REG - Verici Dx PLC - 2022 Annual Results
05/06/2023 07:15
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RNS Number : 5718B Verici Dx PLC 05 June 2023
Verici Dx plc
("Verici Dx" or the "Company")
2022 Annual Results
Successful transition from a research to commercial-stage company
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for
organ transplant, announces its audited final results for the year ended 31
December 2022 and provides a progress update since year end.
Strategic progress (including post-period end)
· Achieved full commercial launch of Tutivia™, the Company's first
product for the detection of acute kidney transplant rejection, in January
2023, leading to first revenues being recognised in FY 2023.
· Expanded its validation trial on Clarava™, the Company's
pre-transplant prognostic test, for a further six months following positive
initial data announced in September 2022. This decision was taken to
strengthen the publication appeal of the trial and demonstrate a statistically
robust and clinically compelling case in support of the commercial rollout and
adoption of the test. The full readout from this trial remains on track to be
announced by the end of June 2023, in line with previous guidance.
· Patient enrolment for the multi-centre clinical validation study of
our third product, Protega™, was completed in the first quarter of 2023,
assessing long-term outcomes for kidney transplant patients.
· Extended cash runway until mid-2024; the Company has retained
sufficient funding to achieve further key milestones in 2023 and the first
half of 2024 which will support commercial adoption, including the publication
of additional data and obtaining both Medicare and private payor pricing and
coverage. A further commercial and operational update will be provided
alongside the Clarava™ data readout.
Operational highlights (including post-period end)
· Announced positive results from the Tutivia™ clinical validation
study in June 2022, for the detection of acute rejection following a kidney
transplant.
· Granted CPT® Proprietary Laboratory Analyses ("PLA") codes for
Clarava™ and Tutivia™ tests by the American Medical Association ("AMA"),
providing the basis for coding and payment within the US healthcare market.
· In May 2023, a gapfill median rate of $2,650 was proposed for
Tutivia™ for kidney transplant rejection by the Centers for Medicare &
Medicaid Services ("CMS") in line with the Company's application.
· Obtained Medicaid approvals in 14 States and a further 11 States are
pending.
· Two key patents granted in the United States underpinning Verici
Dx's products.
· Achieved CLIA Certificate of Compliance for laboratory in Nashville,
TN, USA, a key requirement to obtaining insurance reimbursement coverage under
Medicare and allowing for expanded commercial launch of Tutivia™, in 45 US
states.
· Completed analytical validation for Clarava™ and Tutivia™ in
February 2022, an essential element of defining the performance
characteristics and platform capabilities of in vitro diagnostic assays and a
key milestone towards commercialisation.
· Announced a collaboration with Illumina, Inc., for early access to the
Illumina Connected Analytics (ICA) platform to expedite the operational launch
of data analysis processing and predictive artificial intelligence component
of Verici's products in due course.
Financial highlights
· Adjusted EBITDA(1) loss of $10.5m (2021: loss of $7.1m).
· Cash balance at 31 December 2022 of $9.81m (2021: $10.3m).
· Raised gross proceeds of £10.0m in March 2022 via Placing and
Subscription.
· Cash runway extended to mid-2024.
Commenting on the performance and outlook, Sara Barrington, Chief Executive
Officer, said:
"2022 was a transformational year for Verici Dx; we began the year as an
R&D-stage company, and have now commercially launched our first product,
Tutivia™, following pleasing validation study results.
"We are well placed to deliver further progress against our strategy in 2023,
building on the initial rollout of Tutivia™ and we remain on track to
announce the data read-out from the extended Clarava™ trial by the end of
June. In addition, we are taking further steps towards reimbursement that will
help accelerate commercial uptake of our lead products."
Investor briefing
As previously announced, an investor meeting covering the FY22 financial
results will be provided following the data read-out from the extended
Clarava™ trial, expected to be announced by the end of June.
Enquiries:
Verici Dx www.v (http://www.vericidx.com) ericidx (http://www.vericidx.com) .com
(http://www.vericidx.com)
Sara Barrington, CEO Via Walbrook PR
Julian Baines, Chairman
Singer Capital Markets (Nominated Adviser & Broker) Tel: +44 20 7496 3000
Aubrey Powell / Sam Butcher
Walbrook PR Limited Tel: +44 20 7933 8780 or vericidx@walbrookpr.com
(mailto:renalytix@walbrookpr.com)
Paul McManus / Stephanie Cuthbert Mob: +44 7980 541 893 / +44 7796 794 663
Sam Allen / Phillip Marriage +44 7502 558 258 / +44 7867 984 082
Footnotes:
1. Earnings before income tax, depreciation and amortisation, adjusted to
exclude exceptional items.
About Verici Dx plc www.vericidx.com (http://www.vericidx.com)
Verici Dx is a developer of a complementary suite of leading-edge tests
forming a kidney transplant platform for personalised patient and organ
response risk to assist clinicians in medical management for improved patient
outcomes. The underlying technology is based upon artificial intelligence
assisted transcriptomic analysis to provide RNA signatures focused upon the
immune response and other biological pathway signals critical for transplant
prognosis of risk of injury, rejection and graft failure from pre-transplant
to late stage. The Company also has a mission to accelerate the pace of
innovation by research using the fully characterised data from the underlying
technology and collaboration with medical device, biopharmaceutical and data
science partners.
The foundational research was driven by a deep understanding of cell-mediated
immunity and is enabled by access to expertly curated collaborative studies in
highly informative cohorts in kidney transplant.
Verici Dx's two lead products are Tutivia™, a post-transplant test focused
upon acute cellular rejection, including sub-clinical rejection and
Clarava™, a pre-transplant prognosis test for the risk of early acute
rejection. These products seek to measure how a patient is likely to respond,
and is responding, to a kidney transplant. These products are underpinned by
extensive patented and published scientific research from the leading Mount
Sinai Medical Center, for which the Company holds an exclusive worldwide
licence.
Chair Statement
I am pleased to report on the twelve months ended 31 December 2022 for Verici
Dx plc. In what has been a very difficult macroeconomic environment, the team
has successfully executed the Company's planned strategy in transitioning to a
commercial-stage company following the initial launch of Tutivia™. This
progress reflects the Company's clear product differentiation and competitive
advantages.
The validation data for Tutivia™, the Company's post-transplant blood test
focused on acute rejection including borderline and sub-clinical rejection,
was presented to the clinical community at the American Transplant Congress
(ATC) in June 2022. The results showed Tutivia's™ ability to provide
actionable data to clinicians for the care management of their patients as
early as the first week post-transplant, enabling them to react proactively to
rejection events. Tutivia's™ significantly higher positive predictive value
("PPV") than currently available single kidney transplant blood tests, as well
as the study design, was very well received by the scientific community and
illustrated the significant potential of Tutivia™ to address the urgent
clinical need for early intervention to minimise rejection post-kidney
transplantation.
Tutivia™ was fully launched in January 2023. Whilst Verici Dx is still in
the early phases of this commercial rollout, the Company is working closely
with a number of leading US transplant centres, to support the integration of
the test into their workflows and help the Verici Dx team better understand
how they can encourage consistent and recurring utilisation going forwards as
they look to accelerate the rollout in the coming months.
In addition, following the positive initial data announced in September 2022
on Clarava™, the Company's pre-transplant prognostic test, the Company chose
to expand its validation trial in order to strengthen the publication appeal
and demonstrate a statistically robust and clinically compelling case to
support the commercial rollout and adoption of the test. The data read-out
from this extended trial remains on track to be announced by the end of June,
in line with previous guidance.
Patient enrolment for the multi-centre clinical validation study of our third
product, Protega™, completed in the first quarter of 2023, assessing
long-term outcomes for kidney transplant patients. The end points of the
Protega™ validation study is expected to be reached in two years. Fibrosis
develops after a patient has had acute rejection that may have caused
antibodies to attack the kidney. Currently histology from biopsy is used to
risk stratify the degree of fibrosis. Protega™ will utilize RNA gene
signatures to more accurately risk stratify the potential outcome from
fibrosis in a transplant patient. This can help clinicians determine the
appropriate treatment to delay or reduce fibrosis progression.
