REG - GENinCode PLC - Half-year report
27/09/2022 07:00
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RNS Number : 7126A GENinCode PLC 27 September 2022
GENinCode Plc
("GENinCode" or the "Company")
Interim results for six months ended 30 June 2022
Oxford, UK. GENinCode Plc (AIM: GENI), the predictive genetics company focused
on the prevention of cardiovascular disease ("CVD"), announces its unaudited
interim results for the six months ended 30 June 2022. The first half of the
2022 saw GENinCode advance its US and UK commercial programmes for the
introduction of its lead products whilst continuing to strengthen and increase
revenues in its EU business.
Operational highlights (including post-period end)
· Filing of FDA Pre-Submission for Cardio inCode® (Cardiovascular
Disease Genetic Risk Score) for the onset of cardiovascular disease.
Progressive discussions with the FDA in advance of the forthcoming 510K
regulatory submission. The submission is expected to be filed with the FDA
over the coming weeks.
· Commissioning of GENinCode US CLIA lab (Clinical Laboratory
Improvement Amendments) facility in Irvine, California. The CLIA lab
application has now been submitted for Cardio inCode®. The Company is
accelerating the set-up of Lipid inCode® as a US lab diagnostic test (LDT)
for the diagnosis of familial hypercholesterolemia (FH).
· Preparation for roll-out of the Company's US Early Access Programs
(EAPs) with its commercial partner EVERSANA Life Sciences LLC ("EVERSANA") to
provide access to Cardio inCode® and Lipid inCode®. First US product
revenues are anticipated in 2023.
· Indiana University collaboration representing flagship facilities in
preparation for introduction of Cardio inCode® to US market.
· Expansion of the research collaboration with Kaiser Permanente,
California to assess Cardio inCode® for the polygenic risk assessment of CVD.
· Milestone statement by American Heart Association (AHA) on the
importance of Polygenic Risk Scores for future risk assessment of
cardiovascular disease.
· Collaboration with BUPA Cromwell Hospital, London for use of the
Lipid inCode® test for FH and generation of first UK product revenues.
· Successful completion and publication of Lipid inCode® NHS clinical
study to improve diagnosis and turnaround time for testing of Familial
Hypercholesterolemia (FH) at reduced cost to the NHS.
· NHS implementation of Lipid inCode® with North East and Cumbria -
Academic Health Science Network (NENC-AHSN) to diagnose FH - this represents
the first commercial polygenic risk CVD test to be implemented by the NHS.
· Completion of first COVID-19 Thrombo inCode® evaluation study for
genetic predisposition to thrombosis - St Pau Hospital, Spain.
Financial highlights
· Revenues increased 11% to £0.7m (2021: £0.6m).
· Adjusted EBITDA loss of £2.3m (2021: loss of £1.0m).
- Increased levels of investment in preparation for the launch of
Lipid inCode® and Cardio inCode®.
· Cash of £12.4m at 30 June 2022 (2021: £1.0m).
- Reflecting the £15.3m of cash, net of expenses, raised at the IPO
in July 2021 and tight cost control over the past year.
Recent developments
The Company also announces today:
· First Cardio inCode® pilot implementation study in the Spanish
region of Extremadura.
· Acquisition of Abcodia Limited, Cambridge and its globally leading
algorithmic technology for the Risk Assessment of Ovarian Cancer Algorithm
(ROCA) test.
· Commissioning of new UK lab operation and UKAS accreditation
submission for Lipid inCode(®) to support the NHS implementation in
NENC-AHSN.
Outlook for second half of 2022
GENinCode continues to advance its US 'soft launch' preparations for Cardio
inCode(®) and Lipid inCode(®) via the roll-out of Early Access Programs (s)
supported by the Company's new US CLIA lab facility in California. The Company
remains focused on its US regulatory and reimbursement submissions for Cardio
inCode(®) and will take advantage of existing reimbursement coverage for its
globally leading familial hypercholesterolemia (FH) test Lipid inCode(®).
Over the remainder of this financial year, the Company expects to complete the
following key deliverables:
· Finalise and file FDA regulatory submission for Cardio inCode(®).
· Advance Cardio inCode(®) clinical utility programmes to support
reimbursement submissions planned in 2023.
· Based on CMS local coverage determination and private payer
reimbursement for FH, initiate the first US Early Access Programs/Physician
Experience Programs for Lipid inCode(®).
