Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (February 2012)
50 slides from Delcath Systems's investor presentation, Feb 14, 2012
Slide 1: Investor Presentation
ca th > 99.1 MiSs: 4F Investor Presentation (NASDAQ: DCTH) February 2012
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: Delcath Systems – Company Highlights
Delcath Systems – Company Highlights • A specialty pharmaceutical and medical device company focused on oncology • Initial focus on delivering high dose chemotherapy to improve disease control of cancers in the liver • CHEMOSAT CE Mark approved – indication permits broad use in liver cancers. Commen
Slide 4: What is CHEMOSAT
What is CHEMOSAT Concentrating the Power of Chemotherapy for Disease Control in the Liver 4 DELCATH SYSTEMS, INC
Slide 5: Initial Focus on Cancers of the Liver
Initial Focus on Cancers of the Liver • Few effective therapies are available for cancers of the liver Large patient population diagnosed annually with primary or metastatic liver cancer The liver is often the life limiting organ for cancer patients and one of the leading causes of cancer death Prog
Slide 6: CHEMOSAT Addresses Potential Multi-Billion Dollar Market
CHEMOSAT Addresses Potential Multi-Billion Dollar Market $2.3 Bn 200000 189,943 HCC 175000 CRC NET 150000 Melanoma 99,749 125000 100000 $2.1 Bn 75000 $2.6 Bn 55,389 52,143 50000 8,708* 7,671 5,585 19,861 33,953 25000 33,966 8,212 7,202 8,708 6,563 4,085 0 USA EU APAC 1. Assumes 2.5 treatments per pa
Slide 7: CHEMOSAT European Commercialization
CHEMOSAT European Commercialization • CE Mark covers 30 countries in Europe • Focus on top 6 countries (DE, UK, FR, IT, SP, NL) and Ireland • Broad indication is for “percutaneous intra-arterial delivery of a chemotherapeutic agent (melphalan hydrochloride) to the liver” • Melphalan for injection ap
Slide 8: CHEMOSAT Training and Marketing Commenced in Europe
CHEMOSAT Training and Marketing Commenced in Europe • Entered training and marketing agreements with leading cancer centers in Europe o Institute of European Oncology (IEO), Milan, Italy o Johann Wolfgang Goethe (JWG) University Hospital, Frankfurt, Germany • Training completed and first patients tr
Slide 9: Team at Institute of European Oncology Performs EU CHEMOSAT Procedure
st Team at Institute of European Oncology Performs 1 EU CHEMOSAT Procedure January 31, 2012 9 DELCATH SYSTEMS, INC
Slide 10: Existing Liver Cancer Treatments Have Limitations
Existing Liver Cancer Treatments Have Limitations Treatment Advantages Disadvantages – Non-invasive – Systemic toxicities Systemic – Repeatable – Limited efficacy in liver – Invasive/limited repeatability Regional – Therapeutic effect – Multiple treatments are (e.g., IHP) – Targeted required, not po
Slide 11: CHEMOSAT System – Where It All Began
CHEMOSAT System – Where It All Began Open Surgical IHP Isolated Hepatic Perfusion: Proof of Concept, but High Morbidity and Non-Repeatable 11 DELCATH SYSTEMS, INC
Slide 12: The Delcath CHEMOSAT System
The Delcath CHEMOSAT System Three Steps 1) ISOLATION 2) SATURATION 3) FILTRATION Advantages • No more open surgery • Minimally invasive, repeatable • Treats entire liver (macro and micro) • Allows for over 100x effective dose escalation of drug agents at tumor site • Improved disease control in the
Slide 13: 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 14: What CHEMOSAT Offers
What CHEMOSAT Offers Patients: o Significant improvement in disease control in the liver compared to standard of care in patients with unresectable hepatic tumors (primary and metastatic) o Manageable systemic toxicities o Time, so that primary cancers can continue to be treated Physicians: o Novel,
Slide 15: Current Patient Referral Path
Current Patient Referral Path Identification of liver involvement with no improvement from systemic Patient therapy Primary Diagnosis Care of Cancer Transferred for chemosaturation Medical Surgical Oncologist Oncologist Offers systemic therapy Offers resection or other focal therapy When liver disea
Slide 16: Positive Phase III Results
Positive 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 (CR + PR +
Slide 17: 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 18: Phase 2 NCI Trial – HCC Cohort
Phase 2 NCI Trial – HCC Cohort • Hepatocellular carcinoma (HCC) is the most common primary cancer of the liver, with approximately 749,000* new cases diagnosed worldwide annually • Nine patients with tumors of hepatobiliary origin: five HCC patients and four cholangiocarcinoma patients • Both groups
