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Innovative Drug Delivery Device Solutions Alan Shortall Chief Executive Officer

Unilife ($UNIS) Investor Presentation - July 2011

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Page 1: Unilife ($UNIS) Investor Presentation - July 2011

Innovative Drug

Delivery Device

Solutions

Alan Shortall

Chief Executive Officer

Page 2: Unilife ($UNIS) Investor Presentation - July 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.

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Page 3: Unilife ($UNIS) Investor Presentation - July 2011

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Introducing Unilife

An emerging global leader for innovative drug delivery devices

Developed full safety syringe portfolio with best-in-class features

Unifill – the world’s only prefilled syringes with integrated safety

Game-changer for the fastest growing, most-profitable syringe market

Sanofi-aventis paid $40MM upfront for access rights in two classes

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

Page 4: Unilife ($UNIS) Investor Presentation - July 2011

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

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Page 5: Unilife ($UNIS) Investor Presentation - July 2011

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

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Page 6: Unilife ($UNIS) Investor Presentation - July 2011

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

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2002 2003 2004 2005 2006 2007 2008 20090

100

200

300

400

500

600

700

800

900

1000

38%46% 54%

63% 67% 69%71%

68%

Needle / Syringe with no Safety Feature Needle / Syringe with Safety Feature

Sharps Injuries among Hospital Workers in Massachusetts 2002 - 2009. Massachusetts Sharps Injury Surveillance System

Needlestick Injuries Caused by Syringes Among Hospital Workers in Massachusetts

Mandatory Use of Safety Devices in Healthcare

Page 7: Unilife ($UNIS) Investor Presentation - July 2011

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

Page 8: Unilife ($UNIS) Investor Presentation - July 2011

8

2006 2007 2008 2009 2010 2011 2012 2013 20140

0.5

1

1.5

2

2.5

3

3.5

4

4.5

Units (billion)

Pharmaceutical Market for Prefilled SyringesPrefilled Syringes - Historical Demand and Forecast Growth*

The fastest-growing and most profitable syringe market*

2.4B prefilled syringes in 2010, 12% annual growth rate** Prefilled Syringes 2010 Greystone Associates

Bill

ions

of

pref

illed

un

its

Page 9: Unilife ($UNIS) Investor Presentation - July 2011

Pharmaceutical Market for Prefilled Syringes

9

Amgen Biogen Idec

GSK JNJ Merck Novartis Pfizer Roche Sanofi Talecris Other0

2

4

6

8

10

12

Other

Vaccines

Immunosuppresants

Immunostimulants

Hormones

Anti-virals

Anti-rheumatic

Anti-thrombotics

Anti-Anemia

Selection of 50 Marketed Prefilled Drugs by Therapeutic Class / Company

Num

ber

of P

refil

led

Dru

gs

Page 10: Unilife ($UNIS) Investor Presentation - July 2011

Standard prefilled syringe (left) next to three attached with an ancillary safety product

Unifill

Market Transition to Prefilled Safety Syringes

10

Page 11: Unilife ($UNIS) Investor Presentation - July 2011

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World’s first and only prefilled syringes with integrated safety

Now in production

Initial shipments commenced

Controlled retraction into barrel

Needle locked after use for convenient, compact disposal

Unifill – The Leading Edge of Our Portfolio

Page 12: Unilife ($UNIS) Investor Presentation - July 2011

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Unifill as a Game Changer

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

+Ancillary Safety Device

Standard Prefill

Syringe

Prefilled Safety

Syringe

Direct Substitute

Unifill platform of prefilled safety syringes

Page 13: Unilife ($UNIS) Investor Presentation - July 2011

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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

Page 14: Unilife ($UNIS) Investor Presentation - July 2011

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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

Page 15: Unilife ($UNIS) Investor Presentation - July 2011

Production Underway, Initial Sales Imminent

Initial Production

Complete Validation

Initial shipments (higher pricing to long-term commercial levels)

Customers Commence Stability Studies etc

Commercial supply agreements (customers give notice on projected orders)

Customer builds inventory in anticipation regulatory approval

Customer receives approval for drug-device combination product

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Q1 2011 Q2 2011 Q3-Q4 2011 2012 2013

Shipments commencing in July to Sanofi and other customers

Initial sales this year at relatively low volumes with high prices

Expected full optimization of 60MM unit line during 2012

Page 16: Unilife ($UNIS) Investor Presentation - July 2011

Market Trends Favoring Unilife’s Expansion

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Specialized Drugs with Customized Devices

^ Pfizer, EvaluatePharma

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

89%

11%

2000

72%

28%

2008

50%50%

2014

Top 100 Drugs^ Small Molecules Large Molecule Biologics / Vaccines

Page 17: Unilife ($UNIS) Investor Presentation - July 2011

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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)

Patient Self-Administration of Injectable Drugs

Patient Self-

Injection Devices

Prefilled Syringes

Auto-Injectors

Patch Pumps

Injection Pens

Liquid / dry recon-

stitution injectors

Market Trends Favoring Unilife’s Expansion

Page 18: Unilife ($UNIS) Investor Presentation - July 2011

Unilife earned a reputation for device innovation via Unifill syringe

Unifill platform now expanding into multiple product variants

Pharmaceutical leaders approaching Unilife with other unmet needs

Drug-specific collaborations from R&D thru to commercial sales

Multiple projects with multiple partners in multiple device areas

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Unifill Prefilled Safety

Syringes

Unifill-Compatible Enhanced

Patient Self-

Injection Devices

Dry Drug Recon-stitution Devices

Large Volume Viscous

Drug Delivery Devices

Targeted Organ

Delivery Devices

Customer-Driven Technology Pipeline

Page 19: Unilife ($UNIS) Investor Presentation - July 2011

Summary

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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

A rich, fast expanding portfolio being driven by customer need