life-saving anti-infective treatments - xelliamenuitembydocid... · table of contents • the...
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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
Xellia at-a-glance
• Specialty pharmaceutical company focused on critical care therapies for life-threatening diseases
• Supplying both APIs and FDFs
• B2B sales 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 in the United States, 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
• 2014: revenue was slightly above 200 MUSD and EBITDA adjusted for exceptional items was 8%
4
Our Heritage
Apothekernes Laboratorium AS was founded by pharmacists in Oslo
Apothekernes Laboratorium started production of penicillin, bacitracin and neomycin in Oslo
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
Alpharma acquired SKW Biotech, Budapest; vancomycin and niche products
Alpharma API business acquired by 3i and members of management team; Xellia is born
Xellia’s facility in Taizhou, China obtained FDA approval to produce vancomycin
Novo A/S acquired the majority stake in the Xellia
Xellia acquires Fresenius Kabi’s lyophilized (freeze-dried) manufacturing facility in Raleigh, North Carolina,
1903 1952 1975 1983 1994 1998 2008 2009
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2013 2014
Our Team
• 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
Xellia’s highly skilled team thrive on a spirit of innovation, excellence and teamwork
6
Our Growth Strategy
2010 2015 2020
Building on strengths in API product franchises
Launching an injectable FDF pipeline
Forward integration of existing APIs to injectable FDFs
Longer term value: developing proprietary delivery systems
Pursuing an ambitious strategy in the injectable anti-infective market targeting 8 to 10% revenue (CAGR)
7
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
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Global Operations
Manufacturing sites
Sales offices
Other offices/R&D centres
Chicago, USA
Tokyo, Japan
Shanghai, P.R. China Zagreb, Croatia
Bangalore, India
Oslo, Norway Budapest, Hungary
Copenhagen, Denmark Taizhou, P.R. China
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Raleigh, USA
Xellia Manufacturing Sites
Outstanding quality track
record
Copenhagen, Denmark Amphotericin B Bacitracin and Bacitracin Zinc (sterilization only) 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) FDA: 2014 ISO 14001 OHSAS 18001
Budapest, Hungary Daptomycin Gramicidin Tyrothricin Vancomycin
FDA: 2014 ISO 14001 OHSAS 18001
Taizhou, P.R. China Vancomycin Bacitracin Bacitracin Zinc
FDA: 2015 ISO 14001 OHSAS 18001 14
Raleigh, USA Vancomycin Leucovorin Panhematin
FDA: 2014
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-to- market entries
Sales and Marketing Offices
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. . . building an attractive pipeline based on standard dosage forms and unique delivery systems
A Balanced Portfolio of Specialized APIs and FDFs
2010 2015 2020
Building on strength in API product franchises
Launching an injectable FDF pipeline
Forward integration of existing APIs to injectable FDFs
Longer term value: developing proprietary delivery systems
17
Product Range
Active Pharmaceutical Ingredients (APIs)
Finished Dosage Forms (FDFs)
Novel Device Delivery Platforms
16 APIs
• Antibacterial agents for treatment of Gram-positive and Gram-negative infections
• Antifungal agents
• Corticosteroids
• Sterile and non-sterile API qualities
19 FDFs/10 Molecules
• Injectables
• Available in dry powder fill or freeze-dried vials
• Packaging
• Labelling
• Capsules
• Inhalation
4 Novel Device Delivery Platforms
• Aqueous Droplet Inhaler (ADI)
• Ready-To-Use (RTU) infusion bags
• SmartPak infusion bags
• Airless Metered Pump (AMP) topical delivery
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Novel Device Delivery Platforms
Airless Metered Pump (AMP) for topical delivery
Aqueous Droplet Inhaler (ADI)
SmartPak infusion bags (”jumbo vial”)
Ready-To-Use (RTU) infusion bags
• Accurate dosing
• No ”mess or spills”
• Licensed to Phoenix Group (New York, USA)
• Available for licensing outside USA
• 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
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Tobramycin
vials
Caspofungin
vials
Amphotericin B
Caspofungin
Forward Integration from API to FDF
Tobramycin
Sulfate
CMS
Colistin
Polymyxin
Vancomycin
HCl Teicoplanin
Bacitracin Bacitracin
Zinc
Tyrothricin
Daptomycin
Polymyxin
vials
AP
I
CMS
vials
FD
F
Attractive FDF pipeline in
development Vancomycin
vials
Vancomycin
caps
Bacitracin
vials
Daptomycin
vials
Teicoplanin
vials
Gram-Negative Antibacterials
Antifungals Gram-Positive Antibacterials
Vancomycin
Base Gramicidin
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Development Pipeline and Filings
. . . continuously growing the pipeline beyond 2015
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• Since 2008, Xellia has shown an impressive increase in the number of new product filings
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)
Xellia’s Balanced Pipeline – Products with an Intrinsic Competitive Advantage
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Vancomycin and Colistimethate Sodium (CMS)
. . . two of our life-saving anti-infective franchises
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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
Vancomycin – Critical in Modern Medicine
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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
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Global Customer Base
• Long-standing international customer base: ~500 active customers
• Top 20 customers account for 60% of sales
50% big and specialty pharma
50% generic
companies
27
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
Asia
17%
Europe
29%
Latin
America
4%
USA
Canada
35%
28
Middle
East
15%
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
Responsiblity to Society – A partnership with SOS Children’s Villages
32
• From January 2015 to January 2018, Xellia has entered a partnership with SOS Children’s Villages to provide full funding to the SOS Children’s Villages Kenya Eldoret Medical Centre.
• At the Eldoret Medical Centre:
• 10 employees
• 6000 patients annually
• Most common ailments: infections, Malaria, HIV and waterborne diseases
• Other outreaches: cancer screeening, HIV-testing, Malezi bora, door-to-door campaigns
• The medical centre works to treat, increase education and prevent life-threatening diseases within the community.
Responsiblity to Society - Xellia and SOS Children’s Villages
33
• “It’s in our corporate DNA to help people in need, as we strive to contribute with the development of medicines to fight life-threatening diseases and ultimately save lives. The partnership with SOS Children’s Villages is felt by us as a natural fit for our company.” Carl-Åke Carlsson, CEO and President at Xellia
• At Xellia, we look forward to embarking on the journey alongside the SOS Children’s Villages Medical Centre in Eldoret Kenya, to reach less fortunate patients and provide them with the possiblity for a brighter and healthier future.
• At Xellia, a variety of activities will be placed into action during 2015 in order to launch our partnership with the SOS Children’s Villages and bring awareness to our social responsibility.
Proven Track Record of Continued Growth
2000 2005 2010 2015 2020
FDF
API
35
Total Revenue (MUSD)
70
~200
~300
~500
135
Xellia - A Trusted Provider of Life-Saving Anti-Infective 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 on-time delivery of competitively priced products
• Continuously expanding product pipeline and geographic reach
36