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JMP Healthcare Conference 2013

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Presented by Mark Saad on July 10, 2013

Presented by Mark Saad on July 10, 2013

Published in: Business, Technology

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  • 1. Cytori Corporate Overview NASDAQ: CYTX Mark E. Saad Chief Financial Officer JMP Securities Healthcare Conference July 10, 2013
  • 2. Safe Harbor Statement This presentation contains certain ‘forward-looking statements’ about Cytori Therapeutics, Inc. 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 involve known and unknown risks that relate to Cytori’s future events or future financial performance and the actual results could differ materially from those discussed in this presentation. Risks and uncertainties that may cause Cytori's actual results to differ materially from those discussed in the presentation can be found in the "Risk Factors" section of Cytori’s Form 10-K, Forms 10-Q and other filings with the United States Securities and Exchange Commission. We would advise reading our most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the United States Securities and Exchange Commission for a more detailed description of these risks. The forward-looking statements contained in this presentation represent Cytori’s estimates and assumptions only as of the date of this presentation and Cytori undertakes no duty or obligation to update or revise publicly any forward-looking statements contained in this presentation as a result of new information, future events or changes in Cytori’s expectations.
  • 3. Cytori Cell Therapy: Summary • Transformative technology platform – Cell therapy regulated as a device • Clinical experience in thousands of patients • Strong IP protection • Near term value drivers – Pilot/phase II US cardiovascular trial data – Key US government contract milestones (BARDA) – Revenue growth, recent Japan approval
  • 4. Cytori Cell Therapy: Unique Attributes Proprietary Formulation of ADRCs • Autologous • Mixed cell population • Various mechanisms • Patented process • Virtually ‘off the shelf’
  • 5. Cytori Cell Therapy: Heterogeneity Mechanisms of Action • Paracrine (local growth factor delivery) • Differentiation • Inflammatory modulation • Angiogenesis • Wound healing Tissue Macrophages 23% White Blood Cells 22% Stem Cells 2% CD34+/ CD31- 37% Endothelial Cells 7% Vascular Smooth Muscle Cells 9%
  • 6. Cytori Cell Therapy: Business Priorities USA / BARDA New Opportunities Commercial Cardiac • Clinical Trial Stage • US Phase II Heart Failure • EU Phase III Heart Attack • Japan approval • EU ‘Vascular’ approval • Cell & Tissue Banking • PG growth • Up to $106 in development funding • Commercial preparedness contract with US Government • Cytori to sell into all other markets
  • 7. Cytori Cell Therapy: Cardiovascular Trials EU Pilot US Pilot Pivotal Acute MI Complete In Progress APOLLO N = 14, Europe ADVANCE N = 216, Europe Chronic Myocardial Ischemia Complete In Progress Future PRECISE N = 27, Europe ATHENA N = 45, USA TBD Summary from European Pilot Trials • AMI- safe and trend of reduction in infarct size, favorable remodeling • HF & CMI- safe & statistically significant stabilization in Max VO2
  • 8. Cytori Cell Therapy: US Pilot Trial Heart Failure (ATHENA) • Refractory heart failure due to chronic myocardial ischemia • Pilot/Phase II ATHENA Trial based on EU Pilot (PRECISE) • 6 Centers • Data 1st Half of 2014 • U.S. Pivotal Design
  • 9. Cytori Cell Therapy: US Government Contract Discussions Begin 2010 Award Announcement Fall, 2012 3 Objectives Trigger Option 1 & 3 Q1, 2014 3 Proof-of-concept Objectives Ongoing Cell viability Animal model POC Next Gen device feasibility $32.6 M Option 1 $23.4M Option 3 Commercial Acquisition at BARDA’s Discretion $45.5M Option 2 Option 1 Objective Triggers Option 2 Q4, 2015 Pre-Award, White Papers, Proposal, Negotiation $4.7M Phase 1 Proof of Concept
