Slide 1: Investor Presentation
Exhibit 99.1 Investor Presentation (NASDAQ: DCTH) May 2012
Slide 2: Forward-looking Statements
Forward-looking Statements This presentation contains forward-looking statements within the meaning of the Safe Harbor Provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statement are subject to certain risks and uncertainties that can cause actual results to differ mater
Slide 3: Our Mission
Our Mission • We are a cancer therapy company • Our technology offers the opportunity to gain control of tumors in the liver • The liver is a site where uncontrolled disease is often life-limiting or leads to withdrawal of systemic treatments in favor of palliative care • We plan on being a fully-in
Slide 4: The Problem
The Problem • Metastatic disease to the liver, brain or lungs is often the life- limiting location of solid tumors o In contrast to the brain and lungs, where systemic chemotherapy and radiation can exert some degree of local control, tumors in the liver are not particularly responsive to chemothera
Slide 5: 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 6: Our Solution
Our Solution • 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 typically takes approximately two ho
Slide 7: The Delcath CHEMOSAT System
The Delcath CHEMOSAT System Chemosaturation 1. ISOLATE 2. SATURATE 3. FILTRATE Improved disease control in the liver Treats entire liver (macro and micro) Controls systemic toxicities Allows for over 100x effective dose escalation at tumor site Repeatable & minimally invasive, Complements systemic t
Slide 8: The Data
The Data • We conducted a randomized Phase 3 study under a Special Protocol Assessment (“SPA”) using Generation 1 of our chemosaturation system in patients with melanoma (ocular and cutaneous) metastatic to the liver • Melanoma liver metastases are relatively homogeneous regardless of origin • Liver
Slide 9: Phase III Clinical Trial Design
Phase III Clinical Trial Design Randomized to CS 92 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 10: Phase 3 Hepatic Progression-free Survival (ITT)
Phase 3 Hepatic Progression-free Survival (ITT) Survival probability 1.0 CS-PHP BAC 0.8 Hazard Ratio: 0.35 0.6 (CI: 0.23-0.54) p<0.0001 8.0 1.6 0.4 0.2 0.0 0 5 10 15 20 25 30 35 Months CS-PHP Demonstrated a 5x Improvement in Primary Endpoint of hPFS 10 DELCATH SYSTEMS, INC
Slide 11: Phase 3 Overall Progression-free Survival (ITT)
Phase 3 Overall Progression-free Survival (ITT) Survival probability 1.0 CS-PHP BAC 0.8 Hazard Ratio: 0.36 0.6 (CI: 0.23-0.57) p<0.0001 6.7 1.6 0.4 0.2 0.0 0 5 10 15 20 25 30 35 Months CS also Demonstrated a Highly Statistically Significant Improvement in Overall PFS 11 DELCATH SYSTEMS, INC
Slide 12: Overall survival (ITT population)
Overall survival (ITT population) BAC vs PHP 1.0 BAC PHP 0.9 Censored observations 0.8 0.7 HR=1.20 (CI: 0.78-1.85) 0.6 p-value = 0.4170 0.5 0.4 0.3 55% Cross-over 0.2 0.1 9.8 10.0 0.0 0 12 24 36 48 60 Time (months) Overall Survival Confounded By Crossover Study Design 12 DELCATH SYSTEMS, INC
Slide 13: Overall survival (ITT population)
Overall survival (ITT population) PHP randomized vs PHP crossover vs BAC only 1.0 PHP randomized BAC crossover* 0.9 BAC only* 0.8 Censored observations 0.7 0.6 0.5 0.4 0.3 0.2 0.1 4.1 9.8 13.1 0.0 0 12 24 36 48 60 Time (months) * Similar patient characteristics and demographics between BAC crossover
Slide 14: Overall survival (ITT population)
Overall survival (ITT population) Total PHP vs BAC only 1.0 Total PHP incl. crossover BAC only 0.9 Censored observations 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 4.1 11.4 0.0 0 12 24 36 48 60 Time (months) Overall Survival Tail For Treated Patients 14 DELCATH SYSTEMS, INC
Slide 15: Positive Phase III Results
Positive Phase III Results* • Primary endpoint exceeded, p value = 0.0001, hazard ratio of .35 o Treatment arm shows 5x median hepatic progression free (hPFS) survival compared to control arm o CS/PHP median hPFS of 8.0 months compared to 1.6 months for BAC o 86% overall clinical benefit (CR + PR +
Slide 16: Melphalan Sensitivity: In Vitro Tumor Cell Lines Study
Melphalan Sensitivity: In Vitro Tumor Cell Lines Study Apoptosis Melphalan Sensitivity- Apoptosis Induction Cancer Origin Induction (Cell lines) (uM) 2.54 Melphalan Conc. achieved during CHEMOSAT = ~192 uM Thyroid Ovarian 4.31 Melanoma 4.53 CNS 6.40 Sarcoma 6.68 Head and Neck 6.78 Bladder 9.50 Colon
