Annual Shareholder Meeting 2013
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Transcript of Annual Shareholder Meeting 2013
Personalized Cell TherapyPersonalized Cell TherapyC Y T O R IC Y T O R I
A TRUSTED LEADER IN CELL THERAPYNASDAQ: CYTX
Safe Harbor Statement
This presentation contains certain ‘forward-looking statements’ about Cytori Therapeutics, Inc. Allstatements, other than statements of historical fact, that address activities, events or developmentsthat 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 byour management in light of their experience and their perception of historical trends, currentconditions, expected future developments and other factors they believe to be appropriate.
The forward-looking statements included in this presentation involve known and unknown risks thatrelate to Cytori’s future events or future financial performance and the actual results could differmaterially from those discussed in this presentation. Risks and uncertainties that may cause Cytori'sactual results to differ materially from those discussed in the presentation can be found in the "RiskFactors" section of Cytori’s Form 10-K, Forms 10-Q and other filings with the United States Securitiesand Exchange Commission. We would advise reading our most recent annual report on Form 10-Kand quarterly report on Form 10-Q filed with the United States Securities and Exchange Commissionfor a more detailed description of these risks.
The forward-looking statements contained in this presentation represent Cytori’s estimates andassumptions only as of the date of this presentation and Cytori undertakes no duty or obligation toupdate or revise publicly any forward-looking statements contained in this presentation as a result ofnew information, future events or changes in Cytori’s expectations.
This presentation contains certain ‘forward-looking statements’ about Cytori Therapeutics, Inc. Allstatements, other than statements of historical fact, that address activities, events or developmentsthat 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 byour management in light of their experience and their perception of historical trends, currentconditions, expected future developments and other factors they believe to be appropriate.
The forward-looking statements included in this presentation involve known and unknown risks thatrelate to Cytori’s future events or future financial performance and the actual results could differmaterially from those discussed in this presentation. Risks and uncertainties that may cause Cytori'sactual results to differ materially from those discussed in the presentation can be found in the "RiskFactors" section of Cytori’s Form 10-K, Forms 10-Q and other filings with the United States Securitiesand Exchange Commission. We would advise reading our most recent annual report on Form 10-Kand quarterly report on Form 10-Q filed with the United States Securities and Exchange Commissionfor a more detailed description of these risks.
The forward-looking statements contained in this presentation represent Cytori’s estimates andassumptions only as of the date of this presentation and Cytori undertakes no duty or obligation toupdate or revise publicly any forward-looking statements contained in this presentation as a result ofnew information, future events or changes in Cytori’s expectations.
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Personalized Cell TherapyPersonalized Cell TherapyImprove the quality & length of life
through innovative CELL THERAPY productsImprove the quality & length of life
through innovative CELL THERAPY products
C E L L T H E R A P Y
World’s Safest Therapeutic Cells that HealWorld’s Safest Therapeutic Cells that Heal
4T R U S T E D L E A D E R I N C E L L T H E R A P Y
CYTORI: A Biotech Company
Near-Term Biotech Value Drivers
* US Clinical Trial DataQ2, ’14 - ATHENA
* US Gov’t Contract ExpansionQ1, ’14 - BARDA
* Strategic Partnership
Adipose-derived stem ®enerative cells (ADRCs)
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Near-Term Biotech Value Drivers
* US Clinical Trial DataQ2, ’14 - ATHENA
* US Gov’t Contract ExpansionQ1, ’14 - BARDA
* Strategic Partnership
1) Advance US Clinical Pipeline
2) Expand Global Clinical Development Pipeline viacommercial business with positive contribution margin
3) Strengthen Financial Position
Corporate ObjectivesCorporate Objectives
1) Advance US Clinical Pipeline
2) Expand Global Clinical Development Pipeline viacommercial business with positive contribution margin
3) Strengthen Financial Position
• US Heart Failure Indication– ATHENA (enrollment / Data)– ATHENA II– Type C Meeting with FDA
• BARDA Complete Phase I – Initiate Phase II of contract• Commercial efforts focused on Investigator Initiated
Studies and generating growth & positive contributionmargin in each region
• Sustainable Organization– Capital Plan– Achieve Budget Goals (revenue, margins, costs)
Vital PrioritiesVital Priorities
• US Heart Failure Indication– ATHENA (enrollment / Data)– ATHENA II– Type C Meeting with FDA
• BARDA Complete Phase I – Initiate Phase II of contract• Commercial efforts focused on Investigator Initiated
Studies and generating growth & positive contributionmargin in each region
• Sustainable Organization– Capital Plan– Achieve Budget Goals (revenue, margins, costs)
ATHENA TrialATHENA Trial
• Added 3 new sites (initiating in September) for a total of 8 sites• Amendment approved by FDA and all IRBs• Amendment to ATHENA (submitted to FDA) to change in inclusion
criteria related to nuclear medicine scanning as recommended bySAB
• New enrollment material to support sites & micro site is online:www.theathenatrial.com
• Aggressive site contact program• New clinical leadership & entire clinical team• IDE approved for ATHENA II with key change in inclusion criteria
related to nuclear medicine scanning as recommended by our SAB
• Added 3 new sites (initiating in September) for a total of 8 sites• Amendment approved by FDA and all IRBs• Amendment to ATHENA (submitted to FDA) to change in inclusion
criteria related to nuclear medicine scanning as recommended bySAB
• New enrollment material to support sites & micro site is online:www.theathenatrial.com
• Aggressive site contact program• New clinical leadership & entire clinical team• IDE approved for ATHENA II with key change in inclusion criteria
