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REG - Intelligent Ultrasnd - Final Results

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RNS Number : 7045M  Intelligent Ultrasound Group PLC  01 May 2024

 

 

The information contained within this announcement is deemed by the Company to
constitute inside information pursuant to Article 7 of EU Regulation 596/2014
as it forms part of UK domestic law by virtue of the European Union
(Withdrawal) Act 2018 as amended. Upon the publication of this announcement
via a Regulatory Information Service, this inside information is now
considered to be in the public domain.

 

 

Intelligent Ultrasound Group plc

("Intelligent Ultrasound" or the "Group" or the "Company")

 

Audited Results for the Year Ended 31 December 2023

 

 

Intelligent Ultrasound Group plc (AIM: IUG), the ultrasound AI software and
simulation company, announces its audited results for the year ended 31
December 2023, showing another year of positive progress.

 

Financial highlights:

·      Group revenue grew by 11% to £11.2m (2022: £10.1m)

·      2022 Group revenue included c.£1.9m of one-off simulation orders
from the NHS, adjusting for this, Group revenue in 2023 increased by 36% (2022
adjusted: £8.2m)

·      Clinical AI-related revenues trebled to £2.0m (2022: £0.7m)

·      Simulation revenues declined by 3% to £9.1m (2022: £9.4m)

·      Adjusting for the one-off orders from the NHS, simulation revenue
in 2023 increased by 21% (2022 adjusted: £7.5m)

·      Loss after tax decreased to £2.6m (2022: £3.0m)

·      Cash at 31 December 2023 of £3.0m (31 December 2022: £7.2m)

 

Operational highlights:

·      GE HealthCare's SonoLyst software, which is powered
by Intelligent Ultrasound's AI software, launched as a standard feature on
the new Voluson Expert 22 and 20 range of women's health ultrasound machines
in Q4 2023

·      Liver images agreement signed with Dundee University in Q4 2023

·      ScanNav FetalCheck development programme announced for new
gestational age AI product in Q4 2023

·      ScanTrainer Endometriosis simulator module released in Q2 2023

 

Post year end:

·      GE HealthCare's SonoLyst software launched as a standard feature
on the new Voluson Signature 20 and as an option on the Voluson Signature 18
range of women's health ultrasound machines

·      ScanNav FetalCheck announced to be used in the largest ever trial
on the use of aspirin to prevent pre-eclampsia, funded by the Bill and Melinda
Gates Foundation

 

Outlook:

·      The UK market is experiencing tougher trading conditions due to
the current reduction in NHS capital expenditure spending but anticipate
growing revenue from high margin AI-related products and non-UK related
simulation markets

·      Implemented tight control on overheads to offset any softness in
UK revenue

·      The business continues to expect revenue in 2024 to be between
£14m to £17m and continues to forecast that it will reach profitability with
its current cash resources

 

Commenting on the results, Riccardo Pigliucci, Chairman of Intelligent
Ultrasound said:

 

"2023 has been another year of important progress for the Group, as we
commercialize our regulatory-approved clinical AI software products and
develop the next generation of diagnostic AI software. We achieved our number
one target for the year, which was to grow AI-related sales to £2m. In
addition, our relationship with GE HealthCare continued to develop positively
with the launch of SonoLystlive, powered by our obstetrics AI software, on the
Voluson Expert ultrasound machine range and post-year end on the Signature
ultrasound range. In Q4 2023, we announced the first trials in Africa that
will be using our ScanNav FetalCheck AI software to enable an unskilled user
to automatically obtain the gestational age of a fetus. With a growing range
of AI related products, we remain excited about the future of the business, in
this growing market."

 

For further information, please contact:

 

 Intelligent Ultrasound Group plc                  www. intelligentultrasound.com (http://intelligentultrasound.com/)
 Stuart Gall, CEO                                  Tel: +44 (0)29 2075 6534
 Helen Jones, CFO

 Cavendish Capital Markets Limited                 Tel:  +44 (0)20 7397 8900

 (Nominated Advisor and Broker)
 Giles Balleny/Dan Hodkinson (Corporate Finance)
 Nigel Birks (ECM)

 Ondraya Swanson (ECM)

 Dale Bellis (Sales)

 

 TB Cardew - PR Advisers  Intelligentultrasound@tbcardew.com (mailto:Intelligentultrasound@tbcardew.com)
 Allison Connolly         Tel: +44 (0)7587 453955
 Emma Pascoe-Watson       Tel: +44 (0)7774 620415
 Jessica Pilling          Tel: +44 (0)7918 584573

 

About Intelligent Ultrasound Group

Intelligent Ultrasound (AIM: IUG) is one of the world's leading 'classroom to
clinic' ultrasound companies, specialising in real-time hi-fidelity virtual
reality simulation for the ultrasound training market ('classroom') and
artificial intelligence-based clinical image analysis software tools for the
diagnostic medical ultrasound market ('clinic'). Based in Cardiff in
the UK and Atlanta in the US, the Group has two revenue streams:

 

Simulation

Real-time hi-fidelity ultrasound education and training through simulation.
Our main products are the ScanTrainer obstetrics and gynaecology training
simulator, the HeartWorks echocardiography training simulator,
the BodyWorks Eve Point of Care and Emergency Medicine training simulator
and the BabyWorks Neonate and Paediatric training simulator. To date over
1,700 simulators have been sold to over 800 medical institutions around the
world.

 

Clinical AI software

Deep learning-based algorithms to make ultrasound machines smarter and more
accessible using our proprietary ScanNav ultrasound image analysis
technology. Current products on the market utilising this technology are GE
HealthCare's SonoLyst software that is incorporated in their Voluson Expert,
Signature and SWIFT ultrasound machines; ScanNav Anatomy PNB that simplifies
ultrasound-guided needling by providing the user with real-time AI-based
anatomy highlighting for a range of medical procedures; and NeedleTrainer
that teaches real-time ultrasound-guided needling and incorporates ScanNav
Anatomy PNB.

 

www.intelligentultrasound.com (http://www.intelligentultrasound.com/)

 

NOTE: ScanNav Anatomy PNB is CE approved and cleared for sale in the US by the
FDA but is not available for sale in any other territory requiring government
approval for this type of product.

 

CHAIRMAN'S STATEMENT

 

This has been a positive year of progress for the Group, driven by our
AI-related sales tripling to £2m (2022: £0.7m) and as a result, Group
revenue rose by 11% to £11.2m (2022: £10.1m). Importantly, our AI software
developments continued to hit significant milestones during the year, with GE
HealthCare launching SonoLystlive as standard on the Voluson Expert range of
ultrasound machines; ScanNav FetalCheck, our new AI gestational age estimation
software that is in development, being purchased for a number of field trials
in Africa funded by the Bill & Melinda Gates Foundation; and commencing
the proof of concept development work for our AI liver software, following the
signing of our data agreement with Dundee University and NHS Trust.

