TIDMGENI
RNS Number : 6665L
GENinCode PLC
17 May 2022
GENinCode Plc
("GENinCode" or the "Company")
Final results
Oxford, UK. GENinCode Plc (LSE: AIM GENI), the predictive
genetics company focused on the prevention of cardiovascular
disease (CVD), announces its results for the twelve months ended 31
December 2021.
The 2021 financial year saw the Company accelerate its
commercial expansion programme, successfully complete its IPO and
admission to the LSE: AIM market and file its Pre-Submission for
regulatory approval of its lead product Cardio inCode(R) with the
US FDA.
Operational and financial highlights
-- Completion of IPO and admission to the LSE: AIM in July 2021 raising gross proceeds of GBP17m
-- Filing of FDA Pre-Submission for Cardio inCode(R) (Genetic
Risk Score) for the onset of cardiovascular disease with
preparations underway for the full regulatory submission
-- Announcement of EVERSANA Life Science Services strategic
collaboration to act as US commercial services partner for
introduction of GENinCode products to the US market
-- Completed Indiana University collaboration representing
flagship facilities in preparation for introduction of Cardio
inCode(R) to US market
-- Announcement of Royal Brompton and Harefield and Guys and St
Thomas' NHS foundation trust collaboration in CVD polygenic risk
assessment and preparations for launch of Lipid inCode(R) testing
for familial hypercholesterolemia
-- Successful completion and publication of Lipid inCode(R) NHS
clinical study to improve diagnosis, turnaround time for testing of
Familial Hypercholesterolemia (FH) at reduced cost to the NHS
-- Announcement of FH pilot with NE-AHSN (North East and Cumbria
- Academic Health Science Network) for implementation of Lipid
inCode(R) with NHS
-- Full year revenues increased 20% to GBP1.2m (2020: GBP1.0m)
-- Increased levels of investment in our commercialisation
programme giving rise to an operating loss of (GBP4.1m) (2020: loss
of (GBP1.1m))
-- Cash reserves of GBP14.6m at 31 December 2021 (2020: GBP2.0m)
Recent developments
The Company announces today:
-- A collaboration with Kaiser Permanente, California to assess
Cardio inCode(R) for the polygenic risk assessment of CVD
-- Commissioning of GENinCode US CLIA lab (Clinical Laboratory
Improvement Amendments) test facility in Irvine, California and
appointment of ResearchDx Inc as the Company's US CLIA partner
-- Announcement of collaboration with BUPA Cromwell hospital,
London for use of the Lipid inCode(R) test for familial
hypercholesterolemia (FH)
-- Completion of first COVID-19 Thrombo inCode(R) evaluation
study for genetic predisposition to thrombosis - St Pau Hospital,
Spain
Outlook for 2022
We will take commercial advantage of our clinically advanced
genetic products to scale the market opportunities open to us. We
are focused on our US regulatory and reimbursement submissions for
Cardio inCode(R) , a first-in-class genetic risk assessment for CVD
and we will accelerate preparations for the US launch and
reimbursement of our globally leading familial hypercholesterolemia
test Lipid inCode(R) .
Over the remainder of the year, we expect to complete the
following key deliverables:
-- Prepare final FDA regulatory submission for Cardio inCode(R)
with a view to gaining approval approximately six months following
submission
-- Based on the recent advances by CMS in local coverage
determination and private reimbursement for FH, prepare to
commercially launch Lipid inCode(R) in the US market
-- Continue to strengthen our partnership with EVERSANA for
product launch preparations in the US market
-- Set-up US CLIA lab for Cardio inCode(R) and prepare Lipid
inCode(R) lab diagnostic test (LDT) service offering
-- Complete our first NHS implementation of Lipid inCode(R) to
advance FH testing with the NHS
-- Commission our new UK lab operation and complete UKAS
accreditation submission for service delivery of Lipid inCode(R) to
support the NHS
-- Continue to build our EU partnerships and develop our ongoing
collaborative discussions with pharmaceutical companies
-- Generate increased Year-on-Year revenue growth
-- Publish first COVID-19 Thrombo inCode(R) evaluation study for
genetic predisposition to thrombosis
Matthew Walls, Chief Executive Officer of GENinCode Plc said:
"We enjoyed a productive 2021 with the successful completion of the
IPO and GBP17m gross fundraise, enabling the expansion of our
commercial programme across our US, UK and EU markets. 2022 has
started well as we continue to deliver the plans set out at the IPO
and focus on the US product launches of Cardio inCode(R) for
cardiovascular disease preventative care and accelerate US launch
plans for Lipid inCode(R) for the management of Familial
Hypercholesterolemia.
"We are working closely with our US collaborative partner,
EVERSANA, on launch planning and advancing our collaborations with
Indiana University and Kaiser Permanente. We continue to build
constructive discussions with the FDA in preparation for our
regulatory filing for Cardio inCode(R). In the UK, we have
successfully completed our NHS clinical study for Lipid inCode(R)
(familial hypercholesterolemia testing) and are now preparing our
first NHS pilot implementation with the North of England-AHSN. We
anticipate continued revenue growth over the 2022 financial
year."
Analyst meeting
The Company will hold an analyst meeting 9:30 a.m. (BST) on
Tuesday 17 May. Matthew Walls, CEO and Paul Foulger, CFO will host
an in-person analyst meeting at the offices of Walbrook PR, 75 King
William Street, London, EC4N 7BE to discuss the financial results
and key topics including business strategy, partnerships,
regulatory and reimbursement processes.
Investor presentation details
The Company will also host a presentation for investors via the
IMC platform at 3pm on 17 May. 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.
CHAIRMAN AND CHIEF EXECUTIVE OFFICER'S STATEMENT
On behalf of the Board, we are delighted to present the
Preliminary report for the twelve-month period ended 31 December
2021 for GENinCode Plc.
Following the successful admission of the Company to the LSE:
AIM market in July 2021, this statement provides a brief
introduction to the Company, a summary of progress over the past
year, recent developments and the outlook for the year ahead.
Introduction
GENinCode is engaged in the genetic risk assessment, prediction,
and prevention of cardiovascular disease (CVD). GENinCode products
and technology have been developed with the aim of prognosing and
predicting the onset of CVD to provide personalised treatment and
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, with
CVD commonly referred to as a 'heart attack' or 'stroke'. 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, 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.
Multiple clinical 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,
advanced molecular testing, genotyping, sequencing, and AI
bioinformatics. 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. The advent of our polygenic risk assessment for CVD
allows the identification and reclassification of individuals
traditionally categorised at 'low' or 'intermediate' risk who are
at higher genetic risk of a CVD event than their current 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 clinical evidence base, granted
intellectual property portfolio and a vision to advance CVD risk
assessment to more precisely align therapeutic treatment and
lifestyle choices to improve patient outcomes.
2021 Business review
In the results for the twelve months ending 31 December 2021,
the Company saw year-on-year revenue growth increase to GBP1.2m
(2020 GBP1.0m) primarily from its European business. The Company's
key products are CE-Marked with Cardio inCode(R) , Thrombo
inCode(R) , Lipid inCode(R) and Sudd inCode(R) generating the core
product revenues. Following the IPO and admission to LSE: AIM the
Company commenced its expansion strategy in the US, UK and Europe
which are the key markets for growth.
