Unilife ($UNIS) - Jefferies Healthcare Conference

Innovative Drug Delivery Device Solutions
Alan Shortall
Chief Executive Officer
Jefferies Global Healthcare Conference
June 6, 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

3
Introducing Unilife
An emerging global leader for innovative drug delivery devices
Developedfullsafetysyringeportfoliowithbest-in-classfeatures
Unifill–the world’s only prefilled syringes with integrated safety
Game-changer for the fastest growing, most-profitable syringe market
Sanofi-aventispaid$40MMupfrontforaccess rights intwoclasses
Discussions accelerating with many other interested companies
Industrialization ahead of schedule, initial sales commence in July
Device portfolio now rapidly expanding, driven by customer need
Highly responsive business structure with a world-class team

Our Business Strategy
Built upfront the operational capabilities to meet pharmaceutical device demands from clinical development to commercial sales
Addressing unmet customer needs with innovation and speed
Lead with Unifill, then expand into other advanced device areas
Focus on customized, differentiated (non-commodity) devices
Collaborating with our partners to develop the right device to deliver the right drug to the right patient, resulting in:
Long-term, preferred source supply contracts with high-margins
Revenue generating opportunities extending beyond product sales into exclusivity fees per therapeutic sub-class, and royalties
4

State-of-the-Art Operational Capabilities
New 165,000sqf state-of-the-art production facility in York, PA
FDA-registered; meets stringent standards for primary drug containers
Designed for growth, with 400MM annual syringe capacity (stage one)
Offers customers a broad spectrum of services at one location
Automated assembly systems used to attain optimal quality
5

6
Safety devices mandated in U.S. healthcare facilities to protect those at risk of needlestick injury; E.U. facilities now following
Reported needlestick injuries largely stable, despite enforcement
Needlestick Injuries Caused by Syringes Among Hospital Workers in Massachusetts
Sharps Injuries among Hospital Workers in Massachusetts 2002 - 2009. Massachusetts Sharps Injury Surveillance System
Mandatory Use of Safety Devices in Healthcare

Proprietary Platform Syringe Technology
Core Features and Benefits
Fully integrated safety features
Passive activation of needle retraction mechanism
Optimal needlestick protection
Operator controlled withdrawal
Directly from body into barrel
No risk of aerosol (splatter)
Non-reusable / tamper-proof
Intuitive use, convenient disposal
7

8
Pharmaceutical Market for Prefilled Syringes
Prefilled Syringes - Historical Demand and Forecast Growth*
Billions of prefilled units
The fastest-growing and most profitable syringe market
2.4B prefilled syringes in 2010, 12% annual growth rate
* Prefilled Syringes 2010 Greystone Associates

Pharmaceutical Market for Prefilled Syringes
9
Selection of Marketed Prefilled Drugs by Therapeutic Class and Company
Number of Prefilled Drugs

Unifill
Standard prefilled syringe (left) next to three attached with an ancillary safety product
Market Transitionto Prefilled Safety Syringes
10

11
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

Unifill as a Game Changer
Ancillary Safety Device
+
Direct Substitute
Unifill platform of prefilled safety syringes
Standard Prefill Syringe
Prefilled Safety Syringe
Capacity for Unifill platform to substitute entire prefilled market
Designed for integration into standard fill-finish lines
USP-compliant materials in the drug fluid path
Eliminates use of ancillary safety, minimal packaging volumes
Uniqueness makes it ideal for brand differentiation
12

13
Innovative Devices Generating Differentiation for Drug
Patent cliff - 30 biologics with $51B sales expire by 2015
Intense competition between branded, generic and biosimilar drugs within many fast-growing therapeutic classes
Innovative devices with superior, value-adding features can:
Deliver powerful brand differentiation in competitive areas
Optimize (or extend) product drug and build market share
Generate unique claims that can obstruct generics
Device-Led Brand Differentiation for Drugs

14
Sanofi paid $40MM for access rights to Unifill in classes of anti-thrombotic agents and vaccines until June 2014
Discussions now accelerating with multiple additional parties
Potential revenue generating opportunities for Unifill syringe include commercial sales, access fees and royalties
Unifill: A challenge most thought impossible

Production Underway, Initial Sales Imminent
15
Initial sales to commence in July this year to multiple customers
Initial sales this year at relatively low volumes with high prices
Expected full optimization of 60MM unit line during 2012

Market Trends Favoring Unilife’s Expansion
16
Specialized Drugs with Customized Devices
Large Molecule Biologics / Vaccines
Top 100 Drugs^ Small Molecules
R&D drug pipelines moving rapidly to large-molecule biologics
Require injection into patient (liquid form or reconstitution)
Pharmaceutical companies seeking devices that can be customized to specific needs of the drug and target patient
^ Pfizer, EvaluatePharma

17
Patient Self-Administration of Injectable Drugs
Patient self-injection desirable
Reduced healthcare costs
Convenient to patient during use, portability and disposal
Adherence to self-treatment
Preference for prescribing
Device segments targeted at patient self-administration (right)
Market Trends Favoring Unilife’s Expansion

Unilife earned a reputation for device innovation via Unifill syringe
Unifill platform now expanding into multiple product variants
PharmaceuticalleadersapproachingUnilifewithotherunmetneeds
Drug-specific collaborations from R&D thru to commercial sales
Multiple projects with multiple partners in multiple device areas
18
Customer-Driven Technology Pipeline

Summary
19
Pharmaceutical demand for innovative, differentiated devices
Customized to meet specific needs of biologics and target patient
Unilife is an emerging leader for advanced drug delivery devices
Fully aligned to serve customer needs with speed and innovation
Unifill: the first and only prefill syringes with integrated safety
Significant commercial potential for broad array of injectable drugs
Arich, fast expanding portfolio being driven by customer need

http://www.proactivenewsroom.com	12
http://www.pitchengine.com	2
http://wordpress	2

Unilife ($UNIS) - Jefferies Healthcare Conference

by ProActive Capital Resources Group

Accessibility

Categories

Upload Details

Usage Rights

3 Embeds 16

Statistics

Unilife ($UNIS) - Jefferies Healthcare Conference Presentation Transcript