EX-99.1 2 d452668dex991.htm DELCATH SYSTEMS, INC. INVESTOR PRESENTATION SLIDES

Investor Presentation (NASDAQ: DCTH) December 2012 Exhibit 99.1

Forward-looking Statements 2 DELCATH SYSTEMS, INC 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 results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to: timing of completion of the FDA’s review of our NDA, the extent to which the FDA may request additional information or data and our ability to provide the same in a timely manner, acceptability of the Phase 1, 2 and 3 clinical trial data by the FDA, FDA approval of the Company's NDA for the treatment of metastatic ocular melanoma to the liver, adoption, use and resulting sales, if any, for the chemosaturation system in the United States, adoption, use and resulting sales, if any, for the Hepatic CHEMOSAT delivery system in the EEA, our ability to successfully commercialize the chemosaturation system in various markets and the potential of the chemosaturation system as a treatment for patients with cancers in the liver, the timing and our ability to successfully enter into strategic partnership and distribution arrangements in foreign markets including Australia and key Asian markets and resulting sales, if any, from the same, patient outcomes using the Generation 2 system, approval of the current or future chemosaturation system for other indications and/or for use with various chemotherapeutic agents, actions by the FDA or other foreign regulatory agencies, our ability to obtain reimbursement for the CHEMOSAT system in various markets, submission and publication of the Phase II and III clinical trial data, the timing and results of research and development projects, the timing and results of future clinical trials including the initiation of clinical trials in key Asian markets with the Hepatic CHEMOSAT Delivery System device for intra-hepatic arterial delivery and extracorporeal filtration of doxorubicin, approval of the Hepatic CHEMOSAT Delivery System to delver and filter doxorubicin in key Asian markets and adoption, sales, if any, and patient outcomes using the same, the timing, price and use, if any, of the committee equity financing facility with Terrapin, the timing and use, if any, of the line of credit from SVB and our ability to access this facility and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.

Our Mission Concentrating the Power of Chemotherapy for Disease Control in the Liver • 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-integrated company and are building the infrastructure to develop and commercialize our products in Europe and North America, while pursuing opportunities in other regions. o In Europe, CHEMOSAT with Melphalan is approved and is currently being sold • We believe that our first product, CHEMOSAT, may extend the lives of a large number of cancer patients 3 DELCATH SYSTEMS, INC

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 chemotherapy and radiation therapy • Existing treatments to control tumors in the liver include: Surgical resection Radioembolization (SIRT) Chemoembolization (TACE) Radiofrequency ablation (RFA), Microwave, Cryoablation Hepatic arterial infusion (HAI) Systemic chemotherapy 4 DELCATH SYSTEMS, INC Existing Liver Cancer Treatments Have Significant Limitations

Existing Liver Cancer Treatments Have Limitations Unmet Medical Need Exists for More Effective Liver Cancer Treatments Treatment Advantages Disadvantages Systemic – Non-invasive – Repeatable – Systemic toxicities – Limited efficacy in liver Regional (e.g., Isolated Hepatic Perfusion) – Therapeutic effect – Targeted – Invasive/limited repeatability – Multiple treatments are required but not possible Focal (e.g. surgery, radioembolization, chemoembolization, radio frequency ablation) – Partial removal or treatment of tumors – Only 10% to 20% resectable – Invasive and/or limited repeatability – Treatment is limited by tumor size, number of lesions and location – Tumor revascularization – Cannot treat diffuse disease 5 DELCATH SYSTEMS, INC

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 6 DELCATH SYSTEMS, INC

Concentrating the Power of Chemotherapy for Disease Control in the Liver 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 typically takes approximately two hours to complete and involves a team including the interventional radiologist and perfusionist • CHEMOSAT (Gen 2) has demonstrated minimal systemic toxicities and impact to blood components in initial commercial use and may complement systemic therapy • CHEMOSAT has been used on approximately 200 patients to date through clinical development and early commercial launch 7 DELCATH SYSTEMS, INC

1. ISOLATE 2. SATURATE 3. FILTRATE The Delcath CHEMOSAT System Minimally Invasive, Repeatable Liver Procedure That Could Complement Systemic Therapy Chemosaturation 8 DELCATH SYSTEMS, INC • 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