Just prior to the IPO, we announced a strategic
commercialisation agreement with EVERSANA Life Sciences Services,
LLC. EVERSANA act as the Company's US commercial services provider
for the launch, market access and distribution of the Company's
products. EVERSANA provides a broad range of commercial services to
the life sciences industry. Its integrated business solutions span
all stages of the product life cycle to deliver long-term,
sustainable value for patients, prescribers, channel partners and
payors. EVERSANA has experience across many commercialisation
areas, in particular reimbursement, pricing intelligence, market
access and payor services. As such EVERSANA represents a strong US
commercial partner capable of accelerating our growth in the US
market.
We have announced collaborations with two leading US healthcare
institutions, Indiana University (IU) School of Medicine and Kaiser
Permanente Department of Research to assess the clinical utility
and validation of our Cardio inCode(R) product in preparation for
FDA regulatory approval. Both collaborations are focused on
clinically advancing and validating the introduction of our lead
product Cardio inCode(R) . IU is focused on assessing the use of
Cardio inCode(R) as a genetic risk enhancer for the onset of
atherosclerosis (ASCVD), whilst Kaiser Permanente is clinically
evaluating Cardio inCode(R) against its population health cohort
for the prediction and onset of CVD. We are also in advanced
discussions with New York Presbyterian (NYP) hospital group (which
includes Weill Cornell and Columbia University hospitals). NYP will
undertake Cardio inCode(R) clinical utility studies in the New York
State primary care network of physicians. These three institutions
will be the flagship facilities and healthcare groups for the
initial adoption of Cardio inCode(R) in the US.
US Regulatory and Reimbursement
We progressed discussions with the FDA through 2021 and were
invited to make a pre-submission of the Cardio inCode(R) regulatory
filing in December 2021. We have subsequently held constructive
discussions with the FDA for the full regulatory filing and expect
to complete this filing over the coming months.
In September 2021 the Centres for Medicare and Medicaid Services
(CMS) repealed the Medicare Coverage for Innovative Technologies
(MCIT) ruling. Resulting from this ruling we are now preparing
clinical utility studies (and accompanying healthcare economics) to
underpin a reimbursement submission via the MolDx(R) programme. The
MolDx(R) submission will establish coverage, pricing and
reimbursement for Cardio inCode(R) . We are also commencing private
payer discussions with health insurance providers. The MolDx(R)
programme works on behalf of CMS to administer Medicare claims via
Medicare Administrative Contractors (MACs). We expect to present
our MolDx(R) reimbursement submission early next year based on the
completion of our clinical utility studies with selected US partner
healthcare institutions.
Following positive public health endorsement of Familial
Hypercholesterolemia (FH) by the Centers for Disease Control Office
of Public Health Genomics (CDC) and the inclusion of FH testing as
a Tier 1 genomic application (i.e. the test has a significant
potential for positive impact on public health based on available
evidence-based guidelines and recommendations), we have accelerated
our plans and preparations for the US soft launch of Lipid
inCode(R) later this year. Our Lipid inCode(R) test and FH panel of
genes is well-positioned to receive Medicare coverage based on
recent policies that have been put in place that support genetic
testing in cardiovascular disease.
Today we announce the completion of our partnership with
ResearchDx, based in Irvine, California for the commissioning of
the GENinCode US CLIA lab. Our US lab will be set-up and
commissioned over the coming months to provide CLIA certified
product services initially focused on Cardio inCode(R) and Lipid
inCode(R) . It is important to note that, once CLIA lab approval
has been granted, we will be able to begin generation of product to
support our US preparations for launch and meaningful revenue
growth.
UK and Europe
In the UK, the NHS Long Term Plan 2019 identifies CVD as a
clinical priority and the single largest condition where lives can
be saved over the next 10 years. The NHS Long Term Plan sets out to
identify 25% of patients suffering with Familial
Hypercholesterolemia (FH) by 2024. FH affects approximately 1 in
200-250 people in the UK who are unable to effectively metabolise
cholesterol leading to the accelerated onset of CVD. GENinCode's UK
strategy is focused on advancing our Lipid inCode(R) test to help
support the NHS meet this plan. During the year we announced our
collaboration with Royal Brompton and Harefield hospitals to
provide CVD clinical genetic testing. RB&H is part of Guy's and
St Thomas' NHS Foundation Trust, the largest specialist heart and
lung centre in England and one of the largest in Europe.
More recently we have announced the successful completion of our
NHS clinical study for FH to deliver improved diagnosis and risk
assessment and a faster turnaround of test results at a lower cost
to the NHS. We have recently commenced a clinical pilot with the
NE-AHSN (North East and Cumbria - Academic Health Science Network)
the centre of excellence for UK FH testing with a view to
supporting the North of England meet its NHS targets.
Today we also announce a collaborative agreement with BUPA
Cromwell Hospital for Lipid inCode(R) testing for FH. This will
allow UK private patients to receive genetic testing for FH from
the BUPA Cromwell hospital based in West London. This agreement
represents the start of UK private patient revenue generation for
Lipid inCode(R) (.)
In Europe, the Company continues to build its business and
evidence based polygenic product profile and has announced sales
and distribution arrangements with Longwood Diagnostics S.L. and
Synlab Diagnostics S.A.U. to support its expansion in Spain. We are
preparing Cardio inCode(R) for piloting for public health CVD risk
assessment in the Spanish regions and expanding our sales team and
collaborative partners in Italy and France.
Following the European outbreak of the COVID-19 pandemic in
northern Spain and Italy we have undertaken a number of clinical
studies to assess the severity of onset of COVID-19 to patients
with a genetic predisposition to thrombosis using our Thrombo
inCode(R) product. The first of these studies based at Hospital St
Pau, Barcelona has now completed its findings and we expect to
present this publication over the coming months.
Intellectual Property
We maintain an ongoing intellectual property programme to
strengthen our existing patent portfolio and advance examinations
across our family of patents for Cardio inCode(R) and Thrombo
inCode(R) . We continue to build our intellectual property
portfolio and are actively evaluating in-licensing opportunities as
appropriate to enhance our competitive product positioning.
Financial review
The first half of 2021 was dominated by preparation for
admission of the Company to the LSE:AIM, which was successfully
completed on 22nd July 2021. The company raised GBP17.0 million
(gross) before expenses. The proceeds are being used to accelerate
our commercial programme in the US, EU, and the UK.
Despite last year's challenges of the COVID-19 pandemic, our EU
business held up well to report revenues of GBP1.2m (2020 GBP1.0m)
for the full year. Gross profit for the year was GBP593k (2020:
GBP523k) with a margin of 52% (2020: 54%) respectively.
Administrative expenses increased to GBP4.0m (2020: GBP1.6m).
The year-on-year cost increase reflecting a first half growth in
staffing and professional costs as the company prepared for
admission to LSE:AIM with the second half ramp up in US investment
following the completion of the EVERSANA partnership with spending
focused on regulatory, reimbursement and market assessment
preparations.
The increased commercial investment gave rise to an operating
loss for the year of (GBP4.1m) (2020: (GBP1.1m)), with the cash
position at the end of December 2021 GBP14.6m (2020: 2.0m).
