Cytori Therapeutics. (NASDAQ: CYTX) Lazard Capital Markets 8th Annual Healthcare Conference November 16, 2011 Mark E. Saad, Chief Financial Officer

Size: px
Start display at page:

Download "Cytori Therapeutics. (NASDAQ: CYTX) Lazard Capital Markets 8th Annual Healthcare Conference November 16, 2011 Mark E. Saad, Chief Financial Officer"

Transcription

1 Cytori Therapeutics (NASDAQ: CYTX) Lazard Capital Markets 8th Annual Healthcare Conference November 16, 2011 Mark E. Saad, Chief Financial Officer 1

2 Safe Harbor Statement 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. 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. 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. 2

3 Investment Summary Large pipeline opportunity EU chronic ischemia approval EU acute heart attack pivotal trial US chronic ischemia pilot trial EU breast reconstruction reimbursement Japan breast reconstruction approval Near term commercial business potential Building for profitable growth Soft tissue and translational research Grow in select emerging markets Established partnerships and potential future licensing $100 MM + in funding to Cytori Multiple development and commercialization partnership prospects Patent protection into mid-2020s and beyond 3

4 Investment Opportunity Regenerative cells in the operating room in real-time About one hour Soft Tissue Repair Cytori Celution System Regenerative cells Cardiovascular Disease Celution currently approved in Europe Scalable platform System/Consumable model 35+ issued patents 4

5 Adipose Tissue: Ideal Source for Cell Therapy Adipose Tissue: Richest source of regenerative cells in the body Soft Tissue Repair Soft Tissue Repair Liposuction Processing Adipose Tissue Adipocytes Multipotent cells Endothelial cells Vasc. smooth muscle cells Tissue resident macrophages Perivascular cells Adipose Derived Regenerative Cells Adipocytes Multipotent cells Endothelial cells Vasc. smooth muscle cells Tissue resident macrophages Perivascular cells 5

6 Adipose Tissue: Ideal Source for Cell Therapy Implication: Real-time access to a patient s own regenerative cells is possible (No lengthy and expensive cell culture or manufacturing involved) Total Nucleated Cells in Adipose 0 Multipotent Cells in Adipose Multipotent Cells in BM Number of Cells (millions) per 100 ml of tissue (1/2 cup) 6

7 Soft Tissue Repair 7

8 Soft Tissue Repair: RESTORE Procedure Celution approved in EU for breast reconstruction Significant unmet medical need Two completed clinical trials Soft Soft Tissue Tissue Repair Safe and effective Repair Soft Tissue Repair Reimbursable $73 $126 $163 Clinical Partner $43 Cell-Enriched Graft Cells Fat 8

9 Soft Tissue Repair: RESTORE 2 Trial Outcomes Soft Soft Tissue Tissue Repair Repair Soft Tissue Repair High satisfaction rates & safety to support reimbursement efforts $73 $ % 80% 60% 40% 20% 0% 6-Mo 12-Mo Post-Marketing Study Design Prospective 71 patient study Patient Satisfaction Physician Satisfaction Co-Primary Endpoints Physicians and patient satisfaction with functional and cosmetic results &improvement in overall breast deformity 9

10 Soft Tissue Repair: Building Toward Launch Soft Soft Tissue Tissue Repair Repair Soft Tissue Repair Breast Reconstruction Path to Market Access 2006 Present RESTORE 1 Initiated in Japan CE Mark for general processing RESTORE 1 data reported Cytori begins RESTORE 2 trial in EU RESTORE 2 enrollment complete Breast reconstruction added to CE Mark UK NIC identifies costeffective-ness Complete RESTORE 2 data reported 10

11 Soft Tissue Repair: Global Development Status EU Breast Reconstruction Regulatory Clinical Data Early Adoption Reimbursement (2013) Japan Breast Reconstruction Clinical Data Regulatory (2012) Reimbursement (2012/2013) Adoption US Parry Romberg Clinical Data Regulatory Reimbursement Adoption Regulatory Clinical Data Stages of Market Access Adoption Reimbursement 11

