C Y T O R I. Personalized Cell Therapy A TRUSTED LEADER IN CELL THERAPY NASDAQ: CYTX

Transcription

1 C Y T O R I Personalized Cell Therapy A TRUSTED LEADER IN CELL THERAPY NASDAQ: CYTX

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 i. Business & Technology Overview ii. ATHENA Trial iii. BARDA iv. Commercial Growth v. Corporate C Y T O R I C E L L

4 The Future of Medicine: Cell Therapy

5 Unique Device Model: Point-of-Care Your tissue is processed right at the side of your bed CE Mark Approved in EU for tissue ischemia & wounds

6 Recurring Revenue Model A proprietary single-use consumable set is required for each procedure (Concept: Razor-blade)

7 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

8 Clinical Leadership Today Thousands of patients around the world have been treated using their own cells with Cytori products

9 Annuity Business Model Worldwide Opportunity (Est. 25,000 Hospitals) % 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 A few uses per week drives Significant revenue **Cartridge ASP expected to be at least $5,000; Est. $2,500 in tissue, $8-12,000 in vascular

10 Strategy 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)

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13 Application Software Operating System

14 Application Software Operating System TRANSLATIONAL MEDICINE

15 Device / Tool Claims

16 Device / Tool Claims

17 Device / Tool Claims

18 Device / Tool Claims INTRAVASE Device Tissue No Option CMI Broad Vascular Access - AMI - PVD / PAD - CHF - Liver - Stroke - Kidney

19 Therapeutic Products Tissue

20 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

21 Refractory Heart Failure 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

22 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 MVO 2 & 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 PRECISE TRIAL (1 of 21 in ADRCs vs 2 of 6 Controls; p=0.10)

23 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 Design Sample Size Study Location Dose: Endpoints 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 Device-based (PMA/IDE) prospective, randomized, placebocontrolled, double-blind safety and feasibility clinical trial 45 Subjects, randomized 2:1 (ADRCs:Placebo) 6 centers in the United States 0.4 million cells/kg body weight - Clinical safety through 12 months - Peak oxygen consumption (VO 2 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 12 mo

24 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 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

25 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

26 Proof-of-Concept Success unlocks Options 1 & 2 up to $ 55 Million BARDA: Proof-of-Concept 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 $4.7 MM in funding Preclinical model Next-Gen Celution development Up to 2 years Proof-of-Con cept Options 1 & 2 Up to $55 MM Development including clinical Govt. has procurement ability Up to $45 MM Pivotal trial FDA submission Option 3

27 Smaller. Faster. Cheaper. Higher Yields. Product Evolution 1. Cytori developed interim Celution 800 System (Cytori) 2. Olympus designed Celution One System (OC-JV) 3. Cytori designed Next Gen System (BARDA)

28 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

29 Commercial Growth to Profitability Japan Europe North America Emerging Markets Profitable region vascular & translational med 3 people Low-cost distributor model 2 people Minimal 2012 loss, Profitable in person Class 1 device designation 2H 2012 Tissue Ischemia CE Mark Intravascular CE Mark Puregraft approved in US & Canada CE Mark in Canada Pending Targeting select countries that recognize CE Mark Distributors and translation med to drive sales Intravascular IRB & translational medicine to drive sales PG extension + growing fat transfer to drive growth & build relationships 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

30 Translational Medicine: Near-Term Revenue Driver Investigator-initiated trials resulting in: Meaningful sales to offset burn Expansion of physician and hospital network Radiation injury Vascular CE Mark Strategic benefit of development of new applications/pipeline Incontinence Pivotal trials, grants (BARDA), partnerships, regulatory approvals, reimbursement

31 Accelerating Revenue Growth 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 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

32 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

33 Financials Current Select Data PF cash & AR (YE 2012) $32 MM Senior Term Loan (GE) $22 MM maturing in 2015 Shares outstanding Warrants 67 MM 10 $3.25 avg. exercise price 2013 Guidance Revenue SG&A R&D $15 MM ($12 m product, $3 m contract) Flat for year Slight increase, more than offset by BARDA revenue

34 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) 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) JAPAN: (1) CELUTION FOR RESTORING BLOOD FLOW( 787)

35 2013 Milestones 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 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) -

36 Personalized Cell C Y Therapy T O R I A T R U S T E D L E A D E R I N C E L L