Capital structure
Following the listing on LSE: AIM the total number of ordinary
shares in issue was 95,816,866. The loss per share for the year
ending 31 December 2021 was 8.05p/share. The Board of Directors
will not be recommending a dividend payment for the year ended 31
December 2021.
Outlook
We will take commercial advantage of our clinically advanced
genetic products to scale the market opportunities open to us. We
are focused on our US regulatory and reimbursement submissions for
Cardio inCode(R) , a first-in-class genetic risk assessment for CVD
and we will accelerate preparations for the US launch and
reimbursement of our globally leading familial hypercholesterolemia
test Lipid inCode(R) .
Over the remainder of the year, we expect to complete the
following key deliverables:
-- Prepare final FDA regulatory submission for Cardio inCode(R)
with a view to gaining approval approximately six months following
submission
-- Based on the recent advances by CMS in local coverage
determination and private reimbursement for FH, prepare to
commercially launch Lipid inCode(R) in the US market
-- Continue to strengthen our partnership with EVERSANA for
product launch preparations in the US market
-- Set-up US CLIA lab for Cardio inCode(R) and prepare Lipid
inCode(R) lab diagnostic test (LDT) service offering
-- Complete our first NHS implementation of Lipid inCode(R) to advance FH testing with the NHS
-- Commission our new UK lab operation and complete UKAS
accreditation submission for service delivery of Lipid inCode(R) to
support the NHS
-- Continue to build our EU partnerships and develop our ongoing
collaborative discussions with pharmaceutical companies
-- Generate increased Year-on-Year revenue growth
-- Publish first COVID-19 Thrombo inCode(R) evaluation study for
genetic predisposition to thrombosis
We have a strong and growing clinical evidence base built on
studies amassed over the past 12 years to more precisely identify
patients at risk of CVD and thereby enable improved preventative
care.
We continue to increase investment in our manpower resource and
expertise as well as exploring other acquisition opportunities to
take advantage of the growth opportunities open to us.
Despite the world market challenges and volatility, the Board
believes our products and technology will deliver significant
investor returns and we would like to thank our investors, Board,
management and employees for their strength and determination in
driving our business growth.
We look forward to updating our investors on our forthcoming
progress.
Matthew Walls William Rhodes
Chief Executive Officer Chairman
16 May 2022 16 May 2022
CFO STATEMENT
2021 2020
GBP'000 GBP'000
Revenue 1,154 961
Gross Profit 593 523
Gross Profit % 51.4% 54.4%
Operating Loss (4,146) (1,050)
Cash and cash equivalents 14,554 2,003
Total Equity 13,718 1,859
--------- ---------
Operating Results
Sales increased by GBP193,311 or 20.1% from GBP960,801 in 2020
to GBP1,154,112 in 2021 and operating loss increased by
GBP3,096,267 from (GBP1,050,004) in 2020 to (GBP4,146,271) in
2021.
Top 5 Geographic Markets
2021 2020
GBP'000 % GBP'000 %
-------- ---- -------- ----
Spain 1,001 86% 817 85%
-------- ---- -------- ----
Italy 95 8% 11 12%
-------- ---- -------- ----
France 32 3% 21 2%
-------- ---- -------- ----
Germany 9 1% 0 0%
-------- ---- -------- ----
ROW 17 2% 12 1%
-------- ---- -------- ----
Total 1,154 961
-------- ---- -------- ----
The gross margin decreased from 54.4% to 51.4%, largely as a
result of the product mix but also due to pricing pressure from the
Company's preferred laboratory service provider in Girona.
Administrative Expenses
2021 2020
GBP'000 GBP'000
Salaries and social security and benefits
in kind 1,677 722
--------- ---------
Royalty expense 55 47
--------- ---------
Audit and accounting 49 36
--------- ---------
US Commercialisation, launch preparation, 1,257 -
market assessment, marketing resources,
and regulatory
--------- ---------
Rent, Utilities, Comms, and IT 202 128
--------- ---------
Travel and entertainment 76 52
--------- ---------
Legal, Professional, and Consultancy 447 369
--------- ---------
Marketing & Market Access 134 79
--------- ---------
Sundry 122 117
--------- ---------
Total Administrative expenses 4,019 1,550
--------- ---------
The number of employees and directors increased from 16 (14 in
Spain and 2 in the UK) at 31 December 2020 to 28 (19 in Spain, 8 in
the UK, and 1 in the US) at 31 December 2021, as the Group
strengthened its management team, increased its regulatory
resources, and put in place a laboratory team in London in
preparation for the commercial launch of Lipid inCode(R) in 2022.
This has resulted in salaries and associated costs increasing from
GBP721,851 to GBP1,677,348 during the period.
In June 2021, the Company entered into a Product
Commercialisation Agreement with Eversana Life Sciences L.L.C.,
whereby EVERSANA would act as the Company's commercial services
provider for the launch, market access, and distribution logistics
for the Company's products in the USA. The cost of US
commercialisation fees in 2021, mainly payable to EVERSANA,
amounted to GBP1,257,138.
Legal, Professional, and Consultancy fees increased from
GBP368,961 in 2020 to GBP446,999 in 2021, mainly as a result of the
extra operational expenses associated with being on the AIM market
(broker fees, nomad fees, Financial PR fees, Registrar fees, AIM
fees etc). Additionally, the Company has increased the size of the
Clinical Advisory Board, both in the UK and the US.
Adjusted EBITDA
2021 2020
GBP'000 GBP'000
Operating Loss (4,146) (1,050)
--------- ---------
Add Back:
--------- ---------
Depreciation & Amortisation 35 23
--------- ---------
Loss on disposal of fixed assets 19
--------- ---------
Share Based Costs 73 -
--------- ---------
Listing Costs 584 -
--------- ---------
Non-recurring Expenditure 9 -
--------- ---------
Adjusted EBITDA (3,426) (1,027)
--------- ---------
Intangible amortisation charges in 2021 were GBP28,922 compared
to a charge of GBP20,876 in 2020; this increase is in line with the
rise in capitalised patent cost activity during the year.
Depreciation charges in 2021 were GBP5,794 compared to a charge of
GBP1,898 in 2020; again, this increase is commensurate with the
increased property, plant and equipment purchases in the year, due
to the increased headcount and associated investment since the IPO
during the period.
Share Options were granted to directors, employees, and certain
advisors in April 2021, hence for the first time, under IFRS 2 the
Company is required to recognise share based payment awards in the
financial statements based on fair value when the awards are
received, which is determined at the grant date for share-based
payments. The charge for the year amounted to GBP72,906 and was
calculated using the Black-Scholes model.
Successful completion of an IPO and admission to the LSE:AIM
took place in July 2021; costs associated with the IPO amounted to
GBP1,727,666. Of this amount, GBP583,669 was charged to the Income
Statement and GBP1,143,997 was netted off against the share
premium.
Non-recurring expenditure of GBP9,051 was incurred by our
Spanish office in 2021 and represented previously capitalised
development costs written off to the Income Statement in the
period.
Taxation
2021 2020
GBP'000 GBP'000
Income Tax 6 116
--------- ---------
As highlighted in note 8 to the Consolidated Financial
Statements, although the expected tax credit at the UK corporation
tax rate of 19% increased from (GBP199,488) in 2020 to (GBP786,028)
in 2021, a large movement in the unrecognised deferred tax asset
balance has resulted in a charge of GBP826,075 to the Income
Statement in the period in accordance with IAS 12 Income Taxes,
leading to a net charge of GBP6,071.
