Overview of Cytori's business as presented at the Lazard Healthcare Investor

1. Cytori Therapeutics
(NASDAQ:
(NASDAQ CYTX)
Lazard Capital Markets 8th Annual Healthcare Conference
November 16, 2011
16
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
trends, conditions,
other factors they believe to be appropriate.
The forward looking statements included in this presentation are also subject
forward-looking
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 th
d i ti f these risks.
ik
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
Soft Tissue Repair
f p
About one hour
Cytori Celution® System Regenerative cells
Cardiovascular Disease
Celution currently approved in Europe
Scalable platform
System/Consumable model
y
35+ issued patents
4

5. Adipose Tissue: Ideal Source for Cell Therapy
Adipose Tissue: Richest source of regenerative cells in the body
Liposuction
Soft Tissue Repair
Soft Tissue Repair Processing
Adipose Tissue Adipose Derived Regenerative Cells
• Adipocytes • Adipocytes
• Multipotent cells
M lti t t ll • Multipotent cells
M lti t t ll
• Endothelial cells • Endothelial cells
• Vasc. smooth muscle cells • Vasc. smooth muscle cells
• Tissue resident macrophages • Tissue resident macrophages
• Perivascular cells • 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)
45 0.5
30
0.25
15
0 0
Multipotent Cells in Adipose
Total Nucleated 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 $73
Two completed clinical t i l
T l t d li i l trials $126
$ 26 $163
Soft Tissue Repair
Soft Tissue Repair Safe and effective Clinical
Soft Tissue Repair
Soft Tissue Repair Reimbursable Partner
‘Cell‐
‘Cell‐Enriched
$43 Graft’
Cells Fat
8

9. Soft Tissue Repair: RESTORE 2 Trial Outcomes
High satisfaction rates & safety to support reimbursement efforts
$73
$126
$
100%
Soft Tissue Repair
Soft Tissue Repair 6-Mo
Soft Tissue Repair 80%
Soft Tissue Repair 12-Mo
60%
40%
20%
0%
Patient Satisfaction
Physician
Post-Marketing Study Design Satisfaction
• Prospective 71 patient study
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
Breast Reconstruction Path to Market Access
2006 – Present
Soft Tissue Repair
Soft Tissue Repair
Soft Tissue Repair
Soft Tissue Repair
2006 2007 2008 2009 2010 2011
• RESTORE 1 • CE Mark for •Cytori begins • RESTORE 2 • Breast • UK NIC
Initiated in l
general RESTORE 2 trial ll
enrollment reconstruction d f
identifies cost‐
Japan processing in EU complete added to CE effective‐ness
• RESTORE 1 Mark • Complete
data reported RESTORE 2
data reported
10

11. Soft Tissue Repair: Global Development Status
EU Breast Reconstruction
Reimbursement
Regulatory
R l Clinical Data
Cli i l D Early Adoption
E l Ad i
(2013)
Japan Breast Reconstruction
Regulatory Reimbursement
Clinical Data Adoption
(2012) (2012/2013)
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
Breast reconstruction in Europe on its own
can get Cytori to p
g y profitability
y
• Target hospitals
Soft Tissue Repair
Soft Tissue Repair
Soft Tissue Repair • Focus on G5
Soft Tissue Repair • Breast recon as entry into Operating Room
Indication Status Next Milestones Market Size
General processing Approved 2008; Continued hospital Tens of millions
$8.4 MM 2010 sales adoption @ KOL sites
Breast cancer
cancer Approved July 2010
July 2010 UK reimbursement
UK reimbursement $300 400 MM
$300‐400 MM
reconstruction 2013 followed by G5
coverage
Wounds Approved July 2010 Initiation of $500 + MM
Independent
I d d t
reimbursement trial
12

13. Soft Tissue Repair: Global Revenue Potential
Celution® Consumable cartridge
Soft Tissue Repair
Soft Tissue Repair
Soft Tissue Repair
Revenue Potential on Consumables alone
Assumption: One Consumable per day
Customer universe: 15,000 h
C t i 15 000 hospitals who buy capitall equipment
it l h b it i t
Soft tissue est. price per consumable - $2,500 ±
Installed Cartridges per Price per Annual Revenue
Systems Year Cartridge Potential
100 260 $2,500 $65 MM
1,000 260 $2,500 $650 MM
10,000 260 $2,500 $6.5 Bil
13

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

15. Cardiac Repair: Global Development Status
EU Chronic Myocardial Ischemia
Clinical Data
Regulatory
g y
CE Mark Application Early Adoption
E l Ad i Reimbursement
R i b
(2012)
Filed Q2 2011
EU Acute Myocardial Infarction
Clinical Data
Pilot complete Regulatory Reimbursement Adoption
Pivotal began 2011
Pi t l b 2011
US Chronic Myocardial Ischemia
Clinical Data
PRE‐IDE Q3 ‘11 Regulatory Reimbursement Adoption
Initiate 2012
Regulatory Clinical Data
Stages of
Market Access
Adoption Reimbursement
15

16. Cardiac Repair: PRECISE CMI Trial
Change in Max Volume of Oxygen (MV02) from Baseline to 6 & 18 months
20 0
20.0
Soft Tissue Repair
Soft Tissue Repair 19.0
Soft Tissue Repair P<0.05 P<0.05
18.0
17.2 17.1
16.0 16.6
15.5 15.3
15 3
14.0 Transplant List
N = 27 pts
(6 placebo/21 treated)
ADRC’s Baseline 6 Mos 18 Mos
Standard of Care 16