 

Strategy

Our unique 'Classroom to Clinic' ultrasound strategy is based on:

·      Growing the Group's 'Classroom' related revenues through
increased sales of our four ultrasound simulator platforms and the continued
expansion of our simulator range into new medical market segments

·      Continuing to build our 'Clinic' related AI revenues through
increased royalty income from GE HealthCare, who incorporate our 20week
obstetrics ScanNav AI technology in their Voluson ultrasound systems;
increased sales of our proprietary stand-alone AI-driven ScanNav Anatomy and
NeedleTrainer Plus systems, sold through our direct sales and reseller
operations; and future new proprietary stand-alone AI-driven products such as
ScanNav FetalCheck gestational age estimation aimed at opening up new global
medical imaging markets

 

This novel 'Classroom to Clinic' approach enables us to work with future
clinical customers early in their medical careers, aiding brand recognition
and product credibility and then, as they progress to real patient scanning
and lifelong learning, supports them with workflow or diagnostic AI-based
medical imaging software. We believe this unique approach to ultrasound will
enable the Group to continue to grow in 2024.

 

People

I would like to thank all our staff, in the UK, US and China, for working so
hard to grow the business during the year and meet all our development and
regulatory milestones.

 

Shareholders

We continue to have a broad spread of supportive shareholders, and we maintain
an open-door policy at our head office in Cardiff and would welcome any
visitors who wish to enjoy a hands-on experience of our cutting edge
'Classroom to Clinic' technology.

 

Board and governance

During the year, Ian Whittaker, who has served as an Executive Director and
Chief Operating Officer (COO) since joining the Group on the acquisition of
Inventive Medical Ltd in August 2016, chose to retire from the Board of
Directors and his position as COO. Ian remains with the Group in a part-time
capacity to assist on projects, as required. The Board extends its thanks to
Ian for his commitment and invaluable contribution to significantly growing
the simulation revenue over the last seven years and wishes him continued
success in his business and personal endeavours.

 

ESG

ESG remains an important part of our reporting, and we believe we continue to
have a positive impact locally, nationally, and globally. We have continued to
make improvements in all aspects of ESG and aspire to be a global force for
good, empowering people to have access to medical ultrasound, one of the
world's most important imaging modalities.

 

Outlook

2023 has been another year of important progress for the Group, as we
commercialize our regulatory-approved clinical AI software products and
develop the next generation of diagnostic AI software. We achieved our number
one target for the year, which was to grow AI-related sales to £2m. In
addition, our relationship with GE HealthCare continued to develop positively
with the launch of SonoLystlive, powered by our obstetrics AI software, on the
Voluson Expert ultrasound machine range and post-year end on the Signature
ultrasound range. In Q4 2023, we announced the first trials in Africa that
will be using our ScanNav FetalCheck AI software to enable an unskilled user
to automatically obtain the gestational age of a fetus.

 

As we start 2024, the UK market is experiencing tougher trading conditions due
to the current reduction in NHS capital expenditure spending. We are therefore
keeping a tight control on our overheads to offset any potential reduction in
UK revenue. When these cost controls are combined with the growing revenue
from our high margin AI-related products and non-UK related simulation
markets, the business continues to forecast that it will reach profitability
with its current cash resources.

 

Riccardo Pigliucci, Non-executive Chairman

 

CEO REVIEW

 

We make clinical diagnostic ultrasound easier to learn and simpler to use by
providing clinicians around the world with real-time support from the
classroom to the clinic. AI is a key element of this unique approach, and the
report below details the progress made in 2023 and the key challenges faced
during the year.

 

SIMULATION (Classroom)

We design, develop, and sell some of the world's leading hi-fidelity
ultrasound training simulators. Training medical professionals in the skills
required to competently scan with diagnostic ultrasound remains an important
building block of our business.

 

The Group's simulation revenue declined slightly by 3% to £9.1m (2022:
£9.4m) in 2023 mainly due to lower-than-expected sales in Western Europe and
China throughout the year and recognised revenue being slightly less than we
anticipated in the final quarter of 2023. However, it should be noted that the
2022 UK simulation revenue figures included c.£1.9m of one-off orders from
the NHS, so adjusting for this, simulation revenue in 2023 actually increased
by 21% (2022*: £7.5m).

 

We have four ultrasound simulation-only platform technologies focused on the
following markets:

·      ScanTrainer - obstetrics and gynecology (OBGYN)

·      HeartWorks - echocardiography and anesthesiology (ECHO)

·      BodyWorks - emergency medicine, critical care, intensive care,
and point-of-care (PoCUS)

·      BabyWorks - neonate and pediatrics

 

These ultrasound training platforms are, in the main, high-value, capital
equipment sold to the global medical institution market, through our direct
sales forces in the US and UK, plus a network of 23 resellers covering over 30
countries in the rest of the world. To date, we have sold c. 1,700 simulators
into over 800 medical institutions around the world.

 

Research & Development

During the financial year, the simulation R&D team focused on the
following developments:

 

3D Echo MPR release for HeartWorks

In February, we added Multiplanar Reconstruction (MPR) as an optional extra to
the HeartWorks simulation platform for cardiac anatomy and echocardiography,
enabling students to build their confidence in 3D cardiac image acquisition
and manipulation techniques.

 

Bodyworks 2.0

In August, we launched BodyWorks 4.5, the latest version of our female patient
point-of-care simulator that includes ten new high-value cases within the lung
and gastric regions, as well as improvements to the custom patient lists to
deliver increased flexibility for trainees and tutors.

 

Babyworks 2.0

In June, we launched an upgraded version of BabyWorks with new modules for
cardiac, cranial, gastric, and line placement. The modules were developed in
collaboration with leading specialists in infant medicine to ensure the
content is aligned with the latest requirements of neonatal and pediatric
point-of-care ultrasound (PoCUS).

 

Endometriosis module for ScanTrainer

It is estimated that 10% of women worldwide have endometriosis so in May, a
new endometriosis augmented reality training module was launched for
ScanTrainer to support clinicians in learning how to locate and identify
endometriotic disease in the ovaries, bowel, and bladder using transvaginal
ultrasound.

 

Territory Review

United Kingdom

Revenue declined by 52% to £2.4m (2022: £4.9m) partly due to £1.9m of
one-off orders from a UK NHS training initiative in 2022. Excluding these
exceptional orders, the UK like-for-like revenue in 2022 declined by 22%.

 

There were two main factors that impacted simulator training budgets in the UK
during 2023. Firstly, the NHS has had to implement cost savings to cover the
increased cost of locum doctors and overtime caused by the doctors strikes
during the year. Secondly, the merger of Health Education England (HEE) and
NHS England impacted one of the biggest sources of funding for simulation in
the NHS. All these reduced anticipated training spend in the second half of
the year, by pushing expected orders into 2024. Although this merger is now
broadly complete, the UK market is dominated by NHS-related spending and there
are concerns that the ongoing junior doctor strike will reduce funds normally
made available for capital purchases. So although there remains strong
purchasing interest in all our simulation products, we are monitoring closely
whether the shortfalls in NHS Trust finances will impact 2024 training
budgets.

