Personalized Cell Therapy C Y T O R I A TRUSTED LEADER IN CELL THERAPY NASDAQ: CYTX
Dec 05, 2014
Personalized Cell Therapy C Y T O R I
A TRUSTED LEADER IN CELL THERAPY NASDAQ: CYTX
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.
i. Business & Technology Overview
ii. ATHENA Trial
iii. BARDA
iv. Commercial Growth
v. Corporate
C Y T O R I C E L L T H E R A P Y
The Future of Medicine: Cell Therapy
T 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
Unique Device Model: Point-of-Care
Your tissue is processed right at the side of your bed
T 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
CE Mark Approved in EU for tissue ischemia & wounds
Recurring Revenue Model
A proprietary single-use consumable set is required
for each procedure
(Concept: Razor-blade)
T 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
Platform: Many Indications
VASCULAR Heart failure Heart attack PVD / PAD Liver Cirrhosis Kidney Injury Stroke Other
TISSUE Fistula
Wounds Incontinence
Sports / Ortho Tissue Ischemia
Breast Recon/Aug Radiation / Burn
T 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
Clinical Leadership Today
Thousands of patients around the world have been treated
using their own cells with Cytori products
T 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
% Hospitals Penetrated
Number of Hospitals
Proc. Per Week
Cartridge ASP ** Annual Revenue
10% 2,500 3 $5,000 $2 billion
20% 5,000 3 $5,000 $4 billion
30% 7,500 3 $5,000 $6 billion
**Cartridge ASP expected to be at least $5,000; Est. $2,500 in tissue, $8-12,000 in vascular
Worldwide Opportunity (Est. 25,000 Hospitals)
Annuity Business Model
T 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
A few uses per week drives Significant revenue
i. Establish ADRC’s as the standard for
cells in the emerging Regenerative
Medicine field (Device / Tool claims)
ii. Develop market access for specific
targeted indications (Therapeutic
Claims)
T 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
Strategy
T 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
T 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
T 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
Operating System Application Software
T 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
Operating System Application Software
TRANSLATIONAL MEDICINE
T 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
Device / Tool Claims
T 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
Device / Tool Claims
T 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
Device / Tool Claims
T 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
Device / Tool Claims
Device INTRAVASE
Broad Vascular Access - AMI - PVD / PAD - CHF - Liver - Stroke - Kidney
No Option CMI
Tissue
T 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
Therapeutic Products
Tissue
i. Business and Technology Overview
ii. ATHENA Trial
iii. BARDA
iv. Commercial Growth
v. Corporate
C Y T O R I C E L L T H E R A P Y
Condition: Severe form of coronary artery disease due to chronic
myocardial ischemia and leads to death
Disease Course: Declining cardiac function leads to heart
transplantation or death
Size of Market: Approx.120K to 250K diagnosed each year in U.S.
(subset of approx. 5.8 MM heart failure patients)
Cytori Cell Therapy: Potential to revive living but stressed heart
tissue; Halt progressive disease & keep patient off transplant list; overcome limits of existing drugs, devices and surgical options
Refractory Heart Failure
ADRCs may preserve functional capacity,
improve perfusion, reduce scar, improve left ventricular
contractility and lead to lower mortality
• Safety: No malignant arrhythmias, adverse events similar in both groups; Harvesting ADRCs and transendocardial delivery is safe
and feasible in patients with CAD
• MVO2 & METS: Preserved function in ADRC at 6 & 18 months
compared to controls (p=0.03, p=0.01)
• Total Left Ventricular Mass (MRI): ADRCs demonstrated
significant improvement over controls (p<0.001)
• Wall Motion Score Index: ADRCs demonstrated significant
improvement in wall motion score index (p<0.04) with a
stabilization of scar size compared to controls
• Inducible Ischemia (SPECT): was reduced in ADRCs patients up
to 18 months (p<0.05)
• Patient Age: Patient’s in ADRCs group are 10 years older than
placebo (65.8 vs 55.7 years; p=0.002)
• Cardiac Mortality: At 27 month follow-up, fewer ADRC patient
deaths compared to controls
(1 of 21 in ADRCs vs 2 of 6 Controls; p=0.10)
PRECISE TRIAL
U.S. Refractory Heart Failure Trial
Adipose-derived regenerative cells in the Treatment of patients
with chronic ischemic HEart disease Not Amenable to surgical or
interventional revascularization Objective To assess the safety and feasibility of Adipose-Derived Regenerative
Cells delivered via an intramyocardial route in the treatment of
chronic ischemic heart disease in patients who are not eligible for
percutaneous or surgical revascularization
Design Device-based (PMA/IDE) prospective, randomized, placebo-
