Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (November 2012)
51 slides from Delcath Systems's investor presentation, Nov 9, 2012
Slide 1: Investor Presentation
Exhibit 99.1 Investor Presentation (NASDAQ: DCTH) November 2012
Slide 2: Forward-looking Statements
Forward-looking Statements Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This presentation contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual re
Slide 3: Our Mission
Our Mission • We are a cancer therapy company • Our technology offers the opportunity to gain control of tumors in the liver • The liver is a site where uncontrolled disease is often life-limiting or leads to withdrawal of systemic treatments in favor of palliative care • We plan on being a fully-in
Slide 4: The Problem
The Problem • Metastatic disease to the liver, brain or lungs is often the life- limiting location of solid tumors o In contrast to the brain and lungs, where systemic chemotherapy and radiation can exert some degree of local control, tumors in the liver are not particularly responsive to chemothera
Slide 5: 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., Isolated Hepatic Perfusion) – Ta
Slide 6: Diffuse Hepatic Metastases from Ocular and Cutaneous Melanoma
Diffuse Hepatic Metastases from Ocular and Cutaneous Melanoma • Diffuse disease in the liver is prevalent • Effective treatment for patients with liver-limited or dominant cancers remains a clinical challenge • Whole organ therapy creates a new option for patients in the management of liver dominant
Slide 7: Our Solution – Whole Organ-Focus Disease Control
Our Solution – Whole Organ-Focus Disease Control • Our proprietary CHEMOSAT system isolates the liver circulation, delivers an ultra-high concentration of chemotherapy (melphalan) to the liver and filters most of the chemotherapy out of the blood prior to returning it to the patient • The procedure
Slide 8: The Delcath CHEMOSAT System
The Delcath CHEMOSAT System 1. ISOLATE 2. SATURATE 3. FILTRATE Chemosaturation • Improves disease control in the liver • Treats entire liver (macro and micro) • Controls systemic toxicities • Allows for over 100x effective dose escalation at tumor site Minimally Invasive, Repeatable Liver Procedure
Slide 9: The Data
The Data • We conducted a randomized Phase 3 study under a Special Protocol Assessment (“SPA”) using Generation 1 of our chemosaturation system with melphalan in patients with melanoma (ocular and cutaneous) metastatic to the liver • Melanoma liver metastases are relatively homogeneous regardless of
Slide 10: Phase III Clinical Trial Design
Phase III Clinical Trial Design Randomized to CS 93 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 11: Positive Phase III Results – Primary Endpoint hPFS
Positive Phase III Results – Primary Endpoint hPFS Hepatic progression-free survival (IRC) Proportion of patients surviving 1.0 5.3 mo Chemosaturation (CS-PHP) Best alternative care (BAC) 0.8 Hazard ratio = 0.50 0.6 (95%CI0.31–0.80) P=0.0029 7.0 1.7 0.4 0.2 0.0 0 5 10 15 20 25 30 Intent-to-treat pop
Slide 12: Positive Phase III Results – Overall PFS
Positive Phase III Results – Overall PFS Overall progression-free survival (investigator) Proportion of patients surviving 1.0 3.8 mo Chemosaturation (CS-PHP) 0.8 Best alternative care (BAC) 0.6 Hazard ratio = 0.42 5.4 (95% CI 0.27–0.64) 1.6 P<0.0001 0.4 0.2 0.0 0 5 10 15 20 25 30 35 40 45 50 55 Int
Slide 13: Overall Survival – Exploratory Subset Analysis
Overall Survival – Exploratory Subset Analysis TOTOL CS-PHP vs BAC ONLY Proportion of subjects surviving 1.0 7.3 mo incl. crossover Total CS-PHP 0.9 BAC only 0.8 0.7 0.6 0.5 4.1 11.4 0.4 0.3 0.2 0.1 0.0 0 12 24 36 48 60 Intent-to-treat population Months Overall Survival Tail For CS-PHP Treated Patie
Slide 14: Positive Phase III Results
Positive Phase III Results • Primary endpoint (hPFS by IRC) exceeded, p value = 0.0029, hazard ratio of 0.50 as of June, 2012 o CS/PHP median hepatic progression free survival (hPFS) was 4-fold of control, or 5.3 months improvement o CS/PHP achieved a median hPFS of 7.0 months vs 1.7 months for BAC
Slide 15: The Evidence for Melphalan