The Company received CPT® Proprietary Laboratory Analyses ("PLA") codes for
Tutivia™ and Clarava™ during the year, representing the first milestone
towards commercial reimbursement for the two tests. Post year end the Company
announced that a gapfill median rate of $2,650 has been proposed for
Tutivia™ for kidney transplant rejection by the Centers for Medicare &
Medicaid Services ("CMS"). Confirmation is expected in November 2023 and the
finalised rate will apply for 3 years from 1 January 2024. The Company is
currently applying for insurance reimbursement coverage for Tutivia™ under a
Local Coverage Determination, issued by MolDx on behalf of Medicare, the US
federal health insurance program, upon publication of the trial results.
In January 2022, the Company secured a collaboration with Illumina, Inc.
(NASDAQ: ILMN), a leading developer, manufacturer and marketer of life science
tools and integrated systems for large scale analysis of genetic variation and
function, whereby Verici Dx integrated both its clinical and research products
within Illumina Connected Analytics (ICA), Illumina's state-of-the-art
software platform and strategic focus area. Verici Dx continues to work with
Illumina, to further develop its research data into a collaborative asset
within the ICA environment for future strategic opportunities.
In March 2022, Verici Dx successfully completed a fundraise, which raised
gross proceeds of £10.0 million (c.$13.0 million), a significant achievement
in a difficult fundraising environment, particularly for AIM-listed healthcare
companies. This is testament to the potential of the platform in meeting the
urgent clinical need to improve outcomes for kidney transplant patients.
Verici Dx's year-end cash position of $9.81 million provides a cash runway
until mid-2024, following recent steps taken by management to control costs
and reduce cash burn. A further commercial and operational update will be
provided alongside the Clarava™ data readout and strategic update.
On behalf of the Board, I would like to thank our employees, investors and
partners for their continued support throughout the year, and we look forward
to providing further updates on our progress over the course of 2023, as we
scale up the Tutivia™ commercial rollout, and provide the data read-out from
the extended Clarava trial later this month.
Julian Baines
Non-Executive Chairman
2 June 2023
Chief Executive Officer's Report
2022 and the post year-end period has been a time of exceptional progress for
Verici Dx as the Company achieved the key strategic goal of moving from a
research-only company to commerciality following the full launch of Tutivia™
in January 2023. In addition, we are on track to announce the data read-out
from the extended Clarava™ trial by the end of June and completed enrolment
for Protega.
The Company also achieved several other key operational milestones,
particularly in reimbursement, achieving a code, a recommended price, and
submitting the publication that will complete the application for coverage
under the Local Coverage Determination ("LCD") from MolDx. CMS issued a
clarification on reimbursement to limit coverage to a single biomarker test
per patient encounter which strengthens the value of Tutivia as a single test
demonstrating balanced accuracy in its clinical performance. We also made
significant progress in promoting our research data for future strategic
collaborations with our development work with Illumina, Inc. (NASDAQ: ILMN)
utilizing their ICA environment.
This progress has continued as we moved into 2023 with the achievement of CLIA
Certification of Compliance for our commercial clinical operations in
Nashville, Tennessee, enabling us to test samples from 45 US states,
applications for the remaining states are in progress and the intellectual
property was further secured by the issuance of two key US patents.
Strong progress on commercial rollout
In June 2022, the data from our international, multi-centre validation study
for Tutivia™ was presented, which demonstrated a significantly higher
Positive Predictive Value ("PPV") than currently available kidney transplant
single genetic expression blood tests, in order for the test to provide
clinicians with an appropriate, reliable call to action to improve patient
outcomes post-transplant. The trial also demonstrated that the test can be
used as soon as the first week post-transplant and was not confounded by other
common conditions such as BK nephropathy. The test's sensitivity when
compared with clinically indicated biopsies in the first 60 days was 83% and
overall patients were six times more likely to reject if they had a high-risk
score from Tutivia™ than those with a low risk score Early reliable data
from a single test gives Tutivia™ a well validated competitive advantage.
We commercially launched Tutivia™ in January 2023, with a number of US
transplant centres under an early adopter program. This is in line with our
strategic plan, and in these initial months we have been supporting these
centres with the adoption and integration of Tutivia™ into their clinical
pathways to encourage consistent and recurring utilisation. This is providing
valuable information for us to make Tutivia™ as simple as possible for
clinicians to use and interpret.
In addition, following the positive initial data announced in September 2022
on Clarava™, the Company's pre-transplant prognostic test, the Company chose
to expand its validation trial for this lead product to strengthen the
publication appeal and demonstrate a statistically robust and clinically
compelling case to support the commercial rollout and adoption of the test.
The data read-out from this extended trial remains on track to be announced by
the end of June 2023, in line with previous guidance.
Protega™ enrolment was completed in the first quarter of 2023, an important
milestone achieved in the completion of our platform offering end to end
transplant testing, from pre-transplant to long-term damage. We expect that
the final validation point will be completed after follow-up at the 24-month
point for the last patient tested, which is expected to be in Q1 2025. The
Company expects to be able to review interim data before that date.
Clear product differentiation and competitive advantages
Our portfolio of innovative kidney transplant tests use advanced
next-generation sequencing to define a personalised risk profile for each
patient using RNA signatures. This allows for the early prognosis of
transplant rejection, deciphering the body's early genetic messages that are
specific to acute rejection. This is a significant advantage over currently
available tests, which detect evidence of damage already occurred and may be
confounded by other conditions.
Our tests enable doctors to make accurate, data-driven clinical decisions, to
assist their care decision-making for patients including choices made about
immunosuppressive therapy protocols and may also inform other aspects of the
post-transplant care pathway over time. This has not only near-term scope to
reduce the unnecessary and serious consequences from over- or under-dosing for
immunosuppression in conjunction with kidney transplant, but also to improve
the longevity of transplanted kidneys and, by reducing the risk and rate of
transplant failure, much broader potential to deliver huge health economic
benefits by improving transplant outcomes.
Tutivia™ has a number of important differentiators from current biomarker
tests. One is the ability to return results as early as the first week
post-transplant for all types of patients. This enables clinicians to act
proactively, rather than reactively, to rejection events. Tutivia™ is also
able to detect sub-acute rejection (before there are other clinical signs) and
is also able to distinguish between rejection and other confounding factors
such as the BK virus.
Currently available single blood tests that look for signs of transplant
damage typically have a high Negative Predictive Value ("NPV") but are
non-specific. This means that if the blood test returns a negative result,
clinicians can be confident that there is no current rejection occurring but
uncertain whether a positive result is from a rejection or an infection, or
physical trauma.
Consequently, these tests function primarily as a 'rule out' tool, but this is
limiting for clinicians, who may need to know with some degree of confidence
whether their patient requires further interventions.
Crucially, our validation study was a blinded 'all-comers' patient population
across 13 international transplant centres. This means that we were able to
test the power of Tutivia™ within a clinically realistic context that
included all types of rejection. We believe that Tutivia™ is the only
product currently on the market to have been validated so comprehensively.
Turning to the Company's second lead product, Clarava™, its initial
validation results were announced in September 2022, and indicated that the
test was able to identify pre-transplant patients most likely to experience a
future kidney rejection event, which has broad implications for treatment
planning and monitoring. The data read-out from the extended trial for Clarava
remains on track to be announced by the end of June 2023.
Delivery of significant operational milestones
In January 2022, we received CPT® Proprietary Laboratory Analyses ("PLA")
codes for Clarava™ and Tutivia™, from the American Medical Association, an
important first step towards commercial reimbursement. CPT® codes offer
health care professionals a uniform language for coding medical services and
procedures and allow clinical laboratories to more specifically identify their
tests when billing Medicare and commercial insurers.
In February 2022, we successfully completed analytical validation for
Clarava™ and Tutivia™, an essential element of defining the performance
characteristics and platform capabilities of in vitro diagnostic assays.
Analytical validation is an important step towards reimbursement coverage
assessment.
We announced in March 2023 that we had successfully progressed our laboratory
registration status to Compliance Certification by the Centers for Medicare
& Medicaid ("CMS'), allowing our commercial clinical operations to process
samples from 45 US states. This followed an inspection by CMS of our clinical
laboratory in Franklin, Tennessee, and represents a major milestone toward US
Medicare reimbursement. The Company is now preparing its submission for
Medicare insurance reimbursement coverage, which will be key to driving
adoption. Eligibility for Medicaid has been approved in 14 states and
submitted in a further 11 states. Eligibility has also been approved with
BlueCross Blue Shield of Tennessee, the largest health benefit plan company in
Tennessee, where the Company's clinical laboratory is located.