 

North America

Revenue increased by over 60% to £4.5m (2022: £2.8m), a record high, with
strong sales across all our simulator product platforms. We were particularly
encouraged by the take-up of our newest simulator, BabyWorks, with medical
schools such as the University of Nebraska Medical Center (UNMC) investing in
the simulator, to expand its clinical simulation program into bedside
ultrasound for infants. We continued to invest in the US-based sales team in
2023 and moved to a larger office and build space in Alpharetta. We also
improved our application specialist web-based demo facilities and with an
encouraging long-term sales pipeline, we look forward to continued growth in
the North American direct-to-market operation in 2024.

 

Rest of the World

Revenue increased by 31% to £2.3m (2022: £1.7m). We currently have 28
resellers that sell our simulators outside the UK and North America, and the
revenue stream has been somewhat of a rollercoaster in recent years. 2023
continued that trend with sales returning to 2021 levels, and although we had
positive sales growth in India, Scandinavia, South Africa, and Israel, the
sales growth in China was slower than expected, and sales in Western Europe,
Gulf, and Australia were disappointing. However, with over £1m of revenue
being generated in the final quarter of 2023 and with the increased range of
products, growing pipeline, and anticipated sales growth from China, we hope
to continue to grow the reseller market in 2024.

 

CLINICAL AI (Clinic)

Real-time clinical AI software that makes medical ultrasound easier to use is
a key part of our 'Classroom to Clinic' vision, and we were delighted that our
AI-related revenue tripled to £2.0m (2022: £0.7m). We are one of the leading
independent AI software vendors in real-time ultrasound image analysis, and
our products provide real-time workflow enhancements that support faster, more
standardized scanning, and importantly also support decision making so that
the stress of scanning can be reduced and the potential 'burnout' of
clinicians being asked to increase productivity is minimized. We have three
AI-related software products available in the market:

 

·      ScanNav Assist obstetric AI software that powers GE HealthCare's
SonoLyst software on their Voluson range of women's healthcare ultrasound
machines;

·      ScanNav Anatomy Peripheral Nerve Block (PNB) for real-time
regional anesthesia highlighting; and

·      NeedleTrainer that incorporates the PNB software to teach
ultrasound-guided needling skills.

 

We expect 2024 to be another year of significant sales growth for our
AI-related products.

 

ScanNav Assist (SonoLyst)

Our ScanNav Assist AI technology drives GE HealthCare's SonoLyst X/IR and Live
software, the world's first fully integrated ultrasound AI tool that
automatically and in real-time recognizes the 21 views recommended for the
second trimester (20-week) fetal sonography scan. Integrated into GE
HealthCare's Voluson SWIFT and Expert ultrasound machines, SonoLyst is
available in two formats:

·      SonoLyst X/IR is a virtual on-board expert utilizing AI to
automatically identify fetal anatomy on the operator's saved views, enhancing
efficiency and providing quality assurance by comparing the image to the
standard criteria to ensure image acquisition quality and consistency.

·      SonoLystlive is a fully automated version of X/IR that
automatically saves the optimal views live as the operator scans, enhancing
efficiency, consistency, and saving up to 40% of time on routine 20-week
scans.

 

By automatically and in real-time supporting the sonographer in their decision
making, the software can also help reduce the often considerable stress of
obtaining the recommended views. The issue of burnout in scanning centers is
increasing around the world, and it is hoped that the adoption of this
technology will help reduce this burden.

 

GE HealthCare is the largest medical imaging company in the world and under
our long-term agreement has exclusive rights to our clinical AI technology in
the field of women's healthcare until 2029. The royalty terms, product sales,
and the timings of the related product launches under this agreement are
undisclosed. The launch in October of SonoLystlive as a standard feature on GE
HealthCare's Voluson Expert 22 and 20 ultrasound machines was a key commercial
milestone as this is GE HealthCare's premium ultrasound machine in the
obstetric market. Post-year-end Sonolystlive was also launched on the Voluson
Signature range.

 

GE HealthCare is the dominant manufacturer in this market, with over 50%
market share of the 35,000 plus ultrasound machines that are sold annually.
We, therefore, expect to see increased SonoLyst sales throughout 2024 and
beyond as SonoLyst continues to be rolled out globally.

 

ScanNav Anatomy Peripheral Nerve Block (PNB)

Our FDA and CE cleared ScanNav Anatomy PNB AI software simplifies
ultrasound-guided needling by providing the user with real-time AI-driven
anatomy highlighting for a range of medical procedures. The device supports
the performance of healthcare professionals who are suitably qualified but who
perform ultrasound-guided local anesthesia procedures on a less frequent
basis. The device supports ten common peripheral nerve blocks and is sold as a
stand-alone screen that is plugged into existing anesthesiology ultrasound
machines to provide clinicians with real-time highlighting of their live
ultrasound image. Our aim is to support anesthetists, who are competent but
less confident in the specialist knowledge of ultrasound anatomy, to perform
nerve blocks and as a result increase the number of ultrasound-guided nerve
blocks that they can perform. The device is available for sale in the US, UK,
France, Germany, Spain, and Scandinavia. During the year, several important
studies were released to demonstrate how ScanNav Anatomy PNB can help support
the adoption of ultrasound-guided regional anaesthesia (UGRA).

 

The accuracy of ScanNav Anatomy PNB was rated as 93.5% by expert clinicians,
with clinical trials demonstrating that ScanNav Anatomy PNB is helpful in
identifying specific structures in up to 99.7% of cases and confirming the
correct block view in up to 99.3% of cases. It could reduce the incidence of
adverse events, such as nerve injury, and block failures by between 62.9% and
86.3%. Studies also demonstrated a relative increase in the delivery of
ultrasound-guided regional anesthesia by 40.4%, showing that ScanNav Anatomy
PNB is helpful to experts in teaching and non-experts in training and clinical
practice.

 

With over 25,000 anesthesiology machines in operation in the US, UK, and
Western Europe markets, and ultrasound-guided peripheral nerve blocks
increasingly being used as a prudent alternative to general anesthesia, as
well as a method of concurrent analgesia, potentially reducing opioid usage,
we continue to believe that ScanNav Anatomy PNB has considerable growth
potential over the coming years. ScanNav Anatomy PNB is also available as a
training simulator for medical learning on volunteers, prior to patient
contact, and is incorporated into our NeedleTrainer simulator.

 

NeedleTrainer

Developed by the clinical AI software team as a spin-off from the ScanNav
Anatomy PNB research and development, NeedleTrainer is the first of its kind,
using a retractable needle and virtual image overlays to simulate needling on
a live participant, using a live ultrasound scan. This enables trainees to
develop hand-eye coordination, optimum positioning, and accuracy in
ultrasound-guided interventional procedures in a realistic and safe clinical
environment with minimal risk.

 

The system is sold with the trainer version of our ScanNav Anatomy PNB
AI-driven software integrated into the device and is also sold as a
stand-alone device, with the GE Vscan Air handheld ultrasound machine.

