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CYTX OneMedForum Investor Talk


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View Cytor's Jan 2011 investor presentation.

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CYTX OneMedForum Investor Talk

  1. 1. Cytori, Inc. (Nasdaq: CYTX) Investor Presentation: OneMedForum January 11, 2011 Christopher J. Calhoun Chief Executive Officer
  2. 2. Safe Harbor Statement <ul><li>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. </li></ul><ul><li>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. </li></ul><ul><li>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. </li></ul>
  3. 3. Cytori’s Vision: Enable Regenerative Medicine <ul><li>Medical devices for regenerative medicine </li></ul><ul><li>Real-time access to stem and regenerative cells from fatty tissue. </li></ul><ul><li>Ischemic conditions: Soft tissue repair, heart disease & others </li></ul>
  4. 4. Business Overview Product Revenue Growth <ul><li>Razor/razorblade business model </li></ul><ul><li>Near-term revenue growth drivers : Approved </li></ul><ul><li>and selling products throughout U.S. and ROW </li></ul><ul><li>Long-term opportunity : Planned & ongoing trials to expand Celution labeling for cardiovascular disease </li></ul><ul><li>Financial stability </li></ul><ul><li>$60 million pro forma cash (end of Q3 2010) </li></ul><ul><li>Significant Market Opportunity </li></ul><ul><li>Cardiovascular repair: multi-billion worldwide market </li></ul><ul><li>Reconstruction/augmentation: $2B + worldwide </li></ul><ul><li>Other opportunities to expand Celution labeling </li></ul>$ Millions
  5. 5. Recent Highlights <ul><li>Increasing installed-based of Celution® System </li></ul><ul><li>Increased 34% year-to-date </li></ul><ul><li>Expanded CE Mark (July ‘10): reconstructive & wounds </li></ul><ul><li>Reimbursement expected to accelerate sales growth </li></ul><ul><li>European post-marketing study complete results H1 ‘11 </li></ul><ul><li>Initiating approval heart attack trial Q1 2011 </li></ul><ul><li>Strategic equity agreement with Astellas Q4 2010 </li></ul><ul><li>$10M including liver partnership right of first refusal </li></ul><ul><li>Completed $20 MM secondary offering October 2010 </li></ul>Revenue Generating Units (Cumulative)
  6. 6. Regenerative Medicine Evolution Treatment Evolution Nothing Devices Drugs Transplants Regenerative Medicine Cell Therapy Introducing new cells into a tissue to treat a disease <ul><li>Embryonic </li></ul><ul><li>Controversial </li></ul><ul><li>few patients treated </li></ul><ul><li>Expensive COGS </li></ul><ul><li>Donor only </li></ul><ul><li>Biologic dev. path </li></ul>Adult Stem Cells (Bone Marrow, Adipose Fat Tissue) Regenerative Medicine The process of creating living, functional tissues to repair or replace tissue or organ function lost due to damage, or congenital defects . <ul><ul><ul><ul><ul><li>Cytori has ONLY medical device that allows for the extraction and re-injection of adipose tissue-derived stem and regenerative cells (ADRC) </li></ul></ul></ul></ul></ul><ul><li>Adipose </li></ul><ul><li>On Market </li></ul><ul><li>path700+ pt treated </li></ul><ul><li>Viable biz. Model </li></ul><ul><li>Donor or autologous </li></ul><ul><li>Device-based </li></ul><ul><li>Bone Marrow </li></ul><ul><li>Difficult to Access </li></ul><ul><li>Expensive COGS </li></ul><ul><li>Donor or autologous </li></ul><ul><li>Biologic dev. path </li></ul>
  7. 7. Cytori’s Approach Cardiovascular Breast Reconstruction Facial Rejuvenation Additional Indications (including radiation injury, urinary incontinence, wound repair) Process Applications Adipose: rich source for stem and regenerative cells Cells available for re-injection in same surgical procedure Adipose tissue processed at point-of-care
  8. 8. Commercial Business Providing Solutions for the “ Future” of Medicine “Today”
  9. 9. Celution® System Sale of system: $100,000 – 220,000 Recurring revenue: $2,500* per-case cartridge * ASP for medical procedures expected to be $5,000 +
  10. 10. Celution® Cell-Enriched Fat Graft $43 $76 Clinical Partner $73 $126 Clinical Partner $128 $163 Clinical Partner Cells Fat ‘ Cell-Enriched Graft’
