NHS are
understood. National Commissioning of our products brings significant upside
to the sales forecasts, but it is outside of our control and therefore the
timing is difficult to predict.
The Directors have reasonable confidence in their ability to raise additional
financing to bridge the funding gap to a positive EBITDA position.
While the Board has a successful track record in raising funds, there remains
uncertainty as to the amount of funding that could be raised from shareholders
or debt providers.
The combination of the above factors represents a material uncertainty that
may cast significant doubt on the Group and Company's ability to continue as a
going concern.
Accordingly, the Directors have concluded that it is appropriate to continue
to adopt the going concern basis of accounting in preparing these financial
statements. These financial statements do not include the adjustments that
would result if the Group and Company were unable to continue as a going
concern.
New accounting standards adopted in the period
There have been no new accounting standards adopted in the period that have
had a material impact on the financial statements.
Estimates
The preparation of interim financial statements requires management to make
judgements, estimates and assumptions that affect the application of
accounting policies and the reported amounts of assets and liabilities, income
and expense. Actual results may differ from these estimates.
In preparing these interim financial statements, the significant judgements
made by management in applying the Group's accounting policies and the key
sources of estimation were the same as those that applied to the consolidated
financial statements for the year ended 30 June 2023, with the exception of
changes in estimates that are required in:
- determining the provision for taxation; and
- determining the carrying value for inventory
Revenue recognition
a. Product sales
Sales of goods are recognised when all the performance obligations have been
completed and when the Group entity has no continuing managerial involvement
nor effective control over the goods. The transfer of control of goods can
pass at various points depending on the shipping terms of the contract with
the customer, they can be at collection from a premises or delivery to the
relevant port or customer designated premises. Where items are sold with a
right of return, accumulated experience is used to estimate and provide for
such returns at the time of sale.
b. Collaboration and licensing revenue
Contractually agreed upfront payments and similar non-refundable payments in
respect of collaboration or licence agreements which are not directly related
to ongoing research activity are recorded as deferred income and recognised as
revenue over the anticipated duration of the agreement. Where the anticipated
duration of the agreement is modified, the period over which revenue is
recognised is also modified.
Non-refundable milestone and other payments that are linked to the achievement
of significant and substantive technological or regulatory hurdles in the
research and development process are recognised as revenue upon the
achievement of the specified milestones.
Income which is related to ongoing research activity is recognised as the
research activity is undertaken, in accordance with the contract. Activity is
measured based on progress and milestones and not cost.
c. Other income - development grant funding
Income receivable in the form of Government grants to fund product development
is recognised as development grant funding over the periods in which the Group
recognises, as expenses, the related eligible costs which the grants are
intended to compensate and when there is reasonable assurance that the Group
will comply with the conditions attaching to them and that the income will be
received. Government grants whose primary condition is that the Group should
purchase or otherwise acquire non-current assets are recognised as deferred
revenue in the Consolidated Balance Sheet and transferred to the Consolidated
Statement of Comprehensive Income on a systematic and rational basis over the
useful lives of the related assets.
Research and development
Research expenditure is written off as it is incurred. Development expenditure
is written off as it is incurred up to the point of technical and commercial
validation. Thereafter, costs that are measurable and attributable to the
project are carried forward as intangible assets, subject to having met the
following criteria:
· demonstration that the product will generate profitable future
economic benefit and of an intention and ability to sell the product;
· assessment of technical feasibility;
· confirmation of the availability of technical, financial and other
resources to complete the development;
· management intends to complete the development so the product will
be available for use; and
· the expenditure attributable to the development can be reliably
measured.
Right-of-use assets (ROU)
At inception of a contract, the Group assesses whether a contract is, or
contains, a lease. A contract is, or contains, a lease if the contract conveys
the right to control the use of an identified asset for a period of time in
exchange for consideration. Leases are recognised as an ROU asset and a
corresponding lease liability at the date at which the leased asset is
available for use by the Group. At the lease commencement date, a ROU asset is
measured at cost comprising the following: the amount of the initial
measurement of the lease liability; any lease payments made at or before the
commencement date less any lease incentives received; any initial direct
costs; and restoration costs to return the asset to its original condition.
The ROU asset is depreciated over the shorter of the asset's useful life and
the lease term on a straight-line basis. If ownership of the ROU asset
transfers to the Group at the end of the lease term or the cost reflects the
exercise of a purchase option, depreciation is calculated using the estimated
useful life of the asset.
Foreign currencies
(a) Functional and presentation currency
Items included in the financial statements of each of the Group's entities are
measured using the currency of the primary economic environment in which the
entity operates ('the functional currency'). The consolidated financial
statements are presented in sterling which is the Group's presentation
currency.
