Annual Report and Financials

for year ended 31 December 2022

Contents

Business Overview

2

Strategic Report

3

 Chair & Chief Executive Officer's Statement

3

 Financial Review

7

 Market Overview

10

 Section 172 Statement

14

Governance

15

 Management Team

15

 Board of Directors

18

 Corporate Governance Statement

19

 Directors' Remuneration Report

23

 Directors' Report

26

 Directors' Responsibilities Statement

28

Financial Statements

29

 Independent Auditor's Report

29

 Consolidated Statement of Income

36

 Consolidated Statement of Comprehensive Income

37

 Consolidated Statement of Financial Position

38

 Consolidated Statement of Changes in Equity

39

 Consolidated Statement of Cash Flows

40

 Notes to the Consolidated Financial Statements

41

 Company Statement of Financial Position

69

 Company Statement of Changes in Equity

70

 Notes to The Company Financial Statements

71

Other

76

 Notice of Annual General Meeting

76

 Company and Adviser Information

82

Annual Report and Accounts 2022 1

Business Overview

Tissue Regenix Group plc (AIM: TRX) is an international, pioneering medical technology company focussed on commercialising our two platform technologies, dCELL®, addressing soft tissue needs, and BioRinse®, providing sterile bone and soft tissue allografts.

We are currently helping to transform the treatment of patients in key surgical applications: Orthopaedics (sports medicine/spine), Dental, General, Foot & Ankle, Plastic Surgery, Urology/Gynaecology, and Ophthalmology.

More details on our operating segments and operations are contained below:

dCELL®

Our patented decellularisation ('dCELL') technology platform removes DNA and other cellular material from animal and human soft tissue leaving an acellular tissue scaffold which is not rejected by the patient's body and can then be used to repair diseased or damaged body parts. Current applications address many critical clinical needs, such as foot and ankle surgery, sports medicine, urological-gynaecological and wound care. This business segment operates primarily under the TRX BioSurgery brand.

BioRinse®

Our proprietary BioRinse technology platform is primarily utilised to provide sterile tissue prepared in a manner to minimise the negative effects of processing. One application of the technology provides a natural bone filler solution, tested for osteoinductivity which can stimulate and regenerate native bone growth. This product has the potential to provide superior clinical outcomes as it contains 100% allograft bone, tested to demonstrate the presence of the key natural bone growth factors, and available in various physical forms. Current applications address many critical clinical needs, such as spine surgery, sports medicine, dental, ophthalmology and wound care. This business segment operates primarily under the CellRight Technologies brand.

GBM-V

Our controlled joint venture company, GBM-V, is a regional tissue bank based in Rostock Germany. It currently produces tissue preparations for ophthalmology, primarily cornea, using conventional, classical methods.

Operations

The Group's main facility is in San Antonio, Texas, and is used for processing dCELL and BioRinse products. As part of the Phase 1 expansion, completed in 2021, we relocated facilities designated for distribution and frozen tissue storage as well as adding two clean rooms at the existing San Antonio facility, bringing the total number of clean rooms to seven. We also have facilities in Leeds, United Kingdom ('UK'), for processing dCELL porcine tissue including OrthoPure® XT, as well as our controlled joint venture GBM-V in Rostock Germany for human tissue in the EU. The Group had an average of 79 employees and 6 Directors in 2022.

2 Tissue Regenix Group plc

Chair & Chief Executive Officer's Statement

"During what has been a year of immense progress with some notable milestones achieved, we have continued to demonstrate and realise operational and commercial growth. This has been the result of our continued focus on our 4S strategy - Supply, Sales Revenue, Sustainability and Scale. We have experienced over 20% revenue growth across the Group, resulting in a positive adjusted EBITDA for the fourth quarter of 2022. Execution of this strategy will continue to provide us with the opportunity to build shareholder value as we broaden our opportunities in regenerative medicine, addressing many critical unmet clinical needs around the globe."

Jonathan Glenn, Chair

2022 performance

2022 has been a solid year of growth, marked by achieving several new milestones for the Group. As we had forecast, our top-line revenues exceeded the prior year and continued a positive growth trajectory. Our three main business units all demonstrated growth building on the strong and sustainable market position we have built for our company. As a result, the Group has demonstrated sales growth greater than its peers over the past three years and succeeded in meeting market expectations. This is despite the significant headwinds faced by commercial healthcare organisations in 2022. We are pleased that the Group continued to execute on its plans to deliver further operational and commercial growth. We have continued to expand our distribution network with new products and increased the number of strategic partners and distributors we work with to broaden the adoption of our innovative products. All of this could not have happened without the talented and dedicated employees of the Group, which we would like to thank for their hard work.

Strategy

Our focus remains on the 4S strategy which continues to be the foundation for how we operate, execute and drive our growth:

  • Supply - highlighted by the fundamental ability to source donor tissue and having the capacity to produce various graft products
  • Sales Revenue - to distribute the finished grafts to the clinicians and institutions that need these products to treat patients
  • Sustainability - to manage sales revenue along with expenses to be a profitable entity that does not need additional external capital to operate
  • Scale - to utilise the first three S's to continue to invest in and grow the business, license or acquire new products, technologies and companies

We believe any significant issues with tissue supply are now behind us and have stabilised, given that capacity has been increased to service our needs through to 2025. Our sales growth continues across all divisions, highlighted by achieving an important milestone for the Group of an adjusted EBITDA profitable fourth quarter of 2022. Sustainability remains a key focus and by delivering this we will create new opportunities for the Group with respect to scale, internally and externally.

BioRinse

Through a primary focus on the United States ('US') orthopaedics and dental markets, our BioRinse portfolio reported a strong performance in 2022 with sales of USD16,049k (2021:USD12,711k). The 26% growth was led by confidence in our ConCelltrate® demineralised bone matrix, and AmnioWorks™ birth tissue product families. Our strategic partners continue to have confidence in the superior performance of our products and our ability to deliver products in the required quantities and timeframes due to our elevated processing capacity. Since the completion of the Phase 1 expansion, we have been able to supply products and adjust to unanticipated customer needs in half the amount of time. Achieving these service levels with our partners and distributors across all the surgical specialties we serve (orthopaedics, sports medicine, spine, dental, trauma, others), has earned us a solid and much improved reputation in the industry. Our growth rate is above the market rate for the period (see Market Overview for more details on underlying market growth rates), with our top five product families demonstrating a greater

Annual Report and Accounts 2022 3

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Disclaimer

Tissue Regenix Group plc published this content on 21 March 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 21 March 2023 08:50:02 UTC.