Creo
Medical Group plc
("Creo"
the "Company" or the "Group")
Final Results
Strong revenue growth and significant
commercial progress
Creo Medical Group plc (AIM: CREO), the medical
device company focused on the emerging field of surgical endoscopy,
announces its audited final results for the 12 months ended 31
December 2023.
Financial
Highlights:
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Total sales in the period of £30.8m (FY22:
£27.2m)
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Creo core product sales and Kamaptive licensing
income in the period of £4.0m (FY22: £2.3m), with 2.5x increase in
Creo core product sales of £2.3m (FY22: £0.9m)
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Gross margin up 1.1 ppt to 49.6% (FY22: 48.5%),
with gross profit of £15.3m (FY22: £13.2m)
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Reduced operating loss of £24.8m for FY23
(FY22: £30.7m)
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Reduced underlying operating loss* of £16.4m
for FY23 (FY22: £20.8m) in-line with market expectations, including
£2.8m (FY22: £4.5m) of R&D credits.
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Research and Development expenditure reduced to
£11.8m (FY22: £13.5m) of which 2/3rds relates to products in
development with the Group's global partners or work carried out on
Speedboat UltraSlim which launched in December 2023.
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£33.7m raised through oversubscribed
fundraise in March 2023.
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£17.4m cash as at 31 March 2024.
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*underlying operating loss is loss
after accounting for share-based payments, depreciation and
amortisation, R&D tax credit, earnout and other one-off
settlements.
Operational
and Commercial Highlights (including post-period
end):
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FDA clearance for Speedboat UltraSlim received
in November 2023; initial uptake has been very positive
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EU launch of Speedboat UltraSlim accelerated by
18 months, following guidance from notified body - first sales
achieved in Q4-23 with exceptional customer feedback and growing
orderbook
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Speedboat UltraSlim roll-out reached Asia
Pacific and Latin America, with first uses in these regions taking
place in December 2023
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Significant progress in roll-out of Creo's core
technology since start of 2023 with 119% increase in user base to
175 (FY22: 80)
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Speedboat Inject selected by the National
Institute for Health and Care Excellence ("NICE") to be scoped and
routed for guidance
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In March 2023, first in-human use of MicroBlate
Flex for the microwave ablation of soft tissue lung lesions safely
completed as part of a lung tissue ablation clinical
study
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○ In February 2024, a robotic guided microwave
ablation of lung tissue in the same sitting as a diagnostic
procedure was performed at the Royal Brompton Hospital, with
MicroBlate Flex used to perform the procedure.
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Medical Device Regulation CE clearance for
Speedboat, adding upper gastrointestinal ("GI") indications (e.g.
swallowing disorders, oesophageal and stomach cancers) in the UK
and mainland Europe, with multiple upper GI Speedboat
procedures performed in Europe during H2-23.
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Most significant data set for Speedboat
Submucosal Dissection ("SSD") procedures to date, showing an 82%
curative rate for lower GI lesions (e.g. bowel and colon) with no
perforations recorded.
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Speedboat Submucosal Dissection ("SSD") service
at Royal Oldham immediately implemented following training, with
multiple cases completed in record time, resulting in immediate
benefits for both patients and waiting lists.
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NHS Supply Chain data announced in April 2024
demonstrated significant cost and operational savings provided by
the use of SSD procedures.
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Collaboration with Khalifa University of
Science & Technology, Abu Dhabi announced post-year
end.
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Increased global reach, with first use of
Speedboat in Croatia, Slovenia, Malaysia and UAE.
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FY24 Update
and Outlook
Q1-24 trading has been in-line with
expectations following the approvals for UltraSlim at the turn of
the year. Following a strong finish in Q4-23, sales momentum in
Creo core products has continued with core revenue in Q1-24 showing
a 14% increase over the FY23 quarterly average, and the Company
expects to see this accelerate in Q2-24, driven by anticipated
strong sales of Speedboat UltraSlim and building on the strong
performance in Q4-23. Consumable sales were impacted by the early
Easter compared to Q4-23, but the Group remains on track for H1-24
targets. Tight control on costs has been maintained, ensuring
that the Group's operating expenses, to date, remain on budget.
This, together with the continuing sales momentum, gives the Board
confidence that the Group will achieve its 2024 objectives for core
revenue and deliver on the potential of Creo's
technology.
Craig
Gulliford, Chief Executive Officer,
commented:
"2023 was a
significant year for Creo, with core technology sales increasing by
c. 2.5x and a 119% increase in our global user base underpinning a
Group-wide revenue increase of 13%.
"We
successfully launched Speedboat UltraSlim in December 2023, the
culmination of the work done to miniaturise our technology to be
compatible with the working channel of all commercially available
endoscopes, further broadening our market reach. The product has
now been used in the UK, USA, LATAM and APAC since launch, with
exceptional feedback received from clinicians around the
world.
"Our
MicroBlate brand has also seen strong progress, with increasing
clinical cases, and pioneering work performed. In combination with
our robotics partners, MicroBlate Flex was used at the Royal
Brompton to ablate a cancerous lung nodule in the same sitting as a
diagnosis performed with robotic platform. This world's-first
combined procedure has the potential to not only dramatically
improve outcomes for lung cancer patients, but to remove the long
and worrying waits between diagnosis and
treatment.
