1. NASDAQ: CYTX
Jefferies Global Healthcare Conference
June 5, 2012
i. Technology & Investment Summary
ii. Cardiovascular Disease Pipeline
iii. Breast Reconstruction & Commercial Business
iv. Business & Economics
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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.
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3. i. Technology & Investment Summary
ii. Cardiovascular Disease Pipeline
iii. Breast Reconstruction & Commercial Business
iv. Business & Economics
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4. Cytori Investment Summary
Overview
Cell therapies sourced from point-of-care device
Cardiovascular disease & soft tissue defects (i.e. breast recon)
Device approved in Europe; starting U.S. clinical trials
Valuable Pipeline
Seeking chronic ischemia approval in Europe
Approved to begin chronic ischemia trial in U.S
EU heart attack pivotal trial
Commercial Business Bridge to Higher Value Markets
Build for profitable growth
Seeking breast reconstruction reimbursement; path to profitability
Enter/grow in emerging markets
Razor-razorblade model: low COGS, high margins
Patent protection into 2030s and beyond
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7. Cell Therapy Platform: Richest Cell Source
Number of Cells (millions) per 100 mL of tissue (1/2 cup)
45 0.5
30
0.25
15
0 0
Multipotent Cells in Adipose
Total Nucleated Cells in Adipose
Multipotent Cells in BM
Implication: Real-time access to a patient’s own regenerative cells is possible
(No lengthy cell culture or manufacturing involved)
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8. Cell Therapy Platform: Multiple Therapies
Cardiovascular Disease Breast Reconstruction
Completed two human trials Approved in Europe
Sustained functional benefit Clinically validated for
at 18 months high physician and
Pivotal heart attack trial in patient satisfaction
Europe underway Seeking reimbursement
US chronic heart disease trial
approved to begin
Discovery of New Applications
Soft Tissue Repair & Wounds Demand by researchers for
Approved in Europe for certain access to cells
chronic wounds Preclinical & clinical studies
Independent studies investigating exploring new indications:
several soft tissue applications Acute renal failure
such as burns, radiation injury, Liver disease
diabetic foot ulcers and others Stress urinary incontinence
Ischemic stroke
9. i. Technology & Investment Summary
ii. Cardiovascular Disease Pipeline
iii. Breast Reconstruction & Commercial Business
iv. Business & Economics
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10. Cardiovascular Disease: Overview
I. Seeking European approval in 2012 in no-option chronic
myocardial ischemia patients
II. Initiating U.S. chronic myocardial ischemia trial 1H 2012;
The ATHENA Trial
III. Enrolling pivotal (approval) heart attack trial in Europe:
The ADVANCE Trial
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11. Chronic Myocardial Ischemia (CMI)
Condition: Severe form of coronary artery disease, limits
mobility, results in chest pains from ischemic tissue
Disease Course: Multiple revascularization procedures
without improvement resulting in limited therapeutic options
Size of Market: Approx.120K to 250K diagnosed each year in
U.S.; subset of approx. 5.8 MM heart failure patients
ADRCs & Cell Therapy: Potential to revive living but stressed
heart tissue; keep patient off transplant list; overcome limits
of existing drugs, devices and surgical options
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12. ADRCs for CMI: Targeted Delivery to Muscle
Direct injection into
“hibernating” heart muscle
via catheter
13. ADRCs for CMI: Clinical Trial Outcomes
20.0 Change in Max Volume of Oxygen (MV02) from Baseline to 6 & 18 months
19.0
P<0.05 P<0.05
Soft Tissue Repair
Soft Tissue Repair
18.0
Soft Tissue Repair
17.2 17.1
16.0 16.6
15.5 15.3
14.0 Transplant List
Baseline
13 6 Mos 18 Mos
ADRC’s N = 27 pts
Standard of Care (6 placebo/21 treated)
14. ADRCs for CMI: Clinical Trial Outcomes
MVO2: significant change at 18 months
• MVO2 correlates to improved survival 28 Month Mortality Rate
• MVO2 ≤ 14 = 47% 1 yr survival rate
METS: significant change at 18 months
Treated 5%
Cytori procedure safe and feasible
through 18-months
Placebo 33%
Lower cardiac mortality rate:
• At avg. follow-up of 28 months:
- 2/6 placebo 0% 10% 20% 30% 40%
- 1/21 treated
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15. Acute Myocardial Infarction (AMI/Heart Attack)
Condition: Artery blockage inhibits blood flow to heart
muscle resulting in stunned ischemic tissue
Disease Course: Large attacks lead to heart failure if
ischemic tissue is not revascularized;
Size of Market: Approx.1 million heart attack patients
admitted to hospital each year
ADRCs & Cell Therapy: Potential to minimize heart damage;
additive to existing treatments; potential to reduce
healthcare costs & rehospitalizations linked to heart failure
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16. ADRCs for AMI: Clinical Trial Outcomes
Potential new approach for treatment of heart attacks
Safe & efficacious
Higher serious adverse event rate in Controls
P < 0.05 for change
from BL for ADRCs
P > 0.05 for change
from BL for Placebo
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17. ADRCs for AMI: Clinical Trial Outcomes
Lower abnormal ventricular beat rate
More significant Ventricular Arrhythmias in
placebo
Higher frequency of recordings with
Ventricular Premature Beats (VPB) in Controls
Higher #of VPBs per recording in placebo
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18. Cytori Cardiac Cell Therapy: Next Steps
Approval decision for European CMI
•Limited launch
•Patient registry
•Build market access; top hospitals in Europe
Initiate ATHENA U.S. pilot trial for CMI
•Multi-center, double-blind, 45 patients
•FDA approved design in Jan 2012
Accelerate enrollment in ADVANCE heart attack pivotal trial
•30-35 sites to treat up to 360 patients
•20+ sites selected and committed
•2012 focus on getting sites online
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19. i. Technology & Investment Summary
ii. Cardiovascular Disease Pipeline
iii. Breast Reconstruction & Commercial Business
iv. Business & Economics
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20. Soft Tissue Repair: RESTORE Procedure
Celution® approved in EU for breast reconstruction $73
Two completed clinical trials $126 $163
Safe: Five-plus years follow-up Clinic
Soft Tissue Repair al
Soft Tissuereimbursement environment
Favorable Repair Partn
er
Limited options available to patients today
‘ADRC-Enriched
$43 Graft’
Cells Fat
21. Soft Tissue Repair: RESTORE Procedure
Pre-Reconstruction; Post radiation 9-Mo Post-Reconstruction using
treatment & tumor resection RESTORE Procedure
22. Soft Tissue Repair: Trial Outcomes
Takeaways:
$73
90% • High satisfaction & safety to support
80% $126
reimbursement
70%
Soft Tissue Repair
Soft Tissue Repair
60% Tissue Repair • Improved breast contour at both six
Soft and 12 months (blinded MRI)
50%
40% • No local cancer recurrences or serious
30% adverse events
20%
10% • Satisfactory results can be achieved in
one procedure for majority of patients
0%
Patient • Competitive approaches more costly:
6-Mo
Satisfaction Physician lengthy hospital stays, repeat
Satisfaction procedures & increase overall burden
12-Mo
on healthcare system
Post-Marketing Study Design
• Prospective 71 patient study
