Final results for the year ended 31 December 2024

Tissue Regenix Group plc

('Tissue Regenix', the 'Group' or the 'Company')

Final results for the year ended 31 December 2024

Investor presentation

Tissue Regenix Group plc (AIM: TRX), the regenerative medical devices company, announces its audited results for the year ended 31 December 2024.

Financial Highlights1

· Revenue growth for the Group of 9%

o  BioRinse® revenues increased by 4% to USD21.0m (2023: USD20.1m), driven by growth in the Group's core allograft and DBM product lines

o  dCELL® revenues increased by 23% to USD7.6m (2023: USD6.2m) as the commercial reorganisation implemented in 2022 continued to mature

· Record adjusted EBITDA profitability of USD1.9m (2023: USD0.7m)

o  This increase in adjusted EBITDA was driven by increased sales revenue and aided by management of administrative expenses to achieve operating leverage

· Gross profit of USD13.6m (2023: USD13.0m)

· Cash position at 31 December 2024 of USD1.9m (2023: USD4.7m). Undrawn debt facility to fund further growth

1 Based on the decision of the Board to divest the Company's interest in the German joint venture GBM-V, the figures in this review do not include the revenues, profits or assets of GBM-V

2 During 2024, the Group reported expenses associated with its strategic review of USD124k (2023: nil). The Group considers these expenses to be exceptional and accordingly are excluded from the calculation of Adjusted EBITDA and EBITDA

Operational Highlights

· Signed BioRinse agreements with nine new strategic partners or stocking distributors who target specialties such as the spine and dental markets

· Restructuring of the dCELL commercial business continued to provide growth opportunities and record revenues for this division

o  Added 41 new distributors for dCELL in 2024 across existing regions

· In June 2024, Tissue Regenix acquired the building in San Antonio that the Company has occupied since 2021 as part of the Phase 1 and 2 expansion plans

o  The efficiencies and changes implemented since 2020-2021 have positively impacted the Group's processing capacity requirements and needs, inducing a review of the Company's preliminary plans for the Phase 2 expansion. An approach has been identified which more closely meets the needs of how the Group processes tissue and provides flexibility to process different tissue types in a more efficient manner. The Company is in the process of finalising the new plans, with construction expected to start in 2025

· In 2024, the Group processed 34% more musculoskeletal and dermis donors than in 2023. This allowed the Company to meet the demand for finished products and support the growth of the demineralised bone matrix and DermaPure® businesses. This resulted in 13% more shipped units Y-o-Y

Post-period end

· David Cocke, Chief Financial Officer, has announced his intent to retire in 2025. David plans to remain with the Group until a replacement is identified and an orderly transition period has taken place

Jonathan Glenn, Chair of Tissue Regenix, commented: "It has been another successful year for the Group, reporting record adjusted EBITDA profitability and top line growth across all divisions. Our commitment to the 4S strategy and our growth pillars has provided a strong foundation for the business which now continues to deliver year-on-year.

"In November 2024, we announced a strategic review of the business which included soliciting offers for the Company. During this review, it was determined that the Company's valuation during this period bore no resemblance to Tissue Regenix's prospects or record of strong delivery. Despite varying degrees of interest in the Company, the equity value could not be used as a basis for a strategic transaction, and the strategic review was concluded in April 2025. The Board's priorities remain in the best interests of our shareholders, and we continue to look forward with a solid business that is constantly adapting to create greater efficiencies and deliver greater shareholder value.

"Finally, I would like to thank David for his contribution to the business over the last four years, a period in which the business has achieved profitability and consecutive record revenue growth. On behalf of the Board and the Group, I wish David all the best in his retirement."

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 2pm (BST) on Tuesday 1 July 2025. 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

For more information, please contact:

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulation ("MAR") EU no.596/2014. Upon the publication of this announcement via Regulatory Information Service ("RIS"), this inside information is now considered to be in the public domain. 

About Tissue Regenix (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 that is not rejected by the patient's body and 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.

Tissue Regenix Group plc

Chair & Chief Executive Officer's Statement

It has been another successful year for the Group, reporting record adjusted EBITDA profitability and top line growth across all divisions. Our commitment to the 4S strategy and our growth pillars has provided a strong foundation for the business which now continues to deliver year-on-year.

In November 2024, we announced a strategic review of the business which included soliciting offers for the Company. During this review, it was determined that the Company's valuation during this period bore no resemblance to Tissue Regenix's prospects or record of strong delivery. Despite varying degrees of interest in the Company, the equity value could not be used as a basis for a strategic transaction, and the strategic review was concluded in April 2025. The Board's priorities remain in the best interests of our shareholders, and we continue to look forward with a solid business that is constantly adapting to create greater efficiencies and deliver greater shareholder value.

Finally, I would like to thank David for his contribution to the business over the last four years, a period in which the business has achieved profitability and consecutive record revenue growth. On behalf of the Board and the Company, I wish David all the best in his retirement.

Jonathan Glenn

Chair

2024 performance

The Group delivered a positive performance in 2024, continuing on a growth trajectory and once again achieving profitability expectations. We saw record adjusted EBITDA profitability and 9% overall revenue growth for the Group. Our dCELL division recorded top line growth of 23% during FY2024, the lead across our divisions. This improvement was achieved through the continued adoption of our products through our strategic partners working alongside our direct distribution activities. The current economic climate, as well as general ebbs and flows of business tempered our overall growth compared to an incredibly strong three years prior, however, we will use our diversity and flexibility to continue to manage these challenges in 2025. Execution, hard work and the dedication of all the employees of the Group provided the foundation needed for our 2024 achievements and the bright future which lies ahead for Tissue Regenix.

Strategy and Growth Pillars

Our focus on the 4S strategy - Supply, Sales Revenue, Sustainability and Scale - continues to provide the solid foundation of how we operate, execute and drive growth and generate value for our shareholders.

Tissue Supply remains an area of investment and focus. It is a very dynamic market as the source and quality can vary which impacts our ability to sustain and grow our business. Supply also refers to our focus on processing capacity to supply products to customers on a timely basis. We consistently identify opportunities for efficiencies which we can employ to enhance our throughput.

Sales and Sustainability are measured through our revenue and profitability growth as well as opportunities to maximise the gift of tissue donation to improve the quality of life of patients. Scale is meeting growth expectations by expanding domestic and global opportunities with tissue in regenerative medicine. 

Our growth pillars have been defined as Base Business, Tissue Partnerships, Market Expansion and Regulatory Evolution. We believe that these growth pillars represent defined tactical activities and areas of focus which drive growth moving forward.

1. Base Business

Our core businesses with our existing and new partners/distributors through the BioRinse and dCELL product lines are the primary drivers of the business. Our customers expect a level of service, and we remain flexible and

responsive to our customer needs. We have supported growth opportunities using our existing capacity and continual focus on operational efficiencies to ensure a supply of products in existing and growing surgical specialties augmented by product enhancements. This growth will also be supported by our current infrastructure and planned capacity enhancements.

BioRinse

The BioRinse portfolio is a very diverse business which generates the bulk of our revenue, reporting sales of USD21,012K (2023: USD20,133K), driven by the U.S. spine, orthopaedics and dental markets. The 4% year on year ('YoY') divisional revenue growth did not reflect the 13% increase in unit shipments of BioRinse finished goods products as the decline in higher per unit priced Release Donor Tissue was offset by increases in our core processed/finished tissue products. We continue to see growth opportunities led by confidence in our demineralised bone matrix ('DBM'), sports medicine and dental products. We realised greater than 32% revenue growth from the prior year from these top three product groups and these portions of the business will continue to drive our growth in 2025.

In 2024, we signed BioRinse agreements with nine new strategic partners or stocking distributors who target specialties such as the spine and dental markets.

