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Tissue Regenix Group plc

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

Interim results for the six months ended 30 June 2025

Tissue Regenix Group plc (AIM: TRX), the regenerative medical devices company, reports its unaudited interim results for the six months ended 30 June 2025 ('H1 2025').

Financial highlights

·    Revenue for the Group decreased 6% as a result of commercial, regulatory and reimbursement challenges

o  BioRinse® revenues decreased by 7% to $9.8million (H1 2024: $10.5million), due to the delays in obtaining regulatory approvals impacting the Group's ability to bring on new customers , an issue corroborated by the American Association of Tissue Banks

o  dCELL® revenues decreased by 4% to $4.0million year-on-year (H1 2024: $ 4.2million) but increased 16% on the prior period (H2 2024: $ 3.5million)

·    Adjusted EBITDA of $0.2 million (H1 2024: $0.9 million)

·    Gross profit margin for H1 2025 decreased to 42% (H1 2024: 55%) primarily driven by production lower yields

·    Cash position at 30 June 2025 of $1.1 million (31 December 2024: $1.9 million)

·    Debt facilities of $16m of which $10.4 million is drawn down (H1 2024: $9.8 million)

·    Due to a change in accounting teams, the Company is aware that estimates used for 2024 year-end inventory and cost of sales were inaccurate and is reviewing the estimates made with the expectation that these historical numbers will require adjustment. This is expected to be clarified in the next month and any restatement will not affect the Company's revenue numbers for FY 2024.

Commercial and operational highlights

·    CE certification received for OrthoPure® XT under the EU Medical Device Regulation and UK Conformity Assessed certification

·    European patent granted for the Company's innovative dCELL® technology

·    Increased commercial activity through the Group's existing dCELL direct distribution network which saw a 10% increase in revenue year-on-year

·    32 new dCELL distributors added in H1 2025

·    Post period end management changes:

o  Jay LeCoque appointed as Executive Chairman

o  Brandon Largent appointed as Interim Chief Financial Officer

o  Resignations of Jonathan Glenn and Trevor Phillips as Non-executive Directors

Daniel Lee, CEO of Tissue Regenix Group plc, said: "Although we have seen a downturn in trading in H1, with a resultant impact on our cash position, we remain confident in the underlying business and market opportunities for our leading products and superior technology. We expect both trading and cash to improve in the longer-term and our focus is to deliver sustainable revenue generating opportunities that accelerate earnings growth and our long-term profitability goals to increase shareholder value."

* Adjusted EBITDA: profit before interest, taxes, depreciation, amortisation and share-based payments

Investor Briefing

Daniel Lee, Chief Executive Officer, Brandon Largent, Interim Chief Financial Officer, and Jay LeCoque, Executive Chairman, will host a live online presentation relating to the interim results via the Investor Meet Company platform today at 16:00 BST (Tuesday 30 September 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:

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 not rejected by the patient's body that can be used to repair diseased or damaged body structures. Current applications address many crucial clinical needs in sports medicine, foot and ankle injuries and wound care.

Tissue Regenix Group plc

2025 has introduced new challenges for the business. During 2020 - 2024, compound annual growth rate (CAGR) was c.20%.  In H2 2024 we began to experience a number of headwinds that led to a decline in revenues across various segments of our diverse business which has continued in H1 2025 ('the Period'). Our business demand remains strong in a number of market segments, but other areas have encountered regulatory, commercial and reimbursement challenges. The Tissue Regenix management team continues to identify opportunities for growth and we remain committed to our 4S (Supply, Sales Revenue, Sustainability and Scale) strategy.  We will continue to initiate the appropriate measures to enable a return to our 2020 - 2024 growth trajectory. 

Revenue

In H1 2025, we experienced a 6.1% decline in our revenue year on year (H1 2025: $13.8million; H1 2024: $14.7million). Historically H2 is a larger revenue contributor, but we experienced declines in H2 2024 as our revenues relative to the immediate past period demonstrated a 1.6% decline (H2 2024: $14.0million). Our H1 2025 revenue is primarily generated by demand for our diversified products primarily through our hybrid U.S. distribution (direct and strategic partners). Orders from our strategic partners, which represents a substantial portion of our revenue, has been impacted by the uncertain economic conditions and we believe this to be a transient issue. 

