LD Micro Conference

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CFO Mark Saad presents at the LD Micro Conference on December 5, 2014

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LD Micro Conference

  1. 1. Cytori Corporate Overview NASDAQ: CYTX December 5, 2013 LD Micro Main Event
  2. 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. 3. Summary Transformative technology platform – Cell therapy regulated as a device – Business model: single use consumables Clinical experience in thousands of patients Strong IP protection Near term value drivers – U.S. government contract milestones (BARDA) – Phase II U.S. cardiovascular trial data – International approvals and revenue growth
  4. 4. AdiposeAdipose-Derived Regenerative Cells: Easily Accessible in Hospital & Clinic Proprietary Formulation of Cells • Autologous (Patient’s own cells) • Point-of-care availability (no offsite manufacturing) • Patented process • Virtually ‘off the shelf’ – ideal for physician workflow
  5. 5. AdiposeAdipose-Derived Regenerative Cells: Commercial Model & Economics Cell therapies offered via device & single-use consumable… allows for favorable pricing, reimbursement, and margins System: • • Low six figure ASP (current generation) 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. 6. AdiposeAdipose-Derived Regenerative Cells: Available via Innovative Device Technology • • • Regulatory Path: U.S. PMA Device, EU and ROW Device Per treatment consumable MSRP $2,000 - $10,000 (indication specific) More than just “stem cells” – Device output yields multiple cell types – Benefit from multiple mechanisms-of-action
  7. 7. AdiposeAdipose-Derived Regenerative Cells: Areas of Focus Cardiac • Completed proof-of-concept trial • Enrolling U.S. Phase II Heart Failure trial Soft Tissue New opportunities leveraging the platform • Up to $106 MM in development funding • Commercial preparedness contract with U.S. Government • Potential to fully fund PMA for burns Commercial Research Market • Japan approval • EU ‘Vascular’ approval • Clinical experience in thousands of patients
  8. 8. Need for Cardiac Cell Therapy Damage from acute MI and chronic ischemia causes: reduced function left ventricular failure . . . Death
  9. 9. Need for Cardiac Cell Therapy Current therapy does not address damage to the heart No Current “Regenerative Therapies” approved for Heart
  10. 10. Need for Cardiac Cell Therapy Cytori Cell Therapy Chronic Myocardial Ischemia Cells delivered intra-myocardial Acute MI Cells delivered intra-coronary within 24 hours of AMI
  11. 11. Cytori Cell Therapy 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
  12. 12. Cardiac Cell Therapy Development Pipeline Development Pipeline Chronic Pilot Complete U.S. Phase II (ATHENA) Pivotal 2015 Pilot trial: • Cells shown to be safe; no adverse effects on rhythm at 6 & 18 months • Statistically significant stabilization in VO2Max vs placebo Phase II ATHENA trials: • 90 patients, multi-center, double blind, placebo-controlled • Advance to pivotal in 2015
  13. 13. Cardiac Cell Therapy PRECISE Pilot Showed Proof-of-Concept Proof-ofObjective: Safety and feasibility of intramyocardial injection in patients not amenable to revascularization Design: Double-blind, randomized, parallel group, placebo-controlled Size 27 subjects (Spain, Netherlands, Denmark; 21 Treated, 6 Placebo) Procedure • Electromechanical mapping (NOGASTAR®) • ≤ 15 intramyocardial injections of cells (median dose = 42 x 106 per subject) or placebo (indistinguishable solution) in the area with inducible ischemia via MYOSTAR® Injection Catheter Note: Higher doses not consistently achieved – all doses combined into one treatment group
  14. 14. Cardiac Cell Therapy PRECISE Pilot Trial: Data Summary Summary Results • Holter: no adverse effects on rhythm at 6 and 18 months • VO2Max: improvement (p<0.05 vs. placebo) – Supported by NYHA improvement trend • MRI: reduction in infarct size (p<0.05 vs. placebo) • No safety issues • Mortality [36 months]: placebo 33% (2/6) , ADRC 14% (3/21)
  15. 15. Cardiac Cell Therapy PRECISE Pilot Trial: Exercise Tolerance Change in VO2Max at 6 and 18 Months 20 VO2 Max 18 16 ADRCs 14 Placebo 12 Baseline 6 months 18 months
  16. 16. Cardiac Cell Therapy ATHENA I & II U.S. Heart Failure Trials • Heart failure due to ischemic heart disease • Phase II Trials based on EU Pilot (PRECISE) • Prospective, double-blind, placebo-controlled trials – 90 patients: 45 patients at lower dose, 45 patients at higher dose – Up to 10 centers • First data readout targeted for 2014 • Potential for pivotal trial initiation in 2015
  17. 17. Cardiac Cell Therapy ATHENA Endpoints • Safety • Treatment emergent Serious Adverse Events (SAEs) • Arrhythmia assessment via 24-hour Holter monitoring • MACE defined as Cardiac Death or Hospitalization for Heart Failure • Efficacy • • • • VO2 Max (treadmill) (6 mo) LVEF, LVESV/LVEDV assessed by Echo (6 mo) Perfusion defect by Rest/Pharmacologic Stress SPECT (6 mo) Heart failure symptoms, angina, and quality of life (3, 6, 12 mo): • NYHA and CCS classifications • Minnesota Living with Heart Failure Questionnaire (MLHFQ) • SF-36 Health Survey
