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UniLife Corporation (NASDAQ: UNIS)Summary of Presentation by CEO Alan Shortall at 31st Annual Cowen & Company Healthcare Conference in Boston
Citation preview
Presentation to Cowen
Healthcare Conference
March 9, 201104/08/23
Cautionary Note Regarding Forward-Looking Statements
This presentation contains forward looking statements under the safe harbor provisions of the US securities laws. These forward-looking statements are based on management’s beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However you should not place undue reliance on any such forward looking statements as these are subject to risks and uncertainties. Please refer to our press release and our SEC filings for more information regarding the use of forward looking statements.
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Introducing Unilife
Markets moving to mandatory safety
Best-in-class safety syringe portfolio
1st product line already FDA-cleared
Only prefilled with integrated safety
$40m agreement with sanofi-aventis
Discussions accelerating with other pharmaceutical companies
State-of-the-art facilities in PA
World-class Board / management
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Emerging Global Leader for Innovative Drug Injection Devices
Unilife’s Operational Capabilities
165,000sqf state-of-the-art production facility in York, PA
Meets stringent pharma standards for primary drug containers
Eleven clean rooms, and other advanced infrastructure
Automated assembly systems used to attain optimal quality
Capacity to produce up to 400m units per year (stage 1)
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The Global Transition to Safety Syringes
Healthcare and pharmaceutical markets being driven by legislation to mandatory use of safety syringes
Needlestick injury reports not declining despite enforcement
Market preference for devices with passive, integrated safety
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Delivery devices increasingly used as brand differentiator
Pharmaceutical Challenges for Prefilled Safety
2.4 billion prefilled syringes
Market growing 12% pa
50+ drugs / vaccines now in a prefilled syringe format
Only clip-on safety options available for compliance
Extra fill-finish process steps
Up to 70% more volume
Similar look / functionality
Standard prefilled syringe (left) next to three attached with an ancillary safety product
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Unifill
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Unilife Technology
Core Proprietary Features
Fully integrated safety features
Automatic needle retraction
Eliminates needlestick risk
Operator controlled withdrawal
Directly from body into barrel
No risk of aerosol (splatter)
Non-reusable / tamper-proof
Intuitive use, convenient disposal
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Developing a Full Proprietary Portfolio
Unifill® Ready-to-Fill syringes (glass barrel filled by pharma)
Commercial release 2011
Development Pipeline
Development Pipeline
Development Pipeline
Approved and launched
Development Pipeline
Staked needle (Subcutaneous)
Attachable needle (IM)
3, 5mL - used with standard luer needles
Staked needle (Insulin / TB)
ProjectTaipan
Project Liger
Unifill syringe
Unifill Select
Unitract 1mL
Unitract Clinical
Confidential Projects
Unitract® Clinical syringes(for use with vials)
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Primary injectable drug container
Only prefilled syringe with safety integrated inside the glass barrel
USP-compliant materials
Integration into fill-finish systems
Minimal packaging, transport and storage volumes
Compact handling, intuitive use
Optimal protection from harm
The Unifill® Ready-to-Fill Syringe
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Unifill preferred across all 5 areas:
Functionality
Safety
Appearance
Ease-of-use
Performance
Independent evaluations with 66 experienced U.S. nurses
Compared to leading prefilled ancillary safety products
Results of Independent Market Evaluations
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Unique drug delivery device – not a commodity
Streamlines filling, packaging, transport and storage systems
Highest levels of protection for healthcare workers or patients
Patent protection up to 2030
Offers strong brand differentiation in competitive drug classes
Can help optimize or extend product lifecycles
Potential to obstruct generic or biosimilar competition
Unique Selling Proposition for Unifill
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Potential Drug Candidates for Unifill Syringe
83 approved and pipeline drugs from 19 pharmaceutical companies across more than 20 therapeutic classes now available or potentially suitable for use in a prefilled syringe designated for subcutaneous injections
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Relationship with sanofi-aventis
Contributed approximately $40m for exclusive right to negotiate purchase of Unifill syringe until June 2014
Parties agreed to a Unifill syringe exclusivity list in March 2010
Thrombotics, vaccines and four other new pre-filled areas
Ten year exclusivity extension per drug class if commercial supply orders placed before 2014
Unilife required to commit only 30% of capacity
Other sub-classes may be added (agreement both parties)
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Other Pharmaceutical Discussions
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Initial Discussions Signed CDA
Request Samples for Validation
Collaboration / Development Agreement
Supply Agreements
Sanofi-aventis
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Preparing for Production and Sales
Qualified components ready – internal testing successful
A dozen experienced suppliers already qualified
Initial production to commence in late-March 2011
First assembly line to have 60 million unit / year capacity
Additional lines to have 150 million unit / year capacity
Initial sales to customers in mid-2011
Used for drug stability testing and market evaluations
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Summary
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Markets driven by legislation to mandatory safety syringe use
Full portfolio of syringes with best-in-class safety features
World’s only prefilled syringes with safety inside glass barrel
$40 million from sanofi-aventis for exclusivity in defined classes
Accelerating talks with many other pharmaceutical leaders
State-of-the art production capabilities to meet demand
Highly experienced team with deep industry expertise
Significant projected revenue growth and attractive margins
2011 focus on production, sales and agreements