Climate Change Data

Cyclopharm Limited

Climate Impact & Sustainability Data (2012, 2017, 2019, 2021)

Reporting Period: 2012

Environmental Metrics

Social Achievements

  • Commenced Phase 3 Clinical Trial in November 2012 at Columbia Presbyterian in New York City for Technegas, a lung imaging device used to diagnose Pulmonary Embolism (PE).

Climate Goals & Targets

Long-term Goals:
  • Becoming Australia's leading provider of FDG and emerging PET radiopharmaceuticals.
Medium-term Goals:
  • Growth in Technegas following regulatory approval in Japan and Russia.
  • Introducing Technegas to the United States market through Phase 3 clinical trial completion.
Short-term Goals:
  • Continued growth in Technegas revenues from targeted marketing in Europe and China.

Environmental Challenges

  • Losses suffered by Molecular Imaging group, Cyclopet, due to aggressive competition from government-owned enterprises (Petnet Australia, a subsidiary of ANSTO).
  • Unfavorable movements in foreign currencies impacting Technegas division profitability.
  • Breach of banking covenants due to losses.
Mitigation Strategies
  • Highlighting market inequity with regulatory authorities and filing a claim with the Australian Federal Court.
  • Implementing operational enhancements in Europe and pursuing sales growth in Asia for Technegas.
  • Capital raising exercise to fund operations of Molecular Imaging Division.

Supply Chain Management

Climate-Related Risks & Opportunities

Reporting Period: 2017

Environmental Metrics

Social Achievements

  • Acquisition of IC Medical, expanding Technegas distribution in Benelux markets and access to respiratory physicians.
  • Restructured German operations, establishing Ireland as the European distribution hub, leading to expected sales and margin increases.

Governance Achievements

  • Appointed Tom McDonald as an independent Non-Executive Director.

Climate Goals & Targets

Medium-term Goals:
  • Expand Technegas revenue and profitability through new indications (COPD, Asthma).
  • Achieve USFDA approval for Technegas sales in the US (targeted for the first half of 2019).
Short-term Goals:
  • Commence sales of Ultralute™ in Europe.
  • Replenish Technegas stocks in China.
  • Increase Technegas sales in France and Germany due to restructuring efficiencies.
  • Recruit 40 patients in the first quarter of 2018 for the USFDA trial and submit an interim study in the second quarter.

Environmental Challenges

  • 8% decrease in sales revenue compared to the previous year, partially due to a planned hiatus in sales to China.
  • Competition from Computed Tomography and DTPA.
  • Restructuring of German operations resulting in a $0.68 million provision.
  • Currency and exchange rate fluctuations.
  • Reliance on distributors and potential loss of key customers.
Mitigation Strategies
  • Renegotiating supply contracts (e.g., France).
  • Expanding Technegas applications to larger markets (COPD, Asthma).
  • Developing alternative sourcing strategies.
  • Formalizing distribution agreements.
  • One-year forward exchange contract for USFDA trial payments.

Climate-Related Risks & Opportunities

Sustainable Products & Innovation

  • Ultralute™

Reporting Period: 2019

Environmental Metrics

Climate Goals & Targets

Medium-term Goals:
  • Expand Technegas’ revenue and profitability by developing additional indications, particularly for asthma and COPD.
Short-term Goals:
  • FDA approval to sell Technegas into the USA market.

Environmental Challenges

  • Legal actions in Germany and Australia against former employees.
  • Disruptions to the supply of nuclear medicine isotopes from ANSTO.
  • IP litigation disruption in Germany.
  • Transition of distribution arrangements in the UK.
  • Global impact of the COVID-19 pandemic.
Mitigation Strategies
  • Vigorously defending intellectual property.
  • Successfully brought an initial civil case against former employee in Germany, receiving a payment of approximately A$339,000.
  • Continuing efforts to recover the remainder of bad debt provision along with other claims.
  • Initiated additional legal proceedings against individuals in Australia linked with former employee.
  • Transitioning distribution arrangements in the UK from a third-party distributor model to direct distribution.
  • Continuing manufacturing activities under the NSW Essential Services Act.
  • Instituting flexible/remote work arrangements where possible.

Supply Chain Management

Climate-Related Risks & Opportunities

Reporting Period: 2021

Environmental Metrics

Social Achievements

  • Appointed Ms Dianne Angus, an experienced Executive and Director in the biotechnology sector as an additional Non-Executive Director.

Climate Goals & Targets

Medium-term Goals:
  • Expand the use of Technegas™ in diagnostic applications beyond Pulmonary Embolism (PE).
  • Expand third-party distribution into Australia.
Short-term Goals:
  • Commencement of sales of Technegas™ in the US.

Environmental Challenges

  • Ongoing challenges and disruption in markets from the global COVID-19 pandemic.
  • Delays to medical procedures in certain markets caused by the ongoing pandemic.
  • Technegas™ service revenue declined marginally over the period, with generator servicing also being impacted globally by travel and access restrictions associated with COVID-19.
  • Litigation in Australia and Germany to defend Cyclopharm’s intellectual property.
  • Changes in the European Union (EU) have required regulators to reassess and recertify all existing medical devices against more onerous Medical Device Regulations, and the scale of this task has slowed the introduction of new products into the EU region.
Mitigation Strategies
  • Securing third-party distribution agreements in Europe and Asia Pacific.
  • Processes in place for rapid commercialisation of Technegas™ in the US.
  • Investing to build the inventory, sales capabilities and infrastructure to support a rapid entry into the US upon USFDA approval.
  • Continuing preparations for US commercialisation of Technegas™.
  • Implementing an updated Quality Management System to include an Electronic Quality Management System (EQMS) at our manufacturing facility in Sydney.
  • Undertaking a comprehensive documentation review of both our medical devices and pharmaceutical products to ensure Cyclopharm meets the compliance requirements of the most recent USFDA guidelines as well as the new International Medical Device Single Audit Program (MDSAP) implemented in 2019 and upcoming compliance with European Medical Device Regulations (MDR).

Supply Chain Management

Climate-Related Risks & Opportunities

Sustainable Products & Innovation

  • Ultralute™ (extends the useful life of Molybdenum-99 generators)