Concentrating the Power of Chemotherapy for Disease Control in the Liver The Data • We conducted a randomized Phase 3 study under a Special Protocol Assessment (“SPA”) using Generation 1 of our chemosaturation system with melphalan in patients with melanoma (ocular and cutaneous) metastatic to the liver • Melanoma liver metastases are relatively homogeneous regardless of origin • Liver metastases are typically the life-limiting aspect of the disease • Melanoma is notoriously insensitive to systemic chemotherapy and our study was a great demonstration of our technology’s potential in a challenging histology 9 DELCATH SYSTEMS, INC

Phase III Clinical Trial Design Randomized to CS 93 patients: ocular or cutaneous melanoma Best Alternative Care (BAC) Investigator and patient decision (any and all treatments) CS/Melphalan Treat every 4 weeks x 4 rounds (responders can receive up to 6 rounds) Cross-over Primary Trial Endpoint • Statistically significant difference in Hepatic Progression Free Survival (“hPFS”): p < 0.05 (IRC) • Over 80% of Oncologic drugs approved by FDA between 2005 – 2007 on endpoints other than overall survival Modeled hPFS for Trial Success: 7.73 months (CS) vs. 4 months (BAC) Secondary Trial Endpoints • Investigator hPFS • Hepatic objective response rate • Overall objective response rate • Overall Survival – Diluted by Cross Over • SAP calls for analysis of various patient subsets Pre-CS (Baseline) Post-CS (22+ Months) Hepatic Response – Metastatic Melanoma Fully Powered, 93 Patient, Randomized, Multi-Center NCI Led Study CS = ChemoSaturation (CHEMOSAT) 10 DELCATH SYSTEMS, INC

INDEPENDENT REVIEW COMMITTEE (IRC) ASSESSMENT - UPDATED ANALYSIS (4 June 2012) Hepatic progression-free survival (IRC) Positive Phase III Results – Primary Endpoint hPFS CS-PHP Demonstrated 4x or 5.3 months Improvement in Primary Endpoint of hPFS 1.0 0.8 0.6 0.4 0.2 0.0 Proportion of patients surviving Hazard ratio = 0.50 (95% CI 0.31–0.80) P=0.0029 Chemosaturation (CS-PHP) Best alternative care (BAC) 0 5 10 15 20 25 30 Intent-to-treat population 7.0 1.7 5.3 mo Months 11 DELCATH SYSTEMS, INC

INVESTIGATOR ASSESSMENT - Overall progression-free survival (investigator) Positive Phase III Results – Overall PFS CS-PHP also Demonstrated a Highly Statistically Significant Improvement in Overall PFS Chemosaturation (CS-PHP) Best alternative care (BAC) Hazard ratio = 0.42 (95% CI 0.27–0.64) P<0.0001 1.0 0.8 0.6 0.4 0.2 0.0 5.4 1.6 3.8 mo 0 5 10 15 20 25 30 35 40 45 50 55 UPDATED ANALYSIS (4 June 2012) Intent-to-treat population Months Proportion of patients surviving 12 DELCATH SYSTEMS, INC

TOTOL CS-PHP vs BAC ONLY Overall Survival – Exploratory Subset Analysis Overall Survival Tail For CS-PHP Treated Patients Proportion of subjects surviving 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 12 36 0 24 48 60 11.4 Total CS-PHP incl. crossover BAC only Months 4.1 Intent-to-treat population 7.3 mo 13 DELCATH SYSTEMS, INC

Positive Phase III 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 control o 75% overall clinical benefit (CR + PR + SD) • Secondary endpoints consistent with primary endpoints o CS/PHP achieved a median overall PFS of 5.4 months vs. 1.6 months for BAC o OS – No difference demonstrated due to heavy crossover from BAC to CS/PHP o Median OS 10.6 months vs. 10.0 months for CS/PHP and BAC respectively • OS exploratory analyses supportive of key observations o Median overall survival of 11.4 months for all patients treated with melphalan, including crossover o BAC patients did not cross-over to CS/PHP had a median survival of 4.1 months o 7 CS/PHP-treated and 3 BAC-only patients still alive as of 6/2012 • Gen 1 Safety profile – consistent with currently approved labeling for melphalan o 30-day deaths on PHP: 3/44 patients (6.8%) 1 Neutropenic Sepsis (2.3%); 1 Hepatic Failure 2.5% (95% tumor burden); 1 gastric perforation o 30-day deaths on BAC: 3/49 patients (6.1%) Trial Outcomes Favorable and Consistent with Special Protocol Assessment 14 DELCATH SYSTEMS, INC