12 Soft Tissue Repair: Near-Term European Market Soft Soft Tissue Tissue Repair Repair Soft Tissue Repair Breast reconstruction in Europe on its own can get Cytori to profitability Target hospitals Focus on G5 Breast recon as entry into Operating Room Indication Status Next Milestones Market Size General processing Approved 2008; $8.4 MM 2010 sales Continued hospital KOL sites Tens of millions Breast cancer reconstruction Approved July 2010 UK reimbursement 2013 followed by G5 coverage Wounds Approved July 2010 Initiation of Independent reimbursement trial $ MM $500 + MM 12

13 Soft Tissue Repair: Global Revenue Potential Celution Consumable cartridge Soft Tissue Repair Soft Tissue Repair Revenue Potential on Consumables alone Assumption: One Consumable per day Customer universe: 15,000 hospitals who buy capital equipment Soft tissue est. price per consumable - $2,500 ± Installed Systems Cartridges per Year Price per Cartridge Annual Revenue Potential $2,500 $65 MM 1, $2,500 $650 MM 10, $2,500 $6.5 Bil 13

14 Cardiovascular Disease Dr. Fernandez-Aviles Principal Investigator for the PRECISE trial Hosp. Gregorio Maranon Madrid, Spain 14

15 Cardiac Repair: Global Development Status EU Chronic Myocardial Ischemia Clinical Data CE Mark Application Filed Q Regulatory (2012) Early Adoption Reimbursement EU Acute Myocardial Infarction Clinical Data Pilot complete Pivotal began 2011 Regulatory Reimbursement Adoption US Chronic Myocardial Ischemia Clinical Data PRE-IDE Q3 11 Initiate 2012 Regulatory Reimbursement Adoption Regulatory Clinical Data Stages of Market Access Adoption Reimbursement 15

16 Cardiac Repair: PRECISE CMI Trial 20.0 Change in Max Volume of Oxygen (MV0 2 ) from Baseline to 6 & 18 months Soft Tissue Repair Soft Tissue Repair 19.0 P<0.05 P< N = 27 pts (6 placebo/21 treated) 14.0 ADRC s Standard of Care Transplant List Baseline 6 Mos 18 Mos 16

17 Cardiac Repair: PRECISE CMI Trial 28 Month Mortality Rate Treated 5% MVO 2 :significant change at 18 months MVO 2 correlates to improved survival MVO 2 14 = 47% 1 yr survival rate METS: significant change at 18 months Cytori procedure safe and feasible through 18-months Lower cardiac mortality rate: At avg. follow up of 28 months: - 2/6 placebo - 1/21 treated Placebo Next Steps: 0% 10% 20% 30% 40% Applying for European Approval 33% Initiating US IDE Clinical Trial: ATHENA Completed pre-ide meeting with FDA 17

18 Cardiac Repair: U.S. CMI Trial Confirmed device designation by FDA Pursuing IDE/PMA clinical trial Pre-IDE meeting with FDA Q Proposed design for Athena trial: Approx. 50 patient pilot Randomized, double-blind, placebo-controlled 1 o Endpoints: Safety & Efficacy Next Steps: Submit IDE application by end of year Initiate 1H

19 Cardiac Repair: APOLLO Acute MI Trial Potential new approach for treatment of heart attacks Strong signals of safety & efficacy Higher SAE rate in Controls Initiated pivotal European clinical trial, ADVANCE P < 0.05 for change from BL for ADRCs P > 0.05 for change from BL for Placebo Difference in reduction of infarct size is maintained in cell-treated patients p<0.05 for change in infarct size for cell-treated patients at 6 and 18 months (paired t-test comparing baseline and follow up for same patients) 19

20 Cardiac Repair: APOLLO Acute MI Trial Lower abnormal ventricular beat rate in cell group More significant Ventricular Arrhythmias in placebo Higher frequency of recordings with Ventricular Premature Beats (VPB) in Controls Higher number of VPBs per recording in placebo 20

21 Cardiac Repair: Significant Market Need Estimated Market Size for Europe Alone Region United Kingdom # of Patients (Incidence) CMI $ 20 Billion* # of Pts (10-Yr Prevalence) 40, ,000 Italy 40, ,000 Germany 55, ,000 France 40, ,000 Spain 30, ,000 Total G5 205,000 2,050,000 Annual Heart Attack Incidence (EU) AMI $ 7 Billion 1.9 million % STEMI (large heart attacks) 38% Target Addressable Procedures 720,000 Est. Price per cardiac consumable $ 10,000 Potential Healthcare Savings for CMI LVAD + Procedure > $200,000 Celution Consumable + Procedure < $50,000 21

