General Annual 1 November 30, 2009 Meeting Disclaimer and - PDF document

General Annual 1 November 30, 2009 Meeting

Disclaimer and Important Notice This presentation has been prepared by Unilife Medical Solutions Limited and its subsidiaries (Unilife).The material that follows is a presentation of general background information about Unilife's activities current at the date of the development of the presentation, p g g p p , November 30, 2009.It is information given in summary form and does not purport to be complete. It is not intended to be relied upon as advice to potential customers and partners and does not take into account the commercial objectives, financial situation or needs of any potential partner Readers should seek their own independent professional advice Statements contained in this presentation of any potential partner. Readers should seek their own independent professional advice. Statements contained in this presentation may contain information relating to Unilife's financial condition, results of operations, business strategies, operating efficiencies, competitive position, growth opportunities for existing products and services, plans and objectives of management and other matters. These statements are estimates reflecting the best judgement of senior management of Unilife and involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested. Nothing contained in this presentation shall constitute an offer to sell or a solicitation of an offer to buy any securities of Unilife in any jurisdiction Unilife does not give any warranty in relation to the contents of this presentation and disclaims all or any liability for claims which may be made by any person acting or omitting to act, on the basis of any representations arising out of or in connection with this presentation. 1

Unilife in 2009 Overview � B est-in-class innovative safety medical devices � ISO-13485 certified with strong automated assembly expertise � Global HQ’s at FDA-registered facility in Pennsylvania (PA) � W orld-class team with device and pharmaceutical expertise � Pharmaceutical and healthcare industry leaders 5

Unilife in 2009 Key delivered milestones � April 09 Complete transition of Unilife HQ to the US � June 09 Industrialisation Agreement with sanofi-aventis � Aug 09 Starts US production Unitract 1mL Syringes � Sep 09 Proposes redomiciliation to US and NASDAQ � Oct 2009 Receipt A$5.6m package from PA Government � Nov 2009 Filed IM (ASIC) and Form 10 (SEC) documents � Nov 2009 Completes $53.6m capital raising � Nov 2009 Appoints Unifill assembly line partner � Nov 2009 Files patents for new pipeline prefilled syringe 6

Unilife in 2009 Corporate Position � Transition of key functions to PA � Foundations of world-class team � 100 staff across three continents � Doubled in size since 2008 � 40 managers, professionals added � Average 23 years experience � Strong industry backgrounds 7

Unilife in 2009 Operational Position � No longer a technology company � Now an industrial manufacturer � ISO-13485 certified � Quality Management System � FDA-registered facility � Automated assembly expertise 8

Unilife in 2009 Relationship with sanofi-aventis � Largest purchaser of prefilled syringes in the world � Global leader in vaccines � Largest pharmaceutical group in Europe � One of the top five pharmaceutical groups in the world � Six year relationship with Unilife 9

Unilife in 2009 Key Terms of Agreements with sanofi-aventis � Signed Exclusive Agreement in June 2008 � Payment of A$16.4m (€10m) on signing of Exclusive Agreement � Industrialisation program with quarterly milestone payments � Milestone payments of €11.5m to date (€5.5m still to come) � Signed Industrialisation Agreement in July 2009 � Committed to fund industrialisation program A$30.4m (€17m) � Retained right to sell to other customers in therapeutic classes to be agreed by both parties 10

Unilife in 2009 Financial Position � A$40.4m in revenue � A$12.8m net profit after tax � A$53.6m capital raising � A$32.1m Private Placement � A$21.5m Share Purchase Plan � A$50m cash balance (25/11/09) 11

Global transition to safety syringes Unsafe injection practices � 1.3m deaths a year from unsafe injections* � 600,000 US healthcare workers incur a needlestick injury each year � More than 50% of injections in developing countries are unsafe * � 1/3 of HIV cases outside Sub-Saharan Africa from injecting drug use^ � Community risk from unsafe disposal + International Association of Safe Injection Technologies (2004) 12 •World Health Organization ^ UNAIDS

Global transition to safety syringes The US Experience � Federal Needlestick Prevention Act � Strict enforcement by OSHA � 1 in 5 OSHA-inspected facilities receive citation for non-compliance � Passive, integrated safety features desired but few available � Canada, EU, Australia following the US towards mandatory use 13

