CYTX BioCentury Future Leaders in the Biotech Industry Presentation


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Dr. Marc Hedrick's presentation at the BioCentury Future Leaders in the Biotech Industry presentation on April 15, 2011

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CYTX BioCentury Future Leaders in the Biotech Industry Presentation

  1. 1. Cytori Therapeutics, Inc. <br />NASDAQ: CYTX<br />BioCentury Future Leaders<br />Marc H. Hedrick, MD, President<br />April 15, 2011<br />
  2. 2. Safe Harbor Statement<br />This presentation may contain certain ‘forward-looking statements’. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. <br />The forward-looking statements included in this presentation are also subject to a number of material risks and uncertainties. We caution investors not to place undue reliance on the forward-looking statements contained in this presentation. <br />We would advise reading our annual report filed with the United States Securities and Exchange Commission on Form 10-K for a more detailed description of these risks.<br />
  3. 3. <ul><li>Business Overview
  4. 4. Cardiovascular Pipeline
  5. 5. Customers Developing New “Apps”
  6. 6. Cosmetic & Reconstruction Commercialization
  7. 7. Barriers to Entry
  8. 8. Summary</li></li></ul><li>Cytori Regenerative Medicine Platform Technology<br />Real-time Access to a Patient’s Own Regenerative Cells<br />Unique ‘Scalable’ Source<br />Powerful Cell Mixture <br />Point-of-Care Platform<br />Regenerative Cells from Adipose Tissue (Fat)<br />≈1 Hour<br />
  9. 9. Device Business Model: Regenerative Cells from Fat<br />Key Attributes of Adipose Derived Regenerative Cells<br />Mixed Cell Population<br />Potency<br />High Cell Number<br />million/100cc<br /><ul><li>No Adipocytes
  10. 10. Multipotent cells
  11. 11. Endothelial cells
  12. 12. Vasc. smooth muscle cells
  13. 13. Tissue resident macrophages
  14. 14. Perivascular cells</li></li></ul><li>Key Business Driver: Consumable Cartridge Sales <br />Cardiovascular Disease<br />Plastic and Reconstructive Surgery<br />Single Use Consumable<br />18K potential customers<br />1 consumable per day <br />6 mm + consumables/year<br />Cell & Tissue Storage<br />Open Op System: ID new “Apps” and Fuel Pipeline<br />
  15. 15. Strong Partnerships & Commercial Network<br />Olympus (Japan): Manufacturing Joint Venture<br /><ul><li> Next-generation Celution
  16. 16. Available for ADVANCE trial
  17. 17. Invested $55 + mm</li></ul>SHIP Holding (Green Hospital Supply)<br /><ul><li> Co-selling StemSource® Cell Banks in Asia</li></ul>GE Healthcare<br /><ul><li> Co-distribute Celution & StemSource in select countries </li></ul>AstellasPharmaceuticals <br /><ul><li> $10 mm equity investment at market premium    
  18. 18. Right-of-first refusal for hepatic disease partnership</li></li></ul><li>Current Global Commercial Activity<br />Frankfurt(logistics)<br />Tokyo(sales)<br />San Diego(HQ)<br />Zug (sales)<br />North America<br />PureGraft<br />StemSource<br />Planned clinical trials<br />Europe & ME<br />Celution System <br />PureGraft<br />Celution CV<br />ADVANCE Acute MI trial<br />Japan & A/P<br />StemSource<br />Celution<br />PureGraft<br />10+ investigator studies<br />
  19. 19. <ul><li>Business Overview
  20. 20. Cardiovascular Pipeline
  21. 21. Customers Developing New “Apps”
  22. 22. Cosmetic & Reconstruction Commercialization
  23. 23. Barriers to Entry
  24. 24. Summary</li></li></ul><li>Cardiac Repair Overview<br />CV Trial Design<br />Multi-center, double-blind, placebo-control <br />Intracoronary and myocardial cell injections safe<br />Strong and consistent efficacy signals <br />Predictors of long-term outcomes improved<br />Two Completed Celution® pilot studies in Europe<br />Chronic myocardial ischemia: PRECISE Trial<br />Seeking CE Mark in “no-option” patients<br />Acute MI(Heart Attack): APOLLO Trial<br />Pivotal EU approval study underway<br />
  25. 25. No Option Chronic Myocardial Ischemia<br />PRECISE Pilot: Intramuscular injection using JNJ Noga Star catheter<br />MVO2:significant change at 18 months<br /><ul><li>MVO2 correlates to improved survival
  26. 26. MVO2≤ 14 = 47% 1 yr survival rate</li></ul>METS: significant change at 18 months<br />Infarct size: 8.2% change at 6 months<br />Lower cardiac mortality rate<br /><ul><li>At avg. follow up of 28 months: </li></ul> - 2/6 placebo pts died of cardiac causes <br /> - 1/21 treated pts died of cardiac causes<br />
  27. 27. No Option Chronic Myocardial Ischemia<br />Potentially sufficient functional improvement for limited ‘no-option’ indication<br /><ul><li>Approx. 200,000 new CMI patients each year in Europe
  28. 28. Notified body submission- H1 2011 </li></ul>Patient criteria<br /><ul><li>No option- not eligible for revascularization, pre transplant</li></ul>Market introduction<br /><ul><li>Patient registry for post-market data and reimbursement
  29. 29. Leverage 30+ ADVANCE trial sites
  30. 30. Build targeted network of regional centers, NOGA sites</li></ul>Economics<br /><ul><li>Cartridge & procedure cost lower than assist devices
  31. 31. Initial: self pay, open coding, new technology payments
  32. 32. Future: Precise + registry = DRG
  33. 33. $200 MM annual est. market (10% of market @ $10,000/cartridge (Est. $5k-10k/cartridge) </li></li></ul><li>ADVANCE: Pivotal EU Trial for Transmural AMI<br />‘Virtual off the shelf’ @ point-of-care<br />APOLLO- Reduced infarct size<br /><ul><li>LV infarct size cut in half in treated group
  34. 34. LVEF difference of 5.7% (SPECT)
  35. 35. 3.5x improvement perfusion
  36. 36. No change in placebo</li></ul>ADVANCE- European pivotal study<br /><ul><li>Approx. 350 patients
  37. 37. Three arms: 20 MM cells, 30 MM cells, & placebo
  38. 38. Up to 35 centers
  39. 39. Enrolling as of Jan 2011 (est.18-24 mo enrollment)</li></li></ul><li><ul><li>Business Overview
  40. 40. Cardiovascular Pipeline
  41. 41. Customers Developing New “Apps”
  42. 42. Cosmetic & Reconstruction Commercialization
  43. 43. Barriers to Entry
  44. 44. Summary</li></li></ul><li>Celution: Discovering New Applications<br />Sold systems/cartridges to researchers to develop new “apps” <br />Cytori selects most promising applications to develop/commercialize <br />- First example is breast reconstruction<br />Current investigator-sponsored trials<br /><ul><li>Radiation injury
  45. 45. SUI
  46. 46. Liver
  47. 47. Renal
  48. 48. Malignant wounds
  49. 49. Cardiomyopathy
  50. 50. Vocal cord paralysis
  51. 51. HIV therapy-induced soft tissue atrophy
  52. 52. Others </li></ul>Common theme: Acute or chronic ischemic tissue<br />
  53. 53. Celution: Discovering New Applications<br />Two Investigator-Initiated Studies<br />Radiation Injury<br />Urinary Incontinence<br />Urethral Lumen<br />Pre-Celution<br />Treatment<br /><ul><li>5 males post radical prostatectomy
  54. 54. Moderate to severe Incontinence
  55. 55. Single treatment
  56. 56. All improved</li></ul>10 weeks<br />Post-Celution<br />Treatment<br />Nagoya & Nagasaki, Japan<br />
  57. 57. <ul><li>Business Overview
  58. 58. Cardiovascular Pipeline
  59. 59. Customers Developing New “Apps”
  60. 60. Cosmetic & Reconstruction Commercialization
  61. 61. Barriers to Entry
  62. 62. Summary</li></li></ul><li>Cytori Technology for Breast Reconstruction<br />RESTORE Procedure<br />Breast conservation = std of care<br />Reconstruction post BCT = un-met need<br />Favorable economics<br />Strong record clinical success<br />Cells in graft counteract radiation effects<br />‘Cell-Enriched <br />Graft’<br />Cells<br />Fat<br />$43<br />$73<br />$128<br />$163<br />$76<br />$126<br />Clinical<br />Clinical<br />Clinical<br />Partner<br />Partner<br />Partner<br />
  63. 63. RESTORE II- 6 and 12 Month Data<br />Post-Marketing Study Design<br /><ul><li>Prospective 71 patient study</li></ul>Co-Primary Endpoints<br /><ul><li>Physicians and patient satisfaction with functional and cosmetic results and improvement in overall breast deformity</li></ul>Results<br /><ul><li>85% phys satisfaction (12-mo)
  64. 64. 75% pt satisfaction on (12-mo)
  65. 65. Improvement in scar, pigmentation, symmetry and defect index (6-Mo):
  66. 66. 2.8 to 3.9 in ptassessment (0-5 scale)
  67. 67. 3.1 to 4.1 in phys. assessment (0-5 scale)</li></ul>Binary patient and physician satisfaction with treatment results at 6- and 12-months <br />19<br />