controlled, double-blind safety and feasibility clinical trial
Sample Size 45 Subjects, randomized 2:1 (ADRCs:Placebo)
Study Location 6 centers in the United States
Dose: 0.4 million cells/kg body weight
Endpoints - Clinical safety through 12 months
- Peak oxygen consumption (VO2 Max) at 6 months
- Perfusion defect at 6 months
- LV end-systolic and diastolic volume at 6 months
- Ejection fraction at 6 months
- Re-hospitalization, heart failure symptoms & quality of life @ 12 mo
Refractory Heart Failure
Status:
All centers actively screening
• Minneapolis Heart Institute (Timothy Henry MD)
• Texas Heart Institute (Emerson Perin MD, PhD, James, Willerson, MD)
• University of Florida (Carl Pepine MD)
• University of South Florida (Leslie W. Miller MD)
• Scripps Green Hospital (Richard Schatz MD)
• Cardiology P.C. (Farrell Mendlesohn MD)
Complete enrollment mid-Summer 2013
6-month data first half 2014
Define Pivotal Trial Design
• Detailed protocol and trial size to be determined by ATHENA outcomes
• Likely endpoints to include a functional and composite clinical outcome
C Y T O R I C E L L T H E R A P Y
i. Business and Technology Overview
ii. ATHENA Trial
iii. BARDA
iv. Commercial Growth
v. Corporate
• $4.7 MM in funding
• Preclinical model
• Next-Gen Celution® development
• Up to 2 years
Proof-of-Concept
• Up to $55 MM
• Development including clinical
• Govt. has procurement ability
Options 1 & 2 • Up to $45 MM
• Pivotal trial
• FDA submission
Option 3
1. ADRCs can be extracted from patients with thermal burn injury
Availability 2. CT-X2 is as good as Celution 800
Processing 3. ADRCs from an irradiated animal improve healing of concomitant thermal burn
Function
BARDA: Proof-of-Concept
Proof-of-Concept Success unlocks Options 1 & 2 – up to $ 55 Million
Product Evolution
Smaller. Faster. Cheaper. Higher Yields.
1. Cytori developed interim Celution 800 System (Cytori) 2. Olympus designed Celution One System (OC-JV) 3. Cytori designed Next Gen System (BARDA)
1. 2. 3.
i. Business and Technology Overview
ii. ATHENA Trial
iii. BARDA
iv. Commercial Growth
v. Corporate
C Y T O R I C E L L T H E R A P Y
Commercial Growth to Profitability
Japan
Profitable region
Class 1 device designation 2H
2012
Distributors and translation med to
drive sales
Europe
vascular & translational med
3 people
Tissue Ischemia CE Mark
Intravascular CE Mark
Intravascular IRB & translational
medicine to drive sales
North America
Low-cost distributor model
2 people
Puregraft approved in US & Canada
CE Mark in Canada Pending
PG extension + growing fat transfer to drive growth & build relationships
Emerging Markets
Minimal 2012 loss, Profitable in 2013
1 person
Targeting select countries that
recognize CE Mark
Intravascular IRB sales
Australia TGA approval pending
% Rev ‘12: 52% 24% 13% 11% profitable investing near B/E near B/E ‘13: Profitable investing break-even profitable
Translational Medicine: Near-Term Revenue Driver
Pivotal trials, grants (BARDA), partnerships, regulatory
approvals, reimbursement
Incontinence
Radiation injury
Vascular CE Mark
Investigator-initiated trials resulting in:
• Meaningful sales to offset burn
• Expansion of physician and
hospital network
• Strategic benefit of development
of new applications/pipeline
T 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
2013 Revenue Guidance of $15 Million
$12 million in product sales
$ 3 million in contract revenue (BARDA)
Accelerate year over year revenue growth
Positive contribution margin for full year 2013
2012 Revenue
Total product revenue of $8.7 million
BARDA contract revenue of $0.4 million
Total cash revenue of $9.1 million, 14% growth over 2011
Q4 gross profit of $2.6 million exceeded S&M expenses of $2.1 million
Accelerating Revenue Growth
T 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
C Y T O R I C E L L T H E R A P Y
i. Business and Technology Overview
ii. ATHENA Trial
iii. BARDA
iv. Commercial Growth
v. Corporate
Financials
Current Select Data
PF cash & AR (YE 2012) $32 MM
Senior Term Loan (GE) $22 MM maturing in 2015
Shares outstanding 67 MM
Warrants 10 MM @ $3.25 avg. exercise price
2013 Guidance
Revenue $15 MM ($12 m product, $3 m contract)
SG&A Flat for year
R&D Slight increase, more than offset by BARDA revenue
T 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
57 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)
T 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
Present / Publish PRECISE long-term data (18 months) -
Advance BARDA toward Phase II -
Partnership with Cash upfront -
Complete patient enrollment in ATHENA by mid-summer 2013 -
Achieve 25 pts enrolled in ADVANCE; Add Canada -
Achieve $15 million revenue target for 2013 (incl $2.5 - 3m Barda) -
Expand PG line (PG-50) with 510k clearance & market launch -
Define approval path with FDA for Refractory Heart Failure in US -
Expand Celution approvals ( ie Canada, Australia) -
2013 Milestones
Personalized Cell Therapy
C Y T O R I
A T 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