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Corporate Report 2019 Enhancing Patient Care and Improving Convenience Highlights Business Corporate Corporate Overview Responsibility Governance

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Corporate Report 2019 Enhancing Patient Care and Improving Convenience Highlights Business Corporate Corporate Overview Responsibility Governance Corporate Report 2019 Enhancing patient care and improving convenience Highlights Business Corporate Corporate Overview Responsibility Governance Our purpose is to save lives by leading the fight against infections. Our goal is to lead the fight against infections by providing anti-infective solutions against multidrug-resistant microorganisms. Highlights 03 Xellia at a glance 05 CEO’s statement 07 Financial highlights 09 Spotlight on Cleveland, Ohio Visit us online xellia.com 01 Xelia Corporate Report 2019 Highlights Business Corporate Corporate Overview Responsibility Governance Novel anti-infective treatments Specialty pharmaceutical company Read about Xellia’s focused on providing important anti- continued expansion infective treatments against serious and growth of its commercial structure and often life-threatening infections. in North America 09 Business Overview Corporate Responsibility Corporate Governance 12 Industrial 18 Corporate responsibility 30 Corporate Governance 13 Institutional 19 Economic sustainability 31 Board of Directors 15 Innovation 20 Health and safety 33 Scientific Advisory Board 16 Antimicrobial resistance 21 Environmental responsibility 34 Executive Management and antibiotic stewardship 23 Social responsibility 28 SOS Children’s Villages Forward-looking statement This report contains certain projections and other forward-looking statements with respect to the financial 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. Xelia Corporate Report 2019 02 Highlights Business Corporate Corporate Overview Responsibility Governance Xellia at a glance Positioned for growth 2019 was a successful year for Xellia with record revenue of 363.8 MUSD (15% increase compared to 2018) following a strong performance in our global industrial (B2B) anti-infective business and substantial growth in the newly established US institutional (B2i) business. In addition, we successfully launched VANCO READY™ in the Xellia’s R&D team is Xellia first launched providing innovative United States, the first product from our evolving Over 1,700 employees several of its own-label solutions to develop in 8 countries around innovative product pipeline. products to the US value-added anti- the world hospital market in 2018 infectives from core portfolio products Over 100 years’ Supply of anti-infective Leading supplier of experience in the products to more than important anti-infectives development, 500 pharmaceutical vancomycin and manufacture and supply companies in over colistimethate sodium of fermented and semi- 70 countries (CMS) synthetic APIs and FDFs 03 Xelia Corporate Report 2019 Highlights Business Corporate Corporate Overview Responsibility Governance Where we operate Europe Asia North America Copenhagen, Denmark Bangalore, India Chicago, US Corporate Headquarters. The largest operational site CMO and commercial group established to manage growing North American Headquarters and commercial office. manufacturing sterile APIs and FDFs. Provides lyophilized and network of CMOs and to capitalize on emerging market dry powder fill vials, release as well as stability testing and opportunities. Xellia’s Global IT Service Center. Cleveland, US packaging. Acquired in 2015, the site will significantly strengthen Xellia’s Hyderabad, India manufacturing capacity for sterile injectable products. Budapest, Hungary Local Quality and Global Procurement and External Supply office. Manufacturing site for specialized APIs and provides Centralized Laboratory Services for Xellia. Shanghai, China Key Corporate Commercial organization supporting the work with partners Sales offices/ Headquarters in Oslo, Norway in the Chinese market. Representative offices Copenhagen, Denmark State-of–the-art R&D Center of Excellence focused on API Manufacturing sites research and development as well as process optimization. Taizhou, China Owned by Established in 2008 as a partnership with Zhejiang Hisun Research & Development sites Zagreb, Croatia Pharmaceutical Company, Ltd. manufactures APIs. Product and Innovation R&D Center of Excellence focused on innovative formulation technologies and FDFs. Tokyo, Japan Commercial organization handling the Japanese market. Xelia Corporate Report 2019 04 Highlights Business Corporate Corporate Overview Responsibility Governance CEO’s statement Positioned for growth 2019 was a successful year for Xellia with record revenue of Three additional strengths are under submission and are expected to be available in the US as early 