 

We also sell a classroom to clinic (C2C) needling package that includes a
NeedleTrainer system placed into the simulation centre and a ScanNav Anatomy
PNB clinical system placed into the operating theatre block room. This enables
trainee anesthetists to learn with confidence, more qualified anesthetists to
conduct peripheral nerve blocks, and increase the number of peripheral nerve
blocks per hospital.

 

During 2023, we progressed the development of our next two AI software
products:

 

ScanNav FetalCheck

At the end of 2023 we announced a new AI development programme for gestational
age estimation in prenatal care. ScanNav FetalCheck is our first diagnostic AI
software that aims to enable a non-skilled or skilled user to automatically
establish the gestational age (GA) accurately with minimal training. Pregnant
women are usually offered two routine ultrasound scans. The first, at 11-14
weeks, is performed to confirm viability of the fetus as well as the
gestational age to pinpoint the likely due date. A second scan at 18-20 weeks
focuses on detecting congenital abnormalities.

 

Additional scans may be offered to monitor high-risk or complex pregnancies.
Having an accurate gestational age is important in the management of
pregnancy, both to assess fetal growth and to inform treatment choice in the
event that complications are seen. However, accurate determination of
gestational age is difficult in low and middle-income countries (LMICs) as,
currently, gestational age must be measured by trained sonographers.

 

Our ScanNav FetalCheck software aims to enable a non-skilled user to obtain an
accurate gestational age with minimal training and without the need for an
expensive high-end ultrasound machine. It has the potential to transform
antenatal care both in LMICs and in high-income countries (HICs) by allowing
the age of the fetus to be assessed in a primary care setting where women need
it.

 

We were also pleased to announce that a leading university in Africa purchased
four ScanNav FetalCheck systems as part of a trial to evaluate biomarkers and
other factors which affect the probability of stillbirth. Post-year-end, we
also announced that our ScanNav FetalCheck AI software is to be used in the
largest-ever trial on the use of aspirin to prevent pre-eclampsia. Conducted
in Kenya, Ghana, and South Africa, the trial is funded by the Bill &
Melinda Gates foundation and led by Concept Foundation. It aims to advance
evidence on pre-eclampsia prevention and inform policies so that women who are
treated with aspirin to prevent pre-eclampsia receive a dose that is both
effective and safe. All clinical trial sites will use Intelligent Ultrasound's
ScanNav FetalCheck software to enable frontline healthcare professionals, with
no prior experience of ultrasound, to quickly estimate gestational age.
ScanNav FetalCheck is currently not licensed for clinical use.

 

ScanNav Liver

In November 2023, we were pleased to announce that we had signed a research
agreement with the University of Dundee to initiate the first phase of
proof-of-concept work to develop AI-based tools for screening patients with
liver disease. Utilizing the comprehensive archive comprising over one million
ultrasound images from approximately 50,000 patients from the University of
Dundee and NHS Tayside, our AI team intends to create machine-learning models
that make it easier to stage liver disease and monitor disease progression.

 

The agreement, which is mainly royalty-based, will allow Intelligent
Ultrasound to develop ultrasound-based AI tools with the potential to support
clinicians in the clinical management of metabolic dysfunction-associated
steatotic liver disease (MASLD) and its advanced form, metabolic
dysfunction-associated steatohepatitis (MASH). MASLD is the leading cause of
liver disease and is closely related to obesity, the rates of which are
rising. Monitoring MASLD is important as patients in the early stages of the
disease may be able to reduce the effects on their liver with dietary and
lifestyle changes if caught in time.

 

Around 30% of the world's population has MASLD, and by 2030, it is expected
that healthcare systems will need to accurately stage the disease to allow
them to target treatment. As current methods for diagnosis are either
invasive, costly, or inaccurate, it is hoped that AI-based ultrasound may
prove to be a cost-effective point-of-care technique that can give clinicians
the answers they need.

 

Prof. John Dillon at the University of Dundee is a world-renowned
hepatologist, who played a major role in introducing Hepatitis C screening in
Scotland. We believe that his team's clinical experience, combined with the
richness of the Dundee dataset, will form a strong pairing with our expertise
in creating healthcare AI solutions. Signing the research agreement was a key
longer-term step for us as we look to build our fourth AI ultrasound platform,
and we have high hopes for this proof-of-concept work.

 

Challenges to the 'Classroom to Clinic' Business

Ultrasound continues to be a growing medical diagnostic tool, with increasing
demand for training tools that can enhance a medical practitioner's scanning
skills and clinical products that can assist sonographers. However, there
continue to be capital expenditure limitations on medical training budgets for
high-value medical simulators, and hospital funding can also be hard to
access, with long adoption periods and purchase cycles of between six to 18
months. This makes revenue forecasting difficult, especially during times of
government spending cutbacks, political upheaval, changes of government, or
pandemics when funds can be diverted to frontline care. The purchasing
decisions made by medical institutions in the simulation market remain broadly
based on the quality of training combined with value for money, rather than
simply the lowest-priced solution.

 

During 2023, we continued to respond well to competitive products and pricing
and margin pressures by offering a variety of purchase price points, expanding
our product extensions, and increasing our e-learning options that can work in
tandem with our hands-on training simulators. To counter clinical funding
constraints, our clinical AI products are competitively priced and aim to
either provide improvements to the workflow, destress the scanning process, or
enable more clinicians to confidently complete a procedure that will save a
hospital money. After a two-year period where we increased our key component
stocks to combat supply chain pressure, during the second half of 2023, we
have been able to reduce our stock levels, and now have only three components
that have a lead time longer than four weeks.

 

We are conscious that, for a relatively small company, there has to be
constant monitoring of cash and stock against revenue forecasts and potential
supply chain spikes. To date we have managed this well and will continue with
the current policy in 2024. We continue to review supplier costs and overheads
and are conducting a component savings review but expect our simulation gross
margin to hold stable in 2024. We are currently reviewing the option for price
increases in the second half of 2024.

 

The AI-based ultrasound imaging software market is recognised as having
significant global potential and as such there is considerable competition
from both the existing ultrasound manufacturers and well-funded independent AI
software vendors. With the revenue models for AI-driven software still in the
relatively early stages of commercialisation, we continue to have a
two-pronged go-to market strategy:

 

·      Our ScanNav Assist software is being sold through a
royalty-based, 'on machine' licence with GE HealthCare, whose established
sales network can provide faster roll-out of our technology in the new
ultrasound machine market; and

·      Our ScanNav Anatomy PNB software is being sold through our own
sales network directly to the global pool of existing ultrasound machines via
our own portable 'plug-in' real-time AI enabled device.

 

Although the restrictions caused by the pandemic have now fully receded in all
our markets, there are several potential threats to the world, regional and
local economies. These include:

·      The continued threat that the Russian invasion and illegal
occupation of Ukraine could escalate to the point where it impacts other
European countries

·      The Israeli-Hamas war and increased tension in the Middle East
region escalating

·      The impact on hospital budgets of an economic slowdown in UK,
Europe and China

·      The disruption to government spending plans that can be caused by
imminent elections in the US and UK

·      The continuation of the junior doctor's strike in the UK
significantly reducing funds available for capital purchases

 

Quality Management System

Meeting the standards of ISO 13485:2016 remains a high priority for the Group,
as we continue to ensure the consistent design, development, production,
installation, and sale of medical devices that are safe for their intended
purpose.

