REG - Tissue Regenix Group - Final results for the year ended 31 December 2023
19/03/2024 07:00
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RNS Number : 3255H Tissue Regenix Group PLC 19 March 2024
Tissue Regenix Group plc
('Tissue Regenix', the 'Group', or the 'Company')
Final results for the year ended 31 December 2023
Annual Report and Notice of AGM
Tissue Regenix Group plc (AIM: TRX), the regenerative medical devices company,
announces its audited final results for the year ended 31 December 2023, with
record revenues and a positive adjusted EBITDA* for the full year, a first for
Tissue Regenix.
Financial Highlights
· Top line revenue growth for the Group of 20%
o This performance marks the sixth consecutive period of half-on-half,
double digit revenue growth (averaging over 20% for the last three years)
o BioRinse® revenues increased by 25% to USD20.1m (2022: USD16.0m), driven
by growth in our flagship products and Released Donor Tissue
o dCELL® revenues increased by 17% to USD6.2m (2022: USD5.3m) as the
commercial reorganisation implemented in 2022 continued to mature
o The Group's joint venture, GBM-V, grew modestly by 2% to USD3.2m (2022:
USD3.1m)
· Positive adjusted EBITDA of USD925k (2022 loss: USD626k), a first for
Tissue Regenix
o Driven by increased sales revenue and improved gross margin; aided by
management of administrative expenses
· Gross profit of USD14.0m (2022: USD11.3m)
o Gross margin increased to 48% (2022: 46%)
· Cash position at 31 December 2023 of USD4.7m (2022: USD5.9m)
o Cash balance increased from H1 2023
Operational Highlights
· Received approval from the Irish Health Products Regulatory Authority
(IHPRA), allowing the Company to distribute tissue within the European Union
from its third-party logistics partner in the Republic of Ireland
· Announced an agreement with Spineart España SLU to distribute
allograft tissue into Spain
· Signed BioRinse agreements with five new strategic partners and six
stocking distributors targeting the spinal and dental markets
· Added 66 new distributors for dCELL in 2023, 206% greater than
targeted
· Signed an exclusive distribution agreement with Kingsung Medical
Group, for the distribution of OrthoPure® XT in China and initiated the
regulatory approval process for China
· Signed distribution agreements for OrthoPure XT in the United Kingdom
and Australia
· Sourced 31% more musculoskeletal and dermis donors and released 38%
more donors versus 2022
Jonathan Glenn, Chair of Tissue Regenix, commented: "2023 was another year of
solid progress for the Group. We have seen record revenues, Tissue Regenix's
first full year positive adjusted EBITDA, improved cash conversion and many
operational highlights including further regulatory approvals, and new and
improved relationships with our many partners. The diligent focus of our
highly motivated team is allowing us to broaden the Group's capacity, continue
to grow the business at an impressive rate and, importantly, build shareholder
value. The Board of Tissue Regenix is confident and excited about the future
and looks forward to further significant progress in 2024."
*Adjusted EBITDA: profit before interest, taxes, depreciation, amortisation,
and share based payments
Annual Report and Accounts and Notice of Annual General Meeting (AGM)
As part of the Company's move to electronic reporting, the Annual Report and
Accounts, notice of AGM and accompanying form of proxy, will be available
later this morning on the Company's website, www.tissueregenix.com
(http://www.tissueregenix.com/) , in accordance with AIM Rule 20. For those
who opted to receive hard copies of the Annual Report, these will be posted
today.
The Company's AGM will be held at DLA Piper, 160 Aldersgate St, Barbican,
London EC1A 4HT on 25 April 2024 at 11.00am. Shareholders are invited to ask
the Board questions about the Annual Report and Accounts or the AGM by email
emailing Walbrook PR at TissueRegenix@walbrookpr.com.
The results of the votes on the proposed resolutions will be announced by RNS
as soon as practicable after the conclusion of the AGM.
Investor Briefing
Daniel Lee, Chief Executive Officer, and David Cocke, Chief Financial Officer,
will host a live online presentation relating to the final results via the
Investor Meet Company platform at 11.00am today. The presentation is open to
all existing and potential shareholders.
Investors can sign up to Investor Meet Company for free and register for the
presentation here:
https://www.investormeetcompany.com/tissue-regenix-group-plc/register-investor
(https://www.investormeetcompany.com/tissue-regenix-group-plc/register-investor)
For more information:
Tissue Regenix Group plc www.tissueregenix.com (http://www.tissueregenix.com)
David Cocke, Chief Financial Officer via Walbrook PR
Cavendish Capital Markets Limited (Nominated Adviser and Broker)
Emily Watts/Geoff Nash/George Dollemore - Corporate Finance
Nigel Birks/Harriet Ward - ECM
Walbrook PR (Financial PR and IR) Tel: +44 (0)20 7933 8780
Alice Woodings/Charlotte Edgar TissueRegenix@walbrookpr.com
About Tissue Regenix (www.tissueregenix.com (http://www.tissueregenix.com) )
Tissue Regenix is a leading medical device company in regenerative medicine.
The Company's patented decellularisation technology (dCELL®) removes DNA and
other cellular material from animal and human soft tissue, leaving an
acellular tissue scaffold not rejected by the patient's body that can be used
to repair diseased or damaged body structures. Current applications address
many crucial clinical needs in sports medicine, foot and ankle injuries, and
wound care.
In August 2017, Tissue Regenix acquired CellRight Technologies®. This
biotech company specialises in regenerative medicine and is dedicated to
developing high-quality, innovative tissue scaffolds to enhance healing
opportunities in defects created by trauma and disease. CellRight's human
tissue products may be used in spine, trauma, general orthopaedic, dental and
ophthalmological surgical procedures.
Chief Executive Officer's Statement
2023 performance
The Group's performance continued the positive trajectory set over the past
three years, achieving numerous milestones over the reporting period. We saw
record revenues for the Group, with top-line revenue growth of 20% during
FY2023. This faster than market growth was driven by the continued adoption of
our products through our strategic partners as well as our direct distribution
activities. The combination of sales growth and a tight focus on overheads
translated into positive adjusted EBITDA* for the year - a first for Tissue
Regenix - and contributed to an increase in our cash balance over the second
half of 2023. These results could not have happened without the hard work and
dedication of all the employees of the Group. We are proud of what we have
achieved so far and believe that a bright future lies ahead for Tissue
Regenix.
