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Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation


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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

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Unilife ($UNIS) Morgan Stanley 2011 Healthcare Presentation

  1. 1. Morgan Stanley GlobalHealthcare ConferenceAlan Shortall, CEOSeptember 14, 2011 NASDAQ (UNIS) and ASX (UNS)
  2. 2. Cautionary Note Regarding Forward-Looking StatementsThis presentation contains forward looking statements under the safeharbor provisions of the US securities laws. These forward-lookingstatements are based on management’s beliefs and assumptions and oninformation currently available to our management.Our management believes that these forward-looking statements arereasonable as and when made. However you should not place unduereliance on any such forward looking statements as these are subject torisks and uncertainties. Please refer to our press releases and our SECfilings for more information regarding the use of forward lookingstatements. 
  3. 3. About UnilifeEmerging Leader for Advanced Drug Delivery SystemsRedefining $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 sectorsDiversified device portfolio driven by unmet customer needs Backed by pharmaceutical partners with long-term, high-value contractsUnifill: World’s only prefilled syringes with integrated safety Sanofi paid $40MM for access in two classes, sales underway 
  4. 4. About UnilifeDevelopment and Commercial Supply Partner State-of-the-art facility in York, PAOperational capabilities and expertise in place to respond topharmaceutical customers with speed, agility and reliability 
  5. 5. About Unilife World-Class High-Performing TeamName Title Previous EmploymentAlan Shortall CEO, Executive Director Founder of UnilifeDr. Ramin Mojdeh COO BD (Head of Pharma Systems & Product Development)Rich Wieland CFO Cytochroma, Advanced Life Sci.Dr. Jack Kelley VP, Strategic Marketing BD, MedtronicMike Ratigan VP, Commercial Development BD, StrykerDr. Masoud Samandi VP, R&D BDIan Hanson Director, Advanced Delivery Medtronic DiabetesMark Hassett VP, Sales Safety Syringes Inc.Dennis Pyers Financial Controller KPMGChris Naftzger General Counsel Chesapeake Corporation, Koch IndustriesManagers of Advanced Drug Delivery Systems include: Dr. Ashley Palmer (BD), Dr. Jyoti Gupta (BD),Dr. Gautam Shetty (BD) and Dr. Molly Miller (BD) 
  6. 6. Injectable Drug Delivery Device MarketTargeting the fastest-growing, highest value sectors Global Injectable Drug DeliveryPrefilled syringes Device Market ($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 suppliersSelf-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. 7. Complex Drugs, Specific Device NeedsTransition of clinical pipelines to large-molecule drugsLarge-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 pipelineAlmost 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. 8. Generating Strong Brand DifferentiationMarket Demand for Innovative, Differentiated DevicesInnovative 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 lifecyclesCollaborations during clinical development can create uniquedrug-device combination products Unique device-related claims may obstruct generic or biosimilar entry 
  9. 9. Patient Self-AdministrationSelf-Injection Market to Double in Size to $1.2B in 2015Increasingly used to treat a rangeof acute and chronic diseases Reduced burden on hospitals Reduced healthcare costs Improves patient quality of lifeSuperior devices can help to: Improve therapy compliance Increased opportunities for prescription and drug reimbursement 
  10. 10. Mandatory Use of Safety Syringes Risk of Harm Remains Despite Strong EnforcementNeedlestick Injuries Caused by Syringes Among Hospital Workers in Massachusetts Sharps Injuries among Hospital Workers in Massachusetts 2002 - 2009. Massachusetts Sharps Injury Surveillance System 
  11. 11. The Unifill SyringeThe Leading Edge of our PortfolioOnly prefilled with integrated safety Automatic, user-controlled retractionUSP compliant materials in fluid pathIntegration into fill-finish systemsSimilar 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. 12. The Unifill SyringeReceived $40MM in payments from Sanofi since 2008Sanofi has exclusive right tonegotiate access in two drugclasses until mid-2014Initial production, sales underway Initial annual capacity 60MM units Additional lines 150MM capacity Initial sales for drug stability testAccelerating discussions withmultiple interested parties 
  13. 13. Customer-Driven Technology PipelineMost Complete Injectable Device Portfolio on the MarketRapid diversification of portfolioenabled by success with Unifill Primary drug containers with integrated safety features Patient self-injection Target organ deliveryDriven by unmet market needs Liquid stable or lyophilized drugs Differentiated delivery systems Can be customized to drug needs 
  14. 14. Unifill SelectOnly prefilled with attachable needles and integrated safetySuitable for filling with either the liquid stable or a diluent foruse with lyophilized drugs supplied in a vialAttachable needles up to 1 ½” in length 
  15. 15. Unifill EZMixOnly prefilled reconstitution syringe with integrated safetyDual or multiple drug containers in single glass barrelLeverages materials and proven technology of Unifill® syringeAddresses unmet patient safety needsHalf 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. 16. Patient Self-Injection SystemsUnifill 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. 17. Patient Self-Injection SystemsAutoInfusor™Only infusion pump system for drugs 5mL or larger in volumeSingle-use, disposable system worn by patient.Automatic drug infusion into subcutaneous tissue at push of buttonCan be pre-set for infusion times from minutes to hours in duration 
  18. 18. Novel Devices for Target Organ DeliverySpecialized high-value devices delivering drug to target organ Target organs may include brain, ear and eyePharmaceutical collaborations to develop unique drug-devicecombination products Device developed in parallel the pipeline drug Can help to enable the commercialization of a pipeline drugFirst organ delivery device scheduled to enter into clinicaltrials with pharmaceutical partner later this year 
  19. 19. Upcoming MilestonesUnifill Syringe Sales to current and additional pharmaceutical customers Placement of Unifill syringe onto drug stability studiesExpanded syringe portfolio Clinical development agreements (EZMix, Select, Auto-Injector) Commencement of initial salesOther Advanced Drug Delivery Systems Clinical development agreements (ie. organ delivery devices) Commencement of sales Continued expansion of proprietary portfolio 
  20. 20. SummaryAdvanced operational capabilities and expertise now in placeUnifill – world’s only prefilled syringes with integrated safety $40MM in payments from Sanofi, initial sales underwayDiversified product portfolio in direct response to unmet needsDiscussions with multiple customers across multiple areasAttractive model with long-term contracts and strong marginsRedefining fast-growing $10 billion injectable device market Targeting fastest-growing, highest-value device sectors Becoming intertwined with global injectable drug market 
  21. 21. Questions 