Intelligent Ultrasnd - Final Results
20/04/2023 07:00
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RNS Number : 8201W Intelligent Ultrasound Group PLC 20 April 2023
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Intelligent Ultrasound Group plc
("Intelligent Ultrasound" or the "Group" or the "Company")
Audited Results for the Year Ended 31 December 2022
Intelligent Ultrasound Group plc (AIM: IUG), the ultrasound artificial
intelligence (AI) software and simulation company, announces its audited
results for the year ended 31 December 2022, showing another year of
significant progress.
Financial highlights:
· Group revenue grew by 33% to £10.1m (2021: £7.6m)
· Clinical AI-related revenue grew by over 200% to £0.7m (2021:
£0.2m)
· Simulation related revenue grew by 28% to £9.4m (2021: £7.4m)
· Loss after tax reduced to £3.0m (2021: £3.6m)
· Year-end cash at £7.2m (31 December 2021: £5.0m) after a £4.8m
placing (net of fees) and no debt (excluding IFRS 16 lease liabilities)
Operational highlights:
· GE HealthCare launched the SonoLyst technology, that utilises our
ScanNav Assist AI software, on the Voluson Expert 22 ultrasound machine in
July
· ScanNav Anatomy Peripheral Nerve Block (PNB), our second
AI-driven product, received FDA De Novo clearance for sale in the US in
October
· NeedleTrainer 2.0, our third AI-related product, to teach
ultrasound-guided needling to medical professionals, was launched in September
and now incorporates the GE HealthCare Vscan Air ultrasound device
· We began a charitable partnership with the World Federation for
Ultrasound in Medicine and Biology ("WFUMB") to support their mission to bring
sustainable ultrasound training programmes to the underserved areas of the
world
Commenting on the results, Riccardo Pigliucci, Chairman of Intelligent
Ultrasound said: "This has been another year of significant progress for the
Group. We have increased Group revenue by over 30%, achieved the important
milestone of FDA clearance for our second AI-driven product and continue to
build an excellent partnership with the world's leading ultrasound company -
GE HealthCare. With a positive start in Q1 23, a growing range of AI and
simulation related products, an established operational base, and year end
cash of £7.2m, we expect to continue this growth during 2023 and remain
excited about the long-term potential of our unique 'Classroom to Clinic'
model."
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
Tel: +44 (0)20 7397 8900
Cenkos Securities - Nominated Advisor and
Broker
Giles Balleny / Max Gould (Corporate Finance)
Dale Bellis / Julian Morse (Sales)
Tel: +44 (0)20 7933 8780 or intelligentultrasound@walbrookpr.com
(mailto:intelligentultrasound@walbrookpr.com)
Walbrook PR
Anna Dunphy / Paul McManus Mob: +44 (0)7876 741 001 / Mob: +44 (0)7980 541 893
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 USA, 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 with Covid-19
module and the new BabyWorks Neonate and Paediatric training simulator. To
date c. 1500 simulators have been sold to over 750 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 22 and SWIFT
ultrasound machines; ScanNav Anatomy PNB that simplifies ultrasound image
interpretation by providing the user with real-time AI-based anatomy
highlighting for a range of ultrasound guided regional anaesthesia procedures;
and NeedleTrainer that teaches real-time ultrasound-guided needling and
incorporates ScanNav Anatomy PNB.
www.intelligentultrasound.com (http://www.intelligentultrasound.com)
CHAIRMAN'S STATEMENT
This has been another year of significant progress across the business. We
have increased Group revenue by 33% to £10.1m (2021: £7.6m), achieved FDA De
Novo clearance for our second AI-driven clinical product in the real-time
ultrasound image analysis market and, with the launch of SonoLyst on the
Voluson Expert 22 ultrasound machine, are building an excellent partnership
with GE HealthCare - the world's leading ultrasound company.
Clinical AI:
· Revenue grew by over 200% to £0.7m in 2022 (2021: £0.2m)
· GE HealthCare launched the SonoLyst technology on the Voluson
Expert 22 ultrasound machine in July. SonoLyst utilises our ScanNav Assist AI
software technology and is the world's first fully integrated ultrasound AI
tool that recognises the 21 views recommended by the International Society of
Ultrasound in Obstetrics and Gynaecology (ISUOG) mid-trimester practice
guidelines for fetal imaging
· ScanNav Anatomy Peripheral Nerve Block (PNB), our second AI
driven product, received FDA De Novo clearance in October for sale in the US
· NeedleTrainer 2.0, our third AI-related product, to teach
ultrasound-guided needling to medical professionals, was launched in September
and now incorporates the GE HealthCare Vscan Air handheld ultrasound device
Simulation:
· Revenue grew by 28% to £9.4m in 2022 (2021: £7.4m), primarily
driven by UK direct sales that grew by 96% to £4.9m (2021: £2.5m)
· Direct sales revenue in the North American market was broadly
flat due to the tighter than expected market in the second half of the year
being positively offset by currency swings
· Sales in Europe and Asia, that are made through our reseller
network, declined to £1.7m (2021: £2.1m), largely due to the restrictions of
Covid-19 on the Chinese market
Group:
· Loss after tax reduced to £3.0m (2021: loss of £3.6m)
· Cash at bank at 31 December 2022 was £7.2m (2021: £5.0m) after
an oversubscribed placing in November raised £4.8m (net of fees) from new and
existing shareholders
· Agreed a charitable partnership with the World Federation for
Ultrasound in Medicine and Biology ("WFUMB") to help support their mission to
bring sustainable ultrasound training programmes to the underserved areas of
the world
Strategy
We continue to progress our unique 'Classroom to Clinic' ultrasound strategy
based on:
· Growing the Group's 'Classroom' related revenues through
increased sales from our existing simulator platforms sold through our direct
sales operations in the UK and US, and our global reseller channels; and the
continued expansion of our range of ultrasound training simulators into new
medical market segments
· Building our 'Clinic' related AI revenues through increased
revenue from royalty sales from GE HealthCare, who incorporate our ScanNav AI
technology in their Voluson SWIFT and Expert 22 ultrasound systems; increased
sales of our proprietary stand-alone AI-driven ScanNav Anatomy and
NeedleTrainer systems, sold through our direct sales and reseller operations;
and future new proprietary stand-alone AI-driven products aimed at new medical
markets
We believe that our 'Classroom to Clinic' approach allows us to capture future
clinical customers early in their medical careers, aiding brand recognition
and product credibility as the ex-trainees progress their careers and increase
their purchasing influence.