The Evidence for Melphalan Melphalan, an established chemotherapy agent, is proven active at high doses with broad antitumor activity Authors Technique N Tumor Drug(s) ORR, % Median OS, months Grover et al. 2004 IHP 13 NET Melphalan ± TNF 50 48 Noter et al. 2004 IHP 8 Ocular melanoma Melphalan 50 10 Alexander et al. 2000 IHP 22 Ocular melanoma Melphalan ± TNF 62 11 Alexander et al. 2003 IHP 29 Ocular melanoma Melphalan 62 12 Alexander et al. 2009 IHP 120 Colorectal Melphalan ± TNF, TNF 61 17 van Iersel et al. 2008 IHP 154 Colorectal Melphalan 50 25 van Iersel et al. 2010 IHP 99 Colorectal Melphalan – 25 Verhoef et al. 2008 PHP 24 Various Melphalan 62 – 4. Alexander HR Jr, et al. Clin Cancer Res 2003;9:6343-9 5. Alexander HR Jr, et al. Ann Surg Oncol 2009;16:1852-9 6. Van Iersel LB, et al. Ann Oncol 2008;19:1127-34 7. Van Iersel LB, et al. Ann Oncol 2010;21:1662-7 8. Verhoef C, et al. Ann Surg Oncol 15:1367-74 1. Grover AC, et al. Surgery 2004;136:1176-82 2. Noter SL, et al. Melanoma Res 2004;14:67-72 3. Alexander HR Jr, et al. Clin Cancer Res 2000;6:3062-70 15 DELCATH SYSTEMS, INC

Melphalan Sensitivity: In Vitro Tumor Cell Lines Study We Believe CHEMOSAT Will Be Effective On a Wide Range of Solid Tumors 192 uM Cancer Origin (Cell lines) Thyroid (2) Ovarian (1) Melanoma (5) CNS (4) Sarcoma (5) Head and Neck (2) Bladder (5) Colon (5) Cervix (3) Cholangiocarcinoma (1) Prostate (2) Pancreas (4) Primary Liver (4) Lung (5) Breast (5) Kidney (5) Uterus (1) Apoptosis Induction (uM) 2.54 4.31 4.53 6.40 6.68 6.78 9.50 15.12 15.16 16.00 17.55 25.00 25.04 28.60 31.82 44.60 35.30 200 150 100 50 0 Melphalan Sensitivity- Apoptosis Induction Tissue of Origin of Cancer Cell Lines Melphalan Conc. Achieved 16 DELCATH SYSTEMS, INC

Our Opportunity Concentrating the Power of Chemotherapy for Disease Control in the Liver • • • • 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 technology with melphalan in a variety of tumor histologies CE Mark approved broad indication Large global market opportunity with pharmaceutical-like gross margin ~ 80% 17 DELCATH SYSTEMS, INC

CHEMOSAT - Potential Multi-Billion Dollar Market $7 Billion Annual Global Opportunity with Pharmaceutical-Like Gross Margins Sources: LEK Consulting, GLOBOCAN, Company estimates. EU: Initial target countries of Germany, UK, Italy, France, Spain, Netherlands, Ireland. APAC: Initial target countries of China, Japan, S. Korea, Taiwan, Australia. Assumes 2.5 treatments per patient. Assumes EU ASP of $15K; US ASP of $25K; APAC ASP of $5K. 200,000 175,000 150,000 125,000 100,000 75,000 50,000 25,000 0 USA EU APAC 5,585 5,585 7,671 99,749 19,861 33,953 52,143 33,966 33,966 7,202 8,212 8,708 6,563 4,085 55,389 $2.2 B 42,367 $2.6 B 189,943 $2.2 B HCC CRC Melanoma NET 18 DELCATH SYSTEMS, INC

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 Global Commercialization Status Addressing A Multi-Billion Dollar Global Market 19 DELCATH SYSTEMS, INC