The UK budget announced on 3 March 2021 an increase in the main
corporation tax rate from 19% to 25% on profits over GBP250,000
with effect from 1 April 2023. Due to the nature of the business
and uncertainty of profit generation the rate has not been
reflected in the consolidated financial statements.
Other comprehensive income
Included in other comprehensive income are the net exchange
differences on translation of foreign operations. The gain on
translation of GBP72,000 in 2021 compares to a gain in 2020 of
GBP440.
The gain in both years arises predominantly due to the
strengthening of the GBP against the Euro. A significant proportion
of the Group's operations are based in Spain and with the
strengthening of GBP in 2021 from an opening rate of GBP1:Eur1.12
to a closing rate at the end of 2021 of GBP1:Eur1.16, this movement
was the main reason for the gain in the period.
Assets and Liabilities
Non-Current Assets
Intangible assets have increased from GBP139,486 at 31 December
2020 to GBP192,602 at 31 December 2021 as the Company continues to
further build its intellectual property portfolio.
Property, plant and equipment has risen from GBP11,129 at 31
December 2020 to GBP46,265 at 31 December 2021 due to laboratory
equipment purchases at the Company's lab premises in London.
Current Assets
The Company holds very little in the way of finished goods and
work in progress, largely because around 60% of its revenues
originate from genomic service testing, as well as the fact that
the kits are mainly ordered and then delivered directly from kit
manufacturer/supplier to customer.
Trade and Other Receivables have increased from GBP248,589 at 31
December 2020 to GBP398,827 at 31 December 2021, predominantly due
a higher level of prepayments as a result of expenditure for the
following period having been invoiced by suppliers before the
period end.
Liabilities
Trade and Other Payables increased from GBP563,495 at 31
December 2020 to GBP1,485,857 at 31 December 2021, split across
non-current liabilities and current liabilities; this rise is
mainly due to the nature of the payment structure set out in the
agreement with our US commercialisation partner, EVERSANA.
Cash flow and working capital
Operating cash outflow increased from (GBP1,037,781) in 2020 to
(GBP3,023,388) in 2021.The increase is largely explained by the
drop-through of increased operating losses, offset by a reduction
in net working capital, largely as a result of increased payables
balances at 31 December 2021.
Net cash flows used in investing activities increased from
(GBP68,273) in 2020 to (GBP145,436) in 2021, reflecting increased
patent expenditure and laboratory equipment in the UK.
Net cash flows from financing activities increased from
GBP3,026,142 in 2020 to GBP15,855,983 in 2021. In 2020, a private
fundraise was carried out, comprising two institutional investors
and a small number of private investors. In July 2021, the Company
announced admission to trading on AIM together with a successful
fundraise for gross proceeds of GBP17m before expenses.
As a result of the above activities there was an overall
increase in cash and cash equivalents of GBP12,551,005 from
GBP2,003,072 at 31 December 2020 to GBP14,554,077 at 31 December
2021.
....................................
Paul Foulger
Chief Financial Officer
16 May 2022
Consolidated Statement of Profit or Loss and Other Comprehensive
Income
for the Year Ended 31 December 2021
Notes 2021 2020
GBP'000 GBP'000
------------------------------------- ------ -------- --------
CONTINUING OPERATIONS
Revenue 4 1,154 961
Cost of sales (561) (438)
GROSS PROFIT 593 523
Administrative expenses (4,019) (1,550)
ADJUSTED EBITDA (3,426) (1,027)
Depreciation (6) (2)
Amortisation (29) (21)
Loss on disposal of fixed
assets (19)
Share based costs (73) -
Listing costs (584) -
Non-recurring expenditure (9) -
OPERATING LOSS (4,146) (1,050)
Other income 7 10 -
LOSS BEFORE INCOME TAX 5 (4,136) (1,050)
Income tax 8 (6) (116)
------------------------------------- ------ -------- --------
LOSS FOR THE FINANCIAL PERIOD (4,142) (1,166)
Other comprehensive income
for the year
Exchange differences on translation 72 -
of foreign operations
LOSS ATTRIBUTABLE TO EQUITY
SHAREHOLDERS OF THE COMPANY (4,070) (1,166)
------------------------------------- ------ -------- --------
EARNINGS PER SHARE
Basic earnings per share
(pence) (8.05) (12.71)
Diluted earnings per share
(pence) (8.05) (12.71)
The notes form part of these financial statements
Consolidated Statement of Financial Position
31 December 2021
2021 2020
Notes GBP'000 GBP'000
------------------------------- ------ -------- --------
ASSETS
NON-CURRENT ASSETS
Intangible assets 12 193 140
Property, plant and equipment 13 46 11
239 151
-------- --------
CURRENT ASSETS
Inventories 14 14 18
Trade and other receivables 15 399 248
Cash and cash equivalents 17 14,554 2,003
Financial assets 16 4 2
14,971 2,271
-------- --------
TOTAL ASSETS 15,210 2,422
======== ========
EQUITY
SHAREHOLDERS' EQUITY
Called up share capital 20 958 114
Share premium 21 15,551 3,318
Other reserves 21 73 -
Retained earnings 21 (2,864) (1,573)
TOTAL EQUITY 13,718 1,859
-------- --------
LIABILITIES
NON-CURRENT LIABILITIES
Trade and other payables 18 661 -
CURRENT LIABILITIES
Trade and other payables 18 825 563
Deferred Tax 19 6 -
TOTAL LIABILITIES 1,492 563
-------- --------
TOTAL EQUITY AND LIABILITIES 15,210 2,422
======== ========
The financial statements were approved by the Board of Directors
on 16 May 2022 and were signed on its behalf by:
..........................................................
Paul Foulger
Director
16 May 2022
The notes form part of these financial statements
Company Statement of Financial Position
31 December 2021
2021 2020
Notes GBP'000 GBP'000
------------------------------ ------ -------- --------
ASSETS
NON-CURRENT ASSETS
Investments 11 31 2
Intangible assets 12 179 101
Property, plant, and
equipment 13 32 -
Trade and other receivables 15 2,791
3,033 103
-------- --------
CURRENT ASSETS
Trade and other receivables 15 168 1,116
Cash and cash equivalents 17 14,243 1,892
14,411 3,008
-------- --------
TOTAL ASSETS 17,444 3,111
======== ========
EQUITY
SHAREHOLDERS' EQUITY
Called up share capital 20 958 114
Share premium 21 15,551 3,318
Share based payment reserve 21 73 -
Retained earnings 21 493 (429)
TOTAL EQUITY 17,075 3,003
-------- --------
LIABILITIES
CURRENT LIABILITIES
Trade and other payables 18 363 108
Deferred Tax 19 6 -
TOTAL LIABILITIES 369 108
-------- --------
TOTAL EQUITY AND LIABILITIES 17,444 3,111
======== ========
As permitted by Section 408 of the Companies Act 2006, the
income statement of the parent company is not presented as part of
these financial statements. The parent company's loss for the
financial year was GBP1,856,657 (2020 - loss of GBP364,036).
