Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Shareholder Meeting (June 2011)
44 slides from Delcath Systems's shareholder meeting presentation, Jun 1, 2011
Slide 1: Shareholder's Meeting May 26, 2011
Exhibit 99.1 Concentrating the Power of Chemotherapy TM Shareholder’s Meeting May 26, 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: Why we do what we do…
Why we do what we do… “My wife was a patient at John Wayne Cancer Center under Dr. Mark Faires 2009-2010….out of all the studies and trials that she went through, your treatments were the only ones that actually made a difference for my wife. The tumors in her liver started to shrink…. Your treatmen
Slide 4: Large Unmet Clinical Need = Large Commercial Opportunity
Large Unmet Clinical Need = Large Commercial Opportunity 355,712 • CE Mark in EU for delivery of melphalan to the liver permits physician use on a broad range of liver cancers • Potential $3 Billion EU Labeled Market Opportunity* • Leverage CE Mark for regulatory approvals in Asia, America’s (EX US)
Slide 5: 12 Months of Accomplishments & Challenges
12 Months of Accomplishments & Challenges Accomplishments: § Successful Phase 3 trial results reported § Completed Phase 2 neuroendocrine metastases trial arm at NCI § Negotiated and Signed long term agreement for U.S. melphalan supply § Created Company’s first strategic plan § Established manufactu
Slide 6: 12 Months of Accomplishments & Challenges
12 Months of Accomplishments & Challenges Challenges: § FDA § Current FDA environment is extremely challenging § Combination products are the most challenging of all (both Drug and Device) § Refusal to File (RTF) § Lack of necessary “bandwidth” for a Pharma/Device company § DCTH Stock “volatility” a
Slide 7: 12 Months of Accomplishments & Challenges
12 Months of Accomplishments & Challenges Accomplishments: § Successful Phase 3 trial results reported § Completed Phase 2 neuroendocrine metastases trial arm at NCI § Negotiated and Signed long term agreement for U.S. melphalan supply § Created Company’s first strategic plan § Established manufactu
Slide 8: Summary of Phase 3 Clinical Trial Results
Summary of Phase 3 Clinical Trial Results § Primary endpoint exceeded, p value = 0.001, hazard ratio of .301 § Treatment arm shows 5x median hepatic progression free (hPFS) survival compared to control arm § CS/PHP median hPFS of 245 days compared to 49 days for BAC § 86% overall clinical benefit (C
Slide 9: Phase 1&2 NCI Trials - Neuroendocrine
Phase 1&2 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 10: 12 Months of Accomplishments & Challenges
12 Months of Accomplishments & Challenges Accomplishments: § Successful Phase 3 trial results reported § Completed Phase 2 neuroendocrine metastases trial arm at NCI § Negotiated and Signed long term agreement for U.S. melphalan supply § Created Company’s first strategic plan § Established manufactu
Slide 11: Created Delcath's First Strategic Plan
Created Delcath’s First Strategic Plan Our Mission: Achieve breakthroughs in regional and targeted therapies for primary and metastatic cancers through the use of proprietary and 3rd party drugs and minimally invasive drug delivery systems that improve clinical outcomes while creating increasing ret
Slide 12: To Achieve Our Mission we will seek to…
To Achieve Our Mission we will seek to… § Expand our pipeline of target indications that have compelling clinical and financial cases and will generate strong IP § Conduct the pre-clinical, clinical, and regulatory work necessary to achieve approvals for targeted indications in jurisdictions around
Slide 13: 12 Months of Accomplishments & Challenges
12 Months of Accomplishments & Challenges Accomplishments: § Successful Phase 3 trial results reported § Completed Phase 2 neuroendocrine metastases trial arm at NCI § Negotiated and Signed long term agreement for U.S. melphalan supply § Created Company’s first strategic plan § Established manufactu
Slide 14: Manufacturing Facility
Yelm Manufacturing Facility
Slide 15: 12 Months of Accomplishments & Challenges
12 Months of Accomplishments & Challenges Accomplishments: § Successful Phase 3 trial results reported § Completed Phase 2 neuroendocrine metastases trial arm at NCI § Negotiated and Signed long term agreement for U.S. melphalan supply § Created Company’s first strategic plan § Established manufactu
Slide 16: Deep and Experienced Management Team
Deep and Experienced Management Team Years of Executive Title Prior Experience Affiliation(s) Eamonn President and CEO AngioDynamics, 30 Hobbs E-Z-EM David CFO AngioDynamics, RBC Capital 28 McDonald Markets Krishna Kandarpa, M.D., CMO and EVP, R&D Harvard, MIT, Cornell, UMass 37 Ph.D. Agustin EVP, G
Slide 17: Board of Directors
Board of Directors Douglas G. Watson Harold Koplewicz, M.D. Chair - N&G Committee Laura Philips, PhD Chairman Pittencrieff Glen Assoc Chair Audit Committee Child Mind Institute, NYU WellGen Gabriel Leung Robert Ladd Roger Stoll, PhD Director Director Chair Comp Committee OSI Pharmaceuticals LaddCap
Slide 18: 12 Months of Accomplishments & Challenges
