REG - Creo Medical Group - Half-year Report
30/09/2024 16:00
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RNS Number : 2983G Creo Medical Group PLC 30 September 2024
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Creo Medical Group plc
("Creo", the "Group" or the "Company")
Unaudited results for the six months ended 30 June 2024
Further core technology growth with stable operating costs
Speedboat UltraSlim fuels continued increase in treated patients, trained
doctors and users
Creo Medical Group plc (AIM: CREO), the medical device company focused on the
emerging field of minimally invasive surgical endoscopy, announces its
unaudited results for the six-month period ended 30 June 2024.
Operational and commercial highlights:
· Growth in adoption of Creo's core technology underpinning increase in
core revenues and continued roll-out progress
· Key product and patient milestones reached:
o Increased global reach with Speedboat UltraSlim cases focusing on roll-out
to existing users in H1
o World's first robotically guided microwave ablation with the Ion robot
from Intuitive Surgical at the Royal Brompton Hospital in February 2024
· Agreement amendment with Intuitive to increase the number of
Microblate Flex sites alongside Ion by Intuitive
· NHS Supply Chain value-based procurement data announced in April
2024, demonstrating significant cost and operational savings when undertaking
Speedboat Submucosal Dissection ("SSD") procedures
· Collaboration agreement signed in February 2024 with Khalifa
University of Science & Technology, Abu Dhabi
· Ongoing discussions with third parties on potential new, and
expansion of existing, Kamaptive licensing opportunities
Post-period end
· First SpydrBlade cases for peroral endoscopic myotomy ("POEMs")
procedures under a controlled market release
· The King's Award for Enterprise in Innovation received in July 2024
in recognition of Speedboat
· Kevin Crofton and Brent Boucher joined as non-executive directors
from 1 July 2024, with Kevin Crofton serving as Chair
· Sale of 51% shareholding in Creo Medical Europe to Micro-Tech and
strategic partnership between both companies, announced on 18 September 2024,
conditional on certain regulatory approvals and anticipated to close in
Q1-2025. Cash proceeds of approximately €30 million at closing, structured
on cash-free, debt-free basis
· Alongside H1-2024 results, Creo announced a proposed conditional
placing to raise a minimum of £12m plus a retail offer (the "Fundraising") as
a mitigation against the Sale completion risk at a time of heightened
geo-political risks. See the separate Fundraising announcement for more
details on the Fundraising and the respective terms and conditions.
Financial Summary
· Growth in Creo core technology, which increased by 78% to £1.6m
compared to £0.9m in H1-2023
· Kamaptive revenue was minimal in the period, reporting £0.1m (H1-2023:
£0.5m) due to timing of contract and milestone payments
o Reflects the amendment to the Intuitive Ion agreement, announced in July
2024, pausing the Phase 3 funded programme and accelerating the commercial
development phase, with Intuitive-led site enrolment expected to commence in
H2-2024
· Consumable sales reduced by 6% to £13.5m (H1-2023: £14.3m), due to
FY-2023 sales being H1 weighted. The Company is on track to exceed total
consumable revenues in 2023 of £26.8m for FY-2024 and the division is trading
in line with management expectations for FY-24
· Total revenue of £15.2m (H1-2023: £15.7m)
· Underlying EBITDA loss increased to £10.5m from £9.2m in H1-2023,
driven by
o reduced R&D tax credits (£0.6m) due to legislature changes
o lower margin with no Kamaptive milestone payments in the period
o slightly lower consumable sales for the period which is expected to
recover in H2-24
· Strict cost control remains in the business, with opex flat to
H2-2023, and further reductions in underlying costs in H2 expected
· Loss per share of 3p (H1-2023: 4p)
· Cash and deposits of £9.8m (FY-2023: £18.5m)
Craig Gulliford, Chief Executive Officer of Creo, said: "The launch of
Speedboat UltraSlim in late 2023, our smallest device to date, was a
significant milestone and helped us to achieve record core product sales for
H1-2024, with growing users, utilisation and a strong pipeline of clinicians
waiting to be trained. During the period we doubled our number of training
centres, offering multi-national and bespoke regional models, which supported
the treatment of more patients than ever before with Creo's core technology
improving lives in EMEA, USA and APAC regions. Our focus in H1 was to roll-out
Speedboat UltraSlim to existing customers with our second half focus shifting
to the new user pipeline.
"Furthermore, our technology continues to demonstrate advantages in the world
of robotic surgery. It was terrific to announce the first ever robotically
controlled lung ablation procedure with our MicroBlate Flex alongside the Ion
robot from Intuitive. This is a significant step forward in the programme with
Intuitive as the team will now work alongside them in the field to roll out to
more sites as part of the amendment to our agreement. We have seen continued
advancement in the period with our Kamaptive partners and are also working
hard to deliver our SpydrBlade technology into this exciting arena. Our
excitement about the size of the opportunities in our chosen markets continues
to grow. Lower than expected Kamaptive revenue reflects the amendment to the
Intuitive Ion agreement, announced in July 2024, pausing the Phase 3 funded
programme and accelerating the commercial development phase, with
Intuitive-led site enrolment expected to commence in H2-2024.
"The recent announcement of an agreement for the sale of 51% of Creo Medical
Europe represents an excellent strategic partnership opportunity for Creo. The
partnership will support our continued commercial growth through Creo Europe
with access to the wider Micro-Tech product portfolio secured under the Creo
Brand. This product range will also be available to Creo's core sales teams
globally to complement our advanced energy portfolio. Additionally, we have
the potential to secure product registration and co-branding in China with our
advanced energy products which will help our APAC growth in the future.
