CSL Limited Annual Report 2010-2011 CSL Limited ABN 99 051 588 348 Annual Report 2010-2011 Financial Calendar 2011 17 August Annual profit and final dividend announcement 19 September Shares traded ex-dividend 23 September Record date for final dividend 14 October Final dividend paid 19 October Annual General Meeting 31 December Half year ends 2012 22 February Half year profit and interim dividend announcement 14 March Shares traded ex-dividend 20 March Record date for interim dividend 13 April Interim dividend paid 30 June Year ends 22 August Annual profit and final dividend announcement 17 September Shares traded ex-dividend 21 September Record date for final dividend 12 October Final dividend paid 17 October Annual General Meeting 31 December Half year ends Cover: Marcus de Alwis is a corporate counsel for CSL and Daria Kurtov is a CSL research scientist at the Bio21 Institute. Both work in Parkville, Australia. Annual General Meeting Share Registry Wednesday 19 October 2011 at 10:00am Computershare Investor Services Pty Limited Function Centre, National Tennis Centre, Yarra Falls, 452 Johnston Street Abbotsford VIC 3067 Melbourne Park, Batman Avenue, Melbourne 3000 Postal Address: GPO Box 2975 Melbourne VIC 3001 Enquiries within Australia: 1800 646 882 AGM Live Webcast Enquiries outside Australia: +61 3 9415 4178 Investor enquiries facsimile: +61 3 9473 2500 The CSL Limited Annual General Meeting will be webcast through Website: www.investorcentre.com CSL’s website: www.csl.com.au Email: [email protected] Log on to the Home Page of CSL’s website and then click on the item called Annual General Meeting webcast. Please see inside back cover for legal notice. CSL Limited 1 Annual Report 2010-2011 Biotherapies for life CSL Limited has over 10,000 staff in more than 20 countries. We produce life-saving and life-enhancing medicines that enable many thousands of people around the world to lead normal healthy lives. Our headquarters is in Australia and we have substantial manufacturing operations in the US, Germany and Switzerland. CSL is a global specialty We support patient, biomedical biopharmaceutical company that and local communities by improving researches, develops, manufactures access to therapies, enhancing and markets biotherapies to treat patients’ quality of life, advancing and prevent serious and rare medical scientific knowledge, supporting conditions. We produce safe and future medical researchers, and effective therapies for patients who engaging our staff in the support rely on them for their quality of life, of local communities. We also and sometimes for life itself. contribute to humanitarian programs and relief efforts around the world. Innovation is at the heart of everything we do. It is reflected Our continuing priority is to develop in our creation of state-of-the-art innovative therapies and programs plasma collection and manufacturing that make a real and lasting facilities, our investment in improving difference to the lives of people current therapies, finding new who use our products, providing indications for existing therapies, new medicines for unmet needs and innovating new therapeutic and continuous improvement products for unmet needs. of our protein-based therapies. To achieve this, we invest in life cycle management and market development for existing products, as well as longer term, new product development opportunities. Contents Year in Review Our Company Financial Report Highlights 3 Corporate Responsibility 20 Directors’ Report 38 Financial Results 4 Directors’ Profiles 22 Auditor’s Independence Declaration 63 Year in Review 5 Executive Management 24 Consolidated Statement of Comprehensive Income 64 CSL Group Business Operations 26 Business Features Consolidated Balance Sheet 65 Share Information 27 CSL Behring 10 Consolidated Statement Shareholder Information 28 CSL Biotherapies 14 of Changes in Equity 66 Corporate Governance 30 Research and Development 18 Consolidated Cash Flow Statement 67 Notes to the Financial Statements 68 Directors’ Declaration 126 Independent Auditor’s Report 127 2 About CSL Limited Our Businesses CSL Behring CSL Biotherapies Research and Development CSL Behring is a global leader CSL Biotherapies provides CSL continues to invest in the in biotherapies with the broadest plasma fractionation services development of protein-based range of quality products in our in Melbourne under contracts medicines to treat serious human industry and substantial markets with Australia, New Zealand, illnesses. Today, most of our in the US, Europe and Japan. Hong Kong, Malaysia, Singapore licensed medicines are purified Our therapies are indicated and Taiwan. We market from human plasma or made for treatment of coagulation commercial plasma products from traditional sources. disorders including haemophilia in Asia (excluding Japan) and In addition, CSL is building and von Willebrand disease, we develop, manufacture and the capabilities required to primary immune deficiencies, market immunohaematology develop future products using hereditary angioedema and products (diagnostic reagents) recombinant DNA technology. inherited respiratory disease. for Australia and Asia Pacific. Global research and development CSL Behring products are CSL Biotherapies manufactures activities support CSL’s licensed also used to prevent haemolytic and markets vaccines and product businesses and the disease in newborns, speed pharmaceutical products in development of new therapies recovery from heart surgery, Australia and New Zealand focusing on products that align prevent infection in people and is responsible for global with our technical and commercial undergoing solid organ sales of our influenza vaccines. capabilities in immunoglobulins, transplants, and help victims specialty products, haemophilia of shock and burns to and coagulation, breakthrough recover faster. therapies and licensing. MARBURG Germany CSL Behring R&D and Manufacturing HATTERSHEIM Germany CSL Behring CSL Biotherapies Sales and Marketing KING OF PRUSSIA US CSL Behring BERN Switzerland SCHWALMSTADT GOETTINGEN TOKYO Japan KANKAKEE US Administration, R&D, Germany Germany CSL Behring CSL Behring CSL Behring Sales and Distribution R&D, Manufacturing, CSL Plasma CSL Plasma R&D, Sales and R&D and CSL Biotherapies Sales and Distribution EU Logistics Centre Testing Laboratory Marketing Manufacturing Sales and Marketing INDIANAPOLIS US KNOXVILLE US CSL Plasma Logistics Centre CSL Plasma Testing Laboratory BOCA RATON US CSL Plasma Administration MELBOURNE Australia CSL Limited Group Head Office, R&D CSL Biotherapies R&D, Manufacturing, Sales, Warehousing and Distribution Regional Sales and Distribution CSL Limited Annual Report 2010-2011 Year in Review 3 Highlights CSL Group Sales by Region 2010 -11 CSL Group Sales by Major Products 2010 -11 Year in Review 2010-2011 Highlights North America 00% Immunoglobulins 00% Europe 00% Plasma-derived coagulants 00% Australia 00% HelixateDear 00% Shareholder, Asia 0% Albumin 00% Other 0% OtherCSL 00% achieved international sales growth for our plasma products this year in both established and emerging markets and continues to build the capacity to develop and produce new and improved therapies. CSL Group Sales by Region 2010 -11 > Net profit after tax was $941 million for the twelve months ended 30 June 2011. This result has been achieved despite an unfavourable foreign exchange impact of $116 million. On a constant currency basis¹, operational net profit after tax was $1,057 million. CSL’s balance sheet North America 41% remains very strong with $479 million cash on hand against borrowings Europe 32% Australia 11% of $416 million. Cash flow from operations was $1,018 million. Asia 9% > Our immunoglobulin portfolio achieved an outstanding result as transitions Other 7% continued to Hizentra® from Vivaglobin®, and to Privigen® from Carimune® and Sandoglobulin®. Strong sales in our critical care portfolio came from fibrinogen products Haemocomplettan® and RiaSTAP™, and from Berinert® our C1 esterase inhibitor for hereditary angioedema. CSL Group Sales by Major Products 2010 -11 > We continue to invest in manufacturing capacity to meet future demand for our products. We have expanded facilities in Bern and received Immunoglobulins 40% approval by the US FDA and European regulatory authorities for our 20% Plasma-derived subcutaneous immunoglobulin Hizentra®. In addition, capacity expansion coagulants 14% Helixate 12% has been completed in Marburg for several critical care products and Albumin 10% a capacity upgrade has been initiated in Kankakee (US) for albumin. Other 24% > We are going to build a 15 million gram capacity Privigen® facility at our Broadmeadows site in Melbourne. Expected to be in place by 2016, the facility will enhance operational integration with CSL Behring to maximise single platform efficiencies and support global demand. > We further progressed development of a family of recombinant coagulation therapies to treat bleeding disorders, concluded Phase III clinical trials for Beriplex® to arrest bleeding caused by anti-coagulant therapy and completed a Phase I safety study supporting the possible use of reconstituted high density lipoprotein, a potential additional breakthrough product made from human plasma. > Supporting our research and development activities, new facilities have been completed in Marburg for the purification and formulation of recombinant products, and construction of a new biotechnology facility commenced in Melbourne for late stage development