 

Workplace environment

We have a great team that has worked incredibly hard all year and I would like
to thank everyone for enabling us to achieve so much.

 

Shareholders

I would also like to thank our shareholders for their continued support as we
grow our classroom to clinic vision and produce cutting edge AI software that
will make ultrasound easier to use for medical professionals around the world.

 

Looking ahead

In 2023 over half of our AI-related revenue came from our women's
health-related AI software sales, which included both GE HealthCare royalty
income, combined with revenue from studies utilising our ScanNav FetalCheck AI
software. We are therefore at a pivotal moment for the Company, and we remain
positive about the outlook for the business in this exciting market.

 

Stuart Gall, Chief Executive Officer

 

FINANCIAL REVIEW

 

Summary financial performance

 

 £m                                     2023    2022    Change (%)

(unless otherwise stated)
 Revenue                                11.17   10.10   +11
 Gross profit                           6.84    6.08    +13
 Gross profit margin (%)                61%     60%     +1
 Expensed R&D                           (1.15)  (1.69)  -32
 Administrative expenses (*restated)    (8.72)  (8.07)  +8
 Operating loss                         (3.02)  (3.67)  -18
 Loss after taxation                    (2.58)  (2.98)  -13
 Gross R&D costs                        (2.96)  (3.20)  -8
 Net cash used in operating activities  (1.71)  (0.68)  +150
 Cash and cash equivalents              3.03    7.17    -58

 

Income statement

 

Revenue

The Group delivered overall growth in revenues of 11% in 2023 to £11.2m
(2022: £10.1m) with Clinical AI revenues experiencing 203% growth from 2022
and Simulation revenues declining slightly by 3%.

 

Simulation

 

 £m                 2023  2022  Change  Adjusted  Change (%)

                                        2022**
 UK                 2.36  4.91  -52%    3.01      -22
 North America      4.51  2.78  +62%    2.78      +62
 Rest of the World  2.27  1.74  +31%    1.74      +31
                    9.14  9.43  -3%     7.53      +21

 

Simulation revenues reduced by 3% in 2023, although 2022 revenues included
£1.9m of 'one-off' revenue from a national NHS England echocardiography
ultrasound training programme. Excluding this exceptional one-off revenue,
simulation revenue on a like-for-like basis increased by 21% in 2023.

 

It was encouraging that North American revenues grew 62% in 2023 after
significant investment in resource and marketing over the past two years.
Despite the strengthening of Sterling against the US Dollar in 2023, the
region saw good growth in sales across all products, in particular BabyWorks,
the newest product in the range.

 

Revenues increased by a third from the reseller network outside of the UK and
North America to £2.27m (2022: £1.74m). Although some countries such as
China and Australia performed below expectation, we started to see strong
sales in the last quarter of the year which is expected to continue into 2024.

 

UK revenues declined by 52% in 2023, partly due to the one-off large NHS order
in the prior year and also due to a reduction in NHS general training budgets
with funding diverted to other priority areas. It should be noted however,
that if we exclude the 'one-off' 2022 orders, the UK like-for-like revenue
declined by 22%.

 

 

*2022 restated for a reclassification of labour and distribution cost

**Adjusted on a 'like-for-like' basis to exclude the £1.9m of one-off sales
in 2022

 

Clinical AI

 

 £m                 2023  2022  Change (%)
 UK                 0.41  0.24  +72
 North America      0.31  0.16  +96
 Rest of the World  1.31  0.27  +382
                    2.03  0.67  +203

 

Clinical AI revenues trebled in 2023 to £2.03m (2022: £0.67m), with positive
growth in sales from NeedleTrainer (NT) and 'Classroom to Clinic' NT products
(C2C), SonoLyst royalty income as well as revenues relating to the ScanNav
Fetalcheck studies.

 

Gross profit

Gross profit increased by 13% to £6.84m (2022 restated*: £6.08m) directly
associated with higher revenues. Average gross margin also improved by 1% to
61% (2022*: 60%).

 

Simulation gross margin percentage in 2023 of 60% remained the same as in 2022
with a more favourable product mix offset by a lower proportion of revenue
coming from direct sales in the UK and North America (75% in 2023 versus 82%
in 2022).

 

Clinical AI gross margin improved to 68% (2022: 58%) with the prior year
margin impacted by the cost of a component upgrade to the NeedleTrainer
demonstration units.

 

Administrative expenses

 

 £m                                        Restated  Change (%)

                                    2023   2022*
 Sales, marketing and distribution  3.77   3.56      +6
 Other general and administrative   3.10   2.75      +13
 Other non-cash costs:
 Share based payment charges        0.24   0.38      -36
 Depreciation and amortisation      1.61   1.38      +17
                                    8.72   8.07      +8

 

Administrative expenses increased by 9% to £8.72m (2022 restated: £8.07m)
with salary increases, higher sales and exhibition-related distribution costs,
and insurance costs in the US, as well as general higher inflationary
increases impacting other administrative costs. Amortisation charges increased
by £0.2m reflecting the higher capitalised development costs in 2022 and
2023. Share-based payment charges reduced by 36% to £0.24m (2022: £0.38m)
with historical share option charges having been fully recognised in the prior
year as well as increased forfeiture rates.

 

Operating loss

The operating loss reduced by 18% to £3.02m (2022: £3.67m) driven partly by
the 13% increase in gross profit and higher capitalised R&D costs.

 

Research and development (R&D) costs

 

 £m           2023  2022  Change (%)
 Expensed     1.15  1.69  -32
 Capitalised  1.81  1.51  +20
              2.96  3.20  -8
 Simulation   0.91  1.24  -27
 Clinical AI  2.05  1.96  +5

The Group incurred lower R&D expenditure in 2023 of £2.96m (2022:
£3.20m). The simulation R&D team was largely focused on continuing to
enhance the BabyWorks functionality as well as the development of the new
version of BodyWorks. Lower external development costs resulted in a 27%
reduction in R&D spend on simulation products. The Clinical AI R&D
team continued to make further improvements to NeedleTrainer, developed
ScanNav FetalCheck, and started the first phase of ScanNav Liver. R&D
expenditure relating to clinical AI products remained broadly flat year on
year at £2.05m (2022: £1.96m).

 

Taxation

The total tax credit in 2023 was £0.44m (2022: £0.72m). The Group claims
annually for R&D tax credits and, since it is loss-making, elects to
surrender these tax credits for a cash rebate. The credit is £0.28m lower
than in 2022 due to changes in the SME R&D tax credit legislation which
came into effect on 1 April 2023 where the enhanced deduction for SMEs reduced
from 130% to 86%, and the amount of tax credit reduced from 14.5% to 10%.