"Over the next six to 12 months, we expect to see the continued growth rate of
our core sales, driven by Speedboat UltraSlim, but with developing progress in
our other product groups. I thank shareholders for their continued support
during the period and look forward to providing further updates."
Enquiries:
Creo Medical Group plc www.creomedical.com (http://www.creomedical.com)
Richard Rees (CFO) Via Walbrook PR
Richard Craven (Company Secretary)
Cavendish Capital Markets Limited +44 (0)20 7220 0500
Stephen Keys / Camilla Hume (NOMAD)
Michael Johnson (Sales)
Deutsche Numis (Joint Broker) +44 (0)20 7260 1000
Freddie Barnfield / Duncan Monteith / Euan Brown
Walbrook PR Ltd Tel: +44 (0)20 7933 8780 or creo@walbrookpr.com (mailto:creo@walbrookpr.com)
Paul McManus / Sam Allen / Mob: +44 (0)7980 541 893 / +44 (0)7502 558 258 / +44 (0)7867 984 082
Phillip Marriage
About Creo Medical
Creo Medical is a company specialising in the development and
commercialisation of minimally invasive electrosurgical devices, aiming to
advance endoscopic procedures with cutting-edge energy solutions.
The Company's mission is to enhance patient outcomes through a portfolio of
electrosurgical devices, all powered by its proprietary CROMA platform, which
is driven by Kamaptive technology. CROMA, equipped with full-spectrum adaptive
technology, optimises surgical performance and patient results. Kamaptive
integrates multiple energy sources in a seamless, intuitive manner, allowing
the technology to adapt dynamically to patient tissue during procedures such
as tissue resection, dissection, coagulation, and ablation. This technology
offers clinicians enhanced precision, flexibility, and control.
CROMA currently delivers bipolar radiofrequency (RF) energy for precise
cutting, along with focused high-frequency microwave (MW) energy for
controlled coagulation and ablation, all through a single accessory port. When
combined with Creo Medical's range of patented electrosurgical devices, this
technology provides clinicians with accurate, adaptable, and controlled
surgical solutions. The Company's Directors believe that their innovative
approach could transform the fields of surgery and endoscopy, offering safer,
less invasive, and more cost-effective options for medical procedures.
For more information, please refer to the website www.creomedical.com
(http://www.creomedical.com/)
Interim results for six months ended 30 June 2024
Chief Executive Review
Commercial and Operations
I am pleased to report continued progress for the first half of 2024. The
launch of a Speedboat UltraSlim in late 2023, our smallest device to-date, was
a significant milestone and helped us to achieve record sales for Creo Core
products in H1-2024 as well as a strong orderbook going into the second half
of the year.
Highlights during the first six months of 2024 include:
· Creo's core technology generating £1.6m in revenue in H1-24,
representing 74% of core revenues for the entirety of FY-2023;
· Stable revenue streams in our Creo endotherapy consumable products;
· Advancement with Kamaptive partners, although no milestone payments
were made in the period (H2-2023: two milestones) due to the short term loss
of upfront product development revenue as progress with Ion continues ahead of
plan by moving into commercial development phase; and
· Continued cost control, with a reduction in cost of goods sold and
operational efficiencies being driven through the organisation.
Speedboat UltraSlim allows us to deliver 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 more doctors and provide better patient outcomes - our core aim. It is
really reassuring to me that our core technology brands, which leverage our
technology developed over the past decade, are all respectively starting to
generate traction commercially.
Creo's products are distributed via direct and indirect sales channels. Creo
has offices across Europe, the USA and APAC with access to other jurisdictions
through the support of distribution partners (predominantly in the EMEA and
APAC regions, but more recently in Latin America). The nature of Creo's sales
and distribution channels, coupled with our enhanced and flexible Pioneer
Clinical Education Programme, allows the implementation of commercialisation
models to reflect the markets in which we are operating (indirect vs. direct).
The increase in revenue from Creo's core products has been driven by an
increase in new and high-volume users, global cases, and Creo's products being
introduced into new territories. The sale of 51% of Creo Medical Europe
represents an excellent strategic partnership for us and will support our
continued commercial growth in the APAC region through product registration
and co-branding in China as well as a strategic development partner for the
EMEA market.
Looking forward, the pipeline of users for Creo's core technology continues to
grow. Multi-national and bespoke regional training and mentoring events, held
during H1-2024, have resulted in 200 users at the end of the period, an
increase of 14% over the 175 users as at 31 December 2023. Management is
confident this growth will continue through the remainder of 2024 and beyond.
Over the year we significantly enhanced our 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 validation of Creo's technology has gathered further momentum following
the selection of Speedboat Inject by the National Institute for Health and
Care Excellence ("NICE") to be scoped and routed for guidance. We have been
working in collaboration with the NHS Supply Chain Value Based Procurement
team who, in April 2024, published early data collected from over 130 patients
to demonstrate that Creo's Speedboat technology had saved East Kent Hospitals
University NHS Trust 59%, or over £5,000 per procedure undertaken, reduced
bed stays by 87%, reduced critical care costs by 99% and had provided a 91%
reduction in accommodation costs per patient.
During 2024 we continued to launch some of our endotherapy accessories in the
USA, which sit alongside the core Creo products. We have now taken these
products into LATAM for the first time and aim to replicate this in APAC
during H2-2024, building on the successes of our European model and growing
the Creo brand.
In 2024 our core technology has 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 in the
next couple of years we aim to build significant revenues across our brand
portfolio, both through our core technology sales channels as well as through
our Kamaptive partnerships.