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: • Educate medical and surgical oncologists via contract organization • Sell to hospital-based oncologists, interventional radiologists, surgeons and C-suite decision makers with combination of direct sales and distributors • Focus on medical and surgical oncologists at referral centers • Hospitals procure melphalan from third parties and physicians use at their discretion • Establish European patient education and awareness programs (PR, website) • Leverage interim reimbursement channels, while pursuing permanent procedure reimbursement • Focused clinical trial program to generate additional data and build clinical experience across multiple centers for various tumor types (e.g. HCC, NET and CRC) Currently In Initial Training and Marketing Phase Establish EU Operations Initial Training and Marketing Full Commercial Launch 20 DELCATH SYSTEMS, INC

Patient Referral Path Interventional Radiologist Offers chemosaturation procedure Patient Primary Care Medical Oncologist Offers systemic therapy Surgical Oncologist Offers resection or other focal therapy Chemosaturation Diagnosis of Cancer Identification of liver involvement with no improvement from systemic therapy 21 DELCATH SYSTEMS, INC When liver disease is controlled, patients return to the Medical Oncologist for additional systemic therapy

CHEMOSAT Training and Marketing Commenced in Europe Continue Training and Marketing Centers Roll-Out • 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, France – Cancer Institute Gustave Roussy (IGR) o Barcelona, Spain – El Hospital Quiron o Naples, Italy – Instituto Nazionale Tumori Fondazione "G. Pascale" o Amsterdam, The Netherlands – Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital o Erlangen, Germany – University Hospital of Erlangen o Pamplona, Spain – Clinica Universidad de Navarra o Bordeaux, France – Hôpital Saint-André (St Andre) o Galway, Ireland – University Hospital Galway (UHG) o Leiden, The Netherlands – Leiden University Medical Center o Southampton, United Kingdom – Southampton University Hospital (SUH) o Göttingen, Germany - University Medical Center Göttingen (UMG) • Training completed and patients treated at IEO, JWG, IGR, St Andre, UHG, SUH and UMG o Liver metastases from cutaneous melanoma, ocular melanoma, gastric cancer, breast cancer, neuroendocrine tumor (NET), hepatocellular carcinoma (HCC) and cholangiocarcinoma DELCATH SYSTEMS, INC 22 • •

European Reimbursement Considerations • No centralized pan-European medical device reimbursement body – reimbursement mechanisms vary greatly at national and regional levels across our target markets • Working with reimbursement specialists to execute plan in each of our key markets for both interim and long term reimbursement • Italy – Secured a pathway for reimbursement using an existing Diagnosis Related Group code (DRG) for use with CHEMOSAT. We will continue to seek additional supplemental new technology payments, and potentially pursue a new higher reimbursing DRG for CHEMOSAT o A limited number of procedures are currently being covered by private payment and research funding • Apply for funding under existing New Technology Payment programs o Italy – First Regional Application submitted for supplemental (in addition to DRG) new technology payments. o Germany - Interim reimbursement process is being actively sponsored and driven by the German Radiology Society – 12 NUB applications filed o United Kingdom – Our lead centers are seeking to gain PCT (Primary Care Trust) approval. This would allow us to perform CHEMOSAT procedures in 3 to 4 key centers in the UK Reimbursement Program Now In Execution Phase DELCATH SYSTEMS, INC 23 • • • •

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 Austrailia • International regulatory submissions status: Application submitted and expected approvals in Hong Kong - 2012 (Gen 2 expected in Dec.) Canada - 2012 (Gen 2 expected in Dec.) Singapore - 2013 Argentina - 2013 Brazil - 2014 Intend to submit applications S. Korea (CHEMOSAT Doxorubicin) Mexico China (CHEMOSAT Doxorubicin) Taiwan Russia India Japan Israel • Utilize 3 party melphalan and doxorubicin available to physicians Combination of Strategic Partnerships and Specialty Distributors DELCATH SYSTEMS, INC 24 rd

U.S. FDA Regulatory Status • NDA accepted and under active FDA review since submission in mid August, 2012. We are working closely with the FDA during the review process. • Based on the FDA’s recommendation, we have decided to focus our NDA’s initial labeling on unresectable metastatic ocular melanoma in the liver • PDUFA goal date of June 15, 2013 assigned by the FDA • FDA advised Oncology Drug Advisory Committee (ODAC) panel to be expected in May 2013 • NDA filing included: o Comprehensive set of additional data in a new FDA compliant CDISC database o Gen 2 filter as part of the Chemistry, Manufacturing and Control (CMC) module • We have also amended IND and Expanded Access Program (EAP) and Gen 2 has been accepted by the FDA for use in EAP, compassionate use and prospective clinical trials in the US DELCATH SYSTEMS, INC 25 • • • • •

U.S. Commercialization Strategy • Initial focus on centers that participated in the phase III clinical trial • Educate Medical Oncologists via Medical Science Liaison (MSL) • Direct strategy to sell to Interventional Radiologists and Oncologists o Approximately 12 sales territories ultimately expanding to as many as 60 territories as revenues ramp • Utilize top centers from Phase III trial as Centers of Excellence for training and support • Intend to seek chemosaturation specific CPT reimbursement code, based upon value proposition relative to other cancer therapies Direct Sales Channels with MSL Clinical Support DELCATH SYSTEMS, INC 26 • • • • •

Clinical Development Program • Goals: Expand US (CS-PHP: MEL) label indications beyond the current 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 (CU), and all future clinical trials • On track to initiate EAP to treat first patient • Activate EU Registry to systematically collect data from commercial experience Establish CHEMOSAT as the Standard of Care (SOC) for Disease Control in the Liver DELCATH SYSTEMS, INC 27 • • • •

Clinical Development Program • Intend to initiate new pivotal trials (first patient enrolled in 2013), 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 Melphalan vs. Available Alternatives Neuroendocrine tumor (NET) with liver dominant disease o Global Phase 3 Randomized CHEMOSAT Melphalan vs. Available Alternatives • Phase 2 studies in multiple indications: HCC, NET, CRC, melanoma • Global Investigator-initiated trials (IITs) – opportunity-driven Establish CHEMOSAT as the Standard of Care (SOC) for Disease Control in the Liver DELCATH SYSTEMS, INC 28 • • •

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. Korea Provides basis for partnership opportunities in China and S. Korea where doxorubicin has a broad label for multiple tumor types 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* Plan to use CHEMOSAT Doxorubicin in Asia Phase III 2L HCC trials Addressing the Large HCC Market Opportunity in China DELCATH SYSTEMS, INC 29 • • • •

2012 Milestones • First patients have been treated with CHEMOSAT Melphalan in Europe - Done • Execute contract for MSL services in EU in 1Q 2012 (Quintiles was selected to support EU launch of CHEMOSAT) - Done • Secure agreements with 8-10 leading cancer centers in EU - Done • Obtain CE Mark for Gen 2 CHEMOSAT Melphalan - Done • US NDA submission in August 2012 - Done • US NDA acceptance with standard review in October 2012 - Done • Obtain CE Mark for CHEMOSAT Doxorubicin in 2H 2012 - Done • Submission for publications of Phase III data and mNET arm of Phase II data in Q4 2012 • First patients enrolled in EAP in Q4 2012 • Initiate EU Registry in Q4 2012 • Potential Asia strategic partnership – dedicated BD with China a top priority DELCATH SYSTEMS, INC 30

Cash & Cash Equivalents: $28.3 million at September 30, 2012 Financing: $21.1 million (net) raised in a follow-on equity offering in May 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 Cash Spend: $14.6 million in 3Q2012 Shares Outstanding: 75.1 million (85.5 million fully diluted Institutional Ownership: 13% Market Capitalization: $120 million as of November 30, 2012 Avg. Daily Volume (3 mo.): 1,000,000 1) Fully diluted includes an additional 4.8 million options and 5.6 million warrants 1 ) DELCATH SYSTEMS, INC 31 Financial Update