The Evidence for Melphalan Melphalan, an established chemotherapy agent, is proven active at high doses with broad antitumor activity 1. Grover AC, et al. Surgery 2004;136:1176-82 4. Alexander HR Jr, et al. Clin Cancer Res 2003;9:6343-9 7. Van Iersel LB, et al. Ann Oncol 2010;21:1662-7 2. Noter SL,
Slide 16: Melphalan Sensitivity: In Vitro Tumor Cell Lines Study
Melphalan Sensitivity: In Vitro Tumor Cell Lines Study 192 uM We Believe CHEMOSAT Will Be Effective On a Wide Range of Solid Tumors 16 DELCATH SYSTEMS, INC
Slide 17: Our Opportunity
Our Opportunity • At the concentrations of melphalan we are achieving in the liver, we believe CHEMOSAT will be effective on a wide variety of histologies • We believe that physicians are recognizing the broad applicability of CHEMOSAT, based on early experience and their interest in testing our tec
Slide 18: CHEMOSAT - Potential Multi-Billion Dollar Market
CHEMOSAT - Potential Multi-Billion Dollar Market $2.2 B 200,000 HCC 189,943 CRC 175,000 NET Melanoma 150,000 99,749 125,000 100,000 $2.2 B 75,000 $2.6 B 55,389 52,143 50,000 8,708* 7,671 5,585 33,953 19,861 25,000 33,966 8,212 7,202 8,708 6,563 4,085 0 USA EU APAC Sources: LEK Consulting, GLOBOCAN,
Slide 19: Global Commercialization Status
Global Commercialization Status Approved (CE Mark Device) NDA Filing Accepted by the FDA with PDUFA goal date of June 15, 2013 Application Submitted/ Planned – Mutual Recognition of European CE Mark Addressing A Multi-Billion Dollar Global Market 19 DELCATH SYSTEMS, INC
Slide 20: European Commercialization Strategy
European Commercialization Strategy Strategy: • Focus efforts in 7 Target Countries (EU 5 + Netherlands & Ireland) • 8-10 leading EU cancer centers as initial training centers • Validate business model and demonstrate scalability • Push and Pull marketing and selling strategy Tactics & Execution: •
Slide 21: Patient Referral Path
Patient Referral Path Identification of liver involvement with no improvement from systemic Patient therapy Primary Diagnosis Care of Cancer Chemosaturation Medical Surgical Oncologist Oncologist Offers systemic therapy Offers resection or other focal therapy When liver disease is controlled, patien
Slide 22: 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 Milan, Italy – European Institute of Oncology (IEO) o Frankfurt, Germany – Johann Wolfgang Goethe-Universität (JWG) o Kiel, Germany – Universitätsklinikum Schleswig
Slide 23: European Reimbursement Considerations
European Reimbursement Considerations • No centralized pan-European medical device reimbursement body – reimbursement mechanisms vary greatly at national and regional levels across our target markets • Working with reimbursement specialists to execute plan in each of our key markets for both interim
Slide 24: 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 o Obtained approval for Gen 2 CHEMOSAT System with melphalan in Austrailia • International regulatory submissions status: Application submitted and
Slide 25: U.S. FDA Regulatory Status
U.S. FDA Regulatory Status • NDA accepted and under active FDA review since submission in mid August, 2012 • We are working closely with the FDA during the review process • PDUFA goal date of June 15, 2013 assigned by the FDA • FDA advised Oncology Drug Advisory Committee (ODAC) panel to be expected
Slide 26: U.S. Commercialization Strategy
U.S. Commercialization Strategy • Initial focus on centers that participated in the phase III clinical trial • Educate Medical Oncologists via Medical Science Liaison (MSL) • Direct strategy to sell to Interventional Radiologists and Oncologists o Approximately 12 sales territories ultimately expand
Slide 27: Clinical Development Program
Clinical Development Program • Goal: o Expand US (CS-PHP: MEL) label indications to include HCC and mCRC o Generate robust clinical data to support commercialization • FDA has accepted IND Amendment to include Gen 2 device in Expanded Access Program (EAP), compassionate use (CU), and all future clin
Slide 28: CHEMOSAT System for Doxorubicin – CE Mark
CHEMOSAT System for Doxorubicin – CE Mark • Satisfied all of the requirements to affix the CE Mark to Hepatic CHEMOSAT Delivery System device for intra-hepatic arterial delivery and extracorporeal filtration of doxorubicin in October, 2012 • Provides a pathway for regulatory approval in China and S.
