Cytori Lazard Healthcare Conf. Presentation

Cytori Therapeutics(NASDAQ CYTX) (NASDAQ: CYTX)

Lazard Capital Markets 8th Annual Healthcare Conference

November 16 2011November 16, 2011

Mark E. Saad, Chief Financial Officer

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Safe Harbor Statement

This presentation may contain certain ‘forward-looking statements’. Allstatements, other than statements of historical fact, that address activities,events or developments that we intend, expect, project, believe orevents or developments that we intend, expect, project, believe oranticipate will or may occur in the future are forward-looking statements.Such statements are based upon certain assumptions and assessmentsmade by our management in light of their experience and their perceptionof historical trends current conditions expected future developments andof historical trends, current conditions, expected future developments andother factors they believe to be appropriate.

The forward looking statements included in this presentation are also subjectThe forward-looking statements included in this presentation are also subjectto a number of material risks and uncertainties. We caution investors not toplace undue reliance on the forward-looking statements contained in thispresentation.

We would advise reading our annual report filed with the United StatesSecurities and Exchange Commission on Form 10-K for a more detailedd i ti f th i k

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description of these risks.

Investment Summary

• Large pipeline opportunity – EU chronic ischemia approval– EU acute heart attack pivotal trialEU 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– Soft tissue and translational research– Grow in select emerging markets

• Established partnerships and potential future licensingEstablished partnerships and potential future licensing– $100 MM + in funding to Cytori– Multiple development and commercialization partnership prospects

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• Patent protection into mid-2020s and beyond

Investment Opportunity

Regenerative cells in the operating room in real‐timeRegenerative cells in the operating room in real‐time

Soft Tissue Repairf pAbout one hour

Cardiovascular DiseaseCytori Celution® System Regenerative cells

Celution currently approved in EuropeScalable platformSystem/Consumable model

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y35+ issued patents

Adipose Tissue: Ideal Source for Cell Therapy

Adipose Tissue: Richest source of regenerative cells in the body

Soft Tissue RepairSoft Tissue RepairLiposuction

ProcessingSoft Tissue Repair Processing

• AdipocytesM lti t t ll

Adipose Derived Regenerative Cells

• AdipocytesM lti t t ll

Adipose Tissue

• Multipotent cells• Endothelial cells• Vasc. smooth muscle cells• Tissue resident macrophages

• Multipotent cells• Endothelial cells• Vasc. smooth muscle cells• Tissue resident macrophages

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• Tissue resident macrophages• Perivascular cells

• Tissue resident macrophages• Perivascular cells

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)

0.545

0.25

30

15

0

Multipotent Cells in AdiposeMultipotent Cells in BM

0

Total Nucleated Cells in Adipose

6

Number of Cells (millions) per 100 mL of tissue (1/2 cup)

Soft Tissue Repair

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Soft Tissue Repair: RESTORE Procedure

Celution® approved in EU for breast reconstructionSignificant unmet medical needT l t d li i l t i l

$73

$ 26 $163

Soft Tissue RepairSoft Tissue RepairSoft Tissue RepairSoft Tissue Repair

Two completed clinical trials Safe and effectiveReimbursable

$126 $163

Clinical

Partner

‘Cell‘Cell‐‐Enriched Enriched $43 Graft’Graft’

CellsCells FatFat

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Soft Tissue Repair: RESTORE 2 Trial Outcomes

$73

$

High satisfaction rates & safety to support reimbursement efforts


$126

80%

100%6-Mo

12-Mo

40%

60%

0%

20%

Post-Marketing Study Design• Prospective 71 patient study

Patient SatisfactionPhysician

Satisfaction

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Co-Primary Endpoints• Physicians and patient satisfaction with functional and cosmetic results &improvement in overall breast deformity

Soft Tissue Repair: Building Toward Launch

Breast Reconstruction Path to Market Access2006 – Present


2006 Present

2006

• RESTORE 1

2007

•CE Mark for l

2008

•Cytori begins

2009

•RESTORE 2 ll

2010

•Breast

2011

•UK NIC d fInitiated in

Japangeneral processing

•RESTORE 1 data reported

RESTORE 2 trial in EU

enrollment complete

reconstruction added to CE Mark

identifies cost‐effective‐ness

•Complete RESTORE 2 data reported

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Soft Tissue Repair: Global Development Status

R l Cli i l D E l Ad iReimbursement

EU Breast Reconstruction

Regulatory Clinical Data Early Adoption(2013)

Japan Breast Reconstruction

Clinical DataRegulatory(2012)

Reimbursement(2012/2013)

Adoption

Japan Breast Reconstruction

US Parry Romberg

Clinical Data Regulatory Reimbursement Adoption

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Regulatory Clinical Data

Adoption Reimbursement

Stages of Market Access

Soft Tissue Repair: Near-Term European Market

Breast reconstruction in Europe on its own can get Cytori to profitability

Soft Tissue Repair

g y p y• Target hospitals• Focus on G5• Breast recon as entry into Operating Room