Team Executive Title Prior Affiliation(s) Years of Experience Eamonn Hobbs President and CEO AngioDynamics, E-Z-EM 31 Graham Miao, Ph.D. EVP & CFO D&B, Pagoda Pharma, Schering-Plough, Pharmacia, JP Morgan 22 Krishna Kandarpa, M.D., Ph.D. CSO and EVP, R&D Harvard, MIT(HST), Cornell, UMass 32 Agustin Gago EVP, Global Sales AngioDynamics, E-Z-EM 30 Jennifer Simpson, Ph.D. EVP, Global Marketing Eli Lilly (ImClone), Johnson & Johnson (Ortho Biotech) 22 Peter Graham, J.D. EVP, General Counsel & Global Human Resources Bracco, E-Z-EM 17 David McDonald EVP, Business Development AngioDynamics, RBC Capital Markets 29 John Purpura EVP, Regulatory Affairs & Quality Assurance E-Z-EM, Sanofi-Aventis 28 Harold Mapes EVP, Global Operations AngioDynamics, Mallinkrodt 26 J. Chris Houchins SVP, Clinical Affairs Arno, Schering-Plough, Pfizer, Pharmacia, GD Searle 21 Gloria Lee, M.D., PH.D. SVP, Global Clinical Development Hoffmann-La Roche, Syndax Pharmaceuticals, Inc. 20 Bill Appling SVP Medical Device R&D AngioDynamics 26 Dan Johnston, Ph.D. VP, Pharmaceutical R&D Pfizer, Wyeth 11 DELCATH SYSTEMS, INC 32

Appendices 33 DELCATH SYSTEMS, INC

Appendix I Intellectual Property 34 DELCATH SYSTEMS, INC

Intellectual Property • Patent Protection o 5 U.S. patents in force and 6 U.S. patent applications pending o 6 foreign patents in force (with patent validity in 22 countries) and 15 foreign patent applications 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 processes • FDA Protection o Orphan Drug Designation granted for melphalan in the treatment of ocular melanoma, cutaneous melanoma and metastatic neuroendocrine tumors, as well as for doxorubicin in the treatment of HCC Provides 7 years of marketing exclusivity post FDA approval o Additional Orphan Drug applications to be filed for other drugs and indications, including melphalan for HCC and CRC Multiple Levels of Protection DELCATH SYSTEMS, INC 35

Appendix II CHEMOSAT Market Opportunity by Disease and Target Counties DELCATH SYSTEMS, INC 36

• Europe – Largest near-term opportunity • CRC – Largest opportunity worldwide • Melanoma – Largest opportunity is in US • China- Largest opportunity for HCC Market Opportunity by Disease (patients) Market Opportunity defined as Total Potential Market (TPM) for CHEMOSAT ® 10000 Melanoma 7500 5000 2500 0 30000 25000 20000 15000 0 10000 5000 NET CRC 40000 30000 20000 10000 0 100000 80000 60000 40000 20000 0 37 DELCATH SYSTEMS, INC HCC 1. Primary cancer incidence 2. Adjusted for predominant disease in the liver (primary or metastatic cancer) 3. Adjusted for addressable patients via Delcath CHEMOSAT ®

Europe Market by Disease – Device Only Germany (Direct) UK (Direct) France (Indirect) Italy (Indirect) Spain (Indirect) Netherlands (Direct) Ireland (Direct) Total Potential (patients) Potential Market ($ MM) 1,2,3 Total Potential Market #Patients Ocular Melanoma 404 297 295 285 197 79 19 1,576 $ 62 Cutaneous Melanoma 1,625 994 753 801 360 379 73 4,987 $ 206 CRC 9,902 5,300 5,475 7,281 4,016 1,644 335 33,953 $1,339 HCC (Primary) 1,637 720 1,514 2,597 1,087 82 35 7,671 $277 NET 1,783 1,336 1,353 1,299 974 360 98 7,202 $ 281 TOTAL 15,351 8,647 9,389 12,263 6,634 2,545 560 55,389 $ 2,166 Europe Presents Significant Potential Market Opportunity Sources: LEK Consulting, GLOBOCAN, Company estimates. 1) Assumes 2.5 treatments per patient. 2) Assumes ASP of ~$15K USD. 3) Assumes mix of direct sales and distributors. 38 DELCATH SYSTEMS, INC

US Market by Disease – Device and Drug Combination Liver Metastasis Potential Market # Patients Potential Market # Procedures Potential Market ($MM) 1,2 Ocular Melanoma 1,685 4,213 $ 105 Cutaneous Melanoma 7,023 17,557 $ 439 CRC 19,861 49,653 $ 1,241 HCC (Primary) 5,586 13,964 $ 349 NET 8,212 20,530 $ 513 TOTAL 42,367 105,917 $ 2,648 Sources: LEK Consulting, GLOBOCAN, Company estimates. 1) Assume 2.5 treatments per patient. 2) Estimated ASP of $25K. 39 DELCATH SYSTEMS, INC

