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Tissue Regenix Group plc

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

Interim results for the six months ended 30 June 2024

Tissue Regenix Group plc (AIM: TRX), the regenerative medical devices company, reports its unaudited interim results for the six months ended 30 June 2024 ('H1 2024'), delivering continued progress across many areas of the business and marking the Group's eighth consecutive reporting period of growth.

Financial highlights

·    Group revenues increased by 16% to USD16.4 million (H1 2023: USD14.1 million), driven by strong performance in the key technology platforms BioRinse® and dCELL®

o  BioRinse sales increased 12% to USD10.5 million (H1 2023: USD9.4 million)

o  dCELL sales were up 34% to USD4.2 million (H1 2023: USD3.1 million), driven by the Group's DermaPure® products

o  The Group's joint venture, GBM-V, generated revenues of USD1.7 million (H1 2023: USD1.6 million), an increase of 6%

·    Adjusted EBITDA* profit more than doubled to USD1.1 million (H1 2023: USD0.4 million)

·    Profit before taxation of USD0.1 million (H1 2023: USD0.9 million loss)

·    Gross profit increased to 53% (H1 2023: 49%; 31 December 2023: 48%) due to greater efficiencies and a favourable product mix

·    Cash position of USD3.5 million (H1 2023: USD4.1 million; 31 December 2023: USD4.7 million)

·    Eighth consecutive reporting period of growth and the seventh consecutive period of double-digit, half-on-half growth

Commercial and operational highlights

·    A 29% year-on-year increase in tissue processing throughout H1 2024

·    OrthoPure XT® sales initiated in the Swiss market with the Group's distribution partner, Geistlich Pharma

·    Impressive growth for the dCELL division (34% H1 2024 vs H1 2023) due in part to the addition of 24 new distributors and shipping of 17% more units in H1 2024 versus the same period in 2023

·    In June 2024, 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 Phase 2 expansion plans to provide additional operational capacity are fully funded by the current business plan, with completion anticipated in 2025

·    Demineralised bone products ('DBM'), the major revenue contributor in the base BioRinse business, grew 26% during H1 2024

·    Continued execution of the Group's 4S strategy and growth pillars

Jonathan Glenn, Chair of Tissue Regenix Group plc, said: "It has been another impressive half for the Group and I am pleased to report continued success through the execution of the Group's 4S strategy. The management team has done a stellar job of driving the business forward through headwinds in certain segments and continues to identify expansion opportunities geographically as well as through new surgical indications. During H1 2024, there has been continued growth across all business segments and an improvement in profitability from H1 2023. We retain a strong cash position to see us through our current business plans, including the Phase 2 capacity expansion of the Group's facility in San Antonio, which is expected to complete in 2025."

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

Investor Briefing

Daniel Lee, Chief Executive Officer, and David Cocke, Chief Financial Officer, will host a live online presentation relating to the interim results via the Investor Meet Company platform at 4.30pm today, Tuesday 10 September 2024. 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

Our management team continues to build on the growth we have generated over the past several years. We are pleased to report that in H1 2024, we made further progress across many areas of our business as well as executed on our 4S (Supply, Sales Revenue, Sustainability and Scale) strategy and tactical growth pillars. We have encountered headwinds in H1 2024, but our diversification and flexibility position us well for further growth in the second half.

Business pace remains strong based on the feedback from our customers, distributors and partners, but supply chain issues, regulatory review delays, reimbursement challenges and personnel shortages have continued to impact all participants in the healthcare market. We remain focused on our strategy as we navigate through any obstacles and continue to grow ahead of industry comparators.

Revenue

We ended H1 2024 with year-on-year sales up 16% at USD16.4 million (H1 2023: USD14.1 million), driven by strong performance in our key technology platforms BioRinse and dCELL. Most of this revenue increase has been driven by demand for our diversified products through our hybrid U.S. distribution (direct and strategic partners). Our outside the U.S. ('OUS') distribution partnerships for allograft tissue products have performed ahead of plan. This performance marks the eighth consecutive reporting period of growth for the Group and the seventh consecutive period of double-digit, half-on-half growth, a commendable achievement for our organisation.

