CSL Ltd Annual Report 2021

COVID-19: Our efforts Despite the constantly challenging environment the pandemic has presented, and the potential for business continuity distraction, CSL not only remained focussed on delivering its promise to patients in the therapeutic areas, but took on extra commitments to protect public health through a number of initiatives and collaboration. CSL has remained agile to stay ahead of the pandemic challenges and redirected resources to where it could add the most value to address the pandemic challenges. From the time the coronavirus was first identified inWuhan, China – where CSL Behring has a manufacturing facility – the company has been assisting in the fight against COVID-19 in a number of ways, including offering expertise, resources, technologies, equipment and materials on a humanitarian basis. As the challenges grow and evolve from the pandemic, we continue to respond. However, it is difficult to quantify the exact impact on the business. We do know the pandemic is ongoing and will continue to influence how CSL manages its operations. We are proud to share our efforts for FY21 as they relate to COVID-19: • In 2020, CSL worked with the University of Queensland in the early stages of its UQ-CSL v451 COVID-19 vaccine candidate. A Phase I clinical trial showed that the vaccine elicited a robust response towards the virus and had a strong safety profile. However, following consultation with the Australian Government, CSL did not progress the vaccine candidate to Phase II or Phase III clinical trials due to the partial immune response causing an unexpected interference with certain HIV testing procedures. It was agreed the changes required to well-established HIV testing procedures in the healthcare setting, to accommodate the rollout of this vaccine, were too significant in the given timeframe. • CSL rapidly established dedicated COVID-19 vaccine teams across its business units and transitioned elements of its Australian manufacturing capacity, at both our CSL Behring Broadmeadows and Seqirus Parkville facilities, to manufacture 50 million doses of AstraZeneca’s COVID-19 vaccine for local use. First doses were rolled out in March 2021 with over 10 million doses released at the end of June 2021. • Seqirus has provided its well-established adjuvant technology – MF59 ® – to the vaccine efforts of multiple entities, including the University of Queensland vaccine development program. MF59 ® is used in CSL’s adjuvanted seasonal flu vaccine for the over-65 age group, one of the most vulnerable populations to COVID-19. Adjuvants can help improve immune response and reduce the amount of antigen needed for each vaccine, enabling more doses to be manufactured more rapidly. In parallel, Seqirus remains focused on the production of seasonal influenza vaccines, the importance of which is very much underscored by the COVID-19 pandemic. • CSL Behring launched a clinical trial into the use of garadacimab (CSL312), our factor XIIa antagonist monoclonal antibody, to treat patients suffering from severe respiratory distress, a leading cause of death in patients with COVID-19–related pneumonia. A Phase II trial to assess the safety and efficacy of the potential treatment was rapidly completed; and whilst garadacimab was found to be safe for these critically ill patients, the treatment was not effective in reducing severe complications of COVID-19. • CSL is evaluating additional assets in its portfolio, and partnerships with external researchers, for potential use in the fight against COVID-19. Our acumen and expertise across vaccine, monoclonal antibody, recombinant and plasma technology platforms, our manufacturing capabilities and partnerships, along with a therapeutic focus in immunology and respiratory, all align with the scope of this disease and, most importantly, our ability to contribute to the development of potential vaccines and treatments. • CSL Behring co-founded the CoVIg-19 Plasma Alliance, an unprecedented industry of 11 plasma companies across 13+ countries and five continents, to develop a potential plasma-derived hyperimmune therapy for treating COVID-19. The one-year collaboration concluded in April 2021 after a Phase III clinical trial of the potential therapy did not meet its endpoints. In addition, CSL’s work on an Australian hyperimmune, which was dependent on positive data, has also been discontinued. CSL Limited Annual Report 2020/21 9