The financial statements were approved by the Board of Directors
on 16 May 2022 and were signed on its behalf by:
..........................................................
Paul Foulger
Director
16 May 2022
The notes form part of these financial statements
GENinCode Plc
Consolidated Statement of Changes in Equity
for the Year Ended 31 December 2021
Called Share based
up Share
share premium payment Retained Total
capital account reserve earnings equity
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
------------------------ -------- -------- ------------ --------- --------
Balance at 1 January
2020 67 - (408) (341)
Changes in equity
Issue of share capital 47 3,318 - - 3,365
Total comprehensive
income - - - (1,165) (1,165)
Balance at 31 December
2020 114 3,318 - (1,573) 1,859
------------------------ -------- -------- ------------ --------- --------
Changes in equity
Reduction of share
premium - (2,779) - 2,779 -
Bonus share issue 458 (458) - - -
Issue of share capital 386 16,614 - - 17,000
Costs of share issue - (1,144) - - (1,144)
Share based payments - - 73 - 73
Total comprehensive
income - - - (4,070) (4,070)
Rounding - - - -
Balance at 31 December
2021 958 15,551 73 (2,864) 13,718
------------------------ -------- -------- ------------ --------- --------
The notes form part of these financial statements
GENinCode Plc
Company Statement of Changes in Equity
for the Year Ended 31 December 2021
Called
up Share
share premium Other Retained Total
capital account reserves earnings equity
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
------------------------ -------- -------- --------- --------- --------
Balance at 1 January
2020 - - (65) (65)
Changes in equity
Issue of share capital 114 3,318 - - 3,432
Total comprehensive
income - - - (364) (364)
Balance at 31 December
2020 114 3,318 - (429) 3,003
------------------------ -------- -------- --------- --------- --------
Changes in equity
Reduction of share
premium - (2,779) - 2,779 -
Bonus share issue 458 (458) - - -
Issue of share capital 386 16,614 - - 17,000
Costs of share issue - (1,144) - - (1,144)
Share based payments - - 73 73
Total comprehensive
income - - - (1,857) (1,857)
Balance at 31 December
2021 958 15,551 73 493 17,075
------------------------ -------- -------- --------- --------- --------
The notes form part of these financial statements
GENinCode Plc
Consolidated Statement of Cash Flows
for the Year Ended 31 December 2021
2021 2020
GBP'000 GBP'000
------------------------------------------------ -------- --------
Cash flows from operating activities
Loss before taxation (4,137) (1,050)
Adjustments for:
Foreign exchange loss/(gain) 136 -
Depreciation and amortisation 35 23
Loss on disposal 19 -
Share based payments 73 -
Movement in translation/retranslation 70
Taxation 6 -
Operating loss before working capital
changes (3,798) (1,027)
------------------------------------------------ -------- --------
Cash used in operations
Decrease / (Increase) in trade and other
receivables (150) 42
(Decrease) / Increase in trade and other
payables 922 (35)
Decrease / (Increase) in inventory 4 (18)
(Increase) in financial assets (2) -
Net cash outflow from operating activities (3,024) (1,038)
------------------------------------------------ -------- --------
Investing activities
Purchase of property, plant, and equipment (41) (5)
Purchase of intangible assets (104) (63)
Net cash flows used in investing activities (145) (68)
------------------------------------------------ -------- --------
Financing activities
Issue of ordinary shares (net of issue
expenses) 15,856 3,026
Net cash flows from financing activities 15,856 3,026
------------------------------------------------ -------- --------
Net change in cash and cash equivalents 12,687 1,920
Cash and cash equivalents at the beginning
of the period 2,003 85
Exchange (losses) on cash and cash equivalents (136) (2)
Cash and cash equivalents at the end
of the period 14,554 2,003
------------------------------------------------ -------- --------
The notes form part of these financial statements
GENinCode Plc
Company Statement of Cash Flows
for the Year Ended 31 December 2021
2021 2020
GBP'000 GBP'000
--------------------------------------------- -------- --------
Cash flows from operating activities
(Loss) for the year (1,857) (364)
Adjustments for:
Foreign exchange loss/(gain) 136 11
Amortisation 120 7
Other income (22) -
Share based payments 73
Taxation 6 -
--------------------------------------------- -------- --------
Operating loss before working capital
changes (1,644) (346)
Changes in working capital
(Increase) in trade and other receivables (73) (90)
Increase/(decrease) in trade and other
payables 254 (376)
Interest receivable 22 (14)
--------------------------------------------- -------- --------
Net cash outflow from operating activities (1,441) (826)
--------------------------------------------- -------- --------
Investing activities
Acquisition of subsidiary (28) -
Purchase of intangible assets (95) (53)
Purchase of tangible assets (35) -
--------------------------------------------- --------
Net cash flows used in investing activities (158) (53)
--------------------------------------------- -------- --------
Financing activities
Loans issued to subsidiary undertakings (1,770) (607)
Proceeds from issue of share capital 15,856 3,365
--------------------------------------------- -------- --------
Net cash flows from financing activities 14,086 2,758
--------------------------------------------- -------- --------
Net change in cash and cash equivalents 12,487 1,878
Exchange (losses)/gains on cash and cash
equivalents (136) (10)
Cash and cash equivalents at the beginning
of the year 1,892 24
--------------------------------------------- -------- --------
Cash and cash equivalents at the end
of the year 14,243 1,892
--------------------------------------------- -------- --------
The notes form part of these financial statements
GENinCode Plc
Notes to the Consolidated Financial Statements
for the Year Ended 31 December 2021
1. Statutory information
GENinCode Plc is a public limited company, registered in England
and Wales. The Company's registered number and registered office
address can be found on the General Information page.
The Group'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 consolidated financial statements comprised of the Company
and its subsidiaries (together referred to as "the Group") as at
and for the year ended 31 December 2021. The parent Company
financial statements present information about the Company as a
separate entity and not about its Group.
2. Accounting policies
Basis of preparation
The consolidated financial statements of the Group have been
prepared using the historical cost convention, on a going concern
basis and in accordance with UK-adopted international accounting
standards ("IFRS") and the Companies Act 2006 applicable to
companies reporting under IFRS, using accounting policies which are
set out below and which have been consistently applied to all years
presented, unless otherwise stated.
On 31 December 2020 IFRS as adopted by the European Union were
brought into UK law and became UK-adopted international accounting
standards with future changes being subject to endorsement by the
UK Endorsement Board.
The financial statements of the Company have been prepared in
accordance with Financial Reporting Standard 101 "Reduced
Disclosure Framework" ('FRS 101') and the requirements of the
Companies Act 2006. The Company will continue to prepare its
financial statements in accordance with FRS 101 on an ongoing basis
until such time as it notifies shareholders of any change to its
chosen accounting framework.
In accordance with FRS 101, the Company has taken advantage of
the following exemptions:
-- Requirements of IAS 24, 'Related Party Disclosures' to
disclose related party transactions entered into between two or
more members of a group;
-- the requirements of paragraphs 134(d) to 134(f) and 135(c) to
135(e) of IAS 36 Impairments of Assets;
-- the requirements of IFRS 7 Financial Instruments:
Disclosures;
-- the requirements of paragraphs 10(d), 10(f), 16, 38A, 38B,
38C, 38D, 40A, 40B, 40C, 40D and 111 of IAS 1 Presentation of
Financial Statements;
-- the requirements of paragraphs 134 to 136 of IAS 1
Presentation of Financial Statements;
-- the requirements of paragraphs 30 and 31 of IAS 8 Accounting
Policies, Changes in Accounting Estimates and Errors.
