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General Annual 1 November 30, 2009 Meeting Disclaimer and - - PDF document
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
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
- f any potential partner Readers should seek their own independent professional advice Statements contained in this presentation
- f 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.
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Best-in-class innovative safety
medical devices ISO-13485 certified with strong automated assembly expertise Global HQ’s at FDA-registered facility in Pennsylvania (PA)
World-class team with device and
pharmaceutical expertise Pharmaceutical and healthcare industry leaders
Unilife in 2009
Overview
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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
Key delivered milestones
Unilife in 2009
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Corporate Position
Unilife in 2009
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
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Operational Position
Unilife in 2009
No longer a technology company Now an industrial manufacturer ISO-13485 certified Quality Management System FDA-registered facility Automated assembly expertise
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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
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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
Unilife in 2009
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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)
Unilife in 2009
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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)
- World Health Organization
^ UNAIDS
Global transition to safety syringes
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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
Global transition to safety syringes
The US Experience
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Global transition to safety syringes
Awaiting products of choice
0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 1999 2000 2001 2002 2003 2004 2005 2006 2007
NSI by syringe / total NSIs NSI involved safety device
US reported needlestick injuries (1999 – 2007)
Syringes responsible for one-third of all injuries Safety devices now cause majority of all injuries
Source – EPINET - IHWSC
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Pharmaceutical Companies Healthcare Facilities Diabetes Harm Reduction Other
Key Markets
Global transition to safety syringes
Market driven solutions: A round peg for a round hole
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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
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Products
Proprietary Safety Syringe Portfolio
Plastic for vial Glass ready-to-fill Insulin, TB and Safe Clinical Range 3 & 5mL Unifill™ syringe Fixed needle Unifill™ Select Attachable needles US production Pipeline Industrialisation Program Pipeline
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Unitract 1mL Syringes
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 Status
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Pharmaceutical Market for 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
Benefits of Prefilled Syringes
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Pharmaceutical Market for Prefilled Syringes
Indicative Consumption
- f Prefilled Syringes by
Pharmaceutical Company
Pfizer 3% J&J 1% Serono 1% Abbott 1%
Sanofi-aventis 28% Sanofi-pasteur 10% GSK 15% Novartis 9% Wyeth 6% Roche 7% Merck 6% Amgen 5% TEVA 5%
Others 2% Biogen-Idec 1%
Calculated by published average unit cost per dose of 50 drugs available in a prefilled syringe format where 2008 annual revenues have been disclosed by the pharmaceutical company. Note - some drugs are available in formats
- ther than a prefilled syringe.
Unilife has used available industry data and its own estimates to calculate the % of doses supplied in a prefilled syringe format. The cost / unit of some drugs vary depending upon the measured dosage.
20+ pharmaceutical participants US$1.5 billion market in 2009 3 billion prefilled syringes by 2012^
^ Greystone Associates. Prefilled Syringes. 2009
Indicative Market Use
- f Prefilled Syringes
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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
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Ancillary Safety Products Attached onto Standard Prefilled Syringes
Pharmaceutical Market for Prefilled Syringes
Unifill syringe Ancillary Safety Products Attached onto Standard Prefilled Syringes
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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
Unifill™ syringe
Key Industrial Advantages
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Provides highest level of safety Fully compliant with legislation Strong market differentiation Extension of product lifecycles Minimal operator retraining Ideal for self-administration
Unifill™ syringe
Key Marketing Advantages
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$33 million program Commenced July 2008 One-year ahead schedule Target completion late-2010 Aggressive ramp plan Product engineered for high- volume production
Unifill™ syringe
Industrialisation Program
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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
Unifill™ syringe
De-risking the Industrialisation Program
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Additional pharmaceutical market opportunities
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Anti-coagulants Vaccine Anti-Infectives Anti-inflammatory Hematology Multiple Sclerosis HGH Obstetrics Other Oncology
Market share of accumulated annual drug sales in therapeutic class / unit dose cost
Sanofi-aventis Sanofi-pasteur GSK Novartis Wyeth Roche Merck Amgen TEVA Pfizer J&J Serono Abbott Biogen-Idec Others
Calculated by published average unit cost per dose of 50 drugs available in a prefilled syringe format where 2008 annual revenues have been disclosed by the pharmaceutical company. Note - some drugs are available in formats other than a prefilled syringe. Unilife has used available industry data and its own estimates to calculate the % of doses supplied in a prefilled syringe format. The cost / unit of some drugs vary depending upon the measured dosage.
Unifill™ syringe
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International patent filings underway Not tied to other product agreements Supplied with attachable needles Ready for injection Retracts needle up to 1½ inches Discussions with interested parties Ideallysuitedforusewithvaccines Designed for Intramuscular (IM) Injection Market
Unifill™ Select
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Unifill™ Select
80% 80% 20% 20%
All Prefilled Therapeutic Markets (except vaccines) Vaccines Only
Indicative Market Use of Prefilled Syringes by Needle Fixture
Fixed Needle Attachable Needle
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Unifill™ Select
Vaccines Vaccine sales to double to US$39 billion in 2013* 70% of vaccine doses now in prefilled syringe format^ Influenza the single largest prefilled syringe application^ 1 billion seasonal influenza vaccine doses made in 2009# 2009 global H1N1 vaccine capacity of 3 billion doses+
* Kalorama Information. Nov 2009 ^ Greystone Associates. Prefilled Syringes. May 2009 # IFPMA / WHO. Influenza Vaccine Demand and Supply. March 2009 + WHO. September 2009
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2010 Business Priorities
Scheduled completion late- 2010 Installation of commercial assembly line Appoint additional suppliers with dual-source goal
Glass barrel Rubber seals
Complete Industrialisation Program
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Finalise exclusivity list with sanofi-aventis Unifill ™ syringe
Supply agreements with sanofi-aventis Agreements with additional pharmaceutical companies
Unifill™ Select syringe Exploring other opportunities for industry collaboration Expand pharmaceutical relationships
2010 Business Priorities
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2010 Business Priorities
Complete ageing studies Commercial release Discussions with several interested healthcare and pharmaceutical companies Opportunities for evaluations
Harm reduction market Healthcare outside the US
Commence Unitract 1mL Sales
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Establish new global headquarters
2010 Business Priorities
Developing major new facility in Pennsylvania Meet anticipated market demand for Unifill™ syringes Financial support from Pennsylvania Government Announcement once development agreement finalised
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A global exchange for global technology leaders ASX vs NASDAQ for Health Care Equipment Companies
Significantly higher PE ratio on NASDAQ Listed Companies: ASX (70) NASDAQ (200) Median market cap: ASX (A$14m) NASDAQ (US$178m)
Allow investment from those with restrictive trading policies New Ticker Codes: NASDAQ – UNIS ASX - UNS
List on NASDAQ
2010 Business Priorities
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Shareholders can choose between trading:
Chess Depository Index (CDIs) on the ASX
Unilife Corporation Common Stock on NASDAQ CDIs exchangeable for common stock on a 6 for 1 basis Computershare can convert CDIs to common stock 24 hours to switch between CDIs and common stock No fees for switching between common stock and CDIs
Trading Options Post-NASDAQ
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Key Upcoming Milestones
Commercial release of US-made Unitract™ 1mL syringes Completion of negotiations for Unifill™ exclusivity list Redomiciliation and listing on NASDAQ Open new global headquarters and production facility in PA Installation of Unifill™ commercial assembly line Completion of Unifill™ industrialisation program Agreements with additional pharmaceutical companies
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