Our SpydrBlade technology delivers laparoscopic cut and coagulate
functionality through an endoscopic device. This provides clinicians with
significant surgical performance from a tiny instrument at the end of an
endoscope. A number of initial cases using our SpydrBlade device have now
taken place, and we expect to launch this device later this year via our core
sales channels. We are also developing the same technology for potential use
with robotic partners. Our technology continues to demonstrate advantages in
the world of robotic surgery, as it can provide the laparoscopic advanced
energy and device performance beyond the complex wrist of a surgical robot.
Our partners recognise this, and we are working hard to deliver SpydrBlade
technology into this exciting arena where the opportunities are vast.
Our MicroBlate technology is focused on treatments for lung, pancreatic,
liver, kidney and bladder cancers. We previously announced early MicroBlate
Fine cases. 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 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. By using Creo's
technology in combination with Ion, clinicians can diagnose and treat tumours
during the same procedure. This is an excellent outcome for the patient and
rewarding for the clinical teams, providing a platform for commercial traction
going forward. As with any business, our achievements are not without
challenges, but we are well positioned for the remainder of 2024 and into
2025.
Strategic Partnership & 51% subsidiary cash sale
We announced on 18 September 2024 that Creo has entered into a binding
agreement with Micro-Tech (NL) International B.V., a wholly owned subsidiary
of Micro-Tech (Nanjing) ("Micro-Tech") for the sale of 51% of the issued share
capital of Creo Medical S.L.U. ("Creo Medical Europe"), a wholly owned
subsidiary of Creo, at an equity value of €72m (the "Sale") on a cash-free,
debt-free basis.
The net proceeds payable to Creo from the Sale (the "Proceeds") will
strengthen the Group's balance sheet, enabling us to continue to invest in our
core Creo and Kamaptive business and deliver on our commercial and operational
objectives. The Proceeds are expected to be approximately €30m, which will
be payable in cash on completion. Ongoing shareholder terms have also been
agreed which include a future exit framework for Creo.
Along with other customary conditions, completion of the Sale is contingent on
Micro-Tech obtaining Outbound Direct Investment clearance in China along with
Foreign Direct Investment clearances in Spain, France, Belgium and Germany.
Whilst there is no certainty as to receipt or timing of receipt of the
necessary approvals to enable completion, it is expected that completion will
take place during Q1 2025 dependent on these relevant clearances being
obtained.
The strategic transaction with Micro-Tech:
· Strengthens Creo's commercial platform;
· Expands Creo's endoscopic therapy product range in all markets;
· Gives Creo Europe access to Micro-Tech's specialised global
distribution and manufacturing expertise; and
· Enables Creo to continue to fund the ongoing strategic development of
its core technology business.
Proposed Fundraise
Alongside our H1-2024 results, we have announced a proposed conditional
placing to raise a minimum £12m plus a retail offer (the "Fundraise"). The
Fundraise is being undertaken to provide balance sheet strength and mitigate
against the risk that the completion of the Sale is delayed, or does not
happen, either due to the necessary approvals not being forthcoming or from
other geo-political risks. It also addresses the funding requirement
identified within the Company's FY23 results in May 2024. On completion of the
Fundraise and upon receipt of the Proceeds from the Sale, Creo will have cash
resources in excess of £40m to take Creo to profitability. See the separate
Fundraise announcement for more details on the Fundraise and the respective
terms and conditions.
Board Changes
As announced on 13 May 2024, and further to the 2023 AGM Statement &
Succession Planning announcement
(https://www.londonstockexchange.com/news-article/CREO/agm-statement-directorate-succession-planning/16015218)
, 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 were
appointed as independent Non-Executive Directors from 1 July 2024, with Kevin
succeeding Charles Spicer as Chair. Both Kevin and Brent have brought with
them a wealth of experience and it has been a pleasure to welcome them to the
team.
I would also like to take this opportunity to again extend my thanks to
Charles for his enormous contribution to Creo during his eight years as Chair
and his invaluable guidance during what was a period of huge growth and
evolution for the business.
Management and Employees
Creo continues to attract and retain talented and experienced individuals
across all business functions. As at 30 June 2024, Creo employed 278 people
(30 June 2023: 279): 245 in EMEA, 27 in the USA, and 6 in APAC. Approximately
144 employees are involved in R&D and Operations, 94 are focused on Sales
and Marketing and 40 employees are within G&A.
In line with Creo's overall objective to improve lives, we have always
recognised our wider ESG responsibilities. Our immediate priority is the
communities that we serve, most obviously our patients and their families
along with the clinicians that treat and care for them. This also includes our
staff, their families, and the local communities in which we employ them. We
continue to assess our responsibilities under the ESG framework and actively
take steps to ensure that we meet our obligations as well as being prepared
for the future. We will report on the actions we have taken during 2024 in our
Annual Report.
Summary and outlook
As the Group continues to execute against its strategy and deliver against
operational milestones, the Board's confidence in the Company's future is
strengthened by the Group's ability to:
· Put our CROMA platform and our suite of devices in the hands of more
clinicians to allow more patients to be treated in an increasing number of
locations around the world;
· Convert clinicians trained via our Pioneer Training Programme into
users in addition to continuing to provide simultaneous multi-jurisdictional
training courses on current and future devices; and
· Engage with third parties to license our Kamaptive technology.
Over the next six to 12 months, we expect to see a continued rate of
commercial progress with the Speedboat UltraSlim device following the limited
market release in late 2023 and growth during the first half of 2024. We will
also see further cases for SpydrBlade and its full launch, and MicroBlate Fine
will be reintroduced into the market following product enhancements.
