Observe Medical ASA
Climate Impact & Sustainability Data (2019, 2020, 2021, 2022, 2023)
Reporting Period: 2019
Environmental Metrics
Total Carbon Emissions:11.5 tCO2e (direct from company vehicles)
Scope 1 Emissions:Not disclosed
Scope 2 Emissions:Not disclosed
Scope 3 Emissions:Not disclosed
Renewable Energy Share:Not disclosed
Total Energy Consumption:Not disclosed
Water Consumption:Not disclosed
Waste Generated:Not disclosed
Carbon Intensity:Not disclosed
ESG Focus Areas
- Hospital Acquired Infections
- Corporate Governance
- Employee Well-being
- Environmental Impact (Transportation)
Environmental Achievements
- Reduced direct CO2 emissions from company vehicles to 11.5 metric tons of CO2.
Social Achievements
- Employee absenteeism rate for illness was 5.5% with no serious work-related injuries.
- Two out of four board members are women.
Governance Achievements
- Implemented a corporate governance regime based on the Norwegian Corporate Governance Code.
- Quality Management System re-certified by Intertek according to SS-EN ISO 13485:2016.
Climate Goals & Targets
Long-term Goals:
- Establish Sippi® as a global niche leader.
Medium-term Goals:
- Not disclosed
Short-term Goals:
- Continue Sippi® launch rollout in Nordics and rest of Europe, preparing for US market entry.
Environmental Challenges
- The COVID-19 situation with national travel restrictions and a fully occupied healthcare system constrained the launch efforts for Sippi®, slowing down or stalling some sales projects.
- The company is focused on one product (Sippi®), making it vulnerable to competition and market risks.
- Potential for malfunction of the technology in complex ICU environments.
- Dependence on distributors for foreign markets.
Mitigation Strategies
- Observe Medical operates at full capacity and is working according to plan, focusing on the international launch and sales of Sippi®.
- Investments in continuous product development and an efficient commercialization strategy.
- Comprehensive measures to protect intellectual property rights.
- Monitoring its value chain closely and maintaining an active profile towards the equity market.
Supply Chain Management
Supplier Audits: Not disclosed
Responsible Procurement
- Not disclosed
Climate-Related Risks & Opportunities
Physical Risks
- Not disclosed
Transition Risks
- Not disclosed
Opportunities
- Not disclosed
Reporting Standards
Frameworks Used: Norwegian Corporate Governance Code
Certifications: ISO 13485:2016
Third-party Assurance: Not disclosed
UN Sustainable Development Goals
- Not disclosed
Not disclosed
Sustainable Products & Innovation
- Sippi® with SippCoat® technology to prevent urinary tract infections.
Awards & Recognition
- Not disclosed
Reporting Period: 2020
Environmental Metrics
Total Carbon Emissions:5 metric tonnes of CO2 (from company vehicles)
ESG Focus Areas
- Working environment
- Business ethics, including supply chain management
- Environmental impact
- Product safety
Environmental Achievements
- Introduced a new company car policy which encourages employees to use an electrical or hybrid car
Social Achievements
- Entered into a bargaining agreement with IKEM, providing employees with good pension and insurance schemes
Governance Achievements
- Adopted and implemented a corporate governance regime based on the Norwegian Corporate Governance Code
Climate Goals & Targets
Short-term Goals:
- Promote more females to senior positions
- Establish and carry out regular employee surveys
- Complete the Employee Handbook
- Establish an external whistleblowing channel
- Start climate accounting on scope 1, 2 and 3
- Zero fossil company cars
- Transition to Medical Device Regulation (MDR)
- Establish a Group wide environmental policy
- Establish a Group wide CSR Policy / Code of Conduct
- Establish a Group wide supplier Code of Conduct
- Provide training on insider information regulations to employees
- Establish a Quality Management System (QMS) with relevant policies/manuals for the entire Group
Environmental Challenges
- COVID-19 situation impacting launch efforts for Sippi®, slowing down sales projects
- Increased competition may lead to reduced pricing potential
- Risk of malfunction of Sippi® technology in complex ICU environments
- Dependence on distributors' ability to perform in foreign markets
- Risk in upscaling production
Mitigation Strategies
- Focusing on accelerating clinical use in the Nordics and selected European markets
- Continuous product development and efficient commercialization strategy
- Comprehensive measures to protect intellectual property rights
- Active profile towards the equity market with a transparent investor relations strategy
- Initiatives to increase revenues from acquired portfolio, reduce spending, and improve operational efficiency
Supply Chain Management
Responsible Procurement
- All suppliers are screened using criteria related to business ethics prior to entering new contracts
Climate-Related Risks & Opportunities
Reporting Standards
Frameworks Used: Oslo Børs’ guidelines for sustainability reporting (Euronext guidelines)
Certifications: ISO 13485:2016
Sustainable Products & Innovation
- Sippi® (digital urine meter)
- SippCoat® (biofilm prevention technology)
Reporting Period: 2021
Environmental Metrics
ESG Focus Areas
- Working environment
- Business ethics, including supply chain management
- Environmental impact
- Product safety
Social Achievements
- Decreased employee turnover rate from 27% in 2020 to 13% in 2021.
- Increased share of female employees to 57% in 2021 (from 55% in 2020).
Governance Achievements
- Adopted a corporate governance regime based on the Norwegian Corporate Governance Code and Market Abuse Regulation (MAR).