· Strengthen the EVERSANA commercial, marketing and selling team in
readiness for US product launch preparations.
· Gain CLIA lab certification for Cardio inCode(®) and accelerate
Lipid inCode(®) lab diagnostic test (LDT) service offering.
· Commence first NHS (NENC-AHSN) patient tests as part of NHS
implementation of Lipid inCode(®) and roll-out FH testing with the NHS via
AHSN networks.
· Advance COVID-19 Thrombo inCode(®) evaluation studies for genetic
predisposition to thrombosis.
· Continue to build our EU partnerships and develop our ongoing
collaborative discussions with pharmaceutical companies.
· Increased Year-on-Year revenue growth.
Matthew Walls, Chief Executive Officer of GENinCode Plc said: "We are
delivering on the plans set out at the IPO, with specific focus on the US
approval, launch and revenue growth of Cardio inCode® and Lipid inCode®. We
are working closely with our US partner collaborators on launch planning and
advancing our Early Access Programs prior to commencing sales in 2023. We have
built a constructive dialogue with the FDA in preparation for our 510k
regulatory filing.
"The commercialisation of Lipid inCode® continues to progress. Familial
(inherited) Hypercholesterolemia (FH) is a key priority to address prevention
of CVD in both the US and UK, and as such we are accelerating the US launch of
Lipid inCode® to seize this opportunity in the space. The Lipid inCode® test
has become the first polygenic test for CVD to be implemented by the UK NHS
following the successful NHS clinical study announced earlier this year.
"We are also announcing today the acquisition of Abcodia Limited, Cambridge,
and its Risk of Ovarian Cancer Algorithm (ROCA) test and technology,
representing our first step into the oncology market. We will provide a
further update on the Abcodia acquisition and the ROCA product and technology
over the short term."
Analyst meeting, 12.30pm today
The Company will hold an analyst meeting 12.30pm (BST) on Tuesday, 27
September. Matthew Walls, CEO and Paul Foulger, CFO will host an in-person
analyst meeting at the offices of Stifel at 150 Cheapside, London, EC2V 6ET to
discuss the financial results and key topics including business strategy,
partnerships, regulatory and reimbursement processes. Analysts interested in
attending should contact Walbrook PR by emailing genincode@walbrookpr.com or
calling 020 7933 8780.
Investor presentation, 4.30 pm today
The Company will also host a presentation for investors via the IMC platform
at 4.30 pm BST on Tuesday, 27 September. The presentation is open to all
existing and potential shareholders. Questions can be submitted pre-event via
your Investor Meet Company dashboard up until 9am the day before the meeting
or at any time during the live presentation. To register for this, please use
the following link:
https://www.investormeetcompany.com/genincode-plc/register-investor
(https://www.investormeetcompany.com/genincode-plc/register-investor)
For more information visit www.genincode.com (http://www.genincode.com)
GENinCode Plc www.genincode.com (http://www.genincode.com) or via Walbrook PR
Matthew Walls, CEO
Paul Foulger, CFO
Stifel Nicolaus Europe Limited (Nomad and Joint Broker) Tel: +44 (0)20 7710 7600
Alex Price / Ben Maddison / Richard Short
Cenkos Securities Plc (Joint Broker) Tel: +44 (0)20 7397 8900
Giles Balleny
Dale Bellis / Michael Johnson (Sales)
Walbrook PR Limited Tel: 020 7933 8780 or
Anna Dunphy / Louis Ashe-Jepson / Phillip Marriage genincode@walbrookpr.com
About GENinCode
GENinCode Plc is a UK based company specialising in genetic risk assessment of
cardiovascular disease. Cardiovascular disease is the leading cause of death
and disability worldwide.
GENinCode operates business units in the UK, in the United States through
GENinCode U.S. Inc and in Europe through GENinCode S.L.U.
GENinCode predictive technology provides patients and physicians with globally
leading preventative care and treatment strategies. GENinCode CE marked
invitro-diagnostic molecular tests combine clinical algorithms and
bioinformatics to provide advanced patient risk assessment to predict disease
onset.
About Cardiovascular Disease
Cardiovascular disease (CVD) is the leading cause of death globally, taking an
estimated 17.9 million lives each year. CVD is a group of disorders of the
heart and blood vessels and include coronary heart disease, cerebrovascular
disease, rheumatic heart disease and other conditions. More than four out of
five CVD deaths are due to heart attacks and strokes, and one third of these
deaths occur prematurely in people under 70 years of age.
