Climate Change Data

IRRAS AB (publ)

Climate Impact & Sustainability Data (2020, 2021, 2022)

Reporting Period: 2020

Environmental Metrics

Social Achievements

  • Launched IRRAS Academy mobile application, downloaded almost 1000 times; providing detailed training videos for every aspect of patient treatment.

Governance Achievements

  • IRRAS AB applies the Swedish Corporate Governance Code.

Climate Goals & Targets

Short-term Goals:
  • Increasing patient treatments and growing revenue by adding reference accounts for IRRAflow throughout the United States and Europe, increasing the contribution of distribution partners, and launching the Hummingbird product family in Europe.

Environmental Challenges

  • COVID-19 pandemic impacted commercial activities, reducing hospital access and travel restrictions; impacting sales and training.
  • Hospital treatment volumes were down, budgets were strictly scrutinized and hospitals favoured different placement agreements for IRRAS control units over a capital purchase.
Mitigation Strategies
  • Adjusted commercial strategies to better support physicians and patients remotely; developed a comprehensive set of world-class digital sales and training capabilities (IRRAS Academy app).
  • Focused commercial efforts on expanding and training European distribution partners; generating patient treatment experience and clinical data to build its key opinion-leading neurosurgeons network.

Supply Chain Management

Climate-Related Risks & Opportunities

Reporting Period: 2021

Environmental Metrics

Social Achievements

  • Increased average number of women employees in the Group to 26 (from 16 in 2020).

Governance Achievements

  • IRRAS secured MDSAP certification, enabling pursuit of key regulatory clearances.
  • The company's quality management system received certification under the Medical Device Single Audit Program (MDSAP).

Climate Goals & Targets

Long-term Goals:
  • Establishing a leading position in the neurocritical care market.
Medium-term Goals:
  • Launching the Hummingbird product family in Europe after receiving CE Mark certification.
  • Introducing next-generation IRRAflow capital equipment and extended shelf-life for disposable products.
Short-term Goals:
  • Increasing commercial adoption and continuing revenue growth in 2022.
  • Adding reference accounts for IRRAflow throughout the United States and Europe.
  • Increasing the contribution of distribution partners.

Environmental Challenges

  • Continued impact of the COVID-19 pandemic on commercial activities, including travel restrictions and reduced neurosurgical ICU capacity.
  • Extended product approval process at new hospitals (6-9 months), particularly due to COVID-related budget scrutiny.
  • Hospitals favoring disposable usage agreements instead of capital purchases for IRRAS control units.
Mitigation Strategies
  • Investment in mobile training resources to overcome COVID travel restrictions.
  • Development of next-generation software to guide nurses through patient treatment.
  • Shifting commercial investment toward education resources.
  • Strategic focus on customers where access and interactions remained possible.
  • Maintaining sales and marketing spending at a comparable level to the beginning of 2020.

Supply Chain Management

Climate-Related Risks & Opportunities

Reporting Standards

Frameworks Used: IFRS

Certifications: ISO 13485:2016, MDSAP

Third-party Assurance: KPMG AB

Reporting Period: 2022

Environmental Metrics

ESG Focus Areas

  • Sustainability

Social Achievements

  • Continuous focus on competency development, work environment, and equality.

Governance Achievements

  • IRRAS AB applies the Swedish Corporate Governance Code.

Climate Goals & Targets

Medium-term Goals:
  • Revenue: SEK 350 million by 2025
  • Gross margin: > 60% by 2025
  • Cash flow breakeven by 2025

Environmental Challenges

  • Consequences of Covid-19, including setbacks in growth opportunities and supplier flows.
  • Overwhelmed reimbursement systems in some key markets.
  • High barriers of entry in a traditionally conservative target market.
  • Risks related to competitors developing superior technology and products.
  • Risks related to product quality not meeting customer expectations.
  • Risks related to adapting to ever-changing macroeconomic development.
  • Risks related to R&D project delays, increased costs, or unsuccessful outcomes.
  • Risks related to impairment of capitalized expenditures.
  • Risks related to clinical study delays, inconclusive results, or unfavorable safety profiles.
  • Risks of business interruptions due to supply chain issues.
  • Risks related to protecting intellectual property or infringement of third-party patents.
  • Risks of litigation and other claims.
  • Dependence on key individuals.
  • Risks related to IT system failures and security breaches.
  • Currency risks due to transaction and translation exposure.
  • Risks related to historic losses and the need for continued external financing.
  • Risks related to share price volatility and limited trading volume.
  • Risks related to product liability requirements.
  • Risks related to complex tax laws and regulations in multiple countries.
  • Risks related to timely payments of taxes and fees.
Mitigation Strategies
  • Bringing more manufacturing in-house to secure long-term viability.
  • Shifting sales focus towards the US market.
  • Generating meaningful clinical data to demonstrate product superiority.
  • Expanding the partnership with Medtronic to increase product awareness and adoption.
  • Proactive steps with vendors to ensure required production demand can be met.
  • Continuous review of insurance coverage to ensure adequacy.
  • Continuous assessment of the Group’s short- and long-term liquidity and financial resources.
  • Continuous efforts to adhere to all applicable laws and regulations.

Climate-Related Risks & Opportunities

Reporting Standards

Frameworks Used: IFRS

Certifications: ISO 13485:2016, FDA 21 CFR Part 820, MDSAP

Third-party Assurance: KPMG AB