(b) Transactions and balances
Foreign currency transactions are translated into the functional currency
using the exchange rates prevailing at the dates of the transactions. Foreign
exchange gains and losses resulting from the settlement of such transactions
and from the translation at year end exchange rates of monetary assets and
liabilities denominated in foreign currencies are recognised in the income
statement, except when deferred in equity as qualifying net investment hedges.
Non-monetary items carried at fair value and denominated in foreign currencies
are retranslated at the rates prevailing on the date when fair value is
determined.
3. Revenue and other income
Revenue is measured at the fair value of the consideration received or
receivable and net of discounts and sales-related taxes.
31 December December 31 December December 30 June
2024 2023 2024
£'000 £'000 £'000
Revenue from customer contracts 298 123 332
Grant and other income 52 115 169
350 238 501
4. Operating segments
Diagnostic Segment Administrative Total
Costs
Six months ended 31 December 2024 £'000 £'000 £'000
Revenue and other income 350 - 350
Operating loss (1,708) (862) (2,570)
Finance income 41
Loss on ordinary activities before taxation (2,529)
Taxation 200
Loss for the financial
Loss for the financial period (2,329)
Diagnostic Segment Administrative Total
Costs
Six months ended 31 December 2023 £'000 £'000 £'000
Revenue and other income 238 - 238
Operating loss (1,638) (721) (2,359)
Net Finance costs (30)
Loss on ordinary activities before taxation (2,389)
Taxation 350
Loss for the financial
Loss for the financial period (2,039)
Diagnostic Segment Administrative Total
Costs
Twelve months ended 30 June 2024 £'000 £'000 £'000
Revenue and other income 501 - 501
Operating loss (3,674) (1,638) (5,312)
Net Finance costs (2,438)
Loss on ordinary activities before taxation (7,750)
Taxation 675
Loss for the financial
Loss for the financial period (7,075)
5. Finance income and costs
31 December December 31 December December 30 June
2024 2023 2024
£000 £000 £000
Interest income on bank deposits 41 18 30
31 December December 31 December December 30 June
2024 2023 2024
£000 £000 £000
Transaction costs relating to share issue - - (566)
Transaction costs relating to investment placing agreement - (40) (38)
Movement in fair value of derivative financial instrument - - (1,852)
Finance lease interest costs - (8) (12)
Finance costs - (48) (2,468)
6. Current tax asset
The current tax asset relates to the estimate of the refund under the R&D
tax credit scheme of £0.9m (H1 2023/4: £1.2m). This includes £0.2m for
the interim period to December 2024 that would be received following
submission of the tax returns for the 12 months to June 2025, with receipt
expected to be in the first quarter of 2026.
7. Earnings per share
The basic earnings per share is calculated by dividing the earnings
attributable to ordinary shareholders for the year by the weighted average
number of ordinary shares in issue during the period. The weighted average
number of shares in issue during the period was 543,141,481 (H1 2023/4:
103,900,492 ). As the Company is loss-making, no potentially dilutive
options have been added into the EPS calculation. (H1 2023/4: no shares).
8. Share capital
Allotted, issued and fully paid: No
£000
Balance at 30 June 2023 99,049,946 1,485
Share issue - equity-settled share-based payments 260,870 4
Share issue 443,830,665 6,658
Balance at 30 June 2024 and 31 December 2024 543,141,481 8,147
9. Other Reserves
Share Premium Account Shares to be issued Employee Share Incentive Plan Reserve Share Options Reserve Reverse Acquisitions Reserve Total
£000 £000 £000 £000 £000 £000
At 30 June 2023 53,336 477 (196) 1,656 (2,496) 52,777
Investment funding arrangement 916 197 - - - 1,113
Equity settled share-based payments - - - 40 - 40
At 31 December 2023 54,252 674 (196) 1,696 (2,496) 53,930
Investment funding arrangement 711 - - - - 711
Share issue 13 - - - - 13
Equity settled share-based payments 2 - - - - 2
At 30 June 2024 54,978 674 (196) 1,696 (2,496) 54,656
Equity settled share-based payments - - - 40 - 40
At 31 December 2024 54,978 674 (196) 1,736 (2,496) 54,696
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
or visit
www.rns.com (http://www.rns.com/)
.
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
. END IR EASDXAAXSEFARecent news on Genedrive
See all newsREG - Genedrive PLC - CYP2C19 ID Kit CE-IVD certification update
AnnouncementREG - AIM - AIM Notice - 03/04/2025
AnnouncementREG - Genedrive PLC - Additional grant funding under DEVOTE programme
AnnouncementREG - Genedrive PLC - Receipt of R&D tax credit
AnnouncementREG - Genedrive PLC - Result of RetailBook Offer
Announcement