REG - Genedrive PLC - Final Results
29/11/2024 07:00
For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20241129:nRSc1026Oa&default-theme=true
RNS Number : 1026O Genedrive PLC 29 November 2024
genedrive plc
("genedrive" or "the Company" or "the Group")
Audited Final Results
genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company,
announces its audited Final Results for the year ended 30 June 2024.
Financial Highlights
· Revenue and other income £0.5m (2023: £0.06m)
· Operating loss for the year of £5.3m (2023: loss of £5.2m)
· R&D spend of £4.2m (2023: £3.9m) focused on
near-commercialisation product development
· Successful equity fundraise of £6m (gross) announced in June 2024
· Cash at bank of £5.2m at 30 June 2024 (2023: £2.6m) and debt free
Operational Highlights (including post period end)
Genedrive® MT-RNR1
· Initial orders of the Genedrive MT-RNR1 Products for new sites in the
UK
· Initial overseas orders of the Genedrive® MT-RNR1 ID Kit
· Royal Sussex County Hospital, Brighton adopts the Genedrive® MT-RNR1
ID Kit for routine use
· Entered into a Clinical Trial Agreement with a leading multi-state
physician organisation for clinical research studies of the Genedrive®
MT-RNR1 Product Range in the US as part of planned FDA submission
· Breakthrough Device Designation received from the FDA
· 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
· Positive value assessment by the Scottish Health Technology Group
following referral by the Accelerated National Innovation Adoption pathway
group in Scotland
Genedrive® CYP2C19
· Genedrive® CYP2C19 achieved UKCA marking
· Key CYP2C19-ID test performance milestone achieved, with Genedrive
CYP2C19 ID kit outperforming the reference laboratory test platform
· NICE recommends the Genedrive® CYP2C19-ID Kit as the platform of
choice for CYP2C19 genotyping strategies for clopidogrel administration in
ischaemic stroke and transient ischaemic attack
· First UK commercial sales of the Genedrive® CYP2C19-ID Kit
· Positive value assessment by the Scottish Health Technology Group
following referral by the Accelerated National Innovation Adoption pathway
group in Scotland
Gino Miele, CEO of genedrive plc, said: "Our AIHL and CYP2C19 interventional
tests are at the forefront of the emerging realisation of pharmacogenetic
testing at the point of care, enabling better health outcomes and improved
safety for patients, whilst offering significant health economic benefits to
global healthcare systems. We made significant progress during the year and
our near-term focus is executing on our commercial growth strategy, by
navigating the reimbursement complexities of the NHS and other countries,
expanding the number of sites using our tests in the UK and making targeted
efforts to initiate in-country live sites in our prioritised international
markets."
For further details please contact:
genedrive plc +44 (0)161 989 0245
Gino Miele CEO / Russ Shaw: CFO
Peel Hunt LLP (Nominated Adviser and Joint Broker) +44 (0)20 7418 8900
James Steel / Patrick Birkholm
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.
Chairman's Statement
Innovative solutions addressing unmet needs
We entered the year with a clear understanding of the obstacles and
opportunities that we faced as a small business operating at the forefront of
the groundbreaking and emerging field of pharmacogenetic testing and I am
delighted to report on a year that marks successive achievements in product
development and implementation, a second NICE recommendation, positive
assessments of our products by the Scottish Health Technology Group, FDA
breakthrough device designation and early stage market momentum.
The strategic decision to focus on enabling pharmacogenetic testing to the
point of need is showing the promise that we believed it would. This is
evidenced by NICE recommending both our MT-RNR1 and CYP2C19 products,
recognising their significant clinical impact and value for money for the NHS.
Our activities in the DEVOTE programme collaboration has been an outstanding
success, verifying and validating our CYP2C19 test, with remarkable results
outperforming the laboratory based reference test and I extend my gratitude to
our long-standing valued colleagues at the Manchester University NHS
Foundation Trust and Health Innovation Manchester for their unwavering
support.
Our tests contribute towards optimising the efficacy and safety of patient
care and during a time of unprecedented pressure on the NHS, we offer a
substantial cost-saving opportunity with our interventions by reducing the
burden of avoidable adverse drug reactions, such as the need for cochlear
implants for AIHL and the avoidance of ineffective treatment of approximately
30% of stroke patients.
Governance and People
On 6 August 2024 James Cheek left the Company and was succeeded as CEO by Dr.
Gino Miele PhD.
Gino has been with the Company since 2011, serving as R&D Director and
since September 2023 as Chief Scientific Officer and an Executive Board
Director. On behalf of the Board, I would like to thank James for his
contributions at genedrive and wish him well for the future.
The Board continues its commitment to maintaining its own efficiency and
competence, with a dedication to ensuring that our governance framework,
internal controls, values, and culture are all in harmony with our strategic
goals and the Company's objectives.
Our people are the core of our business and the driving force behind the
Company. I want to extend my heartfelt appreciation to each of them for their
steadfast resilience, innovative mindset, and relentless determination in both
the creation and delivery of our product, and navigation of complex healthcare
market access and reimbursement routes.
Funding
In my report last year, it was made very clear that given the limitations of
the cash runway the Company needed to raise funds to support the operational,
commercialisation and growth plans of the business.
We completed an equity fund raise in June 2024 and the net proceeds of £5.4m
extended our cash runway materially. The Group's operating expenses are
currently running at around £0.5m per month and are expected to be maintained
at around this level pending increased commercial traction. To help achieve
this we have increased our commercial team in the UK and distribution network
in the Middle East and we are generating revenues from routine use of our
tests on a small scale, but have a pipeline of opportunities that, if
converted, would see a significant step up in revenues during calendar year
2025 and a reduction in the level of cash burn.
Outlook
Gino was instrumental to our product development, successful NICE
recommendations, FDA breakthrough designation, DEVOTE program outcomes, and is
a world leading expert in near-patient pharmacogenetics. With his commercial
insights aligned to clinical decision maker needs, we are delighted to have
him at the helm as we commercialise our products.
Robust research and development is at the heart of our Company, by applying
our deep expertise in developing cutting-edge in-vitro pharmacogenetic assays
we are able to provide innovative solutions to address global unmet needs and
facilitate better patient outcomes.
In closing, I would like to extend my sincere gratitude to you, our valued
shareholders especially for the considerable financial support shown at the
time of our financing, along with our dedicated staff and collaboration
partners, for your continued effort.
Dr Ian Gilham
Chairman
Chief Executive's Review
Pioneering pharmacogenetics
Overview
I am pleased to report on the significant progress that has been made across
all aspects of the Group this year and offer my sincere thanks to our
entrepreneurial people at genedrive past and present that have worked
tirelessly in order to position our company at the forefront of the emerging
area of near patient pharmacogenetic (PGx) testing.
Being first to market and pioneering in the field of near-patient
pharmacogenetics is a demanding mission, operating in a very heavily regulated
field with no precedence or predicate, and with the funding and reimbursement
complexity of the overburdened NHS making our domestic market challenging to
penetrate quickly.
PGx implementation into clinical practice at scale is an emerging field, and
particularly so when positioned near-patient, with many development,
regulatory, and clinical implementation challenges being addressed and solved
for the first time. With our deep accruing expertise in this paradigm we are
uniquely positioned to capitalise on the opportunities our innovative and
disruptive interventional products offer.
The progress we have made this year has been significant. To have two
recommendations by the highly respected and influential NICE body is
remarkable for a healthcare company of our size and low-cost base operating in
this space, and we are well aligned with the recent recommendations of Lord
Darzi's report on the NHS to the UK Secretary of State for Health and Social
Care with respect to an increased focus on prevention as opposed to treatment.
Both our MT-RNR1 and CYP2C19 products have the potential to prevent harm to,
and significantly improve the lives of thousands of patients worldwide, some
of those at the most vulnerable and early stage of their lives, whilst at the
same time offering significant financial benefits to funding-pressured
healthcare systems, and I am extremely proud of our team at genedrive and
visionary collaborators in bringing these products to the market. Our
CYP2C19 genotyping intervention can rapidly identify stroke patients who would
otherwise be prescribed medication potentially ineffective for them at a time
in their lives when optimal therapeutic management is critical, and at the
same time being estimated to offer the NHS approximately £160m of financial
savings per year. "Spend to save" is a mantra at the heart of our
commercialisation efforts.
Our products, whilst offering significant financial and patient benefits, are
robust and highly accurate compared to platforms several-fold more expensive,
time-consuming and costly to operate. Our DEVOTE study exemplified this,
where the genedrive CYP2C19 test outperformed the laboratory reference test
with respect to speed, accuracy and target coverage, with the latter being
exceptionally important with respect to improving inequalities in
healthcare.
Our MT-RNR1 interventional test enables clinicians within the required
timeframe to avoid prescription of aminoglycoside antibiotics to individuals
who would otherwise potentially suffer from hearing loss. This is
particularly significant in vulnerable newborns in neonatal intensive care
settings and is a known adverse event risk which can now be reduced. The
NIHR i4i and Office for Life Sciences OLS funding programme is aimed
specifically at technologies which have been recommended for use in the NHS by
NICE via the EVA, with the goal of NIHR and the Government's Office for Life
Sciences via this programme being to drive adoption and implementation of
innovative technologies such as ours into the UK's NHS, to the positive
benefit of healthcare economies and ultimately significantly improving patient
outcomes.
We are delighted that our clinical collaborators have been successfully
awarded a funding package under this programme for our MT-RNR1 product, and it
represents a key step in enabling generation of real world evidence data
requirements of NICE and which will run in parallel to our continued expansion
of domestic and international sales strategies.
Performance
Whilst healthcare institutions move slowly, with market access and
reimbursement routes convoluted, particularly in the UK NHS and for first-time
innovative products, commercialisation efforts are beginning to be realised,
with revenue and other income of £0.5m being a credible increase from the
prior year. Importantly, we have a pipeline of opportunities for both
products and once implemented, each site becomes a source of recurring
revenue. Key to this for both our tests in the UK will be NHS budget
provision and commissioning at national level, with inclusion of specific test
codes within the NHS for point of care genetic testing, and/or procedural
changes to permit reallocation of budgetary requirements for procurement from
further down the patient care pathway at the point of addressing the effect
(harm) to the point of the intervention, inevitably involving separate
departments.
MT-RNR1 is now in routine use in the NHS at 9 hospitals and the NICE EVA
programme via NIHR will see this increase to 14, throughout the UK nations. I
have a deep sense of pride in our achievements to date of preventing profound,
irreversible and lifelong hearing loss in babies in NICUs using our test, and
we are making every effort to ensure that the rest of the country can rightly
expect to receive the same equality of care.
NICE recommendation for use in the UK NHS and Breakthrough Device Designation
by the US FDA underpin recognition of the positive benefits our MT-RNR1 ID kit
provides, and positive value assessments by the Scottish Health Technology
Group, leading to considerations of phased roll out at national level in
Scotland is a significant achievement.
Likewise, full recommendation of our CYP2C19 ID kit and the need for
interventional CYP2C19 genotyping in ischaemic stroke and transient ischaemic
attack by NICE and positive value assessment by the Scottish Health Technology
Group, with health economics estimated to be in the order of £160m financial
savings to NHS England per year are powerful drivers of anticipated uptake.
Performance of our CYP2C19 ID kit in clinical studies under the DEVOTE program
was exceptional, with our device outperforming the laboratory platform costing
approximately 20X more with respect to speed of time to result, accuracy and
target coverage. Whilst positioned primarily for near-patient testing, our
CYP2C19 test with its clear advantages is equally at home in traditional
laboratory settings.
Outlook
With our innovative products directly addressing a current unmet clinical need
in a cost-effective manner to healthcare systems, I am optimistic about what
the future holds for your Company.
Being at the forefront of the realisation of this emerging field, we are under
no illusions of the scale of the challenge that we face, but we have the
determination, requisite skills and commitment to achieving improvements in
healthcare, and as such we are continuing to forge the required relationships
to surmount these obstacles.
Our near-term focus is executing on our commercial growth strategy, by
navigating the reimbursement complexities of the NHS and other countries,
expanding the number of sites using our tests in the UK and making targeted
efforts to initiate in-country live sites in our prioritised international
markets.
The unmet clinical needs are clear and ratified by national guidance, our
solutions are proven in real-world settings and with similar applicability
globally. To have two products recommended by NICE for their clinical and
financial benefit is an very significant achievement for a company of our
size.
The US represents a significant market opportunity for both our products, and
I was delighted when we received the FDA breakthrough device designation in
recognition of our MT-RNR1 ID kit being in the best interests of patients,
offering a potentially quicker and more cost effective route to the US
market. We remain on track for design and initiation of required studies and
are in discussions with FDA under the Breakthrough Device Program relating to
these. In addition, we are hopeful that the performance data generated under
the PALOH-UK (NIHR/OLS) programme will contribute significantly to clinical
evidence generation requirements of the FDA, potentially reducing or removing
the need for in-country clinical studies. It is not possible to forecast
exact timings, but our expectation is that approximately 12 months are
required for completion of these studies followed by the subsequent FDA review
period, potentially expedited under the Breakthrough Program, of 1 year.
Whilst there is a comparable CYP2C19 genotyping test which has been cleared
via the 510(k) route in the US, our CYP2C19 ID kit offers several
differentiating advantages, and as such we are actively pursuing access to the
US market via a route that otherwise would potentially be more time-consuming
and costly.
CYP2C19 recommendation from NICE differs from MT-RNR1 in that NICE recommend
CYP2C19 genotype guided prescription of clopidogrel, with our CYP2C19 ID kit
as the platform of choice for point of care strategies. Unlike MT-RNR1
assessed under the NICE EVA route for our product specifically, there is no
requirement to generate additional evidence. With a high prevalence of the
CYP2C19 genotype in patients from otherwise underrepresented ethnic groups
(c30% in the UK general population, which rises to up to 60% in certain
ethnicities ) our intervention aligns with goals to address and improve
equitable access to healthcare. Our first UK sales for CYP2C19 in the
largest hyper acute stroke centre in NHS England is testament to the emerging
"pull" from key clinical decision makers in adopting and implementing our
product in UK stroke centres.
Our CYP2C19 ID Kit is currently UKCA certified, permitting commercialisation
in the UK and we continue with the submission for CE-IVD, which will permit
similar efforts throughout Europe. UKCA is also accepted in certain Middle
Eastern countries, and we are actively pursuing opportunities for
commercialisation in advance of CE-IVD in these regions.
Lastly, the US remains an important target market for our CYP2C19 product,
with recent recommendations published by key opinion leaders in the American
Heart Association highlighting the need for CYP2C19-genotype guided
prescription of Clopidogrel in cardiovascular indications, and we will
progress the process for attaining regulatory approval there in the future.
Dr Gino Miele
Chief Executive Officer
Financial Review
Revenue and other income for the year was £0.5m (2023: £0.06m) as hospitals
begin to adopt our technology. The MT-RNR1 test is in routine use in Greater
Manchester and elsewhere and the NICE EVA evidence generation will see the
test adopted in a total of 14 sites during FY25.
Research and development costs were £4.2m (2023: £3.9m) focussing on the
near commercialisation product development, validation and verification of
CYP2C19 in preparation for regulatory approval. Administration costs were
£1.6m (2023: £1.4m) increasing due to employment costs as we enhanced our
sales and support efforts. The operating loss for the year was £5.3m (2023:
£5.2m).
Financing costs and income
Financing costs were £2.5m (2023: £0.79m) and included a non-cash fair value
adjustment in respect of the derivative financial instrument of £1.85m (2023:
£0.76m) and the transaction costs relating to the share issue of £0.57m
(2023: £nil). Financing income was consistent in both years at £0.03m
(2023: £0.03m).
Taxation
The tax credit for the year was £0.7m (2023: £0.8m). The Group investment in
R&D falls within the UK Government's R&D tax relief scheme for small
and medium sized companies where it meets the qualifying criteria and as the
Group did not make a profit in the year it is collected in cash following
submission of tax returns. The £0.7m is a receivable on the balance sheet at
the year end and is lower than in the previous year due to reductions in the
enhanced relief available from April 2023.
Cash resources
Net cash outflow from operating activities before taxation was £4.6m (2023:
£4.8m). The operating loss cashflows were £5m (2023: £4.9m) with a working
capital inflow of £0.4m (2023: £0.1m) mainly due to the movement in trade
and other payables.
The tax credit received was £0.8m (2023: £1m) and relates to cash received
under the UK Government's R&D tax relief scheme.
Capital expenditure in the period was £0.03m (2023: £0.05m) and the proceeds
from investment funding, net of transaction costs were £6.6m (2023: £2.0m).
The increase in cash for the year was £2.6m (2023: £2.0m decrease) meaning a
closing cash position of £5.2m (2023: £2.6m).
Funding
The equity fund raise announced in May 2024 provided a c.£5.4m net capital
injection prior to the year end.
During the year the Company drew down £1.2m from the Investor Placing
Agreement dated 31 March 2023, which has been fully converted into equity
resulting in a debt free balance sheet by the year end (2023: £1.3m). Further
details can be found in note 18.
The Company also continues to actively seek non-dilutive funding and
participation in the DEVOTE programme saw the Company receive c£0.2m and
avoid a further c.£1.0m of costs that would otherwise have been absorbed by
the Company for the successful validation and verification of our CYP2C19
product.
Balance sheet
Fixed assets were £0.2m (2023: £0.4m) and include right to use lease assets
of £0.02m (2023: £0.2m).
Current assets of £6.6m (2023: £4.1m) included cash of £5.2m (2023:
£2.6m). Inventories of £0.4m (2023: £0.5m), consisted mainly of finished
goods raw materials used in manufacturing and R&D. The remainder of
current asset values were in receivables of £0.4m (2023: £0.2m) and tax.
The tax receivable was £0.7m (2023: £0.8m) for the current year Corporation
Tax Research and Development tax claim.
Current liabilities were £1.4m (2023: £2.4m) and the prior year include a
derivative financial instrument of £1.3m resulting from the Investor Placing
Agreement, as set out in note 18.
The shares to be issued reserve of £0.7m (2023: £0.5m) relates to the
warrants issued as part of the Investor Placing Agreement.
Net assets closed at £5.4m (2023: £2.0m) and the movement in the accumulated
losses reserve for the year was £5.2m (2023: £5.2m).
Going concern
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 is expected to see over £0.5m of revenue commencing in November
2024.
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 first sale 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 various forecast scenarios that were considered by the Board, identify
costs mitigations that could extend the cash runway, and the Directors have
reasonable confidence in their ability to raise additional financing if
required 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.
As described in the accounting policies, we continue to adopt a going concern
basis for the preparation of the accounts, but the combination of the above
factors represent a material uncertainty that may cast significant doubt on
the Group and Company's ability to continue as a going concern.
Russ Shaw
Chief Financial Officer
Consolidated Statement of Comprehensive Income
for the year ended 30 June 2024
Note Year ended Year ended
30 June 30 June
2024 2023
£'000 £'000
Continuing operations
Revenue 2 501 55
Research and development costs (4,175) (3,924)
Administrative costs (1,638) (1,355)
Operating loss (5,312) (5,224)
Finance costs 3 (2,468) (787)
Finance income 3 30 30
Loss on ordinary activities before taxation (7,750) (5,981)
Taxation 4 675 831
Loss for the financial year (7,075) (5,150)
Loss/total comprehensive expense for the financial year (7,075) (5,150)
Loss per share (pence)
- Basic and diluted 5 (4.7p) (5.5p)
Consolidated Balance Sheet
as at 30 June 2024
Note 30 June 30 June
2024 2023
£'000 £'000
Assets
Non-current assets
Property, plant and equipment 174 392
174 392
Current assets
Inventories 381 525
Trade and other receivables 382 158
Current tax asset 675 831
Cash and cash equivalents 5,188 2,601
6,626 4,115
Total assets 6,800 4,507
Liabilities
Current liabilities
Trade and other payables (1,422) (935)
Lease liabilities (19) (222)
Derivative financial instruments 6 - (1,290)
(1,441) (2,447)
Non-current liabilities
Lease liabilities - (19)
Total liabilities (1,441) (2,466)
Net assets 5,359 2,041
Equity
Called-up equity share capital 7 8,147 1,485
Other reserves 8 54,656 52,777
Accumulated losses (57,444) (52,221)
Total equity 5,359 2,041
Consolidated Statement of Changes in Equity
for the year ended 30 June 2024
Share Other Accumulated Total
capital
reserves
equity
losses
£'000 £'000
£'000
£'000
Balance at 30 June 2022 1,388 51,294 (47,071) 5,611
Transactions with owners in their capacity as owners:
Share issue - 2 - 2
Investment funding arrangement, net of transaction costs 97 1,385 - 1,482
Equity-settled share-based payments - 96 - 96
Transactions settled directly in equity 97 1,483 - 1,580
Total comprehensive loss for the year - - (5,150) (5,150)
Balance at 30 June 2023 1,485 52,777 (52,221) 2,041
Transactions with owners in their capacity as owners:
Share issue: January 2024 4 13 - 17
Share issue: June 2024 6,000 - - 6,000
Investment funding arrangement, net of transaction costs 658 1,824 - 2,482
Equity-settled share-based payments - 42 - 42
Transactions settled directly in equity 6,662 1,879 - 8,541
Total comprehensive loss for the year - - (7,075) (7,075)
Settlement of Financial Derivative Liability 1,852 1,852
Balance at 30 June 2024 8,147 54,656 (57,444) 5,359
Consolidated Cash Flow Statement
for the year ended 30 June 2024
Note Year ended Year ended
30 June 30 June
2024 2023
£'000 £'000
Cash flows from operating activities
Operating loss for the year (5,312) (5,224)
Depreciation, amortisation and impairment 54 61
Depreciation, right-of-use assets 193 193
Share-based payment 59 96
Operating loss before changes in working capital (5,006) (4,874)
Decrease in inventories 144 223
Increase in trade and other receivables (224) (51)
Increase / (decrease) in trade and other payables 487 (59)
Net cash outflow from operating activities before taxation (4,599) (4,761)
Tax received 831 956
Net cash outflow from operating activities (3,768) (3,805)
Cash flows from investing activities
Finance income 30 29
Acquisition of plant and equipment (29) (52)
Proceeds from disposal of discontinued operations - 15
Net cash inflow / (outflow) from investing activities 1 (8)
Cash flows from financing activities
Proceeds from the investment placing agreement 6 1,200 2,300
Transaction costs relating to investment placing agreement (48) (283)
Proceeds from share issue 6,000 -
Transaction costs relating to share issue (566) -
Repayment of lease liabilities (222) (193)
Net inflow from financing activities 6,364 1,824
Net increase / (decrease) in cash equivalents 2,597 (1,989)
Effects of exchange rate changes on cash and cash equivalents (10) 1
Cash and cash equivalents at beginning of year 2,601 4,589
Cash and cash equivalents at end of year 5,188 2,601
Analysis of net funds
Cash at bank and in hand 5,188 2,601
Net cash 5,188 2,601
Notes to the Financial Information
for the year ended 30 June 2024
General information
genedrive plc ('the Company') is a company incorporated and domiciled in the
UK. The registered head office is The CTF Building, Grafton Street, Manchester
M13 9XX, United Kingdom.
genedrive plc and its subsidiaries (together, 'the Group') is a molecular
diagnostics business developing and commercialising a low-cost, rapid,
versatile, simple-to-use and robust point-of-need or point-of-care diagnostics
platform for the diagnosis of infectious diseases and for use in patient
stratification (genotyping), pathogen detection and other indications.
genedrive plc is a public limited company, whose shares are listed on the
London Stock Exchange Alternative Investment Market.
1. Significant accounting policies
The financial information for the year ended 30 June 2023 has been extracted
from the Group's audited statutory financial statements which were approved by
the Board of Directors on 28 November 2023 and which have been delivered to
the Registrar of Companies for England and Wales. The report of the auditor on
these financial statements was unqualified, did not contain a statement under
Section 498(2) or Section 498(3) of the Companies Act 2006.
The report of the auditor on the 30 June 2024 statutory financial statements
was unqualified, did not contain a statement under Section 498(2) or Section
498(3) of the Companies Act 2006, but did draw attention to the Group's
ability to continue as a going concern by way of a material uncertainty
paragraph.
The information included in this announcement has been prepared on a going
concern basis under the historical cost convention as modified by the
revaluation of financial assets and financial liabilities (including
derivative instruments) at fair value through profit or loss, and in
accordance with UK-adopted International Accounting Standards.
The information in this announcement has been extracted from the audited
statutory financial statements for the year ended 30 June 2024 and as such,
does not constitute statutory financial statements within the meaning of
section 435 of the Companies Act 2006 as it does not contain all the
information required to be disclosed in the financial statements prepared in
accordance with UK-adopted International Accounting Standards.
This announcement was approved by the board of directors on 29 November 2024
and authorised for issue via RNS.
Going concern
The Group's business activities, market conditions, principal risks and
uncertainties along with the Group's financial position are described in the
full annual accounts. The Group funds its day-to-day cash requirements from
existing cash reserves, revenue generation and other income. These matters
have been considered by the Directors in forming their assessment of 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 will see over £0.5m of revenue commencing in November 2024.
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 first sale 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 if required 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.
2. Operating segments
For internal reporting and decision-making, the Group is organised into one
segment, Diagnostics. Diagnostics is commercialising the Genedrive® point-of
need molecular testing platform. In future periods, and as revenue grows, the
Group may review management account information by type of assay and thus
split out Diagnostics into segments - however, for now, the single segment is
appropriate.
The chief operating decision-maker primarily relies on turnover and operating
loss to assess the performance of the Group and make decisions about resources
to be allocated to each segment. Geographical factors are reviewed by the
chief operating decision-maker, but as substantially all operating activities
are undertaken in the UK, geography is not a significant factor for the Group.
Accordingly, only sales have been analysed into geographical statements.
The results of the operating division of the Group are detailed below.
Business segments Diagnostics Corporate Total
segment costs £'000
£'000 £'000
Year ended 30 June 2024
Revenue 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 year (7,075)
Total comprehensive expense for the year (7,075)
Business segments Diagnostics Corporate Total
segment costs £'000
£'000 £'000
Year ended 30 June 2023
Revenue 55 - 55
Operating loss (3,869) (1,355) (5,224)
Net finance costs (757)
Loss on ordinary activities before taxation (5,981)
Taxation 831
Loss for the financial year (5,150)
Total comprehensive expense for the year (5,150)
Diagnostics Corporate Total
segment costs £'000
£'000 £'000
Year ended 30 June 2024
Segment assets 821 5,979 6,800
Segment liabilities (886) (555) (1,441)
Year ended 30 June 2023
Segment assets 960 3,547 4,507
Segment liabilities (877) (1,589) (2,466)
Additions to non-current assets: Diagnostics segment £23k (2023: £353k) and
Corporate costs £6k (2023: £88k).
Geographical segments
The Group's operations are located in the United Kingdom. The following table
provides an analysis of the Group's revenue and other income by customer
location:
All on continuing operations Year ended Year ended
30 June
30 June
2024
2023
£'000 £'000
United Kingdom 411 35
Europe 74 16
United States of America - 4
Rest of the world 16 -
501 55
Revenues from three customers accounted for more than 10% of total revenue in
the current year (2023: three).
3. Finance income and costs
Year ended Year ended
30 June
30 June
2024
2023
£'000 £'000
Interest income on bank deposits 30 30
Year ended Year ended
30 June
30 June
2024
2023
£'000 £'000
Transaction costs relating to share issue (566) -
Transaction costs relating to investment placing agreement (note 18) (38) (81)
Movement in fair value of derivative financial instrument (note 18) (1,852) (675)
Finance charge on leased assets (12) (31)
Finance costs (2,468) (787)
4. Taxation
(a) Recognised in the income statement
Current tax:
Year ended Year ended
30 June
30 June
2024
2023
£'000 £'000
Research and development tax credits (675) (831)
Total tax credit for the year (675) (831)
(b) Reconciliation of the total tax credit
The tax credit assessed on the loss for the year is lower (2023: lower) than
the weighted average applicable tax rate for the year ended 30 June 2024 of
25% (2023: 20.5%). The differences are explained below:
Year ended Year ended
30 June
30 June
2024
2023
£'000 £'000
Loss before taxation on continuing operations (7,750) (5,981)
Tax using UK corporation tax rate of 25% (2023: 20.5%) (1,938) (1,226)
Adjustment in respect of R&D tax credit claimed (61) (295)
Items (taxable) for tax purposes - permanent 603 140
Items not deductible for tax purposes - temporary (2) (2)
Deferred tax not recognised 723 686
Rate differences - (134)
Total tax credit for the year (675) (831)
No deferred tax assets are recognised at 30 June 2024 (2023: £nil). Having
reviewed future profitability in the context of trading losses carried, it is
not probable that there will be sufficient profits available to set against
brought forward losses.
The Group had trading losses, as computed for tax purposes, of approximately
£23,942k (2023: £21,676k) available to carry forward to future periods; this
excludes management expenses.
5. Earnings per share
2024 2023
£'000 £'000
Loss for the year after taxation (7,075) (5,150)
Group 2024 2023
Number Number
Weighted average number of ordinary shares in issue 151,441,746 94,165,295
Potentially dilutive ordinary shares - -
Adjusted weighted average number of ordinary shares in issue 151,441,746 94,165,295
Loss per share on continuing operations
- Basic (4.7)p (5.5)p
- Diluted (4.7)p (5.5)p
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 year.
As the Company is loss-making, no potentially dilutive options have been added
into the EPS calculation. Had the Company made a profit in the period:
Group 2024 2023
Number
Number
Potentially dilutive shares from share options and warrants 8,616,321 1,163,817
Potentially dilutive shares within the SIP 551,835 339,967
Potentially dilutive ordinary shares 9,168,156 1,503,784
6. Derivative Financial Instruments
On 31 March 2023, the Company entered into an Investor Placing Agreement for
up to £5m with RiverFort Global Opportunities PCC Limited ("Noteholders").