The most important behavioural risk factors of heart disease and stroke are
unhealthy diet, physical inactivity, tobacco use and harmful use of alcohol.
The effects of behavioural risk factors may show up in individuals as raised
blood pressure, raised blood glucose, raised blood lipids, and overweight and
obesity. These "intermediate risks factors" can be measured in primary care
facilities and indicate an increased risk of heart attack, stroke, heart
failure and other complications.
Cessation of tobacco use, reduction of salt in the diet, eating more fruit and
vegetables, regular physical activity and avoiding harmful use of alcohol have
been shown to reduce the risk of cardiovascular disease. Health policies that
create conducive environments for making healthy choices affordable and
available are essential for motivating people to adopt and sustain healthy
behaviours.
Identifying those at highest risk of CVDs and ensuring they receive
appropriate treatment can prevent premature deaths. Access to noncommunicable
disease medicines and basic health technologies in all primary health care
facilities is essential to ensure that those in need receive treatment and
counselling.
CVD causes a quarter of all deaths in the UK and is the largest cause of
premature mortality in deprived areas and is the single biggest area where the
NHS can save lives over the next 10 years. CVD is largely preventable, through
lifestyle changes and a combination of public health and NHS action on smoking
and tobacco addiction, obesity, tackling alcohol misuse and food
reformulation.
Genetic risk assessment can help early detection and treatment of CVD to help
patients live longer, healthier lives. Many people are still living with
undetected, high-risk conditions such as high blood pressure, raised
cholesterol, and atrial fibrillation (AF). Progress continues in the NHS to
identify and diagnose people routinely knowing their 'ABC' (testing and
monitoring of AF, Blood pressure and Cholesterol) set out in the NHS 10 Year
plan.
GENinCode Plc
Chief Executive's Statement
For the six months ended 30 June 2022
Introduction
On behalf of the Board, I am delighted to present the interim report for the
six-month period ended 30 June 2022 for GENinCode Plc.
Following the IPO in July 2021, this statement provides an introduction to
GENinCode, a summary of progress over the first half of the 2022 financial
year and the outlook for the year ahead.
Introduction
GENinCode is engaged in the risk assessment, prediction, and prevention of
cardiovascular disease (CVD). Our polygenic products and technology have been
developed with the aim of prognosing and predicting the onset of CVD to
deliver personalised treatment to improve patient outcomes. CVD accounts for
around 18 million deaths annually, representing approximately 31 per cent. of
all deaths worldwide with the global cost of CVD estimated to reach
approximately $1.04 trillion by 2030.
CVD encompasses all conditions linked to the heart and blood vessels and is
currently the leading cause of death globally. Four out of five deaths related
to CVD are a result of heart attacks and strokes, and one third of these
deaths occur prematurely in people under the age of 70. There are
approximately 550 million people living with heart and circulatory diseases
worldwide. This number has been rising due to changing lifestyles, ageing, and
a growing population and improved survival rates from heart attacks and
strokes.
In the US, CVD affects over 85 million people and accounts for more than
one-third of all deaths. Common characteristics which put individuals at risk
of CVD include raised blood pressure and high cholesterol levels, as well as
obesity, lack of exercise and the co-occurrence of other diseases such as
diabetes. Approximately 655,000 people in the US die from CVD each year, with
coronary artery disease and heart attacks the most common.
The Company was incorporated in September 2018 to acquire the assets,
intellectual property, and know-how of the Ferrer inCode and Gendiag.exe
businesses, part of Grupo Ferrer Internacional S.A., a large Spanish
multinational private pharmaceutical and healthcare company. The technology
and products acquired included Cardio inCode(®), Lipid inCode(®), Thrombo
inCode(®) and Sudd inCode(®). Over €50 million has been invested in the
research and development of these products since 2007. The Company has begun
to commercialise these products in Europe and is now targeting the UK and US.
Multiple studies have shown that an individual's genetic load contributes
between 40 to 50 per cent. to the development of CVD, highlighting genetics as
one of the most significant contributing factors to the onset of
cardiovascular disease.