Also in March 2023, the Company announced it has been granted two key patents
in the United States that support and protect the Company's core technologies
in RNA signature biomarker tests used for assessment of the prognostic risk
pre-transplant (Clarava™) and post-transplant (Tutivia™) of acute kidney
transplant rejection. The protection of the Company's intellectual property is
fundamental to our strategy of amassing full transcriptomic data from the
biological systems and interactions associated with transplant rejection and,
over the longer term, informing transplant analysis in other organs and in the
broader field of immune-mediated diseases.
In May 2023, the price recommendation from MolDx was issued in line with
Company expectations and highly indicative for the national listing at the end
of the year following a period of public consultation, with a listed price
then being valid for three years from January 2024.
Completion of partnerships and agreements
In January 2022 we entered into a collaboration with Illumina, granting us
early access to Illumina Connected Analytics (ICA), Illumina's new software
platform, which provides us with the ability to process large datasets in a
streamlined manner. This supports our leading-edge technology approach and
provides a foundation for future data science discovery, expansion and
collaboration opportunities.
Collaborating with such a high-quality partner as Illumina is an indicator of
the strength of our platform, and access to the ICA platform has materially
enhanced our data processing capabilities, as well as boosted our ability to
develop highly predictive products in the future. This partnership supports
our wider goal of improving patient outcomes within organ transplantation,
where there remains an urgent clinical need.
Management and staff
As of 31 December 2022, the Company had 15 Full Time Equivalents ("FTE")
employees.
Financials
Statement of Comprehensive Income
The adjusted EBITDA loss, being the loss for the year, before the deduction of
interest, taxation, amortisation and depreciation, and excluding the
share-based payments charge, was US$10,497,000 (2021: US$7,151,000) The
increase arises from the significant increase in clinical trial and associated
costs, including the hiring of six new members of the team in the year, of
which three were hired to commence the commercial launch of Tutivia(TM). The
largest items of expenditure remain staff costs of US$2,889,000 (2021:
US$2,392,000) and research and development costs of US$4,832,000 (2021:
US$3,344,000). All research and development costs arise from third parties,
this does not include any allocation of internal costs. We started the year
with 10 full time employees and ended the year with 15 full time employees,
both numbers excluding our non-executive directors.
Statement of Financial Position and Cash Flows
Cash balance at year end was US$9,805,000 (2021: US$10,340,000). Cash
outflow from operations was US$10,068,000 (2021: US$6,336,000) with cash
outflow on additions to tangible and intangible assets of US$1,308,000 (2021:
US$966,000). The biggest constituent of spend on capital expenditure being
the construction of our CLIA laboratory in Tennessee. In March 2022 we
concluded a share issue raising gross proceeds of GBP10.0m, which after costs
generated a net cash inflow of US$12,629,000.
Within current and non-current liabilities, we entered a financing transaction
in December 2022 to secure favourable terms on a new sequencer. At 31
December 2022 the liability was US$239,000 (2021: US$Nil). We also entered
into a five-year lease on our new CLIA laboratory in Tennessee in September
2022 resulting in the recognition of a right of use asset and corresponding
liability. At 31 December 2022 the liability was US$461,000 (2021: US$Nil).
The largest balance within our accruals continues to be our accruals for
costs incurred at the clinical trial sites not yet invoiced being US$912,000
(2021 - US$851,000).
As of 31 December 2022, the Company had a cash balance of $9.81m. The Company
has closed the New York Laboratory, taken headcount reduction and clinical
trial cost containment steps in recent months and, as a result, has extended
the current cash runway to last until mid-2024. The Company is focused on
early revenue generation during the first half of this year and will seek to
extend and broaden its revenue streams from additional centres in the second
half of 2023.
Outlook
Over the course of 2023, we will look to gradually accelerate the Tutivia™
commercial rollout with more leading US centres and expect to expand our first
revenues. We expect to secure both Medicare and private payor pricing and
coverage for Tutivia™ this year, which will be a key catalyst in enabling a
more widespread adoption of the test. Following our receipt of the CLIA
Certificate of Compliance, we will also look to receive full accreditation in
the remaining five states that are not covered under the CLIA certification,
including New York.
As announced on 31 May, the data read-out from the extended Clarava™ trial
remains on track to be announced by the end of June 2023.
We are also looking to extend and broaden our revenue streams this year, which
could include potential collaborations with pharmaceutical and medtech/data
companies that could benefit from the application of the Company's
transcriptomic analysis technology in different settings.
We are developing a health economics model to aid our commercialisation
efforts, which we expect to submit for publication by the end of the year. We
are also expected to engage in clinical utility and real-world evidence
studies to further support adoption of our products both later this year and
into next year.
On behalf of the Board, I would like to thank the shareholders for their
support in this transformational year for the Company and we look forward to
delivering further commercial progress over the course of 2023 as we continue
to deliver on our strategy of transforming kidney transplant outcomes.
Sara Barrington
Chief Executive Officer
2 June 2023
Consolidated statement of profit or loss and other comprehensive income
for the year ended 31 December 2022
Year to Year to
31 December 31 December
Note 2022 2021
US$'000 US$'000
Administrative expenses 5 (10,497) (7,151)
Depreciation and amortisation (640) (438)
Exceptional expense - share based payments 20 (318) (740)
_________ _________
Loss from operations (11,455) (8,329)
Finance income 9 53 -
Finance expense 9 (5) -
_________ _________
Loss before tax (11,407) (8,329)
Tax expense 10 - -
_________ _________
Loss from continuing operations (11,407) (8,329)
Other comprehensive income:
Exchange (losses) / gains arising on translation of foreign operations (2,016) (50)
_________ _________
Total comprehensive income (13,423) (8,379)
_________ _________
Earnings per share attributable to the 11
ordinary equity holders of the parent
Loss per share
Basic and diluted (US$) ($0.069) ($0.059)
_________ _________
The results reflected above relate to continuing operations.