Slide 19: Melphalan Efficacy for Metastatic Colorectal Cancer
Melphalan Efficacy for Metastatic Colorectal Cancer • Substantial clinical evidence of benefit of using melphalan to treat mCRC via isolated hepatic perfusion (IHP) procedure Over 800 patients treated in 15 studies since 1998 Patients treated only once Median response rate of 47% (range 29%-76%)¹ •
Slide 20: Product Development Pipeline
Product Development Pipeline Initial Opportunity Near Term (< 5 years) Intermediate Term (> 5 years) • All liver cancers – melphalan • Doxorubicin system CE Mark • CHEMOSAT for additional drugs • Class III medical device rd • mCRC and HCC clinical trials • CHEMOSAT for other organs (lung • 3 party m
Slide 21: CHEMOSAT Doxorubicin Development
CHEMOSAT Doxorubicin Development • Multiple published phase I/II studies from MD Anderson Cancer Center and Yale with percutaneous hepatic perfusion (PHP) and Kobe University using doxorubicin show promising response rates for HCC* • STATUS: o First pass removal efficiency 95% in initial in vitro st
Slide 22: Clinical Development Program
Clinical Development Program • Goal Expand indications for HCC and mCRC with US registration trials Generate robust clinical data to support commercialization • Potential 2012 clinical trials HCC: Global Phase 2 randomized 1L CHEMOSAT Melphalan vs. Sorafenib HCC: US registration – Global Phase 3 ran
Slide 23: Generation Two CHEMOSAT Melphalan
Generation Two CHEMOSAT Melphalan STATUS: • Consistent first pass removal efficiency of 98% or better in both in vitro and pre-clinical GLP animal studies • New trade secret manufacturing process for filter medium • Filed for CE marking for Gen Two • Anticipate approval in 1Q2012 EXPECTED BENEFITS:
Slide 24: European Commercialization Strategy
European Commercialization Strategy Strategy: • Focus efforts in Target Countries • 8-10 leading EU cancer centers as initial training centers • Push and Pull marketing and selling strategy • Validate business model and demonstrate scalability Tactics & Execution: • Educate medical oncologists via c
Slide 25: European Reimbursement Considerations
European Reimbursement Considerations • No centralized pan-European medical device reimbursement body – regional and national systems • Devices typically reimbursed under Diagnosis Related Groups (DRG) as part of a procedure • Immediate reimbursement plans: Utilize existing codes where permitted unt
Slide 26: European Interim New Technology Reimbursement Programs
European Interim New Technology Reimbursement Programs Interim New Technology Payment Programs Already Exist in Major European Markets 26 DELCATH SYSTEMS, INC
Slide 27: U.S. FDA Regulatory Status
U.S. FDA Regulatory Status • Pre-NDA submission meeting with FDA conducted in January 2012 • Satisfied with FDA response • Addressed RTF related issues Manufacturing plant inspection timing Product and sterilization validation Additional statistical analysis clarification Additional safety data • Co
Slide 28: U.S. Commercialization Strategy
U.S. Commercialization Strategy • Initial focus on leading cancer centers and referring community hospitals • Educate Medical Oncologists via Contract Medical Science Liaison (MSL) • Direct Strategy to sell to Interventional Radiologists and Surgeons: 12 Sales territories ultimately expanding to as
Slide 29: U.S. Reimbursement Strategy
U.S. Reimbursement Strategy • Intend to seek chemosaturation specific codes based upon value proposition relative to other cancer therapies Physician: • Use existing miscellaneous DRG procedure code • Apply for a CAT I code following FDA approval Hospital: • Apply for new ICD-9/10 procedure code to
Slide 30: International Strategy beyond EU and US
International Strategy beyond EU and US • Leverage CE Mark to obtain reciprocal regulatory approvals for CHEMOSAT System in other international markets • International regulatory submissions status: Application submitted, potential approval Australia - 2012 Hong Kong - 2012 S. Korea - 2013 Singapore
Slide 31: Intellectual Property
Intellectual Property • Patent Protection o 7 issued U.S. patents, 10 foreign patents issued and 4 pending o Primary device patent set to expire August 2016 o Up to 5 years of patent extension post FDA approval • Trade Secret Protection o Developed improved filter media via new manufacturing process
Slide 32: Experienced Management Team
Experienced Management Team Years of Executive Title Prior Affiliation(s) Experience Eamonn Hobbs President and CEO AngioDynamics, E-Z-EM 31 D&B, Pagoda Pharma, Schering- Graham Miao, Ph.D EVP & CFO 22 Plough, Pharmacia, JP Morgan Krishna Kandarpa, M.D., Harvard, MIT(HST), Cornell, CMO and EVP, R&D
