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Corporate Report 2014 Corporate Report 2014 Xellia 2014 1 CONTENTS Contents 2 Xellia at a glance 3 2014 highlights 5 Spotlight on growth 9 Business overview 15 Corporate responsibility 24 Corporate governance Forward-looking statement This report contains certain projections and other forward-looking statements with respect to the fi nancial condition, results of operations, businesses and prospects of New Xellia Group A/S (“Xellia”). These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. Xellia 2014 1 Headquartered Owned by in Copenhagen, Novo A/S since XelliaXellia atat aa glanceglance Denmark July 2013 Xellia is a specialty pharmaceutical company focused on providing important anti-infective A GLANCE XELLIA AT treatments against serious and often life-threatening infections Xellia is developing novel antibiotics effective against resistant species in partnership with SINTEF Materials and Chemistry and the Statens Serum Institut supported by a grant from the Research Council of Norway Oslo, Norway Our new state-of–the-art R&D Center of Excellence focused on APIs and discovery of novel anti-infectives opened in November 2014 Copenhagen, Denmark Xellia’s headquarters. Our biggest operation, manufactures both sterile APIs and FDFs, provides lyophilized vials and dry powder Budapest, Hungary Manufactures several unique products and fill vials, stability testing and packaging provides additional capacity for Vancomycin. This facility houses fermentation pilot plants, and is our site for introducing and scaling-up new APIs Chicago, USA Commercial Shanghai, China organization in Commercial and back-office Xellia’s major market organization supporting the work with partners in the Chinese market Tokyo, Japan Commercial organization handling the challenging Japanese market Raleigh, USA Acquired from Fresenius Kabi in July 2014, our first US manufacturing facility significantly expands our capacity for the production of Taizhou, China Established in 2008 as a injectable pharmaceutical products partnership with Zhejiang Hisun Pharmaceutical Company, Ltd. Bangalore, India CMO and commercial group established to manage growing network of CMOs Key: and to capitalize on emerging market opportunities including India Manufacturing Zagreb, Croatia R&D Our Product and Innovation R&D Center Sales of Excellence focused on innovative Other formulation technologies and FDFs 1000 500 100 Xellia has over 1,000 We supply our anti-infective Over 100 years’ experience in employees in eight countries products to more than 500 the development, manufacture around the world pharmaceutical companies and supply of generic in over 70 countries fermented and semi-synthetic 1 APIs and FDFs Xellia is the leading supplier of important anti-infectives Vancomycin and Colistimethate Sodium (CMS) Xellia 2014 2 TS GH I GHL ACCOUNTS 2013 ACCOUNTS I 2014 highlights H 2014 2014 was an important year of strategic investment and growth for Xellia. It was also our first entire year of operations under the ownership of Novo A/S, a committed long-term investor with life science sector insights, and governance by our independent Board of Directors. While Xellia’s business has always been grounded in the development, manufacture and supply of important generic anti-infective active pharmaceutical ingredients (API) and injectable finished dosage form (FDF) products, we are progressively re-shaping our business. During 2014 we decided to increase and refocus our resources on developing a balanced portfolio IN 2014 WE of more innovative and proprietary anti-infective products. We continue to ESTABLISHED A produce generic anti-infectives; however during the year we discontinued certain activities in adjacent therapeutic areas that were not core to our stRONG PLATFORM business in order to prioritize our efforts within innovative anti-infectives. FOR THE GROWTH OF OUR BUSINESS Operations In 2014 we made excellent progress I would also like to highlight that this CARL-ÅKE CARLSSON strategically despite some operational year we maintained our impeccable CHIEF EXECUTIVE OFFICER XELLIA PHARMACEUTICALS challenges. Expansion of the business compliance track record with the to better serve our customers and regulators across all manufacturing to increase our focus on R&D and facilities, in what continues to be innovation were significant objectives a challenging environment for the for us this year. pharmaceutical industry. In 2014, we have continued to build on the In July we acquired a dedicated sustainability program initiated We welcomed Mads Bodenhoff, lyophilized (freeze-dried) vial in 2013 across our manufacturing Anders B. Spohr and Geelanie Briones manufacturing facility in Raleigh, sites aimed at improving energy