Driven by Our Promise CSL Limited Annual Report 2021/22
Contents Annual General Meeting The 2022 Annual General Meeting (AGM) of CSL Limited (ABN 99 051 588 348) will be held on Wednesday, 12 October 2022 at 10am (Melbourne time) at the Clarendon Auditorium, Melbourne Convention and Exhibition Centre, South Wharf, Melbourne 3000. CSL Calendar 2022 17 August Annual results and final dividend announcement 6 September Shares trade ex-dividend 7 September Record date for final dividend 5 October Final dividend paid 12 October Annual General Meeting 31 December Half Year ends 2023 15 February Half Year results and interim dividend announcement 9 March Shares trade ex-dividend 10 March Record date for interim dividend 5 April Interim dividend paid 30 June Full Year ends 16 August Annual results and final dividend announcement 11 September Shares trade ex-dividend 12 September Record date for final dividend 4 October Final dividend paid 11 October Annual General Meeting 31 December Half Year ends About this report This Annual Report combines CSL’s financial and non-financial performance in one comprehensive account, linking our sustainability and strategic priorities to our business results. Unless otherwise stated, this report covers CSL’s subsidiaries as listed on page 131. CSL conducted its fifth sustainability materiality assessment in 2021/22. The prioritised results of our assessment are available within this report and on CSL.com. In addition to an independent audit of our consolidated financial accounts, limited assurance on a selection of corporate responsibility (CR) metrics has been provided by Ernst & Young, and an assurance statement for non-financial indicators, along with more detailed Group and CR information, including our materiality assessment, can be found on CSL.com (Our Company > Corporate Responsibility). Find out more CSL.com 1 Chair and CEO message 2 2 Our Company 8 3 Our Performance and Strategy 16 4 Our Material Risks 24 5 Our Future Prospects 26 6 Powered by Innovation 29 7 Our People 37 8 Environment 42 9 Social 48 10 Governance 54 11 Financial Performance 63 12 Share Information 147 13 Key Performance Data Summary 150 14 Medical Glossary 151 Legal notice: This report is intended for global use. This 2022 Annual Report is a summary CSL’s operations and activities for the 12-month period ended 30 June 2022 and financial position as at 30 June 2022. This report covers CSL’s global operations, including subsidiaries, unless otherwise noted. A reference to CSL, CSL Group, we, us and our and similar expressions refer collectively to CSL Limited and its related bodies corporate. Some statements about products, registered product indications or procedures may differ in certain countries. Therefore, always consult the country-specific product information, package leaflets or instructions for use. For more information, please contact a local CSL representative. Brand names designated by a ® or a ™ throughout this publication are trademarks either owned by and/or licensed to CSL or its affiliates. Not all brands mentioned are used or registered as trade marks in all countries served by CSL. Forward-looking statements This report contains forward-looking statements including statements with respect to future company compliance and performance. This report also includes forward-looking statements regarding climate change and other environmental and energy transition scenarios. While these forward-looking statements reflect CSL’s expectations at the date of this report, they are not guarantees or predictions of future performance or statements of fact. These statements involve known and unknown risks and uncertainties. Many factors could cause the Group’s actual results, performances or achievements to differ, possibly materially, from those expressed in the forward-looking statements. These factors (including significant geopolitical issues relating to war in Ukraine, supply chain disruptions, energy security and inflation) include changes in government and policy; actions of regulatory bodies and other governmental authorities such as changes in taxation or regulation (or approvals under regulation); the effect of economic conditions; technological developments in the healthcare field; advances in environmental protection processes; and uncertainty and disruption caused by the COVID-19 pandemic and geo-political developments. There are also limitations with respect to scenario analysis, and it is difficult to predict which, if any, of the scenarios might eventuate. Scenario analysis is not an indication of probable outcomes and relies on assumptions that may or may not prove to be correct or eventuate. Readers are cautioned not to place undue reliance on forward-looking statements. Except as required by applicable laws or regulations, CSL does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Non-IFRS References to AASB refer to the Australian Accounting Standards Board and IFRS refers to the International Financial Reporting Standards. There are references to IFRS and non-IFRS financial information in this report. Non-IFRS financial measures are financial measures other than those defined or specified under any relevant accounting standard and may not be directly comparable with other companies’ information. Non-IFRS financial measures are used to enhance the comparability of information between reporting periods, and enable further insight and a different perspective into the financial performance. Non-IFRS financial information should be considered in addition to, and is not intended to be a substitute for, IFRS financial information and measures. Non-IFRS financial measures are not subject to audit or review. CSL Limited ABN 99 051 588 348
CSL Limited Annual Report 2021/22 1 Our Purpose The people and science of CSL save lives. We develop and deliver innovative medicines that help people with serious and life-threatening conditions live full lives and protect the health of communities around the world. Our CSL Values guide us in creating sustainable value for our stakeholders. Arthur grew up playing sports and later moved on to weightlifting and bowling. In his late 30s, however, he was robbed of his mobility and left in severe pain by chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a rare neurological disorder that can lead to symptoms such as weakness, paralysis or impairment in motor function, especially in the arms and legs. After following a journey to diagnosis that lasted nearly 15 years, Arthur finally found the right treatment and is getting back to some of the activities that make himwho he is. He’s also advocating for fellow CIDP patients and encouraging others to do the same. As he puts it, ‘We need to speak up, work hard and be determined to overcome this.’ Staying active has always been a priority for Arthur. Arthur’s story