During the Period we achieved an adjusted EBITDA profit of $ 0.2 million (H1 2024: $ 0.9million) and expect to regain our growth trajectory for full year 2025.

Base Business Growth Pillar

The BioRinse portfolio returned sales of $9.8 million in H1 2025; a 7% decrease year on year (H1 2024: $ 10.5million); a -7% decrease against H2 2024 ($ 10.5million). The issues we noted in H2 2024 have carried over to H1 2025 especially with our released donor tissue ('RDT') which experienced a double-digit revenue decline as delays in obtaining regulatory approvals have impacted our ability to bring on new customers in new markets. This issue has been identified by the American Association of Tissue Banks with the Food and Drug Administration (http://www.aatb.org/sites/default/files/Government%20Advocacy%20Correspondence/AATB%20CBER%20CFG%208.22.25.pdf)

Our demineralised bone matrix ('DBM') products were positive performers as we recorded 4% growth in H1 2025 year on year. We anticipate future growth as our key partners continue to expand their commercial efforts in the spine and other markets and have positive outlooks for increased demand. In contrast, the economic uncertainties of H1 2025 have impacted finished goods orders as orders from our largest BioRinse partner were flat year on year. Overall BioRinse products decreased 1.5% year on year. Also impacting our H1 2025 performance were the c.$600k of stocking backorders from 2023 that were fulfilled in H1 2024 as one of our partners entered a new market.

Revenue from our amnion product lines decreased in H1 2025 year on year but we have noted product growth in H1 2025 vs H2 2024. We expect continued reimbursement pressures for wound care products as the Center for Medicare Services reviews reimbursement levels in the U.S. so we will continue to see some pressures for our amnion products in that segment of the market. We will continue to adjust our focus across our diverse product portfolio partners to meet demand and maximize revenue opportunities. Commercial diversity has been instrumental in our organic growth over the past several years and forward demand signals remain positive. 

Sales for the dCELL® portfolio, dominated by our DermaPure® products, decreased by 4% year on year (H1 2025: $4.0m; H1 2024: $4.2m) but increased 16% from the prior period (H2 2024: $3.5million). Impacting our results in this segment was the double-digit revenue decrease year on year by our dCELL strategic partner in urological/gynaecological surgery. We continue to drive increased commercial activity through our existing direct distribution network which posted a 10% increase in revenue year over year aided by the addition of 32 new distributors in H1 2025. We also seek growth opportunities with strategic partners who wish to add dermal tissue options to their portfolio in the wound care market. The dCELL products were our growth leaders in 2024 and we believe that this growth recovery will continue a positive trajectory into 2025.

As we respond to market demands, we increased our processing throughput by 7% year on year. Our yields dropped significantly in H1 2025 especially with segments of our bone-based products whichhas impacted on the availability of specific product families. The supply chain for human tissue processing can be quite variable as relies on the availability of individual donor tissue.  Accordingly this may limit opportunities to produce the required types or volumes of tissue products in demand. We have now refined our specifications and are working with our recovery partners to improve yields and maximize the gift of human tissue donation. As demand normalizes, these increases will require us commit additional  of resourceto optimize our tissue needs and meet the increased demand. This will be a focused priority for our team in H2 and going into 2026.

Tissue Partnerships

Maintaining a reliable and adequate supply of donor tissue for our operational needs continues to be a priority and an important factor in being flexible to meet our variable processing needs. We still have the opportunity to manage our excess tissue inventories and offer this tissue to other domestic and outside the U.S. ('OUS') tissue processors. We utilise any excess tissue supply with value-added services and offer this tissue to other domestic and OUS tissue processors. In H2 2024, we encountered a significant drop in demand and were unable to supplant lost opportunities due to delays and backlogs seen in both domestic and OUS regulatory agencies. We recently have begun to receive Certificate to Foreign Government approvals and have seen an upturn in RDT opportunities in the latter half of 2025.

