Unilife ($UNIS) - Jefferies Healthcare Conference

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Unilife Corp. (NASDAQ: UNIS; Stock Twits: $UNIS) is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication.

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Unilife ($UNIS) - Jefferies Healthcare Conference

  1. 1. Innovative Drug Delivery Device Solutions<br />Alan Shortall<br />Chief Executive Officer<br />Jefferies Global Healthcare Conference<br />June 6, 2011<br />
  2. 2. Cautionary Note Regarding Forward-Looking Statements <br />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.<br />2<br />
  3. 3. 3<br />Introducing Unilife<br />An emerging global leader for innovative drug delivery devices <br />Developedfullsafetysyringeportfoliowithbest-in-classfeatures<br />Unifill–the world’s only prefilled syringes with integrated safety <br />Game-changer for the fastest growing, most-profitable syringe market<br />Sanofi-aventispaid$40MMupfrontforaccess rights intwoclasses<br />Discussions accelerating with many other interested companies<br />Industrialization ahead of schedule, initial sales commence in July<br />Device portfolio now rapidly expanding, driven by customer need<br />Highly responsive business structure with a world-class team <br />
  4. 4. Our Business Strategy<br />Built upfront the operational capabilities to meet pharmaceutical device demands from clinical development to commercial sales<br />Addressing unmet customer needs with innovation and speed<br />Lead with Unifill, then expand into other advanced device areas<br />Focus on customized, differentiated (non-commodity) devices <br />Collaborating with our partners to develop the right device to deliver the right drug to the right patient, resulting in:<br />Long-term, preferred source supply contracts with high-margins<br />Revenue generating opportunities extending beyond product sales into exclusivity fees per therapeutic sub-class, and royalties<br />4<br />
  5. 5. State-of-the-Art Operational Capabilities<br /><ul><li>New 165,000sqf state-of-the-art production facility in York, PA
  6. 6. FDA-registered; meets stringent standards for primary drug containers
  7. 7. Designed for growth, with 400MM annual syringe capacity (stage one)
  8. 8. Offers customers a broad spectrum of services at one location
  9. 9. Automated assembly systems used to attain optimal quality</li></ul>5<br />
  10. 10. 6<br />Safety devices mandated in U.S. healthcare facilities to protect those at risk of needlestick injury; E.U. facilities now following <br />Reported needlestick injuries largely stable, despite enforcement<br />Needlestick Injuries Caused by Syringes Among Hospital Workers in Massachusetts<br />Sharps Injuries among Hospital Workers in Massachusetts 2002 - 2009. Massachusetts Sharps Injury Surveillance System<br />Mandatory Use of Safety Devices in Healthcare<br />
  11. 11. Proprietary Platform Syringe Technology<br />Core Features and Benefits<br /><ul><li>Fully integrated safety features
  12. 12. Passive activation of needle retraction mechanism
  13. 13. Optimal needlestick protection
  14. 14. Operator controlled withdrawal
  15. 15. Directly from body into barrel
  16. 16. No risk of aerosol (splatter)
  17. 17. Non-reusable / tamper-proof
  18. 18. Intuitive use, convenient disposal</li></ul>7<br />
  19. 19. 8<br />Pharmaceutical Market for Prefilled Syringes<br />Prefilled Syringes - Historical Demand and Forecast Growth*<br />Billions of prefilled units<br /><ul><li>The fastest-growing and most profitable syringe market
  20. 20. 2.4B prefilled syringes in 2010, 12% annual growth rate</li></ul>* Prefilled Syringes 2010 Greystone Associates <br />
  21. 21. Pharmaceutical Market for Prefilled Syringes<br />9<br />Selection of Marketed Prefilled Drugs by Therapeutic Class and Company<br />Number of Prefilled Drugs<br />
  22. 22. Unifill<br />Standard prefilled syringe (left) next to three attached with an ancillary safety product<br />Market Transitionto Prefilled Safety Syringes<br />10<br />