Consolidated statement of financial position
as at 31 December 2022
Note 2022 2021
US$'000 US$'000
Assets
Current assets
Trade and other receivables 15 520 656
Cash and cash equivalents 9,805 10,340
_________ _________
10,325 10,996
_________ _________
Non-current assets
Property, plant and equipment 12 2,010 786
Intangible assets 13 1,970 2,007
_________ _________
3,980 2,793
_________ _________
Total assets 14,305 13,789
_________ _________
Liabilities
Current liabilities
Trade and other payables 16 (2,096) (1,804)
Lease liabilities 17 (156) -
Non-current liabilities 17 (544) -
_________ _________
NET ASSETS 11,509 11,985
_________ _________
Issued capital and reserves attributable to
owners of the parent
Share capital 18 219 182
Share premium reserve 19 32,946 20,354
Share-based payments reserve 19 3,853 3,535
Foreign exchange reserve (1,037) 979
Retained earnings (24,472) (13,065)
_________ _________
TOTAL EQUITY 11,509 11,985
_________ _________
Consolidated statement of cash flows
for the year ended 31 December 2022
Year to Year to
31 December 31 December
Note 2022 2021
US$'000 US$'000
Cash flows from operating activities
Loss from operations (11,407) (8,329)
Adjustments for:
Depreciation of property, plant and equipment 497 295
Amortisation of intangible fixed assets 143 143
Finance income (53)
Finance expense 5 -
Share-based payment expense 318 740
_________ _________
(10,497) (7,151)
Decrease / (increase) in trade and other receivables 136 (331)
Increase in trade and other payables 293 1,146
Income taxes paid - -
_________ _________
Net cash outflow from operating activities (10,068) (6,336)
_________ _________
Cash flows from investing activities
Purchases of property, plant and equipment (1,040) (618)
Purchase of intangibles (268) (348)
_________ _________
Net cash used in investing activities (1,308) (966)
Cash flows from financing activities
Issue of ordinary shares 13,070 -
Expenses of share issue (441) -
Interest received 53 -
Interest paid (5) -
Repayment of lease liabilities (3) -
Loan repayments - (74)
_________ _________
Net cash inflow / (outflow) from financing activities 12,674 (74)
Net increase / (decrease) in cash and cash equivalents 1,298 (7,376)
Cash and cash equivalents at beginning of year 10,340 17,751
Exchange (losses) / gains on cash and cash equivalents (1,833) (35)
_________ _________
Cash and cash equivalents at end of year 4 9,805 10,340
_________ _________
Consolidated statement of changes in equity
for the year ended 31 December 2022
Share Share Share-based Foreign Retained Total Total
capital premium payment exchange earnings attributable equity
reserve reserve to equity
holders of
parent
US$ US$ US$ US$ US$ US$ US$
1 January 2021 182 20,354 2,795 1,029 (4,736) 19,624 19,624
Comprehensive income for the period
Loss - - - - (8,329) (8,329) (8,329)
Other comprehensive Income - - - (50) - (50) (50)
_________ _________ _________ _________ _________ _________ _________
Total comprehensive Income for the year - - - (50) (8,329) (8,379) (8,379)
_________ _________ _________ _________ _________ _________ _________
Contributions by and distributions to owners
Share-based payment - - 740 - - 740 740
_________ _________ _________ _________ _________ _________ _________
Total contributions by and - - 740 - - 740 740
distributions to owners
_________ _________ _________ _________ _________ _________ _________
31 December 2021 182 20,354 3,535 979 (13,065) 11,985 11,985
_________ _________ _________ _________ _________ _________ _________
Consolidated statement of changes in equity
for the year ended 31 December 2022 (continued)
Share Share Share-based Foreign Retained Total Total
capital premium payment exchange earnings attributable equity
reserve reserve to equity
holders of
parent
US$ US$ US$ US$ US$ US$ US$
1 January 2022 182 20,354 3,535 979 (13,065) 11,985 11,985
Comprehensive income for the year
Loss - - - - (11,407) (11,407) (11,407)
Other comprehensive Income - - - (2,016) - (2,016) (2,016)
_________ _________ _________ _________ _________ _________ _________
Total comprehensive Income for the year - - - (2,016) (11,407) (13,423) (13,423)
_________ _________ _________ _________ _________ _________ _________
Contributions by and distributions to owners
Issue of share capital 37 13,033 - - - 13,070 13,070
Costs of share issue - (441) - - - (441) (441)
Share-based payment - - 318 - - 318 318
_________ _________ _________ _________ _________ _________ _________
Total contributions by and 37 12,592 318 - - 12,947 12,947
distributions to owners
_________ _________ _________ _________ _________ _________ _________
31 December 2022 219 32,946 3,853 (1,037) (24,472) 11,509 11,509
_________ _________ _________ _________ _________ _________ _________
Notes forming part of the consolidated financial statements
for the year ended 31 December 2022
1 General information
The principal activity of Verici Dx plc (the "Company") is the development of
prognostic and diagnostic tests for kidney transplant patients.
The Company is a public limited company incorporated in England and Wales and
domiciled in the UK. The address of the registered office is Avon House, 19
Stanwell Road, Penarth, Cardiff CF64 2EZ and the company number is 12567827.
The Company was incorporated as Verici Dx Limited on 22 April 2020 as a
private company and on 9 September 2020 the Company was re-registered as a
public company and changed its name to Verici Dx plc.
2 Summary of significant accounting policies
The principal accounting policies adopted in the preparation of the historical
financial information of the Company, which have been applied consistently to
the period presented, are set out below:
Basis of preparation
Information in this preliminary announcement does not constitute statutory
accounts of the Group within the meaning of section 434 of the Companies Act
2006. The annual financial information presented in this preliminary
announcement is based on, and is consistent with, that in the Group's audited
financial statements for the year ended 31 December 2022. Those financial
statements will be delivered to the Registrar of Companies following the
Company's Annual General Meeting. The financial statements of the Group are
prepared in accordance with UK-adopted International Accounting Standards ("UK
IFRS") and applicable law. The independent auditors' report on those financial
statements is unqualified and does not contain any statement under section 498
(2) or 498 (3) of the Companies Act 2006. The independent auditors' report
draws attention to the material uncertainty referred to below under 'Going
concern'.
The functional currency and the presentational currency of the Company is
United States dollars ("USD" or "US$") as this is the currency of the primary
economic environment that the Company operates in.
New standards are not expected to impact the Company or Group as they are
either not relevant to the Company's or Group's activities or require
accounting which is consistent with the Company's and Group's current
accounting policies. The Directors have considered those standards and
interpretations which have not been applied in these financial statements but
which are relevant to the Company's or Group's operations that are in issue
but not yet effective and do not consider that they will have a material
effect on the future results of the Company or Group.
Other
The Group does not expect any other standards issued by the IASB, but not yet
effective, to have a material impact on the group.
Measurement convention
The financial information has been prepared under the historical cost
convention. Historical cost is generally based on the fair value of the
consideration given in exchange for assets.
The preparation of the financial information in compliance with IFRS requires
the use of certain critical accounting estimates and management judgements in
applying the accounting policies. The significant estimates and judgements
that have been made and their effect is disclosed in note 3.
Basis of consolidation
Where the Company has control over an investee, it is classified as a
subsidiary. The Company controls an investee if all three of the following
elements are present: power over the investee, exposure to variable returns
from the investee, and the ability of the investor to use its power to affect
those variable returns.
Control is reassessed whenever facts and circumstances indicate that there may
be a change in any of these elements of control.
The consolidated financial statements present the results of the Company and
its subsidiaries ("the Group") as if they formed a single entity. Intercompany
transactions and balances between group companies are therefore eliminated in
full.
The consolidated financial statements incorporate the results of business
combinations using the acquisition method. In the statement of financial
position, the acquiree's identifiable assets, liabilities and contingent
liabilities are initially recognised at their fair values at the acquisition
date. The results of acquired operations are included in the consolidated
statement of profit or loss and other comprehensive income from the date on
which control is obtained. They are deconsolidated from the date on which
control ceases.
Going concern
In view of the early stage of its commercial development the Group funds its
activities from existing cash resources, the generation of cash receipts from
commercial revenues in future periods and, if required, additional equity or
debt funding for future working capital needs.
The Group did not generate any commercial revenue in the period but continues
to execute the commercial introduction of Tutivia™, the first product for
kidney transplant rejection. The Group will only expand its sales headcount if
revenue demand exceeds current expectation and can also explore other
strategic options to increase sales distribution of Tutivia and launch its
second lead product, Clarava™ by the end of 2023. The Company retains
sufficient funding to achieve further key milestones in 2023 and the first
half of 2024, which will support commercial adoption including the publication
of additional data and obtaining both Medicare and private payor pricing and
coverage.
At 31 December 2022 the Group had available cash resources of $9.8 million
(2021 - $10.3 million). The Group is focused on early revenue generation and
first revenue is expected during the first half of 2023. The Group will seek
to extend and broaden its revenue streams from additional medical centres in
the second half of 2023. There are, however, uncertainties in relation to the
quantum and timing of cash receipts from revenue. The Group has therefore
taken headcount reduction and clinical trial cost containment steps in recent
months and, as a result, has extended the current cash runway.
The Directors have prepared cash flow forecasts for the Group for a period of
at least 12 months from the date of approval of these financial statements.
Those forecasts include estimates of cash receipts from commercial revenues at
levels in line with market expectations. The Directors have also prepared a
number of reasonably possible sensitivity scenarios including reduced levels
of cash receipts from revenues, and a scenario in which the Group receives no
cash at all from commercial revenues in the going concern period, even though
that is not considered to be a reasonably possible outcome.
Having considered the cash flow forecasts and sensitivity scenarios above and
taken into account the information and estimates available at the date of
approving these financial statements, the directors consider it is appropriate
to adopt the going concern basis in preparing the financial statements for the
group. Although the company's projections, including expected levels of
revenue generation, indicate sufficient funds through to the second half of
2024, it is reasonably possible that the group will require additional funding
during, or shortly after a period of 12 months from the date of approval of
these financial statements. The directors will seek to put in place funding
arrangements which may from time to time be required but such arrangements are
not presently committed. This represents a material uncertainty in relation to
the group's funding arrangements.
Taxation
Income tax expense represents the sum of the tax currently payable and
deferred tax.
