Climate Change Data

Environmental Metrics

Social Achievements

• SelectMDx inclusion in European Urology Association (EAU) clinical guidelines.
• SelectMDx inclusion in the Dutch Diagnosis Related Groups (DRG) reimbursement system.
• Publication of US and EU health economic studies showing SelectMDx cost savings.

Governance Achievements

• Adoption of the 2009 Belgian Corporate Governance Code, with explanations for deviations.
• Establishment of an audit committee and a nomination and remuneration committee.
• Annual assessment of the Board of Directors, its committees, and individual directors.

Climate Goals & Targets

Environmental Challenges

• Commercial challenges in the US, resulting in lower-than-expected ConfirmMDx adoption and revenue.
• Increased operating expenses in 2018 due to increased selling expenses in the US.

Mitigation Strategies

• New leadership with CEO Michael K. McGarrity.
• Refocused strategy on ConfirmMDx and SelectMDx, reducing operating expenses and delaying certain pipeline initiatives.
• Targeted commercial plan to drive revenue growth.

Supply Chain Management

Climate-Related Risks & Opportunities

Reporting Standards

Frameworks Used: IFRS

Certifications: CLIA, ISO 9001, CAP

Third-party Assurance: BDO Réviseurs d’Entreprises SCRL

Environmental Metrics

Climate Goals & Targets

Environmental Challenges

• The ongoing outbreak of the novel coronavirus (“COVID-19”) resulted in significant declines in sales of the Company’s ConfirmMDx and SelectMDx tests during 2020, adversely affected sales in 2021, and could continue to impact volumes in 2022, and the business may experience other adverse effects as a result of the pandemic.
• We have a history of losses, and expect to incur net losses in the future and may never achieve profitability.
• We might require substantial additional funding to continue our operations and to respond to business needs or take advantage of new business opportunities, which may not be available on acceptable terms, or at all.
• Our commercial success will depend on the market acceptance and adoption of our current and future tests.
• Our financial results are largely dependent on sales of one test, and we will need to generate sufficient revenues from this and other future solutions to grow our business.
• We face uncertainties over the reimbursement of our tests by third party payors.
• Billing and collections processing for our tests is complex and time-consuming, and any delay in transmitting and collecting claims could have an adverse effect on revenue.
• Our business and reputation will suffer if we are unable to establish and comply with, stringent quality standards to assure that the highest level of quality is observed in the performance of our tests.
• We expect to make significant investments to research and develop new tests, which may not be successful.
• Failure to comply with governmental payor regulations could result in us being excluded from participation in Medicare, Medicaid or other governmental payor programs, which would adversely affect our business.
• We conduct business in a heavily regulated industry, and changes in regulations or violations of regulations may, directly or indirectly, adversely affect our results of operations and financial condition and harm our business.
• If the FDA were to begin requiring approval or clearance of our tests, we could incur substantial costs and time delays associated with meeting requirements for premarket clearance or approval.
• The dual listing of our ordinary shares and ADSs following the U.S. offering may adversely affect the liquidity and value of the ADSs.

Supply Chain Management

Climate-Related Risks & Opportunities

Reporting Standards

Frameworks Used: IFRS

Certifications: CAP, CLIA, ISO 13485:2016

Third-party Assurance: BDO Réviseurs d’Entreprises. SRL

Environmental Metrics

Climate Goals & Targets

Environmental Challenges

• History of losses and expectation of future net losses.
• Potential need for substantial additional funding.
• Market acceptance and adoption of tests.
• Reliance on sales of one test.
• Uncertainty over reimbursement of tests.
• Complex and time-consuming billing and collections.
• Maintaining stringent quality standards.
• Significant investments in R&D.
• Compliance with governmental payor regulations.
• Compliance with regulations in a heavily regulated industry.
• Potential FDA requirements for approval or clearance of tests.
• Increased costs of dual listing on NASDAQ and Euronext Brussels.
• Additional regulatory compliance requirements as a U.S. public company.
• Potential control by certain significant shareholders.
• Fluctuation in share price.
• Trading on multiple markets.
• Potential future capital increases diluting existing shareholders' interests.
• Supply chain disruptions.
• Data security and privacy risks.
• Potential loss of foreign private issuer status.

Mitigation Strategies

• Capital increase completed in February 2023.
• Diversification of revenue through acquisition of GPS test and launch of Resolve mdx.
• Ongoing efforts to secure and maintain favorable coverage and reimbursement.
• Stringent quality management systems and compliance programs.
• Investment in R&D and new product development.
• Compliance programs and internal controls.
• Dual listing compliance initiatives.
• Internal control systems.
• Standstill undertaking and agreements with executive officers, directors, and shareholders regarding share sales.
• Alternative sourcing strategies (for supply chain disruptions).
• Data protection measures.
• Contingency plans for loss of foreign private issuer status.

Supply Chain Management

Climate-Related Risks & Opportunities

Reporting Standards

Frameworks Used: IFRS

Certifications: CAP, CLIA, ISO 13485:2016

Third-party Assurance: BDO Réviseurs d’Entreprises. SRL