 

As at 31 December 2023, the Group had cumulative gross UK tax losses of
approximately £20.02m (31 December 2022: £18.81m) for which the Group
continues to hold a cautious view, and consequently chooses to not recognise
those losses as a deferred tax asset.

 

Balance sheet and working capital

Net assets at 31 December 2023 were £9.74m (31 December 2022: £12.2m).

 

Intangible assets of £4.10m increased by £0.82m, with £1.81m of R&D
costs capitalised in 2023 (2022: £1.49m), offset by £0.99m amortisation
charge. Capitalised R&D costs were higher in the year despite lower
R&D spend due to more expenditure meeting the criteria for capitalisation
in 2023.

 

Working capital reduced by £3.16m to £5.07m at 31 December 2023 (31 December
2022: £8.23m) with cash and cash equivalents decreasing by £4.14m, offset by
higher trade and other receivables of £1.37m due to a higher proportion of
orders being received in November and December compared to the prior year.
Inventory of £1.45m was lower by £0.15m (2022: £1.60m) following a review
during the year to reduce the inventory of certain raw material components.

 

Included within current assets is the R&D tax credit receivable of £0.46m
(31 December 2022: £0.71m). This is £0.25m lower than at 31 December 2022
due to the changes in the SME R&D tax credit legislation from 1 April
2023.

 

During the year £1.81m (2022: £1.47m) of product development costs were
capitalised within intangible assets with more development cost meeting the
criteria for capitalisation in 2023 compared to the prior year.

 

Current liabilities were £3.27m (31 December 2022: £3.28m), with trade
payables of £1.23m (31 December 2022: £1.36m) and accruals of £1.12m (31
December 2022: £0.97m) largely relating to sales-based royalties payable,
sales commissions and annual bonuses. Lease liabilities of £0.69m (31
December 2022: £0.49m) increased in the year following the expansion of the
warehouse facility in Caerphilly in August 2023 as well as a move to a new
office in North America.

 

Deferred income at 31 December 2023 was £0.57m (31 December 2022: £0.55m)
which relate to extended warranties and technical support. These amounts are
deferred and released to the income statement over the life of the extended
warranty and support period.

 

The share-based payment reserve increased by £0.24m to £2.00m (31 December
2022: £1.75m) due to the share-based payment charge of £0.25m for the year.

 

Cash flow

 

The Group reported cash and cash equivalents of £3.03m at 31 December 2023
(31 December 2022: £7.17m), a decrease of £4.14m.

 

 £m                                                2023    2022
 Operating                                         (1.71)  (0.69)
 Investing                                         (2.12)  (1.82)
 Financing                                         (0.24)  4.55
 Exchange (gains)/losses                           (0.07)  0.18
 (Decrease)/increase in cash and cash equivalents  (4.14)  2.22

 

Operating cash outflows increased by £1.02m in 2023. Despite reduced
operating cash outflows of £0.79m, this was offset by adverse movements in
working capital of £1.24m (2022: £0.26m) particularly due to timing of
invoicing impacting trade and other receivables as well as lower R&D tax
credits received in the year of £0.69m (2022: £0.96m).

 

The net cash outflow arising from investing activities was £2.12m (2022:
£1.82m) relating to capitalised R&D expenditure of £1.81m (2022:
£1.47m) and £0.33m (2022: £0.38m) of property, plant and equipment, the
majority of which relates to the capitalisation of sales demonstration
equipment.

 

The net cash outflow from financing activities was £0.24m (2022: £4.55m
inflow), mainly relating to lease payments of £0.21m and the associated
interest. The prior year included the net funds received following the share
placing in November 2022.

 

Going concern

In undertaking a going concern review, the Directors have reviewed three
financial projections to 31 December 2025 based on the existing base budget, a
flexed, more conservative version of the base budget and a reforecast based on
current trading; all of which include estimates and assumptions regarding the
product development projects, sales pipeline, future revenues and costs and
timing and quantum of investments in the R&D programmes. Post-year-end,
the Company secured access to a £2 million overdraft facility with HSBC which
provides additional liquidity to support the Company's working capital needs
but is scheduled for review within 12 months of signing the financial
statements. If the Group subsequently becomes reliant on the availability of
the facility to meet its short-term liquidity needs, a failure to renew or
extend the facility could impact its ability to continue as a going concern.
Additionally, if the Group's performance does not meet that projected and
available facilities are insufficient to meet its liquidity needs then the
Group may need to find alternative sources of finance. These circumstances
represent a material uncertainty that may cast significant doubt upon the
Group's and the Company's ability to continue as a going concern.

 

Notwithstanding the uncertainties around timing and magnitude of future
cashflows, the Directors believe existing cash reserves, expected cash flows
from operating activities as well as the availability of the overdraft
facility if required, are sufficient to meet the Group and Company's
obligations as they fall due for at least the next twelve months from the date
of approval of these financial statements.

 

The Directors have therefore concluded that it is appropriate to prepare the
Group and Company financial statements on a going concern basis. The financial
statements do not include any adjustments that would result if the Group or
the Company was unable to continue as a going concern.

 

Helen Jones

Chief Financial Officer

 

CONSOLIDATED STATEMENT OF PROFIT AND LOSS AND OTHER COMPREHENSIVE INCOME

for the year ended 31 December 2023

 

 

 Continuing operations                                                           Note           Restated

                                                                                       2023     2022*

                                                                                       £'000    £'000
 Revenue                                                                         2     11,173   10,100
 Cost of sales                                                                         (4,334)  (4,024)
 Gross profit                                                                          6,839    6,076
 Other income                                                                          9        8
 Administrative expenses                                                               (9,868)  (9,756)
 Operating loss                                                                        (3,020)  (3,672)
 Finance income                                                                        26       1
 Finance costs                                                                         (29)     (31)
 Loss before taxation                                                                  (3,023)  (3,702)
 Taxation                                                                        3     441      718
 Loss attributable to the equity shareholders of the Parent                            (2,582)  (2,984)
 Other comprehensive income
 Items that may be reclassified to profit or loss:
 Exchange gain arising on translation of foreign operations                            (90)     238
 Other comprehensive gain for the period                                               (90)     238
 Total comprehensive loss attributable to the equity shareholders of the Parent        (2,672)  (2,746)
 Loss per ordinary share attributable to the equity shareholders of the Parent
 Basic and diluted (pence)                                                       4     (0.79)   (1.08)

 

*See note 1 for details of the restatement as a result of a change in
accounting policy

 

 

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

as at 31 December 2023

 

 