Current tax
Current tax payable is based on taxable profit for the year. Taxable profit
differs from net profits as reported in the income statement because it
excludes items of income or expense that are taxable or deductible in other
years and it further excludes items that are never taxable or deductible. The
Company's liability for current tax is calculated using tax rates that have
been enacted or substantially enacted by the reporting end date.
Deferred tax
Deferred tax is the tax expected to be payable or recoverable
on temporary differences between the carrying amounts of assets and
liabilities in the historical financial information and the corresponding tax
bases used in the computation of taxable profit and is accounted for using the
balance sheet liability method. Deferred tax liabilities are generally
recognised for all taxable temporary differences and deferred tax assets are
recognised to the extent that it is probable that taxable profits will be
available against which deductible temporary differences can be utilised. Such
assets and liabilities are not recognised if the temporary differences arise
from goodwill or from the initial recognition of other assets and liabilities
in a transaction that affects neither the tax profit nor the accounting
profit.
The carrying amount of deferred tax assets is reviewed at each
reporting end date and reduced to the extent that it is no longer probable
that sufficient taxable profits will be available to allow all or part of the
asset to be recovered. Deferred tax is calculated at the tax rates that are
expected to apply in the period when the liability is settled, or the asset is
realised. Deferred tax is charged or credited in the income statement, except
when it relates to items charged or credited directly to equity, in which case
the deferred tax is also dealt with in equity. Deferred tax assets and
liabilities are offset when the company has a legally enforceable right to
offset current tax assets and liabilities and the deferred tax assets and
liabilities relate to taxes levied by the same tax authority.
Share-based payments
Where equity settled share options are awarded to employees, the fair value of
the options at the date of grant is charged to the consolidated statement of
comprehensive income over the vesting period. Non-market vesting conditions
are taken into account by adjusting the number of equity instruments expected
to vest at each reporting date so that, ultimately, the cumulative amount
recognised over the vesting period is based on the number of options that
eventually vest. Non-vesting conditions and market vesting conditions are
factored into the fair value of the options granted. As long as all other
vesting conditions are satisfied, a charge is made irrespective of whether the
market vesting conditions are satisfied. The cumulative expense is not
adjusted for failure to achieve a market vesting condition or where a
non-vesting condition is not satisfied.
Where equity instruments are granted to persons other than employees, the
consolidated statement of comprehensive income is charged with the fair value
of goods and services received.
Foreign currency translation
a) Function and presentational currency
Items included in the financial statements of the Group are
measured using USD, the currency of the primary economic environment in which
the entity operates ('the functional currency'), which is also the Company's
presentation currency.
b) Transactions and balances
Foreign currency transactions are translated into the functional currency
using the exchange rates prevailing at the dates of the transactions. Foreign
exchange gains and losses resulting from the settlement of such transactions
and from the translation at year-end exchange rates, of monetary assets and
liabilities denominated in foreign currencies to USD, are recognised in the
income statement.
Intangible assets
Intangible assets are measured at cost less accumulated amortisation and any
accumulated impairment losses.
Patents are recognised at fair value at the acquisition date. Patents have a
finite useful life and are subsequently carried at cost less accumulated
amortisation and impairment losses.
The Company amortises intangible assets with a limited useful life on a
straight-line basis. The following rates are applied:
Licence and patents - the shorter of the remaining life of the license and 15
years
Tangible assets
Tangible fixed assets are stated at cost net of accumulated depreciation and
accumulated impairment losses. Costs comprise purchase costs together with any
incidental costs of acquisition.
Depreciation is provided to write down the cost less the estimated residual
value of all tangible fixed assets by equal instalments over their estimated
useful economic lives on a straight-line basis. The following rates are
applied:
Plant and machinery - 3 years
The assets' residual values, useful lives and depreciation methods are
reviewed, and adjusted prospectively if appropriate, if there is an indication
of a significant change since the last reporting date. Low value equipment
including computers is expensed as incurred.
Impairment of tangible and intangible assets
At each reporting end date, the Company reviews the carrying amounts of its
tangible and intangible assets to determine whether there is any indication
that those assets have suffered an impairment loss. If any such indication
exists, the recoverable amount of the asset is estimated in order to determine
the extent of the impairment loss (if any). Where it is not possible to
estimate the recoverable amount of an individual asset, the Company estimates
the recoverable amount of the cash-generating unit to which the asset belongs.
The recoverable amount is the higher of fair value less costs to sell and
value in use. In assessing value in use, the estimated future cash flows are
discounted to their present value using a pre-tax discount rate that reflects
current market assessments of the time value of money and the risks specific
to the asset for which the estimates of future cash flows have not been
adjusted.
If the recoverable amount of an asset (or cash-generating unit) is estimated
to be less than its carrying amount, the carrying amount of the asset (or
cash-generating unit) is reduced to its recoverable amount. An impairment loss
is recognised immediately in profit and loss, unless the relevant asset is
carried at a revalued amount, in which case the impairment loss is treated as
a revaluation decrease.
Where an impairment subsequently reverses, the carrying amount of the asset
(or cash-generating unit) is increased to the revised estimate of its
recoverable amount, but so that the increased carrying amount does not exceed
the carrying amount that would have been determined had no impairment loss
been recognised for the asset (or cash-generating unit) in prior years. A
reversal of an impairment loss is recognised immediately in profit and loss.
Leases
All leases are accounted for by recognising a right-of-use asset and a lease
liability except for:
· Leases of low value assets; and
· Leases with a duration of 12 months or less.
Lease liabilities are measured at the present value of the contractual
payments due to the lessor over the lease term, with the discount rate
determined by reference to the rate inherent in the lease unless (as is
typically the case) this is not readily determinable, in which case the
Company's incremental borrowing rate on commencement of the lease is used.
Variable lease payments are only included in the measurement of the lease
liability if they depend on an index or rate. In such cases, the initial
measurement of the lease liability assumes the variable element will remain
unchanged throughout the lease term. Other variable lease payments are
expensed in the period to which they relate.
On initial recognition, the carrying value of the lease liability also
includes:
· amounts expected to be payable under any residual value guarantee
· the exercise price of any purchase option granted in favour of the
Company if it is reasonably certain to assess that option
· any penalties payable for terminating the lease, if the term of the
lease has been estimated on the basis of termination option being exercised.
Right of use assets are initially measured at the amount of the lease
liability, reduced for any lease incentives received, and increased for:
· lease payments made at or before commencement of the lease
· initial direct costs incurred; and
· the amount of any provision recognised where the Company is
contractually required to dismantle, remove or restore the leased asset
(typically leasehold dilapidations - see note 19).
Subsequent to initial measurement lease liabilities increase as a result of
interest charged at a constant rate on the balance outstanding and are reduced
for lease payments made. Right-of-use assets are amortised on a straight-line
basis over the remaining term of the lease or over the remaining economic life
of the asset if, rarely, this is judged to be shorter than the lease term.
When the company revises its estimate of the term of any lease (because, for
example, it re-assesses the probability of a lessee extension or termination
option being exercised) it adjusts the carrying amount of the lease liability
to reflect the payments to make over the revised term, which are discounted
using a revised discount rate. The carrying value of lease liabilities is
similarly revised when the variable element of future lease payments dependent
on a rate or index is revised, except the discount rate remains unchanged. In
both cases an equivalent adjustment is made to the carrying value of the
right-of-use asset, with the revised carrying amount being amortised over the
remaining (revised) lease term. If the carrying amount of the right-of-use
asset is adjusted to zero, any further reduction is recognised in profit or
loss.
Financial instruments
The Company classifies financial instruments, or their component parts, on
initial recognition as a financial asset, a financial liability or an equity
instrument in accordance with the substance of the contractual arrangement.
Financial assets and financial liabilities are recognised on the statement of
financial position when the Company becomes a party to the contractual
provisions of the instrument.
a) Financial assets
Financial assets are classified, at initial recognition, at amortised cost or
carrying value. The classification of financial assets at initial
recognition depends on the financial asset's contractual cash flow
characteristics and the Company's business model for managing them.
The classification depends on the purpose for which the financial assets were
acquired. Management determines the classification of its financial assets at
initial recognition and re-evaluates this classification at every reporting
date.
As at the reporting date, the Company did not have any financial assets
subsequently measured at fair value.
b) Financial liabilities
All financial liabilities are initially measured at fair value and, in the
case of loans and borrowings, net of directly attributable transaction costs.