In the NeedleTrainer/Anatomy PNB example, there is a direct path from first
learning basic skills with simulation in the classroom then, under
supervision, learning on patients in clinical practice with the AI support
tools and finally providing real-time AI-based support to practitioners'
independent clinical practice.
We believe this unique 'classroom to clinic' approach to ultrasound will
enable the Group to continue to grow in 2023 and reach profitability by the
end of 2024.
People
Our people continue to have a pivotal role in our success and I would like to
thank all our staff, in both the UK and the US, for working so hard and
performing so well during a record year. Without their invaluable contribution
we would not have achieved all the key milestones we set out to shareholders
at the beginning of the year.
Shareholders
We are privileged to have such a supportive group of shareholders. During the
second half of the year, we raised £5.2m (£4.8m net of fees) from new and
existing shareholders and I would like to thank them for their continued
support. It was pleasure to meet a number of our shareholders during our two
technology open days that were held in London, and we will look to expand
these events in 2023. As always, we maintain an open-door policy at our head
office in Cardiff and welcome any visitors who wish to experience our cutting
edge 'classroom to clinic' technology.
Board and governance
The Board aims to maintain the highest standards of corporate governance and
is continuing to appoint new diverse, experienced and independent
non-executive Directors, as some of our longest serving Directors retire.
· In August 2022 we were delighted to welcome Dr Christian Guttmann
as a Non-executive Director to the Board. Christian is a recognised leader in
shaping the global agenda on AI regulation and standards, as well as having
outstanding AI research, development and commercialisation experience. He
has edited and authored seven books, over 50 publications and has three
patents in the field of AI
· At the 2022 AGM Prof Nazar Amso, one of the original founders of
the company and David Baynes, representing the largest pre-listing investor,
did not seek re-election and retired from the Board
· On 31 December 2022 Andrew Barker, who joined the Board after the
acquisition in 2017 of Intelligent Ultrasound Ltd, retired.
I would like to thank all three retiring Directors for their outstanding
contribution to the business. They have all worked tirelessly to support the
Group and their input to the Board will be missed.
ESG
This is our second full year of ESG reporting and we have continued to make
significant progress in all aspects of our reporting. For the first time we
have provided a full calculation of our Scope 3 emissions and are delighted to
be working with the World Federation for Ultrasound in Medicine and Biology
("WFUMB") in their mission to bring sustainable ultrasound training programmes
to the underserved areas of the world. We continue to instigate new
initiatives to promote better employee and local engagement and believe we
continue to have a positive impact locally, nationally and globally. We look
forward to continuing our ESG journey.
Outlook
This has been another year of significant progress for the Group. We have
increased Group revenue by over 30%, achieved the important milestone of FDA
clearance for our second AI-driven product and continue to build an excellent
partnership with the world's leading ultrasound company - GE HealthCare.
With a positive start in Q1 2023, a growing range of both AI and simulation
related products, an established operational base, and year end cash of
£7.2m, we expect to continue this growth during 2023 and remain excited about
the long-term potential of our unique 'Classroom to Clinic' model.
Riccardo Pigliucci
Non-executive Chairman
CEO REVIEW
Our vision is to 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. With the global market for artificial
intelligence (AI) based ultrasound software expected to be $1.3bn by 2028, AI
remains a key element of our approach, as we expand both our simulation and
clinical sales operations.
Based in Cardiff (UK), Alpharetta (US) and with representation in Beijing
(China), the report below details the progress made in 2022 and the key
challenges faced during the year.
SIMULATION (Classroom)
Training medical professionals in the specialist skills required to
competently scan a patient using the diagnostic capabilities of ultrasound
remains a key foundation stone of our business. We design, develop and sell
some of the world's leading hi-fidelity ultrasound training systems and
consider ourselves one of the world's leading companies in this growing
market.
