Tissue Regenix Group Regulatory News (TRX)

Prior to publication, the information contained within this announcement was deemed by the Company to constitute inside information as stipulated under the UK Market Abuse Regulation. With the publication of this announcement, this information is now considered to be in the public domain.

Tissue Regenix Group plc

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

Interim results for the six months ended 30 June 2023

Tissue Regenix Group plc (AIM: TRX), the regenerative medical devices company, reports its unaudited interim results for the six months ended 30 June 2023 ('H1 2023'). This was a period of continued growth particularly within Tissue Regenix's BioRinse® and dCELL® businesses, positioning the Group favourably for growth in H2 2023.

Financial highlights

· Group revenues increased by 19% to USD14.1 million (H1 2022: USD11.8 million), driven by the strong performance of BioRinse and dCELL

· Gross profit for the period increased to 49% (H1 2022: 46%) driven primarily by efficiencies from the Phase 1 expansion

· Adjusted EBITDA profit* of USD0.4 million against an adjusted EBITDA loss of USD0.5 million in H1 2022. This is a significant achievement and the Group has now been profitable on an adjusted EBITDA basis for the last twelve months

· Cash position as at 30 June 2023 of USD4.1 million (30 June 2022: USD6.2 million), sufficient to support current business growth plan

· BioRinse portfolio returned sales of USD9.4 million (H1 2022: USD7.8 million); a 20% increase against the comparative period

· Sales for the dCELL portfolio, including DermaPure® products and OrthoPure® XT, up 29% to USD3.1 million (H1 2022: USD2.4 million)

· Sixth consecutive reporting period of growth and the fifth consecutive period of double-digit half-on-half growth compares favourably to our markets which have grown in the mid-single digits

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

Commercial and operational highlights

· 15% year-on-year increase in processing throughput during H1 2023, as a result of the Phase 1 capacity expansion

· 37% increase in finished product availability for the OrthoPure XT product in H1 2023

· The reorganisation of the Group's US commercial operation for the dCELL business continued to show growth across the regions. In H1 2023, 25 new distributors were added for the dCELL line. The benefits of this were seen in the 29% revenue growth which was accompanied by an overall 24% increase in unit distribution. Sales growth in the period was aided by contributions from OrthoPure XT

· Addition of a UK distributor for OrthoPure XT and distribution agreements for China and Australia

Daniel Lee, Chief Executive Officer of Tissue Regenix Group plc, said: "We are extremely pleased with the growth seen by the Company in H1 2023, which is our sixth consecutive reporting period of growth. We retain a strong cash position to support our current business growth plans and we continue to reap the benefits and efficiencies of the Phase 1 capacity expansion at our San Antonio facility.

"We continue to see increased sales for our dCELL and BioRinse product families which have contributed to our first 12 months of profitability on an adjusted EBITDA basis. It has been a strong period for Tissue Regenix, having outperformed the market in respect of growth in our key businesses and in H2 2023 we look forward to continuing our successes through additional partnerships and product lines. We continue to build on our momentum and expect 2023 to be another year of above market growth."

Investor Presentation

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 4.30 p.m. BST today. The presentation is open to all existing and potential investors.

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

A copy of the interim results report will be made available on the Company's website later today at www.tissueregenix.com

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 is headquartered in the UK with its principal operations in the US.

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

Introduction

In 2021, we introduced our 4S strategy consisting of Supply, Sales revenue, Sustainability and Scale. These pillars have remained the key performance indicators by which we measure the business, and it is extremely pleasing to see the results that the Group is now delivering. Led by the executive management, the entire team at Tissue Regenix has shown what can be achieved when all the different elements of the business are driving towards one goal. While we are pleased with our achievements to date there remains a lot of opportunities ahead of us.

We have created a commercially focussed global regenerative medtech company in a high-growth sector focused on soft tissues and bone, with a multi-billion-dollar addressable market opportunity in the United States ('US') alone.

Our core product portfolio has two technology platforms:

• dCELL: used to produce allograft (DermaPure) and xenograft (OrthoPure XT) soft tissue products to promote healing and regeneration; and

• BioRinse: natural bone filler solutions verified to be osteoinductive to stimulate and regenerate native bone growth.

These technologies have been used to create regenerative products with applications in biosurgery, orthopaedics and dentistry. In addition, we have broadened our range of services to include distributing allograft tissue products outside of the US and to utilise any excess tissue supply and provide value-added services in offering tissue to other tissue processors.