Slide 17: Our Opportunity
Our Opportunity • At the concentrations of melphalan we are achieving in the liver, we believe CHEMOSAT will be effective on a wide variety of histologies • We believe that physicians are recognizing the broad applicability of CHEMOSAT, based on early experience and their interest in testing our tec
Slide 18: CHEMOSAT - Potential Multi-Billion Dollar Market
CHEMOSAT - Potential Multi-Billion Dollar Market $2.2 B 200,000 HCC 189,943 CRC 175,000 NET Melanoma 150,000 99,749 125,000 100,000 $2.2 B 75,000 $2.6 B 55,389 52,143 50,000 8,708* 7,671 5,585 33,953 19,861 25,000 33,966 8,212 7,202 8,708 6,563 4,085 0 USA EU APAC Sources: LEK Consulting, GLOBOCAN,
Slide 19: Global Commercialization Status
Global Commercialization Status Approved (CE Mark Device) Regulatory Filing (NDA) Planned in August, 2012 Application Submitted/ Planned – Mutual Recognition of European CE Mark in 2012-2013 On The Cusp of Addressing A Multi-Billion Dollar Global Market in Next Two Years 19 DELCATH SYSTEMS, INC
Slide 20: European Commercialization Strategy
European Commercialization Strategy Strategy: • Focus efforts in 7 Target Countries (EU 5 + Netherlands & Ireland) • 8-10 leading EU cancer centers as initial training centers • Validate business model and demonstrate scalability • Push and Pull marketing and selling strategy Tactics & Execution: •
Slide 21: Patient Referral Path
Patient Referral Path Identification of liver involvement with no improvement from systemic Patient therapy Primary Diagnosis Care of Cancer Chemosaturation Medical Surgical Oncologist Oncologist Offers systemic therapy Offers resection or other focal therapy When liver disease is controlled patient
Slide 22: CHEMOSAT Training and Marketing Commenced in Europe
CHEMOSAT Training and Marketing Commenced in Europe • Entered training and marketing agreements with leading cancer centers in Europe o Institute of European Oncology (IEO), Milan, Italy o Johann Wolfgang Goethe (JWG) University Hospital, Frankfurt, Germany o University Medical Center Schleswig-Hols
Slide 23: European Reimbursement Considerations
European Reimbursement Considerations • No centralized pan-European medical device reimbursement body – regional and national systems • Devices typically reimbursed under Diagnosis Related Groups (DRG) as part of a procedure • Working with reimbursement specialists to develop a plan in each of our k
Slide 24: 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 • International regulatory submissions status: Application submitted and expected approvals in Australia - 2012 (approved) Hong Kong - 2012 S. Korea
Slide 25: U.S. FDA Regulatory Status
U.S. FDA Regulatory Status • Pre-NDA submission meeting with FDA conducted in January 2012 o Satisfied with FDA response o Addressed RTF related issues Manufacturing plant inspection timing Product and sterilization validation Additional statistical analysis clarification Additional safety data • Co
Slide 26: U.S. Commercialization Strategy
U.S. Commercialization Strategy • Initial focus on leading cancer centers and referring community hospitals • Educate Medical Oncologists via Medical Science Liaison (MSL) • Direct strategy to sell to Interventional Radiologists and Surgeons: 12 sales territories ultimately expanding to as many as 6
Slide 27: Clinical Development Program
Clinical Development Program • Goal: o Expand indications for HCC and mCRC with US registration trials o Generate robust clinical data to support commercialization • Submitted IND Amendment to include Gen 2 in Expanded Access Program (EAP), compassionate use and all future clinical trials o Assuming
Slide 28: 2012 Milestones
2012 Milestones • First patients have been treated with CHEMOSAT Melphalan in Europe - Done • Execute contract for MSL services in EU – 1Q 2012 (Quintiles was selected to support EU launch of CHEMOSAT) - Done • Secure agreements with 6-8 leading cancer centers in EU - Done • Obtain CE Mark for Gen 2
Slide 29: Financial Update
Financial Update Cash & Cash Equivalents: $20.8 million at March 31, 2012 $4.8 million raised via At-The-Market (ATM) Financing Program equity offering program in Q1 2012 Working Capital Line of Credit $20.0 million credit facility Cash Spend: $14.7 million in Q1 2012 Debt: None 1 Shares Outstanding
