EX-99.1 2 d301979dex991.htm DELCATH SYSTEMS, INC. INVESTOR PRESENTATION SLIDES

Exhibit 99.1

2 DELCATH SYSTEMS, INC 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, assumptions and other statements that are not historical facts. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions, which could cause actual results to differ materially from expected results, performance or achievements expressed or implied by statements made herein. Our actual results could differ materially from those anticipated in forward- looking statements for many reasons, including, but not limited to; uncertainties relating to the time required to build inventory and establish commercial operations in Europe, CE Marking for the Generation Two CHEMOSAT system, adoption, use and resulting sales, if any, for the CHEMOSAT system in the EEA, our ability to successfully commercialize the CHEMOSAT system and the potential of the system as a treatment for patients with cancer in the liver, availability of melphalan in the EEA, acceptability of the Phase III clinical trial data by the FDA, our ability to address the issues raised in the Refusal to File letter received from the FDA and the timing of our re-submission of our NDA, re- submission and acceptance of the Company’s NDA by the FDA, approval of the Company’s NDA for the treatment of metastatic melanoma to the liver, adoption, use and resulting sales, if any, in the United States, approval of the current or future chemosaturation system for other indications or the same indication in other foreign markets, actions by the FDA or other foreign regulatory agencies, our ability to successfully enter into distribution and strategic partnership agreements in foreign markets and the corresponding revenue associated with such foreign markets, our ability to secure reimbursement for the chemosaturation system, progress of our research and development programs and results of future clinical trials, uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities, overall economic conditions and other factors described in our filings with the Securities and Exchange Commission including the section entitled ‘‘Risk Factors’’ in our most recent Annual Report on Form 10-K and our Reports on Form 10-Q and Form 8-K.

3 DELCATH SYSTEMS, INC Delcath Systems – Company Highlights • A specialty pharmaceutical and medical device company focused on oncology • Initial focus on delivering high dose chemotherapy to improve disease control of cancers in the liver • CHEMOSAT CE Mark approved – indication permits broad use in liver cancers. Commenced initial treatment procedures in Europe • Addressing potential multi-billion dollar European market opportunity • Unique device/drug product with statistically significant clinical trial results • Seeking regulatory approval in multiple international markets • Intend to file US NDA in 2Q2012 seeking initial indication for metastatic melanoma to the liver • IP and orphan drug designations create competitive barriers Concentrating the Power of Chemotherapy for Disease Control in the Liver

4 DELCATH SYSTEMS, INC What is CHEMOSAT Concentrating the Power of Chemotherapy for Disease Control in the Liver

5 DELCATH SYSTEMS, INC Initial Focus on Cancers of the Liver • Few effective therapies are available for cancers of the liver Large patient population diagnosed annually with primary or metastatic liver cancer The liver is often the life limiting organ for cancer patients and one of the leading causes of cancer death Prognosis after liver involvement is poor • Multi-billion dollar annual global revenue market opportunity • CHEMOSAT is uniquely positioned to treat the entire liver as standalone or complementary therapy Major Global Unmet Medical Need and Significant Market Opportunity

6 DELCATH SYSTEMS, INC 0 25000 50000 75000 100000 125000 150000 175000 200000 USA EU APAC 8,708 6,563 4,085 8,212 7,202 33,966 19,861 33,953 52,143 5,585 7,671 99,749 HCC CRC NET Melanoma CHEMOSAT Addresses Potential Multi-Billion Dollar Market *TPM for initial U.S. labeled indication only Estimated $7 Billion Annual Global Revenue Opportunity, Near Term Primarily in Europe EU: Initial target countries of Germany, UK, Italy, France, Spain, Netherlands, Ireland APAC: Initial target countries of China, Japan, S. Korea, Taiwan, Australia Sources: LEK Consulting, GLOBOCAN, Company estimates 55,389 $2.1 Bn 8,708* $2.6 Bn 189,943 $2.3 Bn 1. Assumes 2.5 treatments per patient 2. Assumes EU ASP of $15K; US ASP of $25K; APAC ASP of $5K

7 DELCATH SYSTEMS, INC CHEMOSAT European Commercialization • CE Mark covers 30 countries in Europe • Focus on top 6 countries (DE, UK, FR, IT, SP, NL) and Ireland • Broad indication is for “percutaneous intra-arterial delivery of a chemotherapeutic agent (melphalan hydrochloride) to the liver” • Melphalan for injection approved in 14 countries and commercially available • Hospitals procure melphalan separately from existing sources • EU headquarters in Galway, Ireland • Direct and indirect selling channels • Push and pull marketing strategy Large European Market Opportunity Concentrated in Target Countries

