CSL Ltd Annual Report 2020

For other international operations, CSL (including CSL Behring and Seqirus) was not found to be in breach of any regulation of the US FDA or the European Medicines Agency (EMA) with respect to the promotion or marketing of medicines, vaccines and therapies. 2 breaches of product marketing and promotional activities by Medicines Australia and PAAB; 0 breaches from the FDA or EMA.* Our expanding footprint CSL reaches patients in more than 100 countries and we continue to deliver on our promise to make our novel therapies available to patients around the world. 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. We continue to see the benefits of our expanding footprint, including double-digit growth from our local investments in the developing countries of Russia and Turkey and within Latin America. 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. Highlights for the reporting period include the following: China CSL Behring has been importing albumin into China for more than 30 years and is the largest supplier of imported human albumin. This year, we transitioned our distribution model frommanagement by third party distributors, to a direct trading model via our own Good Supply Practice (GSP) license. This provides a number of benefits, including improved participation in the value chain, removing reliance on third parties and importantly allowing CSL Behring to work directly with clinicians. It is also an important step towards CSL’s ability to be able to broaden its product offering and aligns the distribution model with other major markets. Colombia November marked the opening of our first office in Colombia. The Bogota location allows CSL Behring to be closer to patients and more attuned to their medical needs. Colombia is a well-developed Latin American market that provides a solid foundation for CSL Behring’s continued regional growth. Italy In August 2019, Seqirus opened new Italian headquarters in San Martino, Monteriggioni, just outside Siena. The expansion was prompted by a growing demand for Seqirus influenza vaccines and the launch of a new cell-based quadrivalent influenza vaccine. Netherlands Seqirus officially opened its new European Centre of Excellence for Research & Development (R&D) and Quality in Amsterdam in September 2019. The €10 million investment was prompted by the expansion of research and development of Seqirus’ differentiated influenza vaccines to match growing demand. The addition of a testing and release laboratory in the European Union (EU) is part of Seqirus’ business continuity plan to ensure regulatory compliance for the release of influenza vaccines to European countries when Brexit transition arrangements conclude. Saudi Arabia CSL Behring established a second office in the Middle East by cutting the ribbon on its first Saudi Arabia location in October. The move follows the opening of the regional headquarters office for the Middle East and Africa region in Dubai in April. The strategic location allows CSL Behring to accelerate business growth and fully build on the opportunities presented by the historical transformation of the country. * Limited assurance by Ernst & Young. CSL Limited Annual Report 2020 41