Slide 1: Investor Presentation
Investor Presentation (NASDAQ: DCTH) August 2011
Slide 2: Forward-looking Statements
Forward-looking Statements This presentation contains forward-looking statements, within the meaning of federal securities laws, related to future events and future financial performance which include statements about our expectations, beliefs, plans, objectives, intentions, goals, strategies, assum
Slide 3: Company Highlights
Company Highlights • Making established chemotherapeutic drugs work better in target organs • Initial focus is high dose chemotherapy for improved disease control in the liver • Successful and highly statistically significant Phase III trial results reported • Received CE Mark approval for Class III
Slide 4: Potential $3.75 Billion Labeled Market Opportunity
Potential $3.75 Billion Labeled Market Opportunity* 355,712 • CE Mark in EU for delivery of melphalan to the liver permits physician use on a broad range of liver cancers • Potential $3 Billion Long term EU Market Opportunity* • Leverage CE Mark to gain regulatory approvals in Asia, America’s (EX US
Slide 5: Spectrum of Liver Cancer Treatments
Spectrum of Liver Cancer Treatments Type of Treatment Advantages Disadvantages o Non-invasive – Systemic toxicities Systemic o Repeatable – Limited efficacy in liver – Invasive/limited repeatability o Therapeutic effect Regional (e.g., IHP) – Multiple treatments are o Targeted required – 90% unresec
Slide 6: Open Surgical IHP - Where It All Began
Open Surgical IHP - Where It All Began Isolated Hepatic Perfusion: Proof of Concept, but High Morbidity and Non-Repeatable 6 DELCATH SYSTEMS, INC
Slide 7: The Delcath Chemosaturation System
The Delcath Chemosaturation System Three Steps of Chemosaturation 1) ISOLATION 2) SATURATION 3) FILTRATION Advantages of Chemosaturation • Improved disease control in the liver • Treats entire liver • Allows for ~ 100x effective dose escalation of drug agents at tumor site • Controls systemic toxici
Slide 8: Melphalan Dosing & Background
Melphalan Dosing & Background Type Dosing (mg/kg) Multiple Myeloma (label) 0.25 Chemoembolization 0.62 Surgical Isolated Hepatic Perfusion (IHP) 1.50 Myeloablation 2.50-3.50 Chemosaturation (PHP) 3.00 • Well understood, dose dependant, tumor preferential, alkylating cytotoxic agent that demonstrates
Slide 9: What Chemosaturation Offers
What Chemosaturation Offers Patients: o Significant improvement in disease control in the liver compared to standard of care in patients with unresectable hepatic melanoma mets o Manageable systemic toxicities o Time, so that primary cancers can continue to be treated Physicians: o Novel, targeted l
Slide 10: Patient referral pathway for chemosaturation
Identification of liver involvement Patient with no improvement from systemic therapy Primary Diagnosis Care of Cancer Medical Surgical Oncologist Oncologist Offers systemic therapy to Offers resection or other focal Transferred for treat Cancer therapy chemosaturation to treat cancer in Liver When
Slide 11: Summary of Phase III Results
Summary of Phase III Results • Primary endpoint exceeded, p value = 0.001, hazard ratio of .301 o Treatment arm shows 5x median hepatic progression free (hPFS) survival compared to control arm o CS/PHP median hPFS of 245 days compared to 49 days for BAC o 86% overall clinical benefit (CR + PR + SD)
Slide 12: Phase I/II NCI Trials - Neuroendocrine
Phase I/II NCI Trials - Neuroendocrine Neuroendocrine Tumor Trial Results (n=23)* Number (n) Pre-CS (Baseline) Primary Tumor Histology Carcinoid 3 Pancreatic Islet Cell 17 Response Not Evaluable (Toxicity, Incomplete Treatment, Orthotopic Liver 4 Transplantation) Post-CS #1 Progressive Disease 1 (+6
Slide 13: High Efficiency (HE) Filter Media Development
High Efficiency (HE) Filter Media Development STATUS: o Melphalan - Achieved consistent in-vitro first pass removal efficiency of 98% or better o Internal development project o Developed trade secret manufacturing process to create new filter medium EXPECTED BENEFITS: o Reduced systemic toxicity for
Slide 14: Product Development Pipeline
Product Development Pipeline Initial Opportunity Near Term (< 5 years) Intermediate Term (> 5 years) • All liver cancers - melphalan • HCC and CRC livers met global • Class III device • Additional drugs clinical trials • 3rd party melphalan • Other organs • Apparatus improvements • Leverage strong d
Slide 15: Clinical Data Development Plans
Clinical Data Development Plans • Utilize High Efficiency (HE) Filter o Concomitant therapy to complement standard of care treatments o Increase safety (reduce systemic side effects) of procedure o Small Pk study commencing in Q4 in Australia • Enroll clinical trials in 2012 to expand data and enhan
Slide 16: Total potential market by region
• US - largest opportunity for Melanoma • China- largest opportunity for HCC • CRC - largest opportunity worldwide 16 DELCATH SYSTEMS, INC *TPM Total Potential Market
Slide 17: EEA Landscape
EEA Landscape • CE Mark device approval covers 30 countries in the European Economic Area (EEA) • Indication is for “intra-arterial delivery of chemotherapeutic agent (melphalan hydrochloride) to the liver” • Hospitals procure melphalan separately from existing sources • Melphalan for injection appr
Slide 18: European Commercialization Plans
European Commercialization Plans Objective: broad commercial adoption Major Assumptions: • HE filter available for full commercial launch ( Q3 2012) • 6-8 Centers of Excellence for training • Initiate test market in 2011 for 6 months to validate assumptions and finalize model • Full commercializatio
Slide 19: European Marketing Considerations
European Marketing Considerations Reimbursement: o No centralized EEA device reimbursement body - regional and national systems o Devices typically reimbursed under DRG as part of a procedure o Immediate reimbursement plans: • Utilize existing codes where permitted until permanent reimbursement esta
Slide 20: European Interim New Technology Reimbursement Programs
European Interim New Technology Reimbursement Programs Interim New Technology Payment Programs Already Exist in Major European Markets 20 DELCATH SYSTEMS, INC
Slide 21: Market by Disease - EEA Device Only
Market by Disease - EEA Device Only Potential Total Germany UK France Italy Spain Netherlands Market Potential (Direct) (Direct) (Indirect) (Indirect) (Indirect) (Direct) ($ millions)1,2,3 (patients) Total Potential Market #Patients Ocular Melanoma 403 296 294 284 197 79 1,553 $46.6 Cutaneous Melano
Slide 22: U.S. FDA Regulatory Status
U.S. FDA Regulatory Status • On February 22, 2011, received Refusal to File (RTF) letter from the FDA § Manufacturing plant inspection timing § Product and sterilization validation § Additional statistical analysis clarification § Additional safety data o RTF stated that safety information provided
Slide 23: Market by Disease - USA
Market by Disease* - USA Potential Market Potential Market Potential Market ($MM) Liver Metastasis # Procedures # Patients $20K ASP ** (Avg 2.5/patient) Ocular 1,622 4,055 $81.1 Melanoma Cutaneous 11,883 29,708 $594.2 Melanoma TOTAL MELANOMA 13,505 33,763 $675.3 (Initial Expected Label) CRC 38,423 9
Slide 24: U.S. Commercialization Strategy
U.S. Commercialization Strategy • Initial focus on leading cancer centers and referring community hospitals • Market to Medical Oncologists via CSO • Direct Strategy to sell to Interventional Radiologists and Surgeons: 12 Sales & Medical Science Liaison territories ultimately expanding to as many as
Slide 25: U.S. Reimbursement Strategy
U.S. Reimbursement Strategy Strategy: intend to seek chemosaturation specific codes based upon value proposition relative to other cancer therapies o Physician: • Applied for CPT Category III code • Convert the Category III code to Category I following FDA approval o Hospital: • Apply for new ICD-9/
