CSL Ltd Annual Report 2021

The COVID-19 pandemic has underscored the importance of CSL’s ability to think globally and act locally to ensure that we can continue to meet growing demand, fulfil the critical need for our lifesaving medicines and improve public health. Throughout the global health crisis, CSL has leveraged its reach and strategic manufacturing and distribution capability with a high degree of coordination, agility and flexibility to continue meeting the needs of patients and healthcare providers worldwide. CSL applies its world-class R&D, commercial strength and patient-focused management, along with its high-quality manufacturing, to develop and deliver innovative biotherapies, influenza vaccines and support programs. Commercial strength With more than 900 active product registrations in over 100 countries, CSL continues to deliver on our promise to make our novel therapies available to patients around the world. Our commercial team continues to carefully and thoughtfully execute on product, therapeutic area and regional product strategies. While we remain agile working through the COVID-19 pandemic, we continue to support demand across our portfolio of therapy areas, with balanced regional and market growth. The Commercial Operations Leadership Team oversees the delivery of our marketplace strategy and the CSL Board has strategic oversight and monitors performance through key subcommittees. The decision to enter newmarkets is a long-term commitment driven by a desire to understand and respond to patients’ needs. While we invest locally to improve disease awareness and access to medicines, we also bring global benefits to the markets we serve. Our people are passionate about connecting local healthcare providers and other stakeholders to the global rare disease community, which in turn accelerates their ability to learn and exchange best practice. Global reach and focus In the past five years, CSL has grown rapidly due to strategic acquisitions, a rise in global demand for our products and investment in increased capacity and modernisation. Our management team has significant experience in the industry and the confidence to drive our promise to patients into the next century. Our commitment to strategic sourcing has allowed CSL to have a reliable supply of lifesaving therapies in multiple facilities across the globe. A number of CSL’s sites are supporting major capacity expansion projects, fromProject Phoenix for base fractionation in Marburg, Germany to Project Protinus for PRIVIGEN ® in Bern, Switzerland and Project Aurora for base fractionation in Broadmeadows, Australia. The timing of these projects coming online will help ensure a seamless supply of products to patients. Although the COVID-19 pandemic briefly slowed construction work on CSL’s state-of-the-art manufacturing facility in Lengnau, Switzerland, the site continues to move toward completion. In May 2020, CSL announced that we have entered into a strategic partnership with Thermo Fisher Scientific for the lease of the Lengnau facility. Thermo Fisher Scientific is scheduled to assume oversight and operation of the facility once construction is completed. When the Seqirus business was formed, there were 400 applications inherited from the legacy businesses. A major milestone was achieved in October 2019 with the three-year Edge program successfully completed, enabling Seqirus to be fully integrated globally on a single information systems platform. This is greatly enhancing collaboration and efficiency across the business. Seqirus has been able to simplify and streamline the testing process to release FLUCELVAX ® influenza vaccine into the US each season. Since 2012, the FDA Center for Biologics Evaluation and Research (CBER) requirement to demonstrate that the influenza virus had been successfully inactivated in our cell-based vaccine was undertaken using egg-based testing. This required complex network logistics to ship a number of bulk lots of FLUCELVAX ® from the US to the Seqirus Liverpool site in the UK for testing each year. Seqirus quality control teams collaborated over multiple years to prove that the cell-based testing was equivalent, or superior, to egg-based testing. With CBER agreement, the egg-based testing is no longer required. With testing now based at our Holly Springs plant in the US, the need for complex shipping is also removed, thereby reducing risk to the product. Seqirus introduced a new process for inspection of harvested allantoic fluid, at the influenza vaccine manufacturing site in Parkville, Australia. This process was designed in-house and has enabled the removal of the cumbersome process of ‘candling’ over 440,000 eggs per day. Seqirus Liverpool, UK has optimised the process for incubation of eggs pre-inoculation that has resulted in yield improvement in certain strains of 15%. Seqirus Liverpool saw the commissioning and start-up of a new line for production of MF59 ® , Seqirus’ novel adjuvant. The line is now operating and capable of producing over 1000L per week of bulk sterile MF59 ® . Production of the Seqirus antivenom portfolio has been improved. The TGA approved the chemistry, manufacturing, control (CMC) regulatory variation for the use of an adjuvant in venom dosing. Use of this adjuvant has significantly increased antibody potency for most antivenoms. CSL Limited Annual Report 2020/21 36 8 Global Reach and Impact