APAC Market by Disease China (Device) S. Korea (Device) Japan (Device) Taiwan (Device) Australia (Device) Total Potential (patients) Potential Market ($MM) 1,2 Total Potential Market #Patients HCC (Primary) 85,780 3,258 8,296 2,152 263 99,749 $ 1,156 Other CRC 31,127 3,245 14,298 1,441 2,031 52,143 $ 642 NET 29,197 1,048 2,759 500 462 33,966 $ 393 Ocular Melanoma 1,765 66 175 31 96 2,134 $ 25 Cutaneous Melanoma 382 43 136 246 1,144 1,951 $ 23 OTHER TOTAL 62,472 4,403 17,368 2,218 3,733 90,194 $ 1,083 TOTAL 148,104 7,661 25,665 4,370 3,996 189,943 $ 2,239 APAC Target Markets Represent Over $2 Billion Potential Market Opportunity Sources: LEK Consulting, GLOBOCAN, Company estimates. 1) Assume 2.5 treatments per patient. 2) Estimated ASP of ~$5K. 40 DELCATH SYSTEMS, INC

Appendix III CHEMOSAT Melphalan Phase I and II 41 DELCATH SYSTEMS, INC

Melphalan Dosing & Background • Well understood, dose dependant, tumor preferential, alkylating cytotoxic agent that demonstrates little to no hepatic toxicity • Manageable systemic toxicities associated with Neutropenia and Thrombocytopenia • Drug dosing 12x higher than FDA-approved dose via systemic IV chemotherapy • Dose delivered to tumor is over 100x higher than that of systemic IV chemotherapy An Established Drug for Liver Cancer Therapy Type Dosing (mg/kg) Multiple Myeloma (label) Chemoembolization Surgical Isolated Hepatic Perfusion (IHP) Myeloablation Chemosaturation (PHP) 0.25 0.62 1.50 2.50-3.50 3.00 DELCATH SYSTEMS, INC 42

Phase II NCI Trial – Metastatic Neuroendocrine Cohort Pre-CS (Baseline) Post-CS #2 (+4 Months) Post-CS #1 (+6 Weeks) Compelling Clinical Data in Attractive mNET Market *Presentation at ECCO/ESMO 2011 annual meeting. Phase II mNET Tumor Cohort (n=24)* Number (n) Primary Tumor Histology Carcinoid Pancreatic Islet Cell Response Not Evaluable (Toxicity, Incomplete Treatment, Orthotopic Liver Transplantation Progressive Disease Minor Response / Stable Disease Partial Response (30.0% - 99.0% Tumor Reduction) Complete Response (No Evidence of Disease) Objective Tumor Response Objective Tumor Response Rate Duration (months) Median Hepatic PFS Overall Survival After CS 4 20 4 2 4 1 13 14 58% 15.5 30.4 DELCATH SYSTEMS, INC 43

Phase II NCI Trial – Hepatobilliary carcinoma • 11 patients with tumors of hepatobiliary origin: 5 HCC, 2 intrahepatic and 3 extrahepatic cholangiocarcinoma,1 mixed histology • CHEMOSAT treatment showed encouraging anti-tumor activities in hepatocellular carcinoma (HCC) o 1 Confirmed partial response lasting 7 months o 2 stable disease lasting 8 months, 6 months respectively • Safety profile – consistent with pivotal US Phase III melanoma trial • HCC is the most common primary cancer of the liver, with approximately 750,000* new cases diagnosed worldwide annually • Intend to invest in new HCC trials with CHEMOSAT Encouraging Initial Positive Signal for Primary Liver Cancer *Source: GLOBOCAN 44 DELCATH SYSTEMS, INC

• 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 Phase II NCI Chemosaturation Trial – mCRC Cohort o Challenges enrolling at NCI o 16 patients treated since 2004 o Inconclusive efficacy due to advanced disease status (generally 5 or 6 line) o Safety profile – expected and consistent with pivotal FDA Phase III melanoma trial • Intend to invest in new mCRC trials with CHEMOSAT Melphalan Strong Rationale for Using CHEMOSAT with Melphalan to Treat mCRC 1) van Iersel LB, Koopman M, Van D, V, et al. Ann Oncol. 2010;21:1662-7. Phase II NCI Trial – mCRC Cohort 45 DELCATH SYSTEMS, INC th th