New and amended standards adopted by the Group
The most significant new standards and interpretations adopted,
none of which are considered material to the Group, are as
follows:
Ref Title Summary Application
date of standards
(periods commencing)
----------- -------------------------- -------------------------------- ----------------------
IFRS9, Interest Rate Benchmark Amendments regarding 1 January 2021
IAS39 Reform Phase 2 measurement and classification
and IFRS7
----------- ------------------------ ---------------------------------- ------------------------
IFRS Insurance contracts 1 January 2021
17
----------- ------------------------ ---------------------------------- ------------------------
IFRS Amendments to Insurance 1 January 2021
4 Contracts - deferral
of IFRS 9 (issued
on 25 June 2020)
----------- ------------------------ ---------------------------------- ------------------------
New standards and interpretations not yet adopted
Unless material the Group does not adopt new accounting
standards and interpretations which have been published and that
are not mandatory for 31 December 2021 reporting periods.
No new standards or interpretations issued by the International
Accounting Standards Board ('IASB') or the IFRS Interpretations
Committee ('IFRIC') have led to any material changes in the
Company's accounting policies or disclosures during each reporting
period.
The most significant new standards and interpretations to be
adopted in the future are as follows:
Ref Title Summary Application
date of standards
(periods commencing)
----- ---------------------- ------------------------- ----------------------
IAS1 Presentation of Amendments regarding 1 January 2023
Financial Statements the classification of
liabilities
Amendments to defer 1 January 2023
effective date of the
January 2020 amendments
----- ---------------------- ------------------------- ----------------------
Going concern
The financial statements have been prepared on the assumption
that the Group is a going concern. When assessing the foreseeable
future, the Directors have considered detailed budgets and
forecasts for the next 12 months from the date of this report and
the cash at bank available as at the date of approval of this
report and are satisfied that the Group should be able to meet its
financial obligations.
The Group holds surplus cash reserves following the placing on
admission to AIM and based on current and expected expenditure has
enough reserves to operate for the foreseeable future.
The Group has an ongoing commitment to keep costs and working
capital under control so that increasing gross profits can drive
positive cash flows. Detailed sensitivity analysis has been
performed to assess the potential impact on the Group's liquidity
caused by delays in revenue growth against expected levels along
with potential mitigating actions which can be taken to safeguard
the Group's cash position. These include working capital controls
and reductions in discretionary spending. These sensitivities
include the expected continued impact of the COVID-19 pandemic,
although to mitigate its potential negative impacts the Group is
developing its own COVID-19 severity and prognosis stratification
product.
Basis of consolidation
Subsidiaries are all entities which the Group has control. The
subsidiaries consolidated in these Group accounts were acquired via
group re-organisation and as such merger accounting principles have
been applied. The subsidiaries' financial figures are included for
their entire financial year rather than from the date the company
took control of them.
Inter-company transactions, balances, and unrealised gains on
transactions between Group companies are eliminated during the
consolidation process.
The subsidiaries prepare their accounts to 31 December under
FRS101; there are no deviations from the accounting standards
implemented by the company. Where necessary accounting policies of
subsidiaries have been changed to ensure consistency with the
policies adopted by the Group.
Property, plant, and equipment
Depreciation is provided at the following annual rates in order
to write off each asset over its estimated useful life.
Depreciation is provided to write off cost, less estimated
residual values, of all property, plant, and equipment, except for
investment properties and freehold land, evenly over their expected
useful lives, calculated at the following rates:
Plant 12%
Equipment 25%
The carrying value of the property, plant and equipment is
compared to the higher of value in use and the fair value less
costs to sell. If the carrying value exceeds the higher of the
value in use and fair value less the costs to sell the asset, then
the asset is impaired, and its value reduced by recognising an
impairment provision.
Intangible assets
(i) Patents and licenses costs
The Group has purchased patents and licences since
incorporation. The costs incurred in obtaining these patents and
licenses have been capitalised. Amortisation is charged as
follows:
Patents Over estimated economic life of 10 years
Licences 20% (estimated useful life of 5 years)
The Patents and license costs are reviewed for impairment
whenever events or changes in circumstances indicate that the
carrying amount may not be recoverable.
(ii) Software costs
The Group has purchased software since incorporation. The costs
incurred in obtaining the software have been capitalised as the
Group uses the software platform to provide results to its
customers.
Amortisation is charged on a straight-line basis at 25% over the
useful life of the related asset. Software costs are reviewed for
impairment whenever events or changes in circumstances indicate
that the carrying amount may not be recoverable.
Foreign currency
The functional currency of the Company is Sterling Pound (GBP)
and its subsidiaries are in Euros (EUR) and US Dollars ($). The
presentational currency of the Company is GBP.
Transactions entered by the Group's entities in a currency other
than the reporting currency are recorded at the rates ruling when
the transactions occur. Foreign currency monetary assets and
liabilities are translated at the rates ruling at the statement of
financial position date. Exchange differences arising on the
re-translation of outstanding monetary assets and liabilities are
also recognised in the income statement.
The exchange rates used in the financial statements are as
follows:
2021 2020
Sterling/euro exchange rates
Average exchange rate for the period 1.163 1.245
Exchange rate at the period end 1.190 1.105
------ ------
Sterling/US dollar exchange rates
Average exchange rate for the period 1.375 n/a
Exchange rate at the period end 1.331 n/a
-------------------------------------- ------ ------
Revenue recognition
Revenue is recognised in accordance with the requirements of
IFRS 15 'Revenue from Contracts with Customers'. The Company
recognises revenue to depict the transfer of promised goods and
services to customers in an amount that reflects the consideration
to which the entity expects to be entitled in exchange for those
goods or services. Revenue is determined to be at the point of
despatch of the product or service unless there are specific
provisions in the relevant contract. Revenue from the provision of
testing and reporting services is recognised upon delivery of the
report to the customer. Invoices are typically raised upon delivery
of the products or reporting services, unless there is a different
contractual requirement, for payment according to credit terms.
Operating leases
Rentals payable under operating leases are charged against the
statement of comprehensive income on a straight-line basis over the
lease term.
Cash and cash equivalents
Cash and cash equivalents include cash in hand and deposits held
on call, together with other short term highly liquid investments
which are not subject to significant changes in value and have
original maturities of less than three months.
Equity
Equity comprises the following:
-- Share capital: the nominal value of equity shares.
-- Retained deficit: losses accumulated to the end of the period.
-- Share premium: excess subscribed above nominal value.
Equity instruments
The Group subsequently measures all equity investments at fair
value. Where the Group's management has elected to present fair
value gains and losses on equity investments in OCI, there is no
subsequent reclassification of fair value gains and losses to
profit or loss following the derecognition of the investment.
Dividends from such investments continue to be recognised in profit
or loss as other income when the Group's right to receive payments
is established. Changes in the fair value of financial assets at
FVPL are recognised in other gains/(losses) in the statement of
profit or loss as applicable. Impairment losses (and reversal of
impairment losses) on equity investments measured at FVOCI are not
reported separately from other changes in fair value.
