unilife ($unis) investor presentation - july 2011
DESCRIPTION
TRANSCRIPT
Innovative Drug
Delivery Device
Solutions
Alan Shortall
Chief Executive Officer
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
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
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
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
6
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
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
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
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
Standard prefilled syringe (left) next to three attached with an ancillary safety product
Unifill
Market Transition to Prefilled Safety Syringes
10
11
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
12
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
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
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
15
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
Market Trends Favoring Unilife’s Expansion
16
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
17
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
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
18
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
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
A rich, fast expanding portfolio being driven by customer need