*(Earnings before interest, taxes, depreciation and amortisation and adjusted
for share-based payments)
Strategy
Our focus on the 4S strategic elements of Supply, Sales Revenue,
Sustainability and Scale continues to provide the foundation of how we
operate, execute and drive growth.
The continued investment that we are making and the focus we are placing on
tissue Supply has enabled us to sustain and grow in line with our business
needs as well as manage the inventories more efficiently and provide tissue to
other tissue processors. Processing capacity, another key element in Supply,
has kept pace with the Group's growth despite resource-related headwinds, as
experienced more broadly across numerous industries.
Our focus on Sales Revenue and Sustainability has been realised in revenue
growth and a positive adjusted EBITDA for the year. Our ability to increase
our cash balance in the second half of 2023 was a milestone for the
organisation and a further demonstration of Sustainability.
Obtaining the regulatory approvals for our third-party logistics partner
provides us the opportunity and flexibility to Scale our allograft business in
markets outside the U.S. ('OUS').
The Group's solid 4S foundation enables us to continue growth plans for Tissue
Regenix and deliver shareholder value.
Growth pillars
The 4S strategy enables us to support defined tactical activities moving
forward. In 2023, we implemented clearly defined growth pillars to provide
further direction and help sustain the growth trajectory for the Group.
The four growth pillars are:
1. Base Business
We will continue to grow our core businesses with our existing and new
partners/distributors through the BioRinse and dCELL product lines. This base
business includes existing specialities and geographic markets. We will
support this growth with logical new product enhancements and clinical- or
market-related activities. This growth will also be supported by our current
infrastructure and planned capacity enhancements.
2. Tissue Partnerships
Our focus on tissue supply is at the core of our growth as it drives our
capacity. We have built supply volumes that exceed our internal needs, so we
have the opportunity to provide donor tissue to other tissue processors
('Released Donor Tissue'). We also have the responsibility of meeting the
donor's desire to have their tissue utilised to help others in a safe and
expeditious manner. Our tissue supply operation adds value by performing the
medical reviews and chart releases required for tissue suitable for immediate
processing by other domestic and OUS partners. These activities help us to
manage our recovery partner relationships and provide opportunities for tissue
that we currently do not utilise in our processing operations.
3. Market Expansion
We will continue to broaden the markets for our products via a two-pronged
approach. The need for tissue-based products in the surgical marketplace is
substantial, and we currently participate in limited segments. We intend to
expand into additional surgical specialities by first generating clinical
experience at institutions where we have an existing base business. This will
serve as the stepping stone for expansion with additional customers and
institutions.
We also plan to expand into markets that have a need for allograft
tissue-based products but currently have limited availability. Our
establishment and receipt of approval to distribute tissue through a
third-party logistics partner provides the conduit for opportunities into the
EU. OrthoPure XT, our xenograft tissue product, received a CE Mark in 2020,
and we continue to identify opportunities to distribute this product in
markets that recognise the CE Mark.
4. Regulatory Evolution
The bulk of our revenue comes from allograft tissue-based products, which are
regulated as Section 361 HCTP (Human, Cell and Tissue Products) in the U.S.
The requirements mandated for Section 361 products place limits on changes to
the allograft tissue; if one works beyond these limits then the product will
need to be regulated as a medical device. Our facility in San Antonio has been
established to meet the requirements of producing Section 361 products. We
intend to evolve and change this facility to become one that is capable of
meeting medical device requirements. This evolution will give us the
opportunity to innovate with human tissue and broaden opportunities for Tissue
Regenix to distribute tissue into certain international markets that regulate
human tissue allografts as medical devices.
BioRinse
The BioRinse portfolio was our top performer over the financial year,
reporting sales of USD20,133k (2022: USD16,049k), driven by the U.S.
orthopaedics, wound care and dental markets. The 25% year-on-year growth was
led by confidence in our Concelltrate, AmnioWorks and other demineralised bone
matrix ('DBM') products in addition to our Released Donor Tissue
relationships. Our ability to supply these products in 2022 translated into
2023 through the conviction of our strategic partners to increase their orders
and grow their respective businesses. Our customers expect a level of service,
and we remain flexible and responsive to our customers' needs.
We continue to grow at above-market rates due to the superior performance of
our products, excellent customer service and adaptability to customer needs.
Our growth rate is above market for the period, but there is still opportunity
for additional growth. We saw greater than 20% growth from the prior year
within our top five product families.
Our focus on supply ensures an adequate and continuous supply of donated human
tissue. As stewards of the gift of human tissue donation, we use every effort
to ensure that the tissue is utilised to produce our high-quality products.
Our management of human tissue donation and the processing of the tissue to
meet product demands can result in excess tissue in our inventories. We have
been able to utilise these inventories, complete the medical review and
release process and provide these value-added tissues to other processors for
their own needs. This ultimately meets our obligation to make sure that the
donated human tissue is used efficiently.
In 2023, after some unanticipated regulatory delays, we received approval to
distribute tissue from our third-party logistics partner in the Republic of
Ireland. This approval has opened up additional markets within the EU. We also
announced our agreement with SpineArt España to distribute allograft tissue
into Spain. Other markets and agreements are still in the discussion phase as
our plan is to explore opportunities for focused commercial distribution in
the Europe, Middle East and Africa ('EMEA') markets.
dCELL
In 2023, the commercial reorganisation of the dCELL business continued to
provide growth opportunities for this division. dCELL is a direct business
with a regional sales management team managing distributors in their
respective territories. This business is highly impacted by Group Purchasing
Organization ('GPO') approvals for our products, which we currently have with
the top five GPOs. As a result, we have placed management in areas that align
with our approvals and will continue to pursue opportunities to help us
achieve coverage over the entire U.S. market. To increase our coverage
footprint, we have targeted areas where we have already established business.
In 2023, our aim was to add 32 new distributors over the year. Pleasingly, we
more than doubled that goal by adding 66 distributors by 31 December 2023,
and, as a result, revenue growth for this division increased 17% year on year
to USD6,183k (2022: USD5,301k).
The OrthoPure(®) XT product is the only non-human biologic tissue graft
available for certain ligament reconstruction procedures. In 2022, we
introduced this product into two new markets and added the UK in 2023. Our
efforts to expand distribution into Australia were impacted by regulatory
approval delays. Additional markets were temporarily put on hold as we
resolved inventory issues in Leeds. Efforts to expand distribution
opportunities will resume this year.