22 Current Commercial Business 22

23 Current Commercial Business Build for profitable growth Manage regions as distinct operating units Establish beach-head customers Near-term catalysts Additional country approvals CE Mark can get Cytori to profitability Multi-hundred million dollar markets accessible with current approvals Enter/grow in emerging markets India and Apollo Hospital as example Other countries to follow 23

24 Current Commercial Business Revenue growth year over year Quarters variable Systems driving revenue EU focus on reconstruction Emerging markets & Asia: - Aesthetics - Reconstruction - Translational research - StemSource cell & tissue banks 24

25 Our Business 25

26 Partners Astellas Pharmaceuticals $10 mm equity investment at $7.00 Potential for future liver disease partnership Green Hospital Supply Co-selling StemSource Cell Banks in Asia GE Healthcare Co-distributer in select countries Lead lender Olympus (Japan): Manufacturing Joint Venture Next-generation Celution One System ADVANCE trial 26

27 Intellectual Property: Foundation for Protection 30+ Patents Issued Worldwide with Pending North America/Europe Asia Emerging Markets US: CELUTION DEVICE ( 484) CELUTION PLUS ADDITIVES ( 420) CELUTION FOR CRS ( 488) STEMSOURCE DEVICE ( 115) CELUTION FUTURE GENERATIONS ( 075) CELUTION PLUS SENSORS FOR CLINICALLY SAFE OUTPUT ( 670) CELUTION FOR BONE ( 043) CELUTION OR CELGRAFT FOR SOFT TISSUE DEFECTS ( 684) BEDSIDE COMPREHENSIVE DEVICE ( 059) CELUTION OUTPUT PLUS PROSTHETIC FOR BONE RELATED DISORDERS ( 716) CELLS PLUS FAT PLUS ADDITIVES ( 795) CELLS PLUS FAT ( 672) Europe: CELUTION FOR ACUTE TUBULAR NECROSIS ( 834) Korea: CELUTION DEVICE ( 995) STEMSOURCE DEVICE ( 812) CELUTION DEVICE ( 139) Singapore: CELUTION DEVICE & FUTURE GENERATIONS ( 683) CELUTION FOR CARDIOVASCULAR ( 590) China: CELUTION DEVICE ( 689) CELUTION FOR CARDIOVASCULAR ( 104) Japan: CELUTION DEVICE ( 952) DEVICES FOR CELLS PLUS FAT ( 041) CLINICALLY SAFE ( 556) Australia: CELUTION DEVICE ( 135) STEMSOURCE DEVICE ( 901) CELUTION FOR CARDIOVASCULAR ( 858) CELUTION DEVICE WITH CENTRIFUGE OR FILTER ( 937) South Africa: CELUTION FOR CARDIOVASCULAR ( 446) Mexico: CELUTION FUTURE GENERATIONS ( 348) CELUTION FOR CARDIOVASCULAR ( 775) Russia: CELUTION FOR CARDIOVASCULAR ( 924) India: CELUTION DEVICE ( 706) CELUTION FUTURE GENERATIONS ( 529) CELUTION DEVICE FOR TREATING WOUND HEALING ( 580) Israel: CELUTION DEVICE WITH CENTRIFUGE OR FILTER ( 800) 27

28 Financials Cash (Q3, 2011) GE Loan $41 million $25 million Shares Outstanding Warrants (average price $ 3.80) Vested Options (average price $5) 55 million 12 million 5 million Q3 New cash used in operating activities $7.9 28

29 Potential Near-Term Catalysts Celution One CE Mark CE Mark for Chronic myocardial ischemia Initiate chronic myocardial ischemia trial in U.S. Breast reconstruction technology evaluation in UK (reimbursement) Celution System approval in additional major countries Additional partnerships 29

30 Cytori Therapeutics (NASDAQ: CYTX) Lazard Capital Markets 8th Annual Healthcare Conference November 16, 2011 Mark E. Saad, Chief Financial Officer 30