They are subsequently measured at amortised cost, where applicable, using the
effective interest method, with interest expense recognised on an effective
yield basis.
c) Cash and cash equivalents
Cash and cash equivalents comprise cash balances and deposits with a maturity
of less than three months at balance sheet date.
Financing expenses
Financing expenses comprise interest payable. Foreign exchange gains and
losses arising on foreign currency transactions are reported within
administrative expenses in the statement of comprehensive income.
Interest payable is recognised in the statement of comprehensive income as it
accrues, using the effective interest method.
Exceptional items
Items considered of such significance to enable the reader to better
understand the results for the year are presented separately as exceptional
items on the face of the statement of comprehensive income.
Research and development costs
Development costs and expenditure on pure and applied research and the
clinical trials are charged to the Income Statement in the year in which they
are incurred. Expenditure incurred on the development of internally
generated products will be capitalised based on the recognition criteria set
aside in IAS 38 "Intangible Assets".
Operating segments
The directors are of the opinion that the business of the Group comprises a
single activity, that of the development of prognostic and diagnostic tests
for kidney transplant patients. Consequently, all activities relate to this
segment.
All the non-current assets of the Company are located in, or primarily relate
to, the USA.
3 Judgements and key sources of estimation uncertainty
The preparation of the Company's historical financial information under UK
IFRS requires the Directors to make estimates and assumptions that affect the
reported amounts of assets and liabilities and the disclosure of contingent
assets and liabilities. Estimates and judgements are continually evaluated and
are based on historical experience and other factors including expectations of
future events that are believed to be reasonable under the circumstances.
Actual results may differ from these estimates.
The Directors consider that the following estimates and judgements are likely
to have the most significant effect on the amounts recognised in the financial
information.
Carrying value of intangible assets, property, plant and equipment
In determining whether there are indicators of impairment of the Company's
intangible assets, the Directors take into consideration various factors
including the economic viability and expected future financial performance of
the asset and when it relates to the intangible assets arising on a business
combination, the expected future performance of the business acquired.
Carrying value of amounts owed by subsidiary undertaking
The operations of the wholly owned subsidiary, Verici Dx Inc, are funded by
the parent company, Verici Dx Plc. As such a receivable balance arises
reflecting the funds advanced. The recoverability of this balance is
dependent upon the economic viability and expected performance of the Group's
developed products.
4 Financial instruments - Risk Management
The Group is exposed through its operations to the following financial risks:
- Credit risk
- Foreign exchange risk
- Liquidity risk and
- Capital disclosures
The Group is exposed to risks that arise from its use of financial
instruments. This note describes the Group's objectives, policies and
processes for managing those risks and the methods used to measure them.
Further quantitative information in respect of these risks is presented
throughout these financial statements.
(i) Principal financial instruments
The principal financial instruments used by the Group, from which financial
instrument risk arises, are as follows:
- Cash and cash equivalents
- Trade and other payables
(ii) Financial instruments by category
Financial asset
Group Company Group Company
Amortised Amortised Amortised Amortised
cost cost cost cost
2022 2022 2021 2021
US$'000 US$'000 US$'000 US$'000
Cash and cash equivalents 9,805 9,345 10,340 10,024
Trade and other receivables 177 18 250 17
Amounts due from subsidiary - 18,122 - 8,226
_________ _________ _________ _________
9,982 9,363 10,590 10,041
Total financial assets _________ _________ _________ _________
Financial liabilities
Group Company Group Company
Amortised Amortised Amortised Amortised
cost cost cost cost
2022 2022 2021 2021
US$'000 US$'000 US$'000 US$'000
Trade and other payables 2,096 105 1,754 131
Leases 700 - - -
_________ _________ _________ _________
Total financial liabilities 2,796 105 1,754 131
_________ _________ _________ _________
(iii) Financial instruments not measured at fair value
Financial instruments not measured at fair value includes cash and cash
equivalents, trade and other receivables, and trade and other payables.
Due to their short-term nature, the carrying value of cash and cash
equivalents, trade and other receivables, and trade and other payables
approximates their fair value.
(iv) Financial instruments measured at fair value
General objectives, policies and processes
The Board has overall responsibility for the determination of the Group's risk
management objectives and policies and, whilst retaining ultimate
responsibility for them, it has delegated the authority for designing and
operating processes that ensure the effective implementation of the objectives
and policies to the Group's finance function.
The overall objective of the Board is to set policies that seek to reduce risk
as far as possible without unduly affecting the Group's competitiveness and
flexibility. Further details regarding these policies are set out below:
Credit risk
Credit risk is the risk of financial loss to the Group if a customer or
counterparty to a financial instrument fails to meet its contractual
obligations. Due to the absence of revenue, the Group's exposure to credit
risk is on cash at bank. The Company only deposits cash with major banks
with high quality credit standing for amounts in excess of US$500,000.
Cash in bank and short-term deposits
The credit quality of cash has been assessed by reference to external credit
rating, based on Standard and Poor's long-term / senior issuer rating:
Group Group Company Company
2022 2022 2022 2022
Cash Cash
Rating at bank Rating at bank
US$'000 US$'000
Bank A A+ 9,345 A+ 9,345
Bank B 260 -
Bank C A+ 200 -
_________ _________
9,805 9,345
_________ _________
Group Group Company Company
2021 2021 2021 2021
Cash Cash
Rating at bank Rating at bank
US$'000 US$'000
Bank A A+ 10,024 A+ 10,024
Bank B 316 -
_________ _________
10,340 10,024
_________ _________
Foreign exchange risk
Foreign exchange risk arises when individual Group entities enter into
transactions denominated in a currency other than their functional currency.
The Group's policy is, where possible, to allow group entities to settle
liabilities denominated in their functional currency. In the period before
commercial revenues US dollars are transferred from the Company to its US
subsidiary to enable it to meet its local obligations. Currently the Group's
liabilities are either US dollar or UK sterling. No forward contracts or
other financial instruments are entered into to hedge foreign exchange
movements, with funds being transferred from the Company to its US subsidiary
using spot rates.
As at 31 December 2022 assets held in Sterling amounted to US$270,000 (2021 -
US$3,538,000) and liabilities held in Sterling amounted to US$105,000 (2021 -
US$131,000).
The effect of a 5% strengthening of the Sterling against US dollar at the
reporting date on the Sterling denominated net assets carried at that date
would, all other variables held constant, have resulted in a decrease in
post-tax loss for the period and increase of net assets of US$8,000 (2021 -
US$170,000). A 5% weakening in the exchange rate would, on the same basis,
have increased post-tax loss and decreased net assets by US$8,000 (2021 -
US$170,000).
Liquidity risk
Liquidity risk is the risk that the Group will encounter difficulty in meeting
its financial obligations as they fall due. This risk is managed by the
production of rolling cash flow projections. The Group's continued future
operations depend on its ability to raise sufficient working capital through
the issue of share capital and generating revenue.
The following table sets out the contractual maturities (representing
undiscounted contractual cash-flows) of financial liabilities which can all be
met from the cash resources currently available:
Between Between Between
Group Up to 3 3 and 12 1 and 2 2 and 5
months months years years
At 31 December 2022 US$'000 US$'000 US$'000 US$'000
Trade and other payables 960 - - -
Leases 45 111 167 377
_________ ________ ________ ________
Total 1,005 111 167 377
_________ ________ ________ ________
Between
Company Up to 3 3 and 12
months Months
At 31 December 2022 US$'000 US$'000
Trade and other payables 19 -
_________ _________
Total 19 -
_________ _________
Between
Group Up to 3 3 and 12
Months months
At 31 December 2021 US$'000 US$'000
Trade and other payables 159 -
Leases - -
_________ _________
Total 159 -
_________ _________
Between
Company Up to 3 3 and 12
Months Months
At 31 December 2021 US$'000 US$'000
Trade and other payables 16 -
_________ _________
Total 16 -
_________ _________
Capital Disclosures
The Group monitors capital which comprises all components of equity (i.e.
share capital, share premium, and accumulated losses).
The Group's objectives when maintaining capital are to safeguard the entity's
ability to continue as a going concern.
