Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (February 2011)
32 slides from Delcath Systems's investor presentation, Feb 8, 2011
Slide 1: Investor Presentation February 2011
Exhibit 99.1 Concentrating the Power of Chemotherapy TM Investor Presentation February 2011 NASDAQ: DCTH
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 § 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 NDA for orphan drug and delivery apparatus and CE Mark for device § Positi
Slide 4: Total potential market and target indications
• Seeking initial indication for 355,712 Melanoma liver mets in USA • Seeking general indication in EU for delivery of melphalan to the liver permits physican use on a broad range of liver cancers Transparent Areas Represent Potential Additional Indications • Asia potentially requires long term clin
Slide 5: 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 6: 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 7: 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 8: 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 l
Slide 9: Patient pathway: identification of liver involvement
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 in Liver chemosaturation When
Slide 10: Patient pathway: identification of liver involvement
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 controlled, patients return to t
Slide 11: 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 12: 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 13: 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 14: 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 15: 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 4 Orthotopic Liver Transplantation) Treatment Progressive 1 Post-CS #1 Disease Minor Response / Stable Disease 3 (+6
Slide 16: 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 • Apparatus improvements • All liver cancers - melph
Slide 17: Largest opportunities by region and cancer type
• US - largest opportunity for Melanoma • China - largest opportunity for HCC • CRC - largest opportunity worldwide *TPM Total Potential Market
Slide 18: CE Mark approval in EU and target countries
§ 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), Lithuania (LT), Luxembourg (LU), Netherlands (NL), Sweden (SE)
Slide 19: Europe is Potential $3.0 Billion Market Opportunity for Device Only
Germany UK France Italy Spain Netherlands Total Potential Potential Market (Direct) (Direct) (Indirect) (Indirect) (Indirect) (Direct) (patients) ($ millions)1,2,3 Total Potential Market #Patients Ocular Melanoma 403 296 294 284 197 79 1,553 $46.6 Cutaneous Melanoma 2,834 1,735 1,314 1,398 628 662 8
Slide 20: Europe Represents Potential $4.1 Billion Market Opportunity
Germany UK France Italy Spain Netherlands Total Potential Potential Market (Direct) (Direct) (Indirect) (Indirect) (Indirect) (Direct) (patients) ($ millions)1,2,3 Total Potential Market #Patients Ocular Melanoma 403 296 294 284 197 79 1,553 $62.1 Cutaneous Melanoma 2,834 1,735 1,314 1,398 628 662 8
Slide 21: Liver Metastasis Potential Market
Liver Metastasis Potential Market Potential Market Potential Market ($MM) # Patients # Procedures $20K ASP ** (Avg 2.5/patient) Ocular 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 96,057 $1,921.1 HCC (Primary) 12,386
Slide 22: Asia Represents Potential $8.2 Billion Market Opportunity
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 CRC 59,644 6,219 27,396 2,762 3,891 99,912 $2,248.0 NET 35,503 1,275 3,355 608 562 41,303 $929.3 Ocular Melano
Slide 23: 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 24: 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 25: 2011 European Commercialization
2011 European Commercialization § Initially Target 6 Markets § 7 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 and training § Establish EU Centers of Exc
Slide 26: 2011 US Commercialization
2011 US Commercialization § 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 cent
Slide 27: 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 28: 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 29: Financials
Financials
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: 42.9 million (49.3 million fully diluted*) § Institutional Ownersh
Slide 31: 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 NDA for orphan drug and delivery apparatus and CE Mark for device § Positi
Slide 32: 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
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