Slide 29: 2012 Milestones
2012 Milestones • First patients have been treated with CHEMOSAT Melphalan in Europe - Done • Execute contract for MSL services in EU in 1Q 2012 (Quintiles was selected to support EU launch of CHEMOSAT) - Done • Secure agreements with 8-10 leading cancer centers in EU - Done • Obtain CE Mark for Gen
Slide 30: Financial Update
Financial Update Cash & Cash Equivalents: $28.3 million at September 30, 2012 $21.1 million (net) raised in a follow-on equity Financing: offering in May 2012 $24.5 million remaining as of September 30, ATM Program 2012 Working Capital Line of Credit: $20.0 million credit facility Debt: None Cash Sp
Slide 31: Team
Team Years of Executive Title Prior Affiliation(s) Experience Eamonn Hobbs President and CEO AngioDynamics, E-Z-EM 31 D&B, Pagoda Pharma, Schering-Plough, Graham Miao, Ph.D. EVP & CFO 22 Pharmacia, JP Morgan Krishna Kandarpa, M.D., CSO and EVP, R&D Harvard, MIT(HST), Cornell, UMass 32 Ph.D. Agustin
Slide 32: Appendices
Appendices 32 DELCATH SYSTEMS, INC
Slide 33: Appendix I Intellectual Property
Appendix I Intellectual Property 33 DELCATH SYSTEMS, INC
Slide 34: Intellectual Property
Intellectual Property • Patent Protection o 5 U.S. patents in force and 6 U.S. patent applications pending o 6 foreign patents in force (with patent validity in 22 countries) and 15 foreign patent applications pending o Primary device patent set to expire August 2016 o Up to 5 years of patent extens
Slide 35: Appendix II CHEMOSAT Market Opportunity by Disease and Target Countries
Appendix II CHEMOSAT Market Opportunity by Disease and Target Counties 35 DELCATH SYSTEMS, INC
Slide 36: Market Opportunity by Disease (patients)
Market Opportunity by Disease (patients) • Europe – Largest near-term opportunity • CRC – Largest opportunity worldwide • Melanoma – Largest opportunity is in US • China - Largest opportunity for HCC Market Opportunity defined as Total Potential Market (TPM) for CHEMOSAT ® 1.Primary cancer incidence
Slide 37: Europe Market by Disease – Device Only
Europe Market by Disease – Device Only Total Potential Germany UK France Italy Spain Netherlands Ireland Potential Market (Direct) (Direct) (Indirect) (Indirect) (Indirect) (Direct) (Direct) 1,2,3 (patients) ($ MM) Total Potential Market #Patients Ocular Melanoma 404 297 295 285 197 79 19 1,576 $ 62
Slide 38: US Market by Disease – Device and Drug Combination
US Market by Disease – Device and Drug Combination Potential Market Potential Market Potential Market Liver Metastasis 1,2 # 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 49,65
Slide 39: APAC Market by Disease
APAC Market by Disease Total Potential China S. Korea Japan Taiwan Australia Potential Market (Device) (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
Slide 40: Appendix III CHEMOSAT Melphalan Phase I and II
Appendix III CHEMOSAT Melphalan Phase I and II 40 DELCATH SYSTEMS, INC
Slide 41: 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 42: Phase II NCI Trial – Metastatic Neuroendocrine Cohort
Phase II NCI Trial – Metastatic Neuroendocrine Cohort Phase II 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 Diseas
Slide 43: Phase II NCI Trial – Hepatobilliary carcinoma
Phase II NCI Trial – Hepatobilliary carcinoma • 11 patients with tumors of hepatobiliary origin: 5 HCC, 2 intrahepatic and 3 extrahepatic cholangiocarcinoma,1 mixed histology • CHEMOSAT treatment showed encouraging anti-tumor activities in hepatocellular carcinoma (HCC) o 1 Confirmed partial respons
Slide 44: Phase II NCI Trial – mCRC Cohort
Phase II NCI Trial – mCRC Cohort • Substantial clinical evidence of benefit of using melphalan to treat mCRC via isolated hepatic perfusion (IHP) procedure o Over 800 patients treated in 15 studies since 1998 o Patients treated only once o Median response rate of 47% (range 29%-76%)1 • Delcath Phase
Slide 45: Appendix IV Published Phase I/II Studies of Doxorubicin with PHP for HCC
Appendix IV Published Phase I/II Studies of Doxorubicin with PHP (percutaneous hepatic perfusion) for HCC 45 DELCATH SYSTEMS, INC
Slide 46: Phase I/II Studies of PHP-Doxorubicin For HCC
Phase I/II Studies of PHP-Doxorubicin For HCC No. of No. of PHP/ Disease stage Median survival Treatment pts pt (tumor diameter) (mo) Response Rates Reference HCC 1–4 IV A: n=66 16 (n=79) IV B: n=13 Doxorubicin 60 –150 mg/m 2 HCC pts Kobe 1 Cisplatin 50–150 mg/m 2 RR 64.5% Phase I/II CHM All multipl
Slide 47: Appendix V Product Development Pipeline
Appendix V Product Development Pipeline 47 DELCATH SYSTEMS, INC
Slide 48: 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 E • Classified as Medical Device U rd • mCRC and HCC clinical trials • CHEMOSAT for other organs (lung • 3
Slide 49: Appendix VI European Regulatory Update
Appendix VI European Regulatory Update 49 DELCATH SYSTEMS, INC
Slide 50: European Regulatory Update
European Regulatory Update • Retained new Notified Body • Device reclassified from class III to class IIB, permitting self-certification in accordance with the same established quality management system o The primary difference between Class III and Class IIb is that for Class IIb medical devices th
Slide 51: Concentrating the Power of Chemotherapy
Concentrating the Power of Chemotherapy™ © 512011 DELCATH DELCATH SYSTEMS, SYSTEMS, INC INC. ALL RIGHTS RESERVED
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