26th annual roth conference
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CFO Mark Saad presents at the 26th Annual Roth Conference on March 12, 2014TRANSCRIPT
Cytori Corporate Overview NASDAQ: CYTX
26th Annual Roth Conference
March 12, 2014
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.
Cytori Investment Summary
Highlights
• Phase II U.S. heart failure trial
• U.S. government contract (BARDA) for thermal burns
• Pipeline of therapeutic indications from independent
studies
Adipose-derived cell therapy with device model
• Cardiovascular disease & soft tissue injury
• Product & contract revenue partially offsets cash burn
• Thousands of patients treated worldwide
Cytori Cell Therapy
Mechanisms
• Improve blood flow
• Modulate inflammation
• Wound healing
• Autologous
• Virtually ‘off the shelf’
• Multiple cell types = multiple mechanisms
System:
• Low six figure ASP
• Next-generation system COGS < $10,000
Per-procedure consumable:
• $8,000-$12,000 for vascular indications
• $2,000-$3,000 for soft tissue
• >80% GM
Cell therapies via proprietary device & single-use consumables =
Favorable pricing and margin opportunity
Cytori Cell Therapy:
Commercial Model & Economics
Therapeutic Focus
CARDIAC SOFT TISSUE COMMERCIAL
RESEARCH MARKET
• U.S. Phase II in CHF
• Long term data from CHF
and AMI trials in EU
• Burns: U.S. gov’t contract
worth up to $106 MM
• Hamstring injury: U.S. trial
• EU/Japan approvals
• Research sales
• 50+ studies completed,
ongoing or planned
Cardiac Cell Therapy
• Damage to the heart leads to
reduced function, heart failure
and death
• Current therapy does not
address damage to the heart
muscle
PRECISE Pilot Showed Proof-of-Concept
PRECISE TRIAL:
• 27 patient double-blind, randomized, placebo controlled European trial
• Intramyocardial injection using electromechanical mapping in area with
inducible ischemia
• 18 month data presented, publication in process
DATA SUMMARY:
Feasibility (Exercise Tolerance)
• VO2Max (maximum oxygen consumption): improvement (p<0.05
vs. placebo)
• METS (metabolic equivalent): improvement (p<0.05 vs. placebo)
Safety
• No safety issues
• Mortality [36 mo]: placebo 33%, ADRCs 14%
12
14
16
18
20
Baseline 6 months 18 months
VO
2 M
ax
Change in VO2Max at 6 and 18 Months
ADRCs
Placebo
PRECISE Pilot Trial: Exercise Tolerance
ATHENA I & II:
U.S. Ischemic Heart Failure Trials
• Prospective, double-blind, placebo-controlled trials
– ATHENA I: 45 patients, 2:1 randomization at lower dose
– ATHENA II: 45 patients, 2:1 randomization at higher dose
– Up to 10 centers
Development Pipeline
Ischemic
Heart
Failure Pilot Complete
U.S. Phase II
(ATHENA I & II)
Pivotal
2015
SAFETY
• Serious Adverse Events (SAEs)
• Arrhythmia assessment
• MACE (Cardiac Death or Hospitalization for Heart Failure)
EFFICACY
• VO2 Max (6 mo)
• LVEF, LVESV/LVEDV (6 mo)
• Perfusion defect (6 mo)
• Heart failure symptoms, angina, and quality of life (3, 6, 12 mo)
ATHENA I Endpoints
Ischemic Heart Disease: Market Dynamics
Ischemic heart disease in the United States
• Direct & indirect costs of heart failure estimated at $19.5B (2009)
• $11.7B paid to Medicare beneficiaries (2006)
• Medical costs of IHD expected to double 2013 to 2030
• Estimated incidence is 200,000 – 500,000 patients/year in the U.S. alone
Ischemic heart disease in Europe
• IHD expected to cost EU economies €60B/yr
• Estimated that 34.4M and 12.1M disability adjusted life years are lost in Europe
and the EU respectively each year due to IHD
Few, if any, new pharmaceutical approaches for IHD
Soft Tissue
• Thermal burns due to radiation injury
• Sports medicine (hamstring injury)
• Wound repair applications
BARDA Contract
Pre-Treatment 18 Mo. Post-Treatment Ex. Cytori Cell
Therapy in a chronic
thermal burn case
study
National preparedness grant worth up to $106 MM to develop
treatment for thermal burns combined with radiation injury
• In-Process Review anticipated in 1H2014 to determine if contract
options are awarded
• Contract options fully fund development from preclinical through FDA
PMA trial
• Cytori maintains commercial rights, possibility of government
procurement purchases
BARDA Development Pathway
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