related to nuclear medicine scanning as recommended by our SAB
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Commercial BusinessFocused on Research Market Sales
• Investigator Initiated Studies• Indication specific global patient Registries• Targeting KOLs for specific indications• Expand ongoing IIS and Pilot work to new centers• Expanding into new markets, and expanding exiting claims
Increasing installed base of systems – est > 200 in the field
Limited consumable sales due to current market dominated by research customers
Registry use and new therapeutic targeted customers will provide more repeatconsumable sales – including our multiple CV sales
Changing Regulatory Landscape in Japan could open first Medical markets withFull Market Access
Positive contribution margin – profitable revenue by region 9
Focused on Research Market Sales• Investigator Initiated Studies• Indication specific global patient Registries• Targeting KOLs for specific indications• Expand ongoing IIS and Pilot work to new centers• Expanding into new markets, and expanding exiting claims
Increasing installed base of systems – est > 200 in the field
Limited consumable sales due to current market dominated by research customers
Registry use and new therapeutic targeted customers will provide more repeatconsumable sales – including our multiple CV sales
Changing Regulatory Landscape in Japan could open first Medical markets withFull Market Access
Positive contribution margin – profitable revenue by region
Commercial: Focused on Revenue GeneratingClinical Development Pipeline
GLOBAL INVESTIGATOR INITIATED CLINICAL STUDIES
Late Stage Active Complete/Published Total
Wound Healing 7 4 8 19
Sports / Ortho 3 7 0 10
Soft Tissue 2 7 4 13
Cardiovascular 8 1 0 9
Other 1 2 1 4
Total 21 21 13 55
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Late Stage Active Complete/Published Total
Wound Healing 7 4 8 19
Sports / Ortho 3 7 0 10
Soft Tissue 2 7 4 13
Cardiovascular 8 1 0 9
Other 1 2 1 4
Total 21 21 13 55
8 Approved IIS in Japan plus 6 current applications under review
• $4.7 MM in funding• Preclinical model• Next-Gen Celution®
development• Up to 2 years
ProofProof--ofof--ConceptConcept
• Up to $56 MM• Development
including clinical• Govt. has
procurement ability
Options 1 & 2Options 1 & 2• Up to $45 MM• Pivotal trial• FDA submission
Option 3Option 3
BARDA: $106 M Contract
ProcessingNext Gen Celution produces comparable output to Celution 800
AvailabilityADRCs can be extracted from patients with thermal burn injury
FunctionADRCs from an irradiated animal improve healing of concomitant thermal burn
Proof-of-Concept Success unlocks Options 1 & 2– up to $ 56 Million targeted for Q1, ‘14
Strengthen Financial PositionStrengthen Financial Position
Debt refinance compete: $8 million additional cash into the company defer principal payments 12+ months
PureGraft Asset divestiture• Cash, A/R at end of Q2 (pro-forma) $ 21.5 million
– Cash includes $5 M from PG asset divestiture
• 2 Key US Milestones with in 12 months– BARDA– ATHENA – US Phase II data
• Capital Plan– Strategic partnerships– Equity
Debt refinance compete: $8 million additional cash into the company defer principal payments 12+ months
PureGraft Asset divestiture• Cash, A/R at end of Q2 (pro-forma) $ 21.5 million
– Cash includes $5 M from PG asset divestiture
• 2 Key US Milestones with in 12 months– BARDA– ATHENA – US Phase II data
• Capital Plan– Strategic partnerships– Equity
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Dominant Intellectual Property Estate62+ Issued Patents; 75+ Pending
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)
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)
US: (6)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 +FAT (‘947)
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: (3)CELUTION FOR BONE (‘043)CELUTION OUTPUT PLUS
PROSTHETIC
FOR BONE RELATED
DISORDERS (‘716)ADRCS FOR WOUND
HEALING (‘580)
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)
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)
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)
US: (6)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 +FAT (‘947)
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: (3)CELUTION FOR BONE (‘043)CELUTION OUTPUT PLUS
PROSTHETIC
FOR BONE RELATED
DISORDERS (‘716)ADRCS FOR WOUND
HEALING (‘580)
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)
Key MilestonesKey Milestones
Australia, New Zealand Approvals• Complete enrollment in the ATHENA trial• Report six month outcomes from the ATHENA trial• Achieve proof-of-concept milestones in the BARDA contract and
qualify Cytori for up to $56 million in additional developmentfunding
• Initiate enrollment in the higher dose ATHENA II trial• Complete enrollment in the ATHENA II trial• Achieve product & contract revenue objective• Strengthen the company’s financial position
Australia, New Zealand Approvals• Complete enrollment in the ATHENA trial• Report six month outcomes from the ATHENA trial• Achieve proof-of-concept milestones in the BARDA contract and
qualify Cytori for up to $56 million in additional developmentfunding
• Initiate enrollment in the higher dose ATHENA II trial• Complete enrollment in the ATHENA II trial• Achieve product & contract revenue objective• Strengthen the company’s financial position
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Key MilestonesKey Milestones
• Expand clinical development pipeline viainvestigator initiated studies
• Additional Japan MHLW-CTG Approved Studies• Japan Legislative / Regulatory changes to Fast Track products• Initiate multiple new patient registries as part of
commercial strategy• Publish the 18-month outcomes from the PRECISE European
chronic ischemic heart failure trial• Continue to expand Intellectual Property portfolio
• Expand clinical development pipeline viainvestigator initiated studies
• Additional Japan MHLW-CTG Approved Studies• Japan Legislative / Regulatory changes to Fast Track products• Initiate multiple new patient registries as part of
commercial strategy• Publish the 18-month outcomes from the PRECISE European
chronic ischemic heart failure trial• Continue to expand Intellectual Property portfolio
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Personalized Cell TherapyPersonalized Cell TherapyC Y T O R IC Y T O R I
T H A N K Y O U !