Our strategy

Our focus on the 4S strategic elements of Supply, Sales Revenue, Sustainability and Scale continues to provide the foundation of how we operate, execute and drive growth.

The continued investment that we are making and the focus we are placing on tissue Supply has enabled us to sustain and grow in line with our business needs as well as manage the inventories more efficiently and provide tissue to other tissue processors. Processing capacity, another key element in Supply, has kept pace with the Group’s growth despite resource-related headwinds, as experienced more broadly across numerous industries.

Our focus on Sales Revenue and Sustainability has been realised in revenue growth and a positive adjusted EBITDA for the year. Our ability to increase our cash balance in the second half of 2023 was a milestone for the organisation and a further demonstration of Sustainability. Obtaining the regulatory approvals for our third-party logistics partner provides us the opportunity and flexibility to Scale our allograft business in markets outside the U.S. (‘OUS’). The Group’s solid 4S foundation enables us to continue growth plans for Tissue Regenix and deliver shareholder value.

Focussing on the four Ss

1Supply

Tissue Regenix benefits from having strong relationships with tissue supplier, which is fundamental for growth
Strategy centres around growth of tissue supply for existing and new customers
Once tissue has been procured, there must be adequate capacity to transform it into finished products
Tissue has delivered this with the expansion of facility and the increase in donor sourcing agreements

2Sales Revenue

Sales revenue is the result supply in conjunction with concerted commercial and product development efforts
Diversified portfolio and customer partners generate Company’s revenues
To ensure long-term objectives are met

3Sustainability

Sustainability occurs when the growth in sales revenue, made possible by supply, funds the Company’s existence without reliance on external capital
Laser focus on revenue growth critical to realising operational leverage and profitability
Tight expense management, with an emphasis towards commercial needs, should accelerate transition to sustainability

4Scale

Driven by sustainability, scale allows the Group to pursue strategic growth alternatives, which further enhance supply, sales revenue and sustainability
The Group continue to look at opportunities to invest in cost reductions, acquire companies and new technologies
Execution of further strategic partnerships can help with long-term growth opportunities

Building on the 4S
Foundation

Our Growth Pillars

The 4S strategy enables us to support defined tactical activities moving forward. In 2023, we implemented clearly defined growth pillars to provide further direction and help sustain the growth trajectory for the Group. The four growth pillars are:

Growth of our base business with existing and new customers

We will continue to grow our core businesses with our existing and new partners/distributors through the BioRinse and dCELL product lines. This base business includes existing specialities and geographic markets. We will support this growth with logical new product enhancements and clinical- or market-related activities. This growth will also be supported by our current infrastructure and planned capacity enhancements.

Growth of our unique capacity to provide donor and in-process tissue

Our focus on tissue supply is at the core of our growth as it drives our capacity. We have built supply volumes that exceed our internal needs, so we have the opportunity to provide donor tissue to other tissue processors (‘Released Donor Tissue’). We also have the responsibility of meeting the donor’s desire to have their tissue utilised to help others in a safe and expeditious manner. Our tissue supply operation adds value by performing the medical reviews and chart releases required for tissue suitable for immediate processing by other domestic and OUS partners. These activities help us to manage our recovery partner relationships and provide opportunities for tissue that we currently do not utilise in our processing operations.

Growth into additional surgical specialities and geographic regions globally

We will continue to broaden the markets for our products via a two-pronged approach. The need for tissue-based products in the surgical marketplace is substantial, and we currently participate in limited segments. We intend to expand into additional surgical specialities by first generating clinical experience at institutions where we have an existing base business. This will serve as the stepping stone for expansion with additional customers and institutions.

We also plan to expand into markets that have a need for allograft tissue-based products but currently have limited availability. Our establishment and receipt of approval to distribute tissue through a third-party logistics partner provides the conduit for opportunities into the EU. OrthoPure XT, our xenograft tissue product, received a CE Mark in 2020, and we continue to identify opportunities to distribute this product in markets that recognise the CE Mark.

Growth into markets requiring device approvals or with products classified as devices

The bulk of our revenue comes from allograft tissue-based products, which are regulated as Section 361 HCTP (Human, Cell and Tissue Products) in the U.S. The requirements mandated for Section 361 products place limits on changes to the allograft tissue; 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. We intend to evolve and change this facility to become one that is capable of meeting medical device requirements. This evolution will give us the opportunity to innovate with human tissue and broaden opportunities for Tissue Regenix to distribute tissue into certain international markets that regulate human tissue allografts as medical devices.

Supply

Sales Revenue

4Ss

Sustainability

Scale