The BioRinse portfolio returned sales of USD10.5 million (H1 2023: USD9.4 million), a 12% increase against the comparative period. This was the result of a large increase in demand for our DBM products as our partners continue to expand their commercial efforts in the spine and other markets. These increases require an ongoing and substantial commitment of resources to meet the demand of our partners. Revenue contributions from the recent expansion of allograft sales to customers outside the U.S. also saw an improvement above expectations. Somewhat offsetting the gains in our bone business were the headwinds encountered in other areas of our diversified product portfolio, including the AmnioWorks® product line and released donor tissue, as our partners encountered reimbursement and regulatory challenges, which have slowed existing and prospective new business opportunities.

Sales for the dCELL portfolio, dominated by our DermaPure products, were up 34% to USD4.2 million (H1 2023: USD3.1 million), building on the momentum from 2023. This was due to increased commercial activity resulting from the commercial reorganisation and expansion efforts in the U.S. OrthoPure XT also provided modest contributions to the overall growth of the dCELL portfolio.

Our German joint venture business, GBM-V, also achieved growth and generated revenue of USD1.7 million (H1 2023: USD1.6 million), an increase of 6%.

Earlier this year, we highlighted that Sales Revenue and Sustainability would be the priorities of the 4S strategy in 2024. In H1 2024, we achieved an adjusted EBITDA profit of USD1.1 million against adjusted EBITDA of USD0.4 million in H1 2023. We continue our commitment to maintain the Company's solid financial position in 2024 and beyond.

The 4S Strategy and Growth Pillars

In 2023, we introduced growth pillars that would be our areas of focus using the foundation that the 4Ss have provided for the organisation.

Base Business Growth Pillar

Our base business is defined as our core business with our existing and new partners/distributors through the BioRinse and dCELL products. The base business also includes existing specialties and geographic markets. Our allograft tissue business continues to grow but, in some segments, has encountered commercial headwinds. Demineralised bone products, the major revenue contributor in our base BioRinse business, grew 26% during H1 2024. Arthrex, one of our strategic partners and a prime user of bone graft products, entered the spine market in H2 2023. Our amniotic tissue products are used primarily in ophthalmology and wound care and are smaller revenue contributors to our overall BioRinse business. Offsetting our DBM gains were the dynamic changes in the wound care market, where we experienced a greater than 50% decrease in sales due in part to the potential U.S. Medicare reimbursement changes announced in H1 2024. Commercial diversity has been instrumental in our organic growth over the past several years, so we will shift our resources into other areas to minimise this disruption. Participation in multiple disciplines has reduced our reliance on any single product line or sector whilst broadening our market reach.

We continue to invest in the reorganisation of our U.S. commercial operation for the dCELL business through expansion of our direct U.S. geographic representation. We experienced impressive growth (34% H1 2024 vs H1 2023) for this division due in part to the addition of 24 new distributors and shipped 17% more units in H1 2024 versus the same period in 2023. Our urological/gynaecological sales partner, ARMS Medical, experienced 19% growth in H1 2024 over the same period in 2023.

We noted a 29% year-on-year increase in tissue processing throughout H1 2024. In adjusting to market demands and commercial headwinds, we shifted resources towards musculoskeletal donor processing and recorded a 52% increase in processing throughout in H1 2024. We believe that there are further benefits to come as we implement our regulatory growth pillar.

In June 2024, we closed on the acquisition of the building we have occupied since 2021, which is central to our Phase 1 and 2 expansion plans. The initial lease, signed in 2019, gave us the option to purchase the building at a pre-set price up to November 2024. The fair market value of the property was appraised higher than the pre-set purchase price, and we were able to arrange attractive fixed-rate financing with no cash down payment. The mortgage payments are on par with our current lease payments and will result in cost savings going forward, as the lease included standard yearly increases. The Phase 2 expansion plans to provide additional operational capacity are sufficiently funded by the current business plan with anticipated completion in 2025.

