Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (June 2011)
41 slides from Delcath Systems's investor presentation, Jun 3, 2011
Slide 1: Investor Presentation
Exhibit 99.1 Investor Presentation (NASDAQ: DCTH) June 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 • Our goal - 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 fo
Slide 4: Large Unmet Clinical Need = Large Commercial Opportunity
Large Unmet Clinical Need = Large Commercial 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 EU Labeled Market Opportunity* Transparent Areas • Leverage CE Mark for regulatory Represent Potentia
Slide 5: Spectrum of Liver Cancer Treatments
Spectrum of Liver Cancer Treatments Type of Treatment Advantages Disadvantages Non-invasive – Systemic toxicities Systemic Repeatable – Limited efficacy in liver – Invasive/limited repeatability Therapeutic effect Regional (e.g., IHP) – Multiple treatments are Targeted required – 90% unresectable Fo
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 (2-5 years) Intermediate Term (> 5 years) • All liver cancers - melphalan • Proprietary melphalan drug • Class III device • Additional drugs approval • 3rd party melphalan • Other organs • Apparatus improvements • Additional data generation
Slide 15: Clinical Data Development Goals
Clinical Data Development Goals • Generate data to establish Chemosaturation as the Standard Of Care (SOC) for disease control in the liver. • Utilize High Efficiency (HE) Filter o Concomitant therapy to complement standard of care treatments o Increase safety of procedure • Potential clinical trial
Slide 16: Largest opportunities by region and cancer type
• 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 approval covers 30 countries in the European Economic Area (EEA) • Product Name: Delcath Hepatic CHEMOSAT Delivery System TM • Approved device indication: “For intra-arterial administration of chemotherapeutic agent (melphalan hydrochloride) to the liver with additional extra
Slide 18: Market by Disease - EEA Device Only
Market by Disease - EEA Device Only Total Potential Germany UK France Italy Spain Netherlands Potential Market (Direct) (Direct) (Indirect) (Indirect) (Indirect) (Direct) (patients) ($ millions)1,2,3 Total Potential Market #Patients Ocular Melanoma 403 296 294 284 197 79 1,553 $46.6 Cutaneous Melano
Slide 19: European Commercialization Plans
European Commercialization Plans Objective: Broad Commercial Adoption Major Assumptions: § High Efficiency (HE) filter available for commercial launch § 6-8 Centers of Excellence for initial training § Initiate test market in 2011 for ~ 6 months to validate assumptions and finalize model § Full comm
Slide 20: European Commercialization Plans
European Commercialization Plans Tactics & Execution: § Market to medical oncologists via contract sales organization (CSO) § Sell to hospital-based interventional radiologists and surgeons with combination of direct sales and distributors § Establish European patient education & awareness programs
Slide 21: 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 22: European Interim New Technology Reimbursement Programs
European Interim New Technology Reimbursement Programs Interim New Technology Payment Programs Already Exist in Major European Markets 22 DELCATH SYSTEMS, INC
Slide 23: European Device Marketing Considerations: Melphalan
European Device Marketing Considerations • Melphalan: o Delcath will market the Hepatic CHEMOSAT delivery system in the EEA for the intra-arterial administration of melphalan to the liver o Physicians will procure melphalan independently o Clinical experience in EEA and publications support use of m
Slide 24: European Device Marketing Considerations: Clinical Data
European Device Marketing Considerations Clinical Data: • Delcath Phase 3 and Phase 2 data supplements extensive surgical IHP data with melphalan • Expect to initiate additional studies with Standard of Care (SOC) in 2012 with availability of HE filter in; o HCC (primary liver cancer) o CRC metastat
Slide 25: 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 26: 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 27: 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 28: 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: • While undergoing FDA review, apply for CPT Category III code • Convert the Category III code to Category I following FDA approval o Hospi
Slide 29: 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 help 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 • In
Slide 30: 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 Market1,2,3,4 (Drug) (Drug) (Device) (Drug) (Device) (patients) Total Potential Market #Patients HCC (Primary) 197,082 7,486 7,625 4,9
Slide 31: 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 32: 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 David McDonald CFO AngioDynamics, RBC Capital 28 Markets Krishna Kandarpa, M.D., CMO and EVP, R&D Harvard, MIT, Cornell, UMass 37 Ph.D. Agustin Gago E
Slide 33: Financials
FINANCIALS
Slide 34: Financial Summary
Financial Summary Financial & Operating Overview • Follow On Offerings: Raised ~ $70 million since November 2009 • Burn Rate: Approximately $2.6 million per month • Cash: ~ $39 million at March 31, 2011 • Debt: None • Shares Out: 43.1 million (49.8 million fully diluted*) • Institutional Ownership:
Slide 35: Company Highlights
Company Highlights • Our goal - 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 fo
Slide 36: 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 37: Appendix II. - Phase 3 Pivotal Trial Details
Appendix II. - Phase 3 Pivotal Trial Details 37 DELCATH SYSTEMS, INC
Slide 38: Phase III Clinical Trial Design
Phase III Clinical Trial Design Randomized to CS 92 patients: ocular or cutaneous melanoma CS/Melphalan Best Alternative Care (BAC) Treat every 4 weeks x 4 rounds Cross- Investigator and patient decision (responders can receive up to 6 rounds) over (any and all treatments) Primary Trial Endpoint Sec
Slide 39: 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 40: 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 41: 2011 DELCATH SYSTEMS, * DELCATH
© 2011 DELCATH * DELCATH SYSTEMS, SYSTEMS, INC INC. ALL RIGHTS RESERVED