genedrive
plc
("genedrive" or the
"Company")
Interim results to 31
December 2023
genedrive plc (LSE: GDR), the point
of care pharmacogenetic testing company, announces unaudited
interim results for the six months to 31 December 2023.
OPERATING HIGHLIGHTS (including post period)
·
Food and Drug Administration ("FDA") progress for
the Genedrive® MT-RNR1 pharmacogenetic test (Antibiotic Induced Hearing
Loss). The Company is in advanced stages of negotiating a
collaboration with a USA-based Medical Group to support a highly
cost-effective pathway for the necessary clinical trials
·
Distributor agreement in place to support the FDA
study and support future sales in the United States
·
NIHR i4i & OLS Real World Evidence Programme
funding application to address NICE EVA evidence generation
requirements for the Genedrive®
MT-RNR1 kit, in partnership with lead partners at
Manchester University NHS Foundation Trust and 14 hospitals
throughout the UK
·
Strategic decision to sell Genedrive® MT-RNR1 kit
direct in the UK and Ireland in 2024 following addition of
increased internal sales capability
·
Royal Sussex County Hospital, Brighton adopts the
Genedrive® MT-RNR1 ID Kit for routine use and ongoing discussions
with other hospitals in the UK and Ireland with further near-term
adoption anticipated
·
Initial international sales of the Genedrive®
MT-RNR1 ID Kit received from France, Austria, Greece, Saudi Arabia,
Turkey and the Netherlands
·
UK Conformity Assessed ("UKCA") marking achieved for new Genedrive® CYP2C19
pharmacogenetic test (stroke treatment selection)
·
£1.2m (of which the Company is expected to receive
c£0.2m directly) multi-partner grant awarded and in progress for
the validation of Genedrive® CYP2C19 ID Kit in time critical NHS
settings
·
The draft NICE guidance recommends CYP2C19
genotyping for clopidogrel treatment and Genedrive® CYP2C19 ID test
modelled to be a clinically and most dominant cost-effective
option. The second consultation on the draft guidance is
scheduled to commence on 3 April 2024 and the final NICE
recommendations are expected to be published in July
2024
FINANCIAL HIGHLIGHTS
· Revenue and other income of £0.24m (H1 2022/3:
£0.02m)
· R&D spend of £1.9m (H1 2022/3: £2.0m)
· Operating loss of £2.4m (H1 2022/3: £2.7m)
· Cash
of £1.2m as at 31 December 2023 (30 June 2023: £2.6m)
· Cash
of £1.2m as at 20 March 2024 following recent receipt of R&D
tax credit of £0.8m
James Cheek, CEO of genedrive plc, commented:
"Following my
arrival in September I have seen the organisation really move
forward with our commercial enterprises and it has been encouraging
to see how we have been able to generate Genedrive®
MT-RNR1
kit sales both inside and outside the UK in such a short space of
time. As well as our commercial focus, I have also been keen to
ensure we have the right strategy for our business overall, leading
to tighter controls over costs. I said in November, that for
MT-RNR1, we would have a new UK site on board soon, sales coming in
from overseas and a distributor in place to help us move forward
with our desire to sell into the much larger USA market (subject to
FDA approval). This has all been achieved and my focus going
forward is on continuing with our MT-RNR1 sales, especially outside
of the UK, as well as building our marketing and sales for CYP2C19
in the UK. Finally, we will seek to raise further equity funding in
the coming weeks in order to provide a longer-term financing
solution for the Company's exciting growth plans. On behalf of
myself and the Board, I would like to thank our shareholders for
their support and I look forward to what I hope will be a
prosperous year."
genedrive plc
|
+44 (0)161
989 0245
|
James Cheek: CEO / Russ Shaw:
CFO
|
|
|
|
Peel
Hunt LLP (Nominated Adviser and 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
|
Anna Dunphy
|
+44
(0)7876 741 001
|
About genedrive
genedrive plc 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. This helps
clinicians to quickly access key genetic information that will help
them make the right choices over the right medicine or dosage to
use for an effective treatment. Based in the UK, the Company is at
the forefront of work on Point of Care pharmacogenetics.