Two areas where this division encountered headwinds in 2024 and impacted overall growth were our Released Donor Tissue ('RDT') and birth tissue products. In particular, the wound care marketplace for birth tissue products experienced the greatest headwinds in 2024. Two issues have impacted this business. The first surrounds the proposed Centers for Medicare & Medicaid Services ('CMS') changes for products which will be reimbursed in the outpatient setting for diabetic and venous leg ulcers and second is what has been described as "skyrocketing cost trends" where products receiving the highest reimbursement garner distribution and customers. These issues impacted the amnion business for one of our strategic partners and resulted in a significant decrease in sales volume over the prior year, in particular during H2 2024 (H1 +11% YoY vs H2 -67% YoY). Though our amnion business in ophthalmology remains strong, we expect the wound care business to remain in flux through 2025. Our plan is to shift our resources to those segments of our business which continue to experience growth.

dCELL

In 2024, the restructuring of the dCELL commercial business continued to provide growth opportunities for this division. dCELL is a more direct business for our organisation as we sell branded products through our regional sales management team who in turn manage distributors in their respective territories. This business is highly impacted by Group Purchasing Organization approvals, so we have placed management in areas which align with our approvals. To increase our depth and breadth in regions where we already have established business, we added 41 new distributors over the year. Our direct business has a focus with orthopaedic, podiatric, plastic and general surgeons. Our partnership with ARMS Medical provides the opportunity to expand into women's health through dermis-based products addressing urogynecological procedures. Combined these efforts resulted in 23% revenue increase year on year by the end of 2024. Our dCELL division reported sales of USD7,634K (2023: USD6,183K), record revenue for this division.

During 2024, we also supported increased market acceptance of our DermaPure products through articles in clinical publications such as Foot and Ankle Orthopedics and Bioengineering. Both manuscripts highlighted the clinical advantages of using human dermal matrices processed using the dCELL technology.

The OrthoPure XT product currently is the only non-human biologic tissue graft produced using the dCELL technology and is available to the European Union ('EU') market for certain ligament reconstruction procedures. In 2024, we introduced this product into the Swiss market and made a distribution change in Germany. Our partner, Geistlich, based on their success with the products in Italy, earned the opportunity to expand their distribution. During the European Society of Sports Traumatology, Knee Surgery and Arthroscopy meeting in Milan in 2024, Geistlich hosted a lunch symposium where the initial positive Italian experiences at the Rizzoli Clinic with the OrthoPure XT were presented. The manuscript from the five-year clinical experience from the initial regulatory approval study has been completed and submitted in May 2025.

GBM-V

In December 2024, our Board took the decision that the operations of this not-for-profit German joint venture were not strategic to the operations of the business and started to consider options to divest the business. We have embraced the diversity of opportunities with various tissue products, but the not-for-profit structure and market dynamics of this joint venture have historically reduced the growth rate of the Group and reduced its profit margins whilst also requiring management resource. We will announce more on this in due course as we look to focus on our more profitable divisions.

2. Tissue Partnerships

Our focus on tissue Supply is a foundation for our own growth, as it drives our internal capacity but is also an opportunity for our organisation to provide tissue to other processors in need of specific tissue types. Any supply

volumes which exceed our internal needs creates opportunities to develop relationships with other tissue processors. In turn, we use these opportunities to obtain tissue which we may need from other processors. Historically, the tissue industry works with recovery agencies, but we have been an advocate of working with tissue processors along with recovery agencies. This is done to meet the global need for tissue products and to help ensure that the gift of human tissue donation is maximised in a timely and efficient manner.

There are definite trends for the types and quantities of tissue that may be in demand by other tissue processors and to meet this demand we constantly review and look for opportunities to work with others. In 2024, we saw a downturn in the opportunities with existing RDT customers, and the regulatory approvals needed for new outside the U.S. tissue processors were significantly delayed. As a result, for the entire year we were impacted by a 37% decline in RDT which was exacerbated in H2 2024 (H1 2024 -5% YoY; H2 2024 -68% YoY). The regulatory approval situation in the U.S. and elsewhere remains slow and the recent political changes and discussion on tariffs has not improved the situation. The uncertainty regarding tariffs has caused some customers to adopt a wait and see position prior to ordering or formalizing commitments. We do believe that as the approvals are received, we can put our RDT business back on a growth trajectory.

3. Market Expansion

We have stated that our two-pronged approach to broaden the markets for our products will encompass identifying and initiating activities in additional surgical specialties through institutions where we have an existing base business and expansion into geographic markets where there is a need for allograft tissue-based products but currently have limited availability.

Our allograft tissue business in the EU demonstrated growth ahead of expectations. This growth was partially limited by ongoing delays in obtaining regulatory approvals for exporting tissue from our EU distribution centre. We continue to identify partners in the EMEA markets and rely on their knowledge of their local markets and regulatory approval processes to continue our expansion.

Our expansion into additional surgical specialties was supported by the development of case reports which highlight the versatility of our DermaPure dermal product. Acellular dermal matrix products are used in numerous surgical specialties, but other dermal allograft products lack the benefits provided by the dCELL process used to produce DermaPure. In 2024 we developed case studies which highlighted the use of DermaPure in augmenting tissue in surgical oncology procedures such as esophagectomy and Whipple procedures, augmenting tendon repairs in the foot and ankle including Achilles lengthening, and replacing tissue lost due to spider bites and amputation repairs. We will continue to expand and demonstrate the benefits of this versatile tissue.

OrthoPure XT, our xenograft tissue device, was designed to meet the clinical need for an off-the-shelf graft for certain ACL ligament reconstruction procedures. The receipt of the CE Mark provided opportunities to distribute the product in EU markets (currently, Italy, Switzerland, Germany) and the UK. Our OrthoPure XT business demonstrated growth in 2024. The CE Mark is accepted in other markets, so we received regulatory approval to distribute this device in New Zealand and are currently establishing distribution opportunities. Our efforts to receive regulatory approval in Australia encountered regulatory delays so we are currently assessing additional approaches to this market. We will continue to identify opportunities to distribute this product in markets which recognise the CE Mark.

4. Regulatory Evolution

The bulk of our revenue comes from allograft tissue-based products which are regulated by Section 361 HCTP (Human, Cell, and Tissue Products) in the U.S. The requirements mandated for Section 361 products place limits on how the products can be produced and how they are used and marketed; 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. In 2024, we began the evolution of our processes and facility to become one that is capable of meeting medical device requirements. By the end of 2024, we had implemented the changes required to meet medical device contract manufacturing requirements for the U.S. Food and Drug Administration ('FDA'). Our next phase in 2025 will be to meet the requirements for ISO 13485 contract manufacturer requirements which is aligned with the immediate needs for our organisation. We will then make plans to be an ISO 13485 product manufacturer as we bring online products which are regulated as medical devices in the global market. A medical device registration is rare for a U.S. tissue processor of our scale. All of this is to give us the opportunity to innovate with human tissue and broaden opportunities for Tissue Regenix to distribute tissue into markets which regulate human tissue allografts as devices.

Growth highlights from our strategic partners and distributors

In 2024, growth from our hybrid commercial model was highlighted by increased demand by our internal commercial distribution, existing commercial partners, and identification of additional accounts or strategic partnerships/distributor relationships.

For BioRinse, our DBM, dental and sports medicine grafts all grew YoY in the 23 - 78% range. This was due to many factors which included our diversity of products (sports medicine, spine, general orthopaedic, dentistry), existing strategic partners, and product improvements.

For dCELL, the 23% growth was achieved by increasing our presence in existing accounts and increasing our number of distributors. The YoY revenue increase was driven primarily by the 86% increase in number of units shipped of our meshed DermaPure products and the accompanying 62% increase in revenue. Our meshed DermaPure products along with additional new products will continue to drive revenue growth for this division in 2025.

Demand for our BioRinse, dCELL and OrthoPure XT products will continue to drive our organic growth in 2025.

Operations and Planning for the Future

For our allograft tissue business, the supply of donor tissue is directly linked to our growth plans. In 2024 we adjusted our tissue intake to meet the shifts we noted in our finished goods for our commercial partners and RDT demand. Overall, we sourced 12% fewer donors than in 2023. These shifts reflected the demands for our own processing of musculoskeletal ('MS') donors and demand from other tissue processors.

In 2024, we processed 34% more MS and dermis donors to meet the demand for finished products and support the growth of our DBM and DermaPure businesses. This resulted in 13% more shipped units YoY which was reflected in the 11% more distribution orders.