to the Xellia Executive Management North Carolina from Fresenius Kabi. efficiencies and carbon footprint team. Mads joined us from Novozymes We have been in partnership with for our products. as Chief Financial Officer andVice Fresenius Kabi for many years as President, Anders is Vice President During the year we completed the a preferred, trusted supplier of Global Product Supply and previously relocation of our new state-of-the- APIs and the acquisition includes held a similar role at LEO Pharma, art R&D Center of Excellence in a continuous manufacturing and and Geelanie is the new Vice President Oslo, Norway, and have extended and supply agreement. Raleigh is Xellia’s Quality and Regulatory Affairs, doubled capacity at our Product and first facility in the US. It was a great joining Xellia from Sandoz. opportunity for us to expand in Innovation R&D Center in Zagreb, this market and to provide a better Croatia. In October, the Zagreb R&D Although we were pleased with the service of supplying FDF products Center was honored to receive a visit progress made this year, we also for our US customers. from HM The Queen Margrethe II of experienced operational challenges Denmark and HRH The Prime Minister affecting a production line at our During 2014 we commenced supply Consort, together with the Danish Copenhagen, Denmark facility, which of several injectable anti-infectives Minister for Food, Agriculture and temporarily reduced our ability to supply to customers in the US following Fisheries, Mr. Dan Jørgensen during certain products to our customers and approvals from the US FDA. Our a State visit to Croatia. Xellia was also incurred additional operating costs. Copenhagen, Denmark lyophilized one of only three Danish companies We immediately implemented measures vials manufacturing facility played selected for inclusion in the visit. to resolve the resulting supply issues a key part in this respect, and during During a tour of the laboratories and maintain our record as a reliable the year we continued to focus on the importance of the role Xellia supplier. We will continue to invest in expanding our vial manufacturing has played in the battle against our technology and equipment and facilities in Copenhagen as well as the infectious diseases and Xellia’s have developed a plan for continuous new facility in Raleigh, NC in order to heritage in antimicrobial products upgrades to minimize any future be able to meet customer demand. was discussed. possibility of supply disruptions. Xellia 2014 3 2014 highlights continued... The combination of the operational Innovation In 2010 we formed Pharmaero ApS, 2014 HIGHLIGHTS challenges and the increase in With the continued investment in a joint venture with Scandinavian resources spent on expanding innovation, we are extending our Health Ltd, a significant player in the our injectable vial manufacturing R&D to focus on improving the injectable device space, to address facilities in Copenhagen and efficacy, safety profile and reducing unmet medical needs in providing Raleigh to meet customer demand the side effects of existing anti- anti-infective treatments localized to negatively impacted the Company’s infectives and developing new drugs the lung and respiratory tract. In 2014 profitability for the year and will to help tackle the global crisis of we continued the development of also have an impact in 2015. Despite antimicrobial resistance. We have drug-device combination products this we were able to achieve our embarked on an ambitious path to providing liquid anti-infective overall performance indicators and develop a pipeline of unique and formulations for inhalation used meet customer requirements and proprietary anti-infective products for the treatment of Pseudomonas expectations at a satisfactory level. starting with line extensions based aeruginosa infections in cystic fibrosis Products and markets on improved formulations, drug- patients. Further clinical studies are Our generic anti-infective business device combinations and in the long planned for 2015, and beyond. is built to meet the immediate and term new anti-infective compounds. Outlook for 2015 long-term requirements of our We appointed an eminent Scientific As we look ahead we will continue customers comprising branded, Advisory Board in 2014 to support to build on the strong platform specialty and generic pharmaceutical us as we increase the breadth of for growth that we established in companies in more than 70 countries our science beyond manufacturing 2014. Going the extra distance to around the world. Our vertical of anti-infective generics to place our customers at the center integration strategy enables us to support more innovative product of everything
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