  23. 23. 11<br /><ul><li>World’s first and only prefilled syringes with integrated safety
  24. 24. Now in production
  25. 25. Controlled retraction into barrel
  26. 26. Needle locked after use for convenient, compact disposal</li></ul>Unifill – The Leading Edge of Our Portfolio<br />
  27. 27. Unifill as a Game Changer<br />Ancillary Safety Device<br />+<br />Direct Substitute<br />Unifill platform of prefilled safety syringes<br />Standard Prefill Syringe<br />Prefilled Safety Syringe<br /><ul><li>Capacity for Unifill platform to substitute entire prefilled market
  28. 28. Designed for integration into standard fill-finish lines
  29. 29. USP-compliant materials in the drug fluid path
  30. 30. Eliminates use of ancillary safety, minimal packaging volumes
  31. 31. Uniqueness makes it ideal for brand differentiation</li></ul>12<br />
  32. 32. 13<br />Innovative Devices Generating Differentiation for Drug<br /><ul><li>Patent cliff - 30 biologics with $51B sales expire by 2015
  33. 33. Intense competition between branded, generic and biosimilar drugs within many fast-growing therapeutic classes
  34. 34. Innovative devices with superior, value-adding features can:
  35. 35. Deliver powerful brand differentiation in competitive areas
  36. 36. Optimize (or extend) product drug and build market share
  37. 37. Generate unique claims that can obstruct generics</li></ul>Device-Led Brand Differentiation for Drugs<br />
  38. 38. 14<br />Sanofi paid $40MM for access rights to Unifill in classes of anti-thrombotic agents and vaccines until June 2014<br />Discussions now accelerating with multiple additional parties<br />Potential revenue generating opportunities for Unifill syringe include commercial sales, access fees and royalties<br />Unifill: A challenge most thought impossible<br />
  39. 39. Production Underway, Initial Sales Imminent<br />15<br />Initial sales to commence in July this year to multiple customers<br />Initial sales this year at relatively low volumes with high prices<br />Expected full optimization of 60MM unit line during 2012<br />
  40. 40. Market Trends Favoring Unilife’s Expansion<br />16<br />Specialized Drugs with Customized Devices<br />Large Molecule Biologics / Vaccines<br />Top 100 Drugs^ Small Molecules<br /><ul><li>R&D drug pipelines moving rapidly to large-molecule biologics
  41. 41. Require injection into patient (liquid form or reconstitution)
  42. 42. Pharmaceutical companies seeking devices that can be customized to specific needs of the drug and target patient</li></ul>^ Pfizer, EvaluatePharma<br />
  43. 43. 17<br />Patient Self-Administration of Injectable Drugs<br />Patient self-injection desirable<br />Reduced healthcare costs<br />Convenient to patient during use, portability and disposal<br />Adherence to self-treatment<br />Preference for prescribing<br />Device segments targeted at patient self-administration (right)<br />Market Trends Favoring Unilife’s Expansion<br />
  44. 44. Unilife earned a reputation for device innovation via Unifill syringe<br />Unifill platform now expanding into multiple product variants<br />PharmaceuticalleadersapproachingUnilifewithotherunmetneeds<br />Drug-specific collaborations from R&D thru to commercial sales<br />Multiple projects with multiple partners in multiple device areas<br />18<br />Customer-Driven Technology Pipeline<br />
  45. 45. Summary<br />19<br /><ul><li>Pharmaceutical demand for innovative, differentiated devices
  46. 46. Customized to meet specific needs of biologics and target patient
  47. 47. Unilife is an emerging leader for advanced drug delivery devices
  48. 48. Fully aligned to serve customer needs with speed and innovation
  49. 49. Unifill: the first and only prefill syringes with integrated safety
  50. 50. Significant commercial potential for broad array of injectable drugs
  51. 51. Arich, fast expanding portfolio being driven by customer need</li>

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