"We expect to
launch our SpydrBlade
brand during 2024 via our core sales channel.
SpydrBlade is also of great interest to our
robotic partners, and we are working hard with them to deliver the
technology into the robotics space.
"The growth seen during the year
throughout all key parts of the
business, and lowered costs all contributed to a reduced operating
loss for the year. This, coupled with the continued momentum we've
seen to start 2024, encourages me as we move closer towards our
goal of achieving cashflow break even in 2025."
Enquiries:
Creo Medical
Group plc
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www.creomedical.com
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Richard Rees (CFO)
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+44 (0)1291 606
005
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Cavendish
Capital Markets Limited
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+44 (0)20 7397
8900
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Stephen Keys / Camilla Hume (NOMAD)
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Michael Johnson (Sales)
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Deutsche Numis
(Joint Broker)
Freddie Barnfield / Duncan Monteith / Euan
Brown
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+44 (0)20
7260 1000
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Walbrook
PR
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Tel: +44
(0)20 7933 8780 or
creo@walbrookpr.com
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Paul McManus / Sam Allen
Phillip Marriage
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Mob: +44
(0)7980 541 893 / +44 (0)7502 558 258
+44
(0)7867 984 082
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About Creo
Medical
Creo Medical is a medical device company
focused on the development and commercialisation of minimally
invasive electrosurgical devices, bringing advanced energy to
endoscopy.
The Company's vision is to improve patient
outcomes through the development and commercialisation of a suite
of electrosurgical medical devices, each enabled by CROMA, powered
by Kamaptive. The Group has developed the CROMA powered by
Kamaptive full-spectrum adaptive technology to optimise surgical
capability and patient outcomes. Kamaptive is a seamless, intuitive
integration of multi-modal energy sources, optimised to dynamically
adapt to patient tissue during procedures such as resection,
dissection, coagulation and ablation of tissue. Kamaptive
technology provides clinicians with increased flexibility,
precision and controlled surgical solutions. CROMA currently
delivers bipolar radiofrequency ("RF") energy for precise localised
cutting and focused high frequency microwave ("MW") energy for
controlled coagulation and ablation via a single accessory port.
This technology, combined with the Group's range of patented
electrosurgical devices, is designed to provide clinicians with
flexible, accurate and controlled clinical solutions. The Directors
believe the Company's technology can impact the landscape of
surgery and endoscopy by providing a safer, less-invasive and more
cost-efficient option for procedures.
For more information, please refer to the
website www.creomedical.com
Chief Executive Review
2023 was a pivotal year for Creo,
with considerable strides made by all areas of the business. With a
particular focus on the commercialisation of our core technology,
and continuing to maximise the value of our global distribution
business, Creo branded products represented 80% of revenues for the
year.
In February 2023, despite the
challenging macroeconomic backdrop and market conditions, we
executed a planned and significantly oversubscribed fundraise. This
fantastic support from existing and new shareholders has provided
us with the financial platform to achieve significant milestones
during the year and has strengthened our cash position from which
we have entered the next stage of our development. We are committed
to the commercialisation of our core technologies and driving the
business to generate self-sustaining cashflows. I thank all
shareholders, new and old, for their support.
The launch of Speedboat UltraSlim in
Q4, our smallest device to date, was a significant milestone and
helped us to achieve record sales for the quarter as well as a
strong orderbook for the first quarter of 2024. During the year,
core technology sales and Kamaptive licensing income increased to
£4.0m (FY22 £2.3m) with core technology sales increasing c. 2.5x,
despite the regulatory clearance for UltraSlim coming later than we
expected in the US, but much earlier than planned in the EU,
setting a strong foundation for 2024.
Overall Group revenues increased
during the year by 13% to £30.8m with our core product revenues
increasing 2.5x from 2022 to £2.3m. We are now starting to see our
user base growth translate into significant revenues for the
business, as shown by strong and growing Q1 24 sales.
Following our cost-intensive product
development cycle in prior years, we have shifted our development
efforts towards funded partnership programmes as part of our
Kamaptive brand, with a heavy focus on our robotics
partners.
This shifting of the innovation cost
base from us to third parties has led to a decrease in operating
costs by 7.9% year-on-year. This evolution led to some overall
headcount reductions where the phase of the programme is less
resource intensive. Despite this exercise, we were able to deliver
a meaningful cost of living corrections, primarily to staff below
the median salary where the dramatic increases in inflation have
hit those the most.
Continuing this traction throughout
2024, and seeing our other key projects and partnerships come to
fruition, puts us in a great position to achieve our goals with
increasing revenues and appropriate cost management.
Product Offering
Our Speedboat UltraSlim is the
ultimate miniaturisation version of our unique Speedboat advanced
energy device. Building on our applauded Speedboat technology, this
process was no mean feat as we deliver unique miniaturised and
widely adopted laparoscopic technology into user environments where
no other company has been able to do so before.
