Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation

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Alan Shortall, CEO September 14, 2011 Morgan Stanley Global Healthcare Conference NASDAQ (UNIS) and ASX (UNS)

description

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. Since its founding in 1935, Morgan Stanley and its people have helped redefine the meaning of financial services. The firm has continually broken new ground in advising our clients on strategic transactions, in pioneering the global expansion of finance and capital markets, and in providing new opportunities for individual and institutional investors. Click below to see a timeline of Morgan Stanley's growth, which parallels the history of modern finance

Transcript of Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation

Page 1: Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation

Alan Shortall, CEOSeptember 14, 2011

Morgan Stanley Global Healthcare Conference

NASDAQ (UNIS) and ASX (UNS)

Page 2: Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation

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.

Page 3: Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation

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

Page 4: Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation

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

Page 5: Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation

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

Page 6: Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation

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

Page 7: Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation

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

Page 8: Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation

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

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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

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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

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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

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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

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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

Page 14: Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation

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

Page 15: Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation

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

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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

Page 17: Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation

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™

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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

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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

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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

Page 21: Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation

Questions