                                Note  2023      2022

                                      £'000     £'000
 Non-current assets
 Intangible assets                    4,095     3,272
 Property, plant and equipment        1,293     1,174
 Trade and other receivables          61        61
                                      5,449     4,507
 Current assets
 Inventories                          1,450     1,603
 Trade and other receivables          3,398     2,025
 Current tax assets                   462       713
 Cash and cash equivalents            3,031     7,166
                                      8,341     11,507
 Total assets                         13,790    16,014
 Current liabilities
 Trade and other payables             (2,698)   (2,732)
 Deferred income                      (294)     (337)
 Lease liabilities                    (244)     (188)
 Provisions                           (35)      (22)
                                      (3,271)   (3,279)
 Non-current liabilities
 Deferred income                      (272)     (209)
 Lease liabilities                    (446)     (298)
 Other payables                       (65)      (65)
                                      (783)     (572)
 Total liabilities                    (4,054)   (3,851)
 Net assets                           9,736     12,163

 Equity
 Share capital                  5     3,269     3,269
 Share premium                        30,207    30,207
 Accumulated losses                   (32,533)  (29,951)
 Share-based payment reserve          1,998     1,753
 Merger reserve                       6,538     6,538
 Foreign exchange reserve             92        182
 Other reserves                       165       165
 Total equity                         9,736     12,163

 

 

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

for the year ended 31 December 2023

 

 

                                                        Share     Share     Accumulated losses  Share-based payment reserve  Merger    Foreign    Other reserves

capital
premium

         £'000               £'000                        reserve   exchange   £'000           Total
                                                        £'000     £'000

                                                                                                                             £'000     reserve                    equity

                                                                                                                                       £'000                      £'000
 As at 31 December 2021                                 2,707     25,959    (26,967)            1,373                        6,538     (56)       165             9,719
 Loss for the year                                      -         -         (2,984)             -                            -         -          -               (2,984)
 Other comprehensive income                             -         -         -                   -                            -         238        -               238
 Total comprehensive loss for the year                  -         -         (2,984)             -                            -         238        -               (2,746)
 Transactions with owners, recorded directly in equity                                                                                                            -
 Issue of share capital                                 562       4,248     -                   -                            -         -          -               4,810
 Cost of share-based awards                             -         -         -                   380                                                               380
 As at 31 December 2022                                 3,269     30,207    (29,951)            1,753                        6,538     182        165             12,163
 Loss for the year                                      -         -         (2,582)             -                            -         -          -               (2,582)
 Other comprehensive income                             -         -         -                   -                            -         (90)       -               (90)
 Total comprehensive loss for the year                  -         -         (2,582)             -                            -         (90)       -               (2,672)
 Transactions with owners, recorded directly in equity  -         -         -                   -                            -         -          -               -
 Cost of share-based awards                             -         -         -                   245                          -         -          -               245
 As at 31 December 2023                                 3,269     30,207    (32,533)            1,998                        6,538     92         165             9,736

 

 

CONSOLIDATED STATEMENT OF CASH FLOWS

for the year ended 31 December 2023

 

 

                                                          2023     2022

                                                          £'000    £'000
 Cash flows from operating activities
 Loss before taxation                                     (3,023)  (3,702)
 Depreciation                                             629      604
 Amortisation of intangible assets                        986      780
 Net finance costs                                        3        30
 Share-based payment charge                               245      380
 Operating cash flows before movement in working capital  (1,160)  (1,908)
 Decrease/(increase) in inventories                       151      (404)
 (Increase)/decrease in trade and other receivables       (1,413)  739
 Increase/(decrease) in trade and other payables          7        (70)
 Movement in provisions                                   13       -
 Cash used in operations                                  (2,402)  (1,643)
 Income taxes received                                    691      959
 Net cash used in operating activities                    (1,711)  (684)
 Cash flows from investing activities
 Purchase of property, plant and equipment                (338)    (357)
 Internally generated intangible assets                   (1,809)  (1,467)
 Interest received                                        26       1
 Net cash used in investing activities                    (2,121)  (1,823)
 Cash flows from financing activities
 Proceeds from issue of new shares                        -        5,200
 Share issue costs                                        -        (390)
 Principal elements of lease payments                     (207)    (231)
 Interest paid                                            (29)     (31)
 Net cash (used in)/generated by financing activities     (236)    4,548
 Net (decrease)/ increase in cash and cash equivalents    (4,068)  2,041
 Cash and cash equivalents at beginning of year           7,166    4,950
 Exchange losses on cash and cash equivalents             (67)     175
 Cash and cash equivalents at end of year                 3,031    7,166

 

 

1.    GENERAL INFORMATION

 

Intelligent Ultrasound Group plc ("the Company") is a publicly limited
liability company incorporated and domiciled in the United Kingdom whose
shares are traded on AIM, a market operated by the London Stock Exchange. The
Company's registration number is 09028611 and its registered office address is
Floor 6A Hodge House, 114-116 St Mary Street, Cardiff, CF10 1DY.

 

These results do not constitute the Group's statutory accounts for the year
ended 31 December 2023 but are derived from those accounts. Statutory accounts
for 2022 have been delivered to the Registrar of Companies and those for 2023
will be delivered following the Company's Annual General Meeting.

The external auditors have reported on those accounts; its report was
unqualified, drew attention by way of emphasis to a material uncertainty
related to going concern as addressed below and the valuation of intangible
assets, investment value and intercompany receivable, and did not contain any
statements under section 498 of the Companies Act 2006.

Going concern

 

In undertaking a going concern review, the Directors have reviewed three
financial projections to 31 December 2025 based on the existing base budget, a
flexed, more conservative version of the base budget and a reforecast based on
current trading; all of which include estimates and assumptions regarding the
product development projects, sales pipeline, future revenues and costs and
timing and quantum of investments in the R&D programmes. Post-year-end,
the Company secured access to a £2 million overdraft facility with HSBC which
provides additional liquidity to support the Company's working capital needs
but is scheduled for review within 12 months of signing the financial
statements. If the Group subsequently becomes reliant on the availability of
the facility to meet its short-term liquidity needs, a failure to renew or
extend the facility could impact its ability to continue as a going concern.
Additionally, if the Group's performance does not meet that projected and
available facilities are insufficient to meet its liquidity needs then the
Group may need to find alternative sources of finance. These circumstances
represent a material uncertainty that may cast significant doubt upon the
Group's and the Company's ability to continue as a going concern.

Notwithstanding this, after making due enquiries and considering the
uncertainty, the Directors believe existing cash reserves, expected cash flows
from operating activities as well as the availability of the overdraft
facility if required, are sufficient to meet the Group and Company's
obligations as they fall due for at least the next twelve months from the date
of approval of these financial statements.

The Directors have therefore concluded that it is appropriate to prepare the
Group and Company financial statements on a going concern basis. The financial
statements do not include any adjustments that would result if the Group or
the Company was unable to continue as a going concern.

 

Impairment assessment of Clinical AI intangible assets

 

For the intangible assets that have a finite life, the Directors considered
the need to impair the carrying value of intangible assets by performing a
review for indicators of impairment by assessing the performance of the assets
against qualitative and quantitative factors. If any of these factors are
present a detailed impairment review is undertaken. A detailed impairment
assessment is performed by assessing the assets value in use which requires
management to make a number of estimates. The most sensitive estimate is in
relation to management's estimates of future revenues on the basis that these
are relatively new products which have no extensive history of sales upon
which to base the forecasts.