8 DELCATH SYSTEMS, INC 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 Institute of European Oncology (IEO), Milan, Italy o Johann Wolfgang Goethe (JWG) University Hospital, Frankfurt, Germany • Training completed and first patients treated at IEO o Ocular melanoma and Gastric cancer liver mets • Agreements with additional leading cancer centers expected in France, UK, Spain, the Netherlands, and Ireland in 1H2012 • Expect training and patient treatments in JWG University Hospital, Frankfurt, Germany in February

9 DELCATH SYSTEMS, INC Team at Institute of European Oncology Performs 1 EU CHEMOSAT Procedure January 31, 2012 st

10 DELCATH SYSTEMS, INC 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., IHP) – Therapeutic effect – Targeted – Invasive/limited repeatability – Multiple treatments are required, not possible Focal (e.g. surgery, radioembolization or SIRT, chemoembolization or TACE, radio frequency ablation or RFA) – Partial removal or treatment of tumors – 80-90% unresectable – Invasive and/or limited repeatability – Treatment is limited by tumor size, number of lesions and location – “See a tumor, treat a tumor”

11 DELCATH SYSTEMS, INC CHEMOSAT System – Where It All Began Open Surgical IHP Isolated Hepatic Perfusion: Proof of Concept, but High Morbidity and Non-Repeatable

12 DELCATH SYSTEMS, INC The Delcath CHEMOSAT System Three Steps 1) ISOLATION 2) SATURATION 3) FILTRATION Advantages • No more open surgery • Minimally invasive, repeatable • Treats entire liver (macro and micro) • Allows for over 100x effective dose escalation of drug agents at tumor site • Improved disease control in the liver • Minimizes systemic toxicities • Complements systemic therapy Minimally Invasive, Repeatable Liver Procedure That Could Complement Systemic Therapy Note: Image not to scale.

13 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 Thromboytopenia • 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 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 An Established Drug For Liver Cancer Therapy

14 DELCATH SYSTEMS, INC What CHEMOSAT Offers Patients: o Significant improvement in disease control in the liver compared to standard of care in patients with unresectable hepatic tumors (primary and metastatic) o Manageable systemic toxicities o Time, so that primary cancers can continue to be treated Physicians: o Novel, targeted liver cancer treatment to complement other cancer therapies o Repeatable, percutaneous procedure o Ability to treat the entire liver, including both visible and micro tumors o Ability to continue treating patients for extra-hepatic disease Compelling Clinical Outcomes and Value Proposition

Current Patient Referral Path Diagnosis of Cancer 15 DELCATH SYSTEMS, INC Transferred for chemosaturation Identification of liver involvement with no improvement from systemic therapy When liver disease is controlled, patients return to the Medical Oncologist for additional systemic therapy Patient Primary Care Medical Oncologist Offers systemic therapy Surgical Oncologist Offers resection or other focal therapy Interventional Radiologist Offers chemosaturation procedure

16 DELCATH SYSTEMS, INC 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 + SD) • Secondary endpoints support results o OS Secondary endpoint – No difference in Kaplan-Meier curves due to cross over treatment response (9.8 months compared to 9.9 months) o CS/PHP median overall PFS of 6.7 months vs 1.6 months for BAC • OS exploratory cohort analysis favorable o Median survival of 9.8 months for treatment arm compared to 4.1 months non-crossover BAC patients o Median survival of 11.4 months for all patients treated with melphalan, including crossover o 9 CS/PHP-treated patients and 3 BAC-treated patients still alive as of 12/2011 • Safety profile – expected and 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 * Updated Investigator results presented at 2011 ECCO/ESMO Annual Meeting

17 DELCATH SYSTEMS, INC Phase 2 NCI Trial – Metastatic Neuroendocrine (mNET) Cohort Pre-CS (Baseline) Post-CS #2 (+4 Months) Post-CS #1 (+6 Weeks) Compelling Clinical Data in Attractive mNET Market Phase 2 mNET Tumor Cohort (n=24)* Number (n) Primary Tumor Histology Carcinoid 4 Pancreatic Islet Cell 20 Response Not Evaluable (Toxicity, Incomplete Treatment, Orthotopic Liver Transplantation) 4 Progressive Disease 2 Minor Response / Stable Disease 4 Partial Response (30.0% - 99.0% Tumor Reduction) 13 Complete Response (No Evidence of Disease) 1 Objective Tumor Response 14 Objective Tumor Response Rate 70% Duration (months) Median Hepatic PFS 15.5 Overall Survival After CS 30.4 *Presentation at ECCO/ESMO 2011 annual meeting