The Company's product portfolio draws on advanced genomic precision testing
using polygenic (multiple genes) technology, molecular testing, genotyping,
sequencing, and AI bioinformatics to risk assess patient DNA. Through a simple
blood or saliva sample, the Company can analyse the genetic variants and
medical information associated with CVD to determine a patient's Genetic Risk
Score (GRS) which is used to assess a patient's cardiovascular risk.
The current standard of care for primary prevention and assessment of the risk
of CVD has been in use and largely unchanged for many years. Our polygenic
risk assessment products for CVD are able to identify, risk assess and
reclassify individuals traditionally categorised at 'low' or 'intermediate'
risk who are in fact at a higher genetic risk of a CVD event (e.g. myocardial
infarction/heart attack) than their current standard of care risk assessment
suggests. This enables earlier in life preventative measures to be adopted to
lower the future risk of a CVD event.
GENinCode has a strong and growing clinical evidence base, granted
intellectual property portfolio with a vision to advance CVD risk assessment
to more precisely align therapeutic treatment and lifestyle choices to improve
patient outcomes.
Our products have commenced revenue generation in Europe. In July 2021 we
successfully completed our admission to AIM and raised £15.3m net of expenses
to accelerate business growth and internationally expand our commercial
program.
Business review
Whilst the post-COVID markets and global economy remains challenging, our EU
business strengthened over the first half with revenues increasing to £664k
(H1 2021 £600k). The first half sales growth net of increased operating costs
gave rise to an adjusted EBITDA loss of (£2.27m) (H1 2021: (£0.98m)),
reflecting the growth in commercial investment across the group.
The first half saw the continued progress with the US Food and Drug
Administration (FDA) following the Pre-Submission of Cardio inCode®
(Cardiovascular Disease Genetic Risk Score) for the onset of cardiovascular
disease. Productive discussions were held with the FDA earlier in the year and
we are now preparing our final 510K regulatory submission. We expect the
submission to be filed with the FDA over the coming weeks.
We have commenced set up of the GENinCode US CLIA lab (Clinical Laboratory
Improvement Amendments) facility in Irvine, California, with the CLIA lab
application now submitted for Cardio inCode®. The CLIA lab is regulated by
the FDA, Center for Medicaid Services (CMS) and Centers for Disease Control
(CDC). Based on recent developments by the CDC to lift the genetic status for
familial hypercholesterolemia (FH) in US public health, we have accelerated
the set-up of our Lipid inCode® product as a US lab diagnostic test (LDT) for
the diagnosis of FH.
We are working with our US commercial partner EVERSANA to prepare for the
roll-out of our US Early Access Programs (EAPs) enabling selected physicians
to access our Cardio inCode® and Lipid inCode® products. The EAP's will
allow the initial 'soft launch' i.e. free of charge access, to our lead
products with the start of US product revenues anticipated in 2023.
Over the first half we announced our collaboration with Indiana University
(IU) School of Medicine, the largest US medical school, in preparation for the
introduction of Cardio inCode® to US market. The program with IU will include
testing Cardio inCode® alongside CT imaging. The first half also saw the
announcement of the expansion of our research collaboration with Kaiser
Permanente, California, to assess Cardio inCode® for the polygenic risk
assessment of CVD. We have collaborated with Kaiser Permanente since 2014 and
the ongoing Kaiser clinical studies are instrumental to growing our US
population evidence base for Cardio inCode®.
There have recently been some significant genetic advances in US health
policies with a milestone statement by American Heart Association (AHA) on the
importance of Polygenic Risk Scores for future risk assessment of
cardiovascular disease. We expect to see continued support for the wider
introduction of polygenic risk assessment products and technology for
cardiovascular disease risk assessment.
In the UK, we announced a collaboration with BUPA Cromwell Hospital, London
for use of our Lipid inCode® test for FH leading to the generation of our
first UK product revenues. In the NHS we successfully completed and published
our first Lipid inCode® NHS clinical study to improve diagnosis, turnaround
time for testing of Familial Hypercholesterolemia (FH) at reduced cost to the
NHS. Following the NHS publication, we announced the NHS implementation of
Lipid inCode® with North East and Cumbria - Academic Health Science Network
(NENC-AHSN). The Lipid inCode® implementation represents the first commercial
polygenic risk CVD test to be adopted by the NHS. We have also recently
completed the commissioning of our new lab based in London and submitted our
UKAS accreditation application for Lipid inCode(®) to support the NHS.