The Speedboat UltraSlim clearance
and launch is a significant event for Creo as it opens up access to
all major commercially used endoscopes on the market, allowing
Creo's technology to treat more patients, collaborate with even
more doctors and provide better patient outcomes - our core
aim.
FDA clearance for Speedboat
UltraSlim came in November 2023. Whilst this was just over a
quarter behind our original goal, the significant additional work
required to achieve this meant that this was an outstanding
performance by the entire Creo team. Not only did we get the USA
clearance, but we were also able to clear the device for use in
Europe more than a year ahead of our expected schedule. This
clearance enabled us to prepare for commercial launch in the
European market and sets us up really well for 2024.
It's really reassuring to me that
the core product brands, which leverage the Creo technology
developed over the past decade, are all starting to monetise
themselves and generate traction commercially.
In 2023 our core technology improved
lives in EMEA, USA and APAC. The vision of placing laparoscopic
surgical capability into the hands of interventional flexible
endoscopists and surgeons is a reality, and the next couple of
years will see us crystallising revenues across our brand
portfolio, both through our core technology sales channels as well
as through our Kamaptive partnerships.
It was announced recently that our
very first case and the first robotic ablation clinical case took
place in late 2023 with Microblate Flex. I have had the privilege
of observing one of these cases, where our technology, in
conjunction with our partner's robotic technology, presents a night
and day comparison with the current alternative patient pathway.
The time, effort and hard work from the team over the last few
years; from design and development to the team working with our
partners represents a terrific achievement. There is still a lot of
work to do with the completion of our clinical studies, but the
expansion beyond this to move towards commercial activity with
customers is really exciting. This brings together commercial
execution, with partner value, innovation and most important of
all, a potential opportunity to improve the survivability of lung
cancer. All this alongside the continued work to expand the
clinical data and experience with Microblate Fine in the early
treatment of pancreatic cancer, liver cancer and other conditions
gives us all a sense of real pride as we are seeing a whole new
cohort of patients whose lives are now beginning to benefit from
our technology which we are confident will be crystallised in
revenue in the coming years.
Over the year, we significantly
enhanced our heralded Pioneer Clinical Education Programme,
doubling the number of training centres and offering multi-national
and bespoke regional models. Most importantly, we supported the
treatment of more patients than ever before.
The process we need to execute for
continued growth and to deliver a step change in patient care
across multiple areas of therapy is clear. The rapid increase in
patients treated, our growing pipeline of future users and our
international successes all validate this. In November, we held a
significant Capital Markets Event, at which several of our clinical
users presented their perspective not just on the technology but,
more importantly, the significant benefits that our technology
brings to patients. One of the most pertinent presentations to me
was an example of a procedure utilising Speedboat to treat
oesophageal cancer, where patients have been known to have to
endure up to 30 repeat endoscopies over three years to manage
strictures. However, utilising Speedboat and Creo's advanced
energy, the clinician has seen significantly reduced, and in some
cases no need for repeat endoscopies. The impact this will have on
reduced demand for endoscopy as well as surgical resources, waiting
lists and improved patient outcomes is what motivates everyone at
Creo the most.
Additional Product and Revenue Streams
We have developed Creo's business
from the outset to have a multi-tiered revenue structure. Our
successful acquisitions have allowed us to maximise the potential
of both our core technology and acquired complementary product
ranges as well as securing some of the best Microwave and RF
engineering capability in the world. With our accelerated growth
and significant international footprint, we are leveraging this
growth and our economies of scale for the benefit of our core
product range.
Our SpydrBlade brand delivers
laparoscopic cut and coagulate functionality through an endoscopic
device. This means that clinicians receive significant surgical
performance from a tiny instrument at the end of an endoscope. We
expect to launch this device in 2024 via our core sales channels.
However, in addition, we are also developing the same technology in
partnership with robotic partners. Our technology is unique in the
world of robotic surgery as we can deliver the energy and device
performance beyond the wrist of the robot to deliver laparoscopic
surgery. Our connected Kamaptive partners, Intuitive Surgical and
CMR, both recognise that and we're working hard with them to
deliver SpydrBlade technology into this exciting arena.
Our MicroBlate programme is focussed
on areas such as treatments for lung, pancreatic, liver, kidney and
bladder cancers.
We've announced early cases with
MicroBlate Fine in the past. The clinical programme has now been
extended to MicroBlate Flex where we successfully delivered first
cases for the treatment of lung cancer as part of a clinical study
with the Royal Brompton Hospital in London. This study looks at the
treatment of lung cancer using bronchoscopic microwave ablation.
This has also included first cases where the device has been used
in combination with Intuitive's Ion platform, which has
traditionally been utilised as a diagnostic tool to detect cancer
in a patient but, now, by using Creo's technology, clinicians can
remove tumours effectively and safely in a matter of minutes during
the same procedure.
This is both amazing for the patient
and rewarding for the clinical teams and sets us up for commercial
traction going forward. As with any business, our achievements are
not without challenges. But we are positioned strongly for 2024,
supported with the financial results delivered in 2023.
Kamaptive Programme
I am particularly pleased with the
progress of our Kamaptive Licensing Programme during 2023. The
quality of our partners demonstrates the wide potential of our
technology, and the revenues received affirm this valuable revenue
tier for Creo.