New Markets

Opportunities to expand into other surgical specialties have been focused on direct distribution with our dCELL products in the U.S. where allografts are regulated as HCTPs (Human Cell and Tissue Products) and marketed within those regulatory guidelines. Our DermaPure dermal allografts have numerous clinical applications across different clinical specialties. Developing this market awareness has been a team effort between clinicians, our clinical affairs staff, and our direct and distributor representatives. Historically our customer base has been predominantly orthopaedic and podiatric clinicians but we are seeing increased uptake across the general surgery and colorectal markets.

In March 2025, we announced the receipt of a European patent for the dCELL technology which is currently utilised to produce our DermaPure and OrthoPure XT products. The receipt of this patent will enable us to protect this patented technology in markets which honour European Patent Office patents.

We continue to focus on geographic expansion and in June we received some approvals which will enable us to initiate new business opportunities in markets outside the U.S.. We will continue to add additional markets in the Europe, Middle East and Africa region based on market demand and receipt of regulatory approvals.

OrthoPure® XT also has provided modest growth to the Group during the Period as we continued to develop global interest. The OrthoPure XT is unique as the only non-human biologic option for certain anterior cruciate ligament (ACL) reconstruction procedures. In March 2025, during the 4^th Annual meeting for SIAGASCOT (Societa Italiana Artroscopia Ginocchio Arto Superiore Sport Cartiligine Technologie Ortopediche) congress in Naples, Geistlich Italia featured the OrthoPure XT during their lunch symposium with presentations by clinicians and scientific personnel on the science and clinical benefits of this product. Tissue Regenix Orthopedics and Geistlich shared an exhibit at the ISAKOS (International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine) in Munich to provide greater awareness to this global audience of the OrthoPure XT. A manuscript on the 5-year clinical follow-up on this novel device is expected to be published in an international journal in 2025. We continue to explore efforts to expand OrthoPure XT distribution in Europe and other markets as we expand globally.

Regulatory Evolution

In H1 2025 we received a final conclusion to the Food and Drug Administration (FDA) audit originally conducted in July 2024. In their final summation they noted no observations nor  any issues. Soon after the receipt of this summary, we received indication that some of the US FDA certificates which have been delayed would now complete their review cycle which we hope to occur by [year end/early2026]

One of our growth pillars is to evolve our capability to be a device manufacturer versus one just focused on human allograft tissue products. To achieve this we have continued to pursue our ISO 13485 certification as a contract manufacturer as this will provide the opportunity to distribute into more international markets and enable us to respond to market demand by one of our key strategic partners. We began the process in May 2025 with a desk audit and had an on-site audit in July. We hope to have this designation before the end of 2025.

Our UK facility in Garforth is currently ISO 13485 certified to manufacture xenograft tendons. We originally received the CE mark designation under the Medical Device Directive (MDD). In 2021 MDD was replaced by the Medical Device Regulation (MDR) as it was intended to "significantly increase safety, transparency, and post-market surveillance for medical devices in Europe." The MDR certification has been especially rigorous for many medical device companies distributing into the EU. In June 2025, we announced our receipt of CE certification under the EU Medical Device Regulation and UK Conformity Assessed certification under the UK Medical Device Regulation for OrthoPure® XT which was a significant accomplishment for our team in Garforth.

Process

During late 2024 our Board approved the initiation of a review of the strategic options for the Company as the Board felt that the value of the Company was not representative of the prospects and delivery which had been seen over the last four years. The process included contacting potential counterparties to assess interest in putting forward proposals that would deliver greater value to Tissue Regenix's shareholders. In April 2025, our Board terminated the strategic review as they did not believe there was a prospect of an appropriate, near-term offer, especially with respect to the share price performance. The Company will remain a standalone independent entity and continue to focus on delivering sustainable growth across all its divisions. 

Outlook

Our dedicated global teams in the U.S., UK and Europe are committed to restoring our growth and continued profitability in 2025. I would like to thank our outgoing Board members for their support and guidance that contributed to the growth of the business over the last few years. Although we have seen a downturn in trading in H1, we remain confident in the underlying business and market opportunities for our leading products and superior technology. Our focus is to deliver sustainable revenue generating opportunities that accelerate earnings growth and our long-term profitability goals to increase shareholder value.

Daniel Lee

Chief Executive Officer

29 September 2025