In 2023, clinical use and traction of the OrthoPure XT device continued to
gain momentum in Italy, and we expect the initial positive Italian experiences
of the OrthoPure XT in broader clinical use to be presented at the European
Society of Sports Traumatology, Knee Surgery and Arthroscopy ('ESSKA') meeting
in 2024. The manuscript on the five-year clinical experience from the initial
regulatory approval study is in final preparation and planned for submission
to a major European publication. During 2023, we also conducted a
retrospective study reviewing DermaPure(®) use in addressing Achilles
tendinopathy. A poster has been presented at the 2024 American College of Foot
and Ankle Surgeons meeting, and a manuscript is to be submitted for
publication soon after.
GBM-V
The GBM-V joint venture operates in a GMP (Good Manufacturing Practice) level
facility that has been producing commercial corneal products since 2016. In
2023, the joint venture faced supply issues in Germany due to customers
requiring the donor tissue to be sourced from donors who not only were COVID
free but also had no history of COVID infection. While this impacted the
growth of tissue supply, the joint venture realised USD3,177k (2022:
USD3,126k) of revenue, which was marginally up on the prior year. Demand for
corneal tissue continues to outpace supply, and efforts to minimise COVID
concerns, alongside efforts by our tissue recovery partner to increase supply,
will continue in 2024.
New strategic partners and distributors
During 2023, we achieved commercial milestones for the Group as we saw record
revenue months across all our human tissue product families - musculoskeletal,
dermis and amnion. These milestones were achieved through the growth of our
commercial partners and securing additional strategic partnerships/distributor
relationships.
For BioRinse, our top customers remained consistent from the prior year. We
saw a 13% increase in the number of units shipped but a 2% decrease in the
number of orders we processed due to a trend towards larger orders. In 2023,
we signed BioRinse agreements with five new strategic partners and six
stocking distributors who target specialities such as the spine and dental
markets.
For dCELL, the number of distributors added by the end of the year was 206%
greater than targeted. Overall revenue was up 17% versus the prior year, which
represented record annual revenue for this division. The number of products
invoiced for dCELL products increased by 3% versus the prior year, and the
revenue increase was due in large part to our product mix shifting to those
with higher Average Selling Prices ('ASPs'). Our meshed DermaPure products
helped to drive this revenue increase, and this sales traction is expected to
continue into 2024.
We continued to pursue the commercialisation of products that utilise our core
technology platforms, provide product line extensions that are faster to
market, address a specific clinical or commercial need and have a customer in
place. In 2023, due to customer requests, we introduced a smaller DermaPure
Mesh product. To address market expectations for our sports medicine tendon
grafts, we implemented new processing protocols and reagents to improve
product safety and implemented a low-dose sterilisation process.
We added UK distribution of the OrthoPure XT in 2023. Further adoption of this
unique product into select European markets was impacted by mid-year
production issues related to a bioburden spike within the processing line at
our Leeds facility. The temporary halt to production affected inventory
availability, so we paused market expansion during this period as we needed
existing inventory to service current customers. Despite this brief setback,
we look forward to the resumption of discussions with additional EU
distribution partners.
During 2023, we continued to pursue our global commercialisation plans for our
tissue-based products. We have already described how our third-party logistics
partner in the Republic of Ireland will be central to our human allograft
tissue opportunities in the EMEA region. We signed an agreement with a Chinese
distributor for our OrthoPure XT product and have initiated the regulatory
approval process for China, which required a regulatory submission, and a
human clinical evaluation in China is planned. The resources needed for this
involved process are being shared with our distribution partner. Another
notable example of the global market demand for our OrthoPure XT product was
adding a distributor in Australia. The CE mark for this product is recognised
in Australia, although additional regulatory approvals are required there
before marketing. The review process in Australia has been slower than
anticipated due to the volume of submissions within the Therapeutic Goods
Administration.
Expanding demand for our existing products with new and existing partners as
well as product line extensions and product improvements are anticipated to
drive our continued organic growth in 2024 and further utilise our facility
and tissues.
Operations
2023 was another year of growth for the Group as we continued operations
throughout the year at all our locations without significant impacts from any
external influences.
For our allograft tissue business, the supply of donor tissue is directly
linked to our growth plans. To meet the need of our commercial partners and
our focus on Supply, in 2023, we sourced 31% more musculoskeletal and dermis
donors and released 38% more donors versus the prior year. These shifts
reflected the demand for our processing of musculoskeletal donors and demand
from other tissue processors for our Released Donor Tissue.
In 2022, we implemented a programme to help us manage the inventory of
Released Donor Tissue by making some of it available to other processing
companies. All tissue we receive needs to go through an internal review and
release process to ensure the safety and quality of the tissue before it is
processed. We continue to expand our relationships with other tissue
processors located domestically or outside the U.S. who wish to have access to
this tissue. This segment of our business has grown dramatically over the
prior year and has become one of the growth pillars for our organisation. This
programme aligns with our responsibility to honour the gift of tissue donation
through utilisation in a timely manner into products that can help patients.
The addition of two sterile packaging rooms in the existing San Antonio
facility from our Phase 1 expansion in 2021 brought the total number of clean
rooms to seven and provided additional capacity and flexibility. We continue
to identify ways in which we can be more efficient with the flexibility we now
have with room utilisation and processing scheduling. As a result, we have
been able to respond to orders or unanticipated changes in almost half the
amount of time prior to the Phase 1 expansion. These rooms effectively provide
approximately USD40m of revenue generation potential and delayed our need for
the Phase 2 expansion and its 8-10 additional clean rooms until 2025, and we
do not anticipate the need for additional equity funding for this further
expansion.
In late 2023, we implemented Sage X3, an enterprise resource planning ('ERP')
system, in our U.S. operations. This ERP product is used to manage financial
aspects of the business, and we believe that this investment will
significantly increase efficiencies for the Group. The transition from our
legacy system has been smooth, and we continue to refine the system to meet
the needs of all groups within the organisation. The implementation of Sage X3
was a multi-year effort involving all segments of the business and two
consulting groups and is a strong strategic investment for the Group that will
support our growth plans.
We believe that the contribution of increased processing efficiency, increased
capacity and state-of-the-art systems will allow us to enjoy improved gross
margins over time.
The pandemic is behind us
In the U.S., the issues of healthcare institution staff shortages still exist
in some geographic areas. We have seen elective procedure volumes improve.