In 2022 simulation revenue increased by 28% to £9.4m (2021: £7.4m) and we
now have four ultrasound simulation-only platform technologies focussed on the
following markets:
· ScanTrainer - obstetrics and gynaecology (OBGYN)
· HeartWorks - echocardiography and anaesthesiology (ECHO)
· BodyWorks - emergency medicine, critical care and point-of-care
(PoCUS)
· BabyWorks (officially launched in the US in January 2022) -
neonate and paediatrics
During 2022, the majority of the simulation revenues came from our
ScanTrainer, HeartWorks and BodyWorks platforms. In 2023 it is anticipated
that BabyWorks will materially contribute to the simulation revenue stream, as
we open up this new market.
The four 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 and a network of 23 resellers covering 33
countries in the rest of the world. To date we have sold c. 1,500 simulators
into over 750 medical institutions around the world.
Research & Development
During the year, the simulation R&D team focussed on four developments:
Launch of BodyWorks 4.0
In October we launched the latest version of our BodyWorks ultra-realistic
female patient simulator for PoCUS scenario training with updated and enhanced
images and an expanded range of modules to teach novice users how to develop
ultrasound skills and competence in a non-clinical environment.
The first set of cardiac pathologies for the BabyWorks simulator
In November we launched the first suite of cardiac pathologies for the new
BabyWorks augmented reality simulator which aims to aid medical trainees in
the diagnosis and understanding of three important cardiac pathologies in the
neonatal and paediatric intensive care settings. Further suites of pathologies
are expected to be developed and launched during 2023.
Range of e-learning modules
With medical professionals needing to continually build their learning and
confidence, during the year we collaborated with a number of experts in their
field to create five distance learning courses that provide high quality
continuous education and improvement within ultrasound and healthcare. Sold as
an integrated package or as an individual license, we expect to continue to
roll out these modules on our simulator platforms during 2023.
New endometriosis module for ScanTrainer for launch in 2023
It is estimated that 10% of women worldwide have endometriosis. The
ScanTrainer endometriosis augmented reality training module will support
clinicians in learning how to locate and identify endometriotic disease in the
ovaries, bowel and bladder using transvaginal ultrasound. The new module is
expected to launch in May 2023.
Territory Review
Simulation revenues again grew strongly during the year, with revenue
increasing by 28% to £9.4m (2021: £7.4m). However, there were significant
variations in the performance across our three sales regions:
United Kingdom
Revenue increased by 96% to £4.9m (2021: £2.5m)
The UK had its second consecutive record year, with NHS spending on our
simulators continuing to grow across all product lines. As indicated in our
interim report in August 2022, we had a high number of one-off, individual
orders from a UK NHS training initiative that totalled c.£1.9m over the full
year. Although all our simulator sales are considered one-offs, if we exclude
these exceptional orders, the UK like-for-like revenue would have been £3.0m,
representing a growth of 15%. With a broad product portfolio, there remains
good scope for growth within the UK and there continues to be strong
purchasing interest in all our simulation products.
We therefore look forward to continuing the growth of the UK direct to market
business in 2023.
North America
Revenue increased by 3% to £2.8m (2021: £2.7m)
Sales in North America grew to a record high of £2.8m, but this was a
disappointing performance relative to our expectations, as a high number of
capital expenditure funding freezes were implemented by the larger teaching
hospitals in the US, resulting in cancelled or delayed purchases of our
simulators in the second half of the year. Although this loss of revenue was
compensated for by a £0.3m positive exchange rate variance, the like-for-like
US dollar sales during the year were down 9% to $3.4m (2021: $3.8m).
However, North America is a key market for the Group and we have therefore
continued to invest in growing the US based sales and marketing operation.
We now have seven sales-related staff supported by a web-based clinical
applications specialist plus an office-based support team in Alpharetta,
Georgia. We believe we will see the benefit of this investment in 2023 and
beyond.
2022 witnessed the beginnings of a post Covid-19 resurgence in major
face-to-face trade exhibitions in the US and with an encouraging start to the
year and a solid pipeline of opportunities, we look forward to a significant
improvement in the North American direct to market business in 2023.
Rest of the World
Revenue declined by 19% to £1.7m (2021: £2.1m)
2022 was a difficult year for the 23 resellers that sell our simulators
outside the UK and North America. Positive sales growth in countries such as
Japan and Germany were offset by the continued Covid-19 restrictions in China,
the loss of revenue from our decision to stop selling in Russia, and a
disappointing market in France, that constrained our joint sales venture with
Skills Meducation, where we are in the early stages of part-funding an
Intelligent Ultrasound only sales team. Although this impacted sales in 2022,
we see a more positive outlook for China with the Covid-19 restrictions
lifting and the recruitment of a new, experienced French sales team is
expected to improve sales in France in 2023.
With the increased range of products, a growing pipeline and anticipated sales
growth from France and China, we look forward to a growing reseller market in
2023.
CLINICAL AI (Clinic)
Real-time clinical AI-driven software that makes ultrasound easier to use for
medical professionals remains a key part of our 'Classroom to Clinic' vision,
and although we are still in the early stages of commercialisation, clinical
AI-related revenue for the year grew over 200% to £0.7m (2021: £0.2m).
Our products provide a range of real-time support to clinicians including
real-time workflow enhancements that support faster, more standardised
scanning, but importantly also support decision making, so that the stress of
scanning is reduced and the 'burn-out' of operators being asked to increase
productivity is minimised.
