Material Risks (alphabetical order) Risk Description and Potential Impacts Managing the Risk 10. Regulatory Compliance • A failure to comply with CSL’s complex and evolving legal and regulatory obligations across its global operations, arising from regulatory change, inadequate processes or ineffective governance that could result in breaches of applicable laws and standards. • S uch non-compliance may lead to regulatory sanctions, loss or suspension of product registrations and operating licences, increased scrutiny from regulators, legal proceedings and reputational damage, with potential adverse impacts on operations and financial performance. • C SL has a variety of programs and documented practices in place to ensure compliance with legal and regulatory obligations. • C SL is frequently inspected by independent regulatory authorities auditing compliance with internationally recognised standards across many of the material risks described in this section, and CSL responds to any findings should they occur. As an example, related to Patient Safety and Product Quality risks, this includes good clinical practice (GCP), good manufacturing practice (GMP), good laboratory practice (GLP), good clinical laboratory practice (GCLP), good research laboratory practice (GRLP) and good distribution practice (GDP). • R egulatory-related risks are overseen by the Board and its Committees. Also refer to page 16 (Clinical Trials), page 38 (Additional Material Topics) and page 53 (Environmental regulation and compliance) of this Annual Report. 11. Supply Chain, Plasma Collection, Capacity and Operations • A disruption, failure or inefficiency within CSL’s global supply chain (including transportation networks and all third-party providers), strategic partnerships, plasma collection, manufacturing network or operational processes arising from supplier constraints, capacity limitations, quality issues, infrastructure or equipment, logistics disruptions or external events that could result in an inability to reliably produce and deliver products. • S uch events may lead to supply interruptions, reduced operational efficiency, increased costs and failure to meet customer and patient demand. • G rowth and increasing network complexity introduce additional risks related to capacity adequacy, inventory management and end-to-end supply chain resilience. • C SL constantly monitors the demand for its products over a ten-year horizon as well as its capacity to acquire raw materials essential to the manufacture of CSL products. • D elivering a positive donor experience is important to maintaining CSL’s collection of plasma. In addition to focusing on donor safety (see above), CSL uses modern techniques and technologies in its plasma collection centres to facilitate an efficient donation process. It updates its plasma collection centres to provide a comfortable donor experience. External sources of plasma may be used, as required, to supplement inventory and ensure reliable supply. • C SL endeavours to invest in manufacturing capacity ahead of projected demand so it can meet the supply needs of patients, while balancing the risk of future changes in demand forecasts and market conditions. • I ts operations also accommodate investments in technology and process improvements to enhance efficiency, maintain regulatory compliance and reduce costs. Such improvements encompass strategies to increase the yield of both immunoglobulin and cell-based influenza vaccines, along with boosting the throughput of its existing facilities. • C SL’s global network strategy continually evaluates short-, mid-, and long-term needs to inform decisions on capital and operational expenditures, including the use of expert third-party providers to enable a resilient, reliable and sustainable supply chain. • C SL examines and prioritises its operational effectiveness efforts, capital plans, inventory targets, supply chain visibility, distribution and regulatory strategies to enhance the position of its products from a business continuity and supply chain resilience standpoint. • Supply chain risks are overseen by the ARMC. 23 CSL Limited Annual Report 2025/26
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