18 DELCATH SYSTEMS, INC Phase 2 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 groups received CHEMOSAT procedures and had positive efficacy signals • The responses were especially encouraging in the HCC group and consisted of confirmed partial response or durable stable disease • Safety profile – expected and consistent with pivotal FDA Phase 3 melanoma trial • Plan to initiate HCC trials with CHEMOSAT in 2H2012 Encouraging Initial Positive Signal For Primary Liver Cancer *Source: GLOBOCAN

19 DELCATH SYSTEMS, INC Melphalan Efficacy for Metastatic Colorectal Cancer • Substantial clinical evidence of benefit of using melphalan to treat mCRC via isolated hepatic perfusion (IHP) procedure Over 800 patients treated in 15 studies since 1998 Patients treated only once Median response rate of 47% (range 29%-76%)¹ • Delcath Phase 2 NCI CHEMOSAT Trial – mCRC Cohort Challenges enrolling at NCI 16 patients treated since 2004 Inconclusive efficacy due to advanced disease status (generally 5 or 6 line) Safety profile – expected and consistent with pivotal FDA Phase 3 melanoma trial • Plan to initiate mCRC trial with CHEMOSAT melphalan in 2H2012 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. th th

20 DELCATH SYSTEMS, INC Product Development Pipeline • Melanoma liver mets • Proprietary drug-melphalan & CHEMOSAT • All liver cancers – melphalan • Class III 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 S. Korea, Japan • CHEMOSAT (Doxorubicin) in China and Taiwan • 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 rd rd rd

21 DELCATH SYSTEMS, INC 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 studies o Utilize new trade secret manufacturing process o Intend to file and seek CE Mark approval in 2H2012 o Plan to use CHEMOSAT doxorubicin in Asia Phase III 2L HCC trials • EXPECTED BENEFITS o Multiple treatments o Reduced systemic toxicity for improved safety profile o Concomitant Therapy (complements systemic therapies) Addressing the Large HCC Market Opportunity in China * See Appendix for list of studies

22 DELCATH SYSTEMS, INC Clinical Development Program • Goal Expand indications for HCC and mCRC with US registration trials Generate robust clinical data to support commercialization • Potential 2012 clinical trials HCC: Global Phase 2 randomized 1L CHEMOSAT Melphalan vs. Sorafenib HCC: US registration – Global Phase 3 randomized 2L CHEMOSAT Melphalan vs. Best Supportive Care (BSC) for Sorafenib failure HCC: Asia Phase 3 randomized 2L CHEMOSAT Doxorubicin vs.Best Supportive Care (BSC) for Sorafenib failure mCRC: Global Phase 2 signal seeking/safety 2L CHEMOSAT Melphalan mCRC: US registration – Global Phase 3 randomized 2L CHEMOSAT Melphalan vs. Approved Alternatives • US Expanded Access Program (EAP) for metastatic Melanoma Establish CHEMOSAT As The Standard Of Care (SOC) For Disease Control In The Liver

23 DELCATH SYSTEMS, INC Generation Two CHEMOSAT Melphalan STATUS: • Consistent first pass removal efficiency of 98% or better in both in vitro and pre-clinical GLP animal studies • New trade secret manufacturing process for filter medium • Filed for CE marking for Gen Two • Anticipate approval in 1Q2012 EXPECTED BENEFITS: • Reduced systemic toxicity • Concomitant Therapy (complements systemic therapies) • Increased utility in a wider range of patients Gen Two Filter Has The Potential to Enhance Procedure and Market Opportunity

24 DELCATH SYSTEMS, INC European Commercialization Strategy Strategy: • Focus efforts in Target Countries • 8-10 leading EU cancer centers as initial training centers • Push and Pull marketing and selling strategy • Validate business model and demonstrate scalability Tactics & Execution: • Educate medical oncologists via contract organization – Medical Science Liaison (MSL) • Sell to hospital-based interventional radiologists, surgeons and C-suite decision makers with combination of direct sales and distributors • Establish European patient education & awareness programs (PR, website) • Leverage existing new technology reimbursement channels, while pursuing permanent procedure reimbursement via Health Technology Assessment (HTA) • Clinical trials to generate additional data for CRC and HCC to support revenue ramp up Currently At Initial Launch Phase

25 DELCATH SYSTEMS, INC 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 • Immediate reimbursement plans: Utilize existing codes where permitted until permanent reimbursement established (e.g. Italy) Apply for funding under existing New Technology Payment programs (e.g. NUB in Germany and HAS in France) Other oncology therapies currently reimbursed, despite lacking randomized data Reimbursement Mechanisms In Place To Support Commercial Launch

