Description

The US is the largest healthcare market in the world and where we see the greatest opportunity.

We intend to leverage our platform technologies dCELL® and BioRinse to further our market penetration through a hybrid sales model, a combination of direct sales, distribution and OEM agreements.

2020 Performance

  • Commenced phase one of capacity expansion programme
  • Entered white label distribution agreement
  • Strengthened relationships with strategic partners
  • Extended roll out of DermaPure® non-oriented product
  • Expanded distribution network
  • With the increased supply chain and production capabilities, expanded distribution of amniotic products to further diversify product mix

Focus and Goals for 2021+

  • Bring onstream phase one of capacity expansion programme
  • Launch new product line extensions and SKUs
  • Assess the commencement of phase two of capacity expansion programme
  • Increase collection of real world clinical data highlighting our product differentiators

Link to KPI's

  • Group sales growth
  • Increase number of strategic partnership and distribution opportunities

Link to risks

  • Finance – Insufficient funds to invest in the required expansion
  • Operational – The Group is unable to expand in line with demand
  • Clinical and Regulatory – Changes in regulatory pathways for products

Commentary

Although COVID-19 may have slowed the commercial expansion of the Company the injection of Capital from the equity fundraise in June has allowed us to commence the facility expansion programme in San Antonio and will provide sufficient working capital to support Company growth and drive towards profitability. Therefore, although we do not consider cash resources a major risk, should the pandemic continue this could become a more pressing concern. During 2021, we will focus on exploiting the milestones achieved in 2020 and pursuing further opportunities with product line extensions and additional capacity.

Strategy in action

Focus

Drive sales growth of product portfolios in the US market through current and potential direct and indirect distribution channels and increasing GPO relationships and penetration

Near 6–12 months

  • Bring onstream phase 1 of the capacity expansion programme
  • Assess commencement of phase 2 of the capacity expansion programme
  • Bring to market new product line extensions
  • Further develop strategic partnerships and identify additional partnerships which will complement our growing portfolio
  • Increase collection of real world clinical data

Mid 12–18 months

  • Look to secure new significant strategic partnerships
  • Continue to identify product opportunities and commercial partnerships

Long 18+ months

  • Further collaboration with strategic partners for future product development, including combination products

Description

Our current commercialisation efforts are focused on the US markets; however, there is the opportunity and market demand for us to enter new geographic territories.

2020 Performance

  • Commenced phase one of the capacity expansion programme
  • Entered into UK and EU distribution agreements for OrthoPure® XT
  • Expanded network of distributors outside of the main US market
  • Identified potential licensing opportunities in other geographic areas

Focus and Goals for 2021+

  • Bring onstream phase one of capacity expansion programme
  • Secure additional distribution partners for the roll out of OrthoPure® XT
  • Ramp up market awareness of BioRinse® products outside of US market
  • Enter distribution arrangements with overseas partners for the supply of our dCELL® product range
  • Continue to pursue potential licensing opportunities in other geographic territories

Link to KPI's

  • Group sales growth
  • Increase number of strategic partnerships and distribution opportunities

Link to risks

  • Operational – The Group is unable to expand in line with demand
  • Clinical and Regulatory – Loss of license or restriction due to regulatory failings
  • Significant change in political or economic landscape

Commentary

Historically, capacity constraints have impacted the Group’s ability to produce sufficient product to service demand outside of the core US markets. However, with the capacity constraints being alleviated by the capacity expansion programme, we envisage that the Group will be able to expand its outreach into additional geographic territories during 2021 and beyond.

Strategy in action

Focus

Continue to build global sales reach through expansion of distribution partnerships and licensing agreements

Near 6–12 months

  • Continued expansion of UK and EU BioRinse® distribution opportunities
  • Roll out of OrthoPure® XT distribution partnerships in the EU

Mid 12–18 months

  • Expand network of distributors outside of the main US and EU markets
  • Pursue licensing and partnership opportunities to expand geographic reach

Long 18+ months

  • Focus on business development for geographic expansion

Description

Our commercial strategy focuses on establishing and building strategic partnerships to further our market penetration.

This allows for the potential to increase OEM agreements and initiate discussions around joint IP collaborations, as well as extending our geographic reach. Key to this, is also increasing our real world clinical data collection to highlight our clinical differentiators for customers, reimbursement agencies, and strategic partners.

2020 Performance

  • Entered white label manufacturing agreement for new product with top 10 global healthcare company
  • Secured additional strategic and distribution partners for existing product portfolio
  • Launched OrthoPure® XT into the European market securing distribution partners in the UK, Poland and Portugal

Focus and Goals for 2021+

  • Ramp up market penetration of our smaller product lines in collaboration with strategic partners
  • Launch new product developments with strategic partners
  • Enter new clinical applications and geographic territories with new and existing strategic partners

Link to KPI's

  • Group sales growth
  • Clinical data collection

Link to risks

  • Operational - The Group is unable to expand in line with demand
  • Commercial - Competitor product could reach the market first, offer pricing advantages or outperform the Group’s products
  • Clinical – Risk of loss of license or restrictions

Commentary

Despite the challenges that COVID-19 presented to the commercial landscape during 2020, the Group was successful in broadening our base of strategic partnerships and OEM agreements, and remains well positioned to build on these relationships moving forward.

Strategy in action

Focus

Pursue further, and develop existing distribution, licensing or IP collaboration partnerships

Near 6–12 months

  • Enter new clinicalapplication areas and launch product line extensions with existing partners
  • Sign agreements with additional strategic partners

Mid 12–18 months

  • Increase licensing and strategic partnerships

Long 18+ months

  • Pursue further joint IP opportunities

Description

Our success is reliant upon the ability to commercialise our current product portfolio and the potential for augmenting this with product line extensions and new innovative products.

We look to establish a database of compelling clinical data to validate our technology platforms and further our physician conversion rates.

These clinical data portfolios are also imperative when we seek new strategic partnership opportunities for negotiating favourable reimbursement pricing and when navigating regulatory clearance in new territories.

2020 Performance

  • Launched new product in collaboration with top 10 global healthcare company
  • Received CE Mark approval for OrthoPure® XT to commence European roll out
  • Collated two year clinical data for OrthoPure® XT, now publicly available
  • 19 new DermaPure® clinical case studies
  • Two new BioRinse® clinical case studies

Focus and Goals for 2021+

  • Expand opportunities for OrthoPure® XT in the UK and select European markets
  • Launch new product developments with strategic partners, specifically for urogynaecology and wound care applications
  • Commence post marketing clinical studies

Link to KPI's

  • Clinical data collection
  • Improve breath of product portfolio and pipeline
  • IP collaboration

Link to risks

  • Clinical and Regulatory – Loss of license or restriction due to regulatory failings
  • Commercial – Competitor product could reach the market first or outperform the Group’s products
  • Finance – Insufficient funds to commence or complete trials
  • Operational – The Group is unable to expand in line with demand
  • Clinical and Regulatory – Changes to the regulatory landscape for our products

Commentary

During 2020, we brought to market two new products that diversify our product portfolio and also provide additional opportunities with new strategic partners and expand our geographic footprint.

During 2021, we intend to expand the market penetration and opportunities for these products as well as develop further product line extensions to address specific clinical applications where we see a market opportunity and have the capabilities to execute quickly.

Strategy in action

Focus

Bring new products and product line extensions to market from pipeline of products currently in development

Near 6–12 months

  • Launch new product line developments
  • Expand rollout of OrthoPure® XT in the UK and select European markets

Mid 12–18 months

  • Pursue internal and external opportunities to broaden product portfolio

Long 18+ months

  • Collaboration with strategic partners for future product development

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