Slide 33: Slide 33
Slide 34: Financial Update
Financial Update • Follow-On Offerings: Raised ~ $94 million since November 2009 • Financing Program: $39.75 million At-The-Market (ATM) equity offering program since December 29, 2011 • Cash: $30.8 million at December 31, 2011 (unaudited) • Burn Rate: $40.1 million full year 2011 (unaudited) • Debt
Slide 35: 2012 Milestones
2012 Milestones • First patients treated with CHEMOSAT melphalan in Europe – 1Q • Execute contract for MSL services in EU – 1Q • Secure agreements with 6-8 leading cancer centers in EU – 1H • Obtain CE Mark for Gen 2 CHEMOSAT melphalan – 1Q • US NDA submission in 2Q 2012 and acceptance in 3Q 2012 •
Slide 36: Appendices
Appendices 36 DELCATH SYSTEMS, INC
Slide 37: Appendix I: CHEMOSAT Market Opportunity by Disease and Target Countries
Appendix I CHEMOSAT Market Opportunity by Disease and Target Counties 37 DELCATH SYSTEMS, INC
Slide 38: Market Opportunity by Disease (patients)
Market Opportunity by Disease (patients) • Europe – Largest near-term opportunity • CRC – Largest opportunity worldwide • Melanoma – Largest opportunity is in US • China- Largest opportunity for HCC Market Opportunity defined as Total Potential Market (TPM) for CHEMOSAT® 1.Primary cancer incidence 2
Slide 39: Europe Market by Disease – Device Only
Europe Market by Disease – Device Only Total Potential Germany UK France Italy Spain Netherlands Ireland Potential Market (Direct) (Direct) (Indirect) (Indirect) (Indirect) (Direct) (Direct) 1,2,3 (patients) ($ MM) Total Potential Market #Patients Ocular Melanoma 404 297 295 285 197 79 19 1,576 $ 62
Slide 40: US Market by Disease – Device and Drug Combination
US Market by Disease – Device and Drug Combination Potential Market Potential Market Potential Market Liver Metastasis # Patients # Procedures ($MM)** Ocular 1,685 4,213 $ 105 Melanoma Cutaneous 7,023 17,557 $ 439 Melanoma TOTAL MELANOMA 8,708 21,770 $ 544 (Initial Expected Label) CRC 19,861 49,653
Slide 41: APAC Market by Disease
APAC Market by Disease Total Potential China S. Korea Japan Taiwan Australia Potential Market (Device) (Device) (Device) (Device) 1,2 (patients) ($MM) Total Potential Market #Patients HCC 85,780 3,258 8,296 2,152 263 99,749 $ 1,156 (Primary) Other CRC 31,127 3,245 14,298 1,441 2,031 52,143 $ 642 NET
Slide 42: Appendix II: Phase 3 Pivotal Trial Details
Appendix II CHEMOSAT melphalan for metastaic melanoma Phase 3 Pivotal Trial Details 42 DELCATH SYSTEMS, INC
Slide 43: Phase III Clinical Trial Design
Phase III Clinical Trial Design Randomized to CS 92 patients: ocular CS = ChemoSaturation (CHEMOSAT) or cutaneous melanoma CS/Melphalan Best Alternative Care (BAC) Treat every 4 weeks x 4 rounds Cross-over Investigator and patient decision (responders can receive up to 6 rounds) (any and all treatme
Slide 44: Positive Phase III Results
Positive 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 (CR + PR +
Slide 45: Phase 3 Hepatic Progression-free Survival (ITT)
Phase 3 Hepatic Progression-free Survival (ITT) Survival probability 1.0 CS-PHP BAC 0.8 Hazard Ratio: 0.35 0.6 (CI: 0.23-0.54) p<0.0001 8.0 1.6 0.4 0.2 0.0 0 5 10 15 20 25 30 35 Months CS-PHP Demonstrated A 5x Improvement In Primary Endpoint of hPFS 45 DELCATH SYSTEMS, INC
Slide 46: Phase 3 Overall Progression-free Survival (ITT)
Phase 3 Overall Progression-free Survival (ITT) Survival probability 1.0 CS-PHP BAC 0.8 Hazard Ratio: 0.36 0.6 (CI: 0.23-0.57) p<0.0001 6.7 1.6 0.4 0.2 0.0 0 5 10 15 20 25 30 35 Months CS Also Demonstrated A Highly Statistically Significant Improvement In Overall PFS 46 DELCATH SYSTEMS, INC
Slide 47: Phase 3 Overall Survival (ITT)
Phase 3 Overall Survival (ITT) Survival probability 1.0 CS-PHP BAC 0.8 Hazard Ratio: 1.08 0.6 (CI: 0.69-1.68) p=0.74 9.8 9.9 0.4 55% crossover 0.2 0.0 0 5 10 15 20 25 30 35 40 45 50 55 Months Overall Survival Confounded By Crossover Study Design 47 DELCATH SYSTEMS, INC
Slide 48: Appendix III: Published Phase I/II Studies of Doxorubicin with PHP for HCC
Appendix III Published Phase I/II Studies of Doxorubicin with PHP (percutaneous hepatic perfusion) For HCC 48 DELCATH SYSTEMS, INC
Slide 49: Phase I/II Studies of PHP-Doxorubicin For HCC
Phase I/II Studies of PHP-Doxorubicin For HCC 49 DELCATH SYSTEMS, INC
Slide 50: DELCATH SYSTEMS, DELCATH
© 502011 DELCATH DELCATH SYSTEMS, SYSTEMS, INC INC. ALL RIGHTS RESERVED
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