Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (April 2011)
31 slides from Delcath Systems's investor presentation, Apr 26, 2011
Slide 1: Investor Presentation April 2011
Exhibit 99.1 Concentrating the Power of Chemotherapy TM Investor Presentation April 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 § Received CE Mark approval for Class III medical device on April 13, 2011 § Posit
Slide 4: 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 • CE Mark in EU for delivery of melphalan to the liver permits physician use on a broad range of liver cancers Transparent Areas Represent Potential • Asia potentially requires lon
Slide 5: Spectrum of Liver Cancer Treatments
Spectrum of Liver Cancer Treatments Type of Treatment Advantages Disadvantages Systemic ü Non- - Systemic invasive 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 Isol
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 demonstrate
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: 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 Transferred for treat Cancer Offers resection or other chemosaturation focal therapy
Slide 10: 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 10
Slide 11: 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 12: ASCO 2010 Presentation of Phase 3 Clinical Trial Results
ASCO 2010 Presentation of Phase 3 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 thera
Slide 13: ASCO 2010 Presentation of Phase 3 Clinical Trial (cont.)
ASCO 2010 Presentation of Phase 3 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 anal
Slide 14: 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 4 Orthotopic (Toxicity, Liver Incomplete Progressive 1 Post-CS #1 Transplantation) Treatment) Disease Minor Response 3 (+6 Weeks) / Stable
Slide 15: Regulatory Status
Regulatory Status Europe: approved as a Class III medical device § ISO 13485 certification for manufacturing facility received February 17, 2011 § Received CE Mark approval as a Class III medical device April 13, 2011 § Melphalan already approved and available in 14 EU countries United States: goal
Slide 16: Product Development Pipeline
Product Development Pipeline Initial Opportunity Near Term (< 5 years) Intermediate Term (> 5 years) • All liver cancers – melphalan • Proprietary melphalan drug • Additional drugs • Class III device approval • Other organs • 3rd party melphalan • Apparatus improvements • Melanoma liver mets • Broad
Slide 17: 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 17
Slide 18: EEA – Landscape
EEA – 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), Lithuani
Slide 19: Market by Disease – EEA Device Only
Market by Disease – EEA 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 $46.6 Cutaneous Melano
Slide 20: Market by Disease – USA
Market by Disease – USA Liver Metastasis Potential Market Potential Market Potential Market ($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 MELANOMA (Initial Expected Label) 13,505 33,763 $675.3 CRC 38,423 96
Slide 21: Market by Disease – Australia/Asia
Market by Disease – Australia/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
Slide 22: Reimbursement Strategy
Reimbursement Strategy Europe: § No centralized EEA reimbursement body § Nationalized healthcare systems in each geography dictate a country by country program § Existing codes likely used until permanent reimbursement established (e.g. Italy) § New technology codes available such as NUB in Germany
Slide 23: Three-Pronged Business Strategy
Three-Pronged Business Strategy Commercialization § Establish direct sales force in Northern Europe and distribution partners in the Southern Europe with commercialization expected to begin in late 2011 § Gain additional regulatory approvals and expand commercialization § Goal: leverage CE Mark to g
Slide 24: 2011 European Commercialization
2011 European Commercialization § Initiate test market in 2011 for 3-6 months to validate assumptions and finalize model § Largest 6 countries accounting for 85%-90% of patients § 8-10 direct sales territories initially to cover UK, Germany, Netherlands (Sales and Medical Science Liaisons) § Distrib
Slide 25: 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 initially to support site initiation and training § Uti
Slide 26: 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 27: 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 28: Financials
Financials 28
Slide 29: Financial Summary
Financial Summary Financial & Operating Overview § Follow On Offerings: Raised ~ $70 million since November 2009 § Burn Rate: Approximately $2.6 million per month § Cash: ~ $39 million at March 31, 2010 § Debt: None § Shares Out: 43.1 million (49.8 million fully diluted*) § Institutional Ownership:
Slide 30: 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 § Received CE Mark approval for Class III medical device on April 13, 2011 § Posit
Slide 31: 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