CSL Annual Report 2024

CSL’s world-class R&D organisation continues to advance as a biotechnology leader by delivering transformative science and technologies developed by CSL’s own high-calibre scientists and innovative scientific collaborations. CSL R&D leverages its expertise in CSL’s strategic platforms – plasma protein technology; recombinant protein technology; cell and gene therapy; and vaccines technology to develop and deliver innovative medicines and vaccines via CSL’s three business units – CSL Behring, CSL Seqirus and CSL Vifor. CSL R&D also applies its clinical, safety and regulatory expertise to support the CSL Plasma unit. These efforts address unmet medical needs, help prevent infectious diseases and protect public health, enabling people everywhere to lead full lives and helping CSL grow in the decades ahead. CSL’s R&D pipeline CSL’s strong R&D pipeline includes potential new treatments that use these platforms in alignment with its leading-edge scientific expertise and commercial capabilities across CSL’s six therapeutic areas: immunology; haematology; cardiovascular and metabolic; respiratory; nephrology and transplant; and vaccines. In 2023/24 CSL invested US$1.4 billion in R&D for its three businesses. Looking towards 2030, R&D continues to strive to deliver on the current portfolio of prospective medicines and vaccines and build a comprehensive and innovative pipeline with the potential to meaningfully impact the lives of patients and to public health. Garadacimab, CSL’s first-in‑class, home-grown recombinant monoclonal antibody targeting activated Factor XII (FXIIa), is being developed as a prospective, long‑term prophylactic treatment for patients with Hereditary Angioedema (HAE). This innovative therapy represents the next chapter in CSL’s commitment to develop optimal treatment options for the full range of patients with HAE. Garadacimab is well-tolerated and convenient, featuring a once-monthly administration schedule and the additional patient-friendly benefit of an autoinjector for ease of use. Global regulatory filings are currently under review, and, for the first time in CSL’s history, the US, EU and Japan filings were achieved within the same fiscal year. Adjuvanted trivalent influenza vaccine manufactured using a cell‑based platform (aTIVc) is the next evolution of CSL’s influenza portfolio. It combines proven technological advances, including the use of a cell-based antigen to address strain mismatch, CSL’s proprietary MF59® adjuvant to improve the immune response, and an optimised dose. By combining these technologies, CSL expects aTIVc to set a new standard of care for influenza protection in older adults. FILSPARI® developed by CSL’s partner Travere Therapeutics, is a novel, non‑immunosuppressive treatment being developed for the treatment of adults with primary immunoglobulin A nephropathy (IgAN), the most common type of glomerular disease worldwide and a leading cause of kidney failure. It is the first and only dual receptor antagonist of endothelin A (ETA) and angiotensin II type I (AT1) receptors, the two critical pathways involved in IgAN disease progression. Therapeutic Areas and Product Portfolio 22 Limited Annual Report 2023/24

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