Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation
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Transcript of Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation
Alan Shortall, CEOSeptember 14, 2011
Morgan Stanley Global Healthcare Conference
NASDAQ (UNIS) and ASX (UNS)
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 filings for more information regarding the use of forward looking statements.
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 $40MM for access in two classes, sales underway
Emerging Leader for Advanced Drug Delivery Systems
About Unilife
Development and Commercial Supply Partner
State-of-the-art facility in York, PA
About Unilife
Operational capabilities and expertise in place to respond to pharmaceutical customers with speed, agility and reliability
World-Class High-Performing Team
Name Title Previous EmploymentAlan Shortall CEO, Executive Director Founder of Unilife
Dr. Ramin Mojdeh COO BD (Head of Pharma Systems & Product Development)
Rich Wieland CFO Cytochroma, Advanced Life Sci.
Dr. Jack Kelley VP, Strategic Marketing BD, Medtronic
Mike Ratigan VP, Commercial Development BD, Stryker
Dr. Masoud Samandi VP, R&D BD
Ian Hanson Director, Advanced Delivery Medtronic Diabetes
Mark Hassett VP, Sales Safety Syringes Inc.
Dennis Pyers Financial Controller KPMG
Chris Naftzger General Counsel Chesapeake Corporation, Koch Industries
Managers of Advanced Drug Delivery Systems include: Dr. Ashley Palmer (BD), Dr. Jyoti Gupta (BD),
Dr. Gautam Shetty (BD) and Dr. Molly Miller (BD)
About Unilife
Targeting the fastest-growing, highest value sectorsGlobal Injectable Drug Delivery
Device Market ($U.SM) 2010-2015
Source: MarketsandMarkets. 2010. Global Injectable Drug Device Market
Prefilled syringes
2.5 B prefilled units sold in 2010
$4.8 B in 2015 (13.5% CAGR)
Handful of component suppliers
Self-injection systems
Auto-Injectors / Auto-Infusors
$1.2 B in 2015 (14.5% CAGR)
Fragmented market, no leader
A $15.8 B market by 2015
Injectable Drug Delivery Device Market
Transition of clinical pipelines to large-molecule drugs
Large-molecule drug market (ie. biologics) $180 B in 2015
20% of total market value (2015)
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
Complex Drugs, Specific Device Needs
More than 1,000 large-molecule drugs such as biologics in development pipeline
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
Generating Strong Brand Differentiation
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
Patient Self-Administration
Risk of Harm Remains Despite Strong Enforcement
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 Syringes
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
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
The Unifill Syringe
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 needsLiquid stable or lyophilized drugs
Differentiated delivery systems
Can be customized to drug needs
Customer-Driven Technology Pipeline
Unifill Select
Only prefilled with attachable needles and integrated safetySuitable for filling with either the liquid stable or a diluent for use with lyophilized drugs supplied in a vialAttachable needles up to 1 ½” in length
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 Reconstitution
Prefilled Syringe and Vial Adapter
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
Patient Self-Injection Systems
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
AutoInfusor™
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
Unifill SyringeSales to current and additional pharmaceutical customers
Placement of Unifill syringe onto drug stability studies
Expanded syringe portfolioClinical development agreements (EZMix, Select, Auto-Injector)
Commencement of initial sales
Other Advanced Drug Delivery SystemsClinical development agreements (ie. organ delivery devices)
Commencement of sales
Continued expansion of proprietary portfolio
Upcoming Milestones
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 marketTargeting fastest-growing, highest-value device sectors
Becoming intertwined with global injectable drug market
Summary
Questions