26 DELCATH SYSTEMS, INC European Interim New Technology Reimbursement Programs Interim New Technology Payment Programs Already Exist in Major European Markets

27 DELCATH SYSTEMS, INC U.S. FDA Regulatory Status • Pre-NDA submission meeting with FDA conducted in January 2012 • Satisfied with FDA response • Addressed RTF related issues Manufacturing plant inspection timing Product and sterilization validation Additional statistical analysis clarification Additional safety data • Continued progress in finalizing data entry and monitoring Completed data migration to new FDA compliant database Created new Case Report Form (CRF) • Plan to file NDA submission in Q2 2012 Progress On Track to Submit NDA

28 DELCATH SYSTEMS, INC U.S. Commercialization Strategy • Initial focus on leading cancer centers and referring community hospitals • Educate Medical Oncologists via Contract Medical Science Liaison (MSL) • Direct Strategy to sell to Interventional Radiologists and Surgeons: 12 Sales territories ultimately expanding to as many as 60 territories as revenues ramp • 5 Clinical Specialists initially to support site initiation and training • Utilize top centers from Phase III trial as Centers of Excellence for training and support Direct Sales Channels Supplemented With Contract MSLs

29 DELCATH SYSTEMS, INC U.S. Reimbursement Strategy • Intend to seek chemosaturation specific codes based upon value proposition relative to other cancer therapies Physician: • Use existing miscellaneous DRG procedure code • Apply for a CAT I code following FDA approval Hospital: • Apply for new ICD-9/10 procedure code to capture full procedure of hepatic isolation and chemosaturation • Request new DRG based on costs above those of existing DRGs and clinical dissimilarity to other hepatic procedures in current DRGs Pursuing New Specific Codes For Chemosaturation Procedure

30 DELCATH SYSTEMS, INC 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, potential approval Australia - 2012 Hong Kong - 2012 S. Korea - 2013 Singapore - 2013 Intend to submit applications Israel Canada Mexico/Argentina/Brazil Russia India Japan China and Taiwan • Utilize 3 party melphalan and doxorubixin available to physicians Combination of Strategic Partnerships and Specialty Distributors rd

31 DELCATH SYSTEMS, INC 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 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

32 DELCATH SYSTEMS, INC Experienced Management 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. CMO and EVP, R&D Harvard, MIT(HST), Cornell, UMass 32 Agustin Gago EVP, Global Sales & Marketing AngioDynamics, E-Z-EM 30 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 Bill Appling SVP Medical Device R&D AngioDynamics 26 J. Chris Houchins SVP, Clinical and Medical Affairs Arno, Schering-Plough, Pfizer, Pharmacia, GD Searle 21 Dan Johnston, Ph.D. VP, Pharmaceutical R&D Pfizer, Wyeth 11

34 DELCATH SYSTEMS, INC Financial Update • Follow-On Offerings: Raised ~ $94 million since November 2009 • Financing Program: $39.75 million At-The-Market (ATM) equity offering program since December 29, 2011 • Cash: $30.8 million at December 31, 2011 (unaudited) • Burn Rate: $40.1 million full year 2011 (unaudited) • Debt: None • Shares Outstanding: 48 million (~55 million fully diluted*) • Institutional Ownership: 22% at December 31, 2011 • Market Capitalization: $ 204 million as of February 9, 2012 • Avg. Daily Volume (3mo) 675,000 As of December 31, 2011 fully diluted includes an additional 4.1 million options at $5.09, 2.5 million warrants at $3.51, and 193,532 unvested restricted shares.

35 DELCATH SYSTEMS, INC 2012 Milestones • First patients treated with CHEMOSAT melphalan in Europe – 1Q • Execute contract for MSL services in EU – 1Q • Secure agreements with 6-8 leading cancer centers in EU – 1H • Obtain CE Mark for Gen 2 CHEMOSAT melphalan – 1Q • US NDA submission in 2Q 2012 and acceptance in 3Q 2012 • Submission for publications of Phase 3 data and mNET arm of Phase 2 data – 2H • First patients enrolled in mCRC and HCC CHEMOSAT melphalan studies, EAP – 2H • Submit and seek approval of CE Mark for CHEMOSAT doxorubicin – 2H • Potential Asia strategic partnership – dedicated BD with China a top priority

36 DELCATH SYSTEMS, INC Appendices

37 DELCATH SYSTEMS, INC Appendix I CHEMOSAT Market Opportunity by Disease and Target Counties

38 DELCATH SYSTEMS, INC • 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 ® 1.Primary cancer incidence 2.Adjusted for predominant disease in the liver (primary or metastatic cancer) 3.Adjusted for addressable patients via Delcath CHEMOSAT ® Sources: LEK Consulting, GLOBOCAN, Company estimates