Soft Tissue RepairSoft Tissue RepairSoft Tissue Repair

Breast recon as entry into Operating Room

Indication Status Next Milestones Market SizeGeneral processing Approved 2008;

$8.4 MM 2010 salesContinued hospital adoption @ KOL sites

Tens of millions

Breast cancer Approved July 2010 UK reimbursement $300‐400 MMBreast cancer reconstruction

Approved July 2010 UK reimbursement 2013 followed by G5

coverage

$300 400 MM

Wounds Approved July 2010 Initiation of I d d t

$500 + MM

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Independent reimbursement trial

Soft Tissue Repair: Global Revenue Potential

Celution® Consumable cartridge


Revenue Potential on Consumables alone

Assumption: One Consumable per day

C t i 15 000 h it l h b it l i t

Installed Cartridges per Price per Annual Revenue

Customer universe: 15,000 hospitals who buy capital equipment

Soft tissue est. price per consumable - $2,500 ±

Installed Systems

Cartridges per Year

Price per Cartridge

Annual RevenuePotential

100 260 $2,500 $65 MM1,000 260 $2,500 $650 MM

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1,000 260 $2,500 $650 MM10,000 260 $2,500 $6.5 Bil

Cardiovascular Disease

Dr. Fernandez-Aviles Principal Investigatorfor the PRECISE trialH G i M

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Hosp. Gregorio MaranonMadrid, Spain

Cardiac Repair: Global Development Status

Clinical Data RegulatoryE l Ad i R i b

EU Chronic Myocardial Ischemia

CE Mark Application Filed Q2 2011

g y(2012)

Early Adoption Reimbursement

EU Acute Myocardial Infarction

Clinical DataPilot complete

Pi t l b 2011Regulatory Reimbursement Adoption

EU Acute Myocardial Infarction

Pivotal began 2011

US Chronic Myocardial Ischemia

Clinical DataPRE‐IDE Q3 ‘11Initiate 2012

Regulatory Reimbursement Adoption

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Regulatory Clinical Data

Adoption Reimbursement

Stages of Market Access

Cardiac Repair: PRECISE CMI Trial

Change in Max Volume of Oxygen (MV02) from Baseline to 6 & 18 months20 0


20.0

19.0P<0.05 P<0.05

18.0

17.117.2

16.0

15 3

16.6

Transplant List14.015.5 15.3

N = 27 pts(6 placebo/21 treated)

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Baseline 6 Mos 18 MosADRC’sStandard of Care

(6 placebo/21 treated)

Cardiac Repair: PRECISE CMI Trial

28 Month Mortality Rate

Treated

33%

5%

MVO2:significant change at 18 months• MVO2 correlates to improved survival• MVO2 ≤ 14 = 47% 1 yr survival rate 0% 10% 20% 30% 40%

Placebo 33%

METS: significant change at 18 months

Cytori procedure safe and feasible through 18-months

Next Steps:

Applying for European ApprovalLower cardiac mortality rate:• At avg. follow up of 28 months:

- 2/6 placebo- 1/21 treated

Initiating US IDE Clinical Trial: ATHENA • Completed pre-IDE meeting with FDA

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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: Next Steps: • Submit IDE application by end of year• Initiate 1H 2012

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Cardiac Repair: APOLLO Acute MI Trial

PPotential newotential new approach approach for treatment of heart attacks for treatment of heart attacks Strong Strong signals of signals of safety & efficacysafety & efficacyHigher SAE rate in ControlsHigher SAE rate in ControlsInitiated pivotal European clinical trial, ADVANCE

Diff i d ti f i f t i i i t i d i llDiff i d ti f i f t i i i t i d i ll t t d ti tt t d ti t

P < 0.05 for change from BL for ADRCs

P > 0.05 for change from BL for Placebo

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Difference in reduction of infarct size is maintained in cellDifference in reduction of infarct size is maintained in cell--treated patientstreated patients

pp<0.05 for change in infarct size for cell<0.05 for change in infarct size for cell--treated patients at 6 and 18 months (paired treated patients at 6 and 18 months (paired tt--test test comparing baseline and follow up for same patients)comparing baseline and follow up for same patients)

Cardiac Repair: APOLLO Acute MI Trial

Lower aLower abnormalbnormal ventricular beat rate in ventricular beat rate in cell groupcell groupMore significant Ventricular Arrhythmias in More significant Ventricular Arrhythmias in placeboplacebo

Higher frequency of recordings with Ventricular Higher frequency of recordings with Ventricular Premature Beats (VPB) in ControlsPremature Beats (VPB) in Controls

Higher number of VPBs per recordingHigher number of VPBs per recording in placeboin placebo

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Cardiac Repair: Significant Market Need

Estimated Market Size for Europe Alone

AMI $ 7 Billion

AMI $ 7 Billion

Annual Heart Attack Incidence (EU) 1 9 millionRegion # of Patients # of Pts (10-Yr