We continue to develop our relationship with our Kamaptive partners, such 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. Discussions with third parties on
potential new, and expansion of existing, Kamaptive licensing opportunities
continue. Management continues to believe that Kampative licensing provides
significant, high margin upside to the Company. The Board also recognises
the significant revenue potential available through Kamaptive, including
through the ability to access commercial revenues more quickly following the
amendment to the Intuitive Ion agreement, but is taking a prudent view and is
assuming no revenue from Kamaptive licensing in the current year and minimal
revenue in FY25.
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 period of strong growth in our
core technology from both existing and new users, helping drive us towards our
goal of self-sustaining cashflows. Following the Sale and deconsolidation of
Creo Europe and based on current core Creo sales growth only, being a prudent
forecast, we now expect EBITDA breakeven to be in 2028.
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. I am proud that we have created a terrific team who know what we
need to achieve in each sector to succeed. I thank all current and past
employees who have made Creo what it is today.
Our goal is to build 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. During the past
12-18 months, I feel we have progressed towards this goal. From the NHS Supply
Chain data, to first cases in the lung with Intuitive Surgical, we are seeing
the realisation of our R&D and its growing impact across the medical
devices market and the benefit it can bring to improve lives. We know that
going into the second half of 2024 we will see more cases, more data and more
partnership progress and I believe that we are in the best global company when
it comes to tackling unmet needs for patients.
Our job is clear: to deliver on what we have clear sight of over the coming
months and years as we become a premier, cash generative, global, medical
device and tech licensing business, transforming and improving the lives of
many thousands as we do so. On behalf of the Board, I thank Creo's
shareholders for their continued support, feedback, and encouragement along
with all members of the Creo team, our clinicians and their patients, our
customers, suppliers, and other partners for all their hard work, support, and
positive contributions during the period.
Craig Gulliford
Chief Executive Officer
30 September 2024
Financial Review
Total sales for the period were £15.2m across all revenue streams. Creo Core
Technology revenues, which comprise the Creo Core products including the
Speedboat UltraSlim and CROMA platform, were £1.6m for the period, an
increase of 78% from H1-2023 (£0.9m) and a 14% increase from H2-2023
(£1.4m). The lower increase against H2-23 compared to H1-23 is due to the
catch-up in backlog which had been built up in H1-2023 leading to higher
H2-2023 revenues.
Kamaptive revenues were £0.1m for the period reflecting a delay in timing of
milestones and payments under our ongoing collaboration (H1-2023: £0.5m,
H2-2023 £1.2m).
Creo's endotherapy consumable sales were 6% below H1-2023 due to sales being
particularly strong in the first half of FY-2023 compared to the second half.
We are however on track to exceed total consumable revenues in 2023 of £26.8m
by end of year, and the division is trading in line with management
expectations for FY24.
6 months to 6 months to 12 months to
(All figures £m) 30-Jun-24 30-Jun-23 31- December-23
Unaudited Unaudited Audited
Creo Consumables 13.5 14.3 26.8
Creo Core 1.6 0.9 2.3
Kamaptive 0.1 0.5 1.7
Total Creo Core Technology (including Kampative) 1.7 1.4 4.0
Total Revenue 15.2 15.7 30.8
Total gross profit for the period decreased to £7.2m (H1-2023: £7.5m) whilst
the gross margin percentage marginally decreased by 0.2% to 47.6% (H2-2023:
47.8%) due to no milestone payments in the six-month period to date compared
to two milestone payments in H2-2023.
Underlying EBITDA loss (EBITDA with R&D tax credits and other accounting
adjustments added back) of £10.5m, representing a 14% increase compared to
the first six months of 2023 (£9.2m). This increase comprises £0.3m of lower
margin, £0.6m in loss of R&D tax credits due to changes in legislation
and £0.4m increase in expense due to accelerated projects as described below.
Underlying administrative expenses (administrative expenses less SIP charge,
share based payments, earnout, depreciation, amortisation and settlements)
increased in the period to £18.4m against the six-month period to 31 December
2023 (£17.9m) reflecting the accelerated work on the SpydrBlade project,
development of a reusable interface cable and increased patent costs
associated with protecting these developments. We expect to see first sales of
the SpydrBlade device in H2-24 and increased margins on core sales due to
reduction in interface cable costs in H2-24. Strict cost controls have
remained during the period particularly around headcount, travel and general
overheads with further savings expected during H2-24.
The underlying operating loss for the period is £10.0m (six months to 30 June
2023: £8.6m) representing a 16% increase in underlying operating loss for the
first six months of 2024 compared to the first six months of 2023.This is a
non-statutory measure which adjusts the operating loss as follows:
Financial Review
6 months to 6 months to 12 months to
(All figures £'m) 30 June 2024 30 June 2023 31 December 2023
Unaudited Unaudited Audited
Revenue 15.2 15.7 30.8
Cost of Sales (8.0) (8.2) (15.5)
Gross Profit 7.2 7.5 15.3
47.6% 47.8% 49.6%
Other Operating Income 0.0 0.0 0.4
Administrative Expenses (20.9) (20.9) (40.5)
Operating Loss (13.7) (13.4) (24.8)
SIP Charge 0.1 0.1 0.2
PPE & Other Settlement 0.0 0.2 0.3
Earnout 0.1 0.4 0.5
Depreciation & Amortisation 1.8 1.7 3.4
R&D expenditure recovered via tax credit scheme 1.2 1.8 2.8
Underlying EBITDA (non statutory measure) (10.5) (9.2) (17.6)
Share based payments (inc. JSOP) 0.5 0.6 1.2
Underlying operating loss (non-statutory measure) (10.0) (8.6) (16.4)
* figures showing '-' are where there is no balance for the period, figures
showing '0.0' is where there is a balance but it is below £0.05m.
