Slide 1: Investor Presentation March 2011
Exhibit 99.1 Concentrating the Power of Chemotherapy TM Investor Presentation March 2011 NASDAQ: DCTH
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Slide 3: 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 4: Company Highlights
Company Highlights § Focused on making established chemotherapeutic drugs work better in target organs § Chemosaturation delivers ultra-high dose chemotherapy to the liver § Successful Phase III trial results reported § Filed CE Mark for Class III medical device, potential approval in mid-2011 § Pos
Slide 5: Potential $3.75 Billion Labeled Market Opportunity
Potential $3.75 Billion Labeled Market Opportunity* • Seeking initial indication for 355,712 Melanoma liver mets in USA • Seeking general device indication in EU for delivery of melphalan to the liver permits physician use on a broad range of liver cancers Transparent Areas Represent Potential Addit
Slide 6: Spectrum of Liver Cancer Treatments
Spectrum of Liver Cancer Treatments Type of Treatment Advantages Disadvantages Systemic ü Non-invasive - Systemic toxicities ü Repeatable - Limited efficacy in liver Regional ü Therapeutic effect - Invasive/limited (e.g., IHP) repeatability ü Targeted - Multiple treatments are required Focal ü Isola
Slide 7: The Delcath Chemosaturation System
The Delcath Chemosaturation System Advantages of Chemosaturation § ISOLATION § Treats entire liver § SATURATION § Allows for ~ 100x effective dose escalation of drug agents at tumor site § FILTRATION § Controls systemic toxicities Note: Image not to scale. Converts Traumatic Open Surgery to Minimall
Slide 8: Melphalan Dosing & Background
Melphalan Dosing & Background Type Dosing (mg/kg) Multiple Myeloma 0.25 (label) Chemoembolization 0.62 Surgical Isolated Hepatic Perfusion 1.50 (IHP) Myeloablation 2.50-3.50 Chemosaturation 3.00 (PHP) § Well understood, dose dependant, tumor preferential, alkylating cytotoxic agent that demonstrates
Slide 9: What Chemosaturation Offers
What Chemosaturation Offers Patients: § Significant improvement in disease control in the liver compared to standard of care in patients with unresectable hepatic melanoma mets § Manageable systemic toxicities §Time, so that primary cancers can continue to be treated Physicians: § Novel, targeted li
Slide 10: Current Patient Referral Path
Current Patient Referral Path Identification of liver Patient involvement with no improvement Primary from systemic Diagnosis of Care therapy Cancer Medical Surgical Oncologist Oncologist Offers systemic therapy to Offers resection or other focal Transferred for treat Cancer therapy to treat cancer
Slide 11: Future Patient Referral Path
Future Patient Referral Path Identification of liver Patient involvement with no improvement Primary from systemic Diagnosis of Care therapy Cancer Medical Interventional Oncologist Radiologist Offers systemic therapy to Offers Chemosaturation treat cancer therapy Resection When liver disease is con
Slide 12: Summary of Phase III Results
Summary of Phase III Results § Primary endpoint exceeded § Secondary endpoints support results § OS cohort analysis favorable § Safety profile - expected and consistent with currently approved labeling for melphalan Trial Outcomes Favorable and Consistent with Special Protocol Assessment 11
Slide 13: Phase III Clinical Trial Design
Phase III Clinical Trial Design Randomized to CS 92 patients: ocular or cutaneous melanoma CS/Melphalan Treat every 4 weeks x 4 rounds Cross- (responders can receive up to 6 rounds) over Primary Trial Endpoint Secondary Trial Endpoints § Statistically significant difference in Hepatic § Hepatic resp
Slide 14: ASCO Presentation of Phase III Clinical Trial Results
ASCO Presentation of Phase III Clinical Trial Results § Trial results exceed primary endpoint expectations; p value = 0.001 § Treatment arm shows 5x median hPFS compared to control arm § CS/PHP median hPFS of 245 days compared to 49 days for BAC § Hazard Ratio = .301 § Patients failed prior therapie
Slide 15: ASCO Presentation of Phase III Clinical Trial (cont.)
ASCO Presentation of Phase III Clinical Trial (cont.) § Majority of BAC patients crossed over and obtained similar response from treatment § Total 93 patient trial - 10 months median OS vs. 4 months expected 1 (due to cross over provision, most patients received PHP/CS treatment) § OS cohort analysi
Slide 16: Phase I/II NCI Trials – Neuroendocrine
Phase I/II NCI Trials – Neuroendocrine Neuroendocrine Tumor Trial Results (n=23)* Number Pre-CS (n) (Baseline) Primary Tumor Histology Carcinoid 3 Pancreatic Islet 17 Cell Response Not Evaluable (Toxicity, Incomplete Treatment) 4 Orthopic Liver Progressive 1 Post-CS #1 Transplantation Disease Minor
Slide 17: Regulatory Status
Regulatory Status Europe: § Submitted technical file for CE Mark as Class III medical device on December 6, 2010 § ISO 13485 certification for manufacturing facility received February 17, 2011 § Goal remains to receive CE Mark approval by mid-2011 United States: § Submitted 505(b)(2) NDA to FDA on D
Slide 18: Product Development Pipeline
Product Development Pipeline Initial Opportunity Near Term (< 5 years) Intermediate Term (> 5 years) • Melanoma liver mets • Broaden label • Additional drugs • Proprietary drug-melphalan • Other liver cancers - melphalan • Other organs & • Apparatus improvements apparatus • All liver cancers - melph
Slide 19: Market Opportunity by Disease (patients)
Market Opportunity* by Disease (patients) • US - largest opportunity for Melanoma • China - largest opportunity for HCC • CRC - largest opportunity worldwide *TPM Total Potential Market 18
Slide 20: EU – Landscape
EU – Landscape § CE Mark approval covers European Economic Area (EEA) § EEA includes 32 countries § 14 countries currently have Melphalan for injection commercially available § Belgium (BE), Czech Republic (CZ), Germany (DE), Estonia (EE), Spain (ES), France (FR), Ireland (IE), Italy (IT), Lithuania
Slide 21: Market by Disease – EU Device Only
Market by Disease – EU Device Only Initial Target Markets (DE, UK, FR, IT, SP, NL) Germany UK France Italy Spain Netherlands Total Potential Potential Market (Direct) (Direct) (Indirect) (Indirect) (Indirect) (Direct) (patients) ($ millions)1,2,3 Total Potential Market #Patients Ocular Melanoma 403
Slide 22: Market by Disease - EU Including Drug
Market by Disease - EU Including Drug Initial Target Markets (DE, UK, FR, IT, SP, NL) Germany UK France Italy Spain Netherlands Total Potential Potential Market (Direct) (Direct) (Indirect) (Indirect) (Indirect) (Direct) (patients) ($ millions)1,2,3 Total Potential Market #Patients Ocular Melanoma 4
Slide 23: Market by Disease - USA
Market by Disease - USA Liver Metastasis Potential Market Potential Market Potential Market ($MM) # Patients # Procedures $20K ASP ** (Avg 2.5/patient) Ocular Melanoma 1,622 4,055 $81.1 Cutaneous Melanoma 11,883 29,708 $594.2 TOTAL (Initial MELANOMAExpected 13,505 33,763 $675.3 Label) CRC 38,423 96,
Slide 24: Market by Disease – Asia
Market by Disease – Asia Initial Target Markets (China, Japan, S. Korea, Taiwan, Australia) China S. Korea Japan Taiwan Australia Total Potential Potential (Drug) (Drug) (Device) (Drug) (Device) (patients) Market 1,2,3,4 Total Potential Market # Patients HCC (Primary) 197,082 7,486 7,625 4,945 604 2
Slide 25: Reimbursement Strategy
Reimbursement Strategy United States: § Have retained leading reimbursement experts § Seek chemosaturation specific codes: Physician: § While undergoing FDA review, apply for CPT Category III code § Convert the Category III code to Category I following FDA approval Hospital: § Apply for new ICD-9/10
Slide 26: Three-Pronged Business Strategy
Three-Pronged Business Strategy Commercialization § Gain regulatory approval § Goal: receive CE Mark approval for Class III medical device by mid-2011 § Goal: re-file NDA by end of September 2011 § Goal: receive FDA approval of NDA in 2012 § Goal: receive EU approval for proprietary drug 2014 § Dire
Slide 27: 2011 European Commercialization
2011 European Commercialization § Initially target 6 markets accounting for 85%-90% of patients § 7 Direct sales territories initially to cover UK, Germany, Netherlands (Sales and Medical Science Liaisons) § Distributors in Spain, Italy, & France § 5 Clinical Specialists to support site initiations
Slide 28: US Commercialization in 2012
US Commercialization in 2012 § Initial focus on top 50 cancer centers and referring community hospitals § 12 Sales & Medical Science Liaison territories ultimately expanding to as many as 60 territories as revenues ramp § 5 Clinical Specialists to support site initiation and training § Utilize top c
Slide 29: Intellectual Property
Intellectual Property Patent Protection § 7 issued U.S. patents, 10 foreign patents issued and 4 pending § Primary device patent set to expire August 2016 § Post FDA approval up to 5 years of patent extension possible FDA Protection § Orphan Drug Designation granted for melphalan in the treatment of
Slide 30: Deep and Experienced Management Team
Deep and Experienced Management Team Years of Executive Title Prior Experience Affiliation(s) Eamonn President and AngioDynamics, 30 Hobbs David CEO CFO E-Z-EM AngioDynamics, RBC Capital Markets 28 McDonald Krishna Kandarpa, M.D., Ph.D. CMO and EVP, R&D Harvard, MIT, Cornell, UMass 37 Agustin EVP, G
Slide 31: Financials
Financials 30
Slide 32: Financial Summary
Financial Summary Financial & Operating Overview § Follow On Offerings: Raised ~ $70 million since November 2009 § Burn Rate: Approximately $2.2 million per month § Cash: ~ $47 million at December 31, 2010 § Debt: None § Shares Out: 43.0 million (49.3 million fully diluted*) § Institutional Ownershi
Slide 33: Company Highlights
Company Highlights § Focused on making established chemotherapeutic drugs work better in target organs § Chemosaturation delivers ultra-high dose chemotherapy to the liver § Successful Phase III trial results reported § Filed CE Mark for Class III medical device, potential approval in mid-2011 § Pos
Slide 34: Appendix I. – Delcath Sources for Market Estimates
Appendix I. – Delcath Sources for Market Estimates American Cancer Society. Cancer Facts & Figures 2010. Atlanta: American Cancer Society; 2010. Alexander, Richard H., David L. Bartlett, and Steven K. Libutti. "Current Status of Isolated Hepatic Perfusion With or Without Tumor Necrosis Factor for th