CSL Limited Annual Report 2021/22 2 1 Chair and CEO Message Chair Message Dear Fellow Shareholders, I am pleased to share our results and operating review for 2021/22, fromwhich you will see that CSL, supported by the strength of its foundations and an agile approach, is poised to deliver sustainable growth to our stakeholders. Poised for Growth CSL has continued to be resilient to the external environment over the 2021/22 financial year. Our 2030 Strategy and our values continue to guide our leaders all the way through to our frontline employees. Measured and ongoing investment into our business has been a key enabler of growth, and will continue to underpin that growth into the future. Our global capital investment program has advanced according to plan, and we continue to make great progress in our research and development (R&D) pipeline. During the financial year, the Board approved the proposed acquisition of Vifor Pharma, a global pharmaceutical company focusing on the treatment areas of iron deficiency, dialysis, nephrology and rare disease. Through this acquisition, our global reach, R&D capabilities, and balance sheet will help accelerate opportunities to bring new and innovative products to the large and underserved community of people suffering with kidney disease and iron deficiencies. The Board looks forward to the full integration of this business and we thank shareholders for their support for this acquisition. Our Governance Priorities Another way we ensure we are poised to take advantage of the many opportunities afforded to us is through rigorous, best-practice governance, which is always a major focus of the Board. In line with an observed trend in many jurisdictions towards a tenure limit for audit firms, we completed a competitive tender process to appoint new external auditors. This appointment is subject to shareholder approval at CSL’s 2023 Annual General Meeting. If approved by shareholders, Deloitte Touche Tohmatsu will be CSL’s external auditor for the 2024 financial year (commencing 1 July 2023). We wish to thank EY for their many years of distinguished service to shareholders. The composition of the Board is an ever-present priority. We aim to have the right skills and expertise to navigate our industry and the broader macro environment. We believe we have a strong and complementary dynamic that will continue our long track record of exceptional governance. The return of our ability to travel has meant that the Board has been able to come together in person more often, and I particularly enjoyed visiting our Kankakee and Holly Springs facilities in the United States with my fellow Board members and meeting the dedicated teams working at those sites. Last year we announced our new sustainability strategy. While this has always been a focus for us at both the Board and operational levels, I am pleased to say the new strategy has provided us a refreshed impetus to be clear about our sustainability priorities. You can read about our progress, and specifically for the environment, further in this document. An Opportune Time Although the global pandemic has entered a new phase, the operating environment continues to prove testing. Once again, I would like to thank our Managing Director and Chief Executive Officer, Paul Perreault, his Global Leadership Group and all of our CSL colleagues for successfully navigating your company through this challenging time. There has been an overwhelming response to the pandemic from the scientific community, including CSL, and the many partners we engage with all over the world. Our partnership with AstraZeneca for example, manufactured 50 million doses of the VAXZEVRIA® COVID-19 vaccine requisitioned by the Australian Government. This enabled the protection of millions of Australians, as well as many of the country’s neighbours in the Pacific region. While we hope that the pandemic challenge starts to fade, it is in the nature of our industry to look to the other problems we try to solve every day, and work out how we can approach themmore effectively. These unmet medical needs are an opportunity for our people, from our scientists, researchers, knowledge workers, to our manufacturing experts and phlebotomists to contribute to helping protect the health of communities around the world. This pursuit has received a great boost over the past two years as we have witnessed new approaches to clinical trials, fast-tracked approval processes and new precedents for what collaboration can look like. This is an opportune time for our company to meet the world’s increasing expectations, and our industry to heighten its contribution to achieving a healthier world.
US$2.255 billion in reported net profit after tax US$2.22 dividend per share for 2022 CSL Limited Annual Report 2021/22 3 Outlook While I began this note expressing my optimism, I am always wary of the broader environment in which we operate. At the time of writing there are significant geopolitical issues relating to war in the Ukraine, supply chain disruptions, energy security, and inflation. There are no quick fixes to many of these issues, but the vital nature of the products and treatments that CSL produces means we can factor in a level of confidence to our growth plan. I can assure you that we will work to control what is within our control with the people who rely on our vaccines and therapies as our priority. As always, in doing so we will continue to strive to create value for shareholders. I am pleased to report that the total full year dividend per share is US$2.22 per share, which is held constant with the previous financial year. Thank you for your ongoing support of our company. Brian McNamee AO Chair More on CSL.com (Investors > Financial Results and Information)
CSL Limited Annual Report 2021/22 4 1 Chair and CEO Message CEO Message Dear Shareholders, I am pleased to be addressing you after another year when CSL was able to deliver solid results, as promised, in an ongoing complex global environment. As I move around and connect with our people, patients and donors, I have been reminded repeatedly that when we trust in science and our purpose, the reward is repaid many times over, and allows us to continue delivering our promises to our stakeholders. Culture is Key Whilst science has firmly and rightly been in the spotlight through the pandemic, progress in this domain does not happen without talented people. As our people continue to connect both virtually and in person across plasma centres, our manufacturing sites, our research labs and our offices, there are many conversations within and between the diverse teams of people who make CSL so successful. The common thread I hear is that, although life has changed, our people stay motivated day-to-day through an overwhelming dedication to our purpose and our values. Together, these have driven a culture that is not easily replicable, and one that I truly believe is unique and enduring at CSL. The science and people of CSL save lives, and it is important to our leaders that employees feel motivated and proud to come to work, and that they have a promising future with us. This priority has been acknowledged this year with CSL honoured to be recognised as one of Australia and New Zealand’s best places to work by the Australian Financial Review. In March, Forbes magazine also named CSL among America’s Best Employers for 2022. It is encouraging to see that we are making progress and are receiving recognition for our efforts. Executing on Our 2030 Strategy CSL’s strategic framework guides us in how we make considered strategic decisions to evolve our organisation so that it remains effective, sustainable and efficient. Our priority areas are: people and culture, focus, innovation, efficiency and supply, sustainable growth and digital transformation. You can read more about these in detail on page 19 of this report, but I want to reiterate that we are executing to plan and I am pleased with the progress we’ve made so far, particularly in relation to setting emissions