39 DELCATH SYSTEMS, INC 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 1. Assumes 2.5 treatments per patient 2. Assumes ASP of ~$15K USD 3. Assumes mix of direct sales and distributors Sources: LEK Consulting, GLOBOCAN, Company estimates

40 DELCATH SYSTEMS, INC US Market by Disease – Device and Drug Combination Liver Metastasis Potential Market # Patients Potential Market # Procedures Potential Market ($MM)** Ocular Melanoma 1,685 4,213 $ 105 Cutaneous Melanoma 7,023 17,557 $ 439 TOTAL MELANOMA (Initial Expected Label) 8,708 21,770 $ 544 CRC 19,861 49,653 $ 1,241 HCC (Primary) 5,586 13,964 $ 349 NET 8,212 20,530 $ 513 OTHER TOTAL (Potential Label Expansion) 33,659 84,147 $ 2,104 TOTAL 42,367 105,917 $ 2,648 1. Assume 2.5 treatments per patient 2. Estimated ASP of $25K Sources: LEK Consulting, GLOBOCAN, Company estimates

41 DELCATH SYSTEMS, INC APAC Market by Disease 1. Assume 2.5 treatments per patient 2. Assume ASP of ~$5K China S. Korea (Device) Japan (Device) Taiwan (Device) Australia (Device) Total Potential (patients) Potential Market ($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

42 DELCATH SYSTEMS, INC Appendix II CHEMOSAT melphalan for metastaic melanoma Phase 3 Pivotal Trial Details

43 DELCATH SYSTEMS, INC Phase III Clinical Trial Design Randomized to CS 92 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 • Over 80% of Oncologic drugs approved by FDA between 2005 – 2007 on endpoints other than overall survival Secondary Trial Endpoints • Hepatic response and duration of hepatic response • Overall response and duration of overall response • Overall Survival – Diluted by Cross Over • SAP calls for analysis of various patient cohorts Pre-CS (Baseline) Post-CS (22+ Months) Hepatic Response – Metastatic Melanoma Fully Powered, 93 Patient, Randomized, Multi-Center NCI Led Study CS = ChemoSaturation (CHEMOSAT)

44 DELCATH SYSTEMS, INC 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 + SD) • Secondary endpoints support results o OS Secondary endpoint – No difference in Kaplan-Meier curves due to cross over treatment response (9.8 months compared to 9.9 months) o CS/PHP median overall PFS of 6.7 months vs 1.6 months for BAC • OS exploratory cohort analysis favorable o Median survival of 9.8 months for treatment arm compared to 4.1 months non-crossover BAC patients o Median survival of 11.4 months for all patients treated with melphalan, including crossover o 9 CS/PHP-treated patients and 3 BAC-treated patients still alive as of 12/2011 • Safety profile – expected and 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 * Updated Investigator results presented at 2011 ECCO/ESMO Annual Meeting

45 DELCATH SYSTEMS, INC Phase 3 Hepatic Progression-free Survival (ITT) Hazard Ratio: 0.35 (CI: 0.23-0.54) 0 5 10 15 20 25 30 35 Months CS-PHP BAC 8.0 1.6 p<0.0001 1.0 Survival probability 0.8 0.6 0.4 0.2 0.0 CS-PHP Demonstrated A 5x Improvement In Primary Endpoint of hPFS

46 DELCATH SYSTEMS, INC Phase 3 Overall Progression-free Survival (ITT) Hazard Ratio: 0.36 (CI: 0.23-0.57) 0 5 10 15 20 25 30 35 Months CS-PHP BAC 6.7 1.6 p<0.0001 1.0 Survival probability 0.8 0.6 0.4 0.2 0.0 CS Also Demonstrated A Highly Statistically Significant Improvement In Overall PFS

47 DELCATH SYSTEMS, INC Phase 3 Overall Survival (ITT) Hazard Ratio: 1.08 (CI: 0.69-1.68) 0 5 10 15 20 25 30 35 40 45 50 55 Months CS-PHP BAC 9.8 9.9 p=0.74 1.0 Survival probability 0.8 0.6 0.4 0.2 0.0 55% crossover Overall Survival Confounded By Crossover Study Design

48 DELCATH SYSTEMS, INC Appendix III Published Phase I/II Studies of Doxorubicin with PHP (percutaneous hepatic perfusion) For HCC

49 DELCATH SYSTEMS, INC Phase I/II Studies of PHP-Doxorubicin For HCC

50 DELCATH SYSTEMS, INC © 2011 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED