Cytori Therapeutics, Inc. <br />Nasdaq: CYTX<br />CitiBank Global Healthcare Conference<br />March 2, 2011<br />
Safe Harbor Statement<br />This presentation may contain certain ‘forward-looking statements’. All statements, other than ...
Enabling Practice of Regenerative Medicine<br />Real-time Access to a Patient’s Own Regenerative Cells<br />Unique Source<...
Device Process: Frees Cells Trapped in Adipose<br />Liposuction<br />Processing<br />Adipose Tissue<br />Adipose Derived R...
Multipotent cells
Endothelial cells
Vasc. smooth muscle cells
Tissue resident macrophages
Perivascular cells
Adipocytes
Multipotent cells
Endothelial cells
Vasc. smooth muscle cells
Tissue resident macrophages
Perivascular cells</li></li></ul><li>Adipose: Rich Source of Regenerative Cells<br />Number of Cells (millions) per 100 mL...
Goal:  Drive Cartridge Sales for Multiple Apps<br />Cardiovascular Disease<br />Plastic and Reconstructive Surgery<br />18...
Strong Partners Supporting Growth<br />Olympus (Japan): Manufacturing Joint Venture<br /><ul><li> Next-generation Celution
Hospital-based device
 Reside in OR, cath lab, or cell & tissue bank
 Available for ADVANCE trial
 Manufacturing expertise & service infrastructure
 Invested $55+mm</li></ul>Green Hospital Supply<br /><ul><li> Co-selling StemSource® Cell Banks in Asia</li></ul>GE Health...
 Received right-of-first refusal for liver disease partnership</li></li></ul><li>Global Sales and Development Organization...
What is the status of the Acute MI Study? <br />
Initiating Pivotal Study in Europe for AMI<br />Intracoronary delivery at point-of-care w/off the shelf catheter<br />Mean...
Compares to no change in placebo</li></ul>Improvement in other measures <br /><ul><li>LVEF difference of 5.7% (SPECT)
3.5 x greater perfusion improvement</li></ul>Initiated pivotal European study (ADVANCE)<br /><ul><li>Approx. 350 patients
Three arms: 20 MM cells, 30 MM cells, & placebo
Up to 35 centers
Started Jan 2011 (est.18-mo enrollment)</li></li></ul><li>Can you explain the chronic myocardial ischemia CE Mark applicat...
Sustained Long Term Functional Benefit<br />Direct injection into heart muscle using JNJ Noga Star catheter<br />MVO2:sign...
MVO2≤ 14 = 47%1 yr survival rate</li></ul>METS: significant change at 18 months<br />Infarct size: 8.2% change at 6 months...
Seeking Indication for Use in Europe for CMI <br />Functional data can support indication in “no-option” patients <br /><u...
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CYTX CitiBank 2010 Global Healthcare Conference

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CFO Mark Saad's presentation on March 2, 2011

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  • The Celution system is originally being marketed to 2 areas of regenerative medicine: reconstructive and aesthetic.The distinction of these two areas is in the location of the procedure and the general reimbursement of the procedure.
  • CYTX CitiBank 2010 Global Healthcare Conference

    1. 1. Cytori Therapeutics, Inc. <br />Nasdaq: CYTX<br />CitiBank Global Healthcare Conference<br />March 2, 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. Enabling Practice of Regenerative Medicine<br />Real-time Access to a Patient’s Own Regenerative Cells<br />Unique Source<br />Syringe of Cells <br />Point-of-Care System<br />≈1 Hour<br />Regenerative Cells Derived from Adipose Tissue (Fat)<br />
    4. 4. Device Process: Frees Cells Trapped in Adipose<br />Liposuction<br />Processing<br />Adipose Tissue<br />Adipose Derived Regenerative Cells<br /><ul><li>Adipocytes
    5. 5. Multipotent cells
    6. 6. Endothelial cells
    7. 7. Vasc. smooth muscle cells
    8. 8. Tissue resident macrophages
    9. 9. Perivascular cells
    10. 10. Adipocytes
    11. 11. Multipotent cells
    12. 12. Endothelial cells
    13. 13. Vasc. smooth muscle cells
    14. 14. Tissue resident macrophages
    15. 15. Perivascular cells</li></li></ul><li>Adipose: Rich Source of Regenerative Cells<br />Number of Cells (millions) per 100 mL of tissue (1/2 cup)<br />Implication: Real-time access to a patient’s own regenerative cells is possible<br />(No lengthy cell culture or manufacturing involved)<br />
    16. 16. Goal: Drive Cartridge Sales for Multiple Apps<br />Cardiovascular Disease<br />Plastic and Reconstructive Surgery<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 />
    17. 17. Strong Partners Supporting Growth<br />Olympus (Japan): Manufacturing Joint Venture<br /><ul><li> Next-generation Celution
    18. 18. Hospital-based device
