Orphazyme A/S
Climate Impact & Sustainability Data (2019, 2021, 2022)
Reporting Period: 2019
Environmental Metrics
ESG Focus Areas
- Diversity
- Human Rights
- Anti-Corruption
Social Achievements
- Maintained a highly satisfactory employee turnover rate.
- 65.5% female and 34.6% male employees, including 67% female and 33% male employees at director level or above.
- Implemented a whistleblower policy in 2018 with mandatory annual meetings for all employees to address potential violations of respect for diversity and human rights.
- Included in supplier contracts a new condition requiring compliance with the Declaration of Helsinki since 2018.
Governance Achievements
- Established a whistleblower policy to report potential violations of laws and internal policies, including fraud and anti-corruption.
- Familiarized all new employees with company policies regarding anti-corruption via the Employee Handbook.
Climate Goals & Targets
Long-term Goals:
- Expand beyond NPC
Medium-term Goals:
- Lean go-to-market roll-out US in 2020
- Lean go-to-market roll-out EU/ROW in H2 2020 - 2021
Short-term Goals:
- US Early Access Program roll-out in 2020
- Preparations for US launch in 2020
Environmental Challenges
- Lack of sufficient financing.
- Non-compliance with legislation and industry standards.
- Attraction and retention of talent.
Mitigation Strategies
- Raised additional capital through a directed share issue and private placement in February 2020, expected to cover financing needs until well into 2021.
- Increased regulatory resources to facilitate interactions with regulators, actively monitor the regulatory environment, and ensure compliance.
- Implemented new IT-security procedures to reduce the risk of cybercrime.
- Established an attractive workplace with high ethical standards, initiatives for personal and professional development, improved health-wellbeing, work-life flexibility, and participation in Orphazyme’s success through long-term incentive plans.
Supply Chain Management
Responsible Procurement
- Requires all suppliers to comply with the Declaration of Helsinki.
Climate-Related Risks & Opportunities
Reporting Period: 2021
Environmental Metrics
ESG Focus Areas
- Human Rights
- Anti-Corruption & Bribery
- Environment & Climate
- Social / Employees
- Business Ethics
- Data Ethics
Social Achievements
- Reached board of directors diversity target (40% women at year-end 2021).
- Maintained a diverse workforce consisting of 58% women and 42% men.
- Workplace assessment survey: 92% satisfaction with physical work environment; 82% satisfaction with psychosocial work environment.
Governance Achievements
- Continued to train existing employees in business ethics and conflict of interest.
- Continued to include business ethics and conflict of interest in onboarding training of all new employees.
Climate Goals & Targets
Environmental Challenges
- Phase 2/3 trial in IBM did not meet its primary and secondary endpoints.
- Phase 3 trial in ALS did not meet its primary and secondary endpoints.
- Received a Complete Response Letter (CRL) from the FDA for arimoclomol in NPC.
- Negative trend vote by the EMA's CHMP for arimoclomol in NPC.
- Financial difficulties leading to in-court restructuring and sale of assets.
Mitigation Strategies
- Restructuring plan implemented, including employee redundancies and termination of onerous contracts.
- Re-focused activities on gaining approval for arimoclomol in Europe and evaluating the regulatory path forward in the U.S.
- Sale of substantially all assets and business activities to KemPharm Denmark A/S.
Supply Chain Management
Climate-Related Risks & Opportunities
Reporting Period: 2022
Environmental Metrics
ESG Focus Areas
- Human Rights
- Anti-Corruption & Bribery
- Environment & Climate
- Social / Employees
- Data Ethics
Environmental Achievements
- Closed its laboratory space in Q1 2022, minimizing potential environmental risks from hazardous substances.
- Continued to focus on efficient energy use and management of office materials in 2022.
Social Achievements
- Assisted staff with IT and health support both in-office and at home working.
- Established a resilient culture centered on trust and collaboration.
- Conducted redundancy processes in accordance with applicable laws and regulations, with a focus on transparency and support.
Governance Achievements
- Maintained highest standards of conduct and did not tolerate bribery or corruption.
- Conducted anti-corruption and bribery training for employees.
Climate Goals & Targets
Medium-term Goals:
- Increase the representation of women on the Board of Directors to 40% by 2026.
Environmental Challenges
- Securities litigation in the United States.
- Retention of key personnel.
- Limited operating business activities and employees following the sale of assets.
- Uncertainty regarding future prospects.
- Potential need to adjust gross to net revenue estimate due to rebates granted to co-financing healthcare authorities.
- Risks related to the Sale of Assets (liability based on contractual obligations).
- Non-compliance with legislation and industry standards.
- Currency risk (DKK, USD, EUR).
- Political and geopolitical conflict (Ukraine conflict).
Mitigation Strategies
- Reached an agreement in principle to settle the class action lawsuit in its entirety.
- Measures in employment contracts to provide time and flexibility to seek alternative solutions in the event of an executive departure.
- Employment agreement with CEO/CFO Anders Vadsholt (six-month notice period).
- Operating business activities in a lean and cost-efficient manner to conserve capital.
- Ongoing assessment of ways to maximize value for shareholders.
- Continued to respect internationally declared human rights and did not employ child labor.
- Followed established procedures for the use and disposal of hazardous substances (no longer relevant due to laboratory closure).