Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Shareholder Meeting (June 2015)
28 slides from Delcath Systems's shareholder meeting presentation, Jun 10, 2015
Slide 1: Investor Presentation – Annual Shareholder Meeting
Exhibit 99.1 Investor Presentation (NASDAQ: DCTH) Annual Shareholder Meeting June 10, 2015
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: About Delcath Systems
About Delcath Systems • A specialty pharmaceutical and medical device oncology company with a principal therapeutic focus on the treatment of primary liver cancer and other cancers that have metastasized to the liver • Proprietary system isolates the liver from circulation, delivers a substantially
Slide 4: Investment Highlights
Investment Highlights • Late-stage asset – approved and initial commercial activities underway in EU; demonstrated clinically meaningful efficacy in more than 600 procedures and multiple tumor types • Active clinical program – initiating global Phase 3 study in ocular melanoma; HCC/ICC Phase 2 progr
Slide 5: 2014-2015 Milestones
2014-2015 Milestones 2014 Accomplishments Phase 2 HCC trial open and first patient treated 100 th patient treated in Europe (commercial and clinical) Positive efficacy data from three institutions presented at ESSO 2014 Product revenue increased 118% Y/Y to $1.1 million Cash burn reduced by 50% Y/Y
Slide 6: The Liver: A Life-Limiting Organ
The Liver: A Life-Limiting Organ • Cancers of the liver remain a major unmet medical need o Large global patient population – approximately 1.2 million* patients diagnosed annually with primary or metastatic liver cancer o The liver is often the life-limiting organ for cancer patients and one of the
Slide 7: Our Solution: Whole Organ-Focus Disease Control
Our Solution: Whole Organ-Focus Disease Control • Our proprietary system isolates the liver circulation, delivers a high concentration of chemotherapy (melphalan) and filters most of the chemotherapy out of the blood prior to returning it to the patient • The procedure typically takes approximately
Slide 8: Existing Liver Cancer Treatments Landscape
Existing Liver Cancer Treatments Landscape 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) – Targeted
Slide 9: The Melphalan Hepatic Delivery System (HDS)
The Melphalan Hepatic Delivery System (HDS) Liver Isolated Via Double Balloon Melphalan Infused Directly Into Liver Blood Exiting The Liver Filtered By Catheter In IVC Via Catheter In Hepatic Artery Proprietary Extra-corporeal Filters • Device designed to administer high-dose chemotherapy to the liv
Slide 10: 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 11: Total Available EU & U.S. Market Opportunity
Total Available EU & U.S. Market Opportunity Annual Potential Annual Potential Annual 2 Cancer Type 1 Eligible Pts Market Opportunity Market Opportunity Incidence 3,5 (millions) (millions)4,5 Ocular Melanoma (OM) 5,700-8,600 2,600-4,300 $104-$215 $208-$430 Cholangio Carcinoma (ICC) 11,500 6,500 $260
Slide 12: 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 13: Clinical Development Program Detail
Clinical Development Program Detail Trials Tumor Objectives Global Phase 3 trial to start 2H-2015 Phase 3 Pivotal Trial OM liver mets Primary endpoint: Overall Survival (OS) Believed to be fastest pathway to NDA approval in the U.S. Protocol 201 (U.S.only) Safety,efficacyof melphalan/HDStreatment fo
Slide 14: OM Metastases Rationale
OM Metastases Rationale • OM has high incidence of liver metastases o Up to 90% of patients with metastases will have liver involvement o Life expectancy of approximately 6 months o 5,700 - 8,600 cases of OM liver metastases diagnosed in U.S. and EU annually • Clear efficacy signal seen in prior Pha
Slide 15: Previous Ocular Melanoma Mets Phase 3 Results
Previous Ocular Melanoma Mets Phase 3 Results Hepatic Progression Free Survival (hPFS) Overall Progression Free Survival (Investigator) Proportion of patients surviving Proportion of patients surviving 1.0 1.0 3.8 mo Chemosaturation (CS-PHP) 5.3 mo Chemosaturation (CS-PHP) 0.8 0.8 Best alternative c
Slide 16: ICC Rationale