We now have three AI-driven software products available in the market:
· ScanNav Assist obstetric AI software that is utilised by GE
HealthCare as SonoLyst on their ultrasound machines
· ScanNav Anatomy Peripheral Nerve Block (PNB) for real-time
regional anaesthesia highlighting
· NeedleTrainer that incorporates the PNB software to teach
ultrasound-guided needling skills
Two major milestones were achieved in the year:
· In July 2022, GE HealthCare launched the SonoLyst technology on
the Voluson Expert 22 ultrasound machine, that utilises our ScanNav Assist AI
software
· In October 2022, ScanNav Anatomy Peripheral Nerve Block (PNB),
our second AI product, received FDA De Novo clearance for sale in the US
We expect 2023 to be a year of significant sales growth in our AI related
sales.
ScanNav Assist
Our ScanNav Assist AI technology drives GE HealthCare's SonoLyst X/IR
software, the world's first fully integrated ultrasound AI tool that
automatically and in real-time recognises the 21 views recommended for fetal
sonography imaging.
Currently available as an optional extra on GE HealthCare's Voluson SWIFT and
Expert 22 ultrasound machines, the SonoLyst software augments a sonographer's
scanning skills, helping faster and more standardised scanning. Acting as a
virtual on-board expert, SonoLyst automatically identifies the fetal anatomy
seen on standard views and can be used to compare the image or view acquired
to a standard criteria, ensuring exam quality and consistency. By
automatically and in real-time supporting the sonographer in their decision
making, the software also helps reduce the often-considerable stress of
obtaining the recommended views.
The issue of burnout in scanning centres is increasing around the world and it
is hoped that the adoption of this technology will help reduce this burden.
Our long-term agreement with GE HealthCare was signed in 2019. GE HealthCare
is the largest medical imaging company in the world, have the exclusive rights
to our clinical AI technology in the field of women's healthcare and have now
launched SonoLyst on two of its Voluson ultrasound machine ranges. The launch
in July of SonoLyst on the Voluson Expert 22 was a key commercial milestone
for Intelligent Ultrasound, as this is GE HealthCare's premium ultrasound
machine in their women's health range.
Over 30,000 ultrasound machines are sold annually in the global obstetrics
market and GE HealthCare is the dominant manufacturer. We therefore expect to
see increased SonoLyst sales throughout 2023 and beyond as SonoLyst continues
to be rolled out on the Expert 22 system.
In January 2022, we announced we had signed an extension to our GE HealthCare
agreement to enable GE HealthCare to utilise the ScanNav Assist AI software in
a new segment of automated ultrasound image analysis, that is outside the
Group's original agreement. As with the main agreement, the terms, product
sales and the timings of the related product launches are undisclosed.
Future variants of ScanNav Assist that will support additional protocol-based
scanning are in advanced development.
ScanNav Anatomy Peripheral Nerve Block (PNB)
ScanNav Anatomy PNB 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
anaesthesia procedures on a less frequent basis.
ScanNav Anatomy PNB achieved a major milestone in October 2022 when it was
cleared by the FDA as a De Novo device for sale in the US. The De Novo
regulatory process provides a marketing pathway to classify novel medical
devices with a low to medium risk for their intended use, where there is no
existing legally marketed comparable device.
The device supports nine common peripheral nerve blocks and is sold as a
stand-alone screen that is plugged into existing anaesthesiology ultrasound
machines to provide clinicians with real-time highlighting of their live
ultrasound. Users can also re-familiarise themselves with blocks that are
carried out less frequently using the system's integrated 3D animations.
ScanNav Anatomy PNB is now available for sale in the UK, France, Germany,
Spain, Scandinavia and the US. With over 25,000 anaesthesiology machines in
operation in these markets, and ultrasound-guided peripheral nerve blocks
increasingly being used as a prudent alternative to general anaesthesia as
well as a method of concurrent analgesia (potentially reducing opioid usage).
Our aim is to support anaesthetists, 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.
A number of studies were released during the year to support the adoption of
the system and 2023 will continue this focus, as we aim to educate and grow
the market for ScanNav Anatomy PNB.
ScanNav Anatomy PNB is also available as a training simulator for medical
learning on volunteers, prior to patient contact (see NeedleTrainer below).
NeedleTrainer
NeedleTrainer was relaunched to the market in September 2022 as a standalone
needle training device incorporating the new GE HealthCare Vscan Air handheld
ultrasound device. Developed by the clinical AI software team as a spin-off
from the ScanNav Anatomy PNB research and development, NeedleTrainer is a
portable, plug-in system that uses a retractable needle and real-time, virtual
image overlays to simulate needling non-invasively on a live volunteer, using
the live ultrasound scan. This enables medical professionals to develop
hand-eye coordination, optimum positioning, and accuracy in ultrasound-guided
interventional procedures in a safe, realistic, simulated-clinical
environment.
The system is sold with the trainer version of our ScanNav Anatomy PNB
AI-driven software integrated into the device and is being sold into major
simulation centres, anaesthesiology departments, emergency and primary
healthcare.
Future ScanNav AI products
During 2022 the focus of the division remained on developing the partnership
with GE HealthCare, commercialising ScanNav Assist, achieving FDA De Novo
clearance for ScanNav Anatomy PNB and relaunching NeedleTrainer with the GE
HealthCare Vscan Air handheld ultrasound system. In addition, the development
team continues to work on proof-of-concept AI software to facilitate the
automatic recognition of abnormalities within a general medical ultrasound
scan, confirming that a clinician has correctly scanned the anatomical area of
interest, and then flagging any areas of potential abnormality, so patients
can be triaged to a specialist.
