Manufacturing Maximising efficiency through innovation. During the period, CSL Seqirus was recognised for its global leadership in pre-pandemic preparedness with the award of contracts for H5 avian flu. ANDEMBRY® Approved in Australia, Brazil, Canada, the European Union, Japan, Israel, New Zealand, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom and United States. The additional approvals of ANDEMBRY® expands CSL’s hereditary angioedema (HAE) franchise and underscores the Company’s legacy of delivering transformational innovations to the HAE community for over four decades. Maximising efficiency through innovation A key priority for CSL is to drive excellence and operational performance across our significant manufacturing network, so that the Company can supply quality product at the lowest possible cost. CSL’s quality and supply performance is strong. During the year, the focus has been on maximising efficiency in two ways: firstly, through a disciplined and rigorous operational excellence program that is well under way; and secondly, our Horizon 1 and 2 yield improvement programs, which have provided multiple proof points of success, providing confidence that CSL will deliver transformative results. Investing in our US footprint This year, CSL also announced plans to expand its US presence over the next five years, resulting in approximately US$1.5b in US capital investments. These investments will strengthen CSL’s US manufacturing capabilities of plasma-derived therapies (PDTs), and help secure the US medicine supply chain. This reflects CSL’s commitment to meet the growing clinical need for immunoglobulin (Ig) over the long term. HEMGENIX® The first one-time gene therapy for adults with haemophilia B, providing durable bleed protection and potentially eliminating the need for routine factor IX prophylaxis. Initially approved in the EU, UK, Canada, Switzerland and Australia, HEMGENIX® also received approvals in FY2025 in Korea, Saudi Arabia, Hong Kong, Taiwan and Singapore. Five-year follow-up data from the Phase III HOPE-B study demonstrates the long-term durability and clinical benefit of a single infusion of HEMGENIX® in adults with haemophilia B. Mean factor IX activity levels were sustained at approximately 36%, with a 63% reduction in annualised bleeding rate versus the lead-in prophylaxis period (1.52 vs 4.16). Most patients (94%) remained free from routine prophylaxis through five years, with substantially reduced factor IX use and favourable long-term safety. These results support the durable efficacy of gene therapy, providing sustained bleed protection and reducing treatment burden over extended follow-up. Commercial Optimise launch excellence to be best in class for patients. 7 CSL Limited Annual Report 2025/26
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