  18. 18. BARDA Contract Contract objective: National preparedness grant worth up to $106 million in reimbursed development funding to create a treatment for thermal burns combined with radiation Clinical development: » PMA-based pathway for traditional burns » Development from preclinical to FDA approval fully funded » Cytori’s first U.S. soft tissue indication Commercialization & Procurement » Cytori maintains commercial rights for approved label » Government can make direct purchases or facilitate orders from hospitals for preparedness purposes » Procurement potential is above and beyond contract funding
  19. 19. BARDA Contract Discussions Begin 2010 Award 3 Proof-of-concept Objectives Announcement Ongoing Fall, 2012 Cell viability Pre-Award, White Papers, Proposal, Negotiation 3 Objectives Trigger Option 1 & 3 Q1, 2014 Option 1 Objective Triggers Option 2 Q4, 2015 $32.6 M Option 1 Animal model POC $45.5M Option 2 Next Gen device feasibility $4.7M Phase 1 Proof of Concept $23.4M Option 3 Commercial Acquisition at BARDA’s Discretion
  20. 20. Commercialization Emphasis: Researchers performing independently funded studies » 50+ studies worldwide completed, in process or planned using Celution® Rationale: New indications and approvals expand pipeline and opportunities I. Ex: BARDA contract worth up to $106 MM (Sep. 2012) II. Ex: Lorem Vascular: $24 MM equity, $500 MM milestones (Nov. 2013) III. Future additional pipeline indications and collaborations Growth: International regulatory approvals and partnerships I. Japan Class I clearance achieved / pending legislation to expand II. Europe: Vascular delivery & ischemic tissue and muscle approvals III. Asia Pacific: » Australia & Singapore approvals
  21. 21. Lorem Vascular Partnership Accelerates Cardiac Business & Revenue Growth Celution® System Commercialization rights Territories: Australia, China, Hong Kong, Malaysia, & Singapore Indications: All indications w/initial focus on cardiac, diabetes and renal Agreement Terms Equity: $24 million; 8 million shares at $3.00 per share Milestones: Up to $500 million in commercial milestones Supply agreement: Cytori receives transfer margin on long-term agreement Partner Lorem Vascular: Newly formed company dedicated to Celution® products Resources: Founders committing capital to fund operations Distribution Plan: Combination of direct sales and distributors
  22. 22. Cytori Cell Therapy: Intellectual Property Meg 60 Patents Issued Worldwide; More than 75 Pending Applications 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) US: (1) CELUTION & FUTURE GENERATIONS (‘075) 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) EUROPE: (2) ADRCS FOR CARDIAC (‘382) OPPOSED DEVICE FOR RESTORING BLOOD FLOW (‘575) US: (4) CELUTION FOR BONE (‘043) CELUTION OUTPUT PLUS JAPAN: (2) CELUTION DEVICE (‘952) CELUTION FOR CLINICALLY SAFE OUTPUT (‘556) KOREA: (3) CELUTION DEVICE (‘995) STEMSOURCE DEVICE (‘812) CELUTION DEVICE (‘139) CHINA: (1) CELUTION & FUTURE GENERATIONS (‘241) HONG KONG (1) CELUTION & FUTURE GENERATIONS (‘322) INDIA: (1) CELUTION WITH FILTER (‘529) CENTRIFUGE OR AUSTRALIA: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘937) INDIA: (1) CELUTION DEVICE (‘706) SINGAPORE: (1) CELUTION & FUTURE GENERATIONS (‘683) AUSTRALIA: (2) CELUTION DEVICE (‘135) STEMSOURCE DEVICE (‘901) ISRAEL: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘800) CHINA: (1) CELUTION DEVICE (‘689) MEXICO: (1) CELUTION & FUTURE GENERATIONS (‘348) OLYMPUS-CYTORI PATENTS NEXT GENERATION DEVICE - JAPAN KOREA: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘305) CENTRIFUGAL CONTAINER (‘020) DIGESTIVE ENZYMES (‘861) JAPAN: (1) CELUTION BUSINESS METHOD 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) OPPOSED AUSTRALIA: (1) ADRCS FOR CARDIAC (‘858) ADRCS FOR REMODELING (‘046) 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) 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) SOUTH AFRICA: (1) ADRCS FOR CARDIAC (‘446) JAPAN: (3) ADRCS FOR WOUND HEALING (‘699) CELUTION OUTPUT PLUS MEXICO: (1) CELUTION FOR RESTORING BLOOD FLOW (‘775) PROSTHETIC ISRAEL: (1) ADRCS FOR CARDIAC (‘354) CANADA: (1) ADRCS FOR RESTORING BLOOD FLOW(‘510) JAPAN: (2) CELUTION FOR RESTORING BLOOD FLOW(‘787) CELUTION FOR REMODELING (‘155) 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) CARDIAC CONTINUED KOREA (1) ADRCS FOR VENTRICULAR DILATION (‘170)
  23. 23. Financial Current Select Data Cash & AR (9/30/13) $13 MM Lorem Vascular Equity $24 MM Commitment ($12 MM received) Senior Term Loan $27 MM (Matures 2017) Shares Outstanding 71 MM + 4 MM to be issued to Lorem Vascular Warrants Outstanding 8.6MM @$2.63 (7.6MM expire by Sept 2014) Guidance 2013 Revenue Estimate $14 Million ($11 MM product + $3 MM BARDA) 2014 Expenses SG&A flat R&D to increase for BARDA; offset by dev. revenues Burn to decrease with sales growth
  24. 24. Upcoming Milestones • Achieve BARDA proof-of-concept objectives – Qualify for up to $56 MM in further development funding • Complete enrollment in the U.S. ATHENA trial • Report six-month outcomes from the U.S. ATHENA trial • Publish three year data from the EU PRECISE chronic ischemic heart failure trial • Obtain product registration for the Celution® System in China • Accelerate growth in product and contract revenues
  25. 25. Cytori Corporate Overview NASDAQ: CYTX Thank you!

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