Continued momentum in H1 2023

In this set of interim figures, we present our maiden adjusted EBITDA profit for a six-month period, and we look forward to continuing to build on this. In fact, the Group has been profitable on an adjusted EBITDA basis for the last twelve months. This has been achieved despite the continued investment into the Group, which is critical for sustained and long-term growth. 

Trading in the period has again been strong, with total revenues up by 19% to USD14.1 million (H1 2022: USD11.8 million), driven by the strong performance of both BioRinse and dCELL. Gross profit for the period has increased to 49% (H1 2022: 46%) as the planned efficiencies from the Phase 1 expansion flowed through. The cash position of the Group as at 30 June 2023 of USD4.1 million (30 June 2022: USD6.2 million; 31 December 2022: USD5.9 million) supports our current business growth plan. Combined with the revolving credit facility that was increased to USD10.0 million in January 2023 (which is not required according to our business plan) the Company's liquidity is strong.

Outlook for H2 2023

We have had a strong start to 2023 and the second half has continued in the same vein. There are lingering issues in the supply chain, with labour disruptions and the wider economic uncertainties but the Company is managing these headwinds well. The Board remains confident about the future as the product portfolio continues to grow, the management team continue to deliver improved performance, and the additional investment we made in the facilities in 2021 ensures we are operationally geared to deliver on our strategic plan. As we make strides in our regulatory and commercial efforts outside of the US ('OUS'), we anticipate future growth potential from these approvals and distribution agreements. We continue to build on our momentum and expect 2023 to be our first full year of profitability on an adjusted EBITDA basis.

Jonathan Glenn

Chair

Tissue Regenix Group plc

As Chief Executive Officer it is always gratifying to say that we have delivered upon a promise. At the 2022 year-end we stated in our Annual Report, "we remain firmly on track for significant growth in 2023." I am pleased to report that in H1 2023 we have continued to make progress across all areas of the business but the growth in our BioRinse and dCELL businesses has been particularly pleasing. Our first half achievements position us favourably for continued growth in H2 2023, which has already started well, and the Board remains confident in meeting market expectations.

Based on the feedback from our customers, distributors and partners, business pace is returning to levels last seen in 2019. Supply chain delivery times, regulatory review delays and personnel shortages continue to impact growth for all participants in the healthcare market, but we are navigating our way through these obstacles and showing growth ahead of industry comparators. Our BioRinse business continues to expand with both existing and new customers, driven mainly by our demineralised bone matrix ('DBM') family, AmnioWorks® product line, and released donor tissue ('RDT').

Revenue

We ended H1 2023 with year-on-year sales up 19% at USD14.1 million (H1 2022: USD11.8 million) driven by strong performances in both of our technology platforms; BioRinse and dCELL. The majority of this revenue growth has been driven by the strength of our products and our US distribution partners. We anticipate that our international distribution partnerships for our allograft and xenograft tissue products to contribute to revenue in 2024 and beyond. Furthermore, this performance marks the sixth consecutive reporting period of growth for the Group and the fifth consecutive period of double-digit half-on-half growth.

The BioRinse portfolio returned sales of USD9.4 million (H1 2022: USD7.8 million); a 20% increase against the comparative period. This growth was the result of continued and increased demand for our diversified product portfolio with existing and new customers, and expansion of our ability to provide RDT to various strategic partners.

Sales for the dCELL portfolio, with our DermaPure products, were up 29% to USD3.1 million (H1 2022: USD2.4 million) continuing the positive trajectory in 2022. This was due to the increased commercial activity resulting from the commercial reorganisation efforts in the US as well as contributions from OrthoPure XT.

In Germany, the joint venture business, GBM-V, remained stable. Donor supply limited sales revenue in H1 2023, which is expected to be a temporary situation. The joint venture generated flat revenue of USD1.6 million (H1 2022: USD1.6 million).

We have spoken on several previous occasions of our drive towards profitability without compromising our growth, our market position, or our R&D capacity. This is not an easy balance to walk but it is one that we are managing successfully. In Q4 2022, we reported adjusted EBITDA profitability, a milestone for the organisation, and in H1 2023, we achieved an adjusted EBITDA profit of USD0.4 million against an adjusted EBITDA loss of USD0.5 million in H1 2022. This demonstrates our commitment to profitability in 2023 and beyond, and illustrates the Company's solid financial position.