We recently announced the completion of our first COVID-19 Thrombo inCode®
evaluation study for patients with a genetic predisposition to thrombosis - St
Pau Hospital, Spain. We are continuing to clinically assess the impact of
thrombosis in the escalation of severe COVID-19 and expect to provide a
further update later this year.
We have also recently announced the first Cardio inCode® pilot implementation
study in the Spanish region of Extremadura. The Extremadura region has a
population of ~ 1 million, with an estimated 50,000 individuals at risk of a
cardiovascular event, e.g. heart attack. Cardio inCode® is expected to change
clinical practice by identifying those individuals at high genetic risk and
improve preventative treatment. Successful completion of the pilot in over 500
individuals will lead to extension of the programme across the Extramadura
region.
We are also announcing in today's interim report the acquisition of the entire
issued share capital Abcodia Limited, Cambridge, and its Risk of Ovarian
Cancer Algorithm (ROCA) test and technology. Based on a proven risk prediction
of ovarian cancer and growing clinical evidence, we believe the ROCA test is
the world's most accurate test for the early detection of familial ovarian
cancer in BRCA+ genetically predisposed women. The ROCA test has been
developed by the Abcodia team along with their NHS and US partners over the
past 10 years and has recently completed its product development and EU
regulatory approval. The ROCA test is poised to engage commercially in the UK,
US and Europe and brings a breakthrough in monitoring for women at risk of
ovarian cancer. Its algorithmic prediction of disease risk provides an
exciting adjunct to our portfolio of risk prediction products for
cardiovascular disease and represents our first step into the oncology market.
Abcodia has been acquired with no upfront consideration on an earnout basis
with a maximum payment of £1m to its institutional, VCT, university research
and high net worth individual shareholders. The earnout is payable over a 6
Year earnout period up to the 31 July 2028 and is based on the ROCA test
generating annual UK based EBIT of up to £1m (based on meeting two
consecutive target EBITs of £350k and £650k respectively). Once each
consecutive EBIT target has been achieved, a subsequent earnout payment of
£350k and £650k respectively will be paid out of the Company's cash
resources at the relevant time. Abcodia generated a loss before tax of £0.60m
for the 12 months to 30 June 2022.
We will provide a further update on the Abcodia acquisition and the ROCA
product and technology over the short term.
We have cash reserves of £12.4m at 30 June 2022 (2021: £1.0m) reflecting the
£15.3m of cash, net of expenses, raised at the IPO in July 2021. We continue
to maintain tight control over our investments commensurate with growth.
Financial review
Despite the continuing challenges of the COVID-19 pandemic, coupled with the
deteriorating global economy, our EU revenues held up well with solid first
half revenue growth to £664k (H1 2021: £600k). In summary, sales advanced to
£664k with an adjusted EBITDA loss of (£2.27m) (H1 2021: (£0.98m)), the
increased loss resulting from higher commercial and scale-up investment across
the Group as we prepare to commercially expand in our core US, UK and EU
growth markets.
Revenue
Revenue for the period was £664k (H1 2021: £600k), an increase of 10.7%.
Spain continues to be the largest region for sales, followed by Italy and
France. We reported our first sales in the UK (£12k), following the
successful results announced for Lipid inCode® at the beginning of the year.
Gross profit
Gross profit was £283k (H1 2021: £320k). The gross profit margin decreased
to 43% (H1 2021: 53%) due in part to pricing pressure for raw materials and
increased contracted service provider costs.
Administrative expenses
In H1 2022, administrative expenses increased to £2.65m (H1 2021: £1.33m).
The increase was largely caused by a) an increase in US commercialisation fees
payable to EVERSANA (H1 2022: £790k v.s. H1 2021: £72k), and b) an increase
in salary costs (H1 2022: £947k v.s. H1 2021: £613k), due to an increased
headcount across the Group.
Operating loss and adjusted earnings before interest tax and depreciation
The Group generated an operating loss of £2.32m (H1 2021: (£1.01m)). We
consider a more meaningful measure of underlying performance is obtained by
examining adjusted EBITDA, which for H1 2022 was a loss of £2.27m (H1 2021:
(£978k)). This excludes the effects of share-based payments of £57k (H1
2021: £17k). The increase in operating loss and adjusted EBITDA is caused by
the increase in administrative expenses, resulting from the increased
investment in personnel and other infrastructure costs in advance of the
intended commercialisation expansion in the US, the EU, and the UK.
Tax
There is a tax charge of £4k (H1 2021: nil).