23. i. Technology & Investment Summary
ii. Cardiovascular Disease Pipeline
iii. Breast Reconstruction & Commercial Business
iv. Business & Economics
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24. Product Pricing
$2,000-$12,000 for per-
procedures cartridge
Low six figure ASP for ASP dependent on
sale & installation indications and formulation
60-80% Margin
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25. Protected into 2030s: 46 Patents WW; 75+ Pending
Devices (Current) Devices Soft Tissue Cardiovascular Therapies Pipeline
Next Recon & Therapies
Generation Aesthetics)
US: (5) US: (1) US: (4) EUROPE: (2) US: (2)
CELUTION DEVICE (‘484) CELUTION FUTURE CELUTION FOR ADRCS FOR CARDIAC (‘382) CELUTION FOR
CELUTION DEVICE PLUS ADDITIVES (‘420) GENERATIONS (‘075) MIXING ADRCS PLUS OPPOSED BONE (‘043)
STEMSOURCE DEVICE (‘115) INDIA: (1) FAT (‘488) DEVICE FOR RESTORING BLOOD FLOW CELUTION OUTPUT
CELUTION DEVICE PLUS SENSORS FOR CELUTION FUTURE CELUTION OR NEXT (‘575) PLUS PROSTHETIC
CLINICALLY SAFE OUTPUT (‘670) GENERATIONS (‘529) GEN DEVICES FOR AUSTRALIA: (1) FOR BONE
BEDSIDE COMPREHENSIVE AUSTRALIA: (1) SOFT TISSUE DEFECTS ADRCS FOR CARDIAC (‘858) RELATED
DEVICE (‘059) CELUTION WITH (‘684) SINGAPORE: (1) DISORDERS (‘716)
JAPAN: (2) CENTRIFUGE OR ADRCS PLUS FAT ADRCS FOR RESTORING BLOOD EUROPE: (2)
CELUTION DEVICE (‘952) FILTER (‘937) PLUS ADDITIVES FLOW(‘590) CELUTION FOR
CELUTION FOR CLINICALLY SAFE OUTPUT SINGAPORE: (1) (‘795) CHINA: (1) ACUTE
(‘556) CELUTION & FUTURE ADRCS PLUS FAT ADRCS FOR RESTORING BLOOD FLOW TUBULAR
KOREA: (3) GENERATIONS (‘672) (‘104) NECROSIS (‘834)
CELUTION DEVICE (‘995) (‘683) JAPAN: (1) RUSSIA: (1) ADRCS FOR
STEMSOURCE DEVICE (‘812) ISRAEL: (1) CELUTION AND NEXT CELUTION FOR RESTORING BLOOD FLOW WOUND
CELUTION DEVICE (‘139) CELUTION WITH GEN DEVICES FOR (‘924) HEALING (‘833)
INDIA: (1) CENTRIFUGE OR MIXING ADRCS PLUS SOUTH AFRICA: (1) JAPAN: (1)
CELUTION DEVICE (‘706) FILTER (‘800) FAT (‘041) ADRCS FOR CARDIAC (‘446) ADRCS FOR
AUSTRALIA: (1) MEXICO: (1) KOREA: (1) MEXICO: (1) WOUND HEALING
CELUTION DEVICE (‘135) CELUTION FUTURE ADRCS PLUS FAT CELUTION FOR RESTORING BLOOD FLOW (‘699)
STEMSOURCE DEVICE (‘901) GENERATIONS (‘041) (‘775) INDIA: (1)
CHINA: (1) ISREAL: (1) ADRCS FOR
CELUTION DEVICE (‘689) ADRCS FOR CARDIAC (‘354) WOUND HEALING
(‘580)
26. Financial Highlights
Cash and cash equivalents (3/31/12) $34.4
Accounts receivable 1.4
Long-term debt (GE Capital) 24.6
2011 Product sales $8.0
2011 Cost of sales 3.8
2011 Gross profit 4.1
2011 Net cash used in op. activities 35.3
2012 Revenue guidance >$9.0
2012 Research & Development Increase
2012 Sales & Marketing Reduce
2012 G&A Reduce
2012 Projected Quarterly Burn <$7 MM
Total shares outstanding (4/30/12) 58.7 MM
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27. Creating Shareholder Value in 2012
1. Move product development pipeline forward
• ATHENA in U.S. for CMI & ADVANCE in Europe for AMI
• European approval decision for no-option CMI in Europe
2. Get commercial business profitable in 12-18 months
• 20+% annual revenue growth until inflection point
• Focus on breast reconstruction reimbursement in UK
• Build market access for no-option CMI in Europe
• Expand regulatory approvals and indications
3. Execute on Corporate Milestones
• Development and commercialization partnerships (i.e. Astellas)
• Reduce total operating expenses & burn through G&A and S&M
reductions offset with increase in R&D
28. Potential Near-Term Catalysts
Receive approval (IDE clearance) to begin ATHENA CMI trial
Celution® approval in additional countries (Russia May ’12, more to come)
Initiate ATHENA trial in U.S.
CE Mark for chronic myocardial ischemia
Breast reconstruction technology evaluation in UK
Strategic Partner(s)