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Annual & Sustainability Report 2018 Contents Introduction This is Sobi 2 CEO letter 6 Sobi’s market in rare diseases 8 Business overview Strategy 10 Meeting patient needs 15 Innovation 30 Manufacture and supply of biologics 34 We make it happen 36 Our Responsibility 40 History and financial overview Sobi’s history 42 The share 44 Five-year summary 47 Reporting Director’s report 50 Financial statements 64 Notes 74 Corporate governance Letter from the Chairman 107 Corporate Governance Report 108 Auditor’s report on the Corporate Governance statement 115 The Board 116 Executive Committee 118 Auditor’s report 120 Sustainability Sustainability management 123 GRI index 130 Auditor’s report on the statutory Sustainability statement 133 Additional information 2019 Annual General Meeting 134 Definitions 135 Glossary 136 This is Sobi’s Annual and Sustainability Report 2018. The audited Annual Report includes pages 50–106. The Sustainability Report is found on pages 12–13, 15–17, 30–31, 34–41, 58–63 and 123–133 and consists of the Company and the Group’s legally required sustainability report according to the Annual Accounts Act, 6 chap. 11§. The report also constitutes our reporting to the UN Global Compact, Communication on Progress. rare strength A specialised biopharmaceutical company dedicated to rare diseases At Sobi, we bring something rare to the rare disease space. By turning our clinical research into treatments that transform lives, and getting them to the people who need them as quickly as possible, we help make medicine more accessible, opening up possibilities for patients and those caring for them. THIS IS SOBI This is Sobi Sobi is an international biopharmaceutical company dedicated to rare diseases. As an integrated company, we have extensive capabilities across the value chain, from the discovery, development and manufacture of medicines to patient access and support. Our plan is to continue diversifying to create a broader yet focused R&D and product portfolio. Haemophilia, Immunology Integrated biopharmaceutical company gically with multiple stakeholders, we create and Specialty Care We cover the entire value chain, from ideation value for all parties – patients and their Our therapies are concentrated within the and research, through preclinical and clinical families, healthcare systems, payers, our areas of Haemophilia, Immunology and development, biologics manufacturing, employees, investors and the pharmaceu- Specialty Care. Uptake of our extended half- regulatory affairs to patient access and dis- tical industry – to deliver new treatments to life recombinant treatments for haemophilia tribution. Our commercial success allows us the people who need them. A and haemophilia B, developed in conjunct- to reinvest in the research and development ion with Sanofi (formerly Bioverativ), is of new therapies that transform the lives of Responsible pricing growing rapidly as they become increasingly people with rare diseases. A vital factor in access to treatment is responsi- accepted as the standard of care in several By promptly turning our clinical research ble pricing. That means balancing the role of a countries. During 2018, we created a strong into groundbreaking treatments, we help sustainable company with being a sustainable Immunology portfolio, and have important make medicine more accessible more part of the healthcare system. Our continual specialty treatments in the area of genetics quickly, opening up new possibilities for dialogue with rare-disease communities, reg- and metabolism. patients and more opportunities for those ulators and budget holders allows us to create caring for them. powerful value propositions and product vali- Patients in over 70 countries Our focus and capabilities, track record dations enabling us to get therapies to patients With our global head office in Stockholm, of bringing rare-disease products to market, efficiently and responsibly. Sweden, our organisation spans 19 coun- and ability to find creative business devel- Together with our partners and stake- tries, delivering treatments to patients in opment and licensing solutions make us an holders, we ensure that we create solutions over 70 countries around the globe. Europe ideal partner for biotech companies with that serve the needs of those affected by and the Middle East – which together promising drug candidates which could rare diseases while also facilitating sustain- with Russia and North Africa comprise our have a high impact in small populations. able growth. EMENAR region – are the core markets for We bring something rare to rare diseases our Haemophilia franchise, while acquisi- Patients’ needs first – a belief in the strength of being focused, tions during 2018 greatly strengthened our In all our partnerships, we put the needs of the power of agility and the potential of the business and footprint in North America, patients first, in the knowledge that good people