Fixed assets
We have capitalised, net of depreciation, a total of £193k (H1 2021: £9k) of
property plant and equipment, reflecting investment in equipment required to
fit out the UK laboratory. Additionally, we have capitalised, net of
amortisation, £176k of intangible assets (H1 2021: £176k). This related to
the application of new patents in various geographical regions which we
believe will enhance the value of the business.
Cash and working capital
The cash position at 30 June 2022 was £12.40m (30 Jun 2021: £0.98m),
reflecting the £15.3m of cash, net of expenses, raised at the time of the IPO
in July 2021.
Capital structure
As at 30 June 2022, the Group had 95,816,866 shares in issue. No shares have
been issued during the period.
Outlook for second half of 2022
GENinCode continues to advance its US 'soft launch' preparations for Cardio
inCode(®) and Lipid inCode(®) via the roll-out of Early Access Programs
(EAPs) supported by the Company's new US CLIA lab facility in California. The
Company remains focused on our US regulatory and reimbursement submissions for
Cardio inCode(®) and will take advantage of the existing reimbursement
coverage for Familial Hypercholesterolemia (FH) testing by accelerating the
set-up of Lipid inCode(®), our globally leading FH test.
Over the remainder of this financial year, the Company expects to complete the
following key deliverables:
· Finalisation and filing of FDA 510K regulatory submission for Cardio
inCode(®).
· Advance Cardio inCode(®) clinical utility programs to support our
reimbursement submissions planned in 2023.
· Based on CMS local coverage determination and private payer
reimbursement for FH, initiate the first US Early Access Programs (EAPs) for
Lipid inCode(®).
· Strengthen the EVERSANA commercial, marketing and selling team in
readiness for US product launch.
· Gain CLIA lab certification for Cardio inCode(®) and accelerate
Lipid inCode(®) lab diagnostic test (LDT) service offering.
· Commence first NHS (NENC-AHSN) patient tests as part of the NHS
implementation of Lipid inCode(®) and roll-out FH testing with the NHS via
AHSN networks.
· Advance COVID-19 Thrombo inCode(®) evaluation studies for genetic
predisposition to thrombosis.
· Continue to build our EU partnerships and develop our ongoing
collaborative discussions with pharmaceutical companies.
· Implementation of the Cardio inCode® pilot in Extremadura, Spain.
· Increased Year-on-Year revenue growth.
We continue to deliver the plans set out at the IPO last year with specific
focus on our US product launch and growth of Cardio inCode® for the
prevention of cardiovascular disease. Based on the US Centres for Disease
Control (CDC) escalation of Familial Hypercholesterolemia (FH) genetic testing
to a Tier 1 public health status, we will accelerate our launch plans for
Lipid inCode® for the management of FH.
We are working closely with our US partner collaborators on launch planning
and advancing our Early Access Programs prior to anticipated sales in 2023. We
have built a constructive dialogue with the FDA in preparation for our 510K
regulatory filing for Cardio inCode®.
In the UK, following the successful NHS clinical studies and pilot programme
we are now implementing Lipid inCode® (familial hypercholesterolemia testing)
in the North of England NENC-AHSN. We continue to strengthen our EU business
and anticipate continued year-on-year revenue growth in in the second half of
2022.
Following today's announcement of the acquisition of Abcodia Limited,
Cambridge, and its Risk of Ovarian Cancer Algorithm (ROCA) test and
technology, we are preparing plans to accelerate revenues for the ROCA product
in the UK and for market entry in the US and EU.