Taxation
Current taxes are based on the results shown in the financial
statements and are calculated according to local tax rules, using
tax rates enacted or substantially enacted by the statement of
financial position date.
Employee benefits
(i) Short-term benefits
Wages, salaries, paid annual leave and sick leave, bonuses and
non-monetary benefits are accrued in the period in which the
associated services are rendered by employees of the Company.
Employee benefit costs
The Group operates a defined contribution pension scheme.
Contributions payable to the Group's pension scheme are charged to
the income statement in the period to which they relate.
Share based payment
The fair value of equity-settled share-based payments to
employees is determined at the date of grant and expensed on a
straight line basis over the vesting period based on the Group's
estimate of shares or options that will eventually vest.
All equity-settled share-based payments are ultimately
recognised as an expense in the profit or loss with a corresponding
credit to the Share based payment reserve. If vesting periods or
other non-market vesting conditions apply, the expense is allocated
over the vesting period, based on the best available estimate of
the number of share options expected to vest. Estimates are
subsequently revised if there is any indication that the number of
share options expected to vest differs from previous estimates. Any
cumulative adjustment prior to vesting is recognised in the current
period. No adjustment is made to any expense recognised in prior
periods if share options ultimately exercised are different to that
estimated on vesting.
Share options granted to employees of subsidiaries are
recognised as an expense in the employing subsidiary and as an
addition to the investment in the subsidiary for the parent
company. The costs are calculated on the same basis as above and
are included upon consolidation.
Upon exercise of share options, the proceeds received net of
attributable transaction costs are credited to share capital, and
where appropriate share premium.
Financial instruments
IFRS 9 requires an entity to address the classification,
measurement and recognition of financial assets and
liabilities.
a) Classification
The Group classifies its financial assets in the following
measurement categories:
-- those to be measured subsequently at fair value (either
through OCI or through profit or loss); and
-- those to be measured at amortised cost.
The classification depends on the Group's business model for
managing the financial assets and the contractual terms of the cash
flows.
For assets measured at fair value, gains and losses will be
recorded either in profit or loss or in OCI. For investments in
equity instruments that are not held for trading, this will depend
on whether the Group has made an irrevocable election at the time
of initial recognition to account for the equity investment at fair
value through other comprehensive income (FVOCI).
The Group classifies financial assets as amortised costs only if
both of the following criteria are met:
-- the asset is held within a business model whose objective is
to collect contractual cash flows; and
-- the contractual terms give rise to cash flows that are solely
payment of principal and interest.
b) Recognition
Purchases and sales of financial assets are recognised on trade
date (that is, the date on which the Group commits to purchase or
sell the asset). Financial assets are de-recognised when the rights
to receive cash flows from the financial assets have expired or
have been transferred and the Group has transferred substantially
all the risks and rewards of ownership.
c) Measurement
At initial recognition, the Group measures a financial asset at
its fair value plus, in the case of a financial asset not at fair
value through profit or loss (FVPL), transaction costs that are
directly attributable to the acquisition of the financial
asset.
Transaction costs of financial assets carried at FVPL are
expensed in profit or loss.
Debt instruments
Amortised cost: Assets that are held for collection of
contractual cash flows, where those cash flows represent solely
payments of principal and interest, are measured at amortised cost.
Interest income from these financial assets is included in finance
income using the effective interest rate method. Any gain or loss
arising on derecognition is recognised directly in profit or loss
and presented in other gains/(losses) together with foreign
exchange gains and losses. Impairment losses are presented as a
separate line item in the statement of profit or loss.
d) Impairment
The Group assesses, on a forward-looking basis, the expected
credit losses associated with any debt instruments carried at
amortised cost. The impairment methodology applied depends on
whether there has been a significant increase in credit risk. For
trade receivables, the Group applies the simplified approach
permitted by IFRS 9, which requires expected lifetime losses to be
recognised from initial recognition of the receivables.
Taxation
Current and deferred tax is charged or credited in profit or
loss, except when it relates to items charged or credited directly
to equity, in which case the related tax is also dealt with in
equity. Current tax is calculated on the basis of the tax laws
enacted or substantively enacted at the reporting date in the
countries where the Company and its subsidiaries operate.
Deferred tax liabilities are generally recognised for all
taxable temporary differences and deferred tax assets are generally
recognised for all deductible temporary differences to the extent
that it is probable that taxable profits will be available against
which those deductible temporary differences can be utilised,
except for differences arising on investments in subsidiaries where
the Group is able to control the timing of the reversal of the
difference and it is probable that the difference will not reverse
in the foreseeable future.
Recognition of the deferred tax assets is restricted to those
instances where it is probable that a taxable profit will be
available against which the difference can be utilised.
Deferred tax is calculated based on rates enacted or
substantively enacted at the reporting date and expected to apply
when the related deferred tax asset is realised, or liability
settled.
Critical accounting estimates and judgements
The preparation of financial information in conformity with IFRS
requires the use of certain critical accounting estimates. It also
requires the Directors to exercise their judgement in the process
of applying the accounting policies which are detailed above. These
judgements are continually evaluated by the Directors and
management and are based on historical experience and other
factors, including expectations of future events that are believed
to be reasonable under the circumstances.
The key estimates and underlying assumptions concerning the
future and other key sources of estimation uncertainty at the
statement of financial position date, that have a significant risk
of causing a material adjustment to the carrying amounts of assets
and liabilities within the next financial period are reviewed on an
ongoing basis. Revisions to accounting estimates are recognised in
the period in which the estimate is revised if the revision affects
only that period, or in the period of the revision and future
periods if the revision affects both current and future
periods.
The estimates and judgements which have a significant risk of
causing a material adjustment to the carrying amount of assets and
liabilities within the next financial year are discussed below:
-- Intangible assets
The assessment of the future economic benefits generated by
these separately identifiable intangible assets and the
determination of its amortisation profile involve a significant
degree of judgement based on management estimation of future
potential revenue and profit and the useful life of the assets.
Reviews are performed regularly to ensure the recoverability of
these intangible assets.
-- Share based payments
The Company has issued share options as an incentive to certain
senior management. The fair value of options granted is recognised
as an expense with a corresponding credit to the share-based
payment reserve. The fair value is measured at grant date and
spread over the period during which the awards vest.
For equity-settled share-based payment transactions, the goods
or services received and the corresponding increase in equity are
measured directly at the fair value of the goods or services
received, unless that fair value cannot be estimated reliably. If
it is not possible to estimate reliably the fair value of the goods
or services received, the fair value of the equity instruments
granted as calculated using the Black-Scholes model is used as a
proxy.
The fair value of share-based payments is measured by use of
valuation models, which take into account conditions attached to
the vesting and exercise of the equity instruments. The expected
life used in the model is adjusted; based on management's best
estimate, for the effects of non-transferability, exercise
restrictions and behavioural considerations. The share price
volatility percentage factor used in the calculation is based on
historical share price performance of a group of peer companies as
historical share price performance was not available for the
Company on the date of grant.
4. Operating segments
The Group has disaggregated revenue into various categories in
the following table which is intended to depict how the nature,
amount, timing and uncertainty of revenue and cash flows are
affected by economic date.