our business is designed to serve. balancing our success in Europe. medicine is good business. Working strate- 70 935 9,139 We serve patients in over Employees SEK M in revenue 70 countries 2 SOBI ANNUAL AND SUSTAINABILITY REPORT 2018 THIS IS SOBI Focus is strength As a specialised biopharmaceutical company, we are dedicated to rare diseases. We see this focus as a strength. With over 80 years of experience, Sobi has a lot to offer in product development and commercialisation. Research R&D enables us to generate innovative treatments, as well as evaluate projects and products from outside Commercialisation Research and further develop them in-house. and patient access Development We cover the entire development process, from pre- clinical and clinical development, to post-approval clinical studies in a real-world setting. rare Manufacturing In addition to in-house biological manufacturing, Sobi strength works with 15 contract manufacturing organisations (CMOs) in Europe and the US. Regulatory Development and Safety Regulatory and safety Patient safety is of utmost importance, and is the guiding principle for our work in the regulatory area, including distribution. Stringent pharmacovigilance and drug safety systems help protect patient safety. Manufacturing Commercialisation and patient access, worldwide The footprint of our commercial organisation con- tinues to grow and covers issues including access to treatment, responsible pricing and education of healthcare professionals. Share of total revenue, by business area 66% Haemophilia +40% of which manufacturing revenue accounts for 5% Revenue growth 2018 34% Specialty Care SOBI ANNUAL AND SUSTAINABILITY REPORT 2018 3 THIS IS SOBI The year in figures 2018 was a year of impressive growth. Revenue was up 40 per cent year on year, with EBITA rising 74 per cent. Product sales in Haemophilia more than doubled, and we achieved double-digit growth in Specialty Care. Key figures SEK M 2014 2015 2016 2017 2018 Total revenue 2,607 3,228 5,204 6,511 9,139 Gross profit 1,548 2,007 3,651 4,657 6,723 Gross margin, % 59 62 70 72 74 % Operating expenses 1,873 1,861 2,518 3,057 3,601 40 Revenue growth EBITA –44 433 1,543 2,053 3,571 EBIT –325 146 1,133 1,600 3,122 Profit/loss for the year –270 83 802 1,149 2,418 Earnings per share, SEK –1.01 0.31 2.99 4.27 8.97 Cash flow from operations 234 507 343 1,333 2,090 Equity per share, SEK 16.6 17.3 19.8 24.6 33.1 Equity assets ratio, % 71 56 54 61 53 % Dividend 0 0 0 0 0 74 EBITA growth No. of employees (full-time equivalent) 589 702 760 800 902 Overview of most important products by revenue Haemophilia Specialty Care SEK M 2018 2017 Change, % SEK M 2018 2017 Change, % Elocta® 3,261 1,557 109 Kineret® 1,320 1,142 16 Alprolix® 974 363 168 Orfadin® 899 862 4 Manufacturing 436 559 –22 Other 908 825 10 Royalty1 1,341 1,203 12 Total 3,127 2,829 11 Total 6,012 3,682 63 1. See page 82 for details. Specialty Care There was a strong performance across the Specialty Care portfolio. Haemophilia Solid growth for Kineret continued across all regions for the full year. Product sales more than doubled. The main countries contributing to this growth were France, Germany, Italy and the UK. 4 SOBI ANNUAL AND SUSTAINABILITY REPORT 2018 THIS IS SOBI The year in brief Acquisitions helped take Sobi to a new level in 2018. Synagis® will strengthen our footprint in the North American market, where business will almost triple compared with 2018. The acquisitions of rights to emapalumab and Synagis create a strong second leg in ­Immunology to better balance our success in Haemophilia. Haemophilia Specialty Care Research & Organisation Development Q1 Q1 Q1 Q1 Ireland becomes the first coun- Sobi launches Ravicti® in FDA accepts investigational new Torbjörn Hallberg joins Sobi as try in Europe where every person Europe and advances the care drug application and grants Fast General Counsel and Head of with haemophilia has access to of patients with urea-cycle Track Designation for SOBI003 Legal Affairs. extended half-life (EHL) thera- disorders. for the treatment of mucopoly- On Rare Disease Day, Sobi pies after new supply contracts saccharidosis (MPS) type IIIA. launches an enhanced corporate are signed with Sobi. Q2 sustainability programme with Sobi becomes the first com- Kineret approved in the Euro- Q2 a strong connection to the pany in France to make EHL pean Union for the treatment of Preliminary phase 1/2a data on company’s strategy of providing treatments available for both Still’s disease. BIVV001 (rFVIIIFc-VWF-XTEN)1, sustainable access to treatments haemophilia A and B. presented at the WFH World for rare diseases. Q3 Congress. Q2 Sobi strengthens the Immunol- Q2 Data released at the World ogy franchise by acquiring the Q3 Sobi appoints Henrik Stenqvist Federation of Hemophilia (WFH) global rights for emapalumab First patient dosed in phase 1/2 as Chief Financial Officer and World Congress in Glasgow from Novimmune.

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