TIDMGENI
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(R)
(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(R). The
Company is accelerating the set-up of Lipid inCode(R) 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(R) and Lipid
inCode(R). First US product revenues are anticipated in 2023.
-- Indiana University collaboration representing flagship
facilities in preparation for introduction of Cardio inCode(R) to
US market.
-- Expansion of the research collaboration with Kaiser
Permanente, California to assess Cardio inCode(R) 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(R) test for FH and generation of first UK product
revenues.
-- Successful completion and publication of Lipid inCode(R) 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(R) 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(R) evaluation
study for genetic predisposition to thrombosis - St Pau Hospital,
Spain.
Financial highlights
-- Revenues increased 11% to GBP0.7m (2021: GBP0.6m).
-- Adjusted EBITDA loss of GBP2.3m (2021: loss of GBP1.0m).
- Increased levels of investment in preparation for the launch
of Lipid inCode(R) and Cardio inCode(R).
-- Cash of GBP12.4m at 30 June 2022 (2021: GBP1.0m).
- Reflecting the GBP15.3m 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(R) 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(R) 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(R) and Lipid inCode(R) 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(R) and
will take advantage of existing reimbursement coverage for its
globally leading familial hypercholesterolemia (FH) test Lipid
inCode(R) .
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(R) .
-- Advance Cardio inCode(R) 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(R) .
-- Strengthen the EVERSANA commercial, marketing and selling
team in readiness for US product launch preparations.
-- Gain CLIA lab certification for Cardio inCode(R) and
accelerate Lipid inCode(R) lab diagnostic test (LDT) service
offering.
-- Commence first NHS (NENC-AHSN) patient tests as part of NHS
implementation of Lipid inCode(R) and roll-out FH testing with the
NHS via AHSN networks.
-- Advance COVID-19 Thrombo inCode(R) 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(R) and Lipid inCode(R). 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(R) 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(R) to seize this
opportunity in the space. The Lipid inCode(R) 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
For more information visit www.genincode.com
GENinCode Plc 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(R) , Lipid inCode(R) , Thrombo inCode(R) and Sudd
inCode(R) . Over EUR50 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
GBP15.3m 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 GBP664k (H1 2021 GBP600k). The first half
sales growth net of increased operating costs gave rise to an
adjusted EBITDA loss of (GBP2.27m) (H1 2021: (GBP0.98m)),
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(R) (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(R).
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(R) 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(R) and
Lipid inCode(R) 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(R) to US
market. The program with IU will include testing Cardio inCode(R)
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(R) 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(R).
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(R) 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(R) 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(R) with North East and Cumbria - Academic Health
Science Network (NENC-AHSN). The Lipid inCode(R) 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(R) to support the
NHS.
We recently announced the completion of our first COVID-19
Thrombo inCode(R) 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(R) 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(R) 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 GBP1m 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 GBP1m (based on meeting two
consecutive target EBITs of GBP350k and GBP650k respectively). Once
each consecutive EBIT target has been achieved, a subsequent
earnout payment of GBP350k and GBP650k respectively will be paid
out of the Company's cash resources at the relevant time. Abcodia
generated a loss before tax of GBP0.60m 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 GBP12.4m at 30 June 2022 (2021:
GBP1.0m) reflecting the GBP15.3m 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 GBP664k (H1 2021:
GBP600k). In summary, sales advanced to GBP664k with an adjusted
EBITDA loss of (GBP2.27m) (H1 2021: (GBP0.98m)), 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 GBP664k (H1 2021: GBP600k), 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 (GBP12k), following the successful results announced for
Lipid inCode(R) at the beginning of the year.
Gross profit
Gross profit was GBP283k (H1 2021: GBP320k). 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 GBP2.65m (H1
2021: GBP1.33m). The increase was largely caused by a) an increase
in US commercialisation fees payable to EVERSANA (H1 2022: GBP790k
v.s. H1 2021: GBP72k), and b) an increase in salary costs (H1 2022:
GBP947k v.s. H1 2021: GBP613k), 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 GBP2.32m (H1 2021:
(GBP1.01m)). We consider a more meaningful measure of underlying
performance is obtained by examining adjusted EBITDA, which for H1
2022 was a loss of GBP2.27m (H1 2021: (GBP978k)). This excludes the
effects of share-based payments of GBP57k (H1 2021: GBP17k). 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 GBP4k (H1 2021: nil).
Fixed assets
We have capitalised, net of depreciation, a total of GBP193k (H1
2021: GBP9k) of property plant and equipment, reflecting investment
in equipment required to fit out the UK laboratory. Additionally,
we have capitalised, net of amortisation, GBP176k of intangible
assets (H1 2021: GBP176k). 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 GBP12.40m (30 Jun 2021:
GBP0.98m), reflecting the GBP15.3m 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(R) and Lipid inCode(R) 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(R) and
will take advantage of the existing reimbursement coverage for
Familial Hypercholesterolemia (FH) testing by accelerating the
set-up of Lipid inCode(R) , 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(R) .
-- Advance Cardio inCode(R) 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(R) .
-- Strengthen the EVERSANA commercial, marketing and selling
team in readiness for US product launch.
-- Gain CLIA lab certification for Cardio inCode(R) and
accelerate Lipid inCode(R) lab diagnostic test (LDT) service
offering.
-- Commence first NHS (NENC-AHSN) patient tests as part of the
NHS implementation of Lipid inCode(R) and roll-out FH testing with
the NHS via AHSN networks.
-- Advance COVID-19 Thrombo inCode(R) 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(R) 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(R) 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(R) 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(R).
In the UK, following the successful NHS clinical studies and
pilot programme we are now implementing Lipid inCode(R) (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 6 months Year ended
to to
Notes 30-Jun 30-Jun 31-Dec-21
2022 2021
GBP'000 GBP'000 GBP'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 6 Pence Pence Pence
during the period
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
GBP'000 GBP'000 GBP'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 6 months Year
to to ended
30-Jun 30-Jun 31-Dec
2021
2022 2021
Notes GBP'000 GBP'000 GBP'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
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'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 6 months 12 months
to to to
Turnover by geographical generation 30-Jun-22 30-Jun-21 31-Dec-21
GBP'000 GBP'000 GBP'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 6 months 12 months
to to to
Income taxes recognised in profit 30-Jun-22 30-Jun-21 31-Dec-21
or loss
GBP'000 GBP'000 GBP'000
----- ------------------------------------ ---------- ---------- ----------
Current tax
GEN inCode SLU 4 - 6
------------------------------------------- ---------- ----------
Tax credit for the period 4 - 6
------------------------------------------- ---------- ---------- ----------
5 Share capital
Issued share capital comprises 30-Jun-22 30-Jun-21 31-Dec-21
GBP'000 GBP'000 GBP'000
----- ------------------------------------ ---------- ---------- ----------
95,816,866 Ordinary shares of
GBP0.01 each 958 958
76,549 Ordinary shares of GBP1
each 76
37,902 B Ordinary shares of GBP1
each 38
------------------------------------------- ---------- ---------- ----------
6 Loss per share
6 months 6 months 12 months
to to to
30-Jun-22 30-Jun-21 31-Dec-21
GBP'000 GBP'000 GBP'000
----- ------------------------------------ ---------- ---------- ----------
Basic and diluted loss per share
Loss after tax (GBP) (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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END
IR EAPNKASLAEFA
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