Slide 30: Team
Team Years of Executive Title Prior Affiliation(s) Experience Eamonn Hobbs President and CEO AngioDynamics, E-Z-EM 31 D&B, Pagoda Pharma, Schering- Graham Miao, Ph.D. EVP & CFO 22 Plough, Pharmacia, JP Morgan Krishna Kandarpa, Harvard, MIT(HST), Cornell, CMO and EVP, R&D 32 M.D., Ph.D. UMass Agustin
Slide 31: Appendices
Appendices 31 DELCATH SYSTEMS, INC
Slide 32: Appendix I: Intellectual Property
Appendix I Intellectual Property 32 DELCATH SYSTEMS, INC
Slide 33: Intellectual Property
Intellectual Property • Patent Protection o 7 issued U.S. patents, 10 foreign patents issued and 4 pending o Primary device patent set to expire August 2016 o Up to 5 years of patent extension post FDA approval • Trade Secret Protection o Developed improved filter media via new manufacturing process
Slide 34: Appendix II: CHEMOSAT Market Opportunity by Disease and Target Countries
Appendix II CHEMOSAT Market Opportunity by Disease and Target Counties 34 DELCATH SYSTEMS, INC
Slide 35: Market Opportunity by Disease (patients)
Market Opportunity by Disease (patients) • Europe – Largest near-term opportunity • CRC – Largest opportunity worldwide • Melanoma – Largest opportunity is in US • China- Largest opportunity for HCC Market Opportunity defined as Total Potential Market (TPM) for CHEMOSAT ® 1.Primary cancer incidence
Slide 36: Europe Market by Disease – Device Only
Europe Market by Disease – Device Only Total Potential Germany UK France Italy Spain Netherlands Ireland Potential Market (Direct) (Direct) (Indirect) (Indirect) (Indirect) (Direct) (Direct) 1,2,3 (patients) ($ 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 TOTAL MELANOMA 8,708 21,770 $ 544 (Initial Expected Label) CRC 19,861 49,65
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: Appendix III: CHEMOSAT Melphalan Phase I and II
Appendix III CHEMOSAT Melphalan Phase I and II 39 DELCATH SYSTEMS, INC
Slide 40: 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 dependant, tumor preferential, alkylating cytotoxic agent that demonstrates
Slide 41: Phase II NCI Trial – Metastatic Neuroendocrine Cohort
Phase II NCI Trial – Metastatic Neuroendocrine Cohort Phase II mNET Tumor Cohort (n=24)* Number (n) Pre-CS (Baseline) Primary Tumor Histology Carcinoid 4 Pancreatic Islet Cell 20 Response Not Evaluable (Toxicity, Incomplete Treatment, Orthotopic Liver 4 Transplantation) Post-CS #1 Progressive Diseas
Slide 42: Phase II NCI Trial – HCC Cohort
Phase II NCI Trial – HCC Cohort • Hepatocellular carcinoma (HCC) is the most common primary cancer of the liver, with approximately 749,000* new cases diagnosed worldwide annually • Nine patients with tumors of hepatobiliary origin: five HCC patients and four cholangiocarcinoma patients • Both group
Slide 43: Phase II NCI Trial – mCRC Cohort
Phase II NCI Trial – mCRC Cohort • Substantial clinical evidence of benefit of using 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 47% (range 29%-76%) 1 • Delcath Phas
Slide 44: Appendix IV: Published Phase I/II Studies of Doxorubicin with PHP for HCC
Appendix IV Published Phase I/II Studies of Doxorubicin with PHP (percutaneous hepatic perfusion) for HCC 44 DELCATH SYSTEMS, INC
Slide 45: CHEMOSAT Doxorubicin Development
CHEMOSAT Doxorubicin Development • Multiple published Phase I/II studies from MD Anderson Cancer Center and Yale with percutaneous hepatic perfusion (PHP) and Kobe University using doxorubicin show promising response rates for HCC* • Status: o First pass removal efficiency 95% in initial in vitro st
Slide 46: Phase I/II Studies of PHP-Doxorubicin For HCC
Phase I/II 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 2 Kobe Cisplatin 50–150 mg/m RR 64.5% 2 Phase I/II CHM All multi
Slide 47: Appendix V: Product Development Pipeline
Appendix V Product Development Pipeline 47 DELCATH SYSTEMS, INC
Slide 48: Product Development Pipeline
Product Development Pipeline Initial Opportunity Near Term (< 5 years) Intermediate Term (> 5 years) • All liver cancers – melphalan • Doxorubicin system CE Mark • CHEMOSAT for additional drugs E • Class III medical device • mCRC and HCC clinical trials • CHEMOSAT for other organs (lung U • 3 rd par
Slide 49: 2011 DELCATH SYSTEMS, 2 DELCATH
© 2011 DELCATH 2 DELCATH SYSTEMS, SYSTEMS, INC INC. ALL RIGHTS RESERVED