Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (January 2016)
24 slides from Delcath Systems's investor presentation, Jan 22, 2016
Slide 1: Investor Presentation January 2016
Investor Presentation (NASDAQ: DCTH) January 2016 Exhibit 99.1
Slide 2: Forward-looking Statements
Forward-looking Statements This presentation contains forward-looking statements, within the meaning of the federal securities laws, related to future events and future financial performance which include statements about our expectations, beliefs, plans, objectives, intentions, goals, strategies, a
Slide 3: Delcath Systems
Delcath Systems Seeking to make a clinically meaningful difference for patients with cancers of the liver Focused on treatment of primary/metastatic liver cancers Proprietary system delivers high-dose chemotherapy (melphalan) directly to the liver with extra-corporeal filtration to limit systemic to
Slide 4: Value Drivers – Near Term Milestones
Value Drivers – Near Term Milestones 2H 2015 Reimbursement in Germany Awarded for 2016 Prior P3 Results Published 1H 2016 FDA SPA Approval FOCUS Trial Initiation 2H 2016 EU Registry Data Readout #2 IIT Data Presentation Interim HCC/ICC Data EU Registry Data Readout #1 German ZE Reimbursement Level D
Slide 5: Cancers of the Liver - A Major Unmet Medical Need
Cancers of the Liver - A Major Unmet Medical Need Large global patient population of ~1.2 million* patients diagnosed annually with primary or metastatic liver cancer Liver a common site of metastases and often the life-limiting organ for cancer patients Prognosis is poor, OS generally <12 months Cu
Slide 6: Limitations of Current Liver Cancer Treatments
Limitations of Current Liver Cancer Treatments Systemic Chemotherapy Regional Therapy Surgical Resection Focal Interventions Emerging Therapy Temozolomide, carboplatin/ Paclitaxel Isolated Hepatic Perfusion Y-90, Chemo/ Radiofrequency Ablation Checkpoint Inhibitors, Immunotherapy Systemic Toxicities
Slide 7: Our Solution – Liver Focused Disease Control
Our Solution – Liver Focused Disease Control CHEMOSAT® Melphalan/HDS product uniquely positioned to treat the entire liver as a standalone or complementary therapy System isolates the liver circulation, delivers a high concentration of chemotherapy (melphalan), filters most chemotherapy out of the b
Slide 8: Benefits Demonstrated in Prior Phase Trial
Months Benefits Demonstrated in Prior Phase 3 Trial Percutaneous Hepatic Perfusion (PHP) Overall Progression Free Survival (INV Assessment) Months 1.0 0.8 0.6 0.4 0.2 0.0 Proportion of patients surviving 5.4 1.6 3.8 mo Best alternative care (BAC) 0 5 10 15 20 25 30 35 40 45 50 55 4 PTS alive as of D
Slide 9: Multi-Billion Dollar Opportunity in Orphan Indications
Multi-Billion Dollar Opportunity in Orphan Indications EU & US TAM Cancer Type Annual Incidence1 Eligible PTS2 Annual Potential Market Opportunity (Millions)3,4 Ocular Melanoma 5,700-8,600 2,600-4,300 ~$104-$430 Intrahepatic Cholangiocarcinoma (ICC) 11,500 6,500 ~$260-$660 Hepatocellular Carcinoma (
Slide 10: Clinical Development Program
Clinical Development Program Program Tumor Type IIT P2 P3 Upcoming Milestones FOCUS Trial P3 Pivotal Study in Hepatic Dominant OM u 202 HCC/ICC Trial (EU Only) u 201 HCC/ICC Trial (US Only) u SPA Agreement Trial Initiation 1st PTS Treated Interim Efficacy/Safety Data Ocular Melanoma (OM) Hepatocellu
Slide 11: Initial EU Commercialization
Initial EU Commercialization CE Marked as Class IIb Medical Device with broad indication ~230 commercial procedures performed on ~140 patients Broad range of tumor types treated National reimbursement established in Germany for 2016 after <3 years of commercial activity Prospective Registry activate
Slide 12: Growing & Expanding Clinical Utilization
Growing & Expanding Clinical Utilization OM vs Other Tumors in New PTS EU clinical adoption increasing Physicians opting to retreat patients as familiarity/confidence grows Data from EU experience presented at multiple medical conferences in 2015 Usage expanding beyond initial use in metastatic OM U