Global transition to safety syringes Awaiting products of choice 70.00% US reported needlestick injuries (1999 – 2007) 60.00% Syringes responsible for one-third of all injuries NSI by 50.00% syringe / Safety devices now cause majority of all injuries total NSIs 40.00% NSI involved 30.00% safety device 20.00% 10.00% Source – EPINET - IHWSC 14 0.00% 1999 2000 2001 2002 2003 2004 2005 2006 2007

Global transition to safety syringes Market driven solutions: A round peg for a round hole Harm Reduction Other Diabetes Key Markets Healthcare Pharmaceutical Facilities Companies 15

Unilife Products Core Technology � Passive retraction mechanism is activated inside the body � Operators control the speed of needle retraction into the barrel � Auto-Disable features prevent product tampering or reuse � Fully integrated safety features 16

Products Proprietary Safety Syringe Portfolio Plastic for vial Glass ready-to-fill Insulin, TB Clinical Range Unifill™ syringe Unifill™ Select and Safe 3 & 5mL Fixed needle Attachable needles US production Pipeline Industrialisation Pipeline Program 17

Unitract 1mL Syringes Status � Designed for healthcare facilities and for self-injection � Approved for use in: � United States (FDA) � Canada � Europe (CE Mark) � Australia � US production August 2009 � Commercial release shortly 18

Pharmaceutical Market for Prefilled Syringes Benefits of Prefilled Syringes � 50+ prefilled drugs and vaccines � Benefits for healthcare workers: � Convenient dose accuracy � Faster and reduced inventory � Benefits for pharmaceutical manufacturers: � Avoid drug wastage (overfill) � Product differentiation 19

Pharmaceutical Market for Prefilled Syringes Indicative Market Use � 20+ pharmaceutical participants of Prefilled Syringes Abbott Biogen-Idec � US$1.5 billion market in 2009 1% 1% Indicative Consumption Serono of Prefilled Syringes by 1% � 3 billion prefilled syringes by 2012^ J&J Pharmaceutical Company Others 1% 2% Pfizer 3% TEVA 5% Sanofi-aventis 28% Amgen Calculated by published average unit cost per dose of 50 drugs available in a prefilled 5% syringe format where 2008 annual revenues have been disclosed by the pharmaceutical Merck company. Note - some drugs are available in formats 6% other than a prefilled syringe. Unilife has used available industry data and Roche its own estimates to calculate the % of doses supplied in a prefilled syringe format. 7% The cost / unit of some drugs vary depending upon the measured dosage. Sanofi-pasteur Wyeth 10% 6% GSK ^ Greystone Associates. Prefilled Syringes. 2009 20 Novartis 15 % 9%

Pharmaceutical Market for Prefilled Syringes � High barriers for market entry � Few glass prefilled suppliers � No integrated safety prefilled � Use of ancillary safety products � Production & shipment costs � Size hinders marketability 21

Pharmaceutical Market for Prefilled Syringes Ancillary Safety Products Ancillary Safety Products Unifill syringe 22 Attached onto Standard Prefilled Syringes Attached onto Standard Prefilled Syringes

Unifill™ syringe Key Industrial Advantages � Primary drug container � Fully integrated medical device � Compatible with standard filling and packaging systems � Per standard handling process � Reduced industrial footprint � 60% reduction packaging, shipment and storage costs 23

Unifill™ syringe Key Marketing Advantages � Provides highest level of safety � Fully compliant with legislation � Strong market differentiation � Extension of product lifecycles � Minimal operator retraining � Ideal for self-administration 24

Unifill™ syringe Industrialisation Program � $33 million program � Commenced July 2008 � One-year ahead schedule � Target completion late-2010 � Aggressive ramp plan � Product engineered for high- volume production 25

Unifill™ syringe De-risking the Industrialisation Program � Mikron engaged as automated assembly line supplier � Proof of Principle for Unifill completed by Mikron at speeds equivalent to high-volume production � Commercial line with 60m annual capacity by late-2010 � Target capacity on completion 50% more than original � High-volume line with 150m annual capacity in late-2011 � Now a process rather than a technical challenge 26