Unilife Corporation (NASDAQ:UNIS - News) is a U.S.-based developer, manufacturer and supplier of advanced drug delivery systems with state-of-the-art facilities in Pennsylvania. Established in 2002, Unilife works with pharmaceutical and biotechnology companies seeking innovative devices for use with their parenteral drugs and vaccines. Unilife has developed a broad, differentiated proprietary portfolio of its own injectable drug delivery products, including the Unifill® and Unitract® product lines of safety syringes with automatic, operator controlled needle retraction. Unifill represents the world's first prefilled syringe technology integrating safety within the primary drug container. The products are ideally positioned to help pharmaceutical companies maximize the lifecycle of their injectable drugs and enhance patient care. Unifill syringes, together with other devices that are part of the Unilife technology platform, can either be supplied to pharmaceutical customers ready for use, or customized to address the specific requirements of targeted novel drugs. For more information on Unilife, please visit www.unilife.com.
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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
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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