Pharmacogenetics looks at how your genetics impacts a medicines
ability to work for you. Therefore, by using pharmacogenetics,
medicines can be made safer and more effective. The Company has
launched its flagship product, the Genedrive® MT-RNR1 ID Kit, which
is a single-use disposable cartridge that circumvents the
requirement for cold chain logistics by providing temperature
stable reagent test kits for use on their proprietary test
platform. This test allows clinicians to make a decision on
antibiotic use within 26 minutes; ensuring vital care is delivered
with no negative impact on the patient pathway.
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
The Company continues to make
significant steps in revolutionising the delivery of personalised
medicine, enhancing health outcomes and generating health economic
benefits. There has been a renewed focus on
our commercial team leading to changes in personnel and structure.
This has allowed us to go direct in the UK and Ireland, enhance our
digital marketing offering and increase our distributor network
worldwide.
Antibiotic Induced Hearing Loss (AIHL) - Genedrive® MT-RNR1-ID
Kit
Our MT-RNR1 ID kit is the world's
first point-of-care genetic test to reduce the risk of antibiotic
induced hearing loss ("AIHL"). Following detection of the MT-RNR1
variant an alternative antibiotic treatment can be prescribed. Our
test has the potential to save thousands of children from lifelong
hearing loss, whilst providing a net positive financial outcome
case to global healthcare systems.
In March 2023, the Genedrive®
MT-RNR1-ID Kit received a recommendation for use in the UK by the
National Institute for Health and Care Excellence ("NICE") under
its Early Value Assessment Programme ("EVA"). The EVA was
introduced to allow 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. The recommendation is conditional on further
evidence being generated and the Company is a partner with clinical
colleagues at Manchester University NHS
Foundation Trust ("MFT") who have
recently applied for funding to address the
NICE EVA evidence generation recommendations, which are required
for progressing the NICE conditional recommendation into a full
recommendation at the earliest opportunity. The NIHR i4i & OLS Real World Evidence Programme is
intended to address each eligible EVA, is being led by Office for
Life Sciences ("OLS") as part of the UK Government's Life Sciences
Vision and is backed by £10m of government funding and is expected
to commence in October 2024.
Royal Sussex County Hospital,
Brighton has adopted the Genedrive® MT-RNR1 ID Kit for routine use.
This was a significant milestone, as it's the first adopter outside
of Greater Manchester and plans are being put into place to roll
out the test in the wider Kent, Surrey and Sussex
region.
We continue to pursue all avenues to
ensure we achieve specialist commissioning before the current
timescale of April 2025. In line with specialist commissioning
being devolved to the Integrated Care Boards ("ICBs"), our initial
discussions have been with the Manchester ICB to obtain funding
from April 2024 for the live sites across the Greater Manchester
region.
In December 2023, following product
registration and language translations, the first international
sales of the Genedrive® MT-RNR1 ID Kit were achieved in France,
Austria, Greece, Saudi Arabia, Turkey and the Netherlands and we
have recently signed new distributors in Italy and the
UAE.
The Company is at advanced stages in
agreeing a partnership with a key strategic USA-based Medical Group
with broad coverage of neonatal intensive care units nationally to
progress our aim of introduction of our MT-RNR1 point of care
pharmacogenetic test to the USA (subject to regulatory
approval). If the partnership is secured it would provide the
Company with a highly cost-effective pathway for the required
regulatory studies for potentially attaining approval in the USA
which would be a key element of the use of proceeds for the
Company's proposed equity financing.
The USA is a particularly attractive
market for this unique test, given its high birth rates, use of
diagnostic testing and reimbursement structure and therefore has
the potential to save many children from life-long deafness. In
2021, 3.7m babies were born in the USA, with approximately 10.5%
born prematurely. It was estimated that malpractice litigation
settlements in cases related to deafness caused by the use of
aminoglycosides average over US$1.1m per case, further adding to
the positive health economic case of providing accurate and timely
testing to reduce unwanted side effects of gentamicin usage and
reduce potential litigation costs.
A distributor agreement is in place
with International Biomedical, Ltd. to support the FDA study and
future sales in the United States. International Biomedical
has over 45 years' experience in the design, manufacture and
distribution of neonatal and perinatal products and solutions,
covering the entire USA.
Genedrive® CYP2C19 ID
Kit
Genedrive® CYP2C19 ID Kit achieved
UKCA marking registration in September 2023. It is a point of care
pharmacogenomic test that can differentiate between patients that
could respond to clopidogrel treatment and those that will not,
allowing more effective drug treatment to be prescribed on a
personalised basis. The test can be performed at the bedside or in
a ward and can deliver a clinically actionable result in just over
one hour.
Suboptimal response to clopidogrel
following stroke is common, as reported by the NHS it is affecting
up to 30% of patients in the general population, which increases to
approximately 50%-60% in certain ethnic groups. In the UK, the
National Institute for Health and Care Excellence ("NICE")
recommended in May 2023 draft guidance that people who have had an
ischaemic stroke or transient ischaemic attack ("TIA") should have
a CYP2C19 genetic test prior to treatment. According to the World
Stroke Organization, globally there are over 77 million people
currently living who have experienced ischaemic stroke. It's
estimated by the Stoke Association that there are 100,000 strokes
in the UK each year.
The Genedrive® CYP2C19 test uses a
single, non-invasive cheek swab sample, and rapidly identifies six
important genetic variants of the CYP2C19 gene, which are
instrumental in the loss of metabolism function and poor activation
of clopidogrel in a patient. The Genedrive® system automatically
interprets the information for the clinician, allowing prompt
administration of an optimised treatment plan. Like all genedrive
products, the tests are presented in a room-temperature stable,
freeze-dried format, allowing testing to be performed by healthcare
workers, away from laboratory locations. In its performance
evaluations, the test achieved 100% accuracy in detecting the
variants that underpin loss of metabolism function.
The Development and Validation of
Technology for Time Critical Genomic Testing ("DEVOTE") grant is
providing acute care patient access and supporting infrastructure
for the Company to assess the real-world clinical performance of
time-critical clinical tests in an NHS setting. The programme, led
by the University of Manchester ("UoM"), builds on the model of the
previous successful UoM/genedrive partnership with the PALOH
programme, which supported the development and evaluation of the
Genedrive® MT-RNR1 ID Kit. The Company is expected to receive
circa £0.2m directly with the £1m balance funding the costs of a
clinical trial that would otherwise have been incurred in
full.
Our participation in the DEVOTE
programme is well underway and is generating additional performance
data in an acute care setting. This expanded dataset is required to
drive our CE-IVD submission, which will allow for subsequent
commercialisation in the EU. Submission is achievable in the
second half of 2024 once genedrive's engagement with DEVOTE has
completed. With an approximate seven-month regulatory review
process, we anticipate CE-IVD certification in early 2025.
Whilst already UKCA marked, our commercialisation efforts in the UK
will commence following successful completion of the DEVOTE
clinical performance study at end of May 2024.
In the UK, the Company will be
selling the product through its direct sales team, and momentum for
adoption is expected to be influenced by positive final NICE
recommendations for CYP2C19 testing. The draft NICE guidance
recommends CYP2C19 genotyping for clopidogrel treatment and
Genedrive® CYP2C19 ID test modelled to be a clinically and most
dominant cost-effective option. The second consultation on
the draft guidance is scheduled to commence on 3 April 2024 and the
final NICE recommendations are expected to be published in July
2024.
Antiplatelet therapies such as
Clopidogrel are recommended by NICE to prevent occlusive vascular
events for people who have had an ischaemic stroke, who have
peripheral arterial disease or multivesicular disease, or for
people who have had a myocardial infarction only if aspirin is
contraindicated or not tolerated. Other antiplatelet drugs can be
used where clopidogrel is contraindicated or not tolerated. Other
antiplatelet therapies have a higher risk of bleeding, although
equivalent efficiency if preceded by CYP2C19 genotype guided
therapy, and so in ischaemic stroke, current draft guidance from
NICE states that CYP2C19 genotyping should be conducted in advance
of Clopidogrel administration within 24 hours for ischaemic
stroke. It is likely that this pathway will be adopted for
other indications requiring clopidogrel, for example, in
cardiovascular indications.
FINANCIAL RESULTS
Revenue and other income in the
period was £0.24m (H1
2022/3: £0.02m).
Research and development costs
continued at similar levels, being £1.9m (H1 2022/3: £2.0m) as the
Company focused on near-commercialisation product
development. Administration costs
continue to be controlled at £721k (H1 2022/3: £713k). The
trading loss for the period was £2.4m (H1 2022/3: £2.7m). Finance
costs in the period of £30k (H1 2022/3: £11k).
After financing costs, the loss
before taxation was £2.4m (H1 2022/3: £2.7m loss before
taxations). The loss after taxation decreases to £2.0m (H1
2022/3: £2.2m loss after taxation) after estimating the six-month
taxation credit as £0.35m (H1 2022/3: £0.5m). The basic loss per
share was 2.0p (H1 2022/3: 2.4p basic loss per share).
Cash Resources
The operating loss for the period
was £2.4m (H1 2022/3: £2.7m) and working capital reduced by
£0.2m (H1 2022/3: £0.1m). Net cash out-flow from operations
was £2.4m (H1 2022.3: £2.4m) and as the R&D tax credit was not
received in the period the net cash flow from operating activities
was also £2.4m.
Cash flows from financing activities
consisted of lease liability repayments of £112k (H1 2022/3: £81k)
and there was £1.2m of proceeds from the Investor Placing Agreement
(H1 2022/3: £nil).
Closing cash was £1.2m (31 December
2022: £2.21m). The cash balance on 21 March 2024 was £1.2m with
£0.8m received from the R&D tax credit post period end; the
current burn rate without any material revenues and assuming
current levels of expenditure is circa £0.4m per month.
Balance Sheet
Balance sheet net assets at 31
December 2023 were £1.5m (30 June 2023: £2m; 31 December 2022:
£3.5m) and the consolidated loss of the period was £2m (H1 2022/3:
£2.2m). As at 31 December 2023 the
amount outstanding from the investor placing agreement was £1m
(30 June 2023: £1.3m) and £0.1m on 21 March 2024.
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 2023; a more detailed explanation of the risks for
the Company can be found on page 20 of the annual
report.
Going Concern
At the current burn rate, the
Company has a cash runway through May 2024. We are confident
that we will continue to gain commercial traction and securing
significant revenues, but due to the time required to achieve this,
as we have already stated, we will require additional
funding. 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. As set out above, the
Company is actively pursuing further equity funding to provide the
necessary resources to execute the Company's growth
strategy.
OUTLOOK
The Board is pleased with the
tangible progress the Group is generating, with a clear focus on
pharmacogenetic testing and the commercialisation of our two
innovative products. This fuels the Board's optimism for future
success, as we strive to generate value for our shareholders while
positively impacting individuals' lives.
The news that funding is to be made
available from the government's Office for Life Sciences via NIHR
for the real world evidence generation required by NICE for our
Genedrive® MT-RNR1 ID Kit is very welcome, affording the potential
for it to move from a conditional recommendation to a full
recommendation with NICE which would accelerate the adoption of the
test in the NHS. Genedrive is a technical partner in an
application from a consortia of 14 hospitals throughout the UK
regions, led by our clinical partners at MFT.
Our equity funding plans are being
advanced and the intention will be to raise sufficient funding to
complete the clinical trials and regulatory approval process in the
USA for the AIHL test whilst also providing sufficient funding to
cover the Company's operating costs for an appropriate period of
time. The Board intends to provide a mechanism for retail
shareholders to participate in any equity financing and a further
announcement will be made in due course.
Securing further funding is key to
the execution of our strategy as is finalising our partnership in
the USA for MT-RNR1 studies required for future de novo submission route for FDA
approval. As a direct result of our collaboration with
clinical colleagues under the DEVOTE programme for CYP2C19, we
should also achieve IVDR approval for CYP2C19 by the end of
2024/early 2025 allowing us to sell the product into Europe and
further afield. With both these products, with strong unmet need,
clear market potential and defined NICE recommendations, genedrive
has significant potential but we will also pursue new developments,
partnerships and opportunities for Pharmacogenetic testing. We
believe we are in the right place at the right time, with the right
products, with little competition in the field of point of care
pharmacogenetic testing.