Non-statutory measures
Whilst underlying EBITDA and underlying operating loss are not statutory
measures, the Board believes they are helpful metrics to provide a meaningful
understanding of the financial information as these measures provide an
approximation of the ongoing cash requirements of the business as it continues
to pursue its future development and ongoing commercialisation of its approved
products. The underlying EBITDA 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 EBITDA excluding share-based payment expenses which are non-cash.
Tax
The Company has not recognised any additional deferred tax assets in respect
of trading losses arising in the current financial period. The Company
recognises tax assets in respect of claims under the UK research and
development Small or Medium-sized Enterprise ("SME") scheme, accrued in line
with costs with any adjustments being made on submission of a claim. We
received £2.6m cash from R&D tax credits in August 2024.
Earnings per share
Loss per share was 3 pence for the period (six-months to 30 June 2023: 4
pence).
Cash flow and Balance Sheet
Net cash used in operating activities was £13.7m for the six months to 30
June 2024 (six months to 30 June 2023: £15.2m) with an increase in
operational expenses offset by a decrease in working capital movements
compared to H1-2023. Cash received from investing activities was £15.1m (six
months to 30 June 2023: £17.1m outflow) due to £15.5m of treasury deposits
maturing during the period and £0.1m of bank interest received offset by
£0.6m spent on development of intangibles and investment in infrastructure.
Net cash generated from financing activities was £5.5m (six months to 30 June
2023: £30.6m) reflecting £6.2m of new loans acquired in Europe during the
period offset by £0.7m of loan and lease repayments during the period.
Total assets at 30 June 2024 decreased to £69.3m (30 June 2023: £88.7m).
Cash and cash equivalents and cash on deposit at 30 June 2024 were £9.8m (30
June 2023: £11.5m). Net assets were £47.4m (30 June 2023: £69.0m).
At 30 June 2024, the debtor position in relation to R&D Tax Credits was
£3.9m including the £2.6m debtor from 2023. Inventory as at 30 June 2023
increased to £8.5m (30 June 2023: £8.0m), representing the increase in stock
holding to facilitate current and expected future orders of core Creo products
Interest bearing liabilities as at 30 June 2024 increased to £14.2m (30 June
2023: £9.2) due to the European loans received in the first part of the year.
2024 Outlook
Trading in core Creo Products (excluding Kamaptive) in the first half of 2024
met management's expectations and remains on the trajectory to meet
management's aims for the Company, including a notable increase in the number
of regular users of Creo's Speedboat device. We anticipate continued revenue
growth and expect to maintain a strong gross margin across our product range
during H2-2024. Active cost control will support a stable cost base, driving
efficiencies through the business.
Richard Rees
Chief Financial Officer
30 September 2024
Consolidated statement of profit and loss and other comprehensive income
6 months to 6 months to 12 months to
(All figures £m) Note 30 June 2024 30 June 2023 31 December 2023
Unaudited Unaudited Audited
Revenue 2 15.2 15.7 30.8
Cost of sales (8.0) (8.2) (15.5)
Gross Profit 7.2 7.5 15.3
Other operating income 0.0 - 0.4
Administrative expenses (20.9) (20.9) (40.5)
Operating loss (13.7) (13.4) (24.8)
Finance expenses (0.3) (0.1) (0.4)
Finance income 0.2 0.3 0.7
Loss before tax (13.8) (13.2) (24.5)
Taxation 1.5 1.6 2.8
Loss for the year (12.3) (11.6) (21.7)
Exchange gain/(loss) on foreign subsidiary (0.7) (1.0) (0.6)
Changes to the fair value of equity investments at fair value through other - - -
comprehensive income
Total other comprehensive income (0.7) (1.0) (0.6)
Total comprehensive loss for the year (13.0) (12.6) (22.3)
Loss per Share
Basic and diluted (£) 3 (0.03) (0.04) (0.07)
* figures showing '-' are where there is no balance for the period, figures
showing '0.0' is where there is a balance but it is below £0.05m.
Consolidated statement of financial position
As at As at 12 months to
(All figures £m) Note 30 June 2024 30 June 2023 31 December 2023
Unaudited Unaudited Audited
Assets
Non-current assets
Intangible assets 6.5 7.3 7.1
Goodwill 18.7 19.0 19.1
Investments 2.1 2.1 2.1
Property, plant and equipment 8.5 9.7 9.1
Deferred tax 1.2 1.4 1.1
Other assets 0.2 0.1 0.2
37.2 39.6 38.7
Current assets
Inventories 8.5 8.0 8.1
Trade and other receivables 9.9 8.3 8.6
Tax receivable 3.9 6.3 2.7
Fixed term deposits - 15.0 15.5
Cash and cash equivalents 9.8 11.5 3.0
32.1 49.1 37.9
Total assets 69.3 88.7 76.6
Shareholder equity
Called up share capital 4 0.4 0.4 0.4
Share premium 180.9 180.9 180.9
Merger reserve 13.6 13.6 13.6
Share option reserve 11.1 10.0 10.5
Foreign exchange reserve (2.5) (2.2) (1.8)
Financial Assets at fair value through other comprehensive income 0.6 0.6 0.6
Accumulated losses (156.7) (134.3) (144.4)
Total equity 47.4 69.0 59.8
Liabilities
Non-current liabilities
Interest-bearing liabilities 10.7 5.6 5.2
Deferred tax liability 1.0 1.7 1.4
Provisions 0.3 0.5 0.3
12.0 7.8 6.9
Current liabilities
Interest-bearing liabilities 3.5 3.6 3.1
Trade and other payables 5.4 7.5 5.7
Other liabilities 0.8 0.6 0.9
Provisions 0.2 0.2 0.2
9.9 11.9 9.9
Total liabilities 21.9 19.7 16.8
Total equity and liabilities 69.3 88.7 76.6
* figures showing '-' are where there is no balance for the period, figures
showing '0.0' is where there is a balance, but it is below £0.05m.