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
have historically always been capital expenditure limitations on medical
training budgets for high value medical simulators and on the clinical side
hospital funding can also be hard to access, with most purchases being made on
a 6 to 18-month purchase cycle. This makes annual revenues harder to forecast,
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 high value sector
of the simulation market remain broadly based on the quality of training
combined with value for money, rather than simply the lowest priced solution.
During 2022, 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.
Although we continued to experience supply chain pressure during the year, we
were able to increase our key component stock holding in 2022, as well as
switch a number of our tracking sensors to an alternative supplier. This
enabled us to successfully avoid any disruption to sales in the year and we
believe it has also minimised the component supply risk for 2023. It did
however increase the amount of cash tied up in stock.
Simulation product cost of goods increased by approximately 6% during the year
and as a result we had to increase the list price of many of our products. We
continue to review supplier costs and overheads but expect the impact of price
rises on our cost of goods in 2023 to be broadly similar to 2022, which we
expect will result in a broadly similar impact on our end user pricing in the
second half of 2023.
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
early stages of commercialisation our two-pronged go-to market strategy aims
to identify the most effective route to material revenues:
· 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.
The challenge of recruiting high calibre AI software engineers eased in 2022
and we hope that the combination of attractive, flexible salary packages, and
a flexible work environment in a vibrant university capital city will enable
this to continue in 2023.
During 2023 we expect the restrictions caused by the pandemic to have fully
receded in all our markets, but there remains a threat that the continued
Russian invasion and occupation of Ukraine could escalate to the point where
it impacts our other European markets.
The impact of inflation and interest rates on global healthcare spending is
also of concern.
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
One of the benefits of the pandemic was that it forced companies to operate
remotely and enabled staff and companies to trial working on a more flexible
basis. Once the full impact of the pandemic ended in 2022, we took the
decision to continue to operate the company on a flexible basis, where
appropriate. This has been well received by our staff and we believe it makes
a significant contribution to the attractiveness of working for Intelligent
Ultrasound. In our 2022 annual staff survey, over 90% of staff recommended the
Group as a great place to work, with many citing that the Company has a great
ethos and is doing rewarding work that is making a real difference to
hospitals and patients around the world.
As ever, our staff have been tremendous throughout the year, and I would like
to thank them for all their hard work in enabling us to achieve a record year.
Shareholders
I would also like to thank our shareholders for not just supporting the £5.2m
placing, but also supporting our vision that a currently small UK company can
be a major player in the $1.3 billion AI related ultrasound imaging market and
produce cutting edge AI software that will make ultrasound easier to use for
medical professionals around the world.
Looking ahead
Five years ago, we embarked on our 'classroom to clinic' vision to specialise
in providing medical professionals with real-time, hi-fidelity, augmented
reality simulation for the ultrasound training market ('the classroom') and
then follow them into clinical scanning and provide real-time, artificial
intelligence-based, clinical image analysis software tools for the diagnostic
medical ultrasound market ('the clinic').
With the important milestone of FDA De Novo clearance achieved for our second
AI-driven product and an excellent partnership with GE HealthCare, we are well
placed to turn our 'classroom to clinic' vision into commercial reality. A
positive start in Q1 2023, a growing range of both AI and simulation related
products, an established operational base, and a successful £5.2m placing
increasing our cash to £7.2m, means we expect 2023 to be a year of continued
commercial growth, as we drive the Group to our goal of profitability by the
end of 2024.
Stuart Gall
Chief Executive Officer
FINANCIAL REVIEW
Summary financial performance:
£m 2022 2021 Change
(unless otherwise stated)
Revenue 10.10 7.60 +33%
Gross profit 6.33 4.66 +36%
Gross profit margin (%) 63% 61% +2%
Total R&D spend (3.20) (3.23) -1%
Administrative expenses (excluding expensed R&D) (8.32) (7.04) +18%
Operating loss (3.67) (4.33) -15%
Loss after taxation (2.98) (3.61) -17%
Net cash used in operating activities (0.68) (1.82) -62%
Cash and cash equivalents 7.17 4.95 +45%
Income statement
Revenue
The Group delivered strong growth in 2022 with revenues up 33% to a record
high of £10.1m (2021: £7.6m) with growth in revenues achieved across both
revenue streams. We continued to experience significant growth in the UK with
revenue up 104% from 2021, however Covid-19 related challenges continued to
impact reseller markets in Asia and Europe where revenues declined by 14% year
on year.
Simulation
£m 2022 2021 Change
UK 4.91 2.51 +96%
North America 2.78 2.73 +3%
Rest of the World 1.74 2.15 -19%
9.43 7.39 +28%
Simulation revenue grew 28% year-on-year largely driven by significant growth
in sales in the UK which almost doubled in 2022, due in part to a NHS
ultrasound training programme to standardise training in echocardiography
across NHS England. Revenue from North America also increased by 3% due to
positive exchange rate movements of £0.3m but on a like for like US dollar
basis revenue had declined by 9% to $3.4m (2021: $3.8m).
It was also another difficult year for our resellers in the Rest of the World
where sales were down 19% to £1.7m (2021: £2.15m) due to ongoing Covid-19
restrictions in China, the decision to prohibit sales to Russia and also a
disappointing performance in France.