During the period ended 31 December 2023, the Clinical AI related and
Simulation assets with a carrying value of £2.1m and £2.0m respectively were
tested for impairment. The calculations use five-year cash flow projections
based on financial budgets approved by management covering a two-year period.
Cash flows for periods three to five are extrapolated using estimated growth
rates and growth rates beyond five years are consistent with forecasts
specific to the sector in which the CGU operates.

Reasonable sensitivities applied to the cashflow projections indicate that
there is significant headroom before any impairment would be required. In the
scenario that Clinical AI revenues only grow by 22.7% year on year in the
value in use calculation, this would result in full impairment of the carrying
value of the asset by £2.1m. If simulation revenue decreased by 50% over the
five years used in the value-in-use calculation for Simulation assets there
would still be adequate headroom.

 

Restatement to Consolidated Statement of Profit and Loss and Other
Comprehensive Income

 

In 2023, there was a change in accounting policy to recognise distribution
costs and warehouse labour within cost of sales instead of administrative
expenses to more accurately reflect the direct costs associated with
generating revenue.

 

For comparative purposes, the 2022 income statement has been restated below:

 

                          As previously reported  Reclassification  As restated

                          2022

                          £'000                   2022              2022

                                                  £'000             £'000
 Revenue                  10,100                  -                 10,100
 Cost of sales            (3,766)                 (258)             (4,024)
 Gross profit             6,334                   (258)             6,076
 Other income             8                       -                 8
 Administrative expenses  (10,014)                258               (9,756)
 Operating loss           (3,672)                 -                 (3,672)

 

 

2.    OPERATING SEGMENTS

 

Operating segments reflect the way in which information is presented to and
reviewed by the Chief Operating Decision Maker (CODM) for the purposes of
making strategic decisions and assessing Group-wide performance. The Group's
Board of Directors ('the Board') is the Group's CODM. The Group evaluates
performance of the operational segments on the basis of revenue and gross
profit. Apart from Intangible assets and Property, plant and equipment, all
other assets and liabilities are reported to the Board at Group level and are
not separated segmentally. The format of revenue reporting is based on the
Group's management and internal reporting (including reports to the CODM). The
Group has two operating segments: Simulation and Clinical AI:

 

·      Simulation: sales of ultrasound simulation systems and related
services

·      Clinical AI: sales of AI-related ultrasound image analysis
software products

 

 

 2023           Simulation  Clinical AI  Total

                £'000       £'000        £'000
 Revenue        9,144       2,029        11,173
 Cost of sales  (3,838)     (496)        (4,334)
 Gross profit   5,306       1,533        6,839

 

 

 2022 (restated)  Simulation  Clinical AI  Total

                  £'000       £'000        £'000
 Revenue          9,432       668          10,100
 Cost of sales*   (3,742)     (282)        (4,024)
 Gross profit     5,690       386          6,076

*See note 1 for details of the 2022 restatement

 

Revenue by destination of external customer

 

                                   2023     2022

                                   £'000    £'000
 United Kingdom                    2,769    5,145
 North America (USA & Canada)      4,828    2,943
 Rest of the World                 3,576    2,012
                                   11,173   10,100
 Timing of revenue recognition:
 At a point in time                10,674   9,591
 Over time                         499      509

 

Clinical AI royalty income is included within Rest of the World based on the
external customer's invoicing country rather than the destination of the end
customer.

 

Included within non-UK revenues are sales to the following country which
accounted for more than 10% of the Group's total revenue for the year:

      2023     2022

      £'000    £'000
 USA  4,021    2,808

 

The Group had no customers who accounted for more than 10% of the Group
revenue for the year ended 31 December 2023 or 2022.

 

Other segment information

              Depreciation          Additions to

and amortisation

                                    non-current assets
              2023       2022       2023        2022

              £'000      £'000      £'000       £'000
 Simulation   1,037      942        1,509       1,258
 Clinical AI  434        299        990         605
 Central      144        143        -           -
              1,615      1,384      2,499       1,863

 

Non-current assets based outside the UK

Right-of-use assets include leased offices for Intelligent Ultrasound North
America Inc (IUNA), based in Georgia. The net book value as at 31 December
2023 was £0.19m (2022: £0.03m).

 

3. TAXATION

 

                                                 2023     2022

                                                 £'000    £'000
 Current tax
 R&D tax credit                                  (460)    (711)
 R&D tax credit relating to prior periods        19       (7)
                                                 (441)    (718)
 Deferred tax
 Origination and reversal of timing differences  -        -
 Effect of tax rate change on opening balance    -        -
                                                 -        -
 Income tax credit                               (441)    (718)

 

4.     LOSS PER ORDINARY SHARE

 

The loss per Ordinary share has been calculated using the loss for the year
and the weighted average number of Ordinary shares in issue during the year as
follows:

                      2023     2022

                      £'000    £'000
 Loss after taxation  (2,582)  (2,984)

 

 Number of Ordinary shares of 1p each                          2023                2022

                                                               No.                 No.
 Basic and diluted weighted average number of Ordinary shares      326.869,921       275,274,014

 Basic and diluted loss pence per share                        (0.79)              (1.08)

 

At 31 December 2023 and 2022 there were share options outstanding which could
potentially have a dilutive impact but were anti-dilutive in both years.

 

 

 

5.     SHARE CAPITAL

 

 Authorised, allotted, issued and fully paid  2023                 2022
                                              Number       £'000   Number       £'000
 Ordinary shares of 1p each
 Balance at 1 January                         326,869,921  3,269   270,653,485  2,707
 Shares issued for cash                       -            -       56,216,436   562
 At 31 December                               326,869,921  3,269   326,869,921  3,269

 

The nominal values and the premium arising on shares issued in 2022 are as
follows:

 Date                   Number      Nominal value  Premium

                        of shares   £'000          £'000
 1 and 2 December 2022  56,216,436  562            4,638

 

On 1 December 2022 the Company placed 56,216,436 newly issued shares of 1
pence each in the capital of the Company at a price of 9.25 pence per share.
Share issue costs of £0.39m have been netted off against share premium
arising on the new share issue.

 

Ordinary shares have a par value of 1 pence. They entitle the holder to
participate in dividends, and to share in the proceeds of winding up the
company in proportion to the number of and amounts paid on the shares held. On
a show of hands, every holder of ordinary shares present at a meeting, in
person or by proxy, is entitled to one vote; and, on a poll, each share is
entitled to one vote. Ordinary shares have equal rights, preferences and no
restrictions on distributions of dividends nor the repayment of capital.

 

The Company does not have a limited amount of authorised capital.

 

6. PUBLICATION OF ANNUAL REPORT

 

It is anticipated that the full Annual Report will be published in May 2023.
Copies will be available at the Company's head office; Floor 6A Hodge House,
114-116 St Mary Street, Cardiff, CF10 1DY and on the Company's website
(www.intelligentultrasound.com (http://www.intelligentultrasound.com) ).

 

 

 

 

 

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