Supply chain issues have been improved, but costs across all aspects of our
operations have increased since the pandemic. We will absorb most of these
increases through efficiencies in our operation. We began the year with issues
related to labour shortages, but by year end we saw some normalisation with
respect to candidates applying for open positions at our U.S. business.
Organisational changes
We will continue to invest in resources that will grow our organisation across
all divisions. Additions and adjustments to our commercial team in BioRinse
and dCELL will seek to bring additional commercial opportunities to our
organisation and spread Tissue Regenix's footprint in the U.S. and OUS.
Outlook
Sales Revenue and Sustainability will continue to be the priorities of the
4S's in 2024. We will continue to build on this base to provide a more solid
foundation for the future. Our four growth pillars are the tactical areas of
focus that will be built on this foundation.
The BioRinse products will continue to be the dominant revenue contributor in
2024. Growth will come from existing and new partners as well as new products.
Our dCELL business is also expected to show further growth as we expand into
new domestic territories where we historically have not had much presence. We
will also use our current footholds to expand into other surgical
specialities, such as oncology and colorectal surgery, as clinicians become
familiar with our practise areas. The inventory of Released Donor Tissue will
be distributed to other processors who have a need for tissue that is ready to
be processed. Our GBM-V joint venture will continue to identify opportunities
to increase their tissue supply and address any issues that have impacted
their growth.
Our geographic outreach with our human tissue dCELL and BioRinse portfolios is
only just beginning as we have our registered logistics partner, which
provides the opportunity to move into numerous EU markets. We will also seek
registrations and distribution partners in other OUS markets for our human
allograft. Interim supply challenges are behind us, and OrthoPure XT will be
introduced into additional EU and other markets in 2024.
Our evolution into a medical device manufacturer will provide us the
flexibility to be more innovative with our products versus 361 HCTP products.
A medical device registration is rare for a tissue processor of our size but
positions us well to consider not only novel products but also entry into
markets that regulate allograft tissue as a medical device.
In 2024, we will begin some of the preliminary planning activities to build
our Phase 2 capacity expansion. In addition to our organic growth plans, we
will continue to examine acquisition opportunities that would allow us to
scale the business for additional longer-term growth.
In 2021, the Board of Tissue Regenix set in place our 4S strategy. It has been
a highly successful strategy for the Group and continues to provide structure
and clear direction for everything that we do. Three years later, we are in a
strong position, with market-leading products that are distributed globally,
production facilities that allow us to fulfil our current growth ambitions, a
balance sheet to support these growth opportunities and a team of people that
are motivated, talented and driven with a very clear idea of where we are
taking the business. I am proud to be a part of the Tissue Regenix Group and
excited for its future prospects in 2024 and beyond.
Daniel Lee
Chief Executive Officer
18 March 2024
Financial Review
Statement of Comprehensive Income
Revenue
During the year ended 31 December 2023, revenue increased by 20% to USD29,493k
(2022: USD24,476k).
The Group experienced growth across all three key business segments for the
year, as more fully described below:
· The BioRinse segment increased top-line sales by 25% to USD20,133k
(2022: USD16,049k), driven by growth in Released Donor Tissue and continued
growth across the allograft segments, led by the AmnioWorks and Concelltrate
100 product families.
· Revenue from the dCELL division increased by 17% to USD6,183k (2022:
USD5,301k) as the commercial reorganisation implemented in 2022 continued to
mature.
· The Group's joint venture, GBM-V, based in Rostock, Germany, grew
modestly by 2% to USD3,177k (2022: USD3,126k).
Cost of sales and gross profit
Gross profit for the year was USD14,040k (2022: USD11,258k). Gross margin
percentage increased to 48% (2022: 46%).
Included in costs of sales is cost of product - USD13,750k (2022: USD12,013k)
- and third-party commissions - USD1,703k (2022: USD1,205k).
Administrative expenses
During 2023, administrative expenses increased by USD1,166k, or 9%, to
USD14,434k (2022: USD13,268k), driven primarily by additional staffing costs.
Adjusted EBITDA
During 2023, the Group reported adjusted EBITDA of USD925k (2022 loss:
USD626k). This shift into positive adjusted EBITDA was driven by increased
sales revenue and gross margin percentage and aided by management of
administrative expenses to achieve operating leverage. In 2023, EBITDA was
USD583k (2022 loss: USD875k) and is adjusted for share based payments of
USD342k (2022: USD249k).
Finance income/charges
Finance income of USD26k (2022: USD8k) primarily represented interest earned
on cash deposits. Finance charges for the year were reported at USD1,301k
(2022: USD826k) and related primarily to interest charges and associated costs
in respect of the MidCap Financial Trust ('MidCap') loan arrangement. Included
in finance charges for 2023 is USD248k relating to a financing fee associated
with the former MidCap loan termination.
Loss for the year
The loss for the year was USD1,657k (2022: loss: USD2,596k), resulting in a
basic loss per share of 2.43 cents (2022: loss per share: 3.83 cents). The
reduction in the loss for the year was driven by the increases in sales
revenue and gross margin percentage.
Taxation
The Group continues to invest in developing its product offering and, as such,
is eligible to submit enhanced research and development tax claims, enabling
it to exchange tax losses for a cash refund. In the year to December 2023, a
refund of USD352k was receivable (2022: USD401k). The year-on-year reduction
was a result of the collection of aged research and development credits during
2023.
Income tax payable in the U.S. amounted to USD310k (2022: USD nil). Gross tax
losses carried forward in the UK were USD60,361k (2022: USD58,900k). The Group
does not currently pay tax in the UK. A deferred tax asset has not been
recognised as the timing and recoverability of the tax losses remain
uncertain.
Statement of Financial Position
As at December 2023, the Group had net assets of USD29,355k (2022:
USD30,401k), of which cash in hand totalled USD4,650k (2022: USD5,949k).
Inventory levels decreased 5% against the 20% sales revenue increase at
USD10,358k (2022: USD10,882k) as the BioRinse and dCELL segments managed stock
levels closely to increase inventory turnover while also keeping adequate
stock levels to meet customer demand. The Released Donor Tissue offering of
the BioRinse segment turns over more rapidly than processed grafts.
Intangible assets increased slightly to USD15,135k (2022: USD15,061k) in the
year. A further USD450k of development costs, relating primarily to clinical
research, were capitalised in the year (2022: USD709k). The balance of
movements in this account relate to amortisation and exchange adjustments.
