Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (January 2013)
54 slides from Delcath Systems's investor presentation, Jan 7, 2013
Slide 1: Investor Presentation
Exhibit 99.1 Investor Presentation (NASDAQ: DCTH) January 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 • Commercial stage company focused on oncology • Proprietary CHEMOSAT delivery systems allow unique whole organ therapy for the liver • CHEMOSAT system has demonstrated extension of progression free survival • Addressing large unmet market need for cancer patients who usual
Slide 4: 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 5: 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 that are effective on
Slide 6: Clinically Differentiated Results
Clinically Differentiated Results • Phase 1, 2 and 3 trials 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) • Neuroendocrine Tumor (NET) Liver Mets o mNET cohort in
Slide 7: 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 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 popu
Slide 8: 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 Chemosaturation (CS-PHP) 0.8 Best alternative care (BAC) 0.6 Hazard ratio = 0.42 5.4 (95%CI0.27–0.64) 1.6 P<0.0001 0.4 0.2 0.0 0 5 10 15 20 25 30 35 40 45 50 55 Intent-
Slide 9: 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 10: 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 11: 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-CS (Baseline) Carcinoid tumor 3 Other NET 8 Response Partial Response (PR) 10 66% Stable disease (SD) 6 disease Progressive disease 3 control Post-CS #1 Not assessed or
Slide 12: Phase 2 NCI Trial – Hepatobilliary Carcinoma Cohort
Phase 2 NCI Trial – Hepatobilliary 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 13: 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 14: Additional Clinical Data Generation
Additional Clinical Data Generation • Goals: Expand US (CS-PHP: MEL) label indications beyond the initial indication we are seeking Generate robust clinical data to support commercialization • FDA has accepted IND Amendment to include Gen 2 device in Expanded Access Program (EAP), compassionate use
Slide 15: 2013 Clinical Development Plan
2013 Clinical Development Plan • Planned 2013 studies, pending discussion with the FDA: Hepatocellular carcinoma (HCC) o Global Phase 3 Randomized CHEMOSAT Melphalan vs. BSC for Sorafenib Failure Advanced colorectal cancer (CRC) with liver dominant metastasis o Global Phase 3 Randomized CHEMOSAT Mel
Slide 16: CHEMOSAT - Potential Multi-Billion Dollar Global Market
CHEMOSAT - Potential Multi-Billion Dollar Global Market $2.2 B $2.3B Initial Opportunity 200,000 HCC 189,943 • $100M Initial on-label CRC opportunity in Ocular 175,000 NET Melanoma in US* Melanoma 150,000 • $2.2B multi-histology opportunity in EU 99,749 125,000 100,000 $2.2 B 75,000 $2.6 B 55,389 52
Slide 17: 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 17 DELCATH SYSTEMS, INC
Slide 18: 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 Eight EU Clinical Sites activated in 2012 • EU clinicians using CHEMOSAT for a broad range of liver metastases o Use includes: cutaneous melanoma, oc
Slide 19: U.S. NDA Under Review
U.S. NDA Under Review • PDUFA date: June 15, 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 Comprehensive set of additional data in a new FDA compliant CDISC database o Gen 2 f
Slide 20: U.S. Commercialization Strategy
U.S. Commercialization Strategy • Launch in Q4 2013 assuming approval on PDUFA date of June 15, 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 support of new
Slide 21: 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 22: Financial Summary
Financial Summary Cash & Cash Equivalents: $28.3 million at September 30, 2012 ATM Program $21.5 million remaining as of November 2012 Committed Equity Financing Facility (CEFF) Up to $35 million as of December 5, 2012 Working Capital Line of Credit: $20.0 million credit facility Debt: None $14.6 mi
Slide 23: 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-Plough, Graham Miao, Ph.D. EVP & CFO 23 Pharmacia, JP Morgan Krishna Kandarpa, M.D., CSO and EVP, R&D Harvard, MIT(HST),
Slide 24: 2012 Accomplishments
2012 Accomplishments • First patients treated with CHEMOSAT Melphalan in Europe in January • Obtained CE Mark for Gen 2 CHEMOSAT Melphalan filter in April • Executed contract for MSL services in EU in 1Q 2012 (Quintiles was selected to support EU launch of CHEMOSAT) • Secured agreements with 14 lead
Slide 25: 2013 Anticipated Milestones
2013 Anticipated Milestones • First patient enrolled in EAP - Q1 2013 • Secure interim reimbursement in Germany and UK - Q1 2013 • Submission for publications of Phase 3 data and mNET arm of Phase 2 data in Q1 2013 • Initiate EU Registry - Q1 2013 • First commercial sale in APLA – Q2 2013 • ODAC Pan
Slide 26: A Compelling Investment Opportunity
A Compelling Investment Opportunity . • Commercial stage company focused on oncology • CHEMOSAT provides a unique whole organ therapy for the liver • CHEMOSAT system has demonstrated extension of progression free survival (PFS) • Addressing large unmet market need for cancer patients who usually die
Slide 27: © 2011 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED
© 2011 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED
Slide 28: Appendices
Appendices 28 DELCATH SYSTEMS, INC
Slide 29: Liver Cancer Treatment Options
Appendix 1 LIVER CANCER TREATMENT OPTIONS 29 DELCATH SYSTEMS, INC
Slide 30: 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 31: 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 32: 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 32 DELCATH S
Slide 33: 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 34: CHEMOSAT Market Opportunity by Disease & Target Countries
Appendix 2 CHEMOSAT MARKET OPPORTUNITY BY DISEASE & TARGET COUNTRIES 34 DELCATH SYSTEMS, INC
Slide 35: Market Opportunity by Disease (patients)
Market Opportunity by Disease (patients) • Europe – Largest near-term opportunity • CRC – Largest opportunity worldwide • Melanoma – Largest opportunity is in the US • China – Largest opportunity for HCC Market Opportunity defined as Total Potential Market (TPM) for CHEMOSAT ® 1.Primary cancer incid
Slide 36: 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 37: 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 CRC 19,861 49,653 $ 1,241 HCC (Primary) 5,586 13,964 $ 349 NET 8,212 20,530
Slide 38: 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 39: High-Dose Melphalan History and Rationale
Appendix 3 HIGH-DOSE MELPHALAN HISTORY AND RATIONALE 39 DELCATH SYSTEMS, INC
Slide 40: 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 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 dependent, tumor preferential, alkylating cytotoxic agent that demonstrates
Slide 42: 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 42 DELCATH SYSTEMS, INC
Slide 43: Phase 3 Trial
Appendix 4 PHASE 3 TRIAL 43 DELCATH SYSTEMS, INC
Slide 44: 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 45: 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 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 co
Slide 46: Published Phase 1/2 Studies of Doxorubicin with CS-PHP
Appendix 5 PUBLISHED PHASE 1 / 2 STUDIES OF DOXORUBICIN WITH CS-PHP 46 DELCATH SYSTEMS, INC
Slide 47: 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) ResponseRates Reference HCC 1–4 IV A: n=66 16 2 (n=79) IV B: n=13 Doxorubicin 60 –150 mg/m HCC pts 1 2 Kobe Cisplatin 50–150 mg/m RR 64.5% 2 Phase I/II CHM All multi
Slide 48: Product Development Pipeline
Appendix 6 PRODUCT DEVELOPMENT PIPELINE 48 DELCATH SYSTEMS, INC
Slide 49: 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 • mCRC and HCC clinical trials • 3 party melphalan • CHEMOSAT for other organs (lung • Gen 2 melphala
Slide 50: 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 o Provides a pathway for regulatory approval in China and S.
Slide 51: Non US/EU Regulatory Update
Appendix 7 NON US/EU REGULATORY UPDATE 51 DELCATH SYSTEMS, INC
Slide 52: 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 Australia • International regulatory submissions status: Application submitted and e
Slide 53: CHEMOSAT Centers
Appendix 8 CHEMOSAT CENTERS 53 DELCATH SYSTEMS, INC
Slide 54: CHEMOSAT Centers in Europe
CHEMOSAT Centers 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-Holstein o Villejuif, Fr
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