Matthew Walls
Chief Executive Officer
27 September 2022
GENinCode Plc
Consolidated Statement of Comprehensive Income
For the six months ended 30 June 2022
Unaudited Unaudited Audited
6 months to 6 months to Year ended
Notes 30-Jun 30-Jun 31-Dec-21
2022 2021
£'000 £'000 £'000
Continuing operations
Revenue 664 600 1,154
Cost of sales (381) (280) (561)
Gross profit 283 320 593
Administrative expenses (2,556) (1,298) (4,019)
ADJUSTED EBITDA (2,273) (978) (3,426)
Depreciation and amortisation (33) (15) (35)
Loss on disposal of fixed assets - - (19)
Share-based payments (56) (17) (73)
Listing costs - - (584)
Non-recurring expenditure - - (9)
Operating Loss (2,362) (1,010) (4,146)
Finance Income 38 - 10
Loss on ordinary activities before taxation (2,324) (1,010) (4,136)
Corporation tax payable 4 (4) - (6)
Loss after taxation (2,328) (1,010) (4,142)
Other comprehensive (expenses) / income
Items that will not be reclassified to profit or loss:
Exchange differences arising on translating foreign operation (253) (5) 72
Other comprehensive (expenses) / income for the period, net of income tax (253) (5) 72
Total comprehensive loss for the period (2,581) (1,015) (4,070)
Loss per ordinary share attributable to
the owners of the parent during the period 6 Pence Pence Pence
Basic (2.7) (887.8) (8.1)
Diluted (2.7) (887.8) (8.1)
GENinCode Plc
Consolidated Statement of Financial Position
As at 30 June 2022
Unaudited Unaudited Audited
As at As at As at
30-Jun 30-Jun 31-Dec
Notes 2022 2021 2021
£'000 £'000 £'000
Non-current assets
Intangible assets 176 176 193
Property, plant & equipment 193 9 46
Total non-current assets 369 185 239
Current assets
Inventory 34 10 14
Trade and other receivables 501 234 399
Financial assets - - 4
Cash and bank balances 12,398 978 14,554
Total current assets 12,933 1,222 14,971
Total Assets 13,302 1,407 15,210
Equity
Share capital 5 958 114 958
Share premium 15,551 3,279 15,551
Share based payment reserve 158 17 73
Exchange movements reserve (184) (8) 69
Retained deficit (5,261) (2,580) (2,933)
11,222 822 13,718
Liabilities
Non-current liabilities
Trade and other payables 1,268 - 661
Current liabilities
Trade and other payables 802 585 825
Deferred tax 10 - 6
Total liabilities 2,080 585 1,492
Total equity and liabilities 13,302 1,407 15,210
GENinCode Plc
Consolidated Statement of Cash Flows
For the six months ended 30 June 2022
Unaudited Unaudited Audited
6 months to 6 months to Year ended
30-Jun 30-Jun 31-Dec
2021
2022 2021
Notes £'000 £'000 £'000
Cash flows from operating activities
Loss before taxation (2,328) (1,010) (4,137)
Adjustments for:
Foreign exchange loss/gain (126) - 136
Share based charged adjustment 57 17 73
Depreciation and amortization 33 15 35
Loss on disposal - - 19
Movement in translation/retranslation (253) (5) 72
Taxation 4 - 6
Operating loss before working capital changes (2,613) (983) (3,796)
Cash used in operations
Decrease / (Increase) in trade and other receivables (102) 15 (150)
(Decrease) / Increase in trade and other payables 584 (21) 922
Decrease/(Increase) in inventory (20) 8 4
Decrease/(Increase) in financial assets 4 (2)
Net cash outflow from operating activities (2,147) (981) (3,022)
Investing activities
Purchase of property, plant and equipment (162) (1) (41)
Purchase of intangible assets - (51) (104)
Net cash flows used in investing activities (162) (52) (145)
Financing activities
Issue of ordinary shares (net of issue expenses) - - 15,856
Net cash flows from financing activities - - 15,856
Net change in cash and cash equivalents (2,309) (1,033) 12,689
Cash and cash equivalents at the beginning of the period 14,554 2,003 2,003
Exchange gains/(losses) on cash and cash equivalents 153 8 (138)
Cash and cash equivalents at the end of the period 12,398 978 14,554
GENinCode Plc
Consolidated Statement of Changes in Equity
For the six months ended 30 June 2022
Share Share Retained Translation Other Total
capital premium profits reserve reserves equity
£'000 £'000 £'000 £'000 £'000 £'000
Balance at 1 Jan 2021 114 3,318 (1,570) (3) - 1,859
Other comprehensive income - - - (5) - (5)
Loss for the period ended 30 June 2021 - - (1,010) - - (1,010)
Capitalisation of IPO costs - (39) - - - (39)
Share based payments - - - - 17 17
Balance at 30 June 2021 114 3,279 (2,580) (8) 17 822
Reduction of share premium - (2,779) 2,779 - - -
Bonus share issue 458 (458) - - - -
Issue of share capital 386 16,653 - - - 17,039
Costs of share issue - (1,144) - - - (1,144)
Share based payments - - - - 56 56
Other comprehensive income - - - 77 77
Loss for the period ended 31 December 2021 - - (3,132) - - (3,132)
Balance at 31 December 2021 958 15,551 (2,933) 69 73 13,718
Other comprehensive income - - - (253) - (253)
Loss for the six months ended 30 June 2022 - - (2,328) - (2,328)
Share based payments - - - - 85 85
Balance at 30 June 2022 958 15,551 (5,261) (184) 158 11,222
Share capital is the amount subscribed for shares at nominal value.