Consolidated statement of changes in equity
Changes to the
fair value of
equity
instruments
at fair value
Called up Share through other Foreign
share Accumulated Share Merger option comprehensive Exchange Total
(All figures £m) Note capital losses premium reserve reserve income Reserve equity
Balance at 1 January 2023 0.2 (122.7) 149.5 13.6 9.3 0.6 (1.2) 49.3
Total comprehensive loss for the period
Loss for the financial period - (11.6) - - - - - (11.6)
Other comprehensive loss/income - - - - - - (1.0) (1.0)
Total comprehensive loss - (11.6) - - - - (1.0) (12.6)
Transactions with owners, recorded directly in equity.
Issue of share capital 4 0.2 - 31.4 - - - - 31.6
Equity settled share-based payment transactions - - - - 0.7 - - 0.7
Balance at 30 June 2023 0.4 (134.3) 180.9 13.6 10.0 0.6 (2.2) 69.0
Total comprehensive loss for the period
Loss for the financial period - (10.1) - - - - - (10.1)
Other comprehensive loss/income - - - - - - 0.4 0.4
Total comprehensive loss - (10.1) - - - - 0.4 (9.7)
Transactions with owners, recorded directly in equity.
Issue of share capital 4 0.0 - (0.0) - - - - 0.0
Equity settled share-based payment transactions - - - - 0.5 - - 0.5
Balance at 31 December 2023 0.4 (144.4) 180.9 13.6 10.5 0.6 (1.8) 59.8
Total comprehensive loss for the period
Loss for the financial period - (12.3) - - - - - (12.3)
Other comprehensive loss/income - - - - - - (0.7) (0.7)
Total comprehensive loss - (12.3) - - - - (0.7) (13.0)
Transactions with owners, recorded directly in equity.
Issue of share capital 4 0.0 - (0.0) - - - - (0.0)
Equity settled share-based payment transactions - - - - 0.6 - - 0.6
Balance at 30 June 2024 0.4 (156.7) 180.9 13.6 11.1 0.6 (2.5) 47.4
* figures showing '-' are where there is no balance for the period, figures
showing '0.0' is where there is a balance but it is below £0.05m.
Consolidated statement of cash flows
6 months to 6 months to 12 months to
(All figures £m) Note 30 June 2024 30 June 2023 31 December 2023
Unaudited Unaudited Audited
Cash flows from operating activities
Loss for the year (12.3) (11.7) (21.7)
Depreciation/amortisation charges 1.8 1.7 3.4
Equity settled share-based payment expenses 0.6 0.7 1.2
Finance expenses 0.3 0.1 0.4
Finance income (0.2) (0.3) (0.7)
Taxation (1.5) (1.6) (2.8)
(11.3) (11.1) (20.2)
(Increase)/Decrease in inventories (0.3) 1.0 (0.4)
Increase in trade and other receivables (1.5) (1.8) (1.4)
Decrease in trade and other payables (0.2) (3.2) (3.7)
(2.0) (4.0) (5.5)
Interest paid (0.3) (0.1) (0.4)
Tax paid (0.1) - -
Tax received - - 4.5
Net cash used in operating activities (13.7) (15.2) (21.6)
Cash flows from investing activities
Purchase of intangible fixed assets (0.1) (0.1) (0.4)
Purchase of tangible fixed assets (0.5) (0.4) (1.2)
Acquisition of subsidiary net of cash acquired - (1.9) (2.4)
Fixed Term Deposits 15.5 (15.0) (15.0)
Interest received 0.2 0.3 0.7
Net cash used in investing activities 15.1 (17.1) (18.3)
Cash flows from financing activities
Capital repaid in respect of loans 6.2 (0.7) (1.4)
Proceeds of new loan (0.4) 0.1 0.2
Principal elements of lease repayments (0.3) (0.3) (0.7)
Capital received in respect of long-term borrowings - - 31.7
Share issue - 31.5 -
Net cash generated from financing activities 5.5 30.6 29.8
Increase/(Decrease) in cash and cash equivalents 6.9 (1.7) (10.1)
Effect of exchange rates in cash held (0.1) 0.1 (0.0)
Cash and cash equivalents at beginning of the year 3.0 13.1 13.1
Cash and cash equivalents at end of the year 9.8 11.5 3.0
* figures showing '-' are where there is no balance for the period, figures
showing '0.0' is where there is a balance but it is below £0.05m.
Notes to the interim financial statements
1. Basis of preparation
The interim financial report for the period ended 30 June 2024 and similarly
the period ended 30 June 2023 has been neither audited nor reviewed by the
auditor. The interim financial report for the period ended 30 June 2024 does
not constitute statutory accounts as defined in section 434 of the Companies
Act 2006. The financial information for the year ended 31 December 2023 has
been based on information in the audited financial statements for that period.
A copy of the statutory accounts for the year ended 31 December 2023 has been
delivered to the Registrar of Companies, the accounts had an unqualified audit
opinion and did not contain a statement under section 498(2) or (3) of the
Companies Act 2006 but did include a reference to a material uncertainty that
might cast significant doubt over the Group's ability to continue as a going
concern, to which the auditor drew attention by way of emphasis.
This interim financial report for the six-month period ended 30 June 2024
(including comparatives for the six months ended 30 June 2023) was approved by
the Board of Directors on 30 September 2024
Going Concern
Following the material uncertainty disclosed in the Company's FY23 results the
Directors are aware that additional cash is required prior to the year end in
order to meet the Company's liabilities. On 18 September 2024 we announced
that we had entered into a binding agreement with Micro-Tech (NL)
International B.V., a wholly owned subsidiary of Micro-Tech (Nanjing)
("Micro-Tech") for the sale of 51% of the issued share capital of Creo Medical
S.L.U. ("Creo Medical Europe"), a wholly owned subsidiary of Creo, at an
equity value of €72m (the "Sale") on a cash-free, debt-free basis. Along
with other customary conditions, completion of the Sale is contingent on
Micro-Tech obtaining Outbound Direct Investment clearance in China along with
Foreign Direct Investment clearances in Spain, France, Belgium and Germany.
Whilst there is no certainty as to receipt or timing of receipt of the
necessary approvals to enable completion, it is expected that completion will
take place during Q1 2025 dependent on these relevant clearances being
obtained.
The Directors are aware that a risk to the Sale completion exists and have
therefore announced, alongside, the interim results a proposed placing to
raise a minimum of £12 million plus a Retail Offer. Whilst completion of
the Fundraising is subject to receiving shareholder approval, the Board is
confident that such approval will be secured.
On the basis of the cash inflow as a result of the Sale and the Proposed
Placing and Retail Offer, the Directors are satisfied that the Company will
have adequate resources to continue in operational existence for a period of
not less than 12 months from the date of signing this interim financial
report. Thus, they continue to adopt the going concern basis of accounting in
preparing the interim financial report.
Accounting policies
The accounting policies used in the preparation of the financial information
for the six months ended 30 June 2024 are in accordance with the recognition
and measurement criteria of UK adopted international accounting standards and
are consistent with those which will be adopted in the annual financial
statements for the year ending 31 December 2024. Whilst the financial
information included has been prepared in accordance with the recognition and
measurement criteria of international accounting standards, the financial
information does not contain sufficient information to comply with
international accounting standards. The Group has not applied IAS 34, Interim
Financial Reporting, which is not mandatory for UK AIM listed Groups, in the
preparation of this interim financial report.
Changes in accounting policy and disclosures
New standards, amendments and interpretations
The following new standards, amendments and interpretations have been adopted
by the Group for the first time for the financial year beginning on 1 January
2024:
· Classification of Liabilities as Current or Non-current -
Amendments to IAS 1 Non-current Liabilities with Covenants-Amendments to IAS 1
· Lease Liability in a Sale and Leaseback - Amendments to IFRS 16
· Supplier finance arrangements - Amendments to IAS 7 and IFRS 7
Principal risks and uncertainties
The principal risks and uncertainties impacting the Group are described in our
2023 Annual Report and remain unchanged at 30 June 2024. We continue to
monitor the global inflationary and economic pressures along with other
geopolitical macro issues.
Critical accounting judgments and key sources of estimation uncertainty
The Group is required to make estimates and assumptions concerning the future.
These estimates and judgements are based on historical experience and other
factors, including expectations of future events that are believed to be
reasonable under the circumstances. The resulting accounting estimates will,
by definition, seldom equal the related actual results. Accounting estimates
and judgements have been required for the production of these Financial
Statements.
Share-based payments
Equity-settled share options are granted to certain officers and employees.
Each tranche in an award is considered a separate award with its own vesting
period and grant date fair value. The fair value of each tranche is measured
at the date of grant using the Black-Scholes option pricing model, the Monte
Carlo method, or a hybrid model where appropriate. Compensation expense is
recognised over the tranche's vesting period based on the number of awards
expected to vest, through an increase to equity. The number of awards expected
to vest is reviewed over the vesting period, with any forfeitures recognised
immediately.
Research and development costs
Capitalisation of development costs requires analysis of the technical
feasibility and commercial viability of the project concerned. Capitalisation
of the costs will only be made where there is evidence that an economic
benefit will flow to the Company.
During the period we capitalised £30k of research and development costs in
relation to our bipolar snare product which we are developing. No other
development costs have been capitalized for the period.
Deferred tax assets
Management judgement is required on whether the Group should recognise any
deferred tax assets for losses. A deferred tax asset is recognised only to the
extent that it is probable that future taxable profits will be available
against which the temporary difference can be utilised.
Given the nature and stage of development of Creo Medical Limited there are
significant losses accumulated to date. To determine whether a deferred tax
asset should be recognised in relation to the future tax deduction that these
losses represent, the Directors have considered the estimated profits over a
medium to long-term forecast and the events required to achieve such
forecasts. Creo Medical UK Limited (formally Albyn Medical Limited acquired in
2020) is forecast to make profits over the medium term and these profits would
be available for Group relief. Therefore, we have recognised a tax asset in
relation to the element of profit expected to be earned in that entity.
Forecasts for Creo Medical Limited continue to show tax losses for at least
the medium term (to three years) as the Group continues to develop and
commercialise its products. Given the extent of uncertainty with forecasting
over a longer-term horizon, it is determined that there is not the level of
convincing evidence that sufficient taxable profit will be available against
which further tax losses or tax credits can be utilised. Thus, there is
considered to be insufficient certainty over the timing and amount of loss
recoverability for any further deferred tax asset to be recognised.
Segmental reporting
An entity is required to disclose information to enable users of its financial
statements to evaluate the nature and financial effects of the business
activities in which it engages and the economic environments in which it
operates. As the Group's global reach has expanded in the period, management
have exercised significant judgement in determining whether presenting segment
information on an alternative basis would better adhere to this core
principle.
Whilst the operations in different geographical locations form a fundamental
part of the Group's long-term strategy, they are in the early stages of
development and the Group continues to focus on the development and
commercialisation of its Core technology and the key range of unique
endoscopic surgical devices and CROMA Advanced Energy Platform. In making
their judgement, the directors considered the Group's activities and the
internal reporting structures, and information regularly reviewed by the
entity's chief operating decision-maker to make decisions about resources to
be allocated and assessing performance.
After the assessment, the directors concluded that financial information at a
consolidated Group level appropriately reflects the business activities in
which the Group is currently engaged, and the economic environment in which it
operates. As explained in the 2023 Annual Report, as the Group continues to
grow it is expected that the internal reporting structure will evolve in order
to meet the changing activities, goals and objectives of the business and
therefore additional operating segments may be identified as appropriate in
future reporting periods.
2. Revenue and other operating income
The revenue split for the Group at 30 June 2024 was as follows:
6 months to 6 months to 12 months to
(All figures £m) 30-Jun-24 30-Jun-23 31-December-23
Unaudited Unaudited Audited
UK 7.1 4.9 9.5
Europe 7.6 10.4 20.7
RoW 0.5 0.4 0.6
Total 15.2 15.7 30.8
3. Earnings per share
6 months to 6 months to 12 months to
30 June 2024 30 June 2023 31 December 2023
(All figures £) Unaudited Unaudited Audited
Loss
Loss attributable to equity holders of Company (basic) (12,309,680) (11,704,505) (21,720,908)
Shares (number)
Weighted average number of ordinary shares in issue during the year 361,663,962 266,484,071 313,004,399
Loss per share
Basic and diluted (0.03) (0.04) (0.07)
Earnings per share has been calculated in accordance with IAS 33 - Earnings
Per Share using the loss for the period after tax, divided by the weighted
average number of shares in issue.
Diluted earnings per share is calculated by adjusting the weighted average
number of ordinary shares in issue to assume conversion of all potential
dilutive ordinary shares. The potential ordinary shares are considered to be
antidilutive on the basis that they reduce the loss per share and are not
included in the Company's EPS calculation, meaning that diluted EPS is the
same as basic EPS.
4. Share capital
Balance at 30 June 2022 (£) 181,205
Issue of share capital
Number of shares 340,890
Price per share (£) 0.001
Share value (£) 341
Balance at 31 December 2022 (£) 181,546
Issue of share capital
Number of shares 169,345,387
Price per share (£) 0.001
Share value (£) 169,345
Balance at 30 June 2023 (£) 350,891
10,360,146
Number of shares
Price per share (£) 0.001
Share value (£) 10,360
Balance at 31 December 2023 (£) 361,251
Number of shares 225,024
Price per share (£) 0.001
Share value (£) 225
Balance at 30 June 2024 (£) 361,476
5. Post balance sheet events
Sale of Controlling Interest of Creo Medical SLU
As per notified in the RNS on 18 September 2024 Creo Medical Group plc entered
into a binding agreement with Microtech (NL) International B.V., a wholly
owned subsidiary of Microtech (Nanjing) Co. Ltd for the sale of 51% of the
issued share capital of Creo Medical Spain S.L.U., a wholly owned subsidiary
of Creo Medical Group plc, at an equity value of €72m (the "Sale") on a
cash-free, debt-free basis.
Along with other customary conditions, completion of the Sale is contingent on
Micro-Tech obtaining Outbound Direct Investment clearance in China along with
Foreign Direct Investment clearances in Spain, France, Belgium and Germany.
Whilst there is no certainty as to receipt or timing of receipt of the
necessary approvals to enable completion, it is expected that completion will
take place during Q1 2025 dependent on these relevant clearances being
obtained.
The Sale generates a return on Creo's initial investment and will strengthen
our balance sheet to invest in our core strategy.
The directors believe the Sale demonstrates the significant value Creo have
created within the European business following its acquisition in 2020.
As at 30 June 2024 there was no commitment to a loss of control of the
European subsidiaries. As such the assets were not classified as held for sale
under IFRS 5 Non-current Assets Held for Sale and Discontinued Operations at
the balance sheet date.
Audit Tender
PwC were appointed as auditor at the last annual general meeting, in
accordance with Section 489 of the Companies Act 2006. During July and August
2024, the Company undertook a competitive review and tender process for the
auditing of its 2024 Annual Report. Following the conclusion of that process,
and in accordance with its terms of reference, the Audit Committee of the
Company recommended to the Board that RSM UK Audit LLP be appointed as
auditors of the Group. RSM UK Audit LLP replaced PwC as auditors in August
2024.
Board Appointments
Further to the AGM Statement & Succession Planning announcement
(https://www.londonstockexchange.com/news-article/CREO/agm-statement-directorate-succession-planning/16015218)
in June 2023, which set out the Company's plan to evolve its Board of
Directors as it enters a new phase of commercial growth, Creo announces the
appointment of Kevin Crofton and Brent Boucher as independent Non-Executive
Directors. Both Kevin and Brent joined the Board with effect from 1 July 2024,
with Kevin succeeding Charles Spicer as Chair.
Richard Rees
Chief Finance Officer
30 September 2024
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