  11. 11. <ul><li>European approval July 2010 </li></ul><ul><li>Hospital-based procedure and call point </li></ul><ul><li>Seeking reimbursement </li></ul><ul><li>Last-Patient / Last Visit Nov 2010 </li></ul><ul><li>Complete results H1 2011 </li></ul><ul><li>Post-marketing RESTORE-2 study </li></ul><ul><li>82% physician satisfaction </li></ul><ul><li>73% patient satisfaction </li></ul><ul><li>Improvement in scar, pigmentation, symmetry and defect index: </li></ul><ul><li>+ 2.8 to 3.9 in patient assessment (0-5 scale) </li></ul><ul><li>+ 3.1 to 4.1 in physician assessment (0-5 scale) </li></ul>Soft Tissue Application: Reconstruction Celution® Cell-Enriched Fat Graft
  12. 12. Initial product introduction early 2008 in Europe and Asia Pacific Soft Tissue Application: Aesthetic Celution® Cell-Enriched Fat Graft
  13. 13. Supplemental Product Line: PureGraft™: Natural Filler Application <ul><li>Optimizes preparation of autologous fat graft </li></ul><ul><li>Worldwide approval </li></ul><ul><li>Complements Celution® in Europe </li></ul><ul><li>Optimizes prep of fat graft </li></ul><ul><li>Celution® lead qualifier </li></ul><ul><li>Stand-alone product in US </li></ul><ul><li>Convert users to Celution® upon U.S. clearance </li></ul><ul><li>Point-of-Entry: Building out US sales team (6 direct reps) </li></ul><ul><li>Addresses $1.7 billion dermal fill market; </li></ul><ul><li>46K annual fat- grafting procedures in U.S. and growing </li></ul>
  14. 14. Supplemental Product Line: StemSource Cell & Tissue Bank <ul><li>Complements plastic surgery practices </li></ul><ul><li>Liposuction customer candidates </li></ul><ul><li>Captures patient retention </li></ul><ul><li>Revenue source </li></ul><ul><li>Worldwide product offering </li></ul><ul><li>System </li></ul><ul><li>Cryopreservation chamber tools </li></ul><ul><li>Proprietary protocol, software, database </li></ul><ul><li>Distribution network </li></ul><ul><li>GE Healthcare: EU, North America </li></ul><ul><li>Green Hospital Supply (Japan, Thailand, Taiwan, Korea) </li></ul><ul><li>Current banking customers in Europe, Japan and U.S. </li></ul>
  15. 15. Near-Term Growth Driver: Soft Tissue Repair <ul><li>Celution product sales: CE Mark designation </li></ul><ul><li>Access to 2/3 worldwide market </li></ul><ul><li>Cosmetic surgery clinics </li></ul><ul><li>Hospitals for breast cancer reconstruction </li></ul><ul><li>July 2010: Expanded CE Mark for reconstructive surgery </li></ul><ul><li>RESTORE-2 final results expected H1 2011 </li></ul><ul><li>Intended to support reimbursement efforts </li></ul><ul><li>Expanding sales force footprint </li></ul><ul><li>16 direct sales and marketing worldwide </li></ul><ul><li>Distributors covering select countries in EU and AP </li></ul>Celution Consumable Shipments (cumulative)
  16. 16. Soft Tissue: International Launch & Expansion <ul><ul><li>Celution® System: </li></ul></ul><ul><ul><ul><li>Sales team to focus on hospitals </li></ul></ul></ul><ul><ul><ul><li>Emphasis: breast reconstruction </li></ul></ul></ul><ul><ul><ul><li>Focus geographies: UK, Italy, & Germany </li></ul></ul></ul><ul><ul><ul><li>GE Healthcare complements direct sales </li></ul></ul></ul><ul><ul><ul><li>RESTORE 2 post-marketing study </li></ul></ul></ul><ul><ul><ul><li>Reimbursement </li></ul></ul></ul><ul><ul><li>PureGraft™ </li></ul></ul><ul><ul><li>Complements Celution® customer’s procedures </li></ul></ul><ul><ul><li>Rely on distributors </li></ul></ul><ul><ul><li>Incentivize distributors to generate Celution® leads </li></ul></ul>Potential System & Consumable Market in the 27 CE Mark Countries Total Hospitals 2,000 Total Breast Recon Procedures/Year *Backlog: 2 MM + patients
  17. 17. Revenue Growth $ Millions
  18. 18. Celution ® Applications under Development
  19. 19. Long-Term Opportunity: Cardiovascular <ul><li>Completed Celution® safety and feasibility studies </li></ul><ul><li>Acute myocardial infarction (Heart Attack) </li></ul><ul><li>Chronic myocardial ischemia (severe form of CHF) </li></ul><ul><li>Design & Outcomes </li></ul><ul><li>Multi-center, double-blind, placebo-controlled </li></ul><ul><li>Demonstrated safety of injection of Celution-derived stem and reg. cells </li></ul><ul><li>Strong and consistent efficacy signals in acute and chronic heart disease </li></ul><ul><li>Improved endpoints are key prognosticators of long-term outcomes </li></ul>