Share premium is the amount subscribed for share capital in excess of nominal
value less share issue costs.
Other reserves arise from the share options issued by the company during the
year ended 31 December 2021.
Retained earnings represents accumulated profit or losses to date.
GENinCode Plc
Notes to the Consolidated Financial Statements
For the six months ended 30 June 2022
1. General information
GENinCode plc (the "Company") is a public limited company admitted to trading
on the AIM market of the London Stock Exchange on 22 July 2021. The Company is
incorporated and domiciled in England and Wales. The registered office of the
Company is One, St. Peters Square, England, M2 3DE. The registered company
number is 11556598.
The Company was incorporated on 06 September 2018.
The Company's principal activity is the development and commercialisation of
clinical genetic tests, to provide predictive analysis of risk to a patient's
health based on their genes.
The financial information set out in this half yearly report does not
constitute statutory accounts as defined in Section 434 of the Companies Act
2006. The statutory financial statements for the year ended 31 December 2021,
prepared under UK adopted International Financial Reporting Standards
("IFRS"), have been filed with the Registrar of Companies. The auditor's
report on those financial statements was unqualified and did not contain
statements under Sections 498(2) and 498 (3) of the Companies Act 2006.
Copies of the annual statutory accounts and the Interim Report can be found on
the Company's website at www.genincode.com.
2. Significant accounting policies and basis of preparation
2.1 Statement of compliance
This half yearly report has been prepared using the historical cost
convention, on a going concern basis and in accordance with UK adopted
International Financial Reporting Standards ("IFRS"), IFRS Interpretations
Committee (IFRIC) and the Companies Act 2006 applicable to companies reporting
under IFRS, using accounting policies which are consistent with those set out
in the financial statements for the year ended 31 December 2021.
2.2 Application of new and revised UK adopted
International Financial Reporting Standards (IFRSs)
There are no IFRSs or IFRIC interpretations that are effective for the first
time in this financial period that would be expected to have a material impact
on the Company.
3. Segmental reporting
The Company has one reportable segment, namely that is the development and
commercialisation of clinical genetic tests, to provide predictive analysis of
risk to a patient's health based on their genes, the geographical split of
revenue generation is below.
6 months to 6 months to 12 months to
Turnover by geographical generation 30-Jun-22 30-Jun-21 31-Dec-21
£'000 £'000 £'000
UK 12 - -
Spain 652 600 1,154
US - - -
664 600 1,154
GENinCode Plc
Notes to the Consolidated Financial Statements (cont.)
For the six months ended 30 June 2022
4 Taxation
6 months to 6 months to 12 months to
Income taxes recognised in profit or loss 30-Jun-22 30-Jun-21 31-Dec-21
£'000 £'000 £'000
Current tax
GEN inCode 4 - 6
SLU
Tax credit for the period 4 - 6
5 Share capital
Issued share capital comprises 30-Jun-22 30-Jun-21 31-Dec-21
£'000 £'000 £'000
95,816,866 Ordinary shares of £0.01 each 958 958
76,549 Ordinary shares of £1 each 76
37,902 B Ordinary shares of £1 each 38
6 Loss per share
6 months to 6 months to 12 months to
30-Jun-22 30-Jun-21 31-Dec-21
£'000 £'000 £'000
Basic and diluted loss per share
Loss after tax (£) (2,581) (1,015) (4,070)
Weighted average number of shares 95,817 114 50,552
Basic and diluted loss per share (pence) (2.7) (887.8) (8.1)
As the Company is reporting a loss from continuing operations for the period
then, in accordance with IAS 33, the share options are not considered dilutive
because the exercise of the share options would have an anti-dilutive effect.
The basic and diluted earnings per share as presented on the face of the
income statement are therefore identical.
7 Events after the reporting date
The Company has evaluated all events and transactions that occurred after 30
June 2022 up to the date of signing of the financial statements.
The Company believes there are no reportable events post reporting date.
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