Climate Goals & Targets
Short-term Goals:
- Seek gender balance in senior positions
- Establish and carry out regular employee surveys
- Complete the Employee Handbook
- Establish an external whistleblowing channel
- Establish a Group wide CSR Policy / Code of Conduct
- Establish a Group wide supplier Code of Conduct
- Provide further training on insider information regulations to employees
- Observe Medical will further work to understand how to reduce our environmental footprints, direct and indirect
- Establish a Group Environmental Policy with guidelines that outlines how to improve environmental performance
- Complete transition to Medical Device Regulation (MDR)
- Establish a joint Quality Management System (QMS) with relevant policies/manuals for the entire Group
Environmental Challenges
- COVID-19 pandemic significantly delayed the planned roll-out of Sippi®.
- Risk of malfunction of Sippi® technology in complex ICU environments.
- Risk of competing product launches with better features or market penetration.
- Risk of unfavorable outcomes in clinical studies impacting new claims for Sippi®.
- Dependence on distributors' ability to perform in foreign markets.
- Risks in upscaling production.
- Supply chain disruptions due to the war in Ukraine and the COVID-19 pandemic.
- Risk of failure to protect intellectual property rights.
Mitigation Strategies
- Continuous product development and efficient commercialization strategy.
- Close monitoring of the geopolitical situation and supply chains.
- Comprehensive measures to protect intellectual property rights.
- Company car policy allowing only electric or plug-in hybrid cars.
- Active post-market surveillance process compliant with MDR and ISO 13485.
Supply Chain Management
Responsible Procurement
- CSR policy and code of conduct for suppliers implemented for Observe Medical Nordic AB. Group-wide policies and code of conduct under development.
Climate-Related Risks & Opportunities
Reporting Standards
Frameworks Used: Oslo Børs’ guidelines for sustainability reporting (Euronext guidelines)
Certifications: ISO 13485:2016 (Observe Medical AB)
Sustainable Products & Innovation
- Sippi® (automated digital urine meter)
- SippCoat® (technology that hampers biofilm formation)
Reporting Period: 2022
Environmental Metrics
ESG Focus Areas
- Working environment
- Business ethics, including supply chain management
- Environmental impact
- Product safety
Environmental Achievements
- Reduced travel activity by using video conferencing tools
- Company car policy allowing only electric or plug-in hybrid cars
Social Achievements
- Zero reported incidents of discrimination
- Implemented a digital group Quality Management System
Governance Achievements
- Established routines and Code of Conduct that covers due diligences on suppliers
- Implemented a digital group Quality Management System
Climate Goals & Targets
Long-term Goals:
- Not disclosed
Medium-term Goals:
- Not disclosed
Short-term Goals:
- Seek gender balance in senior positions
- Complete Employee Handbooks for the Group
- Establish an external whistleblowing channel
- Establish a Group wide CSR Policy / Code of Conduct
- Establish a Group wide supplier Code of Conduct
- Provide further training on insider information regulations to new employees
- Further work to understand how to reduce environmental footprints
Environmental Challenges
- Loss of Covid-19 related revenues
- Increased operating expenses due to Biim Ultrasound consolidation
- Supply chain disruptions due to the war in Ukraine and post-Covid-19 effects
- Risk of competing product launches
- Risk of malfunction of Sippi® technology
- Dependence on distributors' ability to perform
- Risk of not succeeding in acquiring the Unometer™ portfolio
- Liquidity risk due to insufficient working capital
Mitigation Strategies
- Completed a Rights Issue of NOK 180 million
- Entered into loan agreements with shareholders
- Actively seeking synergistic opportunities (acquisitions)
- Securing key hires
- Investing in sales channels and resources
- Exploring potential finance providers and investors
- Developing cost-efficient manufacturing alternatives
Supply Chain Management
Responsible Procurement
- CSR policy and code of conduct for suppliers implemented for Observe Medical Nordic AB
- All suppliers are screened using criteria related to business ethics
Climate-Related Risks & Opportunities
Reporting Standards
Frameworks Used: Oslo Børs’ guidelines for sustainability reporting (Euronext guidelines)
Certifications: ISO 13485:2016
Reporting Period: 2023
Environmental Metrics
ESG Focus Areas
- Working environment
- Business ethics, including supply chain management
- Environmental impact
- Product safety
Social Achievements
- Implemented a digital group Quality Management System (QMS) that covers development, manufacturing and sales of medical devices in all legal entities and sites within the group
Governance Achievements
- Adopted a corporate governance regime based on, and in all material aspects in compliance with the Norwegian Corporate Governance Code
Climate Goals & Targets
Short-term Goals:
- Seek gender balance in senior positions
- Complete Employee Handbooks for the Group
- Establish an external whistleblowing channel
- Establish a Group wide CSR Policy / Code of Conduct
- Establish a Group wide supplier Code of Conduct
- Provide further training on insider information regulations to new employees
- Observe Medical will further work to understand how to reduce our environmental footprints, direct and indirect
- Establish a Group Environmental Policy with guidelines that outlines how to improve environmental performance
Environmental Challenges
- Increased competition may lead to reduced pricing potential for Observe Medical’s products
- Main operational risk short term for Biim relates to the continued roll-out and degree of adoption of the product in Fresenius Medical Care’s dialysis clinics in the US
- Geo-political factors disrupting global supply chains
- Liquidity challenges
Mitigation Strategies
- Initiated short-term cost-saving measures, including temporary layoff of staff
- Engaged in constructive dialogues with its creditors to manage short-term liquidity
- Completed a Rights issue to cover working capital needs
- Entered into an agreement on the purchase of receivables with Avida to reduce credit risk and improve working capital
Supply Chain Management
Responsible Procurement
- CSR policy and code of conduct for suppliers implemented for Observe Medical Nordic AB
- All suppliers are screened using criteria related to business ethics prior to entering new contracts
Climate-Related Risks & Opportunities
Reporting Standards
Frameworks Used: Oslo Børs’ guidelines for sustainability reporting (Euronext guidelines)
Certifications: ISO 13485:2016
Sustainable Products & Innovation
- Sippi® digital urine meter