James Cheek
Chief Executive Officer
Dr Ian Gilham
Chairman
28 March 2024
UNAUDITED CONSOLIDATED STATEMENT OF COMPREHENSIVE
INCOME
For the six months ended 31
December 2023
|
|
Six months
ended
|
Six months
ended
|
Year ended
|
|
|
31 December
2023
|
31 December
2022
|
30 June
2023
|
|
|
Unaudited
|
Unaudited
|
Audited
|
|
Note
|
£000
|
£000
|
£000
|
|
|
|
|
|
Revenue and other income
|
(4)
|
238
|
21
|
55
|
Research and development
costs
|
|
(1,876)
|
(1,988)
|
(3,924)
|
Administrative costs
|
|
(721)
|
(713)
|
(1,355)
|
|
|
|
|
|
Operating loss
|
(4)
|
(2,359)
|
(2,680)
|
(5,224)
|
|
|
|
|
|
Finance costs
|
(5)
|
(30)
|
(11)
|
(757)
|
|
|
|
|
|
Loss
on ordinary activities before
taxation
|
|
(2,389)
|
(2,691)
|
(5,981)
|
Taxation
|
|
350
|
500
|
831
|
Loss
for the financial period
|
|
(2,039)
|
(2,191)
|
(5,150)
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive expense for the period
|
|
(2,039)
|
(2,191)
|
(5,150)
|
|
|
|
|
|
Loss per share (pence)
|
|
|
|
|
-Basic
|
|
(2.0)p
|
(2.4)p
|
(5.5)p
|
-Diluted
|
|
(2.0)p
|
(2.4)p
|
(5.5)p
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
UNAUDITED CONSOLIDATED STATEMENT OF CHANGES IN
EQUITY
For the six months ended 31
December 2023
|
Share
Capital
(unaudited)
£000
|
Other
Reserves
(unaudited)
£000
|
Accumulated
Losses
(unaudited)
£000
|
Total
(unaudited)
£000
|
|
|
|
|
|
At
30 June 2022
|
1,388
|
51,294
|
(47,071)
|
5,611
|
Equity -settled share-based
payments
|
-
|
34
|
-
|
34
|
Transactions settled directly in
equity
|
-
|
34
|
-
|
34
|
Total comprehensive loss for the
period
|
-
|
-
|
(2,191)
|
(2,191)
|
At
31 December 2022
|
1,388
|
51,328
|
(49,262)
|
3,454
|
Share issue
|
-
|
2
|
-
|
2
|
Investment funding arrangement, net
of costs
|
97
|
1,385
|
-
|
1,482
|
Equity -settled share-based
payments
|
-
|
62
|
-
|
62
|
Transactions settled directly in
equity
|
97
|
1,449
|
-
|
1,546
|
Total comprehensive loss for the
period
|
-
|
-
|
(2,959)
|
(2,959)
|
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
|
|
|
|
|
|
|
|
|
|
|
UNAUDITED CONSOLIDATED BALANCE SHEET
As
at 31 December 2023
|
31 December
|
31 December
|
30 June
|
|
2023
|
2022
|
2023
|
|
(unaudited)
|
(unaudited)
|
(audited)
|
Note
|
£000
|
£000
|
£000
|
Non-current assets
|
|
|
|
Intangible assets
|
-
|
-
|
-
|
Plant and equipment
|
279
|
503
|
392
|
|
279
|
503
|
392
|
Current assets
|
|
|
|
Inventories
|
539
|
665
|
525
|
Trade and other
receivables
|
214
|
126
|
158
|
Current tax
asset
(6)
|
1,181
|
1,456
|
831
|
Cash and cash
equivalents
|
1,226
|
2,083
|
2,601
|
|
3,160
|
4,330
|
4,115
|
Liabilities
|
|
|
|
Current liabilities
|
|
|
|
Trade and other payables
|
(788)
|
(1,066)
|
(935)
|
Lease liabilities
|
(129)
|
(221)
|
(222)
|
Derivative financial
instruments
|
(1,016)
|
-
|
(1,290)
|
|
(1,933)
|
(1,287)
|
(2,447)
|
Non-current liabilities
|
|
|
|
Lease liabilities
|
-
|
(92)
|
(19)
|
Total liabilities
|
(1,933)
|
(92)
|
(2,466)
|
|
|
|
|
Net
assets
|
1,506
|
3,454
|
2,041
|
|
|
|
|
Capital and reserves
|
|
|
|
Called-up equity share
capital
(8)
|
1,836
|
1,388
|
1,485
|
Other
reserves
(9)
|
53,930
|
51,328
|
52,777
|
Accumulated losses
|
(54,260)
|
(49,262)
|
(52,221)
|
Total shareholder equity
|
1,506
|
3,454
|
2,041
|
|
|
|
|
UNAUDITED CONSOLIDATED CASH FLOW
STATEMENT
For the six months ended 31
December 2023
|
31 December
2023
(unaudited)
|
31 December
2022
(unaudited)
|
30 June
2023
(audited)
|
|
|
|
|
£'000
|
£'000
|
£'000
|
Cash
flows from operating activities
|
|
|
|
Operating loss for the
period
|
(2,359)
|
(2,680)
|
(5,224)
|
Depreciation and amortisation on
non-leased assets
|
28
|
32
|
61
|
Depreciation on right-of-use
assets
|
90
|
81
|
193
|
Share - based payment
|
40
|
34
|
96
|
Operating loss before changes in working capital and
provisions
|
(2,201)
|
(2,533)
|
(4,874)
|
Increase/ (decrease) in
inventories
|
(14)
|
83
|
223