Slide 26: Strategy For Asia, Ex US America's, MEA and Australia
Strategy For Asia, Ex US America’s, MEA and Australia • Intend to leverage CE Mark to obtain reciprocal regulatory approvals for our Delcath Hepatic CHEMOSAT System • Utilize existing 3rd party melphalan available to physicians • Seek to secure strategic partners and specialty distributors • Intend
Slide 27: Market by Disease - Australia/Asia
Market by Disease - Australia/Asia Initial Target Markets (China, Japan, S. Korea, Taiwan, Australia) Total Potential China S. Korea Japan Taiwan Australia Potential Market (Drug) (Drug) (Device) (Drug) (Device) 1,2,3,4 (patients) Total Potential Market #Patients HCC (Primary) 197,082 7,486 7,625 4,
Slide 28: Intellectual Property
Intellectual Property Patent Protection • 7 issued U.S. patents, 10 foreign patents issued and 4 pending • Primary device patent set to expire August 2016 • Up to 5 years of patent extension post FDA approval Trade Secret Protection • Developed High Efficiency (HE) filter media via new manufacturing
Slide 29: Deep and Experienced Management Team
Deep and Experienced Management Team Years of Executive Title Prior Affiliation(s) Experience Eamonn Hobbs President and CEO AngioDynamics, E-Z-EM 30 AngioDynamics, RBC Capital David McDonald CFO 28 Markets Krishna Kandarpa, CMO and EVP, R&D Harvard, MIT, Cornell, UMass 37 M.D., Ph.D. Agustin Gago E
Slide 30: Financials
FINANCIALS
Slide 31: Financial Summary
Financial Summary Financial & Operating Overview • Follow On Offerings: Raised ~ $94 million since November 2009 • Burn Rate: Anticipate ~$3.0 million per month • Cash: ~ $53 million at July 31, 2011 • Debt: None • Shares Out: 48.0 million (54.8 million fully diluted*) • Institutional Ownership: ~ 2
Slide 32: Company Highlights
Company Highlights • Making established chemotherapeutic drugs work better in target organs • Initial focus is high dose chemotherapy for improved disease control in the liver • Successful and highly statistically significant Phase III trial results reported • Received CE Mark approval for Class III
Slide 33: Appendix I. - Delcath Sources for Market Estimates
Appendix I. - Delcath Sources for Market Estimates American Cancer Society. Cancer Facts & Figures 2010. Atlanta: American Cancer Society; 2010. Alexander, Richard H., David L. Bartlett, and Steven K. Libutti. "Current Status of Isolated Hepatic Perfusion With or Without Tumor Necrosis Factor for th
Slide 34: Appendix II. - Phase 3 Pivotal Trial Details
Appendix II. - Phase 3 Pivotal Trial Details 34 DELCATH SYSTEMS, INC
Slide 35: Phase III Clinical Trial Design
Phase III Clinical Trial Design Randomized to CS 92 patients: ocular or cutaneous melanoma CS/Melphalan Treat every 4 weeks x 4 rounds Cross- (responders can receive up to 6 rounds) over Primary Trial Endpoint Secondary Trial Endpoints • Statistically significant difference in Hepatic Progression •
Slide 36: ASCO 2010 Presentation of Phase 3 Clinical Trial Results
ASCO 2010 Presentation of Phase 3 Clinical Trial Results • Trial results exceed primary endpoint expectations; p value = 0.001 • Treatment arm shows 5x median hPFS compared to control arm • CS/PHP median hPFS of 245 days compared to 49 days for BAC • Hazard Ratio = .301 • Patients failed prior thera
Slide 37: ASCO 2010 Presentation of Phase 3 Clinical Trial (cont.)
ASCO 2010 Presentation of Phase 3 Clinical Trial (cont.) • Majority of BAC patients crossed over and obtained similar response from treatment • Total 93 patient trial - 10 months median OS vs. 4 months expected1 (due to cross over provision, most patients received PHP/CS treatment) • OS cohort analy
Slide 38: 2011 DELCATH SYSTEMS, * DELCATH
© 2011 DELCATH * DELCATH SYSTEMS, SYSTEMS, INC INC. ALL RIGHTS RESERVED