CSL Ltd Annual Report 2021

The safety of our donors, employees and the plasma we collect is of paramount importance. To ensure the continuous safety of the donors and the plasma supply, donors are carefully screened and tested for infectious diseases. Plasma and plasma products undergo rigorous quality controls and inspections throughout every step of the manufacturing process, from the collection of plasma to the final packaging of the finished product, to ensure that our plasma products are of the highest quality and safety. Reporting transparency and performance The SARS-CoV-2 virus causing COVID-19 is large in size (approximately 120nm in diameter). The relatively large size and lipid envelope makes it highly susceptible to steps with virus inactivation and removal capacity used during the manufacturing processes, such as pasteurisation, solvent-detergent (S/D) treatment, low pH incubation, dry-heat treatment, and virus filtration. The effectiveness of these processes has been demonstrated on other coronavirus lipid- enveloped model viruses that are quite similar to SARS-CoV-2, such as SARS-CoV, human coronaviruses 229E and OC43, and porcine coronavirus TGEV. Based on these data, we were assured that existing manufacturing processes will provide significant safety margins for our plasma products against SARS-CoV-2. Studies completed in our laboratories and published in the medical literature have verified this confidence. (Schraeder, T, Koch, J, Ross, R., et. al. ‘Effective coronavirus reduction by various production steps during the manufacture on plasma-derived medicinal products’, Transfusion , 2020, 60: 1334–35.) Sustainability Strategy – Social At CSL our greatest opportunity to contribute to society is through the development of new therapies for serious unmet medical needs and through the continued supply of life-saving vaccines and plasma/ protein-based therapies. Our relationship with plasma donors underpins our ability to contribute to our local communities. In 2021, we developed a sustainability strategy underpinned by three strategic pillars, including ‘social’. Our social strategy focus areas include: • being trusted by donors through a focus on their health and wellbeing, and their communities; • strengthening societal health through access to our existing products and therapies and investment in innovation; and • enhancing our recognition as a patient-focused leader. Planning activities to ensure we have the best available information to identify gaps and drive improvements across these focus areas has commenced. Value and access CSL invests in programs to develop and supply innovative vaccines and therapies that protect public health, and extend and improve the lives of people living with serious and rare diseases. The value our products provide to patients and society is substantial and meaningful to patients, healthcare providers, health insurance payers and healthcare systems around the world. We are proud of these contributions and work diligently to ensure that patients and communities have access to biopharmaceuticals. We work with governments, health insurance payers and other stakeholders to support timely and appropriate market entry and access, as both play a critical role in the development of reimbursement frameworks and patient access regimes. We articulate and communicate comprehensive evidence on the value of our innovations to inform access and reimbursement decisions, and we provide patient assistance programs and support advocacy efforts that improve access to care. In 2020/21, CSL’s investment for humanitarian access programs and product support initiatives totalled US$20.2 million.* In the US, access programs are critical to patients who are uninsured, underinsured or who cannot afford therapy. US$20.2 million supporting product access across the world* We are also committed to pricing practices that reflect the value our products bring to patients and society. To that end, we evaluate real-world and clinical trial data that demonstrate the clinical benefits our therapies deliver, as well as the cost savings they provide to overall healthcare. We also consider patient needs and preferences and the improvements our therapies offer to improve patients’ quality of life and productivity. As a leader in our space, we are committed to dialogue with all interested stakeholders on how best to ensure continued patient access and affordability of medicines, and to preserve an ecosystem that sustains medical innovation for patients today and in the future. In 2020/21, there were no findings against CSL relating to a breach of any fair trading or competition laws. 9 A TrustedHealth Partner * Limited assurance by Ernst & Young. Accounting practices for Seqirus Australia product donations changed in 2020/21 to account for indirect and direct costs (versus direct only for prior years). CSL Limited Annual Report 2020/21 44