CMI $ 20 Billion*

CMI $ 20 Billion*

Annual Heart Attack Incidence (EU) 1.9 million

% STEMI (large heart attacks) 38%

Region (Incidence) Prevalence)UnitedKingdom

40,000 400,000

Italy 40,000 400,000Target Addressable Procedures 720,000

Est. Price per cardiac consumable $ 10,000

Italy 40,000 400,000

Germany 55,000 550,000

France 40,000 400,000p $ ,

Spain 30,000 300,000

Total G5 205,000 2,050,000Potential Healthcare Savings for CMI

LVAD + Procedure > $200 000

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LVAD + Procedure > $200,000Celution Consumable + Procedure < $50,000

Current Commercial Business

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Build for profitable growth• Manage regions as distinct operating units• Establish beach head customers • Establish beach-head customers

Near-term catalysts • Additional country approvals

CE Mark can get Cytori to profitabilityCE Mark can get Cytori to profitability• Multi-hundred million dollar markets accessible with current approvals

E t / i i k t Enter/grow in emerging markets • India and Apollo Hospital as example• Other countries to follow

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• Revenue growth year over year

Q t i bl• Quarters variable

• Systems driving revenue

• EU focus on reconstruction

• Emerging markets & Asia: Emerging markets & Asia:

- Aesthetics- Reconstruction

Translational research - Translational research - StemSource® cell & tissue banks

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Our Business

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Partners

Astellas Pharmaceuticals • $10 mm equity investment at $7.00• Potential for future liver disease partnershipp p

Green Hospital Supplyp 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

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Intellectual Property: Foundation for Protection

North America/Europe Asia Emerging Markets

US: Korea: Australia:

30+ Patents Issued Worldwide with 100 + Pending

US:CELUTION DEVICE (‘484)CELUTION PLUS ADDITIVES (‘420)CELUTION FOR CRS (‘488)STEMSOURCE DEVICE (‘115)CELUTION FUTURE GENERATIONS (‘075)

Korea:CELUTION DEVICE (‘995)STEMSOURCE DEVICE (‘812)CELUTION DEVICE (‘139)

Singapore:

Australia:CELUTION DEVICE (‘135)STEMSOURCE DEVICE (‘901)CELUTION FOR CARDIOVASCULAR (‘858)CELUTION DEVICE WITH CENTRIFUGE ORFILTER (‘937)CELUTION FUTURE GENERATIONS ( 075)

CELUTION PLUS SENSORS FOR CLINICALLY SAFE OUTPUT(‘670)CELUTION FOR BONE (‘043)CELUTION OR CELGRAFT FOR SOFT TISSUE DEFECTS(‘684)

Singapore:CELUTION DEVICE & FUTURE GENERATIONS(‘683)CELUTION FOR CARDIOVASCULAR (‘590)

China:

( )

South Africa:CELUTION FOR CARDIOVASCULAR (‘446)

Mexico:C (‘348)BEDSIDE COMPREHENSIVE

DEVICE (‘059)CELUTION OUTPUT PLUS PROSTHETICFOR BONE RELATED DISORDERS (‘716)CELLS PLUS FAT PLUS ADDITIVES (‘795)C P F (‘672)

China:CELUTION DEVICE (‘689)CELUTION FORCARDIOVASCULAR (‘104)

Japan:

CELUTION FUTURE GENERATIONS (‘348)CELUTION FOR CARDIOVASCULAR (‘775)

Russia:CELUTION FOR CARDIOVASCULAR (‘924)

CELLS PLUS FAT (‘672)

Europe:CELUTION FOR ACUTETUBULAR NECROSIS (‘834)

pCELUTION DEVICE (‘952)DEVICES FOR CELLS PLUS FAT (‘041)CLINICALLY SAFE (‘556)

India:CELUTION DEVICE (‘706)CELUTION FUTURE GENERATIONS (‘529)CELUTION DEVICE FOR TREATING WOUNDHEALING (‘580)

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Israel:CELUTION DEVICE WITH CENTRIFUGE ORFILTER (‘800)

Financials

Cash (Q3, 2011) $41 million

GE L $25 illiGE Loan $25 million

Shares Outstanding 55 millionW t ( i $ 3 80) 12 illiWarrants (average price $ 3.80) 12 millionVested Options (average price $5) 5 million

Q3 N h d i ti ti iti $7 9Q3 New cash used in operating activities $7.9

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Potential Near-Term Catalysts

Celution® One CE Mark

CE Mark for Chronic myocardial ischemia

I iti t h i di l i h i t i l i U S Initiate chronic myocardial ischemia trial in U.S.

Breast reconstruction technology evaluation in UK (reimbursement)

Celution® System approval in additional major countries

Additional partnerships

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Cytori Therapeutics(NASDAQ CYTX) (NASDAQ: CYTX)

Lazard Capital Markets 8th Annual Healthcare Conference

November 16 2011November 16, 2011

Mark E. Saad, Chief Financial Officer

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Investor Relations

Cytori Lazard Healthcare Conf. Presentation