5 Expenses by nature
Year to Year to
31 December 31 December
2022 2021
US$'000 US$'000
Employee benefit expenses (see note 7) 2,889 2,392
Depreciation of property, plant and equipment 497 295
Amortisation of intangible assets 143 143
Research and development costs 4,832 3,344
Licenses 550 250
Professional costs 1,325 921
Share-based payment expense for non-employees 129 309
Foreign exchange loss / (gain) 36 (182)
Other costs 964 857
Costs of share issue 90 -
6 Auditors' remuneration
During the year the Group obtained the following services from the Company's
auditor:
Year to Year to
31 December 31 December
2021 2021
US$'000 US$'000
Fees payable to the Company's auditor for the audit of the parent Company and 48 43
consolidated financial statements
Fees payable to the Company's auditor for other services:
Tax advisory and compliance services - 1
_________ _________
Total 48 44
_________ _________
7 Employee benefit expenses
Year to Year to
31 December 31 December
2022 2021
US$'000 US$'000
Employee benefit expenses (including directors) comprise:
Wages and salaries 2,279 1,658
Benefits 191 143
Share-based payment expense (note 20 (#_37._Share-based_payment) ) 189 431
Social security contributions and similar taxes 146 104
Pension contributions 84 56
_________ _________
2,889 2,392
_________ _________
Key management personnel compensation
Key management personnel are those persons having authority and responsibility
for planning, directing and controlling the activities of the Group, including
the Directors of the Company.
Year to Year to
31 December 31 December
2022 2021
US$'000 US$'000
Salary 493 560
Share based payment expense 7 -
_________ _________
500 560
_________ _________
The average number of employees (including Directors) in the Group in the year
was 17 (2021 - 13).
8 Segment information
The Group has one division being the development of prognostic and diagnostic
tests for kidney transplant patients.
9 Finance income and expense
Year to Year to
31 December 31 December
2022 2021
US$'000 US$'000
Finance income
Bank interest 53 -
_________ _________
Total finance income 53 -
_________ _________
Finance expense
- -
Interest on lease liabilities 5 -
_________ _________
Total finance expense 5 -
_________ _________
10 Tax expense
Year to Year to
31 December 31 December
2022 2021
US$'000 US$'000
Current tax expense
Current tax on loss for the year - -
_________ _________
Total current tax - -
Deferred tax asset
On losses generated in the year - -
_________ _________
- -
_________ _________
The reasons for the difference between the actual tax charge for the year and
the standard rate of corporation tax in the United Kingdom applied to profits
for the year are as follows:
Year to Year to
31 December 31 December
2022 2021
US$'000 US$'000
Loss for the period (11,407) (8,329)
_________ _________
Tax using the Company's domestic tax rate of 19% (2,167) (1,583)
Expenses not deductible for tax purposes 79 58
Accelerated capital allowances (251) (143)
Unrecognised deferred tax assets 3,240 2,328
Different tax rates applied in overseas jurisdictions (901) (660)
_________ _________
Total tax expense - -
_________ _________
The unrecognised deferred tax relates to two elements: the unrecognised
deferred tax arising on share-based payments of US$85,000 (2021 - US$199,000)
and unrecognised deferred tax on taxable losses of US$3,155,000 (2021 -
US$2,129,000). Total taxable losses carried forward comprise of Federal US
losses of $6,334,000 (US$4,848,000) which do not expire but can only offset
against 80% of taxable profits from the same trade. In addition, US tax
losses of $13,316,000 (US$3,708,000) are carried forward as research and
development taxable asset to be used against future profits from the same
trade. Tax losses in the UK at US$1,449,000 (US$897,000). No deferred tax
asset is recognised for these losses due to early stage in the development of
the Group's activities.
11 Earnings per share
Year to Year to
31 December 31 December
2022 2021
Total Total
Numerator US$ US$
Loss for the period used in basic EPS (11,407,527) (8,329,829)
Denominator
Weighted average number of ordinary shares used in basic EPS 164,667,754 141,747,816
Resulting loss per share (US$0.069) (US$0.059)
The Company has one category of dilutive potential ordinary share, being share
options (see note 19). The potential shares were not dilutive in the period as
the Group made a loss per share in line with IAS 33.
12 Tangible assets
Leasehold Plant & machinery
Group property Total
US$'000 US$'000 US$'000
Cost or valuation
At 1 January 2021 - 594 594
Additions - 618 618
Foreign exchange movements - (6) (6)
_________ _________ _________
At 31 December 2021 - 1,206 1,206
Additions 1,288 455 1,743
Foreign exchange movements - (59) (59)
_________ _________ _________
At 31 December 2022 1,288 1,602 2,890
_________ _________ _________
Accumulated depreciation and impairment
At 1 January 2021 - (130) (130)
Depreciation - (295) (295)
Foreign exchange movements - 5 5
_________ _________ _________
At 31 December 2021 - (420) (420)
Depreciation (76) (421) (497)
Foreign exchange movements - 37 37
_________ _________ _________
At 31 December 2022 (76) (804) (880)
_________ _________ _________
Net book value
At 31 December 2022 1,212 798 2,010
_________ _________ _________
At 31 December 2021 - 786 786
_________ _________ _________
Included in leasehold property at 31 December 2022 are right of use assets
with a cost of US$465,000 and accumulated depreciation of $28,000 relating to
the lease of the Company's laboratory in Tennessee. Included within plant
and machinery is an asset financed under a leasing contract with a cost of
US$238,000. The liability is secured against the asset.
12 Tangible assets (continued)
Plant & machinery
Company Total
US$'000 US$'000
Cost or valuation
At 1 January 2021 568 568
Additions - -
Foreign exchange movements (6) (6)
_________ _________
At 31 December 2021 562 562
Additions - -
Foreign exchange movements (59) (59)
_________ _________
At 31 December 2022 503 503
_________ _________
Accumulated depreciation and impairment
At 1 January 2021 (126) (126)
Depreciation (191) (191)
Foreign exchange movements 5 5
_________ _________
At 31 December 2021 (312) (312)
Depreciation (172) (172)
Foreign exchange movements 37 37
_________ _________
At 31 December 2022 (447) (447)
_________ _________
Net book value
At 31 December 2022 56 56
_________ _________
At 31 December 2021 250 250
_________ _________
13 Intangible assets
Group License and patents Total
US$'000 US$'000
Cost
At 1 January 2021 1,839 1,839
Additions 398 398
Foreign exchange movements (18) (18)
_________ _________
At 31 December 2021 2,219 2,219
Additions 268 268
Foreign exchange movements (185) (185)
_________ _________
At 31 December 2022 2,302 2,302
_________ _________
Accumulated amortisation and impairment
At 1 January 2021 (72) (72)
Amortisation charge (143) (143)
Foreign exchange movements 3 3
_________ _________
At 31 December 2021 (212) (212)
Amortisation charge (143) (143)
Foreign exchange movements 23 23
_________ _________
At 31 December 2022 332 332
_________ _________
Net book value
At 31 December 2022 1,970 1,970
_________ _________
At 31 December 2021 2,007 2,007
_________ _________
13 Intangible assets (continued)
Company License and patents Total
US$'000 US$'000
Cost
At 1 January 2021 1,722 1,722
Additions 54 54
Foreign currency movements (18) (18)
_________ _________
At 31 December 2021 1,758 1,758
Additions 15 15
Foreign currency movements (185) (185)
_________ _________
At 31 December 2022 1,588 1,588
_________ _________
Accumulated amortisation and impairment
At 1 January 2021 (71) (71)
Amortisation charge (124) (124)
Foreign exchange movements 3 3
_________ _________
At 31 December 2021 (192) (192)
Amortisation charge (104) (104)
Foreign exchange movements 23 23
_________ _________
At 31 December 2022 (273) (273)
_________ _________
Net book value
At 31 December 2022 1,315 1,315
_________ _________
At 31 December 2021 1,566 1,566
_________ _________
The licence was acquired from Renalytix AI Plc on 4 May 2020 pursuant to a
purchase of business assets.. This license in turn was granted to Renaltix
AI Plc by the Icahn School of Medicine at Mount Sinai for rights to
intellectual property and data to support the FractalDx families of diagnostic
assays. In addition amounts are spent on the prosecution and protection of
patent applications.
The Group has tested the carrying value for impairment at 31 December 2022.
