JMP Healthcare Conference 2013

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Cytori Corporate Overview NASDAQ: CYTX Mark E. Saad Chief Financial Officer JMP Securities Healthcare Conference July 10, 2013

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Presented by Mark Saad on July 10, 2013

Transcript of JMP Healthcare Conference 2013

Page 1: JMP Healthcare Conference 2013

Cytori Corporate Overview NASDAQ: CYTX

Mark E. Saad

Chief Financial Officer

JMP Securities Healthcare Conference

July 10, 2013

Page 2: JMP Healthcare Conference 2013

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.

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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

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Cytori Cell Therapy: Unique Attributes

Proprietary Formulation of ADRCs

• Autologous

• Mixed cell population

• Various mechanisms

• Patented process

• Virtually ‘off the shelf’

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Cytori Cell Therapy: Heterogeneity

Mechanisms of Action

• Paracrine (local growth factor delivery)

• Differentiation

• Inflammatory modulation

• Angiogenesis

• Wound healing

Tissue Macrophages

23%

White Blood Cells

22% Stem Cells

2%

CD34+/CD31-

37%

Endothelial Cells

7%

Vascular

Smooth

Muscle Cells

9%

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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

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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

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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

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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

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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

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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

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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

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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®