Our focus on the optimisation and
commercialisation of our product range will maximise the impact of
our Kamaptive Licensing Programme.
We now have a clear roadmap to
enable our Kamaptive Licensing Programme and additional products to
work in tandem with Creo's core technology, providing a
multifaceted business capable of reaching far more patients and
potential markets than we would have imagined a few years ago. We
are now bringing laparoscopic capability to flexible endoscopy, in
both large and exciting markets underserved by advanced
energy.
We have also recently announced our
strategic partnership with Khalifa University which will enable us
to utilise its world class facilities and resources to further
develop our product offering and take advantage of IP that is
currently not being monetised.
The Kamaptive Licensing Programme
offers significant potential beyond our current partnerships to
develop a range of potential derivatives of our technology into
other partner programmes.
The next stage of the 'tech play in
medical devices' is equally exciting. As our partnerships bear
fruit, my vision is to launch the CROMA - powered by Kamaptive
developer eco-system, safely giving commercial access to our unique
core technology to a wide range of potential partners, inspired by
the reality of the current partner programmes.
Tying this all together is the
continued development of CROMA and with it, the prospect of
delivering truly game changing real time tissue characterisation
software. This has the potential to add tremendous value to
flexible endoscopy. The prospect of enhanced precision and control
opens up a new frontier for patient outcomes, as well as the
potential benefits to robotic surgical programmes.
Third party validation
During 2023, Royal Oldham Hospital
purchased the CROMA system for use across their endoscopy
department to launch a Speedboat Submucosal Dissection
("SSD") service. The results reported illustrate the positive
impact of Speedboat and the launch of the SSD service on patient
outcomes, waiting lists and the prevention of bowel cancer. Having
attended Creo's 'Pioneer' training programme and installed devices
across multiple endoscopy rooms immediately, the hospital performed
five SSD cases in its first afternoon, with over thirty further
patients successfully treated within weeks, delivering excellent
patient outcomes and at a significantly lower cost to the Trust
plus reducing patient backlog and reducing time to be
seen.
The validation of Creo's technology
has gathered further momentum with the selection of Speedboat®
Inject by the National Institute for Health and Care Excellence
("NICE") to be scoped and routed for guidance, and by an ongoing
collaboration with NHS Supply Chain. Early data collected from over
130 patients shows that we have saved a Trust 62% or over £5,000 in
cash per procedure undertaken, reduce bed stays by 87% and critical
care by 100%. Importantly, this data is only related to the SSD procedure element, and does not
include additional benefits and costs savings previously identified
and reported by the Company, which included downstream costs
associated with recurrence of lesions and procedure-related
complications commonly associated with surgical alternatives to
SSD. During 2023 we continued to launch in
the USA some of our endotherapy accessories, which sit alongside
the core Creo GI products. We aim to replicate this into APAC
during 2024, building on the successes of our European model and
growing the Creo brand.
Encouraging Outlook
Over the next six to 12 months, we
expect to see an increasing rate of progress with the Speedboat
UltraSlim device following the limited market release in late 2023.
After carefully launching the product into the field, we have
received fantastic feedback from our clinicians. At one centre, 15
cases were performed in two days to really evaluate and extend the
capabilities of the device. All feedback so far has been extremely
positive.
We are actively obtaining the
regulatory clearances in our APAC regions and others to allow us
even greater commercial and global reach. We'll be submitting and
expecting clearance for the SpydrBlade product to come through
during the course of 2024 which will be going into the GI
space.
We continue to develop our
relationship with our Kamaptive partners such as Intuitive and CMR
as well as the Khalifa Strategic Partnership to help utilise our IP
and ensure future development continues through funded projects
including integration of the SpydrBlade into robotic laparoscopic
tools.
The most challenging period for any
company is the transition from development to commercial
profitability. The strides we have made during the year keep us on
the right path. We look forward to another year of strong growth in
our core technology from both existing and new users, helping drive
us towards our goal of self-sustaining cashflows.
It is testament to the dedication
and tenacity of the Creo team, many of whom have been here since
IPO, that we have been able to achieve such significant milestones
and I would like to extend my utmost thanks to the current and past
employees who have made Creo what it is today.
Building Creo into a company that
can compete with well established, multi-billion pound MedTech
giants both in terms of the quality of technology and the quality
of the service it facilitates, is not the work of a moment. It
takes time. During 2023, I feel we have taken great strides towards
this. From the NHS Supply Chain data to first cases in the lung
with Intuitive Surgical and from the Cleveland Clinic to our
partnership with Khalifa University, we are seeing the realisation
of our R&D and its growing impact across the medical devices
market. We know that 2024 will bring with it more cases, more data
and more partnership progress and it's exciting to know that we are
in the very best global company when it comes to tackling unmet
needs for patients across the globe.
It is both a source of great pride
and satisfaction to me that we have created a terrific team who
know what we need to do in each sector to succeed. Our job is
clear: to deliver on what we have very clear sight of over the
coming months and years to become a premier, cash generative global
medical device and tech licensing business, transforming, and
improving the lives of many thousands as we do so.