  • 10. Cytori Platform: Clinical Trials and Studies 43 total: 2 Cytori sponsored trials & 41 investigator studies USA 1 EU 23 AP 13 EM 6 Soft Tissue: 18 Wound: 7 Ischemia: 2 Ortho/Sport: 8 Vital Organ: 8 Total: 43
  • 11. Cytori Cell Therapy: Product Economics System: • Low six figure ASP (current generation) • Next-generation system COGS ~ $10,000, flexible model Procedures / Year Est. Consumable ASP Est. Revenue Est. Consumable Gross Profit 100,000 $10,000 $1 Billion $800 + Million Per-procedure consumable: • $8,000-$12,000 for vascular indications • >80% GM
  • 12. Cytori Cell Therapy: Intellectual Property DEVICES CURRENT DEVICES NEXT GENERATION COSMETIC & RECONSTRUCTIVE SURGERY CARDIOVASCULAR THERAPIES PIPELINE THERAPIES US: (6) CELUTION DEVICE (‘484) CELUTION DEVICE PLUS ADDITIVES (‘420) STEMSOURCE DEVICE (‘115) CELUTION DEVICE PLUS SENSORS FOR CLINICALLY SAFE OUTPUT (‘670) BEDSIDE COMPREHENSIVE DEVICE (‘059) CELUTION DEVICE CD31 POSITIVE CELLS (‘276) JAPAN: (2) CELUTION DEVICE (‘952) CELUTION FOR CLINICALLY SAFE OUTPUT (‘556) KOREA: (3) CELUTION DEVICE (‘995) STEMSOURCE DEVICE (‘812) CELUTION DEVICE (‘139) INDIA: (1) CELUTION DEVICE (‘706) AUSTRALIA: (2) CELUTION DEVICE (‘135) STEMSOURCE DEVICE (‘901) CHINA: (1) CELUTION DEVICE (‘689) OLYMPUS-CYTORI PATENTS NEXT GENERATION DEVICE - JAPAN CENTRIFUGAL CONTAINER (‘020) DIGESTIVE ENZYMES (‘861) US: (1) CELUTION & FUTURE GENERATIONS (‘075) CHINA: (1) CELUTION & FUTURE GENERATIONS (‘241) INDIA: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘529) AUSTRALIA: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘937) SINGAPORE: (1) CELUTION & FUTURE GENERATIONS (‘683) ISRAEL: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘800) MEXICO: (1) CELUTION & FUTURE GENERATIONS (‘348) KOREA: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘305) JAPAN: (1) CELUTION BUSINESS METHOD US: (7) CELUTION FOR MIXING ADRCS PLUS FAT (‘488) CELUTION OR NEXT GEN DEVICES FOR SOFT TISSUE DEFECTS (‘684) ADRCS PLUS FAT PLUS ADDITIVES (‘795) ADRCS PLUS FAT (‘672) ADRCS PLUS FAT COMPOSITION (‘121) CURRENT CELUTION DEVICE PLUS FAT (‘947) ADRC’S PLUS FAT PLUS BUFFER (‘834) JAPAN: (1) CELUTION AND NEXT GEN DEVICES FOR MIXING ADRCS PLUS FAT (‘041) KOREA: (3) ADRCS PLUS FAT (‘454) CELUTION OR NEXT GEN DEVICES FOR SOFT TISSUE DEFECTS (‘508) ADRCS PLUS FAT METHOD (‘666) EUROPE: (2) ADRCS FOR CARDIAC (‘382) OPPOSED DEVICE FOR RESTORING BLOOD FLOW (‘575) OPPOSED AUSTRALIA: (1) ADRCS FOR CARDIAC (‘858) SINGAPORE: (1) ADRCS FOR RESTORING BLOOD FLOW(‘309) CHINA: (1) ADRCS FOR RESTORING BLOOD FLOW (‘104) HONG KONG: (1) ADRCS FOR RESTORING BLOOD FLOW (‘085) RUSSIA: (1) CELUTION FOR RESTORING BLOOD FLOW (‘924) SOUTH AFRICA: (1) ADRCS FOR CARDIAC (‘446) MEXICO: (1) CELUTION FOR RESTORING BLOOD FLOW (‘775) ISRAEL: (1) ADRCS FOR CARDIAC (‘354) CANADA: (1) ADRCS FOR RESTORING BLOOD FLOW(‘510) JAPAN: (1) CELUTION FOR RESTORING BLOOD FLOW(‘787) US: (4) CELUTION FOR BONE (‘043) CELUTION OUTPUT PLUS PROSTHETIC FOR BONE RELATED DISORDERS (‘716) CELUTION FOR TREATING WOUND HEALING (‘580) ADRC’S FOR RENAL (‘229) EUROPE: (2) CELUTION FOR ACUTE TUBULAR NECROSIS (‘834) ADRCS FOR WOUND HEALING (‘833) JAPAN: (3) ADRCS FOR WOUND HEALING (‘699) CELUTION OUTPUT PLUS PROSTHETIC FOR BONE RELATED DISORDERS (‘119) CELUTION FOR PERIPHERAL VASCULAR DISEASE (‘511) INDIA: (1) ADRCS FOR WOUND HEALING (‘580) KOREA: (1) ADRCS FOR WOUND HEALING (‘909) 60 Patents Issued Worldwide; More than 75 Pending Applications
  • 13. Cytori Cell Therapy: 2013 Milestones • Publish PRECISE long-term data, (18 months) • Complete patient enrollment in ATHENA • BARDA progress: Phase II • Achieve $15 million revenue target for 2013 (incl. $2.5 mm – $3 mm BARDA) • Additional country approvals for Celution®

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