Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (October 2013)
32 slides from Delcath Systems's investor presentation, Oct 17, 2013
Slide 1: Investor Presentation
Exhibit 9.1 Investor Presentation (NASDAQ: DCTH) October 2013
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: Investment Thesis
Investment Thesis § Liver cancer therapy company § Innovative Delcath Hepatic Delivery System (HDS) in combination with high dose well-established chemotherapeutic drug Melphalan to address an underserved liver cancer market § Clinically proven therapeutic concept for liver cancers § Positive effica
Slide 4: Product Status
Product Status Ex U.S. Markets U.S. Market CHEMOSAT® Melphalan for Injection with Hepatic Delivery System Delcath Hepatic Delivery System § Regulated as a Class IIb Medical § Clinical development stage - proprietary Device Drug/Device Combination Product Regulated as a drug 505(b)(2) NDA by § Indica
Slide 5: The Delcath Hepatic Delivery System
The Delcath Hepatic Delivery System 4. Filtered blood returned to systemic circulation via 3. Filters jugular vein Veno-veno 1. Melphalan Bypass Pump administration 2. Blood and melphalan directly into collected in IVC as they Hepatic Artery exit liver via hepatic blood flow 5 DELCATH SYSTEMS, INC v
Slide 6: Positive Efficacy Signals in Multiple Liver Tumor Types
Positive Efficacy Signals in Multiple Liver Tumor Types 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Phase 1 Unresectable hepatic tumors N=34 PHP Phase 2 Unresectable hepatic tumors N=56 PHP Phase III Melanoma Liver Mets OS Follow-up N=93 44 PHP, 49 BAC EU Retro- R
Slide 7: Clinically Differentiated Results
Clinically Differentiated Results § Phase 1, 2 and 3 trials produced positive results in multiple tumor types § Melanoma Liver Mets § Positive Phase 3 results in hepatic metastatic melanoma § n=93 (90% ocular melanoma, 10% cutaneous melanoma) § Neuroendocrine Tumor (NET) Liver Mets § mNET cohort in
Slide 8: Phase 3 Results – Primary Endpoint hPFS
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% 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-to-treat population M
Slide 9: Phase 3 Results – Overall PFS
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% 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 Intent-to-trea
Slide 10: Risks associated with the CHEMOSAT/MELPHALAN HDS Procedure
Risks associated with the CHEMOSAT/MELPHALAN HDS Procedure § In clinical trials using early versions of the device, the integrated safety population of patients showed risks associated with the MELPHALAN HDS procedure: § 4.1% incidence of deaths due to adverse reactions; § 4% incidence of stroke; §
Slide 11: FDA Complete Response Letter (CRL) on Melanoma NDA
FDA Complete Response Letter (CRL) on Melanoma NDA § Issued in September, 2013 § Among FDA requests § Well-controlled randomized trial(s) to establish the safety and efficacy using the to-be-marketed device configuration § Overall survival as the primary efficacy outcome measure § Demonstrate clinic
Slide 12: HCC Rationale – U.S. & Global
HCC Rationale – U.S. & Global *Source: GLOBOCAN 12 DELCATH SYSTEMS, INC
Slide 13: Encouraging Signal in Previous P2 HCC Study with Mel/HDS
Encouraging Signal in Previous P2 HCC Study with Mel/HDS Subject Age Sex Race Baseline Number Hepatic hPFS Overall OS ID (yr) (M/F) tumor of PHP response/ (month) PFS (Month) burden (% received overall (month) of hepatic response involveme nt) 008 57 F white 5 3 SD/SD 4.37 4.37 19.88 010 63 M white
Slide 14: Global Hepatocellular Carcinoma (HCC) Clinical Plan
Global Hepatocellular Carcinoma (HCC) Clinical Plan § Global Phase 2 – Mel/HDS – sorafenib sequential treatment of HCC confined to the liver § Multi-center, open label trial § Staged trial design with early opportunity for interim analysis/proof of concept in 2014 § Objective Response Rate (CR + PR)
Slide 15: CHEMOSAT: Expanding Clinical Use in the EU
CHEMOSAT: Expanding Clinical Use in the EU § Continued commercial market access and clinical adoption activities in key EU countries § Current focus on Germany, UK, Italy § 12 Clinical Sites treated patients in EU § Clinicians using CHEMOSAT for a broad range of liver metastases § Including: cutaneo
Slide 16: CHEMOSAT: Multiple Tumor Types Treated in Europe
CHEMOSAT: Multiple Tumor Types Treated in Europe 16 DELCATH SYSTEMS, INC
Slide 17: CHEMOSAT Treatment Sites in Europe
CHEMOSAT Treatment Sites in Europe § Milan, Italy – European Institute of Oncology § Frankfurt, Germany – Johann Wolfgang Goethe-Universität § Villejuif, France – Cancer Institute Gustave Roussy § Bordeaux, France – Hôpital Saint-André § Galway, Ireland – University Hospital Galway § Southampton, Un