reduction targets. I would also like to elaborate on Dr McNamee’s comments regarding Vifor Pharma. In December, we were pleased to enter into an agreement to acquire Vifor Pharma, a global specialty pharmaceutical company with leadership in renal disease and iron deficiency. The acquisition fits strongly with our strategy. It adds a durable and growing business with leadership positions across nephrology, dialysis and iron deficiency, and will provide a platform to build a significant renal franchise. It also extends the reach of CSL’s high-value pipeline in the renal space by leveraging enhanced access to unique patient populations which will support clinical trial execution. The acquisition was funded through an institutional placement, a share purchase plan and a debt raising and I would like to thank all of our stakeholders for the overwhelming support they have shown for the transaction. Now, we look forward to the important work of integrating this business into the CSL family and driving the sustainable growth that this acquisition will add to the CSL business. Investment and Innovation In 2021/22, CSL increased its investment into research and development by 17% at constant currency. Enduring organisations have many high-value capital allocation options; initiatives to invest in that will help the organisation prosper into the future. Optionality is a good problem to have, and one that our leadership group debates regularly. While these can take years to realise, it is great to share the achievement when we do. One recent example was the completion of the US$156 million expansion of our CSL Seqirus manufacturing facility in Holly Springs, North Carolina in the US. This new fill and finish production line gives us the ability to streamline our production process more efficiently, which ultimately helps us to better meet the needs of our patients and, in turn, better meet the needs of public health. CSL Seqirus’ new A$800+ million cell culture vaccine production facility in Tullamarine is also making good progress and when finished (expected to be in 2026) will be the only one of its kind in the Southern Hemisphere. Our R&D pipeline is at the heart of future therapies and our investment in our R&D infrastructure is significant. Construction of our new R&D campus in Marburg, Germany, is nearly complete and this building will have capacity to house about 500 R&D employees, who will form strong, collaborative linkages with our other R&D campuses around the world. In Melbourne, Australia, our state-of-the-art global R&D campus and new corporate headquarters under construction in Parkville’s biomedical precinct are well advanced, with plans for completion in early 2023. We have also made good progress in our investment into our late-stage R&D pipeline. In May, we received notice that the US Food and Drug Administration had accepted our Biologics License Application, for priority review, for the promising gene therapy etranacogene dezaparvovec. In clinical trials, etranacogene dezaparvovec has been shown to significantly reduce the rate of annual bleeds in people with haemophilia B after a single, one-time infusion compared to when these people were receiving recombinant factor IX therapy alone. If approved, it would be the first ever gene therapy treatment option for the haemophilia B community. This is a great development, and we are excited about the prospect of launching new and innovative products over the coming years.
CSL Limited Annual Report 2021/22 5 Another example of a valuable investment relates to improving our donors’ experience when they visit our centres. Plasma donors are a fundamental part of our business, and without thempatients would not have access to life-changing medicines. In order to optimise their experience in our centres, we are employing a new plasmapheresis platformutilising technology to support a safe, efficient and improved experience for plasma donors, as well as a better process for CSL Plasma employees. We will introduce this new technology across our 300 US centres in the future. A Promising Future In closing, I would like to thank our people, shareholders, partners, plasma donors and the many other stakeholders who allow us to bring people and science together to execute on our strategy. This combination helps us to achieve our purpose, which is to develop and deliver innovative medicines that help people with serious and life-threatening conditions live full lives and protect the health of communities around the world. While we are not immune to the macroeconomic environment, I can assure you we will continue to operate with resilience, integrity and agility and deliver sustainable growth Paul Perreault CEO and MD Acquisition of Vifor Pharma We recently announced the acquisition of Vifor Pharma (Vifor), a leading Swiss based company. Vifor has a world-leading iron replacement platform for treatment of diseases such as iron deficiency anaemia and continues to generate extensive clinical data in related areas of high unmet medical need, such as iron deficiency in heart failure and patient blood management. Through its extensive dialysis portfolio, Vifor has built a strong presence in renal diseases which continues to benefit from the introduction of novel therapies impacting disease progression. A cornerstone of Vifor’s growth strategy has been its strategic partnerships, which have allowed Vifor to both broaden its portfolio and provide patients access to the treatments they need. The Vifor business enhances CSL’s established focus on protecting the health of patients with a range of rare and serious medical conditions. Some of the strategic benefits of CSL’s acquisition of Vifor include: • Strengthening CSL’s Value driven strategy: Vifor adds a durable and growing business with leadership positions across complementary and adjacent franchises, delivering greater benefit to patients. • Combined with CSL’s R&D capabilities and financial scale, it enables a significant renal disease franchise to be established in this large and growing market. • Extends the reach of CSL’s high value pipeline: Together, CSL and Vifor will have a complementary portfolio and enhanced access to unique patient populations for future clinical studies. We look forward to aligning the rebrand of Vifor to CSL Vifor and integrating the business within CSL’s organisational structure and our 2030 Strategy. CSL People & Culture Patients and Public Health • Immunology • Haematology • Transplant • Respiratory • Cardiovascular and Metabolic • Influenza • Nephrology/Dialysis Efficiency & Focus Innovation Sustainable Growth Digital Transformation Reliable Supply • Products • Delivery • Services • Technology • Yield • Technology • Operational Excellence • Capital Project Execution • Partnerships • Plasma • Recombinants • Cell and Gene Therapy • Influenza Vaccines • Iron Therapy • Business Model • Connected Healthcare • New Capabilities CSL’s 2030 strategy with Vifor
CSL Limited Annual Report 2021/22 6 1 Chair and CEO Message Patient focus Innovation Integrity Collaboration Superior performance Our Values CSL’s strong commitment to living our values has guided us for many decades. Our values are fundamental to our success – helping us to save lives, protect the health of people and earn our reputation as a trusted and reliable global leader. They are at the core of how our employees interact with each other, make decisions and solve problems.