    19. 19. Reside in OR, cath lab, or cell & tissue bank
    20. 20. Available for ADVANCE trial
    21. 21. Manufacturing expertise & service infrastructure
    22. 22. Invested $55+mm</li></ul>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 $7.00 per share    
    23. 23. Received right-of-first refusal for liver disease partnership</li></li></ul><li>Global Sales and Development Organization<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 />Japan & A/P<br />StemSource<br />PureGraft <br />10+ investigator studies<br />Europe & ME<br />Celution® System (Plastic Srg) <br />Celution System (Recon Srg)<br />PureGraft™<br />Chronic myo. ischemia submission (no option)<br />Acute MI trial underway<br />
    24. 24. What is the status of the Acute MI Study? <br />
    25. 25. Initiating Pivotal Study in Europe for AMI<br />Intracoronary delivery at point-of-care w/off the shelf catheter<br />Meaningful reduction in infarct size<br /><ul><li>LV infarct size cut in half in treated group
    26. 26. Compares to no change in placebo</li></ul>Improvement in other measures <br /><ul><li>LVEF difference of 5.7% (SPECT)
    27. 27. 3.5 x greater perfusion improvement</li></ul>Initiated pivotal European study (ADVANCE)<br /><ul><li>Approx. 350 patients
    28. 28. Three arms: 20 MM cells, 30 MM cells, & placebo
    29. 29. Up to 35 centers
    30. 30. Started Jan 2011 (est.18-mo enrollment)</li></li></ul><li>Can you explain the chronic myocardial ischemia CE Mark application? <br />
    31. 31. Sustained Long Term Functional Benefit<br />Direct injection into heart muscle using JNJ Noga Star catheter<br />MVO2:significant change at 18 months<br /><ul><li>MVO2 correlates to improved survival
    32. 32. 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 />Procedure safe and feasible through18-mo<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 />
    33. 33. Seeking Indication for Use in Europe for CMI <br />Functional data can support indication in “no-option” patients <br /><ul><li>Approx. 200,000 new CMI patients each year in Europe
    34. 34. Submit application in H1 2011
    35. 35. Unknown: If CMI indication-for-use would be catheter-specific</li></ul>Rollout<br /><ul><li>Patient registry for post-market data and reimbursement
    36. 36. Leverage ADVANCE trial sites
    37. 37. Seek to build targeted network of regional centers</li></ul>Patient criteria<br /><ul><li>Not eligible for revascularization
    38. 38. Not eligible for transplant </li></ul>Potential economics<br /><ul><li>Initially for private pay
    39. 39. Currently approx. 40 NOGA Star systems
    40. 40. Cartridge & procedure cost substantially lower than LVAD </li></li></ul><li>How are investigator-sponsored studies/academic hospital customers helping Cytori’s business? <br />
    41. 41. Celution: Discovering New Applications<br />Selling systems to researchers to develop new “apps”<br />Investigator-sponsored trials taking place worldwide<br />Radiation injury <br />SUI<br />Liver<br />Renal<br />Malignant wounds<br />Cardiomyopathy<br />Vocal cord paralysis <br />HIV therapy-induced soft tissue atrophy <br />Others <br />Link: Most indications involve restoring blood flow to damaged tissue <br />Cytori to select most-promising applications to advance or commercialize <br />
    42. 42. Celution: Discovering New Applications<br />Representative Investigator-Initiated Studies<br />Urinary Incontinence<br />Radiation Injury<br />Urethral Lumen<br />Pre-Celution<br />Treatment<br /><ul><li>5 males post radical prostatectomy
    43. 43. Moderate to severe Incontinence
    44. 44. Single treatment
    45. 45. All improved</li></ul>10 weeks<br />Post-Celution<br />Treatment<br />Dr. Gotoh<br />Nagoya, Japan<br />
    46. 46. What is the relevance of the new breast reconstruction developments? <br />
    47. 47. RESTORE Procedure for Breast Reconstruction<br />‘Cell-Enriched <br />Graft’<br />Treatment not complete until reconstruction<br />Hospital-based procedure and call point <br />Limited options for lumpectomy patients<br />Favorable reimbursement environment<br />Cells: improve “ischemic” state<br />$43<br />$73<br />$128<br />Cells<br />Fat<br />$163<br />$76<br />$126<br />Clinical<br />Clinical<br />Clinical<br />Partner<br />Partner<br />Partner<br />
    48. 48. Restore 2 Results Show Long-Term Success<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)
    49. 49. 75% pt satisfaction on (12-mo)
    50. 50. Improvement in scar, pigmentation, symmetry and defect index (6-Mo):
    51. 51. 2.8 to 3.9 in ptassessment (0-5 scale)