363.8 MUSD (15% increase compared to 2018) following a as 2020, expanding the portfolio to a total strong performance in our global industrial (B2B) anti-infective of seven dosage strengths. business and substantial growth in the newly established US The product is the first of Xellia’s evolving innovative pipeline of formulation improvements institutional (B2i) business. In addition, we successfully launched for established drugs from our core portfolio. VANCO READY™ in the United States, the first product from our These products are designed to provide improved convenience and ease of use for evolving innovative product pipeline. healthcare professionals and enhance Carl-Åke Carlsson patient care. Chief Executive Officer Building momentum in the US hydrochloride, allowing Xellia to leverage its Major milestone passed with the institutional market capabilities, strengths and customer base to ability to commence manufacturing drive sales of the products to the institutional Over this year, we have leveraged the commercial market. The collaboration and opportunity to at Xellia Cleveland organization established in 2018 and launched work with eTon fits well with the ambition to bring At the start of 2020, the FDA performed a the existing portfolio of established anti- more ready-to-use products to the US market, comprehensive cGMP inspection of the infective products under the Xellia brand, where time and alignment to industry guidelines Cleveland, Ohio site as outlined in the Modified securing strong market positioning for key are critical to the patient, and our overall mission Consent Decree entered after Xellia’s acquisition products. to bring life-saving medicines that address of the site in 2015. In March 2020, the FDA In March 2019, we entered into a long-term patients’ unmet needs. notified Xellia of the successful outcome of the partnership with Civica Rx comprising several inspection. Subsequently, Xellia is now preparing important anti-infective injectables. Civica Rx is Successful launch of VANCO READY™ for commercial manufacture of aseptic a non-profit, non-stock corporation committed in the US injectables at the Cleveland site. The first to stabilizing supply of essential generic VANCO READY™ is the only ready-to-use and products to be manufactured will be lyophilized medications in a hospital setting and was room-temperature-stable vancomycin injection vancomycin vials, further strengthening Xellia’s established to reduce chronic generic drug currently available in the US. We launched the robust supply chain for this critical product. shortages in the US. In October we commenced first two dosage strengths in March 2019, after Since the acquisition of the Cleveland site supply of the first product (vancomycin receiving FDA approval for the product in towards the end of 2015, Xellia has made hydrochloride for injection, USP), which is now February. A total of four strengths were available significant investments to upgrade the aseptic available in the US under the Civica Rx label. in the US market by the end of the year following manufacturing facilities, implement a new quality additional launches in September and December, Post year end, in January 2020, we entered into management system and establish fully trained with more than 1,200 institutions across the a collaboration with eTon Pharmaceuticals, Inc. manufacturing and quality teams. country using the product. for the co-promotion of Biorphen®, the first ready-to-use formulation of phenylephrine 05 Xelia Corporate Report 2019 Highlights Business Corporate Corporate Overview Responsibility Governance To read more about our vertical We will continue to invest in the site during However, we have also continued to see price integration strategy see page 12 2020 as we expand our capabilities to also pressure and increased competition from include ready-to-use bags. The manufacturing manufacturers operating in Asia. We have lines will be used both to produce VANCO been able to offset this pressure on revenue READY™ as well as other products requiring through increased sales of other products in production output of key products, as well as We continue to benefit from a strong and loyal aseptic fill capabilities. other markets. This serves to reinforce the a favorable product mix across the business. customer base, and on behalf of the Board and importance of our global business model and In 2019, we entered an agreement to divest our The net result for the year was 64.9 MUSD management team, I would like to thank them all vertical integration strategy, which enables us to Raleigh, North Carolina facility to Sagent (2018: 17.7 MUSD loss), which is a record for their continued support. I would also like to provide customers with both Active Pharmaceuticals. During the year, we prepared result for Xellia. thank the
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