Appendix IV Published Phase I/II Studies of Doxorubicin with PHP (percutaneous hepatic perfusion) for HCC DELCATH SYSTEMS, INC 46

3 No. of pts No. of PHP/ pt Disease stage (tumor diameter) Treatment Median survival (mo) Response Rates Reference HCC (n=79) CHM (n=23) 1–4 1–2 IV A: n=66 IV B: n=13 All multiple bilobar Extrahepatic disease in 52% Doxorubicin 60–150 mg/m² Cisplatin 50–150 mg/m² Mitomycin C 50–200 mg/m² 16 13 HCC pts RR 64.5% 5-year survival 20.3% Kobe Phase I/II HCC (n=11) 1–3 Mean 9.5 cm Doxorubicin 60–120 mg/m² 6.5 13 (responders) 2 (non-responders) RR 20% MDACC Phase I HCC (n=5) CHM (n=8) Other (n=8) 2–4 Extrahepatic disease in 17% Doxorubicin 50–120 mg/m² 5-FU 1000–5000 mg/m² NR RR 22% Yale Phase I HCC (n=7) Other (n=11) 1–10 NR Doxorubicin 90–120 mg/m² 23 (responders) 8 (non-responders) RR 58% Yale 4 Phase I Phase I/II Studies of PHP-Doxorubicin For HCC Delivered Safely in Multiple Studies with Promising Response Rates 1) Ku Y et al. Chir Gastroenterol 2003;19:370–376. 2) Curley SA et al. Ann Surg Oncol 1994;1:389–99. 3) Ravikumar TS et al. J Clin Oncol 1994;12:2723–36. 4) Hwu WJ et al. Oncol Res 1999;11:529–37. 47 DELCATH SYSTEMS, INC 1 2

Appendix V Product Development Pipeline 48 DELCATH SYSTEMS, INC

Product Development Pipeline • Melanoma liver mets • Proprietary drug-melphalan & CHEMOSAT • All liver cancers – melphalan • Classified as Medical Device • 3 party melphalan • Gen 2 melphalan CE Mark • CHEMOSAT for additional drugs • CHEMOSAT for other organs (lung and brain) • mCRC and HCC indications Initial Opportunity Near Term (< 5 years) Intermediate Term (> 5 years) • Doxorubicin system CE Mark • mCRC and HCC clinical trials • CHEMOSAT for additional drugs • CHEMOSAT for other organs (lung and brain) • CHEMOSAT Melphalan in Taiwan and Japan • CHEMOSAT Doxorubicin in China and South Korea • 3 party doxorubicin • CHEMOSAT for additional drugs • CHEMOSAT for other organs (lung and brain) • CHEMOSAT Melphalan in Australia and Hong Kong • 3 party melphalan Development Aligned to Address Significant Market Opportunity U S E U A S I A rd rd rd 49 DELCATH SYSTEMS, INC

Appendix VI European Regulatory Update 50 DELCATH SYSTEMS, INC

European Regulatory Update • Retained new Notified Body • Device reclassified from class III to class IIB, permitting self-certification in accordance with the same established quality management system o The primary difference between Class III and Class IIb is that for Class IIb medical devices the Notified Body is not required to carry out an examination of the product’s design dossier as part of its conformity assessment o The Company must continue to comply with the essential requirements of the EU Medical Devices Directive (Directive 93/42 EC) and is subject to a conformity assessment procedure requiring the intervention of a Notified Body o The conformity assessment procedure for Class IIb medical devices requires the manufacturer to lodge an application for the assessment of its quality system for the design, manufacture and inspection of its medical devices by a Notified Body o The Notified Body will audit the system to determine whether it conforms to the provisions of the Medical Devices Directive. If the Notified Body’s assessment is favorable it will issue a Full Quality Assurance Certificate, which enables the manufacturer to draw a Declaration of Conformity and affix the CE mark to the medical devices covered by the assessment o Thereafter, the Notified Body will carry out periodic audits to ensure that the approved quality system is applied by the manufacturer. 51 DELCATH SYSTEMS, INC

© 2011 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED