Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (April 2013)
55 slides from Delcath Systems's investor presentation, Apr 30, 2013
Slide 1: Investor Presentation
Exhibit 99.1 Investor Presentation (NASDAQ: DCTH) April 2013
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: Investment Considerations
Investment Considerations • Early stage, commercial Company focused on oncology • Proprietary CHEMOSAT ® Hepatic Delivery System allows unique whole organ therapy for the liver • CHEMOSAT system has demonstrated extension of progression free survival • Addressing large unmet market need for cancer p
Slide 4: Our Product
Our Product US Market Ex US Markets • Proposed Trade Name • Marketed under the trade name TM Melblez Kit (Melblez (melphalan) for CHEMOSAT ® Hepatic Delivery Injection for use with the Delcath System Hepatic Delivery System) • Regulated as a Class IIb Medical • Proprietary Drug/Device Combination De
Slide 5: The Delcath Hepatic Delivery System
The Delcath Hepatic Delivery System • Improves disease control in the liver • Treats macro and micro tumors • Controls systemic toxicities • Allows for over 100x dose escalation at tumor site Minimally Invasive, Repeatable Procedure That Could Complement Systemic Therapy 5 DELCATH SYSTEMS, INC
Slide 6: Melanoma Liver Metastases
Melanoma Liver Metastases • A challenging histology • Notoriously insensitive to systemic chemotherapy and focal interventions • CHEMOSAT has demonstrated ability to extend progression free survival Our Opportunity • Ability to achieve ultra-high concentrations of chemotherapy provides potential tre
Slide 7: Clinically Differentiated Results
Clinically Differentiated Results • Phase 1, 2 and 3 trials with percutaneous hepatic perfusion (PHP) produced positive results in multiple histologies • Melanoma Liver Mets o Positive Phase 3 results in hepatic metastatic melanoma o n=93 (90% ocular melanoma, 10% cutaneous melanoma) • Neuroendocrin
Slide 8: Positive Phase 3 Results – Primary Endpoint hPFS
Positive Phase 3 Results – Primary Endpoint hPFS Hepatic progression-free survival (IRC) Proportion of patients surviving 1.0 5.3 mo Percutaneous Hepatic Perfusion (PHP) Best alternative care (BAC) 0.8 Hazard ratio = 0.50 0.6 (95% CI 0.31–0.80) P=0.0029 7.0 1.7 0.4 0.2 0.0 0 5 10 15 20 25 30 Intent-
Slide 9: Positive Phase 3 Results – Overall PFS
Positive Phase 3 Results – Overall PFS Overall progression-free survival (investigator) Proportion of patients surviving 1.0 3.8 mo Percutaneous Hepatic Perfusion (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
Slide 10: Overall Survival – Exploratory Subset Analysis
Overall Survival – Exploratory Subset Analysis TOTAL PHP vs BAC ONLY Proportion of subjects surviving 1.0 7.3 mo Total PHPincl. crossover 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 PHP Treated Patients 10 DEL
Slide 11: Phase 2 Multi-Histology NCI Trial – Summary
Phase 2 Multi-Histology NCI Trial – Summary • Strong efficacy signals in mNET o 42% objective Response Rate (ORR) vs ~10% for approved targeted therapy o 66% patients had hepatic tumor shrinkage and durable disease stabilization • Positive Signal in primary hepatic malignancies (HCC and Cholangiocar
Slide 12: Phase 2 NCI Trial – Metastatic Neuroendocrine Cohort
Phase 2 NCI Trial – Metastatic Neuroendocrine Cohort Phase 2 mNET Tumor Cohort (n=24)* Number (n) Tumor Types Pancreatic NET 13 Pre-PHP (Baseline) Carcinoid tumor 3 Other NET 8 Response Partial Response (PR) 10 66% disease Stable disease (SD) 6 control Progressive disease 3 Post-PHP #1 Not assessed
Slide 13: Phase 2 NCI Trial – Hepatobiliary Carcinoma Cohort
Phase 2 NCI Trial – Hepatobiliary Carcinoma Cohort • Best hepatic tumor response by modified RECIST assessed by investigators o Partial response (PR) 1 patient o Stable disease (SD) 4 patients o Progressive disease 1 patient o Not assessed or evaluable 2 patients • Median duration of response o hPR
Slide 14: Phase 2 NCI Trial – mCRC Cohort
Phase 2 NCI Trial – mCRC Cohort • Substantial clinical evidence of benefit of using ultra-high dose 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 ~50-60% and median OS
Slide 15: Additional Clinical Data Generation
Additional Clinical Data Generation • Goals: Expand US (PHP: MEL) label indications beyond the initial indication we are seeking Generate robust clinical data to support commercialization • FDA has accepted IND Amendment that includes Gen 2 device in Expanded Access Program (EAP), compassionate use
Slide 16: 2013 Clinical Development Plan
2013 Clinical Development Plan • Planned company sponsored trials, subject to agreement with FDA Hepatocellular carcinoma (HCC) o Global Phase 3 Randomized CHEMOSAT Melphalan vs. best supportive care (BSC) for patients who have failed Sorafenib (or are intolerant) Primary endpoint: Overall Survival
Slide 17: Long Term Potential - Multi-Billion Dollar Global Market
Long Term Potential - Multi-Billion Dollar Global Market $2.5B Initial Opportunity 189,943 200,000 HCC CRC $300M Initial on-label 175,000 opportunity in Ocular NET Melanoma in US* Melanoma 150,000 $2.2B multi-histology opportunity in EU 99,749 125,000 100,000 75,000 55,389 52,143 50,000 42,367 7,671
Slide 18: Global Commercialization Status
Global Commercialization Status Approved (CE Mark Device) NDA Filing Accepted by the FDA with PDUFA goal date of Sept. 13, 2013 Mutual Recognition of European CE Mark – Applications Planned or Submitted Addressing A Multi-Billion Dollar Global Market 18 DELCATH SYSTEMS, INC
Slide 19: CHEMOSAT: EU Launch Underway
CHEMOSAT: EU Launch Underway • Marketing in target EU countries - Italy, Germany, France, UK, Ireland, NL, Spain • Training completed in key centers o Nine EU Clinical Sites activated as of March, 2013 • EU clinicians using CHEMOSAT for a broad range of liver metastases o Use includes: cutaneous mel
Slide 20: CHEMOSAT: Multiple Tumor Types Treated in Europe
CHEMOSAT: Multiple Tumor Types Treated in Europe Ocular Melnaoma Cutaneous Melanoma HCC Cholangelcarcinoma mNET Breast Gastric CRC Anal Muc Mel • Physicians are recognizing the potential of CHEMOSAT in various tumor types • CHEMOSAT utilized in Germany, Italy, UK, France, Ireland, and the Netherland
Slide 21: U.S. NDA Under Review
U.S. NDA Under Review • Oncology Drug Advisory Committee (ODAC) panel scheduled for May 2, 2013 • PDUFA Goal Date: September 13, 2013 • Initial indication: unresectable metastatic ocular melanoma in the liver o Provides lowest risk pathway to FDA approval and fastest access • NDA filing included: o
Slide 22: U.S. Commercialization Strategy
U.S. Commercialization Strategy • Launch in Q1 2014 assuming approval on PDUFA goal date of September 13, 2013 • Initial commercial focus on centers that are active in the EAP or participated in the Phase 3 clinical trial • Utilize active EAP hospitals as Centers of Excellence for training and suppo
Slide 23: Barriers to Entry
Barriers to Entry • Patent Protection o 6 U.S. patents in force and 6 U.S. patent applications pending o 9 foreign patents in force (with patent validity in 25 countries) and 14 foreign patent applications pending o Primary US device patent set to expire August 2016 o Up to 5 years of patent extensi
Slide 24: Financial Summary
Financial Summary Cash & Cash Equivalents: $42.8 million at March 31, 2013 (unaudited) up to $50.0 million available upon registration ATM Program statement being declared effective by the SEC Committed Equity Financing Up to $23.9 million as of March 31, 2013 Facility (CEFF) Working Capital Line of
Slide 25: Management: A Track Record of Success
Management: A Track Record of Success Years of Executive Title Prior Affiliation(s) Experience Eamonn Hobbs President and CEO AngioDynamics, E-Z-EM 32 D&B, Pagoda Pharma, Schering- Graham Miao, Ph.D. EVP & Chief Financial Officer 23 Plough, Pharmacia, JP Morgan Eli Lilly (ImClone), Johnson & Jennife
Slide 26: 2013 Anticipated Milestones
2013 Anticipated Milestones First patient enrolled in EAP - Q1 2013 Obtained NUB Value 4 interim reimbursement in Germany – Q12013 Initiated EU Retrospective Data Collection – Q2 2013 • ODAC Panel Meeting May 2, 2013 • Obtain interim reimbursement in UK – Q2 2013 • Submission for publications of Pha
Slide 27: A Compelling Investment Opportunity
A Compelling Investment Opportunity • Early stage, commercial Company focused on oncology • Proprietary CHEMOSAT ® Hepatic Delivery System allows unique whole organ therapy for the liver • CHEMOSAT system has demonstrated extension of progression free survival • Addressing large unmet market need fo
Slide 28: © 2011 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED
© 2011 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED
Slide 29: Appendices
Appendices 29 DELCATH SYSTEMS, INC
Slide 30: Liver Cancer Treatment Options
Appendix 1 LIVER CANCER TREATMENT OPTIONS 30 DELCATH SYSTEMS, INC
Slide 31: The Problem