  68. 68. EU Market Analysis for Restore Procedure<br />Ex. 1- Based on EU Hospital Penetration<br />Ex. 2- Based on UK Patient Adoption<br />2,000<br />Procedures/Year<br />Number of Hospitals<br />Note- Backlog: 2 mm patients<br />1 System in 10% of hospitals using 1 consumable/day = $146 MM <br />UK only- 10% penetration of incidence = $25 MM/year<br />
  69. 69. EU Breast Reconstruction Commercialization<br />Approved Therapy in Europe<br /><ul><li>Regulatory- clinical indication for reconstruction in July 2010
  70. 70. RESTOREII, phase IV trial- full 6 month and top-line 12 month data</li></ul>Favorable market dynamics and economics<br /><ul><li>Unmet need
  71. 71. Minimally invasive , out-patient
  72. 72. Cost savings</li></ul>Targeted Launch coincidence with Celution ONE Approval<br /><ul><li>Q2 2011
  73. 73. NICE evaluation
  74. 74. France, Germany, Italy, Spain, Switzerland, and UK
  75. 75. Pursue reimbursement on regional basis
  76. 76. Marketed under name RESTORE Procedure
  77. 77. Support patient awareness/education (
  78. 78. Directed efforts toward surgeons (Cytori Exchange) </li></li></ul><li>Natural Breast Augmentation<br />Initial product introduction early 2008 in Europe and Asia Pacific<br />
  79. 79. Supplemental Product: PureGraft™ Natural Fill<br />Fat grafting market growth<br />100K fat-graft cases/yr in US, EU each<br />Product attributes <br />Optimizes, dialyzes fat graft (for non-cell enriched) <br />Complements Celution (EU)<br />Celution lead qualifier (EU)<br />US and European approval <br />Low cost consumer awareness campaign<br /><ul><li>TV, print and radio outreach around customers</li></ul>Distributor model <br /><ul><li>Sound Surgical is first in the US
  80. 80. Multiple in Europe
  81. 81. Minimal training requirements </li></ul> units shipped in 2010 since Q2 launch (1,000 + in Q4)<br />
  82. 82. Commercial Performance: Systems and Consumables<br />Consumable Growth<br />Growing Installed Base<br />
  83. 83. Commercial Performance: Revenue<br />
  84. 84. <ul><li>Business Overview
  85. 85. Cardiovascular Pipeline
  86. 86. Customers Developing New “Apps”
  87. 87. Cosmetic & Reconstruction Commercialization
  88. 88. Barriers to Entry
  89. 89. Summary</li></li></ul><li>Barriers-to-Entry<br />Knowledge-based barriers to entry:<br /><ul><li>31 issued patents/100 pending
  90. 90. Intellectual Property: patents, trade secrets, know-how </li></ul>Economics-based barriers to entry:<br /><ul><li>Exclusive supply chains for critical components, e.g., Celase
  91. 91. Long-term partnerships: fund development enforce IP, e.g., Olympus</li></ul>Commercial based-barriers to entry:<br /><ul><li>Set the standard/establish operating ecosystem
  92. 92. Branding
  93. 93. Create customer loyalty with quality product and service
  94. 94. Protect, use and enforce trademarks
  95. 95. Marketing support </li></ul>27<br />
  96. 96. <ul><li>Business Overview
  97. 97. Cardiovascular Pipeline
  98. 98. Customers Developing New “Apps”
  99. 99. Cosmetic & Reconstruction Commercialization
  100. 100. Barriers to Entry
  101. 101. Summary</li></li></ul><li>Celution One: Next Generation Product<br />Commercially available in Europe in 2011<br />Hospital-based system- Restore Procedure<br />ADVANCE Study, CV therapy<br />Recon<br />Formula transfer price<br />Cardiac<br />Other Apps<br />Manufacturing JV<br />Commercial rights<br />
  102. 102. Strengthened Balance Sheet, Growing Business<br />Cash: $52.7 million (12/31)<br /><ul><li>Includes $10 MM strategic equity deal with AstellasPharma (Dec. 10)</li></ul>Long-term Debt: $20 million (GE/SVB/Oxford term loan)<br />Shares Outstanding: 52 million<br />Revenue Growth<br />
  103. 103. Near Term Catalysts<br />Growth in commercial reconstructive and aesthetics business<br />Full RESTORE 2 data set presented<br />Breast augmentation investigator study publication, ENHANCE<br />Celution ONE- EU launch into Breast Recon/ OR market<br />Expanded sales team and reimbursement <br />PG approval Japan<br />Growing sales and device placements<br />Celgraft launch<br />Development Pipeline<br /><ul><li>Initiate ADVANCE and site activation</li></ul>Report 18-Mo APOLLO data<br />Potential approval and launch Celution ONE for no-option ischemia<br />US clinical and regulatory milestones<br />Partner expansion<br />
  104. 104. Thank You<br />