CSL Limited Annual Report 2021/22 7 With the pending arrival of twins and a newly earned master’s degree in hand, Danielle is leading a fulfilling life. As a rare disease patient, however, it wasn’t always an easy path to where she is now. Danielle is living with common variable immunodeficiency, which is one of hundreds of primary immunodeficiency (PI) conditions. People living with a PI are especially vulnerable to infections. It took Danielle about 10 years to get the right diagnosis. Now that she’s managing her condition with the right treatment, Danielle is paying it forward by mentoring other PI patients and showing them how it’s possible to live the life they’ve always envisioned. Danielle is leading a fulfilling life. Focus Danielle's story
CSL Limited Annual Report 2021/22 8 CSL at a glance 40+ Countries of operations around theworld US$10.6 billion in annual revenue 30,000+ employees around the world 2,000+ R&D employees 330 Plasma collection centres across China, Europe and North America US$4.6 billion in R&D investments in the last 5 years to advance product pipeline Our businesses CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, haematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients’ lead full lives. CSL Behring operates one of the world’s largest plasma collection networks CSL Plasma. CSL Seqirus As one of the leading influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. CSL Seqirus operates state-of-the-art production facilities in the United States (US), the United Kingdom (UK) and Australia and utilises both egg-based and cell-based manufacturing technologies as well as a proprietary adjuvant. It has leading research and development (R&D) capabilities, a broad and differentiated product portfolio and commercial operations in more than 20 countries. 2 Our Company
CSL Limited Annual Report 2021/22 9
CSL Limited Annual Report 2021/22 10 Our R&D Pipeline Our research and development pipeline CSL’s world-class R&D organisation continues to evolve as a biotechnology leader by advancing high-quality science and technologies developed by our own high-calibre scientists and innovative collaborations. R&D utilises its expertise in our strategic platforms – plasma fractionation; recombinant protein technology; cell and gene therapy; and vaccines technology. This ensures CSL can develop and deliver innovative medicines and vaccines that address unmet medical needs, help prevent infectious disease and protect public health, and help patients lead full lives. CSL’s strong R&D pipeline includes new treatments that utilise these platforms and align with its leading-edge scientific technology and commercial capabilities across our six therapeutic areas: immunology; haematology; cardiovascular and metabolic; respiratory; transplant; and influenza vaccines. In 2021/22 CSL invested US$1.16 billion* in R&D across our businesses. Looking towards 2030, R&D continues to strive to deliver on the current portfolio of medicines and vaccines and build a full and innovative pipeline that will make a meaningful difference to the lives of patients with rare and serious diseases. This pipeline is expected to contribute new revenue streams well into the following decades. *Limited assurance by Ernst & Young 2 Our Company
CSL Limited Annual Report 2021/22 11 Global Research and Development Pipeline 2021/22 Immunology Clinical Registration Post-Launch HAEGARDA® (C1 Esterase Inhibitor subcutaneous) Hereditary Angioedema HIZENTRA® (20% subcutaneous Ig) Multiple Indications PRIVIGEN® (10% intravenous Ig) Multiple Indications Garadacimab (Anti-FXIIa mAb) Hereditary Angioedema HIZENTRA® (20% subcutaneous Ig) Dermatomyositis HIZENTRA® (20% subcutaneous Ig) Systemic Sclerosis CSL324 (Anti-G-CSFRmAb) Hidradenitis Suppurativa CSL730 (Recombinant Trivalent Human IgG1 Fc Multimer) Multiple Indications* Haematology Clinical Registration Post-Launch AFSTYLA® (Recombinant FVIII) Haemophilia A IDELVION® (Recombinant rFIX-FP) Haemophilia B Etranacogene dezaparvovec (Recombinant adeno-associated viral vector with codon-optimized Padua derivative of Human FIX cDNA) Haemophilia B KCENTRA® (Prothrombin Complex Concentrate) Trauma CSL889 (Hemopexin) Sickle Cell Disease Respiratory Clinical Registration Post-Launch ZEMAIRA®/RESPREEZA® (Alpha 1 Antitrypsin) AAT Deficiency Garadacimab (Anti-FXIIa mAb) Interstitial Lung Disease/Idiopathic Pulmonary Fibrosis Trabikibart (Anti-Beta Common mAb) Asthma CSL787 (Nebulised Ig) Non-Cystic Fibrosis Bronchiectasis Cardiovascular and Metabolic Clinical Registration Post-Launch CSL112 [Apolipoprotein A-I (human)] Acute Coronary Syndrome CSL346 (Anti-VEGFBmAb) Diabetic Kidney Disease Transplant Clinical Registration Post-Launch Clazakizumab (Anti-IL-6 mAb) Chronic Active Antibody-Mediated Rejection CSL964 (Alpha 1 Antitrypsin) Prevention of Graft-versus-Host Disease CSL964 (Alpha 1 Antitrypsin) Treatment of Graft-versus-Host Disease* Influenza Vaccines Clinical Registration Post-Launch AUDENZ™ (Adjuvanted Cell-based Pandemic Vaccine) Influenza A (H5N1) FLUAD® (Trivalent Adjuvanted Vaccine) Influenza FLUAD® (Quadrivalent Adjuvanted Vaccine) Influenza FLUCELVAX® (Quadrivalent Cell-based Vaccine) Influenza FOCLIVIA®/FOCETRIA (Adjuvanted Egg-based Pandemic Vaccine) Influenza A (H5N1) aQIVc (Adjuvanted Quadrivalent Cell-based Vaccine) Influenza Outlicensed Programs Clinical Registration Post-Launch Eblasakimab (Anti-IL-13RmAb) Atopic Dermatitis Mavrilimumab (Anti-GM-CSFRmAb) Giant Cell Arteritis, Rheumatoid Arthritis** * Partnered Project **Mavrilimumab Phase II studies in GCA & RA complete. Kinikska evaluating development in rare cardiovascular diseases. CSL’s pipeline also includes Life Cycle Management projects that address regulatory post-marketing commitments, pathogen safety, capacity expansions, yield improvements, and new packages and sizes.
CSL Limited Annual Report 2021/22 12 Our Product Portfolio CSL Behring We meet patients’ needs using the latest recombinant and plasma-derived technologies. CSL Behring discovers, develops and delivers the broadest range of products in the industry for treating rare and serious diseases such as haemophilia, von Willebrand disease (vWD), primary immune deficiencies (PID), chronic inflammatory demyelinating polyneuropathy (CIDP), hereditary angioedema (HAE) and inherited respiratory disease. CSL Behring’s products are also used in cardiac surgery, for burns treatment and for urgent warfarin reversal. Immunology Our world leading immunoglobulin franchise is the cornerstone of the immunology therapeutic area. Key CSL Behring products in market include PRIVIGEN®, HIZENTRA®, BERINERT®, HAEGARDA® and a range of hyperimmunes. Haematology We are focused on maximising the value of our existing portfolio, developing new therapies and identifying transformational treatments to help patients realise a life full of potential. Key CSL Behring products in market include IDELVION®, AFSTYLA®, HUMATE P®/HAEMATE®, BERIPLEX®/KCENTRA®, VONCENTO®/BIOSTATE® and albumin. Cardiovascular and metabolic We are focused on improving and extending the lives of patients with cardiovascular disease (CVD) and diabetic kidney disease. Respiratory Respiratory diseases impose an enormous burden on patients and society and are a leading cause of death and disability worldwide. Key CSL Behring products in market include ZEMAIRA®/RESPREEZA®. Transplant While advances in transplantation techniques and therapies have markedly improved short-term patient survival, transplant rejection remains one of the greatest limitations to long-term graft and patient survival for both solid organ and haematopoietic stem cell transplant recipients. We are focused on developing therapies to address transplant rejection. CSL Seqirus Our broad range of influenza vaccines meets the needs of different populations around the world. In Australia and New Zealand, CSL Seqirus is a leading provider of in-licensed vaccines and specialty pharmaceuticals. It is also the world’s only supplier of a unique range of products made in the national interest for the Australian Government, including antivenoms and Q fever vaccine. Influenza Vaccines Egg-based and cell-based products, seasonal, pre-pandemic and pandemic influenza vaccines. Products of National Significance Q fever vaccine and antivenoms for venomous creatures in Australia and other Pacific countries. In-licensed Vaccines and Pharmaceuticals For Australia and New Zealand. 2 Our Company
CSL Limited Annual Report 2021/22 13 Operating Review CSL Behring Total revenue was US$8,598 million, up 2%1 when compared to the prior comparable period. Immunoglobulin (Ig) product sales of US$4,024 million, were down 3%1 as supply was constrained by the lower plasma collected in the previous year. Despite the challenging environment, HIZENTRA® (Immune Globulin Subcutaneous (Human), 20% Liquid) sales were steady due to the preference for home administration and the continued uptake for HIZENTRA® for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a debilitating neurological disorder. PRIVIGEN® (Immune Globulin Intravenous (Human), 10% Liquid) declined modestly, impacted by supply constraints and the patient preference for HIZENTRA®. Underlying demand for Ig continues to be robust due to significant patient needs in core indications – namely Primary Immune Deficiency, Secondary Immune Deficiency and CIDP. Specialty product sales of US$1,792 million, up 3%1 led predominately by demand for KCENTRA® and to a lesser extent HAEGARDA®. KCENTRA® (4 factor prothrombin complex concentrate) recorded sales growth of 18%1, as hospital demand for the product returned to pre-pandemic levels driven by penetration within large hospitals and expansion into smaller regional accounts. HAEGARDA®, a therapy for patients with hereditary angioedema, grew by 5%1, driven by continued patient growth and a continued shift from on-demand to prophylaxis treatment. New launches in Europe and Australia have contributed to the rise in patient numbers. Growth in the specialty portfolio was offset by lower wound healing product sales in Japan and a decline in ZEMAIRA® (alpha-1-proteinase inhibitor) following supply interruptions at our Kankakee facility in the US. Haemophilia product sales of US$1,166 million increased 8%1. IDELVION®, CSL Behring’s novel long-acting recombinant factor IX product, achieved strong growth of 20%1 driven by its clinical profile that continues to attract patient demand and gain market share. It remains the market leader for the treatment of haemophilia B patients. The haemophilia A market has been competitive resulting in sales declines for AFSTYLA®, a novel recombinant factor VIII product, and plasma-derived products. Albumin sales of US$1,072 million, were down 1%1. Sales in China were up strongly whereas sales in other major market such as the US and Europe declined modestly due to the supply constraints from the lower plasma collections in the previous year. Plasma collections Whilst plasma collections were adversely impacted by the COVID-19 pandemic in the previous financial year, this year saw strong growth with plasma volumes collected up 24%. This was the result of targeted marketing efforts and enhanced digital initiatives to attract donors. The cost of collections also increased including donor compensation and labour. CSL Seqirus Total revenue of $1,964 million, was up 13%1 driven by growth in seasonal influenza vaccines and CSL Seqirus’ differentiated high value products, in particular FLUAD®, the adjuvanted product for the elderly market. 1 Constant Currency removes the impact of exchange rate movements to facilitate comparability of operational performance for the Group. This is done in three parts: a) by converting the current year net profit of entities in the group that have reporting currencies other than US Dollars, at the rates that were applicable to the prior comparable period (Translation Currency Effect); b) by restating material transactions booked by the group that are impacted by exchange rate movements at the rate that would have applied to the transaction if it had occurred in the prior comparable period (Transaction Currency Effect); and c) by adjusting for current year foreign currency gains and losses (Foreign Currency Effect). The sum of translation currency effect, transaction currency effect and foreign currency effect is the amount by which reported net profit is adjusted to calculate the result at constant currency.
CSL Limited Annual Report 2021/22 14 Our locations Marburg Germany Amsterdam Netherlands Goettingen Hattersheim Schwalmstadt Germany Tokyo Japan Hong Kong China Sydney Australia Melbourne Australia Group Head Office Wuhan China Maidenhead UK Liverpool UK Basel Switzerland Bern Switzerland Boca Raton US Knoxville US Indianapolis US Holly Springs US Cambridge US Pasadena US Mesquite US Kankakee US King of Prussia US Research and Development Manufacturing Commercial Operations Testing Laboratory Logistics Centre Distribution Warehousing Administration Regional Sales and/or Distribution Less than 50 centres More than 300 centres Plasma collection centres 2 Our Company
CSL Limited Annual Report 2021/22 15 Efficiency and reliable supply
CSL Limited Annual Report 2021/22 16 3 Our Performance and Strategy Business performance highlights Focus • Remained focused on delivering on our promise to patients and public health during an unprecedented time of uncertainty. • US$17.8 million supporting product access across the world.* • US$50 million in global community investment across our strategic areas of support. Innovation • Research and development (R&D) investment of US$1.16 billion.* • Etranacogene dezaparvovec (Haemophilia B gene therapy) primary end point achieved in HOPE-B study with MAA (EU) and BLA (US) submitted. • Garadacimab Phase III study enrolment completed for HAE. • CSL112 (currently in Phase III for cardiovascular disease) continues to progress with over 80% enrolment. • Phase II study for an adjuvanted QIV cell-based influenza vaccine completed. • Government funding for new biotech start-up incubator partnership between CSL, WEHI and University of Melbourne. • Achieved 24 product registrations or new indications across the globe. Efficiency and reliable supply • Ongoing investment in major capital projects at all manufacturing sites to support future growth. • In 2021/22, 27 new plasma collection centres opened. • New plasmapheresis platform approved. • Participated in 406 regulatory inspections of our manufacturing facilities and plasma collection centres.* • 135 million influenza vaccine doses distributed by CSL Seqirus. • Fill and finish capacity expansion projects completed at Holly Springs and Liverpool for influenza vaccines. Sustainable growth • Revenue up 3% at constant currency. • Significant growth in plasma collections. • Strong performance by HIZENTRA®, our market leading subcutaneous immunoglobulin product with sales up 20%. • KCENTRA®, our peri-operative bleeding product, grew 18% as hospital demand returned to pre-pandemic levels. • CSL Seqirus revenue up 13% at constant currency driven by strong growth in seasonal influenza vaccines and product differentiation. • US$9.9 billion distributed in supplier payments, employee wages and benefits, shareholder returns, government taxes and community contributions.* • Announced Science Based Targets initiative aligned emissions reduction targets. Digital transformation • Enhanced CSL Plasma Donor App with new functionality. • Progression of the converged enterprise network strategy across the organisation. • Initiation of our next generation Donation Management System. People and culture • Achieved 77.9% employee engagement* score, an increase on the previous year. • 44% female representation at Board level, 61% female across the Group.* • Established early career programs for STEM talent around the globe to build our future talent pipeline. • CSL named among America’s best employers by Forbes magazine and also recognized as one of Australia and New Zealand’s Best Places to Work by The Australian Financial Review. * Limited assurance by Ernst & Young. Patients and Public Health underpin everything we do
CSL Limited Annual Report 2021/22 17 Financial Highlights & Reported Results 1 For shareholders with an Australian registered address, the final dividend of US$1.18 per share (approximately A$1.68) will be franked to 10% for Australian tax purposes and paid on 5 October 2022. For shareholders with a New Zealand registered address, the dividend of US$1.18 per share (approximately NZ$1.86) will be paid on 5 October 2022. The exchange rates will be fixed at the record date of 7 September 2022. All other shareholders will be paid in US$. CSL also offers shareholders the opportunity to receive dividend payments in US$ by direct credit to a US bank account. 2 Constant Currency removes the impact of exchange rate movements to facilitate comparability of operational performance for the Group. This is done in three parts: a) by converting the current year net profit of entities in the group that have reporting currencies other than US Dollars, at the rates that were applicable to the prior comparable period (Translation Currency Effect); b) by restating material transactions booked by the group that are impacted by exchange rate movements at the rate that would have applied to the transaction if it had occurred in the prior comparable period (Transaction Currency Effect); and c) by adjusting for current year foreign currency gains and losses (Foreign Currency Effect). The sum of translation currency effect, transaction currency effect and foreign currency effect is the amount by which reported net profit is adjusted to calculate the result at constant currency. Expense performance • Research and development (R&D) expenses were US$1,156 million, up 17%2 when compared to the prior comparable period. The increase in expenses reflect further progression of our R&D projects since the easing of COVID-19 restrictions. • Selling and marketing expenses (S&M) were steady2 at US$961 million in comparison to the previous year. Whilst we had additional expenses on Etranacogene dezaparvovec pre-launch activities, we managed to hold S&M expenses in-line with prior year. • General and administrative (G&A) expenses were US$688 million, an increase of 4%2 when compared to the prior comparable period. The increase in G&A expenses were largely related to costs associated with acquiring Vifor. Excluding Vifor acquisition costs, G&A expenses were lower than prior year. • Depreciation, amortisation (D&A) expense and impairment was US$668 million, up 14%2 in comparison to the prior comparable period. D&A has increased due to continued commissioning of major capital and IT projects. • Net finance costs were US$148 million, down 4%2. The decrease in net finance costs were predominantly related to an increase in finance income, largely driven by higher interest rates and operating cash balances inclusive of the equity proceeds related to the acquisition of Vifor. Financial position • Cashflow from operations was US$2,629 million, down 27%. This reflects lower profit before tax and significant increase in inventories driven by higher plasma costs per litre and improved plasma volumes collected. • Cashflow used for investing was US$1,636 million, down 2% when compared to the prior comparable period, predominantly driven by lower capital spend. • CSL’s balance sheet remains in a strong position with net assets of US$14,578 million. • Current assets increased by 123% to US$16,461 million. The main driver was from strong cash inflows from operations as well as equity and debt proceeds related to the acquisition of Vifor. • Non-current assets increased by 10% to US$11,885 million in comparison to the previous year. The increase is mainly due to continued capital project spend, new right of use assets relating to leases of new facilities together with the on market acquisition of a minority of Vifor shares. • Current liabilities increased by 129% to US$7,108 million. The significant increase is mostly related to debt finance raised for the Vifor acquisition, which was treated as a current liability at 30 June due to a redemption feature should the deal not have completed. Following the subsequent completion of the Vifor acquisition, the related debt will be classified as non-current from the date of completion with the redemption feature now being met. • Non-current liabilities were steady at $6,660 million compared to last financial year. Increase in deferred tax liabilities were mostly offset by lower non-current interest-bearing liabilities and borrowings coupled with decrease in retirement benefit liabilities. Sales revenue was US$10,136 million Interim unfranked dividend of US$1.04 per share Final 10% franked dividend of US$1.18 per share1 = + Total ordinary dividends for 2022 US$2.22 per share CSL announced a net profit after tax of US$2.255 billion for the 12 months ending 30 June 2022 6% Net profit after tax at constant currency2 declined
CSL Limited Annual Report 2021/22 18 Our Value Creation Chain CSL People & Culture Patients and Public Health Strategic Sustainability Pillars & Focus Areas Environment Social Workforce CSL’s Strategy Value we create Our expertise and operations Sourcing including plasma collection Pharmacovigilance CSL’s Purpose, Values and Code of Responsible Business Practice Early stage research & collaboration Product development & clinical trials Manufacturing & distribution Sales, marketing, policy advocacy & patient support What we depend on Unmet need Opportunities to improve and protect the quality of life of patients and communities in therapy areas we treat. Natural resources Includes: plasma donations for rare and serious diseases; influenza virus strains for product manufacture; and environmental inputs such as water and energy. Physical assets Plasma centres to collect rawmaterial, manufacturing facilities for our products, warehouses, offices for our people and laboratories for our scientists. Our people 30,000+ people with diverse skills that are driven by our purpose and values. Financial resources Cash, equity and debt for future growth. Collaborators and business partners Accessing and sharing intellectual know how to develop and innovate our products. A healthier more productive society Protecting global health and the wellbeing of individuals, families, businesses and communities from life-threatening and/or complications resulting from influenza. Saving and/or improving the quality of life of hundreds and thousands of people with rare and serious diseases. Sustainable financial growth Delivering consistent, profitable and responsible growth for our investors, which fuels innovation and development. Social and economic opportunity Enabling hundreds of thousands of people to benefit from opportunity created by growing along with us, including employees, suppliers, plasma donors and research partners. Our promise to patients 3 Our Performance and Strategy