17. Cardiac Repair: PRECISE CMI Trial
28 Month Mortality Rate
Treated 5%
Placebo 33%
MVO2:significant change at 18 months
• MVO2 correlates to improved survival
• MVO2 ≤ 14 = 47% 1 yr survival rate 0% 10% 20% 30% 40%
METS: significant change at 18 months
Next Steps:
Cytori procedure safe and feasible through
18-months
Applying for European Approval
Lower cardiac mortality rate:
• At avg. follow up of 28 months: Initiating US IDE Clinical Trial: ATHENA
- 2/6 placebo
- 1/21 treated
• 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 Q3 2011
Proposed design for “Athena” trial:
• Approx. 50 patient pilot
• Randomized double-blind, placebo controlled
Randomized, double blind placebo-controlled
• 1o Endpoints: Safety & Efficacy
Next Steps:
• Submit IDE application by end of year
• Initiate 1H 2012
18

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 iin reduction of iinfarct size iis maintained iin cell-t
Diff d ti f f t i i t i d cell-treated patients
ll t d ti t
p<0.05 for change in infarct size for cell-treated patients at 6 and 18 months (paired t-test
cell-
comparing baseline and follow up for same patients)
19

20. Cardiac Repair: APOLLO Acute MI Trial
Lower abnormal ventricular beat rate in cell group
abnormal
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
CMI AMI
$ 20 Billion* $ 7 Billion
# of Patients # of Pts (10-Yr
Region Annual Heart Attack Incidence (EU) 1.9
1 9 million
(Incidence) Prevalence)
United 40,000 400,000
Kingdom % STEMI (large heart attacks) 38%
Italy 40,000 400,000
Target Addressable Procedures 720,000
Germany 55,000 550,000
France 40,000 400,000
Est. Price per cardiac consumable
p $ 10,000
,
Spain 30,000 300,000
Total G5 205,000 2,050,000
Potential Healthcare Savings for CMI
LVAD + Procedure > $200 000
$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
beach-head
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
E t / i i k t
• India and Apollo Hospital as example
• Other countries to follow
23

24. Current Commercial Business
• Revenue growth year over year
• Q
Quarters variable
t i bl
• 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
p p
Green Hospital Supply
p pp y
• 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 100 + Pending
North America/Europe Asia Emerging Markets
US: Korea: Australia:
CELUTION DEVICE (‘484) CELUTION DEVICE (‘995) CELUTION DEVICE (‘135)
CELUTION PLUS ADDITIVES (‘420) STEMSOURCE DEVICE (‘812) STEMSOURCE DEVICE (‘901)
CELUTION FOR CRS (‘488) CELUTION DEVICE (‘139) CELUTION FOR CARDIOVASCULAR (‘858)
STEMSOURCE DEVICE (‘115) CELUTION DEVICE WITH CENTRIFUGE OR
CELUTION FUTURE GENERATIONS (‘075)
( 075) Singapore: FILTER (‘937)
( )
CELUTION PLUS SENSORS FOR CLINICALLY SAFE OUTPUT CELUTION DEVICE & FUTURE GENERATIONS
(‘670) South Africa:
(‘683)
CELUTION FOR BONE (‘043) CELUTION FOR CARDIOVASCULAR (‘446)
CELUTION FOR CARDIOVASCULAR (‘590)
CELUTION OR CELGRAFT FOR SOFT TISSUE DEFECTS
(‘684) Mexico:
China: CELUTION FUTURE GENERATIONS (‘348)
BEDSIDE COMPREHENSIVE CELUTION DEVICE (‘689)
DEVICE (‘059) CELUTION FOR CARDIOVASCULAR (‘775)
CELUTION FOR
CELUTION OUTPUT PLUS PROSTHETIC CARDIOVASCULAR (‘104)
FOR BONE RELATED DISORDERS (‘716)
Russia:
CELUTION FOR CARDIOVASCULAR (‘924)
CELLS PLUS FAT PLUS ADDITIVES (‘795)
Japan:
p
CELLS PLUS FAT (‘672)
CELUTION DEVICE (‘952) India:
DEVICES FOR CELLS PLUS FAT (‘041) CELUTION DEVICE (‘706)
Europe: CLINICALLY SAFE (‘556) CELUTION FUTURE GENERATIONS (‘529)
CELUTION FOR ACUTE CELUTION DEVICE FOR TREATING WOUND
TUBULAR NECROSIS (‘834) HEALING (‘580)
Israel:
CELUTION DEVICE WITH CENTRIFUGE OR
FILTER (‘800)
27

28. Financials
Cash (Q3, 2011) $41 million
GE L
Loan $25 million
illi
Shares Outstanding 55 million
Warrants (
W t (average price $ 3.80)
i 3 80) 12 million
illi
Vested Options (average price $5) 5 million
Q3 N
New cash used iin operating activities
h d ti ti iti $7.9
$7 9
28

29. Potential Near-Term Catalysts
Celution® One CE Mark
CE Mark for Chronic myocardial ischemia
Initiate h
I iti t chronic myocardial ischemia trial in U.S.
i di l i h i ti li US
Breast reconstruction technology evaluation in UK (reimbursement)
Celution® System approval in additional major countries
Additional partnerships
29

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