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Company Overview Presentation for November 2014.
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Company Overview Presentation for November 2014.
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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’
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®