Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (November 2011)
41 slides from Delcath Systems's investor presentation, Nov 18, 2011
Slide 1: Investor Presentation
Exhibit 99.1 Investor Presentation (NASDAQ: DCTH) November 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 is 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 3 trial results reported • Encouraging Phase 2 data in a
Slide 4: Potential Multi-Billion Dollar Market Opportunity
Potential Multi-Billion Dollar 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: Identification of liver involvement with no improvement from systemic therapy
Identification of liver involvement Patient with no improvement from systemic therapy Primary Diagnosis Care of Cancer Medical Oncologist Oncologist Offers systemic therapy to Offers resection or other focal Transferred for treat Cancer therapy chemosaturation to treat cancer in Liver When liver dis
Slide 11: Summary of Updated Phase III Results
Summary of Updated Phase III Results* • Primary endpoint exceeded, p value = 0.0001, hazard ratio of .35 o Treatment arm shows 5x median hepatic progression free (hPFS) survival compared to control arm o CS/PHP median hPFS of 8.0 months compared to 1.6 months for BAC o 86% overall clinical benefit (
Slide 12: Phase 2 NCI Trial - Metastatic Neuroendocrine (mNET) Cohort
Phase 2 NCI Trial - Metastatic Neuroendocrine (mNET) Cohort Phase 2 mNET Tumor Cohort (n=24)* Number (n) Pre-CS (Baseline) Primary Tumor Histology Carcinoid 4 Pancreatic Islet Cell 20 Response Not Evaluable (Toxicity, Incomplete Treatment, Orthotopic Liver 4 Transplantation) Post-CS #1 Progressive D
Slide 13: Gen Two High Efficiency (HE) Filter
Gen Two High Efficiency (HE) Filter STATUS: o Melphalan - consistent first pass removal efficiency of 98% or better in both in vitro and pre- clinical, GLP animal studies o New trade secret manufacturing process for filter medium o Accelerated development timeline o Filed for CE marking for Gen Two
Slide 14: Product Development Pipeline
Product Development Pipeline Initial Opportunity Near Term (< 5 years) Intermediate Term (> 5 years) • All liver cancers - melphalan • Class III device • Proprietary melphalan drug • 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 Gen Two High Efficiency (HE) Filter o Concomitant therapy to complement standard of care treatments o Increase safety of procedure • Potential clinic
Slide 16: Largest opportunities by region and disease
• US - largest opportunity for Melanoma • China- largest opportunity for HCC • CRC - largest opportunity worldwide 16 DELCATH SYSTEMS, INC *TPM Total Potential Market
Slide 17: European Markets
European Markets • CE Marking on CHEMOSAT device 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 injec
Slide 18: European Commercialization Plans
European Commercialization Plans Objective: Commercial adoption Major Assumptions: • Gen Two HE filter available for commercial launch • Focus efforts in Target Countries • 6-8 Initial Training centers • Initiate test market in 2012 for 6 months to validate assumptions and finalize model • Full comm
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 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 $46.6 Cutaneous Melano
Slide 22: U.S. FDA Regulatory Status
U.S. FDA Regulatory Status • On February 22, 2011, received Refusal to File (RTF) letter from the FDA § Manufacturing plant inspection timing § Product and sterilization validation § Additional statistical analysis clarification § Additional safety data o RTF stated that safety information provided
Slide 23: Market by Disease - USA
Market by Disease* - USA Potential Market Potential Market Potential Market ($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 for CPT Category III code • Convert the Category III code to Category I following FDA approval o Hospital: • Apply for new IC
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 Combinati
Slide 27: International Regulatory Status Update
International Regulatory Status Update • Leveraging the CE Mark for CHEMOSAT • Completed product notification process for CHEMOSAT system with the Medicines and Medical Device Safety Authority in New Zealand • Submitted applications to obtain regulatory approval for CHEMOSAT in Australia, Singapore
Slide 28: Market by Disease - Australia/Asia
Market by Disease - Australia/Asia Initial Target Markets (China, Japan, S. Korea, Taiwan, Australia) China S. Korea Japan Taiwan Australia Total Potential (Drug) (Drug) (Device) (Drug) (Device) Potential Market (patients) 1,2,3,4 Total Potential Market #Patients HCC (Primary) 197,082 7,486 7,625 4,
Slide 29: 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 30: 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 Dun & Bradstreet, Pagoda Pharma, Graham Miao, Ph.D EVP & CFO 21 Schering-Plough, Pharmacia AngioDynamics, RBC Capital David McDonald EVP Business Deve
Slide 31: Financials
FINANCIALS
Slide 32: Financial Summary
Financial Summary Financial & Operating Overview • Follow On Offerings: Raised ~ $94 million since November 2009 • Burn Rate: $3.4 million average per month Q3 2011 • Cash: $44.7 million at September 30, 2011 • Debt: None • Shares Out: ~48 million (~55 million fully diluted*) • Institutional Ownersh
Slide 33: Company Highlights
Company Highlights • Our goal is 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 3 trial results reported • Encouraging Phase 2 data in a
Slide 34: 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 35: Appendix II. - Phase 3 Pivotal Trial Details
Appendix II. - Phase 3 Pivotal Trial Details 35 DELCATH SYSTEMS, INC
Slide 36: 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 37: 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 38: 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 39: 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 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
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