Though we have additional processing headroom from our Phase 1 expansion, we initiated a review of our Phase 2 expansion needs. The efficiencies and changes we have implemented since 2020-2021 have positively impacted our processing capacity requirements and needs. In mid-2024 we presented to our Board preliminary plans for our Phase 2 expansion which differs from our previous plans. With capital efficiency and flexibility in mind, we have identified an approach where we will create an additional large clean room where we will have multiple laminar flow hoods and work areas. This approach more closely meets the needs of how we process tissue and gives us flexibility to process different tissue types in a more efficient manner. Previously we considered building additional traditional clean rooms which also comes with additional construction cost, time and operational costs. We are in the process of finalising and confirming our designs with the plan to solicit proposals and initiate construction as dictated by business need.

In June 2024, we announced the purchase of our building in Universal City, Texas, which, until then was leased as part of our Phase 1 and 2 expansion plans. We negotiated in the lease a purchase option for the building at a pre-set price through November 2024. This was a logical option as we had invested a significant amount of capital to prepare the facility for our long-term plans. The appraisal determined that the purchase option was below the fair market value of the property. Coupled with fixed interest rates and no cash down payment requirement from our lenders, these factors made it an attractive opportunity for the Company to buy the building. The mortgage payments are on par with the historic lease payments and will not be subject to standard increase clauses. The purchase makes strong financial and commercial sense for the Group as we consider our expansion plans.

Strategic Process

In November 2024, we announced that we had initiated and were conducting a review of the Company's strategic options which included soliciting offers for the Company. The Company engaged a financial adviser to contact a limited number of potential counterparties to assess whether such parties could put forward a proposal that would deliver greater value to Tissue Regenix's shareholders than pursuing a standalone independent strategy. There was no certainty that any offer would be made as a result of contact with these potential counterparties, nor as to the terms which our Board would deem reasonable in the best interests of our shareholders. Despite continued positive performance and news, the Company's valuation during this period bore no resemblance to the prospects or typical valuation for a business in this sector. The Board believed that despite varying degrees of interest in the Company, the equity value could not be used as a basis for a strategic transaction. In early April 2025, the Board determined that, based on discussions to date, an appropriate offer was not forthcoming, discussions with any interested parties were terminated and the strategic process was concluded.

Outlook

As has been widely reported, we have already seen great changes and uncertainty in 2025 in the U.S. and around the globe which have created additional political, regulatory and financial headwinds. We cannot control these elements of change, but our priority remains in delivering our existing strategies. Sales Revenue and Sustainability will continue to be the focus of our 4S's and executed through the growth pillars in 2025. The strategy has built a strong foundation, and we will continue to build from this foundation a more robust company for the future.

The BioRinse products will continue to be the dominant revenue contributor in 2025. Whilst the headwinds we encountered during the year have not ended, we are confident with our product range, our positioning and our ability to continue to grow. Growth will come from existing and new partners in spine, sports medicine and dentistry. Our dCELL business will also become a more significant contributor of growth as we develop greater penetration into the markets we currently serve and expand into other surgical specialties as clinicians become familiar with the versatility of our products. We plan to augment our inventory of donor tissue through partnerships with other processors. As we receive additional regulatory approvals, any excess inventories will be managed through distribution to other processors globally who have a need for tissue which is ready to be processed.

Growth of our geographic outreach with our human tissue dCELL and BioRinse portfolios may be tempered due to trading issues with the EU and other markets. We remain optimistic that the delayed regulatory approvals for our RDT opportunities will change for the positive. Our unique xenograft tissue product, OrthoPure XT, will continue to develop traction in existing markets and as it is introduced into additional EU markets in 2025. We also have activities associated with rationalising our cost structure to provide for additional efficiencies.

In 2025, we will complete plans to initiate our Phase 2 capacity expansion to provide more flexibility for the future. In addition to our organic growth plans, we will continue to look at other opportunities or avenues to inorganically Scale the business for additional longer-term growth.

We have a well-placed, well-resourced and well-regarded business with the right strategy in place to allow us to grow significantly in the coming years. Whilst we encountered a wide variety of events during 2024 that were in no way foreseeable, we managed our way through them with proficiency and adaptability which has allowed us to not only meet profit expectations but to place the Company in a very secure position. We are excited about the future and believe the Company is well placed to take advantage of all the opportunities in front of us.

As a final note, David Cocke, our Chief Financial Officer since January 2021, has announced his intent to retire in

2025. A formal date has yet to be determined but David plans to remain with the organisation until a replacement is identified allowing an orderly transition period. We would like to thank David for his significant contribution to the business and a further announcement will be made in due course.

Jonathan Glenn

Chair

24 June 2025

Daniel Lee

Chief Executive Officer

24 June 2025

Tissue Regenix Group plc

Financial Review

This financial review does not include the revenues, profits or assets of GBM-V which are presented as discontinued operation and disposal group held for sale in the Consolidated Statement of Income and Consolidated Statement of Financial Position respectively. Where appropriate, comparative numbers related to the Consolidated Statement of Income in respect of GBM-V have been adjusted.

Consolidated Statement of Income

Revenue

During the year ended 31 December 2024, revenue increased by 9% to USD28,646k (2023: USD26,316k).

The Group experienced growth across its key business segments for the year, as more fully described below:

· The BioRinse segment increased top-line sales by 4% to USD21,012k (2023: USD20,133k), driven by growth in our core allograft and DBM product lines.

· Revenue from the dCELL division increased by 23% to USD7,634k (2023: USD6,183k) as the commercial reorganisation implemented in 2022 continued to mature.

Cost of sales and gross profit

Gross profit for the year was USD13,621k (2023: USD12,980k). Gross margin percentage was 47% (2023: 49%).

Included in costs of sales is cost of product - USD12,377k (2023: USD11,633k) - and third-party commissions - USD2,298k (2023: USD1,703k).

Administrative expenses

During 2024, administrative expenses decreased by USD446k, or 3%, to USD13,148k (2023: USD13,594k), driven primarily by reduced staffing costs in the BioRinse segment.

Strategic Review Expenses

During 2024, the Group reported expenses associated with its strategic review of USD124k (2023: nil). The Group considers these expenses to be exceptional and accordingly are excluded from the calculation of Adjusted EBITDA and EBITDA

Adjusted EBITDA

During 2024, the Group reported adjusted EBITDA of USD1,879k (2023: USD689k). This increase in adjusted EBITDA was driven by increased sales revenue, gross profit and aided by management of administrative expenses to achieve operating leverage. In 2024, EBITDA was USD1,516k (2023: USD347k) and is adjusted for share- based payments of USD363k (2023: USD342k).

Finance income/charges

Finance income of USD10k (2023: USD26k) primarily represented interest earned on cash deposits. Finance charges for the year were reported at USD923k (2023: USD1,301k) and related primarily to interest charges and associated costs in respect of the MidCap Financial Trust ('MidCap') loan arrangement. Finance charges in 2023 included USD248k relating to a financing fee associated with the former MidCap loan termination.

Loss for the year

The loss for the year was USD681k (2023: loss: USD1,657k), resulting in a basic loss per share of 0.96 cents (2023: loss per share: 2.43 cents).

Adjusting for the impact of discontinued operations on the loss for the year, the loss for the year from continuing operations was USD853k (2023: USD1,877k), resulting in a basic loss per share of 1.20 cents (2023: loss per share 2.67 cents). The reduction in the loss for the year was driven by the increase in sales revenue, gross profit and lower administrative and finance expenses.

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 2024, a refund of USD190k was receivable (2023: USD352k). The year-on-year reduction was a result of the continued transition into commercial activities and away from research and development activities.

Income tax payable in the U.S. amounted to USD630k (2023: USD310k). Gross tax losses carried forward in the UK were USD60,898k (2023: USD60,361k). 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.

Consolidated Statement of Financial Position

As at December 2024, the Group had net assets of USD29,056k (2023: USD29,355k), of which cash in hand totalled USD1,870k (2023: USD4,650k).