The Directors carried out the annual impairment review, as required by IAS 36,
to determine whether there was any requirement for an impairment provision in
respect of goodwill as at 31 December 2023.
The results of the test indicated that the recoverable amount of the Group's
non-current assets was at least equal to the carrying amount of those assets
and, therefore, no provision for impairment was required as at 31 December
2023 (2022: USD nil).
Working capital increased slightly in the year to USD9,9,705k (2022:
USD9,442k), driven by a decrease in payables made possible by improved debtor
collections and lower inventory investment. As mentioned above, the Released
Donor Tissue offering of the BioRinse segment turns over more rapidly, which
speeds up the sales cycle, allowing for faster cash generation. The Statement
of Financial Position includes income tax receivable of USD352k (2022:
USD401k) in respect of UK research and development tax credits.
Loans and borrowings and lease liability
Borrowings include the USD5,985k debt facility through MidCap and the
USD3,410k lease liability related to the Group's leasehold in San Antonio
(2022: USD6,258k and USD3,350k, respectively). The MidCap debt facility
includes USD2,000k in respect of the term loan and USD4,148k in respect of the
revolving credit facility, net of USD163k of capitalised debt issue costs. In
January 2023, the Group elected to increase its current revolving credit
facility from USD5,000k to USD10,000k and extend the maturity until 2028.
Repayment of the term loan in equal instalments commenced in February 2024.
Dividend
No dividend has been proposed for the year to 31 December 2023 (2022: nil).
Accounting policies
The Group's consolidated financial information has been prepared in accordance
with UK-adopted International Accounting Standards ('UK-adopted IAS').
Going concern
The Group financial statements have been prepared on a going concern basis
based on cash flow projections approved by the Board for the Group for the
period to 31 December 2025 (the 'Cash Flow Projections'). Funding requirements
are reviewed on a regular basis by the Group's Chief Executive Officer and
Chief Financial Officer and are reported to the Board at each Board meeting,
as well as on an ad hoc basis if requested. Until sufficient cash is generated
from its operations, the Group remains reliant on cash reserves of USD4,650k
at 31 December 2023 and the ongoing support of MidCap (borrowings of USD5,985k
at 31 December 2023) and other lending institutions to meet its working
capital requirements, capital investment programme and other financial
commitments. Repayment on the MidCap borrowings commenced in February 2024.
In compiling the Cash Flow Projections, the Board has considered a downside
scenario regarding the effect of reduced and delayed revenues due to slower
market uptake of the Group's product offerings. The Cash Flow Projections
prepared by the Board, including the downside scenario, indicate that the
Group will still have cash reserves at the end of the forecast period. The
Group's Cash Flow Projections assume that the MidCap revolving credit facility
is available throughout the forecast period and that the term loan repayment
begins in 2024. The availability of these facilities is dependent upon
compliance with a rolling 12-month revenue covenant that is measured on a
monthly basis. The Cash Flow Projections, including the downside scenario,
indicate compliance with this covenant throughout the forecast period.
In summary, the Directors have considered their obligations in relation to the
assessment of the going concern basis for the preparation of the financial
statements of the Group and have reviewed the Cash Flow Projections, including
the downside scenario. On the basis of their assessment, they have concluded
that the going concern basis remains appropriate for use in the financial
statements.
Cautionary statement
The strategic report, containing the strategic and financial reports of the
Group, contains forward-looking statements that are subject to risk factors
associated with, amongst other things, economic and business circumstances
occurring from time to time within the markets in which the Group operates.
The expectations expressed within these statements are believed to be
reasonable but could be affected by a wide variety of variables beyond the
Group's control. These variables could cause the results to differ materially
from current expectations. The forward-looking statements reflect the
knowledge and information available at the time of preparation.
David Cocke
Chief Financial Officer
18 March 2024
Consolidated Statement of Income
For the year ended 31 December 2023
2023 2022
USD'000 USD'000
Revenue 29,493 24,476
Cost of sales (15,453) (13,218)
Gross profit 14,040 11,258
Administrative expenses (14,434) (13,268)
Operating loss (394) (2,010)
Finance income 26 8
Finance charges (1,301) (826)
Loss on ordinary activities before taxation (1,669) (2,828)
Taxation 12 232
Loss for the year (1,657) (2,596)
Loss for the year attributable to:
Owners of the parent company (1,713) (2,695)
Non-controlling interest 56 99
(1,657) (2,596)
Loss per Ordinary Share
Basic and diluted, cents per share (2.43) (3.83)*
The loss for the year arises from the Group's continuing operations.
*Restated to reflect the share consolidation that became effective on 28 April
2023.