  20. 20. Acute Myocardial Infarction (AMI) (APOLLO Trial – pilot study) <ul><li>Meaningful reduction in infarct size </li></ul><ul><li>Entire cohort of patients </li></ul><ul><ul><li>32% to 15% in treated group </li></ul></ul><ul><ul><li>No change in untreated group </li></ul></ul><ul><li>Matched pair </li></ul><ul><ul><li>5.1% greater reduction in treated </li></ul></ul><ul><li>5.7% improvement in LVEF (SPECT) </li></ul><ul><li>3.5 x greater perfusion improvement </li></ul>
  21. 21. Cardiovascular: Next Steps <ul><li>Initiate pivotal AMI Study in Europe (ADVANCE) </li></ul><ul><li>Approx. 350 patients </li></ul><ul><li>Three arms: 20 MM cells, 30 MM cells, & placebo </li></ul><ul><li>Up to 35 centers </li></ul><ul><li>Utilize Celution® One </li></ul><ul><li>To begin Q1 2011 </li></ul><ul><li>Add other vascular indications: </li></ul><ul><li>Chronic Heart Disease </li></ul><ul><li>Peripheral Vascular Disease </li></ul><ul><li>Others </li></ul>
  22. 22. Chronic Heart Disease (CHD) (PRECISE Trial – pilot study) <ul><li>MVO 2 :significant change at 18 months </li></ul><ul><li>MVO 2 correlates to improved survival </li></ul><ul><li>MVO 2 ≤ 14 = 47%1 yr survival rate </li></ul><ul><li>METS: significant change at 18 months </li></ul><ul><li>Infarct size: 8.2% change at 6 months </li></ul><ul><li>Celution® procedure safe and feasible through18-months </li></ul><ul><li>Lower cardiac mortality rate: </li></ul><ul><li>At avg. follow up of 28 months: </li></ul><ul><li>- 2/6 placebo pts died of cardiac causes </li></ul><ul><li>- 1/21 treated pts died of cardiac causes </li></ul>
  23. 23. Strong R&D Pipeline <ul><li>Initiate pivotal AMI Study in Europe (ADVANCE) </li></ul><ul><li>Investigator-sponsored trials </li></ul><ul><ul><li>SUI </li></ul></ul><ul><ul><li>Liver </li></ul></ul><ul><ul><li>Renal </li></ul></ul><ul><ul><li>Malignant wounds </li></ul></ul><ul><ul><li>Cardiomyopathy </li></ul></ul><ul><ul><li>Vocal cord paralysis </li></ul></ul><ul><ul><li>HIV therapy-induced soft tissue atrophy </li></ul></ul><ul><ul><li>Others </li></ul></ul><ul><li>Celution® One: Next-generation product </li></ul><ul><ul><li>Available for ADVANCE heart attack trial </li></ul></ul><ul><ul><li>Manufacturing expertise </li></ul></ul><ul><ul><li>Service infrastructure </li></ul></ul><ul><ul><li>Committed Partner: invested $55+mm </li></ul></ul>
  24. 24. Balance Sheet Highlights <ul><li>Cash: $60 million pro forma (less Q4 2010 burn) </li></ul><ul><ul><li>Cash (9/30/10): $30.7 M </li></ul></ul><ul><ul><li>Equity Raise (Oct. 10): $19.3 M </li></ul></ul><ul><ul><li>Strategic Equity (Dec. 10): $10 M investment from Astellas Pharma </li></ul></ul><ul><li>Long-term Debt: $20 million (GE/SVB/Oxford term loan) </li></ul><ul><li>Shares Outstanding: 52 million as adjusted </li></ul>
  25. 25. Key Takeaways <ul><li>Providing solutions for the “Future” of medicine “Today” </li></ul><ul><li>Near-term system and consumable revenue growth driven by soft tissue </li></ul><ul><li>Recent approvals, expanded indications, and pursuing reimbursement </li></ul><ul><li>Enormous opportunity in ischemic conditions </li></ul><ul><li>Strong partners/investors: GE Healthcare, Olympus, Green Hospital, Astellas </li></ul><ul><li>Strong balance sheet </li></ul>
  26. 26. Upcoming Milestones <ul><li>Growth in commercial reconstructive and aesthetics business </li></ul><ul><li>Increase installed base / consumable usage & orders </li></ul><ul><li>Sales force shift toward hospitals with recon indications </li></ul><ul><li>RESTORE 2 data to support European/AP sales </li></ul><ul><li>Pursue reimbursement </li></ul><ul><li>Distributor model in EU for PureGraft </li></ul><ul><li>Up-sell Celution to high volume PureGraft users </li></ul><ul><li>Development Pipeline </li></ul><ul><li>Initiate ADVANCE </li></ul><ul><li>Seek no-option chronic ischemia approval </li></ul><ul><li>Report 18-Mo APOLLO data </li></ul><ul><li>US clinical and regulatory progress </li></ul><ul><li>Corporate </li></ul><ul><li>Continue partnering discussions </li></ul>
  27. 27. Thank You Investor Presentation: OneMedForum January 11, 2011 Christopher J. Calhoun Chief Executive Officer