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Key risks
Operations
Environmental
COVID-19
•
Quality Assurance: Telix operates in a complex, highly regulated environment relating to the manufacture and supply of medical treatments for humans. Telix
has implemented a Quality Management System (QMS) which is paramount to ensuring patient safety, however, for issued product that is not in line with Telix
and global specifications, Telix may incur liabilities such as product recall obligations.
IT and Infrastructure: TLX remains open to threats of cyber-attack, data theft and data loss.
Seneffe decommissioning and buildout: Telix has decommissioned two cyclotrons from a brownfield site in Belgium and is installing a new cyclotron as it
plans for operations at 'Telix Manufacturing Solutions'. This will require significant management time from Telix as it establishes appropriate monitoring, training
and review processes to ensure that this decommissioning and construction is completed in accordance with all applicable laws and regulations, including any
environmental laws.
Environmental safety: There is a risk associated with the production, transportation and storage of radiopharmaceutical products. In the event that there is
environmental damage arising from an issue with such products, Telix may incur significant costs in mitigation and remediation of such damage. Telix seeks to
use qualified suppliers for the transport of product and materials, and provide comprehensive employee training regarding these risks, however, this may not be
sufficient to prevent such incidents from occurring.
As a result of the COVID-19 pandemic, Telix may experience further disruptions that could potentially lead to additional delays in accomplishing key business
objectives. Key risks include:
Impact on supply chain - including CMOs whose facilities are seconded for vaccine and therapy manufacturing; and transport / logistics with border
restrictions across and within country borders.
Impact on manufacturing capacity - worldwide distribution issues may have a negative impact on operations in biologics, radiochemistry and fill finish.
Impact on clinical trials - Telix may face difficulties recruiting clinical trial participants in the context of COVID-19, in particular due to the vulnerable
nature of Telix's targeted participants. There may also be disruptions to clinical trials due to health care facilities prioritising management and treatment of
COVID-19 patients, and unavailability of staff due to COVID-19 infection or isolation requirements.
Impact on regulatory reviews - Government-mandated isolation and/or border control policies may impact Telix employees and/or employees
of regulatory agencies. Reductions in workforce availability may impact the timing for the submission and/or review of regulatory applications. Such
delays may further impact timing for future approval decisions and/or commercialisation of associated products.
Impact on workplace morale: Telix has a strong focus on culture, values and workplace health and safety, and has number of wellbeing initiatives in
place to seek to address existing and potential future impacts of the pandemic. Those initiatives may not all be successful and Telix may experience loss of
key staff and/or reduced workforce capacity.
Telix Pharmaceuticals Limited (ASX: TLX)
TELIX
PHARMACEUTICALS
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