The instrument was entered by way of an initial drawdown in the amount of £2m
and related issuance of 6,250,000 shares priced at nominal value of 1.5 pence
to be used to facilitate the settlement of amounts advanced under the
investment agreement Further drawdowns totalling £1.5m were made and the
remaining balance as at the balance sheet date of £1.5m under the Facility is
available for the Company to drawdown, at its discretion, but subject to there
being no trading Material Adverse Change:
(a) the Share Price falling below 16 pence
(b) the 3 day average volumes traded being less than £100,000
(c) the 10 day average trading volumes being less than £100,000 and
(d) the amount outstanding under the Facility being no more than £700,000;
Any outstanding liability after the disposal by the Noteholder of the shares
issued in exchange for each drawdown can be settled at the discretion of the
Noteholder by further subscription to the Company's shares. The Company can
also elect to settle the outstanding liability with a 10% premium on the
balance. As the value of the outstanding amount is expected to move with the
Company's share price, the instrument met the definition of a derivative and
is initially recognised at fair value with changes in fair value recognised in
profit and loss.
There was no outstanding liability as at 30 June 2024 (2023: £1.29m).
Pursuant to the facility, the Noteholders were granted warrants exercisable at
1.5p to subscribe for 8,616,321 shares. All warrants remain outstanding at
30 June 2024 and can be exercised at any time from the date of issue for a
period of four years.
The warrants are initially valued using a model which utilised observable
market factors such as the share price at the date of the grant, the term of
the award, the share price volatility and the risk-free interest rate (Level 2
inputs).
The Company made drawdowns of £1.2m during the financial year (2023: £2.3m),
which has all been settled by the issue of equity and received a non-cash fair
value adjustment, which can be summarised as follows:
Derivative financial liability Finance Equity Warrants Total
£'000 costs £'000 £'000 £'000
£'000
Proceeds 615 - 1,117 568 2,300
Transaction costs - (81) (191) (91) (363)
615 (81) 926 477 1,937
Fair value movement 675
At 30 June 2023 1,290
Proceeds 947 - - 253 1,200
Transaction costs - (38) - (10) (48)
947 (38) - 243 1,152
Equity Settlement (4,091)
Fair value movement 1,854
At 30 June 2024 -
In the year to June 2023 the transaction costs include fees of £80,000
payable to the Noteholders that were settled by issue of shares and included
in share premium (note 8).
The derivative has been marked to market through profit or loss, immediately
prior to conversion, such that the time value of money on the option is
captured in the income statement.
7. Share capital
Allotted, issued and fully paid:
Number £'000
Balance at 30 June 2022 92,542,446 1,388
Share issue - equity-settled share-based payments 7,500 -
Share issue 6,500,000 97
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 543,141,481 8,147
Over the months of May and June 2024 the Company issued 400,000,000 shares as
part of a placing and open offer to shareholders for net proceeds of £5.434m.
During the year the Company issued 43,830,665 (2023: 6,500,000) shares with a
nominal value of £658,000 (2023: £97,000) as part of the Investor Placing
Agreement detailed in note 6.
8. Other reserves
Share premium account Shares to be issued Employee share incentive plan Share Reverse acquisition reserve Total equity
reserve
options reserve
£'000 £'000
£'000 £'000
£'000 £'000
Balance at 30 June 2022 52,426 - (196) 1,560 (2,496) 51,294
Investment funding arrangement (note 6) 910 477 - - - 1,387
Equity-settled share-based payments - - - 96 - 96
Transactions settled directly in equity 910 477 - 96 - 1,483
Balance at 30 June 2023 53,336 477 (196) 1,656 (2,496) 52,777
Investment funding arrangement (note 6) 1,581 243 - - - 1,824
Equity-settled share-based payments 13 - - 42 - 55
Transactions settled directly in equity 1,594 243 - 42 - 1,879
Balance at 30 June 2024 54,930 720 (196) 1,698 (2,496) 54,656
Shares to be issued relates to the warrants issued; full details are contained
in note 6.
The employee share incentive plan reserve is the historic cost of shares
purchased to satisfy share rights under the Share Investment Plan ("SIP") of
£196k. The Company no longer buys shares to satisfy the SIP.
The reverse acquisition reserve arises as a difference on consolidation under
merger accounting principles and is solely in respect of the merger of the
Company and Epistem Ltd, during the year ended 30 June 2007.
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 FR DBBDBCXDDGSIRecent 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