Download - Jefferies 2012 Global Healthcare Conference
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NASDAQ: CYTXJefferies Global Healthcare Conference
June 5, 2012
i. Technology & Investment Summaryii. Cardiovascular Disease Pipelineiii. Breast Reconstruction & Commercial Businessiv. Business & Economics
Safe Harbor Statement
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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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i. Technology & Investment Summaryii. Cardiovascular Disease Pipelineiii. Breast Reconstruction & Commercial Businessiv. Business & Economics
Cytori Investment Summary
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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
Cell Therapy: Fourth Tenet of Medicine
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Cell Therapy Platform: Innovative & Affordable
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Cardiovascular Disease
Celution® System:
point-of-care device
Adipose-derived
regenerative cells (ADRCs)
Fat (adipose) tissue
from minor liposuction
Cell Therapy Platform: Richest Cell Source
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Number of Cells (millions) per 100 mL of tissue (1/2 cup)
0
0.25
0.5
Multipotent Cells in AdiposeMultipotent Cells in BM
0
15
30
45
Total Nucleated Cells in Adipose
Implication: Real-time access to a patient’s own regenerative cells is possible(No lengthy cell culture or manufacturing involved)
Cell Therapy Platform: Multiple Therapies
Approved in Europe
Clinically validated for high physician and
patient satisfaction
Seeking reimbursement
Completed two human trials
Sustained functional benefit at 18 months
Pivotal heart attack trial in Europe underway
US chronic heart disease trial approved to begin
Approved in Europe for certain chronic wounds
Independent studies investigating several soft tissue applications such as burns, radiation injury, diabetic foot ulcers and others
Demand by researchers for access to cells
Preclinical & clinical studies exploring new indications:
Acute renal failure Liver disease Stress urinary incontinence Ischemic stroke
Cardiovascular Disease
Soft Tissue Repair & Wounds
Discovery of New Applications
Breast Reconstruction
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i. Technology & Investment Summaryii. Cardiovascular Disease Pipelineiii. Breast Reconstruction & Commercial Businessiv. Business & Economics
Cardiovascular Disease: Overview
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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
Chronic Myocardial Ischemia (CMI)
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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
ADRCs for CMI: Targeted Delivery to Muscle
Direct injection into “hibernating” heart muscle
via catheter
ADRCs for CMI: Clinical Trial Outcomes
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Soft Tissue RepairSoft Tissue Repair
Soft Tissue Repair
Change in Max Volume of Oxygen (MV02) from Baseline to 6 & 18 months
Baseline 6 Mos 18 Mos
Transplant List
20.0
18.0
16.0
14.0
19.0
15.5 15.3
16.6
17.117.2
ADRC’sStandard of Care
P<0.05 P<0.05
N = 27 pts
(6 placebo/21 treated)
ADRCs for CMI: Clinical Trial Outcomes
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MVO2: significant change at 18 months• MVO2 correlates to improved survival
• MVO2 ≤ 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
0% 10% 20% 30% 40%
Placebo
Treated
33%
5%
28 Month Mortality Rate
Acute Myocardial Infarction (AMI/Heart Attack)
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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
ADRCs for AMI: Clinical Trial Outcomes
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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
ADRCs for AMI: Clinical Trial Outcomes
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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
Cytori Cardiac Cell Therapy: Next Steps
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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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i. Technology & Investment Summaryii. Cardiovascular Disease Pipelineiii. Breast Reconstruction & Commercial Businessiv. Business & Economics
Soft Tissue RepairSoft Tissue Repair
Celution® approved in EU for breast reconstruction
Two completed clinical trials
Safe: Five-plus years follow-up
Favorable reimbursement environment
Limited options available to patients today
$43
$73
$126 $163Clinic
alPartner
Cells Fat
‘ADRC-Enriched Graft’
Soft Tissue Repair: RESTORE Procedure
Soft Tissue Repair: RESTORE Procedure
Pre-Reconstruction; Post radiation treatment & tumor resection
9-Mo Post-Reconstruction using RESTORE Procedure
Soft Tissue RepairSoft Tissue Repair
Soft Tissue Repair
$73
$126
Post-Marketing Study Design
• Prospective 71 patient study
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Patient
Satisfaction Physician
Satisfaction
6-Mo
12-Mo
Soft Tissue Repair: Trial Outcomes
Takeaways:
• High satisfaction & safety to support
reimbursement
• Improved breast contour at both six
and 12 months (blinded MRI)
• No local cancer recurrences or serious
adverse events
• Satisfactory results can be achieved in
one procedure for majority of patients
• Competitive approaches more costly:
lengthy hospital stays, repeat
procedures & increase overall burden
on healthcare system
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i. Technology & Investment Summaryii. Cardiovascular Disease Pipelineiii. Breast Reconstruction & Commercial Businessiv. Business & Economics
Product Pricing
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Low six figure ASP for
sale & installation
$2,000-$12,000 for per-
procedures cartridge
ASP dependent on
indications and formulation
60-80% Margin
Devices (Current) Devices
Next
Generation
Soft Tissue
Recon &
Aesthetics)
Cardiovascular Therapies Pipeline
Therapies
US: (5)
CELUTION DEVICE (‘484)
CELUTION DEVICE PLUS ADDITIVES (‘420)
STEMSOURCE DEVICE (‘115)
CELUTION DEVICE PLUS SENSORS FOR
CLINICALLY SAFE OUTPUT (‘670)
BEDSIDE COMPREHENSIVE
DEVICE (‘059)
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: (1)
CELUTION DEVICE (‘135)
STEMSOURCE DEVICE (‘901)
CHINA: (1)
CELUTION DEVICE (‘689)
US: (1)
CELUTION FUTURE
GENERATIONS (‘075)
INDIA: (1)
CELUTION FUTURE
GENERATIONS (‘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
US: (4)
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)
JAPAN: (1)
CELUTION AND NEXT
GEN DEVICES FOR
MIXING ADRCS PLUS
FAT (‘041)
KOREA: (1)
ADRCS PLUS FAT
(‘041)
EUROPE: (2)
ADRCS FOR CARDIAC (‘382)
OPPOSED
DEVICE FOR RESTORING BLOOD FLOW
(‘575)
AUSTRALIA: (1)
ADRCS FOR CARDIAC (‘858)
SINGAPORE: (1)
ADRCS FOR RESTORING BLOOD
FLOW(‘590)
CHINA: (1)
ADRCS FOR RESTORING BLOOD FLOW
(‘104)
RUSSIA: (1)
CELUTION FOR RESTORING BLOOD FLOW
(‘924)
SOUTH AFRICA: (1)
ADRCS FOR CARDIAC (‘446)
MEXICO: (1)
CELUTION FOR RESTORING BLOOD FLOW
(‘775)
ISREAL: (1)
ADRCS FOR CARDIAC (‘354)
US: (2)
CELUTION FOR
BONE (‘043)
CELUTION OUTPUT
PLUS PROSTHETIC
FOR BONE
RELATED
DISORDERS (‘716)
EUROPE: (2)
CELUTION FOR
ACUTE
TUBULAR
NECROSIS (‘834)
ADRCS FOR
WOUND
HEALING (‘833)
JAPAN: (1)
ADRCS FOR
WOUND HEALING
(‘699)
INDIA: (1)
ADRCS FOR
WOUND HEALING
(‘580)
Protected into 2030s: 46 Patents WW; 75+ Pending
Financial Highlights
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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
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
Creating Shareholder Value in 2012
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)
Potential Near-Term Catalysts