Cytori Corporate Overview NASDAQ: CYTX

Transcription

1 Cytori Corporate Overview Jefferies Global Healthcare Conference June 4, 2014 Mark Saad, CFO

2 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.

3 Cytori Investment Summary Adipose-derived cell therapy with device model Cardiovascular disease & soft tissue injury Product & contract revenue partially offsets cash burn Thousands of patients treated worldwide Highlights Phase II U.S. heart failure trial U.S. government contract (BARDA) for thermal burns Pipeline of therapeutic indications from independent studies

4 Cytori Cell Therapy Autologous Virtually off the shelf Multiple cell types = multiple mechanisms Mechanisms Improve blood flow Modulate inflammation Wound healing

5 Cytori Cell Therapy: Commercial Model & Economics Cell therapies via proprietary device & single-use consumables = Favorable pricing and margin opportunity 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

6 Therapeutic Focus CARDIAC SOFT TISSUE COMMERCIAL RESEARCH MARKET U.S. Phase II in CHF Long term data from CHF & AMI trials in EU Burns: U.S. gov t contract worth up to $106 MM EU/Japan approvals Research sales 50+ studies completed, ongoing or planned

7 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

8 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 Long term data accepted for publication in the American Heart Journal in April 2014 DATA SUMMARY: Feasibility (Exercise Tolerance) Safety VO 2 Max (maximum oxygen consumption): improvement (p<0.05 vs. placebo) METS (metabolic equivalent): improvement (p<0.05 vs. placebo) No safety issues Mortality [36 mo]: placebo 33%, ADRCs 14%

9 VO 2 Max PRECISE Pilot Trial: Exercise Tolerance 20 Change in VO 2 Max at 6 and 18 Months ADRCs 14 Placebo 12 Baseline 6 months 18 months

10 ATHENA I & II: U.S. Ischemic Heart Failure Trials Development Pipeline Ischemic Heart Failure Pilot Complete U.S. Phase II (ATHENA I & II) Pivotal 2015 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

11 ATHENA I Endpoints SAFETY Serious Adverse Events (SAEs) Arrhythmia assessment MACE (Cardiac Death or Hospitalization for Heart Failure) EFFICACY VO 2 Max (6 mo) LVEF, LVESV/LVEDV (6 mo) Perfusion defect (6 mo) Heart failure symptoms, angina, and quality of life (3, 6, 12 mo)

12 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 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

13 Soft Tissue Thermal burns due to radiation injury Sports medicine Wound repair applications

14 BARDA Contract National preparedness grant worth up to $106 MM to develop treatment for thermal burns combined with radiation injury In-Process Review scheduled for June 10, 2014 to review completion of milestones & review next steps Contract options fully fund development from preclinical through FDA PMA trial Cytori maintains commercial rights, possibility of government procurement purchases Pre-Treatment 18 Mo. Post-Treatment Ex. Cytori Cell Therapy in a chronic thermal burn case study

15 BARDA Development Pathway Discussions Begin 2010 Award Announcement Fall, Proof-of-concept Objectives Ongoing Cell viability 3 Objectives Trigger Option 1 & 3 Q2, 2014 Option 1 Objective Triggers Option 2 Q4, 2015 Pre-Award, White Papers, Proposal, Negotiation Animal model POC Next Gen device feasibility Up to $32.6 M Option 1 Up to $45.5M Option 2 $4.7M Phase 1 Proof of Concept Up to $23.4M Option 3 Commercial Acquisition at BARDA s Discretion

16 Sports Medicine Cytori s research provides a foundation for addressing sports related injuries through: Modulation of healing Reduction of inflammation Benefits observed in a number of complex tissue and muscle injuries, including heart disease 20 patient open-label, investigator initiated ACL study in Spain underway Led by Dr. Ramon Cugat, President of the Medical Council for the Catalan Soccer Delegation's Health Insurance Company Enrollment expected to be completed 2H

17 Wound Repair: Independent Research Promising data from multiple independent research studies Broad range of indications, including: - Cryptoglandular peri-anal fistula - Fistula post gastroenterological surgery - Diabetic foot ulcer - Scleroderma in the hand - Crohn s fistula Ex: Chronic radiation wound case study in Japan Exposed Sacrum 90% cells to circular area around sore 10% cells to sore itself Immediate Pre Op Intra Op, Debrided Intra Op, Post-Cell Rx 1 Year Post Op 17

18 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

19 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

20 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 ACL Parry Rhomberg syndrome Ischemic heart disease

21 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

22 Commercial Partnership: Lorem Vascular Celution System Commercialization Rights Newly formed company dedicated to Celution products Australia, China, Hong Kong, Malaysia, & Singapore Agreement Terms $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

23 Global Intellectual Property 66 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 Geographic Distribution Patent Type 33% 16% 7% 29% 15% U.S. Japan Europe Asia-Pacific - Other Other 18% 18% 23% 41% Devices - Current/Next-Gen Cardiovascular Reconstructive Surgery Pipeline Therapies

24 Financials Current Select Data Cash $22.8 MM (pro forma as of 3/31/14) Senior Term Loan $27 MM (Matures 2017) Shares Outstanding Warrants Outstanding 79.5 MM (7.5 MM expire within one year)

25 Cytori Management Marc Hedrick, MD, President & CEO StemSource Founder, UCLA Mark Saad, Chief Financial Officer UBS, Saloman, Smith Barney Steven Kesten, MD, EVP & Chief Medical Officer Uptake Medical, Boehringer Ingelheim, Rush Presbyterian St. Luke s Medical Center Clyde Shores, EVP, Marketing & Sales Baxter, Abbott Laboratories, Amgen, Prometheus Laboratories, decode Genetic Seijiro Shirahama, President Asia Pacific Touchmetrics K.K., Bristol-Myers Squibb K.K., Baxter Biotech Group

26 Upcoming Milestones CARDIOVASCULAR Complete enrollment in the U.S. ATHENA trial Report six-month outcomes from the U.S. ATHENA trial SOFT TISSUE BARDA decision for potential contract expansion COMMERCIAL RESEARCH SALES Modest growth in product & contract sales in 2014 Achieve product registration for the Celution System in China

27 Cytori Investment Summary Adipose-derived cell therapy with device model Cardiovascular disease & soft tissue injury Product & contract revenue partially offsets cash burn Thousands of patients treated worldwide Highlights Phase II U.S. heart failure trial U.S. government contract (BARDA) for thermal burns Pipeline of therapeutic indications from independent studies

28 Cytori Corporate Overview Thank you!