Craig Gulliford
Chief Executive Officer
14 May 2024
Chair's statement
Creo's sights remain set on maturing
as an international MedTech group focused on the clinical and
commercial adoption of a full suite of electrosurgical products.
2023 had already delivered another positive year of progress when,
in November, we received 510(k) clearance from the US FDA for our
Speedboat UltraSlim device. This was pivotal because it is the
ultimate version of Speedboat, the culmination of substantial
shareholder investment and a long programme of work to miniaturise
the technology to cover all foreseeable market applications. Its
reduced size makes it compatible with all endoscopes with a 2.8mm
(or larger) working channel. This accesses most GI endoscopic
procedures and therefore expands the universe of clinicians and
patients who can benefit from Creo's innovative
technology.
The US clearance followed guidance
from our notified body of an EU regulatory pathway that accelerated
the European UltraSlim launch by around eighteen months.
It has now been used successfully in the UK, USA, LATAM and
APAC to treat precancerous lesions in the colon, oesophagus and
stomach, as well as in oesophageal and gastric POEM procedures (to
address swallowing disorders and gastroparesis).
Following that late-in-the-year
milestone, we achieved record sales in the last quarter of 2023.
More widely, we can report growth in all key parts of the business,
strong progress in our robotics partnerships, improved overall
gross margins, and reduced expenses given tight cost control - all
contributing to a reduced operating loss for the year. In March
2023, against the backdrop of economic and geopolitical
uncertainty, we completed an oversubscribed equity raise with gross
proceeds of approximately £33.7 million. This gave us the financial
resources and wider confidence to execute the vital next steps in
our strategy. We remain immensely grateful to our existing and
new shareholders who supported the raise and welcome those
newcomers to the register.
Notwithstanding this technological,
clinical, commercial and corporate progress, like most companies,
we faced continued global and local challenges. The delay in FDA
approval for UltraSlim by just over a quarter limited its
contribution to Group revenues during the year but has set a
positive basis for 2024. The short notice legislative changes
around the UK's R&D tax regime resulted in a materially
unhelpful reduction in our R&D tax credit. Therefore, our
operating loss, while still reduced, was higher than it would
otherwise have been. And, of course, as our shareholders are well
aware, the continued volatility in the smaller cap stock market
impacted the otherwise encouraging recovery of our share price
since the equity raise.
Management and
Employees
Creo invests in talented and experienced
individuals across the full range of business functions needed for
success. Given the intensity of our R&D investment since our
IPO, our headcount peaked during the second half of 2022.
But, since then, we have gradually reduced that headcount,
wherever possible by taking advantage of natural attrition. The
Remuneration Committee, chaired by Ivonne Cantu, aims to implement
a remuneration policy that promotes long-term success and aligned
with the interests of our shareholders and other stakeholders. As
flagged in last year's report, our LTIP awards had historically
been based on pre-grant performance conditions on the same basis as
the annual bonus. Following feedback from shareholders, the
committee is now incorporating forward-looking performance targets
as conditions for vesting as the Company enters a full commercial
phase.
The Board thanks all our employees for their
hard work, commitment and patience during the year which, most
critically, laid the foundations for the UltraSlim
launch.
Sustainability
Creo's mission to improve lives sits at the
heart of our wider ESG responsibilities. We continue to be
committed to best practice in our environmental and social policies
under the umbrella term of 'sustainability' which emphasises our
core social impact of improving clinical outcomes for patients. Our
strategy focuses on three key areas: healthcare impacts; people and
our communities; and, of course, our planet.
As we continue to gather clinical data, such as
the NHS study showing reduced inpatient stay time, it is clear that
not only do our devices provide monetary benefits but they also
lead to a reduction in environmental impact that the procedure has.
We look forward to exploring the beneficial environmental impact of
using our devices as opposed to traditional surgical pathways
during the next few years.
Governance
The Company has in place a
strengthened governance framework with energetic engagement by the
non-executive Directors at Board level, through the committees, and
in discussion with shareholders and advisers. The Group continues
to adopt the QCA Code of Conduct with its ten principles to deliver
growth, maintain a dynamic management framework, and build trust.
The Audit Committee, chaired by John Bradshaw, our Senior
Independent Director, meets regularly to review and monitor the
financial statements, accounting principles, internal controls and
risk management systems. The Committee also monitors the
relationship with our auditors to ensure independence and
objectivity.
In addition to the regular
communications and meetings with shareholders, in November we held
a gratifyingly well-attended Capital Markets Event at the offices
of Deutsche Numis, where the team provided greater detail on the
commercial and clinical progress of our products and leading NHS
clinicians gave presentations explaining their experiences in using
Creo's products in clinical practice.
As announced on 13 May 2024, and
further to the 2023
AGM Statement & Succession Planning
announcement, which set out the
Company's plan to evolve its Board of Directors as it enters a new
phase of commercial growth, Kevin Crofton and Brent Boucher have
been appointed as independent Non-Executive Directors. Both Kevin
and Brent are expected to join the Board with effect from 1 July
2024, with Kevin succeeding me as Chair. It has been a privilege to
serve as Creo's Chair and work alongside my fellow directors and
our dedicated staff since our IPO in 2016. I welcome Kevin and
Brent, with their invaluable skillsets and experience, to the Board
and wish them and Creo the best of luck as they accelerate our
clinical and commercial progress around the world.