2021 2020
GBP GBP
----------------------------------------- ------ -----
Revenue from sale of kits and provision
of support services 1,154 961
Primary Geographic Markets
Chile 8 7
France 32 21
Italy 95 111
Sweden 4 -
Mexico - 1
Peru 6 4
Spain 1,001 817
Germany 8 -
Total revenue per geographical
markets 1,154 961
----------------------------------------- ------ -----
5. Loss from operations
2021 2020
GBP'000 GBP'000
---------------------------------------- -------- --------
Loss is stated after charging:
Cost of inventory 561 438
Staff costs 868 385
Social security 224 111
Royalty expense 55 47
Operating expenses - External services 1,354 740
Directors salaries and fees 586 226
Depreciation and amortisation 35 23
---------------------------------------- -------- --------
5a. Auditor's remuneration
2021 2020
GBP GBP
----------------------------------------- ----- -----
Fees payable to the company's auditor
for the audit of the company's annual
accounts 25 9
Fees payable to the company's auditor
and its associates for other services:
Accounts compilation - 7
Accounting and taxation services 36 20
Total 61 36
----------------------------------------- ----- -----
7. Finance income
2021 2020
GBP'000 GBP'000
---------------------- -------- --------
Bank interest income 8 -
Other revenue 2 -
Total 10 -
---------------------- -------- --------
8. Income tax
2021 2020
GBP'000 GBP'000
-------------------------------- -------- --------
Current tax credit
GENinCode S.L.U. - (116)
Total current tax - (116)
-------- --------
Deferred tax
Accelerated capital allowances 6 -
Total current tax 6 -
-------- --------
Total 6 (116)
-------------------------------- -------- --------
The charge for the year can be reconciled to the loss in the
consolidated statement of comprehensive income as follows:
2021 2020
GBP'000 GBP'000
----------------------------------- -------- --------
(4,137) (1,050)
Expected tax credit at the UK
corporation tax rate of 19% (786) (200)
Movement in unrecognised deferred
tax asset 826 (79)
Permanent differences - (30)
Spanish deferred tax recognised
in excess of UK deferred tax (45) 193
Expenses disallowed for tax 5 -
Accelerated Capital Allowances (6) -
Total (6) (116)
----------------------------------- -------- --------
Factors affecting current and future taxation
Unrelieved tax losses carried forward have not been recognised
as a deferred tax asset as there is currently insufficient evidence
that the asset will be recoverable in the foreseeable future.
The UK budget announced on 3 March 2021 confirm an increase in
the main corporation tax rate from 19% to 25% on profits over
GBP250,000 with effect from 1 April 2023. Due to the nature of the
business and uncertainty of profit generation the rate has not been
reflected in the consolidated financial statements.
10. Earnings per share
Basic earnings per share is calculated by dividing the earnings
attributable to ordinary shareholders by the weighted average
number of ordinary shares outstanding during the period.
Diluted earnings per share is calculated using the weighted
average number of shares adjusted to assume the conversion of all
dilutive potential ordinary shares.
Reconciliations are set out below.
2021
-----------------------------------------------------------------------
Per-share
Earnings amount
-----------
Weighted
average
number of
GBP'000 shares pence
----------------------------------- --------- ----------- ----------
Basic EPS
Earnings attributable to ordinary
shareholders (4,070) 50,552,205 (8.05)
Effect of dilutive securities - - -
Diluted EPS
Adjusted earnings (4,070) 50,522,205 (8.05)
----------------------------------- --------- ----------- ----------
2020
-----------------------------------------------------------------------
Per-share
Earnings amount
-----------
Weighted
average
number of
GBP'000 shares pence
----------------------------------- --------- ----------- ----------
Basic EPS
Earnings attributable to ordinary
shareholders (1,166) 9,170,609 (12.71)
Effect of dilutive securities - - -
Diluted EPS
Adjusted earnings (1,166) 9,170,609 (12.71)
----------------------------------- --------- ----------- ----------
The Company has options issued over 8,059,500 (2020, nil)
ordinary shares.
Due to the losses incurred from continuing operations in the
years reported, there is no dilutive effect from the existing share
options.
The weighted average for 2020 assumes the sub-division of shares
per Note 20 were in place from 1 January 2020.
15. Trade and other receivables
Group
2021 2020
GBP'000 GBP'000
------------------- -------- --------
Trade receivables 234 240
Other receivables 31 1
Prepayments 134 7
Total 399 248
------------------- -------- --------
Company
2021 2020
GBP'000 GBP'000
-------------------------- -------- --------
NON-CURRENT
Intercompany receivables 2,791 -
Total 2,791 -
-------------------------- -------- --------
CURRENT
Intercompany receivables - 1,020
Trade receivables 60 65
Other receivables 31 31
Prepayments 77 -
Total 168 1,116
-------------------------- -------- --------
General terms for settlement of debt with clients are 30 days
from the date of invoice for private entities and 60 days with
public entities.
The carrying value of trade and other receivables classified at
amortised cost approximates fair value.
17. Cash and cash equivalents
Group
2021 2020
GBP'000 GBP'000
--------- -------- --------
Total 14,554 2,003
--------- -------- --------
Company
2021 2020
GBP'000 GBP'000
--------- -------- --------
Total 14,243 1,892
--------- -------- --------
Where cash at bank earns interest, interest accrues at floating
rates based on daily bank deposit rates.
The fair value of the cash & cash equivalent is as disclosed
above. For the purpose of the cash flow statement, cash and cash
equivalents comprise of the amounts shown above.
18. Trade and other payables
Group
2021 2020
GBP'000 GBP'000
---------------- -------- --------
NON-CURRENT
Trade payables 661 -
Total 661 -
---------------- -------- --------
CURRENT
Trade payables 345 193
Accruals 243 63
Tax payable 100 131
Other payables 137 177
Total 825 564
---------------- -------- --------
Company
2021 2020
GBP'000 GBP'000
---------------- -------- --------
Trade payables 100 82
Accruals 238 26
Tax payable 21 -
Other payables 4 -
Total 363 108
---------------- -------- --------
General terms for settlement of debt are 60 days in general,
after the invoice has been remitted from supplier.
The carrying value of trade and other payables classified at
amortised cost approximates fair value.
20. Share capital
2021 2020
GBP'000 GBP'000
------------------------------------ -------- --------
114,361 Ordinary Shares of GBP1.00
each 114
95,816,866 Ordinary shares of
GBP0.01 958
Total 958 114
------------------------------------ -------- --------
-- On 9 July 2021 the company subdivided 382,295 GBP1.00
Ordinary shares into 38,229,500 GBP0.01 Ordinary shares and 189,510
GBP1.00 B Ordinary shares into 18,951,000 GBP0.01 B Ordinary
shares.
-- On 9 July 2021 the company amalgamated the Ordinary and B
Ordinary shares together as Ordinary shares.
-- On 12 July 2021 the company issued 457,444 ordinary shares via a bonus share issue for 44p.
-- On 22 July 2021 the company issued 386,364 ordinary shares
via an Initial Public Offering for 44p.
-- All shares of the Company rank pari passu in all respects.
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END
FR BSGDURUBDGDL
(END) Dow Jones Newswires
May 17, 2022 02:00 ET (06:00 GMT)
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