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Morgan Stanley Global
Healthcare Conference
Alan Shortall, CEO
September 14, 2011



                     NASDAQ (UNIS) and ASX (UNS)
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 releases and our SEC
filings for more information regarding the use of forward looking
statements.




                                                                          
About Unilife
Emerging Leader for Advanced Drug Delivery Systems

Redefining $10 B+ injectable drug delivery device market
   Innovative, differentiated devices that can enable, enhance and extend
   commercial lifecycles for brand-name, generic or biosimilar drugs

   Targeting fastest-growing, most profitable market sectors

Diversified device portfolio driven by unmet customer needs
   Backed by pharmaceutical partners with long-term, high-value contracts

Unifill: World’s only prefilled syringes with integrated safety
   Sanofi paid $40MM for access in two classes, sales underway

                                                                    
About Unilife
Development and Commercial Supply Partner

                                    State-of-the-art
                                    facility in York,
                                    PA




Operational capabilities and expertise in place to respond to
pharmaceutical customers with speed, agility and reliability




                                                           
About Unilife
 World-Class High-Performing Team
Name                 Title                         Previous Employment
Alan Shortall        CEO, Executive Director       Founder of Unilife
Dr. Ramin Mojdeh     COO                           BD (Head of Pharma Systems & Product Development)
Rich Wieland         CFO                           Cytochroma, Advanced Life Sci.
Dr. Jack Kelley      VP, Strategic Marketing       BD, Medtronic
Mike Ratigan         VP, Commercial Development BD, Stryker
Dr. Masoud Samandi                                 VP, R&D              BD
Ian Hanson           Director, Advanced Delivery   Medtronic Diabetes
Mark Hassett         VP, Sales                     Safety Syringes Inc.
Dennis Pyers         Financial Controller          KPMG
Chris Naftzger       General Counsel               Chesapeake Corporation, Koch Industries

Managers of Advanced Drug Delivery Systems include: Dr. Ashley Palmer (BD), Dr. Jyoti Gupta (BD),
Dr. Gautam Shetty (BD) and Dr. Molly Miller (BD)

                                                                                                    
Injectable Drug Delivery Device Market
Targeting the fastest-growing, highest value sectors
                                           Global Injectable Drug Delivery
Prefilled syringes                        Device Market ($U.SM) 2010-2015

   2.5 B prefilled units sold in 2010
                                           A $15.8 B
   $4.8 B in 2015 (13.5% CAGR)           market by 2015

   Handful of component suppliers

Self-injection systems
   Auto-Injectors / Auto-Infusors

   $1.2 B in 2015 (14.5% CAGR)

   Fragmented market, no leader
                                        Source: MarketsandMarkets. 2010.
                                        Global Injectable Drug Device Market
                                                                               
Complex Drugs, Specific Device Needs
Transition of clinical pipelines to large-molecule drugs

Large-molecule drug market
                                             More than 1,000
(ie. biologics) $180 B in 2015               large-molecule drugs
                                             such as biologics in
   20% of total market value (2015)          development pipeline

Almost all require injection

   Liquid stable or lyophilized form

   Specific molecular, formulation
   and patient needs for delivery

   High-value drugs (hundreds or
   thousands of dollars a dose)        Small molecule   Biologics

                                                                
Generating Strong Brand Differentiation
Market Demand for Innovative, Differentiated Devices

Innovative devices can deliver strong brand differentiation
   Growing competition in therapeutic classes (novel, generic, biosimilar)

   Potential to increase / protect market share for new or approved drugs

   Patent Cliff - 30 biologics with $51 B sales to expire by
   2015
   Transition into superior devices can help to extend product lifecycles

Collaborations during clinical development can create unique
drug-device combination products
   Unique device-related claims may obstruct generic or biosimilar entry
                                                                      
Patient Self-Administration
Self-Injection Market to Double in Size to $1.2B in 2015

Increasingly used to treat a range
of acute and chronic diseases
   Reduced burden on hospitals

   Reduced healthcare costs

   Improves patient quality of life

Superior devices can help to:
   Improve therapy compliance

   Increased opportunities for
   prescription and drug reimbursement
                                                       
Mandatory Use of Safety Syringes
 Risk of Harm Remains Despite Strong 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


                                                                                                                             
The Unifill Syringe
The Leading Edge of our Portfolio

Only prefilled with integrated safety

    Automatic, user-controlled retraction

USP compliant materials in fluid path

Integration into fill-finish systems

Similar size to standard prefilled syringe

    60-70% less packaging, transport and
    storage costs to clipon safety products

    Intuitive use by either healthcare
    workers or patients
                                              
The Unifill Syringe
Received $40MM in payments from Sanofi since 2008

Sanofi has exclusive right to
negotiate access in two drug
classes until mid-2014
Initial production, sales underway

   Initial annual capacity 60MM units

   Additional lines 150MM capacity

   Initial sales for drug stability test

Accelerating discussions with
multiple interested parties
                                                    
Customer-Driven Technology Pipeline
Most Complete Injectable Device Portfolio on the Market

Rapid diversification of portfolio
enabled by success with Unifill
   Primary drug containers with
   integrated safety features
   Patient self-injection
   Target organ delivery
Driven by unmet market needs
   Liquid stable or lyophilized drugs
   Differentiated delivery systems
   Can be customized to drug needs

                                                    
Unifill Select




Only prefilled with attachable needles and integrated safety
Suitable for filling with either the liquid stable or a diluent for
use with lyophilized drugs supplied in a vial
Attachable needles up to 1 ½” in length


                                                                
Unifill EZMix

Only prefilled reconstitution syringe with integrated safety

Dual or multiple drug containers in single glass barrel

Leverages materials and proven technology of Unifill® syringe

Addresses unmet patient safety needs

Half the steps of use as conventional reconstitution systems
(left) and fewer steps than prefilled syringe with diluent (right)

   Traditional                      Prefilled
   Reconstitution                   Syringe and
                                    Vial Adapter

                                                               
Patient Self-Injection Systems




Unifill Auto-Injector

   Unifill syringe gives compact size relative to conventional auto-injectors

   True end-of-dose indicator (audible, tactile click, plus visual window)

   Patient never sees the needle during any stage of use



                                                                       
Patient Self-Injection Systems




AutoInfusor™
Only infusion pump system for drugs 5mL or larger in volume

Single-use, disposable system worn by patient.

Automatic drug infusion into subcutaneous tissue at push of button

Can be pre-set for infusion times from minutes to hours in duration

                                                              
Novel Devices for Target Organ Delivery

Specialized high-value devices delivering drug to target organ

   Target organs may include brain, ear and eye

Pharmaceutical collaborations to develop unique drug-device
combination products

   Device developed in parallel the pipeline drug

   Can help to enable the commercialization of a pipeline drug

First organ delivery device scheduled to enter into clinical
trials with pharmaceutical partner later this year


                                                                 
Upcoming Milestones
Unifill Syringe
  Sales to current and additional pharmaceutical customers
  Placement of Unifill syringe onto drug stability studies
Expanded syringe portfolio
  Clinical development agreements (EZMix, Select, Auto-Injector)
  Commencement of initial sales
Other Advanced Drug Delivery Systems
  Clinical development agreements (ie. organ delivery devices)
  Commencement of sales
  Continued expansion of proprietary portfolio
                                                             
Summary
Advanced operational capabilities and expertise now in place
Unifill – world’s only prefilled syringes with integrated safety
   $40MM in payments from Sanofi, initial sales underway

Diversified product portfolio in direct response to unmet needs
Discussions with multiple customers across multiple areas
Attractive model with long-term contracts and strong margins
Redefining fast-growing $10 billion injectable device market
   Targeting fastest-growing, highest-value device sectors

   Becoming intertwined with global injectable drug market

                                                              
Questions

            

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Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation

  • 1. Morgan Stanley Global Healthcare Conference Alan Shortall, CEO September 14, 2011 NASDAQ (UNIS) and ASX (UNS)
  • 2. 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 releases and our SEC filings for more information regarding the use of forward looking statements. 
  • 3. About Unilife Emerging Leader for Advanced Drug Delivery Systems Redefining $10 B+ injectable drug delivery device market Innovative, differentiated devices that can enable, enhance and extend commercial lifecycles for brand-name, generic or biosimilar drugs Targeting fastest-growing, most profitable market sectors Diversified device portfolio driven by unmet customer needs Backed by pharmaceutical partners with long-term, high-value contracts Unifill: World’s only prefilled syringes with integrated safety Sanofi paid $40MM for access in two classes, sales underway 
  • 4. About Unilife Development and Commercial Supply Partner State-of-the-art facility in York, PA Operational capabilities and expertise in place to respond to pharmaceutical customers with speed, agility and reliability 
  • 5. About Unilife World-Class High-Performing Team Name Title Previous Employment Alan Shortall CEO, Executive Director Founder of Unilife Dr. Ramin Mojdeh COO BD (Head of Pharma Systems & Product Development) Rich Wieland CFO Cytochroma, Advanced Life Sci. Dr. Jack Kelley VP, Strategic Marketing BD, Medtronic Mike Ratigan VP, Commercial Development BD, Stryker Dr. Masoud Samandi VP, R&D BD Ian Hanson Director, Advanced Delivery Medtronic Diabetes Mark Hassett VP, Sales Safety Syringes Inc. Dennis Pyers Financial Controller KPMG Chris Naftzger General Counsel Chesapeake Corporation, Koch Industries Managers of Advanced Drug Delivery Systems include: Dr. Ashley Palmer (BD), Dr. Jyoti Gupta (BD), Dr. Gautam Shetty (BD) and Dr. Molly Miller (BD) 
  • 6. Injectable Drug Delivery Device Market Targeting the fastest-growing, highest value sectors Global Injectable Drug Delivery Prefilled syringes Device Market ($U.SM) 2010-2015 2.5 B prefilled units sold in 2010 A $15.8 B $4.8 B in 2015 (13.5% CAGR) market by 2015 Handful of component suppliers Self-injection systems Auto-Injectors / Auto-Infusors $1.2 B in 2015 (14.5% CAGR) Fragmented market, no leader Source: MarketsandMarkets. 2010. Global Injectable Drug Device Market 
  • 7. Complex Drugs, Specific Device Needs Transition of clinical pipelines to large-molecule drugs Large-molecule drug market More than 1,000 (ie. biologics) $180 B in 2015 large-molecule drugs such as biologics in 20% of total market value (2015) development pipeline Almost all require injection Liquid stable or lyophilized form Specific molecular, formulation and patient needs for delivery High-value drugs (hundreds or thousands of dollars a dose) Small molecule Biologics 
  • 8. Generating Strong Brand Differentiation Market Demand for Innovative, Differentiated Devices Innovative devices can deliver strong brand differentiation Growing competition in therapeutic classes (novel, generic, biosimilar) Potential to increase / protect market share for new or approved drugs Patent Cliff - 30 biologics with $51 B sales to expire by 2015 Transition into superior devices can help to extend product lifecycles Collaborations during clinical development can create unique drug-device combination products Unique device-related claims may obstruct generic or biosimilar entry 
  • 9. Patient Self-Administration Self-Injection Market to Double in Size to $1.2B in 2015 Increasingly used to treat a range of acute and chronic diseases Reduced burden on hospitals Reduced healthcare costs Improves patient quality of life Superior devices can help to: Improve therapy compliance Increased opportunities for prescription and drug reimbursement 
  • 10. Mandatory Use of Safety Syringes Risk of Harm Remains Despite Strong 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 
  • 11. The Unifill Syringe The Leading Edge of our Portfolio Only prefilled with integrated safety Automatic, user-controlled retraction USP compliant materials in fluid path Integration into fill-finish systems Similar size to standard prefilled syringe 60-70% less packaging, transport and storage costs to clipon safety products Intuitive use by either healthcare workers or patients 
  • 12. The Unifill Syringe Received $40MM in payments from Sanofi since 2008 Sanofi has exclusive right to negotiate access in two drug classes until mid-2014 Initial production, sales underway Initial annual capacity 60MM units Additional lines 150MM capacity Initial sales for drug stability test Accelerating discussions with multiple interested parties 
  • 13. Customer-Driven Technology Pipeline Most Complete Injectable Device Portfolio on the Market Rapid diversification of portfolio enabled by success with Unifill Primary drug containers with integrated safety features Patient self-injection Target organ delivery Driven by unmet market needs Liquid stable or lyophilized drugs Differentiated delivery systems Can be customized to drug needs 
  • 14. Unifill Select Only prefilled with attachable needles and integrated safety Suitable for filling with either the liquid stable or a diluent for use with lyophilized drugs supplied in a vial Attachable needles up to 1 ½” in length 
  • 15. Unifill EZMix Only prefilled reconstitution syringe with integrated safety Dual or multiple drug containers in single glass barrel Leverages materials and proven technology of Unifill® syringe Addresses unmet patient safety needs Half the steps of use as conventional reconstitution systems (left) and fewer steps than prefilled syringe with diluent (right) Traditional Prefilled Reconstitution Syringe and Vial Adapter 
  • 16. Patient Self-Injection Systems Unifill Auto-Injector Unifill syringe gives compact size relative to conventional auto-injectors True end-of-dose indicator (audible, tactile click, plus visual window) Patient never sees the needle during any stage of use 
  • 17. Patient Self-Injection Systems AutoInfusor™ Only infusion pump system for drugs 5mL or larger in volume Single-use, disposable system worn by patient. Automatic drug infusion into subcutaneous tissue at push of button Can be pre-set for infusion times from minutes to hours in duration 
  • 18. Novel Devices for Target Organ Delivery Specialized high-value devices delivering drug to target organ Target organs may include brain, ear and eye Pharmaceutical collaborations to develop unique drug-device combination products Device developed in parallel the pipeline drug Can help to enable the commercialization of a pipeline drug First organ delivery device scheduled to enter into clinical trials with pharmaceutical partner later this year 
  • 19. Upcoming Milestones Unifill Syringe Sales to current and additional pharmaceutical customers Placement of Unifill syringe onto drug stability studies Expanded syringe portfolio Clinical development agreements (EZMix, Select, Auto-Injector) Commencement of initial sales Other Advanced Drug Delivery Systems Clinical development agreements (ie. organ delivery devices) Commencement of sales Continued expansion of proprietary portfolio 
  • 20. Summary Advanced operational capabilities and expertise now in place Unifill – world’s only prefilled syringes with integrated safety $40MM in payments from Sanofi, initial sales underway Diversified product portfolio in direct response to unmet needs Discussions with multiple customers across multiple areas Attractive model with long-term contracts and strong margins Redefining fast-growing $10 billion injectable device market Targeting fastest-growing, highest-value device sectors Becoming intertwined with global injectable drug market 
  • 21. Questions 