The Problem • Metastatic disease to the liver, brain or lungs is often the life- limiting location of solid tumors o Often life-limiting or leads to withdrawal of systemic treatments in favor of palliative care • Effective treatment for patients with liver-limited or dominant cancers remains a clini
Slide 32: 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 33: Diffuse Hepatic Metastases from Melanoma
Diffuse Hepatic Metastases from 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 disease 33 DELCATH S
Slide 34: 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 35: Market Opportunity by Disease & Target Countries
Appendix 2 MARKET OPPORTUNITY BY DISEASE & TARGET COUNTRIES 35 DELCATH SYSTEMS, INC
Slide 36: Market Opportunity by Disease (patients)
Market Opportunity by Disease (patients) Melanoma • Europe – Largest near-term opportunity 10000 7500 • CRC – Largest opportunity worldwide 5000 2500 • Melanoma – Largest opportunity is in the US 0 • China – Largest opportunity for HCC HCC NET 100000 30000 25000 80000 20000 15000 10000 60000 5000 0
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 1,2,3 # Patients # Procedures ($MM) Ocular 1,685 4,213 $ 300 Melanoma Cutaneous 7,023 17,557 $ 439 Melanoma CRC 19,861 49,653 $ 1,241 HCC (Primary) 5,586 13,964 $ 349 NET 8,212 20,5
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: High-Dose Melphalan History and Rationale
Appendix 3 HIGH-DOSE MELPHALAN HISTORY AND RATIONALE 40 DELCATH SYSTEMS, INC
Slide 41: 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;9:6343-97. Van Iersel LB, et al. Ann Oncol 2010;21:1662-7 2. Noter SL, e
Slide 42: 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 Percutaneous Hepatic Perfusion (PHP) 3.00 • Well understood, dose dependent, tumor preferential, alkylating cytotoxic agent th
Slide 43: Melphalan Sensitivity: In Vitro Tumor Cell Lines Study
Melphalan Sensitivity: In Vitro Tumor Cell Lines Study 192 uM We Believe Our Technology Will Be Effective On a Wide Range of Solid Tumors 43 DELCATH SYSTEMS, INC
Slide 44: Phase 3 Trial
Appendix 4 PHASE 3 TRIAL 44 DELCATH SYSTEMS, INC
Slide 45: Phase III Clinical Trial Design
Phase III Clinical Trial Design Randomized to PHP 93 patients: ocular PHP = Meblez Kit/CHEMOSAT or cutaneous melanoma PHP/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 treatments)
Slide 46: Positive Phase 3 Results
Positive Phase 3 Results • Primary endpoint (hPFS by IRC) exceeded, p value = 0.0029, hazard ratio of 0.50 as of June, 2012 o PHP median hepatic progression free survival (hPFS) was 4-fold of control, or 5.3 months improvement o PHP achieved a median hPFS of 7.0 months vs 1.7 months for BAC control
Slide 47: Published Phase 1/2 Studies of Doxorubicin with PHP
Appendix 5 PUBLISHED PHASE 1 / 2 STUDIES OF DOXORUBICIN WITH PHP 47 DELCATH SYSTEMS, INC
Slide 48: Phase 1 & 2 Studies of PHP-Doxorubicin For HCC
Phase 1 & 2 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 2 (n=79) IV B: n=13 Doxorubicin 60 –150 mg/m HCC pts 1 Kobe Cisplatin 50–150 mg/m 2 RR 64.5% Phase I/II CHM All multip
Slide 49: Product Development Pipeline
Appendix 6 PRODUCT DEVELOPMENT PIPELINE 49 DELCATH SYSTEMS, INC
Slide 50: Product Development Pipeline
Product Development Pipeline Initial Opportunity Near Term (< 5 years) Intermediate Term (> 5 years) • All liver cancers – melphalan • Classified as Medical Device • CHEMOSAT for additional drugs rd E • 3 party melphalan • mCRC and HCC clinical trials • CHEMOSAT for other organs (lung U • Gen 2 melp
Slide 51: CHEMOSAT Delivery System for Doxorubicin – CE Mark
CHEMOSAT Delivery 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 basis for partnership opportunities in C
Slide 52: Non US/EU Regulatory Update
Appendix 7 NON US/EU REGULATORY UPDATE 52 DELCATH SYSTEMS, INC
Slide 53: International Strategy beyond EU and US
International Strategy beyond EU and US Leverage CE Mark to obtain reciprocal regulatory approvals for CHEMOSAT Systems in other international markets o Obtained approval for Gen 2 CHEMOSAT Delivery System for Melphalan in Australia International regulatory submissions status: Application submitted
Slide 54: CHEMOSAT Centers
Appendix 8 CHEMOSAT CENTERS 54 DELCATH SYSTEMS, INC
Slide 55: Active CHEMOSAT Centers in Europe
Active CHEMOSAT Centers in Europe • Milan, Italy – European Institute of Oncology (IEO) • Frankfurt, Germany – Johann Wolfgang Goethe-Universität (JWG) • Villejuif, France – Cancer Institute Gustave Roussy (IGR) • Amsterdam, The Netherlands – Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospi