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Corporate Report 2018 Contents Corporate Report 2018 Contents Xellia at a Glance 3 CEO’s Statement 4 2018 Highlights 6 Forward-looking statement This report contains certain projections and other forward-looking statements with respect to the fi nancial Business Overview 7 condition, results of operations, businesses and prospects of New Xellia Group A/S (“Xellia”). These statements are Corporate Responsibility 12 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. Corporate Governance 22 Xellia 2018 2 HIGHLIGHTS Headquartered in Copenhagen, Denmark Owned by Xellia at a glanceGlance Specialty pharmaceutical company focused on providing important anti-infective treatments against serious and often life-threatening infections. Over 1,600 Over 100 years’ experience in Supply our anti-infective Leading supplier of important First launched several of Our R&D team is providing employees the development, manufacture products to more than 500 anti-infectives Vancomycin our own-label products innovative solutions to develop in 8 countries and supply of fermented and pharmaceutical companies and Colistimethate Sodium to the US hospital value-added anti-invectives worldwide semi-synthetic APIs and FDFs in over 70 countries (CMS) market in 2018 from core portfolio products State-of–the-art R&D Center of Excellence Product and Acquired in 2015, the site focused on API research and development Xellia’s Corporate Headquarters. Innovation will significantly strengthen as well as process optimization. Our biggest operation manufactures sterile Manufactures several R&D Center of Xellia’s manufacturing APIs and FDFs. Provides lyophilized and New North Oslo, Norway specialized APIs and Excellence focused Commercial capacity for sterile injectable dry powder fill vials, release and stability American provides Centralized on innovative organization products. testing and packaging. Headquarters and Laboratory Services formulation handling the commercial office. technologies challenging Cleveland, USA Copenhagen, Denmark for the group. and FDFs. Japanese Chicago, USA Budapest, Hungary market. Zagreb, Croatia Tokyo, Japan Divested to Sagent Established in 2008 as a partnership Pharmaceuticals in Q1 2019, and with Zhejiang Hisun Pharmaceutical transitioning to new owner. Company, Ltd. Manufactures APIs. Raleigh, USA Taizhou, P.R. China CMO and commercial group established to Commercial organization Manufacturing Sites manage growing network supporting the work with of CMOs and to capitalize partners in the Chinese Sales Offices on emerging market market. opportunities. Other offices/R&D centres Shanghai, P.R. China Xellia 2018 3 Bangalore, India HIGHLIGHTS XelliaCEO’s atStatement a glance Built a commercial pharmaceutical This regulatory approval is an important institutional business in the US validation of our product strategy which we 2018 proved to be a transformative year for Xellia. We In April, we appointed Craig Boyd to the new executed in 2014 and is based on developing successfully established a new North American commercial leadership role of President, Xellia North a pipeline of innovative value-added anti- America. Craig has been pivotal in helping infectives that are centered on formulation organization and commenced sale of our anti-infective drug us build an experienced commercial team improvements for established drugs from products under the Xellia brand directly to the United States of over 40 new employees focused on our core portfolio. During 2018 we spearheading the launch and selling the continued to apply innovative science (US) hospital market. At the start of 2019 we received US Company’s own branded high quality, solutions to progress this work focusing on Food and Drug Administration (FDA) approval of our novel specialty injectable anti-infective drugs line extensions of other established anti- Premixed Vancomycin Injection in a Ready-to-Use (RTU) bag, to the US institutional markets. This infectives. These products are designed to commercial organization is now housed provide improved convenience and ease of the fi rst product from our pipeline of innovative, value-added in our newly established North American use for healthcare professionals and anti-infective therapies. headquarters in Chicago. enhance patient care. In November, we achieved an important Strengthened role as leading global milestone for our US market strategy as we industry supplier of important anti- successfully launched our fi rst lyophilized infectives WE CONTINUED TO FOCUS ON OUR VERTICAL vial product, Vancomycin Hydrochloride for As a leading global industry supplier of INTEGRATION STRATEGY. THIS APPROACH ENABLES Injection USP, under the Xellia label, within several established anti-infective