The recoverable amount was assessed in the basis of value in use. The assessed
value exceeded the carrying value and no impairment loss was recognised. The
key assumptions in the calculation to assess value in use are future revenues
and costs and the ability to generate future cash flows. Recent working
capital projections approved by the Board were used as well as forecasts for a
further four years, followed by an extrapolation of expected cash flows and
the calculation of a terminal value.
14 Subsidiary
The principal subsidiary of Verici Dx plc, which has been included in these
consolidated financial statements at a cost of US$10, is as follows:
Country of incorporation and Proportion of ownership
Name principal place of business interest at 31 December
2021 and 2022
Verici Dx Inc United States of America 100%
15 Trade and other receivables
Group Company Group Company
2022 2022 2021 2021
US$'000 US$'000 US$'000 US$'000
Prepayments 343 60 406 101
Other debtors 177 18 250 17
Amount due from wholly owned subsidiary undertaking - 18,122 - 8,226
_________ _________ _________ _________
520 18,200 656 8,344
_________ _________ _________ _________
16 Trade and other payables
Group Company Group Company
2022 2022 2021 2021
US$'000 US$'000 US$'000 US$'000
Trade payables 960 19 160 16
Accruals 1,136 86 1,644 165
_________ _________ _________ _________
Total trade and other payables 2,096 105 1,804 181
_________ _________ _________ _________
The carrying value of trade and other payables classified as financial
liabilities measured at amortised cost approximates fair value.
The only movements within financial liabilities relate to payments for payable
and leases within the Financial Instruments note.
17 Lease liabilities
Land and Plant and
Group buildings machinery Total
US$'000 US$'000 US$'000
At 1 January 2021 - - -
Interest expense - - -
Repayments - - -
________ ________ ________
At 31 December 2021 - - -
________ ________ ________
Additions 465 238 703
Repayments (8) - (8)
Interest expense 4 1 5
________ ________ ________
At 31 December 2022 461 239 700
________ ________ ________
The Company acquired an asset under capital lease financing arrangements.
The Company operates from one office which is rented under a lease agreement
ending on 1 November 2027 under which rent is payable monthly.
2022 2021
US$'000 US$'000
Maturity of lease liabilities
Within 3 months 45 -
Between 3 - 12 months 111 -
Between 1 - 2 years 167 -
Between 2 - 5 years 377 -
________ ________
700 -
________ ________
18 Share capital
Issued and fully paid
2022 2022
Number US$
Ordinary shares of £1 each
On incorporation 1 1
__________ __________
Ordinary shares of £0.001 each
Sub-division of existing shares into 1,000 ordinary shares 1,000 1
Issue of new shares 59,415,135 74,864
Issue of shares on conversion of Convertible Loan Notes 9,831,681 12,771
Placing and offer of shares on admission to AIM 72,500,000 93,978
__________ __________
At 31 December 2021 141,747,816 181,614
Issue of new shares 28,571,429 37,342
__________ __________
At 31 December 2022 170,319,245 218,956
__________ __________
On 7 July 2020 the entire issued share capital of the Company was sub divided
to create 1,000 ordinary shares of £0.001 each and 59,415,135 ordinary shares
of £0.001 each were allotted pursuant to a dividend in specie by the then
parent company, Renalytix AI Plc. Those 59,416,135 shares were then
immediately reclassified as 59,416,134 A shares and one Golden Share and all A
shares and the Golden Share converted into ordinary shares at the time of the
Company's admission to AIM on 3 November 2020.
On 28 October 2020 pursuant to the conversion of the Convertible Loan Notes is
issue at that time of $2,500,000, a further 9,831,681 new ordinary shares were
issued.
On 3 November 2020 pursuant to the Company's shares being admitted to AIM, a
market operated by the London Stock Exchange, 72,500,000 new ordinary shares
were issued at an issue price of £0.20 per share raising gross proceeds of
US$18,795,500 (£14,500,000).
On 11 March 2022 the Company issued 28,571,429 ordinary shares of £0.001 at
an issue price of £0.35 per share raising gross proceeds of US$13,070,000
((£10,000,000).
19 Reserves
The following describes the nature and purpose of each reserve within equity:
Reserve Description and purpose
Share premium Amount subscribed for share capital in excess of nominal value.
Foreign exchange reserve Gains/losses arising on retranslating the net assets of parent company
operations into US dollars.
Retained earnings All other net gains and losses and transactions with owners (e.g. dividends)
not recognised elsewhere.
20 Share-based payment
On 28 October 2020, the Board adopted the Share Option Plan to incentivise
certain of the Group's employees and Directors. The Share Option Plan provides
for the grant of both EMI Options and non-tax favoured options. Options
granted under the Share Option Plan are subject to exercise conditions as
summarised below.
The Share Option Plan has a non-employee sub-plan for the grant of Options to
the Company's advisors, consultants, non-executive directors, and entities
providing, through an individual, such advisory, consultancy, or office holder
services and a US sub-plan for the grant of Options to eligible participants
in the Share Option Plan and the Non-Employee Sub-Plan who are US residents
and US taxpayers.
With the exception of options over 10,631,086 shares, which vested immediately
on grant in 2020, the options vest equally over twelve quarters from the grant
date. If options remain unexercised after the date one day before the tenth
anniversary of grant such options expire. The Options are subject to exercise
conditions such that they shall, subject to certain exceptions, vest in equal
quarterly instalments over the three years immediately following the date of
grant, which vesting shall accelerate in full in the event of a change of
control of the Company.
Weighted
average
exercise
price (p) Number
Outstanding at 22 April 2020 - -
Granted during the period 32 14,574,782
Exercised during the period 20 (10,631,086)
________ _________
Outstanding at 31 December 2020 32 3,943,696
Granted during the year 62.61 990,000
_________ _________
Exercisable at 31 December 2021 26.03 4,933,696
________ _________
Cancelled in the year (120,000)
Granted in the year 1,564,370
________ ________
Exercisable at 31 December 2022 23.86 6,378,066
________ ________
_________
Exercisable at 31 December 2021
26.03
4,933,696
________
_________
Cancelled in the year
(120,000)
Granted in the year
1,564,370
________
________
Exercisable at 31 December 2022
23.86
6,378,066
________
________
The exercise price of options outstanding at 31 December 2022 ranged between
20p and 69.5p and their weighted average contractual life was 3.85 years.
The weighted average fair value of each option granted during the year was
25.98p. The weighted average fair value of the options outstanding at 31
December 2022 was 23.86p.
The fair value of each share option granted has been estimated using a
Black-Scholes model and ranges from 10p to 23p. The inputs into the model are
a share prices of 20p, 40p,45.5p, 50p and 69.5p and exercise prices of 20p,
40p,45.5p, 50p and 69.5p and expected volatility of 52.34%, no expected
dividend yield, contractual life of between 2.9 and 1.9 years and a risk-free
interest rate of 0.925%. As of 31 December 2022, none of the granted stock
options have been exercised.
20 Share-based payment (continued)
The Group recognised total expenses of $318,000 (2021 - $741,000) within
administrative expenses relating to equity-settled share-based payment
transactions during the period.
21 Related party transactions
The following items are included as disclosures in accordance with IFRS:
i. In the year to 31 December 2022 an amount of US$51,000 (2021 -
US$352,000) was invoiced by Renalytix Plc as full reimbursement for expenses
incurred on behalf of the Company as a cost sharing arrangement for a quality
management software product. As of 31 December 2022 the amount owed to
Renalytix Plc was US$22,000 (2021 - US$22,000).
ii. In the year to 31 December 2022 an amount of US$750,000 (2021 -
US$35,000) was invoiced by Icahn School of Medicine at Mount Sinai for
milestone fees due under the license agreement described in the Admission
Document. As of 31 December 2022 the amount owed to Icahn School at Medicine
at Mount Sinai was US$Nil (2021 - US$Nil).
iii. In the year to 31 December 2022 an amount of US$17,000 (2021 - US$Nil)
was invoiced by EKF Diagnostic Holdings Plc for services rendered in the year.
As of 31 December 2022 the amount owed to EKF Diagnostic Holdings Plc was
US$Nil (2021 - US$Nil).
There are no additional AIM Rule 13 disclosures required in relation to these
items.
22 Events after the reporting date
There have been no events subsequent to the year-end that require disclosure
in these financial statements.
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