Clinical AI
£m 2022 2021 Change
UK 0.24 0.02 0.22
North America 0.16 - 0.16
Rest of the World 0.27 0.19 0.08
0.67 0.21 0.46
Clinical AI revenues began to gain commercial traction in 2022 with revenues
increasing to £0.67m (2021: £0.21m). AI royalty revenue in 2022 and 2021 is
split based on the location of the country of invoicing rather than by end
user geographical location.
Gross profit
Group gross profit increased by 36% to £6.33m (2021: £4.66m), the increase
being higher than revenue growth due to a higher weighting of direct versus
reseller sales as well as favourable USD exchange rate movements.
Simulation gross margin percentage went up 2% to 63% (2021: 61%) with 82% of
revenue coming from direct sales in the UK and North America (2021: 71%) as
well as favourable USD exchange rate movements. We were also able to pass on
some inflationary raw material cost pressures where possible through sales
price increases. Some supply chain disruption continued to present
challenges during the year, but these were overcome by maintaining adequate
buffer inventories.
Clinical AI gross margin declined to 60% (2021: 74%) due to the one-off cost
of a component upgrade to the NeedleTrainer V2 demonstration units, which
reduced gross margin by 14%. Excluding this one-off cost, the Clinical AI
gross margin increased to 79% on a like-for-like basis.
Administrative expenses
£m 2022 2021 Change
Sales, marketing and distribution 3.08 2.44 +26%
Other general and administrative 3.48 2.86 +22%
Other non-cash costs:
Share based payment charges 0.38 0.53 -28%
Depreciation and amortisation 1.38 1.19 +16%
8.32 7.02 +18%
Administrative expenses, excluding expensed R&D costs, increased by 18%
to £8.32m (2021: £7.02m). Despite some challenges affecting the US market in
2022, the long-term opportunity for commercial growth exists and to address
this we have further invested in sales and marketing in this key region as
well as in our UK marketing and product management teams to be able to
maximise the potential from these growth opportunities. In addition, a lot of
the sector conferences and exhibitions, key to sales lead generation, that
were cancelled or held virtually in 2021 returned in 2022, resulting in an
increase of marketing costs of £0.17m (+67%) in 2022. Sales travel also
returned to pre-pandemic levels in 2022, increasing costs year on year by
£0.15m.
Other general and administrative costs increased by 22% due partly to
headcount increases in central functions combined with salary increases, as
well as higher general travel costs and legal and professional costs.
Operating loss
The operating loss reduced by 15% to £3.67m (2021: £4.33m) due to the 36%
improvement in gross profit, partly offset by a 18% increase in administrative
expenses (detailed above).
Research and development (R&D) costs
£m 2022 2021 Change
Expensed 1.69 1.96
Capitalised 1.51 1.27
Total R&D 3.20 3.23 -1%
Simulation 1.24 1.15 +8%
Clinical AI 1.96 2.08 -6%
The Group incurred R&D expenditure of £3.20m (2021: £3.23m).
The Simulation R&D team was largely focused on increasing the BabyWorks
functionality as well as development of the new version of BodyWorks.
The Clinical AI R&D team continued the development of the ScanNav
Anatomy PNB product, in particular in relation to progressing the product
through US FDA regulatory clearance, achieved in October 2022, as well as
further improvements to NeedleTrainer and the development of other variants of
ScanNav Assist. With significant costs of taking ScanNav Anatomy PNB through
US FDA clearance incurred in 2021, Clinical AI R&D costs were lower in
2022.
Taxation
The total tax credit in 2022 was £0.72m (2021: £0.76m). The Group claims
each year for R&D tax credits and, since it is loss-making, elects to
surrender these tax credits for a cash rebate.
As at 31 December 2021, the Group had cumulative gross UK tax losses of
approximately £19.2m (31 December 2021: £17.3m) for which the Group
continues to hold a cautious view, and consequently the Group has chosen not
to recognise those losses fully as a deferred tax asset.
Balance sheet
The balance sheet was strengthened in December following a successful share
placing and subscription of a net £4.81m after costs. This contributed
significantly to net assets increasing to £12.16m at the year end (31
December 2021: £9.72m).
Included within trade and other receivables of £2.03m (31 December 2021:
£2.65m) are trade receivables of £1.36m (31 December 2021: £1.89m), lower
than the previous year end due to timing of invoicing and customer payments in
the last quarter.
Inventory of £1.60m (31 December 2021: £1.20m) increased by £0.40m due to
timing of receipt of certain high value bulk stock items as well as an
adequate amount of buffer stock in the event of any supply chain disruption.
Included within current assets is the R&D tax credit receivable of £0.71m
(31 December 2021: £0.95m). This is £0.24m lower than as at 31 December 2021
due to the balance in 2021 including £0.2m of the 2020 receivable, which was
received at the start of 2022.
During the year £1.49m (2021: £1.27m) of product development costs were
capitalised within intangible assets with more development costs meeting the
criteria for capitalisation in 2022 compared to the prior year.
Current liabilities were to £3.28m (31 December 2021: £3.21m), with trade
payables of £1.36m (31 December 2021: £1.35m) and accruals of £0.97m (31
December 2021: £1.23m) largely relating to sales-based royalties payable,
sales commissions and annual bonuses. Lease liabilities of £0.49m (31
December 2021: £0.67m), relating to offices, the warehouse facility and
company cars, reduced by £0.18m in 2022 with ongoing lease payments. New
leases in the year related to the US office lease renewal.