Tissue Partnerships Growth Pillar

Efforts to maintain a supply of donor tissue for our operational needs continue to be a priority and have enabled us to be flexible in meeting our processing needs through the dynamic demand cycles of H1 2024. Maintaining this balance has been challenging due to the rapid shifts we have seen in various market segments. These challenges have impacted the management of our tissue inventories and our relationships with our recovery partners, so in H1 2024 we added two additional recovery partners. To help us manage our tissue inventories, we utilise excess tissue supply with value-added services and offer this tissue to other domestic and OUS tissue processors.

Our domestic relationships remain steady, and we continue to identify additional opportunities. Opportunities OUS have encountered delays due to the backlogs seen in both domestic and OUS regulatory agencies. Once these approvals are granted, we expect to see the volumes we anticipated resume.

New Markets Growth Pillar

Another growth pillar for our organisation was to distribute our tissue-based products into new markets - geographic as well as surgical indications. Opportunities to expand into other surgical specialties will initially be realised with our dCELL products in the U.S. where allografts are regulated as Human Cell and Tissue Products ('HCTPs').

The goal has been to develop a market awareness amongst clinicians that may utilize the dCELL products and their unique attributes to see how they can be beneficial in procedures commonly performed today. Developing this market awareness has been a team effort between clinicians, clinical affairs staff, and our direct and distributor representatives. This effort is ongoing and will have longer term benefits. Initially, we have developed new case studies to document novel uses of our DermaPure products.

The Group is continually looking for new areas to expand market distribution and will be well positioned for additional global growth opportunities with both our allograft and xenograft products. In late 2023, we announced our approval to distribute allograft tissue from our logistics hub in Ireland, and in February 2024, we announced the first shipments from this logistics hub to a customer in the EU. We are pleased to report that in H1 2024, shipments exceeded expectations for this young business. We have added additional markets but have encountered delays due to the need for local regulatory approvals. We will continue to add additional markets in the Europe, Middle East and Africa region based on market demand and local regulatory requirements.

We continue to address the global interest in OrthoPure XT, the only non-human biologic option for certain anterior cruciate ligament reconstruction procedures. In May 2024, during the 21^st European Society for Sports Traumatology, Knee Surgery and Arthroscopy congress in Milan, Geistlich Italia featured the OrthoPure XT during their lunch symposium. The presentation by Professor Stefano Zaffagnini of the Rizzoli Istituto on the positive one-year clinical impressions from this Italian study were well received. We added the Swiss market in H1 2024, with Geistlich as our distribution partner and plan to continue to evaluate our new and existing OrthoPure XT distribution partners. Regulatory approvals for the OrthoPure XT have been impacted by the overall slowdown in regulatory reviews and approvals, specifically our efforts in Australia and China.

Regulatory Evolution Growth Pillar

As mentioned in the full year 2023 results, we are evolving our U.S. operation from an allograft tissue processor of Section 361 HCTPs to one that meets medical device requirements. This will give us the opportunity to innovate with human tissue and broaden opportunities for Tissue Regenix to distribute tissue into markets that regulate human tissue allografts as devices.

During H1 2024, our quality group has been steadily executing on our plans to be an ISO 13485 compliant medical device manufacturer by 2025. A limited number of Section 361 allograft tissue processors have achieved this level in their quality systems, and ISO is a globally recognised standard. Our progress has already given us the opportunity to meet U.S. Food and Drug Administration (FDA) requirements for medical devices should we choose to obtain that certification.

Outlook

Our strong growth in H1 2024 is the result of the dedication of our global teams in the U.S., UK and Europe. We are pleased to demonstrate another period of above market growth despite the headwinds mentioned previously.  The performance of the group over the last three years gives us confidence in moving forward, and the Board will continue to explore additional opportunities for expansion in each of our growth pillars.

Daniel Lee

Chief Executive Officer