CSL Limited Annual Report 2021/22 19 Our 2030 Strategy CSL is driving sustainable growth to bring lifesaving therapies to patients and protect public health across the globe. We are focused on delivering across our therapeutic areas through innovation and our tireless approach to efficiency and reliable supply. CSL’s 2030 Strategy has been developed to maximise our capabilities and advantages in a competitive and constantly changing world. Historically and to this day, we are continuously innovating to increase efficiencies in our supply chain with plasma collections to finished product for our plasma-derived protein therapeutics – a business that has grown sustainably over the years, is difficult to replicate and does not face patent cliffs. Our differentiated cell-based and adjuvanted influenza products offer communities improved protection against influenza, and our extensive experience in rare disease allows us to focus on patients in our core therapeutic areas, delivering next-generation innovative products across multiple platforms. Our strategic pillars are represented in the Our 2030 Strategy (with Vifor) graphic on page 5. We focus on supporting patients and global public health in our core therapeutic areas. Our sustained investment in innovation, with an R&D budget of around US$1 billion, allows us the resources to develop the next generation of products to serve patients and public health. We are driven to be a leader in our fields of expertise and deliver a reliable supply of our lifesaving therapies. For sustainable growth of the enterprise, we are committed to serving our populations with the best available therapy across our strategic scientific platforms – plasma fractionation, recombinant protein technology, cell and gene therapy and vaccines. We see the promise of digital transformation to drive efficiency in our business and innovation to patients. At the centre of it all, we are investing in the more than 30,000 people who make up CSL, while remaining environmentally responsible as part of our sustainability strategy. Driving Sustainable Growth of Our Core Platforms Plasma-derived therapies rely on plasma collections from donors to manufacture lifesaving products at our sites around the world. While the pandemic disrupted collections, we continued to invest in centre openings, operational improvements and digital engagement to donors through our CSL Plasma app to drive our sustainable growth path as conditions become more favorable. Today, collection volumes are exceeding our pre-pandemic levels. As plasma collection volumes increase, we continue our investment in efforts to increase the yield of proteins recovered from each litre of plasma. Our commitment to innovation and our end-to-end network approach allow us to look at new ways to recover as much lifesaving protein as possible, from systematic process improvements through to highly innovative, transformative technologies. CSL’s core plasma products have a long history of being safe and effective. We continue to explore the potential benefits of our existing products in new indications to expand the number of patients that can benefit. We are also looking at new products derived from plasma, such as CSL112, which has the potential to be another important, lifesaving product and drive sustainable growth for the enterprise. CSL Seqirus distributed a record number of vaccine doses in the last year, reflecting the public health benefits of our innovative influenza vaccines product portfolio. We also continue to invest in the capabilities needed to drive sustainable growth, including commercial, R&D, medical and government affairs, which are critical to driving recognition of the benefits of our differentiated vaccine technologies. We are taking a pioneering role in innovation, leveraging our cell, adjuvant and self-amplifying mRNA (sa-mRNA) technologies. Several of our products have been recognised by achieving preferred recommendations fromNational Immunisation Technical Advisory Groups. To support future growth in vaccines, we are also investing in newmanufacturing capabilities, including recently completed fill and finish expansions in Liverpool, UK, and Holly Springs, North Carolina, US, and ongoing work at our new cell-based manufacturing facility in Tullamarine, Australia, which is expected to commence commercial vaccine production in 2026. Disruptive R&D Innovation to Better Meet the Needs of Patients and Public Health We are committed to serving patients and public health within our therapeutic areas by developing novel therapeutics and vaccines using our plasma fractionation, recombinant protein technology, cell and gene therapy and vaccines platforms. Today, we have a single, integrated R&D portfolio encompassing all programs across multiple therapeutic areas and scientific platforms, providing strong foundations for sustainable growth. Bringing together and integrating resources in our R&D functions allows us to share capabilities when possible and to enrich collaboration in functions where capabilities remain separate. The integrated portfolios, scientific synergies and complementary mindset will serve to build an even more robust pipeline and future for CSL. There are already numerous success stories of teams joining forces to solve challenging problems. Our focus on patients and innovation has delivered novel products like our class-leading recombinant factor IX albumin fusion protein, IDELVION®, for the treatment of haemophilia B. IDELVION® is the most trusted brand in the haemophilia B space and we continue to deliver for patients with the promising etranacogene dezaparvovec, a gene therapy with transformative potential to the lives of haemophilia B patients.
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