Inventory levels increased 35% at USD14,006k (2023: USD10,358k) as the headwinds faced in our RDT business led to a build-up of certain tissue types.

Intangible assets increased to USD15,767k (2023: USD15,135k) in the year. A further USD770k of development costs, relating primarily to clinical research and systems development, were capitalised in the year (2023: USD450k). The balance of movements in this account relate to amortisation, exchange adjustments and reclassification from property, plant and equipment.

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 2024.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 2024 (2023: USD nil). See notes 4 and 15.

Working capital increased in the year to USD13,245k (2023: USD9,705k), driven by an increase in inventory as noted in the discussion of inventory levels above, slightly offset by an increase in trade and other payables. The Consolidated Statement of Financial Position includes income tax receivable of USD190k (2023: USD352k) in respect of UK research and development tax credits.

Loans and borrowings

Borrowings include the USD7,249k debt facility from MidCap (2023: USD5,985k). The USD3,030k borrowings relates to the Group's purchase of its former leasehold property in San Antonio in June 2024 (2023: USD3,410k in respect of all leases). The MidCap debt facility includes USD1,542k in respect of the term loan and USD5,829k in respect of the revolving credit facility, net of USD122k 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. In June 2024 the Group exercised an option to increase the revolving credit facility to USD6,000k. In February 2025 another option was exercised to increase the revolving credit facility to USD7,000k. Repayment of the term loan in equal instalments commenced in February 2024. See Note 21.

Dividend

No dividend has been proposed for the year to 31 December 2024 (2023: nil).

Accounting policies

The Group's consolidated financial information has been prepared in accordance with UK-adopted International Accounting Standards ('UK-adopted IAS'). The Group's significant accounting policies, which have been applied consistently throughout the year, are set out on pages 45 to 53.

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 2026 (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 USD1.9 million at 31 December 2024 and the ongoing support of MidCap (borrowings of USD7.4 million at 31 December 2024 with USD3.0 million additional credit available from February 2025), and other lending institutions (borrowings of USD3.0 million at 31 December 2024) to meet its working capital requirements, capital investment programme and other financial commitments.

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 and other credit facilities are available throughout the forecast period. The availability of the MidCap facility is dependent upon compliance with a rolling 12-month revenue covenant that is measured on a monthly basis. The other credit facility contains a debt service covenant related to the CellRight Technologies, LLC business unit which is measured on an annual basis. The Cash Flow Projections, including the downside scenario, indicate compliance with these covenants 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 these financial statements.

Principal risks and uncertainties

The principal risks and uncertainties facing the Group are set out on pages 13 to 15.

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

24 June 2025

Tissue Regenix Group plc

.

Tissue Regenix Group plc

Consolidated Statement of Financial PositionAs at 31 December 2024

The consolidated financial statements were approved by the Board of Directors and authorised for issue on 24 June 2025 and are signed on its behalf by:

Daniel Lee

Chief Executive Officer

Tissue Regenix Group plc

Tissue Regenix Group plc

Tissue Regenix Group plc

1. Corporate information

Tissue Regenix Group plc (the 'Company' and, together with its subsidiaries, the 'Group') is a public company limited by shares, domiciled and incorporated in England and Wales under the Companies Act 2006. Its registered number is 05969271.

The address of the registered office is Unit 3, Phoenix Court, Lotherton Way, Garforth LS25 2GY.

The nature of the Group's operations and its principal activity is that of an international medical technology company focused on commercialising two platform technologies, dCELL, addressing soft tissue needs, and BioRinse, providing sterile bone and soft tissue allografts.

2. Adoption of new and revised standards

Standards adopted during the year

The Group has adopted all of the new or amended Accounting Standards and interpretations issued by the International Accounting Standards Board ('IASB') that are mandatory and relevant to the Group's activities for the current reporting period.

The following new and revised Standards have been adopted but have not had any material impact on the amounts reported in these financial statements:

Amendments to IAS 1 - Classification of liabilities as current or non-current

Amendments to IFRS 16 - Lease liability in a sale and leaseback

Amendments to IAS 1 - Non-current liabilities with covenants

Amendments to IAS 7 and IFRS 7 - Supplier finance arrangements

Standards issued but not yet effective

Any new or amended Accounting Standards or interpretations that are not yet mandatory (and in some cases, had not yet been endorsed by the UK Endorsement Board) have not been early adopted by the Group for the year ended 31 December 2024. They are as follows:

Amendments to IAS 21 - Lack of exchangeability

Amendments to IFRS 10 and IAS 28 - Sale or contribution of assets between an investor and its associate or joint venture

IFRS 18 - Presentation and disclosures in financial statements

IFRS 19 - Subsidiaries without public accountability: disclosures

Amendments to the SASB standards to enhance their international applicability

Amendments to IFRS 9 and IFRS 7 regarding the classification and measurement of financial instruments

Annual improvements to IFRS accounting standards - Volume 11

IFRS S1 - General requirements for disclosure of sustainability - related financial information

IFRS S2 - Climate-related disclosures

The Directors have not yet considered the impact adoption of these Standards or interpretations in future periods will have on the financial statements of the Company or the Group.

3. Significant accounting policies

Basis of preparation

The financial statements have been prepared in accordance with UK-adopted International Accounting Standards and with the requirements of the Companies Act 2006 as applicable to companies reporting under those standards.

The financial statements have been prepared on the historical cost basis. Historical cost is generally based on the fair value of the consideration given in exchange for assets.

The financial statements are presented in United States dollars ('USD'). All amounts have been rounded to the nearest thousand, unless otherwise indicated.

As described below, the Directors continue to adopt the going concern basis in preparing the consolidated and the Company financial statements.

The accounting policies set out below have, unless otherwise stated, been applied consistently to all periods presented in these financial statements.

The preparation of the financial statements in compliance with UK-adopted International Accounting Standards requires management to make estimates and the Directors to exercise judgement in applying the Group's accounting policies. The significant judgements made by the Directors in the application of these accounting policies that have a significant impact on the financial statements and the key sources of estimation uncertainty are disclosed in note 4.

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 2026 (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 USD1.9 million at 31 December 2024 and the ongoing support of MidCap (borrowings of USD7.4 million at 31 December 2024 with USD3.0 million additional credit available from February 2025), and other lending institutions (borrowings of USD3.0 million at 31 December 2024) to meet its working capital requirements, capital investment programme and other financial commitments.

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 and other credit facilities are available throughout the forecast period. The availability of the MidCap facility is dependent upon compliance with a rolling 12-month revenue covenant that is measured on a monthly basis. The other credit facility contains a debt service covenant related to the CellRight Technologies, LLC business unit which is measured on an annual basis. The Cash Flow Projections, including the downside scenario, indicate compliance with these covenants 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 these financial statements.

Basis of consolidation

The consolidated financial statements incorporate the financial statements of the Company and its subsidiary undertakings (together 'the Group') made up to 31 December each year.

Subsidiary undertakings are those entities controlled directly or indirectly by the Company. Control is achieved when the Company is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power over the entity. In assessing control, the Group takes into consideration potential voting rights. The acquisition date is the date on which control is transferred to the acquirer. The financial results of subsidiaries are included in the consolidated financial statements from the date that control commences until the date that control ceases. Losses applicable to the non-controlling interests in a subsidiary are allocated to the non-controlling interests even if doing so causes the non-controlling interests to have a deficit balance.

Transactions eliminated on consolidation

Intra-group balances and transactions, and any unrealised income and expenses arising from intra-group transactions, are eliminated.

Non-controlling interest

Non-controlling interests are measured at their proportionate share of the acquiree's identifiable net assets at the date of acquisition. Changes in the Group's interest in a subsidiary that do not result in a loss of control are accounted for as equity transactions. Losses applicable to the non-controlling interests are allocated to the non-controlling interests even if doing so causes the non-controlling interests to have a deficit balance.

Controlled joint venture

In January 2016, the Group entered a joint venture establishing GBM-V GmbH, a company incorporated in Germany. The Group controls the majority of the voting rights, and, consequently, the results for this entity are consolidated in full within these financial statements with the recognition of a non-controlling interest within equity.

