Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (January 2011)
34 slides from Delcath Systems's investor presentation, Jan 12, 2011
Slide 1: Investor Presentation January 2011
Exhibit 99.1 Concentrating the Power of Chemotherapy TM Investor Presentation January 2011 NASDAQ: DCTH 1
Slide 2: 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 3: Company Highlights
Company Highlights § Our mission is making established chemotherapeutic drugs work better in target organs § Chemosaturation delivers ultra-high dose chemotherapy to the liver, while complementing systemic cancer therapies § Minimally invasive approach to regional cancer therapy that combines well-e
Slide 4: Deep and Experienced Management Team
Deep and Experienced Management Team Years of Executive Title Prior Affiliation(s) Experience Eamonn President and AngioDynamics, -Z-EM 30 Hobbs David CEO CFO AngioDynamics,ERBC Capital Markets 28 McDonald Krishna Kandarpa, M.D., Ph.D. CMO and EVP, R&D Harvard, MIT, Cornell, UMass 37 Agustin EVP, Gl
Slide 5: Recent Accomplishments
Recent Accomplishments § Built leadership team with deep pharmaceutical, device and commercialization experience § Established manufacturing facility § Reported successful Phase III Trial results § Signed long-term supply agreement with leading melphalan manufacturer § Raised over $70 million in equ
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: Open Surgical IHP - Where It All Began
Open Surgical IHP - Where It All Began IHP: Proof of Concept, but High Morbidity and Non-Repeatable 7
Slide 8: 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 9: 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 (PHP) 3.00 § Well understood, dose dependant, tumor preferential, alkylating cytotoxic agent that demonstrates
Slide 10: 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 11: 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 Oncologist Oncologist Offers systemic therapy to Offers resection or other focal Transferred for treat Cancer therapy to treat cancer in Liver
Slide 12: 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 13: 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 in accordance with currently approved labeling for melphalan Trial Outcomes Favorable and Consistent with Special Protocol Assessment 13
Slide 14: Phase III Clinical Trial Design
Phase III Clinical Trial Design Randomized to CS 92 patients: ocular or cutaneous melanoma CS/Melphalan Best Alternative Care (BAC) Treat every 4 weeks x 4 rounds Cross- Investigator and patient decision (responders can receive up to 6 rounds) over (any and all treatments) Primary Trial Endpoint Sec
Slide 15: 2010 ASCO Presentation of Phase III Clinical Trial Results
2010 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 the
Slide 16: 2010 ASCO Presentation of Phase III Clinical Trial (cont.)
2010 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 an
Slide 17: Phase I/II NCI Trials - Neuroendocrine
Phase I/II NCI Trials - Neuroendocrine Neuroendocrine Tumor Trial Results (n=23)* Number Pre-CS (n) (Baseline) Carcinoid 3 Pancreatic Islet 17 Cell Not Evaluable (Toxicity, Incomplete reatment, 4 Orthotopic Liver Transplantation) T Progressive 1 Post-CS #1 Disease Minor Response / Stable Disease 3 (
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 • Drug-melphalan & apparatus • Other liver cancers - melphalan • Other organs • Apparatus improvements • All liver cancers - melphalan • Propr
Slide 19: 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 20: Market Opportunity by Geography (patients)
Market Opportunity* by Geography (patients) 355,712 • Initial indication for Melanoma liver mets in USA • General indication in EU for delivery of melphalan to the liver permits physican use on a broad range of liver Transparent Areas cancers Represent Potential Additional Indications • Asia potenti
Slide 21: 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 21
Slide 22: Market by Disease - USA
Market by Disease* - USA *TPM Total Potential Market ** Estimated ASP 22
Slide 23: EU - Landscape
EU - Landscape Initial Target Markets (DE, UK, FR, IT, SP, NL) § CE Mark approval in EU-covers 29 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),
Slide 24: 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 25: Market by Disease - EU
Market by Disease - EU 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 403 296 294 284
Slide 26: 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 HCC (Primary) 197,082 7,486 7,625 4,945 604 217,742 $4,899.2 OTHER CRC 59,644 6
Slide 27: Three-Pronged Business Strategy
Three-Pronged Business Strategy Commercialization § Gain regulatory approval • Goal: receive CE approval for Class III device mid 2011 • Goal: receive FDA approval for drug and delivery system mid 2011 • Goal: receive EU approval for proprietary drug 2014 § Build out direct specialty sales force for
Slide 28: Reimbursement Strategy
Reimbursement Strategy • Have retained leading reimbursement consultants • Seek chemosaturation specific codes in U.S.: 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 pr
Slide 29: Financials
Financials 29
Slide 30: Financial Summary
Financial Summary Financial & Operating Overview § Follow On Offerings: Raised ~ $70 million in last twelve months § Burn Rate: Approximately $2.2 million/month § Cash: ~ $54.1 million at September 31, 2010 § Debt: None § Shares Out: 42.8 million (49.4 million fully diluted*) § Institutional Ownersh
Slide 31: Potential 2011 Milestones
Potential 2011 Milestones Regulatory • FDA acceptance of NDA; PDUFA date established • CE Mark approval • NDA approval Publication • Phase 3 metastatic melanoma to the liver • Phase 2 metastatic neuroendocrine (NET) to the liver Clinical • Phase 2 top line data release • Presentation of Phase 2 data
Slide 32: Company Highlights
Company Highlights § Our mission is making well-established chemotherapeutic drugs work better in target organs § Chemosaturation delivers ultra-high dose chemotherapy to the liver, while complementing systemic cancer therapies § Minimally invasive approach to regional cancer therapy that combines w
Slide 33: 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
Slide 34: Investor Presentation January 2011
Concentrating the Power of Chemotherapy TM Investor Presentation January 2011 NASDAQ: DCTH 34
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