Slide 13: 2015 Data Presentations
2015 Data Presentations Abstract N= Efficacy Toxicity/AEs Notes OS CR PR SD HPFS Zager – SSO 30 (CM, OM) 736 days 310 days OS results provide confidence for new P3 Trial Southampton - ASCO 20 2 13 2 GR1 (n=12), GR2 (n=13), GR3(n=5) GR4(n=1) 11 pts alive median 280 days, 1 CR ongoing >1yr LUMC - CIRS
Slide 14: Cash & Capital Resources
Cash & Capital Resources Cash & Cash Equivalents $16.7 million at Sept 30, 2015 Debt None ATM Program1 $40 million available at Sept 30, 2015 Shares Outstanding 21.8 million (41.3 million fully diluted2) at Sept 30, 2015 Subject to market conditions and certain limitations Fully diluted includes app
Slide 15: Investment Highlights
Investment Highlights Attractive multi-billion dollar orphan drug business model Unique, highly differentiated solution Late-stage asset in US with active clinical development program Early commercial activity in EU with increasing sales/procedure volumes Imminent valuation drivers FDA SPA Agreement
Slide 16: Concentrating the Power of Chemotherapy
Concentrating the Power of Chemotherapy™ INC. ALL
Slide 17: Appendix
Appendix 17 DELCATH SYSTEMS, INC
Slide 18: SSO 2015 Hepatic Progression Free and Overall Survival
SSO 2015 Hepatic Progression Free and Overall Survival after Regional Therapy to the Liver for Metastatic Melanoma - Moffitt Cancer Center (Tampa, FL) Methods – Retrospective analysis of 30 patients with ocular or cutaneous melanoma treated with Melphalan/HDS (n=10), chemoembolization (CE, n=12), an
Slide 19: ASCO 2015 Single Centre Experience of Chemosaturation
ASCO 2015 Single Centre Experience of Chemosaturation Percutaneous Hepatic Perfusion in the Treatment of Metastatic Uveal Melanoma - Southampton University Hospital (UK) Methods - Analysis of 20 ocular melanoma patients who received 34 TX Results - Eleven patients remain alive after a median of 280
Slide 20: CIRSE 2015 Safety and efficacy of 2nd Generation filter
CIRSE 2015 Safety and efficacy of Delcath 2nd Generation filter in PHP with melphalan for unresectable hepatic metastases of colorectal cancer and uveal melanoma - Leiden University Medical Center (the Netherlands) 15 PHP procedures performed with CHEMOSAT on 10 pts; PK blood samples @ baseline, set
Slide 21: ECCO 2015 Treating Unresectable Liver Metastases of Uveal Melanoma
ECCO 2015 Treating Unresectable Liver Metastases of Uveal Melanoma with (Percutaneous) Isolated Hepatic Perfusion with Melphalan: Results from Two Experienced Centers - Leiden University Medical Center, Erasmus Medical Center (the Netherlands) Methods - Investigators compared TX with IHP and PHP for
Slide 22: EADO 2015 Liver Directed Treatment of Metastatic Uveal Melanoma
EADO 2015 Liver Directed Treatment Of Metastatic Uveal Melanoma By Chemosaturation Via Percutaneous Hepatic Perfusion – A Single Centre Experience Southampton University (United Kingdom) Methods – A retrospective evaluation of 20 patients treated with CHEMOSAT over 3 years; analysis of survival, tum
Slide 23: EADO 2015 Treating Unresectable Liver Metastases With PHP
EADO 2015 Treating Unresectable Liver Metastases Of Uveal Melanoma With Percutaneous Hepatic Perfusion With Melphalan, Leiden University Medical Center, Erasmus Cancer Institute (the Netherlands) presented by Dr. Mark Burgmans (Leiden) Methods - two-center Phase 2 study aims to evaluate 20 patients
Slide 24: EADO 2015 Chemosaturation for Hepatic Metastases from Uveal Melanoma
EADO 2015 Chemosaturation with Percutaneous Hepatic Perfusion of Melphalan for Hepatic Metastases from Uveal Melanoma: Multi-institutional Evaluation, poster presented by lead author Prof. Thomas Vogl, Frankfurt University Hospital Methods - retrospective evaluation of non-resectable hepatic metasta
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