Goodwill

Goodwill arising on the acquisition of a subsidiary undertaking is the difference between the fair value of the consideration payable and the fair value of the identifiable assets, liabilities and contingent liabilities acquired. Goodwill is tested annually for impairment as described below.

Foreign currencies

The individual financial statements of each component entity are presented in the currency of the primary economic environment in which the entity operates (the 'functional currency'). For the purposes of the consolidated financial statements, the results and the financial position of each Group entity are expressed in USD, which is the presentation currency for the consolidated financial statements.

In preparing the financial statements of the individual companies, transactions in currencies other than the functional currency of each group company ('foreign currencies') are translated into the functional currency at the rates of exchange prevailing on the dates of the transactions. At each reporting date, monetary assets and liabilities that are denominated in foreign currencies are retranslated into the functional currency at the rates prevailing on the reporting date. Non-monetary assets and liabilities carried at fair value that are denominated in foreign currencies are translated at the rates prevailing at the date when the fair value was determined. Non-monetary items that are measured in terms of historical cost in a foreign currency are not retranslated.

Foreign exchange differences are recognised in the profit or loss in the period in which they arise, except for foreign exchange differences on monetary items receivable from or payable to a foreign operation for which settlement is neither planned nor likely to occur and which, therefore, form part of the net investment in the foreign operation. Foreign exchange differences arising on the translation of the Group's net investment in foreign operations are recognised within the cumulative translation reserve via the statement of other comprehensive income. On disposal of foreign operations and foreign entities, the cumulative translation differences are recognised in the income statement as part of the gain or loss on disposal.

For the purpose of presenting company and consolidated financial statements, the assets and liabilities of the Company, and the Group's component entities that have a functional currency other than USD, are translated using exchange rates prevailing at the end of each reporting period. Income and expense items are translated at the average exchange rates for the period unless exchange rates fluctuate significantly during that period, in which case the exchange rates at the date of transactions are used. Foreign exchange differences arising, if any, are recognised in other comprehensive income and accumulated in equity. Equity items are translated at the exchange rates at the date of transactions, and foreign exchange differences arising, if any, are accumulated directly in equity.

On the disposal of a foreign operation (e.g. a disposal of the Group's entire interest in a foreign operation, a disposal involving loss of control over a subsidiary that includes a foreign operation or a loss of joint control over a jointly controlled entity that includes a foreign operation), all of the accumulated exchange differences in respect of that operation attributable to the Group are reclassified to profit or loss. Where there is no change in the proportionate percentage interest in an entity then there has been no disposal or partial disposal, and accumulated exchange differences attributable to the Group are not reclassified to profit or loss.

Fair value adjustments arising on the acquisition of a foreign operation are treated as assets and liabilities of the foreign operation and translated at the rate of exchange prevailing at the end of each reporting period. Exchange differences arising are recognised in equity.

Research and development

Research costs are charged to profit and loss as they are incurred. An intangible asset arising from development expenditure on an individual project is recognised only when all of the following criteria can be demonstrated:

· It is technically feasible to complete the product, and management is satisfied that appropriate regulatory hurdles have been or will be achieved.

· Management intends to complete the product and use or sell it.

· There is an ability to use or sell the product.

· It can be demonstrated how the product will generate probable future economic benefits.

· Adequate technical, financial and other resources are available to complete the development or use or sell the product.

· Expenditure attributable to the product can be reliably measured.

Such intangible assets are amortised on a straight-line basis from the point at which the assets are ready for use over the period of the expected benefit and are reviewed for an indication of impairment at each reporting date. Other development costs are charged against profit or loss as incurred since the criteria for capitalisation are not met.

The costs of an internally generated intangible asset comprise all directly attributable costs necessary to create, produce and prepare the asset to be capable of operating in the manner intended by management. Directly attributable costs include employee costs incurred on technical development, testing and certification, materials consumed and any relevant third-party costs. The costs of internally generated developments are recognised as intangible assets and are subsequently measured in the same way as externally acquired intangible assets. The assets are reviewed for indicators of impairment, but they are not amortised until completion of the development project.

Property, plant and equipment and right-of-use assets

Property, plant and equipment assets are stated at their historical cost of acquisition less any provision for depreciation or impairment.

Depreciation is provided on all property, plant and equipment assets at rates calculated to write each asset down to its estimated residual value evenly over its expected useful life, as follows:

Buildings over 39 years

Laboratory equipment over 5-7 years

Computer equipment over 3 years

Fixtures and fittings over 5 years

Land is not depreciated.

A right-of-use asset is recognised at commencement of the lease and initially measured at the amount of the lease liability plus any incremental costs of obtaining the lease and any lease payments made when or before the leased asset is available for use by the Group. The right-of-use asset is subsequently measured at cost less accumulated depreciation and any accumulated impairment losses. 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.

Intangible assets

Intangible assets are stated at fair value at acquisition. They are subsequently held at cost less any provision for impairment or amortisation. Intangible assets are amortised through administrative expenses within the income statement over their expected useful life as follows:

Trademarks over 5 years

Customer relationships over 10 years

Process and information technology over 10 years

Supplier agreements over 5 years

Impairment of property, plant and equipment, right-of-use and intangible assets

At each reporting date, the Group reviews the carrying amounts of its property, plant and equipment and right-of-use assets to determine whether there is any indication that those assets have suffered an impairment loss. If any such indication exists, the recoverable amount of the asset is estimated in order to determine the extent of the impairment loss (if any).

In respect of goodwill and intangible assets with an indefinite life, the Group performs an annual impairment review as required by IAS 36.

For the purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units ('CGUs')).

Discounted cash flow valuation techniques are generally applied for assessing recoverable amounts using Board- approved forward-looking cash flow projections and terminal value estimates, together with discount rates appropriate to the risk of the related CGUs.

If the recoverable amount of an asset is estimated to be less than its carrying amount, the carrying amount of the asset is reduced to its recoverable amount. An impairment loss is recognised as an expense immediately.

Inventories

Inventories are recognised at the lower of cost and net realisable value. Cost is determined using the first in, first out method and represents the purchase cost, including transport, for raw materials, together with a proportion of manufacturing overheads based on normal levels of activity for work in progress and finished goods. In cases where monetary amounts cannot be observed directly, judgements and assumptions are used to arrive at accounting estimates. The effect of any change in an accounting estimate is recognised by adjusting the carrying amount of inventory in the period of change.

Appropriate provisions for estimated irrecoverable amounts are recognised in the income statement when there is objective evidence that the assets are impaired.

Non-current assets or disposal groups classified as held for sale

Non-current assets, or disposal groups comprising assets and liabilities are classified as held for sale if their carrying amount will be recovered principally through a sale transaction rather than through continued use. For non-current assets or assets of disposal groups to be classified as held for sale, they must be readily available for immediate sale in their present condition and their sale must be highly probable.

Such assets or disposal groups are generally measured at the lower of their carrying amount and fair value less costs of disposal.

An impairment loss is recognised for any initial or subsequent write down of the non-current assets and assets of disposal groups to fair value less costs of disposal. A gain is recognised for any subsequent increase in fair value less costs of disposal but not in excess of any cumulative impairment previously recognised.

Once classified as held for sale, intangible assets and property, plant and equipment are no longer amortised or depreciated. Interest and other expenses attributable to the liabilities of assets held for sale continue to be recognised.

Non-current assets classified as held for sale, and the assets of disposal groups classified as held for sale are presented separately on the face of the Statement of Financial Position, in current assets. When applicable, the liabilities of disposal groups classified as held for sale are presented separately on the face of the Statement of Financial Position, in current liabilities.

Share-based payments

Share options

Equity settled share-based payment transactions are measured with reference to the fair value at the date of grant, recognised on a straight-line basis over the vesting period, based on management's estimate of shares that will eventually vest. The fair value of options is measured using a binomial model where the performance conditions of grants are market-based, the Monte Carlo model where there are multiple performance conditions and the Black-Scholes model where there are non-market related performance conditions. See note 26 for more information on performance conditions.

At each reporting date before vesting, the cumulative expense is calculated, representing the extent to which the vesting period has expired and management's best estimate of the achievement or otherwise of non-market conditions and the number of equity instruments that will ultimately vest. The movement in cumulative expense since the previous reporting date is recognised in the Consolidated Statement of Income, with a corresponding entry in equity.

The grant by the Company of options and share-based compensation plans over its equity instruments to the employees of subsidiary undertakings in the Group is treated as a capital contribution. The fair value of employee services received, measured by reference to the grant date fair value, is recognised over the vesting period as an increase to investment in subsidiary undertakings, with a corresponding credit to equity in the parent entity accounts.

Jointly held shares

Where an employee acquires an interest in shares in the Company jointly with the Tissue Regenix Employee Share Trust, the fair value of the option at the purchase date is recognised on a straight-line basis over the vesting period. The fair value benefit is measured using a binomial valuation model, considering the terms and conditions upon which the jointly owned shares were purchased.

Financial assets and liabilities

Recognition of financial assets and financial liabilities

Financial assets and financial liabilities are recognised on the Group's Statement of Financial Position when the Group becomes a party to the contractual provisions of the instrument and are initially measured at fair value. Transaction costs are included as part of the initial measurement, except for financial assets measured at fair value through profit or loss.

Financial assets are subsequently measured at either amortised cost or fair value depending on their classification. Classification is determined based on both the business model within which such assets are held and the contractual cash flow characteristics of the financial asset unless an accounting mismatch is being avoided.

Financial liabilities are subsequently measured at either amortised cost or fair value.

Derecognition of financial assets and financial liabilities

The Group derecognises a financial asset only when the contractual rights to cash flows from the asset expire or it transfers the financial asset and substantially all the risks and rewards of ownership of the asset to another entity. If the Group neither transfers nor retains substantially all the risks and rewards of ownership and continues to control the transferred asset, the Group recognises its retained interest in the asset and an associated liability for the amount it may have to pay. If the Group retains substantially all the risks and rewards of ownership of a transferred financial asset, the Group continues to recognise the financial asset and also recognises a collateralised borrowing for the proceeds received.

On derecognition of a financial asset or financial liability, a gain or loss is recognised in profit or loss.

Impairment of financial assets

The Group recognises a loss allowance for expected credit losses on financial assets that are measured at amortised cost. The measurement of the loss allowance depends upon management's assessment at the end of each reporting period as to whether the financial instrument's credit risk has increased significantly since initial recognition, based on reasonable and supportable information that is available without undue cost or effort to obtain.

Where there has not been a significant increase in exposure to credit risk since initial recognition, a 12-month expected credit loss allowance is estimated. This represents a portion of the asset's lifetime expected credit losses that is attributable to a default event that is possible within the next 12 months. Where a financial asset has become credit impaired or where it is determined that credit risk has increased significantly, the loss allowance is based on the asset's lifetime expected credit losses. The amount of expected credit loss recognised is measured on the basis of the probability-weighted present value of anticipated cash shortfalls over the life of the instrument discounted at the original effective interest rate.

Trade and other receivables

Trade and other receivables do not carry any interest and are initially recognised at fair value. They are subsequently measured at amortised cost using the effective interest rate method less any provision for impairment.

An expected credit loss ('ECL') model, as introduced under IFRS 9, broadens the information that an entity is required to consider when determining its expectations of impairment. Under this model, expectations of future events must be taken into account, and this will result in the earlier recognition of larger impairments against trade and other receivables.

In applying the ECL model management considers the probability of a default occurring over the contractual life of its trade receivables balances on initial recognition of those assets.

Impairment provisions are recognised for the Group as follows, representing the expected credit losses over the contracted life of these balances:

Not overdue 0% of aged receivables

0 - 3 months overdue 0% of aged receivables

3 - 4 months overdue 25% of aged receivables

4 - 5 months overdue 50% of aged receivables

Over 5 months overdue 100% of aged receivables

Trade and other payables

Trade and other payables are not interest-bearing and are initially recognised at fair value. They are subsequently measured at amortised cost using the effective interest method.

Borrowings

Borrowings are interest-bearing and are initially recognised at fair value less the directly attributable costs of issue. They are subsequently measured at amortised cost using the effective interest method.

Cash and cash equivalents

Cash and cash equivalents comprise cash at hand and deposits on a term of not greater than three months. The Group places its funds with financial institutions with an A rating or higher.

Equity instruments

An equity instrument is any contract that evidences a residual interest in the assets of the Group after deducting all of its liabilities. Equity instruments issued by the Group are recognised at the proceeds received, net of direct issue costs.

The costs of an equity transaction are accounted for as a deduction from equity to the extent that they are incremental costs directly attributable to the equity transaction that would otherwise have been avoided.

Leases

On commencement of a contract that gives the Group the right to use assets for a period of time in exchange for consideration, the Group recognises a right-of-use asset and a lease liability unless the lease qualifies as a 'short-term' lease (where the term is 12 months or less with no option to purchase the leased asset) or a 'low-value' lease (where the underlying asset is USD5,000 or less when new).

The lease liability is initially measured at the present value of the lease payments during the lease term discounted using the interest rate implicit in the lease or the incremental borrowing rate if the interest rate implicit in the lease cannot be readily determined. The lease term is the non-cancellable period of the lease plus extension periods that the Group is reasonably certain to exercise and termination periods that the Group is reasonably certain not to exercise. Lease payments include fixed payments less any lease incentives receivable, variable lease payments dependent on an index or a rate and any residual value guarantees.

The lease liability is subsequently increased for a constant periodic rate of interest on the remaining balance of the lease liability and reduced for lease payments. Interest on the lease liability is recognised in profit or loss. Variable lease payments not included in the measurement of the lease liability, as they are not dependent on an index or rate, are recognised in profit or loss in the period in which the event or condition that triggers those payments occurs.

Taxation

Tax on the profit or loss for the year comprises current and deferred tax. Tax is recognised in the Statement of Income except to the extent that it relates to items recognised directly in equity or other comprehensive income, in which case it is recognised directly in equity or other comprehensive income.

Current tax is the expected tax payable or receivable on the taxable income or loss for the year, using tax rates enacted or substantively enacted at the Statement of Financial Position date, and any adjustment to tax payable in respect of previous years.

Deferred tax is provided on temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. The following temporary differences are not provided for: the initial recognition of goodwill, the initial recognition of assets or liabilities that affect neither accounting nor taxable profit other than in a business combination and differences relating to investments in subsidiaries to the extent that they will probably not reverse in the foreseeable future. The amount of deferred tax provided is based on the expected manner of realisation or settlement of the carrying amount of assets and liabilities, using tax rates enacted or substantively enacted at the Statement of Financial Position date.

Revenue

Revenue is measured as the fair value of the consideration received or receivable in exchange for transferring goods to a customer, net of discounts, VAT and other sales-related taxes. The Group recognises revenue when it transfers control over a good or service to a customer. In some instances, for a small proportion of the business, goods are held by third parties (e.g. hospitals) and revenue is recognised upon utilisation within surgical procedures.

Bill-and-hold sales

The Group has bill-and-hold arrangements with customers, and this revenue is recognised when the Group considers that performance obligations have been met and they meet the following criteria:

· The reason for the bill-and-hold arrangement must be substantive (usually, the arrangement has been requested by the customer to facilitate their shipping arrangements).

· The product must be identified separately as belonging to the customer (that is, it cannot be used to satisfy other orders).

· The product must be ready for physical transfer to the customer.

· The Group cannot have the ability to use the product or direct it to another customer.

Strategic review expenses

Strategic review expenses comprise all expenditure incurred in respect of projects undertaken by management for the development of strategic plans for the Group. This includes any associated third-party professional adviser costs, and all such costs would be incremental to the Group's usual administrative costs.

Segmental reporting

Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision-maker. The chief operating decision-maker, who is responsible for allocating resources and assessing the performance of the operating segments and making strategic decisions, has been identified as the Board of Directors.

Discontinued operations

A discontinued operation is a component of the Group's business, the operations and cash flows of which can be clearly distinguished from the rest of the Group, and which:

· Represents a separate major line of business or geographical area of operations;

· Is part of a single co-ordinated plan to dispose of a major separate line of business or geographic area of operations; or

· Is a subsidiary acquired exclusively with a view to resale.

Classification as a discontinued operation occurs at the earlier of disposal or when the operation meets the criteria to be classified as held for sale.

The results of discontinued operations are presented separately on the face of profit or loss and other comprehensive income. The comparative statement of profit or loss and other comprehensive income is re-presented as if the operation had been discontinued from the start of the comparative year.

4. Critical accounting judgements and key sources of estimation uncertainty

In the application of the Group's accounting policies, which are described in note 3, 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 2024.

The carrying amount of non-current assets at 31 December 2024 was USD24.1 million (2023: USD24.2 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% (2023: 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 2024 (2023: nil). See note 15.

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.

Inventory

Critical judgements

Inventories are recognised at the lower of cost and net realisable value. Cost is determined using the first in, first out method and represents the purchase cost, including transport, for raw materials, together with a proportion of manufacturing overheads based on normal levels of activity for work in progress and finished goods. At 31 December 2024, the Directors made a judgement with regard to the costs used in determining the value of the Group's inventory, and determined that certain costs not previously included should now form part of the carrying amount of inventory.

Estimates

The effect of any change in an accounting estimate is recognised by adjusting the carrying amount of inventory in the period of change, and the total impact at 31 December 2024 was to increase the carrying value of inventory by USD1.3 million.

Classification and recoverability of a disposal group

Critical judgements

At 31 December 2024, the Directors had undertaken an active plan to dispose of its controlling interest in the assets and liabilities of GBM-V GmbH. The Directors consider that the net assets are available for immediate sale in their present condition, and that a sale is highly probably within twelve months. As a result, the Directors consider the assets and liabilities meet the definition of a disposal group held for sale under IFRS 5 and have reclassified them as such at 31 December 2024. See note 19.

Estimates

In accordance with the measurement criteria of IFRS 5, the disposal group held for sale has been measured at the lower of its carrying amount and fair value less costs to sell. The Directors have based their estimation of fair value on indicative offers received to date and the offer most likely to proceed to completion. As a result, no impairment loss was recognised on classification as a disposal group held for sale.

Discontinued operations

Critical judgements

GBM-V GmbH is considered to represent a component of the Group which represents a separate geographical area of operations and whose cash flows can be clearly distinguished from the rest of the Group. The Directors, therefore, consider that it meets the criteria of IFRS 5 to be presented as discontinued operations at the time the assets and liabilities meet the criteria to be classified as held for sale.

Discontinued operations have been presented as a single amount on the face of the Consolidated Statement of Income and Statement of Comprehensive Income. The Consolidated Statement of Income and Statement of Comprehensive Income for the prior period has been restated to conform to this presentation. See note 11.

5. Segmental information

The following table provides disclosure of the Group's revenue by geographical market based on the location of the customer:

Analysis of revenue by customer

During the year ended 31 December 2024, the Group had one customer who individually exceeded 10% of revenue. This customer generated 23% of revenue (2023: 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.

Subsequent to the operations of GBM-V being classified as discontinued operations, the Board of Directors has determined that the Group has two operating segments for internal management, reporting and decision-making purposes, namely dCELL and BioRinse.

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.

Refer to the Business Overview on page 2 for more details on the Group's operating segments and operations.

Segmental information is presented below.

6. Finance income

7. Finance charges

8. Loss on ordinary activities before taxation

The loss before taxation for the year has been arrived at after charging:

*Strategic review expenses relate to costs incurred in respect of the Boards review of the Company's strategic options as announced in November 2024. It includes associated third-party professional adviser costs which are incremental to the Group's usual administrative costs.

9. Staff costs

The average monthly number of employees (including Directors) was:

Their aggregate remuneration comprised:

Included within wages and salaries are other staff benefits provided to employees. The cost of providing these benefits is USD0.6 million (2023: USD0.6 million).

Included within group salaries is USD38,824 capitalised to development costs, and USD0.6 million included within the carrying value of inventory.

Refer to the Directors' Remuneration Report for details regarding the remuneration of the highest paid Director and the total amounts for Directors' remuneration in accordance with Schedule 5 to the Accounting Regulations.

10. Taxation

The charge/(credit) for the year can be reconciled to the loss per the Consolidated Statement of Income as follows:

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.

11. Discontinued operations

During the year ended 31 December 2024, the Board took the decision that the operations of the Group's not-for-profit joint venture, GMB-V, were not strategic to the operation of the business and were, therefore, committed to a plan to sell the operations or group of assets, and an active programme to locate a buyer and complete a sale was undertaken.

The operations of GMB-V have been presented as discontinued operations for the year ended 31 December 2024. A single amount is presented on the face of the Consolidated Statement of Income, comprising the post-tax result of discontinued operations. The Consolidated Statement of Income for the prior period has been restated to conform to this presentation.

The results of the discontinued operations, which have been included in the Consolidated Statement of Income for the year ended 31 December 2024, were as follows:

During the year, the discontinued operations contributed USD59,567 inflow (2023: USD129,678 inflow to the Group's net cash inflow) to the Group's net cash outflow from operating activities, USD6,056 (2023: USD9,056) to outflow from investing activities and USD nil (2023: nil) to net cash inflow from financing activities.

 12. 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.

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 calculation of the basic and diluted loss per Ordinary Share is based on the following data:

The Company has options issued over 2,532,440 (2023: 2,585,537) Ordinary Shares and warrants issued over 30,968 (2023: 30,968) Ordinary Shares, and there are 161,128 (2023: 161,128) jointly owned shares that are potentially dilutive. See note 26.

13. Property, plant and equipment

Property, plant and equipment with a carrying amount of USD5.2 million (2023: USD5.7 million) have been pledged to secure borrowings of the Group. The Group is not permitted to pledge these assets as security for other borrowings or to sell them to another entity.

Reclassification

During the year ended 31 December 2024, certain assets previously classified as computer equipment were reclassified as intangible assets. See note 15.

Option to purchase

In June 2024, the Group exercised an option to purchase 1740 Universal City Boulevard, San Antonio, a property previously held as a right-of-use asset under the terms of a lease. The cost and accumulated depreciation of the building have been reclassified from right-of-use assets. See note 14.

The carrying value of the property at 31 December 2024 was USD2.9 million on which the Bank of San Antonio has a first lien security interest, Universal City Business Park LLC has a second lien security lien and MidCap holds a third lien security interest. See note 21.

14. Right-of-use assets

Option to purchase

At 31 December 2023, the Group had a ten-year fixed lease over US land and buildings, which included an option to purchase within the first five years, being up to November 2024. 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. As a result, the Directors decided that it would be beneficial to exercise the option to purchase and this was completed in June 2024. The cost and accumulated depreciation of the building have been reclassified as property, plant and equipment. See note 13.

15. Intangible assets

Development costs represent expenditure on clinical evaluation studies relating to the Group's products. The assets are reviewed for indicators of impairment but are not amortised until completion of the development project.

Computer software represents third-party purchased software which is amortised over 3 years, and software development costs which are reviewed for indicators of impairment but are not amortised until completion of the development project.

Goodwill, customer relationships, trademarks, process and information technology and supplier agreements relate to the acquisition of CellRight Technologies LLC in 2017.

Goodwill represents the excess of the consideration paid over the fair value of the assets acquired.

Customer relationships represent the fair value attributed to the customer base existing on acquisition. The carrying value of these assets is USD0.8 million, and the remaining useful life is 2.6 years.

Trademarks relate to registered trademarks acquired in the acquisition, which have now been amortised in full.

Process and information technology represent the fair value attributed to in-house developed technology for each product group, 'trade secrets' and in-house developed information technology. The carrying value of these assets is USD0.4 million, and the remaining useful life is 2.6 years.

Supplier agreements relate to agreements for the supply of human tissue, which have now been amortised in full.

The assets acquired on the acquisition of CellRight Technologies are subject to annual impairment testing as described below.

Reclassification

During the year ended 31 December 2024, certain assets previously classified as property, plant and equipment were reclassified as intangible assets. See note 13.

