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