products the US hospital market. During 2019 we will including Vancomycin, Colistimethate US TO ENSURE A RELIABLE QUALITY SUPPLY TO OUR continue to launch a range of Xellia-branded Sodium (CMS), Bacitracin and Daptomycin CUSTOMERS AND AVOID SHORTAGES FOR OUR KEY important anti-infective injectable our customers include over 500 branded, DRUG PRODUCTS. products. specialty and generic pharmaceutical companies across 70 countries. These Carl-Åke Carlsson, Chief Executive Offi cer, Submission and US FDA approval of customers rely on us to ensure continued " Xellia Pharmaceuticals. Premixed Vancomycin Injection RTU supply and consistent quality. During 2018 In 2018 we submitted a New Drug we continued to work closely with our Application (NDA) to the US FDA for the customers to meet the needs in their fi rst room temperature stable Premixed respective markets. To further enhance Vancomycin Injection RTU in a bag. In our customer focus during 2018 we February 2019 we received regulatory re-organized our business into regional " approval enabling our commercial team to launch the product in the US market. Xellia 2018 4 HIGHLIGHTS CEO’s Statement and FDFs, and management of a lean, fast development projects which, due to and complex supply chain which centres on changes in accounting estimates were excellence and redundancy. This approach written-off at the end of 2018. business units and established a dedicated of substantial equipment upgrades and enables us to ensure a reliable quality organization to support our industrial building improvements. These are now supply to our customers and avoid Outlook for 2019 customers in international markets. completed, but took longer than originally shortages for our key drug products. We will continue to make substantial anticipated. We expect to commence investments in 2019 as we complete the Throughout the year we continued to the fi nal FDA approval process in 2019 In 2018 we strengthened our leadership strategic projects we have undertaken over witness strong demand for key products following which we will be able to commence team further by appointing Matthew the recent years. We expect to start to see from our core portfolio. We continued to full manufacturing operations at the site. Anderson as our new Chief Financial Offi cer a positive impact in 2019 on sales of the experience price pressure and increased and Jamie Iudica as Senior Vice President of strategic investments made over recent competition particularly from manufacturers At our Copenhagen production site we also Global Product Supply. Both Matthew and years including new product launches in the operating in Asia for certain markets and made substantial progress in the 25MUSD Jamie bring the right competencies and US, and we anticipate a signifi cant increase products. We were able to off-set the expansion and upgrade of the sterile drive to support the growth of our global in both revenue and profi tability compared resulting decline in revenue through manufacturing facilities that we initiated in business. to 2018. increased sales of other products in other 2017. We completed the construction of the markets. This serves to re-enforce the new state-of-the-art multi-storey building Financial I would like to thank all our customers for importance of our global business model and have commenced the installation of the The 2018 fi nancial performance was in line their support and Board of Directors and and vertical integration strategy which latest sterile manufacturing equipment and with expectations with a marginal reduction Scientifi c Advisory Board for their enables us to provide customers with both containment solutions. in revenue and a more substantial decline in continued strategic input and counsel. Active Pharmaceutical Ingredients (APIs) profi tability following the signifi cant and Finished Dosage Forms (FDFs) as well At the end of February 2019 we entered growth which we experienced in the Finally, a massive thank you to all our valued as our continued focus on delivering into an agreement to divest our Raleigh, previous years. Revenue for the year was employees – or Xellians as we call ourselves performance excellence whilst maintaining North Carolina manufacturing plant to 315.7 MUSD (2017: 317.1 MUSD) whereas – for all their hard work and loyalty, without cost competitiveness. The year was also Sagent Pharmaceuticals. We will continue EBITDA was 62.1 MUSD (2017: 86.5 MUSD). which the transformation of our business affected by an extended shut-down of to operate the plant for a transitional period The reduced profi tability for the year is due from a supplier of established anti-infective a production line at one of our API as we gradually transition the operations
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