Life-saving Anti-Infective Treatments Month Year First name Last name Job Title Table of Contents • The Company • Competencies and Services • Facilities and Locations • Product Portfolio • Vancomycin and CMS Key Anti-Infective Franchises • Our Customers • Our Culture • Xellia in Summary 2 The Company 3 Xellia at-a-glance • Specialty pharmaceutical company focused on critical care therapies for life-threatening diseases • • B2B sales to approx. 500 customers in 70 countries • 50+ years’ expertise in supplying fermented and semisynthetic products that are challenging to manufacture • State-of-the-art production facilities in Europe and Asia with global regulatory approval and an unsurpassed compliance track record • Continuously expanding product pipeline and geographic reach • Wholly owned by Novo A/S and well financed with growing sales • 4 Supplying both APIs and FDFs 2013: sales in excess of MUSD 220 and EBITDA margins close to 30% Our Heritage 1903 Apothekernes Laboratorium AS was founded by pharmacists in Oslo 5 1952 Apothekernes Laboratorium started production of penicillin, bacitracin and neomycin in Oslo 1975 1983 1994 Apothekernes Laboratorium established in the US; market leader in bacitracin Apothekernes Laboratorium acquired Dumex A/S, Copenhagen - bacitracin, polymyxin B, colistin, and amphotericin B Alpharma formed by a merger of Apothekernes Laboratorium Inc, Apothekernes Laboratorium AS and Dumex; vancomycin R&D Start-up 1998 Alpharma acquired SKW Biotech, Budapest; vancomycin and niche products 2008 Alpharma API business acquired by 3i and members of management team; Xellia is born 2009 Xellia’s facility in Taizhou, China obtained FDA approval to produce vancomycin 2013 Novo A/S acquired the majority stake in the Xellia 2014 Xellia acquires Fresenius Kabi’s lyophilized (freeze-dried) manufacturing facility in Raleigh, North Carolina, Our Team Xellia’s highly skilled team thrive on a spirit of innovation, excellence and teamwork 6 • Management team: applying extensive, international pharmaceutical experience to drive business strategies and growth • Quality and Regulatory Affairs: ensuring highest quality standards are met in production, products and procedures • Research and Development: developing efficient processes, new FDFs, innovative delivery systems and advanced analytical tools • Manufacturing: specializing in technologically difficult manufacturing processes including fermentation, purification, semi-synthesis and freeze-drying • Sales and Marketing: building strong relationships with customers, responding with on-time delivery and premium quality products Our Growth Strategy Pursuing an ambitious strategy in the injectable anti-infective market targeting 8 to 10% revenue (CAGR) Longer term value: developing proprietary delivery systems Launching an injectable FDF pipeline Forward integration of existing APIs to injectable FDFs Building on strengths in API product franchises 2010 7 2015 2020 Competencies and Services 8 R&D: Delivering Valuable Products for the Future • Focused on “difficult-to-develop” products with an intrinsic competitive advantage 1. Increasing barrier-to-entry (IP, technologies, product mix, containment etc.) 2. Value added IP position (innovative, patent-enabling development strategies including patent positioning and filing our own applications) 3. Limited competition (specialist technology, experience and “know-how”, niche products) 4. Cost competitive (superior technology) 5. First to market (speed is essential and critical for success) • Creating a balanced and attractive new product pipeline 9 Manufacturing and Supply Capabilities with Exceptional Technical Support • Excellence in manufacturing using: • High-yielding microbial producer strains and efficient fermentation processes • Robust purification processes, producing consistent high purity products • Advanced analytical methods for monitoring quality and compliance to Pharmacoepial requirements • Final handling expertise including all common drying technologies (filter-, vacuum-, freeze-, and spray-drying) • Fill-finish capabilities for most vial sizes and high volumes • Continuity of global supply and on-time delivery of competitively priced products 10 Contract Development and Manufacturing Services • Services typically confined to: • Xellia’s current products, where there may be a need for special API qualities or dosage forms • Derivatives of Xellia’s current products, showing increased activity, extended spectrum, reduced toxicity or different mode of action • New products (including NCEs) where Xellia may exploit established R&D and manufacturing capabilities 11 Facilities and Locations 12 Global Operations Budapest, Hungary Oslo, Norway Taizhou, P.R. China Copenhagen, Denmark Tokyo, Japan Chicago, USA Zagreb, Croatia Raleigh, USA Bangalore, India Manufacturing sites Sales offices Other offices/R&D centres 13 Shanghai, P.R. China Xellia Manufacturing Sites Copenhagen, Denmark Budapest, Hungary Amphotericin B Colistimethate Sodium Colistin Sulfate Polymyxin B Sulfate Tobramycin Sulfate Vancomycin (HCL and Base) Vancomycin vials (0.5g, 1.0g, 5g, 10g) Colistimethate sodium vials (1 miu, 2 miu, 150 mg) Daptomycin Gramicidin Tyrothricin Vancomycin FDA: 2014 ISO 14001 FDA: 2014 ISO 14001 Outstanding quality track record Raleigh, USA Vancomycin Leucovorin Panhematin FDA: 2014 Taizhou, P.R. China Vancomycin Bacitracin Bacitracin Zinc FDA: 2012 14 Sales and Marketing Offices Locations Copenhagen, Chicago, Singapore, Shanghai and Tokyo Service Building strong relationships with major pharmaceutical companies Responding with on-time delivery of premium quality products Pro-actively driving fast-tomarket entries 15 Product Portfolio 16 A Balanced Portfolio of Specialized APIs and FDFs Longer term value: developing proprietary delivery systems . . . building an attractive pipeline based on standard dosage forms and unique delivery systems Launching an injectable FDF pipeline Forward integration of existing APIs to injectable FDFs Building on strength in API product franchises 2010 17 2015 2020 Product Range Active Pharmaceutical Ingredients (APIs) 16 APIs • 18 Antibacterial agents for treatment of Grampositive and Gramnegative infections Finished Dosage Forms (FDFs) 19 FDFs/10 Molecules • Injectables Novel Device Delivery Platforms 4 Novel Device Delivery Platforms • Available in dry powder fill or freeze-dried vials • Aqueous Droplet Inhaler (ADI) • Packaging • Ready-To-Use (RTU) infusion bags • Antifungal agents • Corticosteroids • Capsules • SmartPak infusion bags • Sterile and non-sterile API qualities • Inhalation • Airless Metered Pump (AMP) topical delivery • Labelling Novel Device Delivery Platforms Airless Metered Pump (AMP) for topical delivery • Accurate dosing • No ”mess or spills” • Licensed to Phoenix Group (New York, USA) • Available for licensing outside USA 19 Aqueous Droplet Inhaler (ADI) SmartPak infusion bags (”jumbo vial”) Ready-To-Use (RTU) infusion bags • Short administration time • Portable (pocket size) • Same efficacy at significantly lower dose of drug • Reduced side effects – no coughing • Handled by PharmAero (Xellia / Scandinavian Health Joint Venture) • 100g drug versus standard 0.5-10g (eg. Vancomcyin) • Ease of drug administration in hospitals • Co-operation with ACS Dobfar (Italy) • Drug and diluents in one dual chamber infusion bag • Hospital use • Less use of hospital staff time • Reduced risk of mistakes in mixing and dosing • Improved healthcare worker safety Forward Integration from API to FDF Gram-Negative Antibacterials Antifungals Tobramycin Sulfate Vancomycin Base Polymyxin Colistin Gramicidin Daptomycin Caspofungin Vancomycin HCl CMS API Gram-Positive Antibacterials Tyrothricin Teicoplanin Amphotericin B Bacitracin FDF CMS vials Tobramycin vials 20 Bacitracin Zinc Vancomycin caps Polymyxin vials Caspofungin vials Vancomycin vials Teicoplanin vials Daptomycin vials Bacitracin vials Attractive FDF pipeline in development Development Pipeline and Filings • Since 2008, Xellia has shown an impressive increase in the number of new product filings . . . continuously growing the pipeline beyond 2015 21 Xellia’s Balanced Pipeline – Products with an Intrinsic Competitive Advantage Super Generics (ADI and RTU) Injectable Patent Challenges (P.IVs) Injectable Specialty Generics (containment products like penems and oncology) Injectable Regular Generics (antibacterials and antifungals) 22 Vancomycin and Colistimethate Sodium (CMS) . . . two of our life-saving anti-infective franchises 23 Vancomycin – Critical in Modern Medicine Key facts In the USA, vancomycin is used for treatment of more than 70% of infections caused by methicillin-resistant strains of Staphylococcus aureus (MRSA) and more than 30% of Clostridium difficile treatments Description Glycopeptide antibiotic Active against a wide variety of Gram-positive bacteria Target Staphylococcus ssp. including MRSA Streptococcus ssp. Clostridium difficile Administration Injection Oral 24 Colistimethate Sodium (CMS) – Emerging as a Sole Effective Antibiotic Key facts Important treatment for pulmonary infections associated with critical and chronic diseases e.g. cystic fibrosis (CMS market larger in EU and ROW than USA) Description Lipopetide antibiotic, prodrug of colistin Active against Gram-negative bacteria Target Acute Pseudomonas aeruginosa and Acinetobacter baumannii infections Multiple Drug Resistant (MDR) Gram-negative infections (only treatment option) Administration Inhalation Injection 25 Our Customers 26 Global Customer Base • Long-standing international customer base: ~500 active customers • Top 20 customers account for 60% of sales 50% generic companies 27 50% big and specialty pharma Worldwide Sales • Undisputed leader in the US and Europe for products within Xellia’s product portfolio • Holds 62 market authorizations in total, allowing business to grow in key markets Europe 29% USA Canada 35% Middle East 15% Latin America 4% 28 Asia 17% Our Culture 29 Xellia’s Values • As one of the leading API companies in the world, the pace at Xellia is fast, the work is fun and we discover interesting challenges around every corner • No matter where we work in or organization or what we do, we share common values that unite us making our company a special place to work • We delight our customers • We drive business results • We collaborate across borders • We have personal drive and commitment • We think and act strategically and globally • We have a supportive leadership philosophy Protect the Patient - Protect our Environment • Quality underpins every aspect of our business • Demonstrated at every stage of product development, manufacture and distribution • We continually endeavour to improve our social, ethical, environmental, health and safety responsibilities • In full compliance with external laws and regulations • We constantly work to ensure that Xellia operates in a responsible manner 31 In Summary . . . 32 Proven Track Record of Continued Growth Total Revenue (MUSD) ~500 ~300 FDF ~200 API 135 70 2000 33 2005 2010 2015 2020 Xellia - A Trusted Provider of Life-Saving AntiInfective Treatments • International specialty pharmaceutical company • Supplying both APIs and FDFs to approx. 500 customers in 70 countries • 50+ years’ expertise in supplying fermented and semi-synthetic products that are challenging to manufacture • State-of-the-art production facilities with global regulatory approval and an unsurpassed compliance track record ensuring continuity of supply and ontime delivery of competitively priced products • Continuously expanding product pipeline and geographic reach 34
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