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ANNUAL and SUSTAINABILITY REPORT 2017 Forward-Looking Statements This Report Includes Forward-Looking State- Ments

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ANNUAL and SUSTAINABILITY REPORT 2017 Forward-Looking Statements This Report Includes Forward-Looking State- Ments Building on our strengths Building ANNUAL AND SUSTAINABILITY REPORT 2017 Forward-looking statements This report includes forward-looking state- ments. Actual results may differ from those stated. Internal factors such as the successful management of research programmes and intellectual property rights may affect future results. There are also external conditions such as the economic climate, political changes and competing research programmes that may affect Sobi’s results. Sobi™ is an international biotechnology company dedicated to rare diseases. Our mission is to transform the lives of people with rare diseases by providing inno ­ vative therapies in our focus areas.” Guido Oelkers, CEO CONTENTS Contents This is Sobi .......................................................................4 The year in brief ..........................................................6 INTERVIEW Interview with the CEO and Chairman ......................8 CEO and Chairman Strategy .....................................................................10 8 Sobi operates throughout the entire value chain, from early research, over to clinical development and into the commercial market. Business areas ...............................................................16 “We can add significant value to our partnerships by leveraging all Haemophilia ..............................................................16 our com petencies, making us the partner of choice for a range of Specialty Care ...........................................................22 companies with innovative products”, says Guido Oelkers, CEO. Biologics Development and Supply ........................28 Innovation ......................................................................30 Sustainability .................................................................36 History & Financial Overview .......................................48 Sobi’s history .............................................................48 The share ...................................................................50 Five-year summary ....................................................53 Reporting ......................................................................54 CFO’s statement .......................................................55 Directors’ Report .......................................................56 Financial statements .................................................66 Notes .........................................................................76 Corportate Governance .............................................108 Corporate Governance Report ..............................108 The Board ................................................................116 Executive Committee .............................................118 Auditors’ report .......................................................120 Sustainability management .......................................123 GRI index .................................................................130 Sustainability Report, auditors’ opinion ................133 Annual General Meeting 2018 ...............................134 STRATEGY Definitions and glossary .........................................135 Sobi’s growth strategy builds on the company’s strengths and aims to capitalise on the potential This is Sobi’s Annual and Sustainability Report 2017. The audited Annual Report in haemophilia and the rare disease areas. includes pages 56–107. The Sustainability Report is found on pages 12–13, 36–47, and 123–132 and consist of the Company and the Group’s legally required sustain- We also aim to strengthen our pipeline and ability report according to the Annual Accounts Act, 6 chap. 11§ . build a foundation for self-sustained R&D. 10 2 SOBI ANNUAL AND SUSTAINABILITY REPORT 2017 CONTENTS THIS IS SOBI HAEMOPHILIA INNOVATION BUSINESS AREAS 16 INNOVATION Sobi introduced recombinant extended half-life factor products to Building on a strong legacy in biotechnology, Sobi30 aims to have SUSTAINABILITY Europe in 2016 and the Middle East in 2016–2017. The products a transformational impact in the rare-disease space. have been well received in the haemophilia community. Sobi’s corporate sustainability programme is closely connect- FINANCIAL OVERVIEW ed to the company’s strategy of providing sustainable access to & HISTORY treatments for rare diseases. REPORTING GOVERNANCE 36 CORPORATE SPECIALTY SUSTAINABILITY CARE SUSTAINABILITY MANAGEMENT Sales for the newly formed business area Specialty22 Care reached REPORTING SEK 2,829 M in 2017. Sobi is exploring several opportunities for Our rapid growth continued throughout 2017, growth that build on the company’s strengths in patient-centric with a remarkable financial performance and development and commercialisation. a resulting strong financial position. 54 SOBI ANNUAL AND SUSTAINABILITY REPORT 2017 3 THIS IS SOBI This is Sobi Sobi is an international rare-disease company dedicated to making a significant difference for individuals with rare diseases by providing access to innovative treatments. Strong and growing portfolio 70 countries across the globe. Europe is the We operate through two business areas: core market for the Haemophilia franchise. OUR VISION Haemophilia and Specialty Care. Our research The Sobi strategy for growth is aimed at and product portfolio is primarily focused on balancing this geographic footprint by haemophilia and specialty care, including expanding Specialty Care in other markets To be recognised as a global leader in inflammation and genetic and metabolic including North America. providing access to innovative treat- diseases. In Haemophilia, we aim for a leader- ments that make a significant differ- ship position in Europe, the Middle East and Win-win collaborations ence for individuals with rare diseases. North Africa. In Specialty Care, we aim to We put the needs of patients first, in the grow our portfolio to leverage our compe- knowledge that this will create long-term, tence in rare-disease and niche indications, sustainable value for everyone. Through stra- and thereby build on the capital generated tegic partnerships with multiple stakeholders, in Haemophilia. we believe it is possible to create a win-win OUR MISSION environment for all parties – patients, health- Integrated biotechnology company care systems, budget holders, our employees, As an integrated biotechnology company, investors and the pharmaceutical industry – We transform the lives of people with we have in-house capabilities that encompass and deliver new treatments to patients. rare diseases by providing innovative the entire value chain, from research, through therapies in our focus areas. preclinical and clinical development, bio- Responsible pricing logics manufacturing and supply, regulatory An effective treatment is one that not only We are growing our haemophilia busi- affairs to patient access and distribution. provides a medical benefit but is also both ness to become a leading player in the The integrated approach is a prerequisite available in the country where the patient EMENAR1 region. for providing proprietary drugs, and an lives and is affordable in the healthcare We look to become the preferred part- enabler for partnerships throughout all system. One of the most crucial factors to ner for the development and commer- stages of drug development. ensure patient access to treatment is resp- cialisation of products in specialty care. onsible pricing. That means balancing the Preferred partner role of a sustainable company with being We continue to identify and develop With our dedication and strong capabilities a sustainable part of the healthcare system. innovative treatments through a self- across the entire value chain, proven track sustained R&D organisation funded record of bringing rare-disease products to Partnership is key by growth in our business areas. the complex European market through a multi- In 2017, the European Commission author- faceted environment, and a demonstrated ised 14 medicines with an orphan designation 1. Europe, Middle East, North Africa and Russia. inherent ability to grow our North American and the US Food and Drug Administration portfolio, we aim to become the preferred (FDA) approved 18 new orphan drugs. The partner for pharmaceutical companies with main driver of this growth is successful legisla- strong franchises and promising drug candi- tion, combined with technological and scien- dates in rare-disease and niche indications. tific advancements, academic partnerships and the increasing availability of infrastruc- Growing international presence ture, together with patient-led international With our head office in Stockholm, Sweden, collaborations which have helped to spur the Sobi organisation spans 19 countries, momentum worldwide. delivering treatments to patients in over 4 SOBI ANNUAL AND SUSTAINABILITY REPORT 2017 THIS IS SOBI THIS IS SOBI BUSINESS AREAS INNOVATION An urgent need for treatments for rare diseases A rare disease affects a small per- centage of the population, and is SUSTAINABILITY often serious, life-threatening or chronically debilitating. Many rare diseases manifest in childhood, and are present throughout a per- son’s life. The causes of many rare diseases remain unknown, and they are often not curable with FINANCIAL OVERVIEW current interventions or medica- tions; this results in a substantial & HISTORY unmet medical need and immense costs for healthcare systems, soci- eties and families. In Europe and North America, an estimated 60 million
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