Consolidated Statement of Comprehensive Income
For the year ended 31 December 2023
2023 2022
USD'000 USD'000
Loss for the year (1,657) (2,596)
Other comprehensive income
Items that may be subsequently reclassified to profit or loss:
Foreign currency translation differences 195 (653)
Total comprehensive loss for the year (1,462) (3,249)
Total comprehensive loss for the year attributable to:
Owners of the parent company (1,518) (3,348)
Non-controlling interest 56 99
(1,462) (3,249)
Consolidated Statement of Financial Position
As at 31 December
2023
2023 2022
USD'000 USD'000
Assets
Non-current assets
Property, plant and equipment 5,748 5,740
Right-of-use assets 3,270 3,203
Intangible assets 15,135 15,061
24,153 24,004
Current assets
Inventory 10,358 10,882
Trade and other receivables 3,730 4,803
Corporation tax receivable 352 401
Cash and cash equivalents 4,650 5,949
19,090 22,035
Total assets 43,243 46,039
Liabilities
Non-current liabilities
Loans and borrowings (5,527) (5,258)
Deferred tax (400) (520)
Lease liability (3,226) (3,216)
(9,153) (8,994)
Current liabilities
Trade and other payables (3,783) (5,510)
Taxation payable (310) -
Loans and borrowings (458) (1,000)
Lease liability (184) (134)
(4,735) (6,644)
Total liabilities (13,888) (15,638)
Net assets 29,355 30,401
Equity
Share capital 15,950 15,950
Share premium 134,253 134,179
Merger reserve 16,441 16,441
Reverse acquisition reserve (10,798) (10,798)
Reserve for own shares (1,257) (1,257)
Share-based payment reserve 1,088 824
Cumulative translation reserve (1,763) (1,958)
Retained deficit (123,764) (122,129)
Equity attributable to owners of the parent company 30,150 31,252
Non-controlling interest (795) (851)
Total equity 29,355 30,401
Consolidated Statement of Changes in Equity
For the year ended 31 December 2023
Share capital USD'000 Share premium USD'000 Merger reserve USD'000 Reserve acquisition reserve USD'000 Reserve for own shares USD'000 Share- based payment reserve Share- based payment reserve Retained deficit USD'000 Total USD'000 Non-controlling interest USD'000 Total equity USD'000
USD'000 USD'000
At 31 December 2021 15,947 134,173 16,441 (10,798) (1,257) 1,573 (1,305) (120,432) 34,342 (950) 33,392
Transactions with owners in their capacity as
owners:
Exercise of share options
3 6 - - - - - - 9 - 9
Transfer to retained deficit in respect of lapsed, expired and exercised
options
- - - - - (998) - 998 - - -
Share-based payments - - - - - 249 - - 249 - 249
Total transactions with owners in their capacity as owners
3 6 - - - (749) - 998 258 - 258
Loss for the year - - - - - - - (2,695) (2,695) 99 (2,596)
Other comprehensive income: Currency translation differences
- - - - - - (653) - (653) - (653)
Total other comprehensive income for the year
- - - - - - (653) - (653) - (653)
Total comprehensive income for the year
- - - - - - (653) (2,695) (3,348) 99 (3,249)
At 31 December 2022 15,950 134,179 16,441 (10,798) (1,257) 824 (1,958) (122,129) 31,252 (851) 30,401
Transactions with owners in their capacity as
owners:
Exercise of share options
- 74 - - - - - - 74 - 74
Transfer to retained deficit in respect of exercised and expired options
- - - - - (78) - 78 - - -
Share-based payments - - - - - 342 - - 342 - 342
Total transactions with owners in their capacity as owners
- 74 - - - 264 - 78 416 - 416
Loss for the year - - - - - - - (1,713) (1,713) 56 (1,657)
Other comprehensive income: Currency translation differences
- - - - - - 195 - 195 - 195
Total other comprehensive income for the year
- - - - - - 195 - 195 - 195
Total comprehensive income for the year
- - - - - - 195 (1,713) (1,518) 56 (1,462)
15,950 134,253 16,441 (10,798) (1,257) 1,088 (1,763) (123,764) 30,150 (795) 29,355
At 31 December 2023
Consolidated Statement of Cash Flows
For the year ended 31 December 2023
2023 2022
USD'000 USD'000
Operating activities
Loss on ordinary activities before taxation (1,669) (2,828)
Adjustments for:
Finance income (26) (8)
Finance charges 1,301 826
Depreciation of property, plant and equipment 395 353
Depreciation of right-of-use assets 132 164
Amortisation of intangible assets 450 618
Share-based payments 342 249
Unrealised foreign exchange loss/(gain) 84 (239)
Operating cash inflow/(outflow) before movements in working capital 1,009 (865)
Decrease/(increase) in inventory 524 (1,163)
Decrease/(increase) in trade and other receivables 1,073 (702)
(Decrease)/increase in trade and other payables (1,836) 1,249
Net cash generated from/(used in) operations 770 (1,481)
Research and development tax credits received 270 187
Net cash generated from/(used in) operating activities 1,040 (1,294)
Investing activities
Interest received 26 8
Purchase of property, plant and equipment (413) (381)
Capitalised development expenditure (450) (709)
Net cash used in investing activities (837) (1,082)
Financing activities
Proceeds from exercise of share options 74 9
(Repayment of)/proceeds from loans and borrowings (238) 1,708
Interest paid on loans and borrowings (567) (450)
Fees paid on loans and borrowings (355) -
Lease liability payments (140) (66)
Lease interest payments (284) (291)
Other interest payments (2) -
Net cash (used in)/generated from financing activities (1,512) 910
Net decrease in cash and cash equivalents (1,309) (1,466)
Cash and cash equivalents at beginning of year 5,949 7,709
Effect of movements in exchange rates on cash held 10 (294)
Cash and cash equivalents at end of year 4,650 5,949
Notes to the Consolidated Financial Statements
For the year ended 31 December 2023
1. Material accounting policies
Basis of preparation
The financial information set out herein 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
extracted from the Company's audited financial statements which were approved
by the Board of Directors on 18 March 2024 and which, if adopted, will be
delivered to the Registrar of Companies for England and Wales.
The financial information for the year ended 31 December 2022 has been
extracted from the Company's audited financial statements which were approved
by the Board of Directors on 20 March 2023.
Statutory accounts for the years ended 31 December 2023 and 31 December 2022
have been reported on by the auditor. Their reports for both years (i) were
unqualified; (ii) did not include a reference to any matters to which the
auditor drew attention by way of emphasis without qualifying their audit
report and (iii) did not contain a statement under section 498(2) or 498(3) of
the Companies Act 2006.
The information in this preliminary statement has been extracted from the
audited financial statements for the year ended 31 December 2023 and as such,
does not contain all the information required to be disclosed in the financial
statements prepared in accordance with UK adopted International Accounting
Standards ('IAS').
The Company is a public limited company incorporated and domiciled
in England and whose shares are quoted on AIM, a market operated by The
London Stock Exchange.
The address of the registered office is Unit 3, Phoenix Court, Lotherton
Way, Garforth LS25 2GY.
Going concern
The Group financial statements have been prepared on a going concern basis
based on cash flow projections, approved by the Board for the Group, for the
period to 31 December 2025 (the 'Cash Flow Projections'). Funding requirements
are reviewed on a regular basis by the Group's Chief Executive Officer and
Chief Financial Officer and are reported to the Board at each Board meeting,
as well as on an ad hoc basis if requested. Until sufficient cash is generated
from its operations, the Group remains reliant on cash reserves of USD4.7
million at 31 December 2023 and the ongoing support of MidCap (borrowings of
USD6.0 million at 31 December 2023) and other lending institutions to meet its
working capital requirements, capital investment programme and other financial
commitments. Repayment of the MidCap borrowings commenced in February 2024.