The Board continues to seek guidance
from our professional advisers, including solicitors, auditors,
remuneration consultants and nominated adviser on recommended best
practice for AIM companies. We thank all those advisers for
their valuable support and enthusiasm for Creo's
mission.
Charles Spicer
Non-Executive Chair
14 May 2024
Financial
Review
This year has seen significant growth in Creo
core product revenues, with our Speedboat UltraSlim device being
cleared in November 2023 helping us achieve record revenues for Q4
2024. These revenues along with cost savings and operational
efficiencies have reduced the underlying EBITDA loss year on year
as anticipated. Our oversubscribed fund raise of £33.7m (before
expenses) in Q1 2023 provides us with the platform to drive towards
our goal of achieving self-sustaining cashflows.
Revenue and
other income
The Group has made significant progress in
establishing sales channels through new products as well as the
development of our commercial footprint with our Kamaptive
Licensing Programme and associated revenues. Our European
operations have continued to be cash generative with our broader
direct and indirect sales channels for Creo across our large
portfolio of products helping us to grow sales by 9% (2022: 8%)
during the year. Revenues billed in the year in relation to
Speedboat and CROMA increased almost 2.5 times to £2.3m (2022:
£0.9m), with Kamaptive licensing revenues from our strategic
partners of £1.7m (2022: £1.4m). £26.8m (2022: £24.9m) was
generated through consumable sales in Creo Europe. This 7.6% growth
(2022: 4%) shows the continued success of this business with
further growth expected as we expand into the USA, LATAM and APAC
in 2024. Other operating income of £0.4m in the 12-month period to
31 December 2023 (2022: £0.1m) relates to the Welsh government
grant.
Gross
Margin
Gross margin improved from 48.5% in 2022 to
49.6% in 2023 driven by strong margins in our Creo core products
and Kamaptive revenues along with stable margin from our consumable
products. As we mature as a business it is expected that margins
will continue to improve with increased sales of the core Creo
products.
Operating
loss
The operating loss for the year decreased to
£24.8m (2022: £30.7m). This 19.2% reduction is a result of a focus
to reduce overall administrative costs (in particular R&D
spend), including baseline headcount costs throughout the year,
coupled with increasing revenue and margin. This decrease in costs
started in H2-22 and is expected to continue into 2024. The
underlying operating loss for the year was £16.4m (2022: £20.8m).
This 21% fall represents a significant reduction and includes
c.£2.0m less than expected R&D tax credit due to legislative
changes following the budget in March 2023. On a like-for-like
basis this would have reduced the underlying operating loss for the
year to £14.4m (2022: £20.8m), a 31% reduction. The underlying
EBITDA loss for the year was £17.6m (2022: £22.1m).
Whilst underlying EBITDA and underlying
operating loss are not statutory measures, the Board believes they
are helpful to include for investors as additional metrics to help
provide a meaningful understanding of the financial information as
this measure provides an approximation of the ongoing cash
requirements of the business as it continues to pursue its future
development and pursue ongoing commercialisation focus of its
approved products. The underlying EBITDA position excludes SIP
charges and Earnout charges (contingent and deferred payments on
previous acquisitions), individual items outside of business
control, expenses which are non-cash and incorporates the recovery
of research and development expenditure which the Group is able to
benefit from through R&D tax credit schemes. The underlying
operating loss position is the same as underlying EBITDA but also
excludes share-based payment expenses which are
non-cash.
|
|
|
12 months
to
|
12 months
to
|
(All figures £'000)
|
|
|
31 December
2023
|
31 December
2022
|
|
|
|
|
|
Revenue
|
|
|
30.8
|
27.2
|
Cost of Sales
|
|
|
(15.5)
|
(14.0)
|
Gross Profit
|
|
|
15.3
|
13.2
|
|
|
|
49.6%
|
48.5%
|
|
|
|
|
|
Other Operating Income
|
|
|
0.4
|
0.1
|
Administrative Expenses
|
|
|
(40.5)
|
(43.9)
|
|
|
|
|
|
Operating Loss
|
|
|
(24.8)
|
(30.7)
|
|
|
|
|
|
SIP Charge
|
|
|
0.2
|
0.1
|
PPE & Other
Settlements
|
|
|
0.3
|
-
|
Earnout
|
|
|
0.5
|
0.9
|
Depreciation &
Amortisation
|
|
|
3.4
|
3.1
|
R&D expenditure recovered via
tax credit scheme
|
|
|
2.8
|
4.5
|
|
|
|
|
|
|
|
|
|
|
Underlying EBITDA (non-statutory measure)
|
|
|
(17.6)
|
(22.1)
|
|
|
|
|
|
Share based payments (inc.
JSOP)
|
|
|
1.2
|
1.3
|
|
|
|
|
|
Underlying operating loss (non-statutory
measure)
|
|
|
(16.4)
|
(20.8)
|
Tax
The tax credits recognised in the current and
previous financial year relate mainly to R&D tax credit claims.