ICC Rationale • Significant market opportunity in U.S. and EU o ~15% of new HCC cases diagnosed annually o ~90% of patients are not suitable for surgical resection o ~20-30% are candidates for focal interventions o Efficacy signals from early commercial uses in EU • Unmet medical need – Delcath is p
Slide 17: HCC Rationale
HCC Rationale • Significant opportunity in the U.S. and EU o HCC most common primary cancer of the liver o ~76,000* cases diagnosed annually • Large unmet medical need in first-line therapy o Only one approved systemic therapy in the U.S., EU and certain Asian markets o ~90% of patients not candidat
Slide 18: Prior FDA Experience
Prior FDA Experience • New Drug Application (NDA) submitted August 2012 seeking indication in OM liver metastases with first-generation filters and procedure • ODAC meeting in May 2013 o Efficacy shown with statistical significance o Negative vote due to benefit/risk analysis o Complete FDA & Delcat
Slide 19: Risks Observed in Previous Clinical Program
Risks Observed in Previous Clinical Program • Risks observed with prior product and procedure protocol • Integrated safety population of patients showed risks associated with melphalan/HDS included: o 4.1% incidence of death due to adverse reactions o 4% incidence of stroke o 2% reported incidence o
Slide 20: Safety Improvements Implemented
Safety Improvements Implemented • New generation filter o Improve filter efficiency and consistency • Vasopressors and methylprednisolone o Reduce cardiovascular risk • Prophylactic transfusions and growth factors o Reduce risk of myelosuppression • Intra-arterial nitroglycerin o Prevent hepatic art
Slide 21: Positive Developments
Positive Developments • Improved device and procedure since prior trials o >200 treatments with improved device and procedure in U.S. and EU o Many issues raised at ODAC have not been reported • Current device/procedure permitting multiple treatment cycles • Recent Presentations & Abstracts at Major
Slide 22: Recent Data Presentations - ASCO 2015
Recent Data Presentations - ASCO 2015 • Analysis of 20 patients who received 34 treatments at Southampton University Hospital o Eleven patients remain alive after a median of 280 days with one complete response ongoing at >1 year o From the diagnosis of liver metastases, 11 patients (55%) survived t
Slide 23: Recent Data Presentations - SSO 2015
Recent Data Presentations - SSO 2015 • Moffitt Cancer Center (Tampa, FL) o Retrospective analysis of 30 patients with ocular or cutaneous melanoma treated with Melphalan/HDS (n=10), chemoembolization (CE, n=12), and yttrium-90 (Y90, n=6) o Study showed significant difference in hepatic progression f
Slide 24: European Commercial Activity
European Commercial Activity CHEMOSAT ® Hepatic Delivery System • Approved as Class IIb Medical Device; kit supplied without melphalan • Broad indication for intra-hepatic administration of melphalan hydrochloride and subsequent filtration of the venous blood return • >180 commercial procedures perf
Slide 25: CHEMOSAT Commercial Treatments in Europe
CHEMOSAT ® Commercial Treatments in Europe Multiple Tumor Types Treated Since EU Launch DISEASE (Commercial Treatments) TREATMENTS 160 200 186 136 140 175 120 150 100 125 111 80 100 60 75 40 52 19 20 9 50 2 2 3 1 6 6 1 1 20 0 25 3 0 Treatments/Re-treatments Increasing 25DELCATH SYSTEMS, INC
Slide 26: Cash & Capital Resources
Cash & Capital Resources Cash & Cash Equivalents $18.5 million at March 31, 2015 Debt None ATM Program 1 $40 million available at March 31, 2015 Shares Outstanding 12.2 million (14.4 million fully diluted 2) at March 31, 2015 1) Subject to market conditions and certain limitations 2) Fully diluted i
Slide 27: In Summary
In Summary Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) • Cancers of the liver remain a multibillion-dollar unmet medical need • Unique, highly differentiated solution • Late-stage asset in U.S., early commercial activity EU • Compelling emer
Slide 28: 2015 DELCATH SYSTEMS, 28DELCATH
© 2015 DELCATH 28DELCATH SYSTEMS, SYSTEMS, INC INC. ALL RIGHTS RESERVED Delcath and CHEMOSAT are registered trademarks of Delcath Systems, Inc.