ubs speialty pharma conference
TRANSCRIPT
Innovative Drug
Delivery Device
Solutions
Ramin Mojdeh, Ph.D.
Executive Vice President and
Chief Operating Officer
UBS Specialty Pharma Conference
May 2011
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.
2
Emerging global leader in innovative drug delivery device solutions
Enable and enhance delivery of drugs by pharmaceutical customers
Rapidly expanding pipeline being driven by customer needs
Unifill – world’s only prefilled platform with integrated safety
NASDAQ listed (UNIS) with state-of-the-art facility in York, PA
3
Introducing Unilife
$30B Injectable drug delivery device market in 2015, 12.3% CAGR
Large macromolecule composition of pharmaceutical pipeline
Safety legislation and sharps management
Devices drive patient acceptance, preference and adherence
Emerging healthcare needs of aging global population
Rising global healthcare standards creating strong market potential
Improved outcomes and economics with use of unit-dose and ready to administer formats
Trend to patients self-administration of injectable drugs
Patent cliff - 30 biologics with $51B sales expire by 2015
4
Attractive Market Trends and Opportunity
Innovative device solutions for commercial drugs/biosimilars
Integrated proprietary primary drug delivery devices with value-add features
Target and address emerging unmet needs for pipeline drugs
Pharmaceutical collaborations – specialized devices for novel drugs
Target high-end of market for differentiated devices, high margins
Strategic sourcing of components
In-house manufacturing and final assembly
5
Strategic Focus
Technology pipeline developed in partnership with customers
Directly responding to emerging customer needs including: Integrated primary drug delivery devices with value-add features and
customization
Advanced syringe systems with integrated safety and transfer mechanisms
Dry drug reconstitution and delivery technologies
Large-volume viscous drugs delivery technologies
Targeted organ delivery devices
Multi-chamber proprietary primary containers and delivery systems
Reusable and disposable self administration device technologies
Technology portfolio can be leveraged to develop customized device concepts according to specific customer needs
6
Customer-Driven Technology Pipeline
7
World’s first and only prefilled syringes with integrated safety
Now in production
Controlled retraction into barrel
Needle locked after use for convenient, compact disposal
Unifill – The Leading Edge of Our Portfolio
Primary drug delivery device with integrated safety
Direct substitute for current prefill and safety prefill syringes
Powerful brand differentiation
Streamlines fill-finish and packaging process
Optimal protection
8
Unifill as a Game Changer
+Ancillary safety needle
Standard Prefill
Syringe
Current Safety
Syringe
+Ancillary safety Device
Standard Prefill
Syringe
Current Safety
Syringe
Direct Substitute
Unifill Platform
2.5B Units Annually
9
Technology solves a technical challenge most thought impossible
Sanofi invested $40MM for access rights to Unifill
Ready for initial shipment in July – well ahead of original schedule
Current capacity of 60MM units, planned 150MM unit line extension
Success in the Face of a Big Challenge
10
Patient requirements
Drug industrialization
requirements
Customized delivery device
Clinical Development (phase I, II, III) Approval
Devices customized to specific requirements of drugs and target patients
Collaboration with drug companies from clinical development through commercial sales
Unique devices increasingly used to differentiate brands, optimize product lifecycles and enhance patient care
Sales
New Paradigm in Drug-Device Development
Summary
11
Unilife - emerging global leader in innovative drug delivery devices
Injectable drug delivery device market is attractive and growing fast
Innovative, differentiated devices for pipeline drugs and biosimilars
Developing rich portfolio of technologies driven by customer need
Unifill: the 1st and only prefill syringe system with integrated safety
The new drug-device paradigm is to target pipeline drugs to develop total system solutions for the pharmaceutical partner
Launch with Unifill, then drive growth with successive introductions
of innovative, differentiated devices