Climate Change Data

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).

Supply Chain Management

Climate-Related Risks & Opportunities