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Key risks
Commercial
Corporate
Clinical and
Regulatory
IP / Licensing
Pricing: There is no guarantee that the Company's products will obtain anticipated selling prices or reimbursement levels, which may impact profitability and
marketability of the products.
Competition: Telix's industry is highly competitive. Many competitors have greater resources to invest including into product development and brand
recognition.
Supply Chain: Telix depends on third parties for the supply of critical materials for the manufacture of products, highly-specialised manufacturing of products,
and the distribution of products once manufactured. Telix may experience disruptions to its supply chain, such as: a shortage of raw materials; lack of capacity
by Telix's key manufacturers to provide the required services during appropriate timeframes; manufacturing quality risks; disruptions associated with distribution
and logistics; labour shortages; and an inability to pass on increased costs of any of the above.
Financial: Proceeds from the Offer may be insufficient for the Company to reach financial self-sustainability if sales are lower than anticipated over the long
term. As a result, Telix may need to raise further capital through equity financing or other means.
Key Person(s): Telix's ability to execute its business plan is highly dependent upon the efforts and abilities of a number of key staff. Telix seeks to maintain
high retention rates through the establishment of a high-quality working environment, competitive salary packages including STI/LTI components and
performance benchmarking, however, this may not be sufficient to attract and maintain the required skilled workforce.
Foreign Exchange: The Group conducts certain clinical and regulatory activities internationally, and accordingly has foreign currency liabilities in Euro (EUR)
and United States Dollars (USD), giving rise to a currency and foreign exchange risk. The Group maintains foreign currency bank accounts denominated in
USD in order to minimise this risk.
Regulatory Approvals: The Company will need approvals from the US FDA and European EMA to commercialise and market approved products, as well as
equivalent regulatory authorities in other foreign jurisdictions to commercialise in those regions. The Company may not receive the necessary regulatory
approvals for any given product.
Regulatory Compliance: Telix is required to comply with a broad range of legal and regulatory requirements (including competition law, anti-bribery, GDPR
and privacy laws). Telix has implemented a commercial compliance system to ensure its regulatory compliance. However, global regulation is multi-disciplinary
and complex and there is a risk that Telix may breach or fail to meet one or more of its compliance and regulatory obligations.
Clinical Trials: Each clinical development phase has a distinct and significant risk of failure or delay, including not meeting clinical endpoints or delay from
extrinsic factors.
Licensors: Most of Telix's products are being developed under license. These licenses come with performance conditions attached which may be triggered if
Telix fails to meet particular milestones. Telix may also encounter potential challenges if a licensor attempts to terminate a licence or enters insolvency.
Intellectual Property: The Company's success will depend partly on its ability to obtain and maintain commercially useful patent claims for its products. Telix
seeks to utilise effective advisory, in-house IP management resources and an internal technical team to effectively manage its product IP, however, any failings
with this system may have a detrimental impact on the Company.
Telix Pharmaceuticals Limited (ASX: TLX)
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TELIX
PHARMACEUTICALSView entire presentation