Operations: The 4S Strategy

Throughout the first six months of 2023 we continued to focus on our 4S strategy: driving Supply, Sales revenue, Sustainability and Scale. Our focus on tissue supply has enabled us to maintain adequate inventories to meet all our processing needs through the demand ebbs and flows experienced during the period. To maintain this streamlined process, we decided to utilise any excess tissue supply with value-added services and offer this tissue to other tissue processors. This also provides the additional benefit of optimising tissue sourcing relationships with our recovery partners as well as improving sales revenue. Consequently, the management of our tissue inventories has become another growth opportunity for our organisation.

We continue to benefit from our Phase 1 capacity expansion as we identify additional efficiencies in our San Antonio processing operations. As a result, we have minimised the impact of staffing issues experienced by ourselves and others in the industry. We noted a 15% year-on-year increase in processing throughput during H1 2023, and believe that there are further benefits to come. One example of an efficiency improvement was moving release testing for our franchise-leading DBM products to an alternative lab which reduced release times by 12%. This will enable us to make more products available and be more responsive to any increases in market demand. 

Our UK operation has responded to our increased commercial efforts for the OrthoPure XT product. In H1 2023, production increases resulted in a 37% increase in finished product availability. We expect demand to increase as we work to further increase supply in H2 2023 as well as our need to provide additional capacity to meet this commercial growth.

Commercial development

Our commercial diversity has been the core of the organic growth in H1 2023. Participation in multiple disciplines has minimised our reliance on any single product line or sector whilst broadening our market reach. The ability to remain responsive and proactive to our customers' and strategic partners' needs is a cornerstone of providing excellence in service when demand dictates. The growth pillars of continuing to service our existing customers and strategic partners, as well as adding new strategic partners in markets within them, are core to our ongoing success.

The reorganisation of our US commercial operation for the dCELL business continued to show growth across the regions with direct and focussed management. In H1 2023, we added 25 new distributors to the dCELL line alone. The benefits of this were seen in the 29% revenue growth which was accompanied by an overall 24% increase in unit distribution, especially the premium value units. ARMS Medical, our urological/gynaecological sales partner, experienced 9% growth in H1 2023 over the same period in 2022.

Yet another growth pillar for our organisation is to begin efforts to more broadly distribute allograft tissue products OUS. We have been successful in developing a strong distribution network in the US and we look forward to replicating this model and growing our market share in other jurisdictions. We have identified several parties to distribute human tissue products in the European Union ('EU') and the United Kingdom ('UK'). We anticipate initiating distribution in H2 2023 pending the completion of regulatory approvals for the EU and other markets outside the US.

During the first half of 2023 the OrthoPure XT product continued to gain adoption in our current EU markets. We continued to address the global interest in the OrthoPure XT, the only non-human biologic option for certain anterior cruciate ligament reconstruction procedures. In the period, we announced the signing of an UK distributor and distribution agreements for China and Australia which will require additional regulatory and clinical approvals. To support the adoption of this novel product we are preparing a manuscript on the five-year clinical results from the OrthoPure XT trial which will be submitted to a noted European orthopaedic journal for publication.

The Group is continually looking for new areas to expand distribution and intends to be well positioned for additional global growth opportunities with both our allograft and xenograft products in H2 2023 and beyond.

Share consolidation

In late April 2023, we implemented a 100:1 share consolidation. The Board believed that a consolidation of the Company's Ordinary Share Capital would result in a more appropriate number of shares in issue for the Company. Further detail on the share consolidation can be found in Note 4 of the interim statements.

Outlook

The growth we have seen in H1 2023 is a testament to the dedication and passion of the entire team at Tissue Regenix. We have had a strong start to H2 2023 and we expect this performance to continue allowing us to deliver a profitable year on an adjusted EBITDA basis. Our growth strategies revolve around building opportunities with existing and new customers and broadening our distribution opportunities wherever we see opportunities, both within the US and across the globe. After the years of reorganisation and rationalisation that we have gone through, the recent periods have been immensely pleasing and I am hugely excited about the future for Tissue Regenix.

Daniel Lee

Chief Executive Officer

Tissue Regenix Group plc

Revenue

During H1 2023, revenue increased 19% to USD14.1 million (H1 2022: USD11.8 million) due to a continued strong performance seen across both technology platforms. The BioRinse division recorded a 20% increase in revenues at USD9.4 million (H1 2022: USD7.8 million), driven by strength in our core demineralised bone grafts and increases in transfers of released donor tissue. The dCELL division recorded a 29% increase in revenues to USD3.1 million (H1 2022: USD2.4 million) as the effects of the commercial reorganisation that started in late 2021 continued to show positive results in addition to sales of OrthoPure XT. Our German joint venture, GBM-V, was stable to the prior period at USD1.6 million (H1 2022: USD1.6 million), due to temporarily reduced donor tissue availability which we believe to be a temporary issue.