Impairment of intangible assets

The Group considers the assets arising on the acquisition of CellRight Technologies LLC to be a single CGU and tests for impairment on an annual basis, or more frequently where there are any indicators of impairment. The aggregate carrying value is compared against the expected recoverable amount of the unit by reference to the present value of the future net cash flow expected to be derived from the asset, its value in use.

Value in use is estimated based on future cash flow discounted to present value using a pre-tax discount rate of 18.3% (2023: 18.3%), which still reflects increases in the risk-free interest rate inherent in the calculation of the weighted average cost of capital. An impairment charge arises where the carrying value exceeds the value in use.

The inputs into cash flow forecasts are based on the most recent budgets/forecasts approved and reviewed by the Directors for the following year, extended forward for the next four years based on expected growth within the CGU over that period. At the end of year five, a terminal value is calculated using a long-term growth assumption of 2% (2023: 2%).

The key inputs to the cash flow forecasts are:

· revenues (based on estimates of revenue growth with both new and existing customers based on an understanding of the needs of those customers and having regard to independent market assessments of market growth);

· gross margin and overheads (based on existing gross margins and adapted for appropriate increases based on the anticipated growth of the business);

· future anticipated capital expenditure (adjusted based on expected future growth); and

· movements in working capital.

The key assumption within the cash flow forecasts relates to sales growth which is inherently difficult to forecast in a rapidly growing market. Across the five-year forecast period, the compound annual growth rate ('CAGR') is 16.8% (2023: 20.5%).

At 31 December 2024, the impairment test prepared by the Directors indicates a recoverable amount based on value in use of USD74 million (2023: USD68.2 million) compared with a CGU carrying amount of USD33.5 million (2023: USD32.6 million). The Directors, therefore, do not consider that an impairment charge is appropriate for the year ended 31 December 2024 (2023: nil). However, in drawing this conclusion, the Directors note the importance of achieving the anticipated CAGR and have calculated that an impairment arises in the event that the CAGR falls to 5.2% (2023: 12.4%) across the five-year period.

16. Inventory

Inventory of finished goods, including goods for resale, is presented net of a provision of USD0.2 million (2023: USD0.2 million).

At 31 December 2024, the Group has recognised the impact of a change in accounting estimates in the carrying amount of inventory. The change arose as a result of a change in the measurement technique used for inventory and resulted in an increase of USD1.3 million in the carrying value at 31 December 2024.

17. Trade and other receivables

The Directors consider that the carrying amount of trade and other receivables approximates to their fair values.

Allowance for expected credit losses

The ageing of the receivables and allowance for expected credit losses provided for above are as follows:

The average credit term with customers is 40 days (2023: 40 days).

Movements in the impairment allowance for trade receivables are as follows:

18. Cash and cash equivalents

Cash and cash equivalents held by the Group at 31 December 2024 were USD1.9 million (2023: USD4.7 million). The Directors consider that the carrying amount of these assets approximates to their fair value and do not believe that the Group is exposed to any significant credit risk on its cash.

19. Disposal group held for sale

During the year ended 31 December 2024, the Board took the decision that the operations of the Group's not-for-profit joint venture, GMB-V, were not strategic to the operation of the business and were, therefore, committed to a plan to sell the operations or group of assets, and an active programme to locate a buyer and complete a sale was undertaken.

At 31 December 2024, assets and liabilities of GMB-V, the sale of which is highly probably to take place within twelve months, have been classified as a disposal group held for sale and presented separately in the Statement of Financial Position.

In accordance with the measurement criteria of IFRS 5, the disposal group held for sale has been measured at the lower of its carrying amount and fair value less costs to sell. The Directors have based their estimation of fair value on indicative offers received to date and the offer most likely to proceed to completion. As a result, no impairment loss was recognised on classification as a disposal group held for sale.

At 31 December 2024, the disposal group comprised the following assets and liabilities:

20. Trade and other payables

The Directors consider that the carrying amount of trade and other payables approximates to their fair value.

Trade payables and accruals principally comprise amounts outstanding for trade purchases and ongoing costs.

The Group has financial risk management policies to ensure that all payables are paid within the credit time frame and no interest is generally charged on balances outstanding.

21. Loans and borrowings

Remaining contractual maturity analysis

The following table details the Group's remaining contractual maturity for its loans and borrowings. The table has been drawn up based on the undiscounted cash flows based on the earliest date on which the loans and borrowings are required to be paid. The table includes both principal and interest cash flows.

The movement in loans and borrowings during the year was:

MidCap facility

In June 2019, the Group signed a US bank facility with MidCap, the terms of which were revised in January 2023 as follows:

· The facility includes a term loan and a revolving credit facility, which originally incurred interest at LIBOR rate plus 6.75% and LIBOR rate plus 4.5% respectively. The LIBOR rate was replaced by Secured Overnight Financing Rate ('SOFR') when LIBOR was discontinued. The floor SOFR rate is 3%.

· The extension of the maturity date of both the term loan and the revolving credit facility to 1 January 2028. The term loan is being repaid over 48 months commencing February 2024.

· An early payment of the exit fee of USD0.25 million (initially due on 1 June 2024) relating to the USD5.5 million term loan which was repaid in 2019. This fee was charged against the revolving credit facility in the year ended 31 December 2023. An exit fee of 4.5% on the remaining balance of the term loan (USD0.09 million) will be due on maturity or earlier settlement if applicable.

· An increase in the funds available under the terms of the revolving credit facility up to USD10 million (with a fee payable in respect of each facility expansion of 0.5%).

Debt issue costs are capitalised against the loan and are amortised over the life of the facilities. No costs were capitalised during the year ended 31 December 2024 (2023: USD0.2 million).

In June 2024, Midcap released its collateral claim on 1740 Universal City Boulevard and now has a third lien security interest on this property. See note 13. In respect of the term loan, Midcap now has a first lien security interest in all assets of the Company other than this property. The carrying amount of these assets at 31 December 2024 is USD5.2 million (2023: USD4.6 million). See note 13.

In June 2024, the Group exercised its option to increase the revolving line of credit by USD1.0 million to USD6.0 million to support the working capital growth of the business. This was further increased by USD1.0 million to USD7.0 million in February 2025.

The revolving credit is subject to a rolling 12-month revenue covenant, which is measured on a monthly basis. The Group was in full compliance with the terms of the covenant in the periods reported.

Other borrowings

In June 2024, the Group exercised an option to purchase 1740 Universal City Boulevard, San Antonio, US., a property previously subject to the terms of a lease. See note 14.

The exercise price of the option was USD3.1 million which was financed by further borrowing as follows:

· Under the terms of an agreement dated 13 June 2024, the Group received a loan of USD 2.6 million from the Bank of San Antonio. The loan bears interest at a rate of 7.29% and the principal and accrued interest are repayable by monthly payments of USD18,983 commencing June 2024 until June 2029 ('the Maturity date'). At the maturity date, the entire principal and accrued interest remaining is payable in full. The Bank of San Antonio has a first lien security interest in the property. See note 13.

The borrowings have an annual debt service covenant and the Group was in full compliance with the terms of the covenant in the periods reported

· Under the terms of an agreement dated 13 June 2024, the Group received a loan of US 0.5 million from Universal City Business Park, LLC. The loan bears interest at a rate of 8.25% and the principal and accrued interest are repayable by monthly payments of USD3,607, commencing 1 August 2024 until 1 July 2029 ('the Maturity date'). At the maturity date, the entire principal and accrued interest remaining is payable in full. Universal City Business Park, LLC has a second lien security interest in the property. See note 13.

Lease liabilities

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 property, plant and equipment: Five-year fixed leases.

The Group's average effective borrowing rate for leases at 31 December 2024 was 9.6% (2023: 9%).

Disclosure of additions to and carrying amounts of right-of-use assets by class has been provided in note 14.

At 31 December 2023, the Group had a ten-year fixed lease over US land and buildings, which included an option to purchase within the first five years, being up to November 2024. 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. As a result, the Directors decided that it would be beneficial to exercise the option to purchase and this was completed in June 2024.

Effect of leases on financial performance

22. Deferred tax liabilities