|
(Increase)/ decrease in trade and
other receivables
|
(56)
|
(19)
|
(51)
|
Decrease/ (increase) in trade and
other payables
|
(147)
|
62
|
(59)
|
Net cash outflow from
operations
|
(2,418)
|
(2,407)
|
(4,761)
|
Tax received
|
-
|
-
|
956
|
Net
cash outflow from operating activities
|
(2,418)
|
(2,407)
|
(3,805)
|
Cash
flows from investing activities
|
|
|
|
Finance income
|
18
|
5
|
29
|
Finance costs
|
(10)
|
(16)
|
-
|
Proceeds from disposal of
discontinued operations
|
-
|
14
|
15
|
Acquisition of plant and equipment
and intangible assets
|
(5)
|
(21)
|
(52)
|
Net
cash inflow/ (outflow) from investing activities
|
3
|
(18)
|
(8)
|
Cash
flows from financing activities
|
|
|
|
Proceeds from the investment placing
agreement
|
1,200
|
-
|
2,300
|
Transaction costs relating to
investment placing agreement
|
(48)
|
|
(283)
|
Repayment of lease
liabilities
|
(112)
|
(81)
|
(193)
|
Net
inflow/ (outflow) from financing activities
|
1,040
|
(81)
|
1,824
|
Net decrease in cash
equivalents
|
(1,375)
|
(2,506)
|
(1,989)
|
Effects of exchange rate changes on
cash and cash equivalents
|
-
|
-
|
1
|
Cash and cash equivalents at
beginning of period
|
2,601
|
4,589
|
4,589
|
Cash and cash equivalents at end of
period
|
1,226
|
2,083
|
2,601
|
Analysis of net funds
|
|
|
|
Cash at bank and in hand
|
1,226
|
2,083
|
2,601
|
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 limited
liability 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 AIM.
The financial information for the
period ended 31 December 2023 and similarly the period ended 31
December 2022 has been neither audited nor reviewed by the auditor.
The financial information for the year ended 30 June 2023 has been
based on information in the audited financial statements for that
period. The interim financial statements for the period ended 31
December 2023 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 2023 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 28 March
2024.
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 2023 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 2024.
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 during the period to June 2025. The Group and
Company does not currently have sufficient cash resources to
continue as a going concern during the forecast period due to the
time expected to be needed to gain commercial traction in its
revenues. Therefore, the Company will need to raise further
equity, or other funding, in the near term in order to continue as
a going concern. The forecasts prepared by the Directors
include a plan to raise additional funds from equity investors or
debt providers to allow the Company to continue as a going
concern.
The Company is confident that given
the health benefits and economics that RNR1 will be a commercial
success. The NICE EVA (Early Value Assessment) recommendation is
testimony to it. Our CYP2C19 product is at validation and
verification stage and has a much larger potential market than RNR1
with a far less complex route to market. The Company recognises the
uncertainty regarding the timing of the associated revenues, given
we are first to market for RNR1 and the funding complexities within
the NHS. NICE recommendations and Specialist Commissioning
will bring significant upside to our sales forecasts, but they are
outside of our control and are therefore uncertain. The
Directors have reasonable confidence in their ability to raise
additional funds given the progress described above and having made
enquiries, have a reasonable expectation that the Group has access
to adequate resources to continue in operational existence for the
foreseeable future.
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
Revenue is measured at the fair
value of the consideration received or receivable and net of
discounts and sales-related taxes.
4.
Operating segments
|
|
|
Diagnostic
Segment
|
Administrative
Costs
|
Total
|
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
Loss for the financial
|
|
|
|
|
350
|
Loss
for the financial period
|
|
|
|
|
(2,039)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diagnostic
Segment
|
Administrative
Costs
|
Total
|
Six
months ended 31 December 2022
|
|
|
£'000
|
£'000
|
£'000
|
Revenue and other income
|
|
|
21
|
-
|
21
|
Operating loss
|
|
|
(1,967)
|
(713)
|
(2,680)
|
Net Finance costs
|
|
|
|
|
(11)
|
Loss
on ordinary activities before taxation
|
|
|
|
|
(2,691)
|
Taxation
Loss for the financial
|
|
|
|
|
500
|
Loss
for the financial period
|
|
|
|
|
(2,191)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diagnostic
Segment
|
Administrative
Costs
|
Total
|
Twelve months ended 30 June 2023
|
|
|
£'000
|
£'000
|
£'000
|
Revenue and other income
|
|
|
55
|
-
|
55
|
Operating loss
|
|
|
(3,869)
|
(1,355)
|
(5,224)
|
Net Finance costs
|
|
|
|
|
(757)
|
Loss
on ordinary activities before taxation
|
|
|
|
|
(5,981)
|
Taxation
Loss for the financial
|
|
|
|
|
831
|
Loss
for the financial period
|
|
|
|
|
(5,150)
|
5.
Net Finance costs
|
31 December
December
|
31 December
December
|
30 June
|
|
2023
|
2022
|
2023
|
|
£000
|
£000
|
£000
|
|
|
|
|
Net interest income on bank
deposits
|
18
|
5
|
30
|
Transaction costs relating to
investment placing agreement
|
(40)
|
-
|
(81)
|
Movement in fair value of derivative
financial instrument
|
-
|
-
|
(675)
|
Finance lease interest
costs
|
(8)
|
(16)
|
(31)
|
|
(30)
|
(11)
|
(757)
|
6.
Current tax asset
The current tax asset relates to tax
owing under the R&D tax credit scheme of £1.2m (H1 2022/3:
£1.5m). A payment of £0.8m was received in March 2024.
The remaining £0.4m is an estimate of the tax credit for the
interim period to December 2023 and this will be received following
submission of the tax returns for the 12 months to June 2024, with
receipt expected to be in the first quarter of 2025.
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 103,900,492
(H1 2022/3: 92,542,446). Potentially dilutive options, after
proceeds from conversion, add no shares to basic weighted average
number of shares in issue (H1 2022/3: 40,342).
8.
Share capital
Allotted, issued and fully
paid:
|
|
No
|
£'000
|
Balance at 30 June 2022 and 31 December 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
|
|
23,390,000
|
351
|
Balance at 31 December 2023
|
|
122,439,946
|
1,836
|
|
|
|
|
During the financial period the
Company issued 23,390,000 shares in genedrive plc as part of the
Investor Placing Agreement entered into on 31 March
2023.
9. Other Reserves
|
Share Premium
Account
£000
|
Shares to be
issued
£000
|
Employee Share Incentive Plan
Reserve
£000
|
Share Options
Reserve
£000
|
Reverse Acquisitions
Reserve
£000
|
Total
£000
|
|
|
|
|
|
|
|
|
|
|
At
30 June 2022
|
52,426
|
-
|
(196)
|
1,560
|
(2,496)
|
51,294
|
Equity settled share-based
payments
|
-
|
-
|
-
|
34
|
-
|
34
|
At
31 December 2022
|
52,426
|
-
|
(196)
|
1,594
|
(2,496)
|
51,328
|
Investment funding
arrangement
|
910
|
477
|
-
|
-
|
-
|
1,387
|
Share issue
|
-
|
-
|
-
|
-
|
-
|
-
|
Equity settled share-based
payments
|
-
|
-
|
-
|
62
|
-
|
62
|
At
30 June 2023
|
53,336
|
477
|
(196)
|
1,656
|
(2,496)
|
52,777
|
Investment funding
arrangement
|
916
|
197
|
-
|
-
|
-
|
1,113
|
Share issue
|
-
|
-
|
-
|
-
|
-
|
-
|
Equity settled share-based
payments
|
-
|
-
|
-
|
40
|
-
|
40
|
At
31 December 2023
|
54,252
|
674
|
(196)
|
1,696
|
(2,496)
|
53,390
|
|
|
|
|
|
|
|
|
|
|
|