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Pioneer in Rare Diseases Sobi in Brief ANNUAL REPORT 2013 Pioneer in Rare Diseases Sobi in Brief ............................................................ Inside cover CEO Statement .......................................................................... 2 Highlights 2013 ........................................................................... 4 Key Figures 2013 ........................................................................ 5 Market ............................................................................................ 6 Strategy ...................................................................................... 10 Pipeline Programmes ............................................................ 12 Haemophilia .............................................................................. 15 Neonatology ............................................................................. 19 Key Therapeutic Areas .......................................................... 21 Inflammation: Kineret ....................................................... 22 Genetics & Metabolism: Orfadin ................................. 25 Partner Products ..................................................................... 28 ReFacto AF ................................................................................ 30 Summary Product portfolio ................................................ 31 Sustainability ............................................................................. 32 GRI Index ............................................................................... 36 Directors’ Report .................................................................... 41 Operations ............................................................................ 41 Risk Management .............................................................. 48 The Sobi Share ..................................................................... 51 Corporate Governance Report ......................................... 53 Board of Directors .............................................................. 58 Executive Leadership Team ............................................ 60 Group Financial Statements ............................................... 62 Parent Company Financial Statements .......................... 68 Notes ........................................................................................... 72 Auditors’ Report .................................................................... 106 Annual General Meeting 2014 ......................................... 107 Disclaimer In order to utilise the ’Safe Harbor’ provisions of the United States Private Securities Litigation Reform Act of 1995, Swedish Orphan Biovitrum is providing the following cautionary statement. This presentation contains forward-looking statements with respect to the financial condition, results of operations and businesses of Swedish Orphan Biovitrum. By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward- looking statements. These factors include, among other things, the loss or expiration of patents, marketing exclusivity or trademarks; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; the impact of Cover competition, price controls and price reductions; taxation risks; the risk of substantial Kineret has been approved for the treatment of NOMID and, in product liability claims; the impact of any failure by third parties to supply materials or services; the risk of delay to new product launches; the difficulties of obtaining 2013, of CAPS. The approval of these indications is a realisation and maintaining governmental approvals for products; the risk of failure to observe of Sobi’s commitment to developing effective treatments for ongoing regulatory oversight; the risk that new products do not perform as we expect; children affected by rare diseases. and the risk of environmental liabilities. A sustainable business with a promising future Early Development Programmes Late-stage Pipeline Medium-term investments to Programmes provide Haemophilia Neonatology ensure commercialisation of the a promising platform late-stage Pipeline Programmes, for the future. see pages 12–20. Continued focus on growth of Core Genetics & Products within key Therapeutic Inflammation Metabolism Areas, see pages 21–27. Operating business An integrated solution for with sustainable commercialisation of niche positive cash flow. Partner Products and speciality products, see pages 28–29. ReFacto AF® Stable contribution to revenues from drug production and royalties, see page 30. Sobi’s key Therapeutic Areas are Inflammation and Genetics & Metabolism with a growing focus on Haemophilia and Neonatology. Sobi in brief Sobi is an international speciality healthcare company We deliver products to specialist physicians and dedicated to rare diseases. Our mission is to develop their patients through our integrated partnership and deliver innovative therapies that improve the model, which involves constant dialogue with legis- lives of patients. lators, regulatory authorities, healthcare systems and patients. Our key Therapeutic Areas are Inflammation and Genetics & Metabolism, with a growing focus on We leverage our world-class capabilities in protein Haemophilia and Neonatology. biochemistry and biologics manufacturing to develop next-generation biological products, often through partnerships. Revenues by product category Revenues by region Employees by function 2013 Total revenues SEK M SEK M % 2013 2012 2,500 1,600 2,177SEK M 1,923 SEK M 2,000 1,200 1,500 Gross margin 800 2013 2012 1,000 400 59% 54% 500 0 0 2013 2012 2011 2013 2012 2011 EBITA Key Therapeutic Areas ReFacto Europe MENAR1 R&D, 27% Marketing & Sales, 34% 2013 2012 Partner Products Other North America RoW Manufacturing, 25% Admin. & Other, 14% 211 SEK M 367 SEK M 1 Middle East, North Africa and Russia Pioneer in rare diseases Sobi is passionate about children’s health. We are dedicated to developing and delivering products to treat rare diseases and conditions that can help restore vitality and hope to young lives. 2013 was eventful and positive for Sobi. We made significant progress in many areas towards our goal of being a leading international speciality healthcare company dedi cated to rare diseases. The operating business showed strong momentum and our pipeline programmes achieved several key milestones during the year. Progress in our operating business Revenues in 2013 increased by 13 per cent compared to the previous year, our gross margin improved by 5 per- centage points to 59 per cent, and we strengthened our company financially through stable positive cash flow and improved operating profit. Our key Therapeutic Areas of Inflammation and Genetics & Metabolism continued their trajectory from 2012, expanding the business in both existing and new markets and growing revenues by 10 per cent. Kineret® was approved in Europe for a new adult and paediatric indication, Cryopyrin-Associated Periodic Syndromes (CAPS), shortly before year end, and we reached an agreement with our distributor for Orfadin® in the US to assume direct responsibility for Orfadin in the US, Canada and Latin America. These developments will continue to support the growth of these businesses. In addition, we have strengthened our Partner Products “Our commercial portfolio with four significant new partnership agreements: • Auxilium Pharmaceuticals for the development and progress forms commercialisation of Xiapex®, a new generation bio- the platform for logic for the treatment of Dupuytren’s contracture, a connective tissue disorder. the launch of • PharmaSwiss for marketing of Megace®, Monopril®, our pipeline” Cefzil® and Duricef® which are approved in the areas of oncology, cardiovascular and anti-inflammatory therapies. • Exelixis to support the distribution and commercialis- ation of Cometriq® for the treatment of metastasised thyroid cancer within the EU and potentially also in other countries. SOBI ANNUAL report 2013 CEO Statement • 3 • Hyperion Therapeutics for the sole rights in seven We also acquired additional rights for Kepivance® which by recruiting several highly experienced professionals. countries in the Middle East for the distribution of a allows us to explore a potential new indication based on Biogen Idec expects to launch both products in the US liquid form of Ravicti®, a drug to treat patients with the results from two phase 3 studies conducted by in 2014, and as of Q1 2014 rFIXFc (AlprolixTM) had been Urea Cycle Disorders (UCD). Amgen. These studies show that Kepivance has the approved in both Canada and in the United States. potential to reduce the incidence and duration of severe At the end of 2013 we had two ongoing paediatric Finally, our ReFacto® manufacturing business was stable oral mucositis in patients undergoing treatment for phase 3 studies with our haemophilia drug candidates in in 2013 with growth of 9 per cent. advanced head and neck cancer. This Kepivance pro- children under the age of 12. Interim results from the Our commercial progress forms the platform for the gramme was presented for the first time at our Capital studies, which were presented in December at the launch of our pipeline. Market Day events in Stockholm and New York in
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