As already noted above, this was c.£2.0m less than expected due to
legislative changes following the budget in March 2023. This has a
direct detrimental impact on cash and P&L for a company such as
Creo. A deferred tax asset has been recognised in respect of the
business combination relating to our Creo Europe subsidiaries. A
£0.75m deferred tax asset has been recognised in respect of tax
losses in Creo Medical Limited which we will utilise through Group
relief of the future profits in Creo Medical UK Limited as in 2022.
No further tax assets in relation to these losses have been
recognised due to the uncertainty over the timing of future
recoverability.
Expenses
Underlying administrative expenses totalled
£32.1m for the year (2022: £34.0m). This 5.6% fall (2022: 6.2%
increase) represents a significant reduction and includes c.£2.0m
less than expected R&D tax credit due to legislative changes
following the budget in March 2023. On a like-for-like basis this
would have reduced the underlying administrative expenses for the
year to £30.1m (2022: £34.0m), a 11.5% reduction. The decrease was
largely driven by savings in R&D including headcount costs
which decreased to £22.2m for the year from £22.9m in following
completion of certain R&D projects. Non employment R&D
costs were £3.5m in the year (2022: £6.9m) representing our move
towards funded R&D projects such as the Intuitive agreement and
our revised patent strategy. This decrease was despite an average
6.1% rise in salaries. Total administrative expenses totalled
£40.5m for the year (2022: £43.9m). Sales and marketing costs were
£4.2m (2022: £3.8m) driven by increased travel compared to 2022 as
well as costs associated with growing our core technology sales.
General and Administrative expenses were £5.4m (2022: £5.1m) with
our facility and utility costs all increased due to inflationary
pressures. Non-cash expenses comprising of SIP charge, earnout
expenses, settlement costs, share based payments and depreciation
and amortisation were £5.2m (2022: £5.2m).
Loss Per
Share
Loss per share was 7 pence (2022: 15 pence)
with reduction driven by reduced EBITDA loss as well as an
increased issued share capital following the fund raise earlier in
the year.
Dividend
No dividend has been proposed for the year to
31 December 2023 (2022: £nil).
Cash Flow and
Balance Sheet
With the support from our shareholders, we were
able to execute on a significantly over subscribed fundraise in
early 2023. This was secured against a backdrop of economic
pressures and difficult market conditions and represents a
significant achievement for the Company, providing us with the
financial platform to deliver future growth. Net cash used in
operating activities was £21.6m (2022: £24.9m), driven by the
investment in operational capacity, focusing on commercial
activities and initial cash outlay for Endotherapy consumable
products in the US and Europe. Net cash used in investing
activities was £18.3m (2022: £6.0m) with the increase driven by the
£15m cash placed on deposit, final payments for the acquisition of
Creo Europe subsidiaries and investment in Creo HQ offset by
interest received. Cash generated from financing activities was
£29.8m during the year with £31.7m (net of expenses) raised from
the fund raise. Total assets at the end of the year increased to
£76.7m (31 December 2022: £75.3m), a 2% increase, reflecting the
increase in cash from the fund raise offset by cash spent in
operations for the year and reduced R&D debtor. Cash and cash
equivalents at 31 December 2023 was £18.5m including cash on
deposit (31 December 2022: £13.1m). Net assets were £59.8m (31
December 2022: £49.3m), a 21% increase due to the equity raise
offset by operating loss and share based payment expense. We began
renewing debt facilities in Europe at the end of 2023 and received
£6.4m in cash post year-end from long term loans. We
have a clear strategy to ensure sufficient cash resources to get us
to profitability, however as a high growth MedTech company future
revenues and future investment are not committed and this
represents a material uncertainty resulting
in significant doubt in respect of going concern as
disclosed in the 2023 annual report and accounts. However, we
believe that the current revenue trajectory, future licensing deals
and operating cost flexibility provide a clear strategy to
ensure sufficient cash resources to get us to
profitability.
Accounting
Policies
The Group's financial statements prepared in
accordance with UK-adopted international accounting standards and
with the requirements of the Companies Act 2006 as applicable to
companies reporting under those standards. The Group's accounting
policies have been applied consistently throughout the
year.
Key
Performance Indicators
As the Group continues to develop and
commercialise its core technology, the Directors consider the key
financial performance indicators to be the level of cash held in
the business, sales and operating expenses controlled and
monitored. The Board performs regular reviews of actual results
against budget, and management monitors cash balances on a monthly
basis to ensure that the business has sufficient resources to enact
its current strategy.
Certain KPIs concern non-financial measures,
such as the number of trainees for our Pioneer Clinical Education
Programme, ESG metrics such as carbon emissions, diversity ratios
and employee engagement. All non-financial measures are monitored
monthly. The Board will continue to review the KPIs used within the
business and assess them as the business grows.
Principal
Risks and Uncertainties
The principal risks and uncertainties facing
the Group are set out in the 2023 Annual Report
and Accounts.
Directors
Details of the Directors who served during the
year ended 31 December 2023 are set out in the
2023 Annual Report and Accounts. Six of the Directors
serving on the Board at the year-end were male with one
female.