    52. 52. 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 />
    53. 53. Data and Approval to Support Growth <br />Key developments to support breast recon demand <br /><ul><li>Expanded indications in July 2010
    54. 54. RESTORE-2 complete results (announced today)</li></ul>Can improve hospital economics <br /><ul><li>Reduced procedure time
    55. 55. Minimally invasive
    56. 56. Short recovery </li></ul>Initial Sales Focus to be targeted<br /><ul><li>France, Germany, Italy, Spain, Switzerland, and UK
    57. 57. Pursue reimbursement on regional basis</li></ul>Implementing sales growth initiatives with new data <br /><ul><li>To be marketed under The RESTORE Procedure
    58. 58. Support patient awareness/education (www.cellreconstruct.eu)
    59. 59. Directed efforts toward surgeons (Cytori Exchange) </li></li></ul><li>How does PureGraft Impact the Business?<br />
    60. 60. Supplemental Product: PureGraft™ Natural Fill<br />Optimizes fat graft prep<br />Worldwide approval<br />Complements Celution® (EU)<br />Celution lead qualifier (EU)<br />Stand-alone product in US <br /> Convert users to Celution® upon U.S. clearance<br /> Point-of-Entry: Building out US sales team (6 direct reps)<br />Targets $1.7 bb dermal fill mkt<br />46K annual fat- grafting procedures in U.S. and growing<br />
    61. 61. Supplemental Product: PureGraft™ Natural Fill<br />Fat grafting is growing trend in plastic surgery<br />Ideally suited for low cost consumer awareness campaign<br /> TV, print and radio outreach around customers<br />Distributor model <br />Sound Surgical is first in the US <br />Multiple in Europe <br />Minimal training requirements <br />1000 + shipped from Q2 2010 launch to YE 2010<br />
    62. 62. When is the Olympus device available? <br />
    63. 63. Celution One: Next Generation Product<br />Commercially available in Europe in 2011<br />Hospital-based system<br />First system installed for ADVANCE<br />Recon<br />Formula transfer price<br />Cardiac<br />Other Apps<br />Manufacturing JV<br />Commercial rights<br />
    64. 64. How strong is the IP?<br />
    65. 65. Barriers-to-Entry<br />Knowledge-based barriers to entry:<br /><ul><li>Intellectual Property: patents, trade secrets, know-how
    66. 66. 30 issued patents/100 pending</li></ul>Economics-based barriers to entry:<br /><ul><li>Exclusive supply chains for critical components, e.g., Celase
    67. 67. Long-term partnerships: fund development enforce IP, e.g., Olympus</li></ul>Brand based-barriers to entry:<br /><ul><li>Set the standard/establish operating system
    68. 68. Create customer loyalty with quality product and service
    69. 69. Protect, use and enforce trademarks </li></li></ul><li>Barriers-to-Entry: 30 Patents, 100 + Pending<br />
    70. 70. Summary<br />
    71. 71. Strengthened Balance Sheet, Growing Business<br />Cash: $60 million pro forma<br /><ul><li>Cash (9/30/10): $30.7 M
    72. 72. Equity Raise (Oct. 10): $19.3 M
    73. 73. Strategic Equity (Dec. 10): $10 M investment from Astellas</li></ul>Long-term Debt: $20 million (GE/SVB/Oxford term loan)<br />Shares Outstanding: 53 million as adjusted <br />Revenue Growth<br />30<br />
    74. 74. Upcoming Catalysts<br />Growth in commercial reconstructive and aesthetics business<br /><ul><li>RESTORE 2 data to support European/Asia Pacific sales</li></ul>Increase installed base / consumable usage & orders<br />Sales force shift toward hospitals with recon indications<br />Pursue reimbursement <br />Development Pipeline<br /><ul><li>Initiate ADVANCE </li></ul>Seek no-option chronic ischemia approval<br />Report 18-Mo APOLLO data<br />US clinical and regulatory progress<br />Corporate<br />Continue partnering discussions <br />31<br />
    75. 75. Enable the Practice of Regenerative Medicine<br />Two areas of focus address ischemic diseases, millions of patients <br /><ul><li>Heart disease
    76. 76. Cosmetic and reconstructive surgery (CRS)</li></ul>Selling approved products today <br /><ul><li>CRS could achieve profitability
    77. 77. Supports pipeline development</li></ul>Razor/razorblade model: <br /><ul><li>Favorable economics can impact demand
    78. 78. High margin consumables</li></ul>Strong Barriers-to-entry<br /><ul><li>30 patents worldwide with long life
    79. 79. Know-how, first mover, and $250 mm invested </li></ul>$60 MM (pro forma) in cash as of 9/30/10<br />Upcoming catalysts to support sales and advance pipeline<br />32<br />
    80. 80. Thank You<br />

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