Gross profit

Gross profit for H1 2023 increased to 49% (H1 2022: 46%) as the efficiencies realised in the Phase 1 expansion flowed through to the gross profit line. Gross profits are also up from the full year ended 31 December 2022 level of 46%.

Loss for the year

The operating loss for H1 2023 reduced to USD0.2 million (H1 2022: USD1.2 million). As forecasted, the Group has become profitable on an adjusted EBITDA basis for the period; an adjusted EBITDA profit of USD0.4 million against an adjusted EBITDA loss of USD0.5 million in H1 2022.

Finance charges for the period include USD0.25 million which represents an exit fee on a portion of the 2019 term loan financing with MidCap which became due and payable when the facility was refinanced in January 2023.

R&D tax credits have decreased from historical levels which was expected as more resources are directed away from the development phase, and the business looks to commercialise more products.

Cash position

The cash position of the Group as at 30 June 2023 was USD4.1 million (30 June 2022: USD6. 2 million; 31 December 2022: USD5.9 million). In January 2023, the Group elected to increase its current revolving credit facility from USD5.0 million to USD10 .0 million and extend the maturity term to 2028. Repayment of the term loan will be made in equal instalments commencing in 2024. Although this financing is not dictated by the current business plan, which is fully funded by the Group's current cash position, the additional liquidity was considered to be a prudent measure.

Tissue Regenix Group plc

Condensed Consolidated Statement of Income

Tissue Regenix Group plc

Condensed Consolidated Statement of Changes in Equity

1. Basis of preparation

This report was approved by the Directors on 4 September 2023.

The Company is domiciled in England and the Company's shares are admitted to trading on the AIM market in the UK.

The Company has chosen not to adopt IAS 34 Interim financial statements in the preparation of the condensed consolidated interim financial statements.

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

The current and comparative periods to June have been prepared using the accounting policies and practices consistent with those adopted in the annual financial statements for the year ended 31 December 2022, and with those expected to be adopted in the Group's financial statements for the year ending 31 December 2023.

Comparative figures for the year ended 31 December 2022 have been extracted from the statutory financial statements for that period which carried an unqualified audit report, did not contain a statement under section 498(2) or (3) of the Companies Act 2006 and have been delivered to the Registrar of Companies.

The financial information contained in this report does not constitute statutory financial statements as defined by section 434 of the Companies Act 2006, and should be read in conjunction with the Group's financial statements for the year ended 31 December 2022. This report has not been audited or reviewed by the Group's auditors.

2. Segmental information

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

Segmental information is presented below.

3. Loss per Ordinary Share

Basic loss per Ordinary Share is calculated by dividing the net loss for the period attributable to owners of the parent company, by the weighted average number of Ordinary Shares in issue during the period, excluding own shares held jointly by the Tissue Regenix Employee Share Trust and certain employees.

Diluted loss per Ordinary Share is calculated by dividing the net loss for the period attributable to owners of the parent company, by the weighted average number of Ordinary Shares in issue during the period adjusted for the dilutive effect of potential Ordinary Shares arising from the Company's share options and jointly owned shares.

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

Due to the losses incurred from continuing operations in the periods reported, there is no dilutive effect from the existing share options and jointly owned shares.

The information shown above has been restated to reflect the share consolidation in all periods presented, which became effective on 28 April 2023. See note 4.

4. Share capital

The Ordinary Shares are fully paid and entitle the holder to full voting rights, to full participation and to distribution of dividends.

The Deferred Shares are not listed on AIM, do not give the holders any right to receive notice of, or to attend or vote at, any general meetings, and have no entitlement to receive a dividend or other distribution other than to a return of capital in the event of a winding up (and only after the holders of the Ordinary Shares have received the sum of £1 million per share).

On 28 April 2023, the Company consolidated every 100 Ordinary Shares of 0.1 pence each into one 'Consolidated Share'. Immediately following the consolidation, each Consolidated Share was sub-divided into one New Ordinary Share and one New Class 2 Deferred Share. The sub-division was structured in such a way that each of the New Ordinary Shares retained the nominal value of 0.1p each. The New Ordinary and Class 2 Deferred Shares have the same rights as the existing Ordinary and Deferred Shares, respectively.

Issued Ordinary Share capital

On 21 June 2022, the Company issued 2,717,391 Ordinary Shares of 0.1 pence each at a price of 0.0276 pence per share, raising gross proceeds of USD9,203 (£7,500), in respect of the exercise of share options.

Movements in share capital during the period were as follows: