Other material disclosure topics The below topics were identified as material topics for disclosure that CSL considers business as usual and a part of its processes. Product quality and safety Ensuring patient safety and product integrity in the development, manufacture and supply of safe, high-quality products is essential to CSL’s ability to protect public health, save lives and improve outcomes for patients with rare and serious diseases. CSL’s independent quality function plays a critical role in delivering on this commitment. It operates to high global standards, supported by a robust framework of global policies, harmonised local procedures and integrated electronic systems that enable consistent and effective management of quality processes across all operations. During the reporting period, CSL’s operations were subject to 381* regulatory inspections worldwide, covering quality systems, plasma collection and manufacturing activities. This included 30* Good Manufacturing Practice (GMP) inspections at manufacturing sites and distribution centres, and 351* inspections at plasma collection centres. These independent reviews are a key mechanism for supporting compliance with regulatory expectations and maintaining stakeholder trust. Importantly, these inspections resulted in no* critical findings that prevented product release, and there were no suspensions or terminations of product licences in any market where CSL operates. Demonstrating how CSL’s global quality framework supports compliance, operational excellence and alignment with regulatory expectations worldwide. In the reporting period, there were four Class II (urgent safety-related) product recalls* initiated. These recalls did not have any impacts to patients. Two recalls involved Hizentra pre-filled syringes (10 mL and 20 mL presentations) distributed in Canada. Both recalls were initiated following technical complaints reporting atypical product appearance. One recall involved a batch of Stonefish Antivenom manufactured by Seqirus. The recall was initiated after a single batch failed to meet the registered potency specification (≥1,400 U/vial) at the 14-month stability time point. One recall involved an In-licensed product for which Seqirus is the Marketing Authorisation Holder. The action followed a complaint identifying inadequate sealing of the blister foil for the 100 mg sustained-release tablets. As the product is classified as a Schedule 8 (S8) medicine, child-resistant packaging is required. The compromised blister integrity was therefore assessed as a significant packaging defect. Investigations conducted by both the manufacturer and Seqirus concluded that the event was isolated in nature. The most probable root cause was identified as a material-handling error during the blister foil setup process at the manufacturing site, resulting in partial or complete loss of sealing integrity. Appropriate corrective and preventive actions were implemented to address the issue and prevent recurrence. This year, there were 23 counterfeit products confirmed by CSL. CSL has implemented mitigation measures to enhance security features on product cartons and labels to improve counterfeit detection; to engage external business partners for supply chain and product security investigations; and to collaborate with health authorities and supply chain partners to aid healthcare representatives and patients to recognise and report suspected products. Fostering a safe and healthy culture During the year, CSL strengthened its approach to environmental, health and safety (EHS), with a focus on enhancing risk management, advancing critical controls and improving workforce engagement across its global operations. Priority was placed on evolving the EHS Management System to support more consistent standards and stronger oversight across all operating environments. Enhancements included targeted improvements in critical risk mitigation, and the prevention of potential serious injuries and fatalities (pSIF), contributing to more proactive and effective risk management outcomes. A continued focus on safety systems and operational controls enabled the identification and implementation of leading practices across CSL’s locations, strengthening execution and reinforcing a disciplined, risk-based approach to safety. CSL Operations launched a Safety Excellence program to strengthen safety performance by embedding EHS into core operations and improving consistency. These efforts aim to build a more connected, collaborative safety culture and achieve sustained risk reduction. CSL also progressed its health and wellbeing initiatives, with a focus on strengthening employee engagement and reinforcing a proactive safety culture. In October 2025, CSL delivered its annual Global Health & Safety Week under the theme ‘Building a safer tomorrow, together’. Strong participation across all sites reinforced leadership commitment, accountability and environmental stewardship. Positive feedback highlighted the impact of targeted engagement and recognition activities in embedding safety expectations. Together, these efforts strengthen cross-functional collaboration and reinforce shared accountability for safety and wellbeing, supporting consistent performance across CSL’s global operations. Additional Material Topics * Limited Assurance by Deloitte. 38 Healthier World
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