• Trial Design: – Part A: 10 patient open-label, safety, feasibility & dose-escalation
– Part B: 60 patient, double-blind, placebo-controlled safety, feasibility & dosing study
– Safety & functional end-points
16
U.S. RECOVER Trial: Hamstring Injury
Randomized, double-blind, placebo-controlled trial to evaluate
Cytori Cell Therapy for tears of the hamstring muscle
• Hamstring injuries are a persistent problem among elite and amateur athletes given the high incidence and recurrence rates, as well as the lengthy recovery time
• Broad range of indications, including:
• Ex: Chronic radiation wound case study in Japan
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Wound Repair: Independent Research
Promising data from multiple independent research studies
- Cryptoglandular peri-anal fistula - Fistula post gastroenterological surgery
- Diabetic foot ulcer - Scleroderma in the hand
- Crohn’s fistula
Exposed Sacrum
1 Year Post Op Immediate Pre Op Intra Op, Debrided
90% cells to circular area
around sore
10% cells to sore itself
Intra Op, Post-Cell Rx
Commercial Research Market: Overview
• Targeted commercial sales ex-US to researchers
performing independently funded studies
• System and consumables sales generate commercial
revenue and gross margin
• Expands pipeline R&D to identify potential indications for
future development and partnering opportunities
Revenue Upside: Research Sales
• Targeted global commercial
sales
• Research customers under
international regulatory
approvals:
• Japan Class I clearance
• CE Mark vascular delivery
(Intravase®)
• New markets: Australia,
Singapore
Completed or ongoing studies Planned studies
Worldwide Investigator-Led Research
50+ studies worldwide completed, in process or planned
• Publications of independent
research using Cytori Cell Therapy
• Broad range of study indications
including:
• Stress urinary incontinence
• Scleroderma
• Hamstring injury
• ACL
• Parry Romberg syndrome
• Ischemic heart disease
Strategic Upside: Research Sales
• Outsources R&D for future pipeline indications
• Supports partnerships and other strategic
collaborations
• Ex: BARDA: U.S. government contract supported by Japanese
research radiation injury data and UK burn data
• Ex: Lorem Vascular: commercialization partnership based on
combination of Cytori clinical data and independent research data
Commercial Partnership: Lorem Vascular
Celution® System Commercialization Rights
Agreement Terms
• Newly formed company dedicated to Celution® products
• Australia, China, Hong Kong, Malaysia, & Singapore
• $24 million; 8 million shares at $3.00 per share
• Up to $500 million in commercial milestones
• Cytori receives transfer margin on long-term agreement
Global Intellectual Property
• 65 patents issued worldwide; 85 applications pending
• Cover current & future Celution® Systems, methods, use of
adipose-derived regenerative cells for soft tissue, cardiac and
pipeline indications
29%
15%
7%
33%
16%
Geographic Distribution
U.S.
Japan
Europe
Asia-Pacific - Other
Other
41%
23%
18%
18%
Patent Type
Devices - Current/Next-Gen
Cardiovascular
Reconstructive Surgery
Pipeline Therapies
Financials
Current Select Data
Cash $24.5 MM (pro forma as of 12/31/13)
Senior Term Loan $27 MM (Matures 2017)
Shares
Outstanding
75 MM
Warrants
Outstanding
8.6MM @$2.63
(7.6 MM expire by Sept 2014)
Upcoming Milestones
CARDIOVASCULAR
– Complete enrollment in the U.S. ATHENA trial
– Report six-month outcomes from the U.S. ATHENA trial
– Publish PRECISE chronic ischemic heart failure trial long-term data
SOFT TISSUE
– BARDA decision for potential contract expansion
– Initiate enrollment in U.S. trial (Part A) for hamstring injury
COMMERCIAL RESEARCH SALES
– Growth in product & contract sales in 2014
– Achieve product registration for the Celution® System in China
Cytori Investment Summary
Highlights
• Phase II U.S. heart failure trial
• U.S. government contract (BARDA) for thermal burns
• Pipeline of therapeutic indications from independent
studies
Adipose-derived cell therapy with device model
• Cardiovascular disease & soft tissue injury
• Product & contract revenue partially offsets cash burn
• Thousands of patients treated worldwide
Cytori Corporate Overview NASDAQ: CYTX
Thank you!