Slide 18: EU Reimbursement Status
EU Reimbursement Status 2012 2013 2014 2015 ZE Denied NUB Value 4 Granted NUB NUB Decision DRG Code ZE Application NUB 2/2013 Resubmission 1 Feb 2014 ~2 years data collection (German Radiology Society) Submission ZE Resubmission October 2013 from 1st introduction 10/2012 March 2013 Alternative Inter
Slide 19: Multiple Capital Resources Available to Execute Plan
Multiple Capital Resources Available to Execute Plan Cash & Cash Equivalents ~ $28 million at September 30, 2013 Debt None ATM Program ~ $47 million at September 30, 2013 Committed Equity Financing Facility (CEFF) ~ $24 million at September 30, 2013 Working Capital Line of Credit $20 million credit
Slide 20: Significantly Reducing Operating Costs
Significantly Reducing Operating Costs Quarterly Cash Utilization: Q1 2013 Act $11.3 million Q2 2013 Act $10.5 million Projected quarterly cash spend*: Q3 2013 Proj $7-$8 million Q4 2013 Proj $6-$7 million Quarterly average 2014 Proj $5-$6 million * Based on current projection, subject to change 20
Slide 21: Investment Thesis
Investment Thesis § Liver cancer therapy company § Innovative Delcath Hepatic Delivery System in combination with high dose well-established chemotherapeutic drug Melphalan to address an underserved liver cancer market § Clinically proven therapeutic concept for liver cancers § Positive efficacy sig
Slide 22: 2013 DELCATH SYSTEMS, * DELCATH
© 2013 DELCATH * DELCATH SYSTEMS, SYSTEMS, INC INC. ALL RIGHTS RESERVED
Slide 23: Appendix
APPENDIX 23 DELCATH SYSTEMS, INC
Slide 24: Leadership Team
LEADERSHIP TEAM Jennifer Simpson, PhD., M.S.N., Graham G. Miao, Ph.D., M.S., MBA Peter J. Graham C.R.N.P. Interim Co-President and Co-CEO, Executive Vice President, Interim Co-President and Co-CEO EVP, Chief Financial Officer General Counsel, Chief EVP, Global Head of Business Compliance Officer and
Slide 25: Publications: Abstracts Accepted in 2012
Publications: Abstracts Accepted in 2012 • Over 20 Abstracts Accepted and Presented in 2012 Ø Moeslein F. Chemosaturation therapy - evolution, clinical Ø Moeslein F. Chemosaturation using percutaneous hepatic perfusion: pre- experience and applications. embolization of GI branches in a phase 3 clini
Slide 26: 2013 Abstracts
2013 Abstracts • Abstracts presented in Q1 2013 o Forster M. Percutaneous hepatic perfusion for unresectable melanoma or sarcoma to the liver: a single institution experience. o Testori A. Chemosaturation therapy with percutaneous hepatic perfusion for unresectable liver metastases: the European Ins
Slide 27: 2013 Planned Publications
2013 Planned Publications • Agarwala, et al. “Treatment of Melanoma Liver Metastases: Impact on Overall Survival” (Submitted) • Ferrucci, et al. “Experience with Generation 1 Filters vs Generation 2 Filters” Under Review • Alexander, et al. “Review of Percutaneous Hepatic Perfusion for Ocular Melano
Slide 28: ODAC Summary
ODAC Summary Procedure-related deaths § Five deaths (4.1%) in the Phase 2 and Phase 3 clinical trials were considered treatment-related and resulted from adverse events § Four deaths in Phase 3 trial; one in Phase 2 trial § Treatment-related deaths in the pooled percutaneous hepatic perfusion (PHP)
Slide 29: ODAC Summary
ODAC Summary § One death due to hepatic failure: § A death due to hepatic failure occurred in male patient in the Phase 3 trial during the first cycle of melphalan/PHP treatment. Following melphalan/PHP treatment, this patient experienced fluid overload, myelosuppression, and hepatorenal syndrome. §
Slide 30: ODAC Summary
ODAC Summary § Prophylactic growth factor support, which is used to treat neutropenia, was not protocol specified and rarely used during P2 and P3 melanoma trials § In patients who have been treated with the Generation Two system, both commercially in Europe and in the US under the Expanded Access P
Slide 31: ODAC Summary
ODAC Summary In FDA’s presentation at ODAC, FDA disagreed with this adjudication and added three additional deaths, for a total of a 7% percent death rate, in the Phase 2 and Phase 3 programs § Two deaths related to hepatic failure § One death related to myelosuppression § Upon being advised of the
Slide 32: EU Reimbursement – Acronym Definition
EU REIMBURSEMENT – Acronym Definition Germany ZE – (Zusatzentgeld) form of additional compensation for approved treatments which are not sufficiently compensated by the existing DRG codes in place. NUB – (Neue Untersuchungs- und Behandlungsmethoden) provides reimbursement between the gap of availabi
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