Deferred income at 31 December 2022 was £0.55m (31 December 2021: £0.53m)
which relates 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 £0.38m to £1.75m (31 December
2021: £1.37m) due to the share based payment charge for the year.
Cash flow
The Group reported cash and cash equivalents of £7.17m at 31 December 2022
(31 December 2021: £4.95m).
Operating cash outflows before working capital movements of £1.91m (2021:
£2.61m) improved by £0.70m in 2022 due to the higher trading levels in the
year offset partly by increases in administrative expenses. Movements in
working capital of £0.26m (2021: £0.31m) and higher R&D tax credits
received in the year of £0.96m (2021: £0.48m) resulted in the net cash used
in operating activities reducing by 62% to £0.68m (2021: £1.82m).
The net cash outflow arising from investing activities was £1.82m (2021:
£1.78m) relating to capitalised R&D expenditure of £1.47m (2021:
£1.28m) and £0.36m (2021: £0.50m) of property, plant and equipment, the
majority of which relates to the capitalisation of sales demonstration
equipment.
The net cash inflow from financing activities was £4.55m (2021: £0.22m
outflow) as a result of the gross proceeds from the share placing of £5.2m
reduced by issue costs of £0.39m. We also paid £0.23m (2021: £0.20m) in
lease payments.
Going concern
In undertaking a going concern review, the Directors have reviewed two
financial projections to 31 December 2024 based on the existing base budget
and a flexed, more conservative version of the base budget; both 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. Both forecasts indicate that the Group
should be able to operate within the limits of its existing resources and
therefore the Directors have a reasonable expectation that the Company and the
Group can continue in operational existence for at least twelve months from
the date of approval of the financial statements. Therefore, the Company and
Group continues to adopt the going concern basis in preparing its financial
statements.
CONSOLIDATED STATEMENT OF PROFIT AND LOSS AND OTHER COMPREHENSIVE INCOME
for the year ended 31 December 2022
Continuing operations Note 2022 2021
£'000 £'000
Revenue 2 10,100 7,596
Cost of sales (3,766) (2,937)
Gross profit 6,334 4,659
Other income 3 8 2
Administrative expenses (10,014) (8,993)
Operating loss (3,672) (4,332)
Finance income 1 1
Finance costs (31) (37)
Loss before taxation (3,702) (4,368)
Taxation 4 718 758
Loss attributable to the equity shareholders of the Parent (2,984) (3,610)
Other comprehensive income
Items that may be reclassified to profit or loss:
Exchange gain arising on translation of foreign operations 238 33
Other comprehensive gain for the period 238 33
Total comprehensive loss attributable to the equity shareholders of the Parent (2,746) (3,577)
Loss per ordinary share attributable to the equity shareholders of the Parent
Basic and diluted (pence) (1.08) (1.34)
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
as at 31 December 2022
Note 2022 2021
£'000 £'000
Non-current assets
Intangible assets 3,272 2,558
Property, plant and equipment 1,174 1,400
Trade and other receivables 61 61
4,507 4,019
Current assets
Inventories 1,603 1,196
Trade and other receivables 2,025 2,650
Current tax assets 713 954
Cash and cash equivalents 7,166 4,950
11,507 9,750
Total assets 16,014 13,769
Current liabilities
Trade and other payables (2,732) (2,767)
Deferred income (337) (206)
Lease liabilities (188) (213)
Provisions (22) (22)
(3,279) (3,208)
Non-current liabilities
Deferred income (209) (320)
Lease liabilities (298) (457)
Other payables (65) (65)
(572) (842)
Total liabilities (3,851) (4,050)
Net assets 12,163 9,719
Equity
Share capital 6 3,269 2,707
Share premium 30,207 25,959
Accumulated losses (29,951) (26,967)
Share-based payment reserve 1,753 1,373
Merger reserve 6,538 6,538
Foreign exchange reserve 182 (56)
Other reserves 165 165
Total equity 12,163 9,719
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
for the year ended 31 December 2022
Share Share Share warrants Accumulated losses Share-based payment reserve Merger Foreign Other reserves
capital
premium
£'000 £'000 £'000 reserve exchange £'000 Total
£'000 £'000
£'000 reserve equity
£'000 £'000
As at 31 December 2020 2,694 25,959 126 (23,381) 842 6,538 (89) - 12,689
Loss for the year - - - (3,610) - - - - (3,610)
Other comprehensive loss - - - - - - 33 - 33
Total comprehensive loss for the year - - - (3,610) - - 33 - (3,577)
Transactions with owners, recorded directly in equity
Issue of share capital 13 - - - - - - 13
Exercise of share warrants - - (126) 24 - - - 165 63
Cost of share-based awards - - - - 531 - - - 531
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
CONSOLIDATED STATEMENT OF CASH FLOWS
for the year ended 31 December 2022
2022 2021
£'000 £'000
Cash flows from operating activities
Loss before taxation (3,702) (4,368)
Depreciation 604 508
Amortisation of intangible assets 780 680
Fair value adjustment to share warrants - 3
Net finance costs 30 36
Share-based payment charge 380 530
Operating cash flows before movement in working capital (1,908) (2,611)
Movement in inventories (404) (149)
Movement in trade and other receivables 739 (592)
Movement in trade and other payables (70) 1,045
Movement in provisions - 12
Cash used in operations (1,643) (2,295)
Income taxes received 959 476
Net cash used in operating activities (684) (1,819)
Cash flows from investing activities
Purchase of property, plant and equipment (357) (503)