In compiling the Cash Flow Projections, the Board has considered a downside
scenario regarding the effect of reduced and delayed revenues due to slower
market uptake of the Group's product offerings. The Cash Flow Projections
prepared by the Board, including the downside scenario, indicate that the
Group will still have cash reserves at the end of the forecast period. The
Group's Cash Flow Projections assume that the MidCap revolving credit facility
is available throughout the forecast period and that the term loan repayment
begins in 2024. The availability of these facilities is dependent upon
compliance with a rolling 12-month revenue covenant that is measured on a
monthly basis. The Cash Flow Projections, including the downside scenario,
indicate compliance with this covenant throughout the forecast period.
In summary, the Directors have considered their obligations in relation to the
assessment of the going concern basis for the preparation of the financial
statements of the Group and have reviewed the Cash Flow Projections, including
the downside scenario. On the basis of their assessment, they have concluded
that the going concern basis remains appropriate for use in this financial
information.
2. Critical accounting judgements and key sources of estimation uncertainty
In the application of the Group's accounting policies, the Directors are
required to make judgements, estimates and assumptions about the carrying
amounts of the assets and liabilities that are not readily apparent from other
sources. The estimates and associated assumptions are based on historical
experience and other factors that are considered to be relevant. Actual
results may differ from these estimates.
The estimates and underlying assumptions are reviewed on an ongoing basis.
Revisions to accounting estimates are recognised in the period in which the
estimate is revised if the revision affects only that period or in the period
of the revision and future periods if the revision affects both the current
and future periods.
The following are the critical judgements and estimations that the Directors
have made in the process of applying the Group's accounting policies and that
have the most significant effect on the amounts recognised in the financial
statements.
Recoverability of non-current assets
The Directors are required by IAS 36 Impairment of assets to carry out an
annual impairment review in respect of goodwill to determine whether there was
any requirement for an impairment provision in respect of the Group's goodwill
at 31 December 2023.
The carrying amount of non-current assets at 31 December 2023 was USD24.2
million (2022: USD24.0 million).
Critical judgements
The Group's non-current assets include intangible assets and goodwill arising
on the acquisition of CellRight Technologies LLC, plus certain property, plant
and machinery and right-of-use assets. It is the Directors judgement that the
recoverable amount of these assets cannot be determined individually and that
this is the smallest identifiable group of assets whose output has an active
market and which generate largely independent cash flows from other assets or
group of assets. It is, therefore, the Directors judgement that these assets
should be considered to be a single cash generating unit ('CGU'). Only the
assets included in the CGU are subject to impairment review.
Estimations
The aggregate carrying value of the CGU was assessed for impairment based on
value in use, which requires the Directors to estimate the future cash flows
expected to arise from the CGU using a suitable discount rate in order to
calculate present value. The future cash flows expected to arise were
calculated using a discount rate of 18.3% (2022: 18.3%) based on the weighted
average cost of capital.
The impairment test indicated that the recoverable amount was at least equal
to the carrying amount of the assets and, therefore, no provision for
impairment was required at 31 December 2023 (2022: nil).
The key inputs to the cash flow forecast are revenues, gross margin and
overheads, future anticipated capital expenditure and movements in working
capital. The key estimation relates to sales growth, which is inherently
difficult to forecast in a rapidly growing market, and it is possible that any
or all of these key assumptions may change, which may then impact the
estimated recoverable amount of the CGU and require a material adjustment to
the carrying value of the assets in future periods.
Leases
Critical judgements
Determining the term of a lease that includes an option to purchase requires
the Directors to use their judgement in determining whether the option is
reasonably certain to be exercised. The Directors' assessment will impact both
the determination of the lease term and the useful economic life of the asset.
In determining the term of a lease, the Directors consider all facts and
circumstances that create an economic incentive to exercise an option to
purchase a leased asset. Periods after the date of the option to purchase are
not included in the lease term if the option to purchase is reasonably certain
to be exercised.
In making their assessment, the Directors considered the potential cash
outflow arising as a result of financing the option to purchase against the
potential cost of ongoing lease payments, the potential market value of the
property, which an independent appraisal indicated would be in excess of the
fixed option exercise price, and the commercial advantages of taking
ownership and control of the property.
The Directors concluded that the option to purchase is reasonably certain to
be exercised, therefore, the lease term has been determined on this basis, and
the USD3 million cash outflow on exercise of the option has been included in
the lease liability.
Estimations
Right-of-use assets are depreciated over the shorter of the useful life of the
asset and the lease term, unless the title to the asset transfers at the end
of the lease term, in which case it is depreciated over the useful life. As a
result of the Directors assessment that the Group will exercise the option to
purchase, the assets are being depreciated over an estimated useful life of 39
years.
3. Segmental information
The following table provides disclosure of the Group's revenue by geographical
market based on the location of the customer:
2023 2022
USD'000 USD'000
US 25,327 20,711
Rest of World 4,166 3,765
29,493 24,476
Analysis of revenue by customer
During the year ended 31 December 2023, the Group had one customer who
individually exceeded 10% of revenue. This customer generated 13% of revenue
(2022: one customer who generated 13% of revenue).
Operating segments
In accordance with IFRS 8, the Group has derived the information for its
operating segments using the information used by the chief operating
decision-maker, who has been identified as the Board of Directors.
The Board of Directors has determined that the Group has three operating
segments for internal management, reporting and decision-making purposes,
namely dCELL, BioRinse and GBM-V.
Central overheads, which primarily relate to operations of the Group function,
are not allocated to an operating segment.
Revenue from all operating segments derives from the sale of biological
medical devices.
