Climate Change Data

BioPorto A/S

Climate Impact & Sustainability Data (2019, 2023)

Reporting Period: 2019

Environmental Metrics

ESG Focus Areas

  • Human rights
  • Labor rights
  • Environment
  • Anti-corruption
  • Diversity & Inclusion

Environmental Achievements

  • Reduced paper consumption through double-sided printing in 2019 compared to 2018.

Social Achievements

  • Established a Code of Conduct covering human rights and labor rights in 2017.
  • Implemented the Code of Conduct into supplier contracts.
  • Provided human rights training for all employees, including new hires.
  • Maintained a safe and healthy work environment with zero work-related injuries and zero employee-related union cases in 2019.
  • Endeavored to achieve an equal gender breakdown and diversity of educational backgrounds, nationalities, and cultures in its staff.
  • Set a target for at least 25% women in management by 2022.

Governance Achievements

  • Added two new US Board members in 2019, bringing US experience and competencies to the Board.
  • Completed a private placement cash issue, raising DKK 36.7 million in June 2019.
  • Established three warrant programs in 2019 to incentivize and retain management and employees.
  • Complied with all but three of the Committee for Corporate Governance recommendations.

Climate Goals & Targets

Long-term Goals:
  • Review new opportunities for NGAL and BioPorto’s antibody library; define a pipeline of targeted assays and biomarkers.
Medium-term Goals:
  • Collect supplementary data to support submission of an application for The NGAL Test in adults.
  • Grow total revenue by 10%.
Short-term Goals:
  • Commence and finalize collection of additional patient data for the FDA application of The NGAL Test for pediatrics.
  • Obtain FDA approval of The NGAL Test for pediatrics.

Environmental Challenges

  • FDA concerns about potential bias in the dataset for the pediatric NGAL Test application.
  • Ceased collaboration with an antibody supplier, impacting antibody revenue.
  • Increased costs related to building the US organization and clinical studies.
  • Increased market volatility and negative reactions due to the COVID-19 outbreak, delaying financing.
Mitigation Strategies
  • Supplemented the pediatric NGAL Test application with additional data to address FDA concerns.
  • Narrowed strategic focus to its own antibodies and biomarkers.
  • Strengthened the US organization with experienced personnel in medical, clinical, and regulatory affairs.
  • Pursued additional financing to support operations.

Supply Chain Management

Responsible Procurement
  • Initiated a process of implementing the Code of Conduct into supplier contracts to ensure that suppliers respect human rights and comply with labor rights.

Climate-Related Risks & Opportunities

Reporting Standards

Frameworks Used: UN Global Compact

Reporting Period: 2023

Environmental Metrics

ESG Focus Areas

  • Human rights
  • Labor rights
  • Environment
  • Anti-corruption
  • Diversity

Environmental Achievements

  • Continued initiatives to minimize environmental impact, including reduced paper consumption, sustainable cleaning equipment, and enhanced waste recycling.
  • Zero environmental incidents reported in 2023.

Social Achievements

  • Implemented a whistleblower scheme, providing a confidential avenue to report human rights violations or unethical behavior.
  • Zero incidents of human rights violations reported in 2023.
  • Zero employee-related cases with unions and zero work-related injuries in 2023.
  • Increased proportion of female employees to 61% and maintained 61% non-Danish employees.
  • Adopted a Diversity Policy committed to equal opportunities for all employees.

Governance Achievements

  • Implemented all but four recommendations from the Committee of Corporate Governance for companies listed on the Nasdaq Copenhagen Stock Exchange.
  • Published a statutory report on Corporate Governance for 2023.
  • Conducted an external self-evaluation of the Board's performance, with positive conclusions.
  • Updated Remuneration Policy and prepared a Remuneration Report in accordance with the Danish Companies Act.
  • Established a Code of Conduct and a whistleblower scheme.

Climate Goals & Targets

Long-term Goals:
  • Reach USD +100m in revenue with increased profitability by 2029.
  • Submit a clearance application to the FDA for adult NGAL use in 2026, enabling US commercialization in 2027.
Medium-term Goals:
  • Reach total revenue of USD 15-25m and become cash flow positive and EBITDA neutral by 2026.
  • Expand the use of ProNephro AKI™ NGAL Tests in the US for pediatric and young adults (Growth driver 2024-2026).
  • Increase sales of NGAL Tests for adults in CE mark countries (Growth 2024-2026).
Short-term Goals:
  • Achieve 30% revenue growth in 2024 (DKK 40m or USD 6m).

Environmental Challenges

  • Market acceptance of products may be lengthy and difficult.
  • Timing of future clinical trials depends on external factors.
  • Failure to commercialize NGAL tests could adversely affect future revenues.
  • Product benefits may not demonstrably drive market adoption.
  • Public health events could impact business.
  • Attracting and retaining qualified personnel in a competitive environment.
  • Complex manufacturing processes.
  • Dependence on sole-source suppliers for raw materials.
  • Patent expirations leading to increased competition.
  • Changes in regulations.
  • Need for additional capital.
  • Incurred net losses and may continue to do so.
  • Obtaining Freedom to Operate in relevant markets.
  • Competition from other companies.
  • Performance of subcontractors.
  • Cyber-attacks.
  • Risks related to trade receivables and inventory.
  • Changes in USD exchange rate and financing costs.
  • Tax risks.
  • Risks related to IT.
Mitigation Strategies
  • Trained commercial and medical liaison personnel, HEOR and reimbursement dossiers to payers.
  • Alignment with competent CRO and internal R&D talent.
  • Key partner negotiations and commercial enablement, customer case stories, and peer-to-peer support.
  • Recent FDA clearance of ProNephro AKI (NGAL).
  • Constantly monitoring news and medical outlets.
  • Offering meaningful work growth opportunities and using tools like LinkedIn.
  • In-house qualified production leadership and personnel.
  • Developing dual-source supply for critical raw materials.
  • Creating new intellectual property and new product introductions.
  • Regulatory intelligence and compliance execution.
  • Financing strategy and plan.
  • Multiyear financial strategy and plans.
  • Freedom to Operate analysis.
  • Creating new intellectual property and new product introductions.
  • Ensuring alternative suppliers for critical subcontractors.
  • Investing in development pipelines, communication with customers, and creating new intellectual property.
  • MFA, device recognition, data recovery processes, phishing awareness, training programs, IT security through Company’s IT suppliers and cyber security insurance.
  • Low expected credit losses and plans to expand key inventory suppliers.
  • Natural hedge for USD expenses and potential for meaningful revenue growth.
  • Use of tax experts.
  • See Cyber-attacks above.

Supply Chain Management

Responsible Procurement
  • Implementing the Code of Conduct into supplier contracts to ensure that suppliers respect human rights and comply with labor rights.

Climate-Related Risks & Opportunities

Reporting Standards

Frameworks Used: UN Global Compact

Third-party Assurance: Deloitte Statsautoriseret Revisionspartnerselskab