Internally generated intangible assets (1,467) (1,275)
Interest received 1 1
Net cash (used in) investing activities (1,823) (1,777)
Cash flows from financing activities
Proceeds from issue of new shares 5,200 13
Share issue costs (390) -
Principal elements of lease payments (231) (195)
Interest paid (31) (37)
Net cash generated by/(used in) financing activities 4,548 (219)
Net increase/(decrease) in cash and cash equivalents 2,041 (3,815)
Cash and cash equivalents at beginning of year 4,950 8,774
Exchange losses on cash and cash equivalents 175 (9)
Cash and cash equivalents at end of year 7,166 4,950
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 2022 but are derived from those accounts. Statutory accounts
for 2021 have been delivered to Companies House and those for 2022 will be
delivered following the Company's Annual General Meeting. The external
auditors have reported on those accounts; its report was unqualified 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 two
financial projections to 31 December 2024 based on the existing base budget
and a flexed, more conservative version of the base budget; both 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. Both forecasts indicate that the Group
should be able to operate within the limits of its existing resources and
therefore the Directors have a reasonable expectation that the Company and the
Group can continue in operational existence for at least twelve months from
the date of approval of the financial statements. Therefore, the Company and
Group continues to adopt the going concern basis in preparing its financial
statements.
The Directors continue to explore additional sources of income and finance
available to the Group to continue the development of its 'classroom to
clinic' business.
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 new products which have no extensive history of sales upon which to base
the forecasts.
During the period ended 31 December 2022, the Clinical AI related assets of
£1.5m 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. A 69%
reduction in the budgeted revenue used in the value-in-use calculation for the
IUL acquired intangible assets would result in full impairment of the carrying
value of the asset by £1.5m.
2. OPERATING SEGMENTS
Operating segments reflect the way in which information is presented to and
reviewed by the 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 & 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
2022 Simulation Clinical AI Total
£'000 £'000 £'000
Revenue 9,432 668 10,100
Cost of sales (3,502) (264) (3,766)
Gross profit 5,930 404 6,334
2021 Simulation Clinical AI Total
£'000 £'000 £'000
Revenue 7,390 206 7,596
Cost of sales (2,883) (54) (2,937)
Gross profit 4,507 152 4,659
Revenue by destination of external customer
2022 2021
£'000 £'000
United Kingdom 5,145 2,553
North America (USA & Canada) 2,943 2,733
Rest of the World 2,012 2,310
10,100 7,596
Timing of revenue recognition:
At a point in time 9,591 7,284
Over time 509 312
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:
2022 2021
£'000 £'000
USA 2,808 2,426
The Group had no customers who accounted for more than 10% of the Group
revenue for the year ended 31 December 2022 or 2021.
Other segment information
Depreciation Additions to
and amortisation
non-current assets
2022 2021 2022 2021
£'000 £'000 £'000 £'000
Simulation 942 843 1,258 1,334
Clinical AI 299 202 605 535
Central 143 143 - -
1,384 1,188 1,863 1,869
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 of 31 December
2022 was £0.03m (2021: £0.07m).
3. OTHER INCOME
2022 2021
£'000 £'000
UK grant income 8 2
4. TAXATION
2022 2021
£'000 £'000
Current tax
R&D tax credit (711) (769)
R&D tax credit relating to prior periods (7) 11
(718) (758)
Deferred tax
Origination and reversal of timing differences - -
Effect of tax rate change on opening balance - -
- -
Income tax credit (718) (758)
5. 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:
2022 2021
£'000 £'000
Loss after taxation (2,984) (3,610)
Number of Ordinary shares of 1p each 2022 2021
No. No.
Basic and diluted weighted average number of Ordinary shares 275,274,014 269,964,886
Basic and diluted loss pence per share (1.08) (1.34)
At 31 December 2022 and 2021 there were share options outstanding which could
potentially have a dilutive impact but were anti-dilutive in both years.
6. SHARE CAPITAL
Authorised, allotted, issued and fully paid 2022 2021
Number £'000 Number £'000
Ordinary shares of 1p each
Balance at 1 January 270,653,485 2,707 269,396,792 2,694
Shares issued for cash 56,216,436 562 1,256,693 13
At 31 December 326,869,921 3,269 270,653,485 2,707
The nominal values and the premium arising on shares issued in 2022 and 2021
are as follows:
Date Number Nominal value Premium
of shares £'000 £'000
19 July 2021 1,256,693 13 -
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.
On 7 July 2021 pursuant to a receipt of notice for the exercise of warrants,
the Company issued 1,256,693 new Ordinary shares with a nominal value of
£0.01 each at a subscription price of £0.01 per Ordinary share. The Company
has received gross proceeds of £12,566.93.
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.
7. PUBLICATION OF ANNUAL REPORT
It is anticipated that the full Annual Report will be published in May 2022.
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
website(www.intelligentultrasound.com (http://www.intelligentultrasound.com)
).
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