dCELL BioRinse GBM-V Central Total
2023 2023 2023 2023 2023
USD'000 USD'000 USD'000 USD'000 USD'000
Statement of Income
Revenue 6,183 20,133 3,177 - 29,493
Gross profit 2,839 10,141 1,060 - 14,040
Depreciation (4) (423) (16) (84) (527)
Amortisation - (450) - - (450)
Operating profit/(loss) 340 1,838 220 (2,792) (394)
Net finance income/(charges)
4 (1,296) - 17 (1,275)
Profit/(loss) before taxation
344 542 220 (2,775) (1,669)
Taxation 202 (190) - - 12
Profit/(loss) for the year
546 352 220 (2,775) (1,657)
dCELL BioRinse GBM-V Central Total
2022 2022 2022 2022 2022
USD'000 USD'000 USD'000 USD'000 USD'000
Statement of Income
Revenue 5,301 16,049 3,126 - 24,476
Gross profit 1,829 8,258 1,171 - 11,258
Depreciation (10) (394) - (113) (517)
Amortisation - (618) - - (618)
Operating (loss)/ profit (994) 678 409 (2,103) (2,010)
Net finance charges - (818) - - (818)
(Loss)/profit before taxation
(994) (140) 409 (2,103) (2,828)
Taxation 112 120 - - 232
(Loss)/profit for the year
(882) (20) 409 (2,103) (2,596)
dCELL BioRinse GBM-V Central Total
2023 2023 2023 2023 2023
USD'000 USD'000 USD'000 USD'000 USD'000
Statement of Financial Position
Non-current assets 1,946 21,987 6 214 24,153
Current assets 5,030 12,649 807 604 19,090
Total assets 6,976 34,636 813 818 43,243
Non-current liabilities - (9,123) - (30) (9,153)
Current liabilities (693) (3,345) (200) (497) (4,735)
Total liabilities (693) (12,468) (200) (527) (13,888)
Net assets 6,283 22,168 613 291 29,355
Capital expenditure 165 167 9 54 395
Additions to intangible assets 334 116 - - 450
dCELL BioRinse GBM-V Central Total
2022 2022 2022 2022 2022
USD'000 USD'000 USD'000 USD'000 USD'000
Statement of Financial Position
Non-current assets 1,376 22,382 13 233 24,004
Current assets 3,571 14,998 806 2,660 22,035
Total assets 4,947 37,380 819 2,893 46,039
Non-current liabilities - (8,921) - (73) (8,994)
Current liabilities (736) (5,171) (255) (482) (6,644)
Total liabilities (736) (14,092) (255) (555) (15,638)
Net assets 4,211 23,288 564 2,338 30,401
Capital expenditure 124 230 9 36 399
Additions to intangible assets 549 160 - - 709
4. Taxation
2023 2022
USD'000 USD'000
Current tax:
UK R&D tax credit (202) (112)
Foreign taxation 310 -
108 (112)
Deferred tax:
Origination and reversal of temporary differences (120) (120)
Tax credit for the year (12) (232)
The credit for the year can be reconciled to the loss per the Consolidated
Statement of Income as follows:
2023 2022
USD'000 USD'000
Loss on ordinary activities before tax (1,669) (2,828)
Loss multiplied by the standard rate of corporation tax for UK companies of
23.52% (2022: 19%)
(393) (537)
Effects of:
Research and development tax credits received
- (80)
Surrender of tax losses for R&D tax credit refund
233 104
Deduction for R&D expenditure (115) (59)
Remeasurement of deferred tax for changes in tax rates
(22) -
Adjustments in respect of prior period current and deferred tax
122 (154)
Movement in deferred tax not recognised on unutilised tax losses
175 (366)
Expenses not deductible for tax purposes 108 980
Origination and reversal of timing differences (120) (120)
Tax credit on loss for the year (12) (232)
The enacted UK corporation tax rate of 25% forms the basis for the UK element
of the deferred tax calculation following the UK budget in 2021, when the
Chancellor announced an increase to the main rate of corporation tax in the UK
to 25% from April 2023.
Unrelieved tax losses carried forward, as detailed below, have not been
recognised as a deferred tax asset as there is currently insufficient evidence
that the asset will be recoverable in the foreseeable future. The losses are
related to UK operations and must be utilised in relation to the same
operations.
2023 2022
USD'000 USD'000
Tax losses
Losses available to carry forward 60,361 58,900
Unrecognised deferred tax asset at 25% (2022: 25%)
15,090 14,725
5. Loss per Ordinary Share
Basic loss per Ordinary Share is calculated by dividing the net loss for the
year attributable to owners of the parent company by the weighted average
number of Ordinary Shares in issue during the year, excluding own shares held
jointly by the Tissue Regenix Employee Share Trust and certain employees.
Diluted loss per Ordinary Share is calculated by dividing the net loss for the
year attributable to owners of the parent company by the weighted average
number of Ordinary Shares in issue during the year adjusted for the dilutive
effect of potential Ordinary Shares arising from the Company's share options
and jointly owned shares.
The calculation of the basic and diluted loss per Ordinary Share is based on
the following data:
2023 2022
USD'000 USD'000
Losses
Losses for the purpose of basic and diluted loss per Ordinary Share being net
loss for the year attributable to owners of the parent company
(1,713) (2,695)
Number Number
Number of shares
Weighted average number of Ordinary Shares for the purpose of basic and
diluted loss per Ordinary Share
70,426,760 70,345,218
Basic and diluted, cents per share (2.43) (3.83)
The Company has options issued over 2,585,537 (2022: 2,009,293) Ordinary
Shares and warrants issued over 30,968 (2022: 30,968) Ordinary Shares, and
there are 161,128 (2022: 161,128) jointly owned shares that are potentially
dilutive.
Due to the losses incurred from continuing operations in the years reported,
there is no dilutive effect from the existing share options and jointly owned
shares.
The information shown above has been restated to reflect the share
consolidation, that became effective on 28 April 2023, in all periods
presented.
6. Lease liabilities
2023 USD'000 2022
USD'000
Current lease liabilities 184 134
Non-current lease liabilities 3,226 3,216
At 31 December 3,410 3,350
Maturity analysis of leases
The maturity of the gross contractual undiscounted cashflows due on the
Group's lease liabilities is set out below based on the period between 31
December 2023 and the contractual maturity date.
2023 USD'000 2022
USD'000
Less than 6 months 236 203
6 months to 1 year 236 203
1 year to 2 years 3,147 412
2 years to 5 years 138 3,107
3,757 3,925
The movement in lease liabilities during the year was:
2023 USD'000 2022
USD'000
At 1 January 3,350 3,482
Cash flows - financing activities - lease repayments (140) (66)
Non-cash movements - additions to right-of-use-assets 195 -
Non-cash movements - net effect of foreign exchange 5 (66)
At 31 December 3,410 3,350
Effect of leases on financial performance
2023 USD'000 2022
USD'000
Depreciation of right-of-use assets 132 164
Interest expense 284 291
416 455
The Group leases properties used for its operations in the UK and the US.
· UK land and buildings: Five-year fixed lease, which included a break
clause in 2023 not exercised.
· US land and buildings: Ten-year fixed lease, which includes an option
to purchase within the first five years, being up to November 2024.
· US property, plant and equipment: Five-year fixed leases.
The Group's average effective borrowing rate for leases at 31 December 2023
was 9% (2022: 9%).
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