Conflicts of
Interest
To address the provisions of section 175 of the
Companies Act 2006 relating to conflicts of interest, the Company's
Articles of Association allow the Board to authorise situations in
which a director has, or may have, a conflict of interest.
Directors are required to give notice of any potential situations
or transactional conflicts that are to be considered at the next
Board meeting and, if considered appropriate, conflicts are
authorised. Directors are not permitted to participate in such
considerations or to vote regarding their own conflicts.
Richard Rees
Chief Financial Officer
14 May 2024
Consolidated
statement of profit or loss and other comprehensive income for the
year ended 31 December 2023
|
|
|
12 months
to
|
12 months
to
|
|
(All figures £m)
|
Note
|
|
31 December
2023
|
31 December
2022
|
|
|
|
|
|
|
|
Revenue
|
2
|
|
30.8
|
27.2
|
|
Cost of sales
|
|
|
(15.5)
|
(14.0)
|
|
|
|
|
|
|
|
Gross Profit
|
|
|
15.3
|
13.2
|
|
|
|
|
|
|
|
Other operating income
|
2
|
|
0.4
|
0.1
|
|
Administrative expenses
|
3
|
|
(40.5)
|
(44.0)
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(24.8)
|
(30.7)
|
|
|
|
|
|
|
|
Finance expenses
|
|
|
(0.4)
|
(0.3)
|
|
Finance income
|
|
|
0.7
|
0.1
|
|
|
|
|
|
|
|
Loss before tax
|
3
|
|
(24.5)
|
(30.9)
|
|
|
|
|
|
|
|
Taxation
|
|
|
2.8
|
4.0
|
|
|
|
|
|
|
|
Loss for the year
|
|
|
(21.7)
|
(26.9)
|
|
|
|
|
|
|
|
Exchange gain/(loss) on foreign
subsidiary
|
|
|
(0.6)
|
1.1
|
|
Changes to the fair value of equity
investments at fair value through other comprehensive
income
|
|
|
-
|
0.4
|
|
|
|
|
|
|
|
Total other comprehensive
income
|
|
|
(0.6)
|
1.5
|
|
|
|
|
|
|
|
Total comprehensive loss for the year
|
|
|
(22.3)
|
(25.4)
|
|
|
|
|
|
|
|
Loss per Share
|
|
|
|
|
|
Basic and diluted (£)
|
4
|
|
(0.07)
|
(0.15)
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As at
|
As at
|
(All figures £m)
|
Note
|
|
31 December
2023
|
31 December
2022
|
|
|
|
|
|
Assets
|
|
|
|
|
Non-current assets
|
|
|
|
|
Intangible assets
|
|
|
7.1
|
8.0
|
Goodwill
|
|
|
19.1
|
19.6
|
Investments
|
|
|
2.1
|
2.1
|
Property, plant and
equipment
|
|
|
9.1
|
10.2
|
Deferred tax
|
|
|
1.1
|
1.5
|
Other assets
|
|
|
0.2
|
0.2
|
|
|
|
|
|
|
|
|
38.7
|
41.6
|
Current assets
|
|
|
|
|
Inventories
|
|
|
8.1
|
9.3
|
Trade and other
receivables
|
|
|
8.6
|
6.8
|
Tax receivable
|
|
|
2.7
|
4.5
|
Fixed term deposits
|
|
|
15.5
|
-
|
Cash and cash equivalents
|
|
|
3.0
|
13.1
|
|
|
|
|
|
|
|
|
37.9
|
33.7
|
|
|
|
|
|
Total assets
|
|
|
76.6
|
75.2
|
|
|
|
|
|
Shareholder equity
|
|
|
|
|
Called up share capital
|
5
|
|
0.4
|
0.2
|
Share premium
|
|
|
180.9
|
149.5
|
Merger reserve
|
|
|
13.6
|
13.6
|
Share option reserve
|
|
|
10.5
|
9.3
|
Foreign exchange reserve
|
|
|
(1.8)
|
(1.2)
|
Financial Assets at fair value
through other comprehensive income
|
|
|
0.6
|
0.6
|
Accumulated losses
|
|
|
(144.4)
|
(122.7)
|
|
|
|
|
|
Total equity
|
|
|
59.8
|
49.3
|
|
|
|
|
|
Liabilities
|
|
|
|
|
Non-current liabilities
|
|
|
|
|
Interest-bearing
liabilities
|
|
|
5.2
|
6.1
|
Deferred tax liability
|
|
|
1.4
|
2.0
|
Provisions
|
|
|
0.3
|
0.4
|
|
|
|
|
|
|
|
|
6.9
|
8.5
|
Current liabilities
|
|
|
|
|
Interest-bearing
liabilities
|
|
|
3.1
|
4.0
|
Trade and other payables
|
|
|
5.7
|
9.0
|
Non interest-bearing
loans
|
|
|
-
|
1.6
|
Other liabilities
|
|
|
0.9
|
2.6
|
Provisions
|
|
|
0.2
|
0.2
|
|
|
|
9.9
|
17.4
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
16.8
|
25.9
|
|
|
|
|
|
Total equity and liabilities
|
|
|
76.6
|
75.2
|
Total cash including fixed term deposits at 31 December 2023
was £18.5m