12 Months of Accomplishments & Challenges Accomplishments: § Successful Phase 3 trial results reported § Completed Phase 2 neuroendocrine metastases trial arm at NCI § Negotiated and Signed long term agreement for U.S. melphalan supply § Created Company’s first strategic plan § Established manufactu
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 § Up to 5 years of patent extension post FDA approval Trade Secret Protection § Developed High Efficiency (HE) filter media via new manufacturing
Slide 20: 12 Months of Accomplishments & Challenges
12 Months of Accomplishments & Challenges Accomplishments: § Successful Phase 3 trial results reported § Completed Phase 2 neuroendocrine metastases trial arm at NCI § Negotiated and Signed long term agreement for U.S. melphalan supply § Created Company’s first strategic plan § Established manufactu
Slide 21: Cleared to Market our Device
Cleared to Market our Device § CE Mark approval covers 30 countries in the European Economic Area (EEA) § Product Name: Delcath Hepatic CHEMOSAT Delivery System § Approved device indication: “For intra-arterial administration of chemotherapeutic agent (melphalan hydrochloride) to the liver with addi
Slide 22: 12 Months of Accomplishments & Challenges
12 Months of Accomplishments & Challenges Accomplishments: § Successful Phase 3 trial results reported § Completed Phase 2 neuroendocrine metastases trial arm at NCI § Negotiated and Signed long term agreement for U.S. melphalan supply § Created Company’s first strategic plan § Established manufactu
Slide 23: Challenges… #1 - FDA
Challenges… #1 - FDA § Overall Climate § Combination (both drug & device) product is the most challenging § RTF Goal: Submit NDA by end of year 23
Slide 24: Why did we get an RTF?
Why did we get an RTF? § On February 22, 2011, received Refusal to File (RTF) letter from the FDA § Manufacturing plant inspection timing § Product and sterilization validation § Additional statistical analysis clarification § Additional safety data § RTF stated that safety information provided in N
Slide 25: Challenges…. #2 - Lack of internal bandwidth
Challenges…. #2 - Lack of internal “bandwidth” Solution: Recruit top Pharma and Device industry talent Improved core competencies and expanded organizational infrastructure 25
Slide 26: Challenges… #3 - Optimized financings
Challenges… #3 - Optimized financings Volatility of DCTH stock and overall market conditions make optimizing equity financings very challenging Solution: Continue to explore all financing alternatives including debt 26
Slide 27: Challenges… #4 - China Strategic Partnership
Challenges… #4 - China Strategic Partnership § Strategic partners in China had strong preference for a doxorubicin CHEMOSAT system since melphalan for injection is not yet approved in China (PRC) § Reluctant to make significant monetary commitments until compelling HCC data is available § De-novo re
Slide 28: Charting a Path Forward
Charting a Path Forward § EU Commercialization Plans § Product Development § Generation 2 Product Roll Out and Implications § HE Filter § Improved isolation/aspiration catheters § Improved clinician interface features § Additional Clinical Data Development Plans § Asia, Ex US Americas, MEA, Australi
Slide 29: 2011 European Commercialization
2011 European Commercialization Major Assumptions: § High Efficiency (HE) filter available for commercial launch § 6-8 Centers of Excellence for initial training § Initiate test market in 2011 for ~ 6 months to validate assumptions and finalize model § Full commercialization in 2012 Strategy and Tac
Slide 30: 2011 European Commercialization
2011 European Commercialization § Market to medical oncologists via contract sales organization (CSO) § Sell to hospital-based interventional radiologists and surgeons with combination of direct sales and distributors § Establish European patient education & awareness programs (PR, website) § Levera
Slide 31: European Device Marketing Considerations
European Device Marketing Considerations Reimbursement: § No centralized EEA device reimbursement body – regional and national systems § Devices typically reimbursed under DRG as part of a procedure § Immediate reimbursement plans: § Utilize existing codes where permitted until permanent reimburseme
Slide 32: Immediate Reimbursement Pathway
Immediate Reimbursement Pathway Immediate Pathway in Primary EEA Markets 32
Slide 33: European Device Marketing Considerations
European Device Marketing Considerations Melphalan: § Delcath will market the Hepatic CHEMOSAT delivery system in the EEA for the intra-arterial administration of melphalan to the liver § Physicians will procure melphalan independently § Clinical experience in EEA and publications support use of mel
Slide 34: European Device Marketing Considerations
European Device Marketing Considerations Clinical Data: § Delcath Phase 3 and Phase 2 data supplements extensive surgical IHP data with melphalan § Expect to initiate additional studies with Standard of Care (SOC) in 2012 with availability of HE filter § HCC § CRC § NET § Marketing to Medical oncolo
Slide 35: Product Development Pipeline
Product Development Pipeline Initial Opportunity Near Term (2 to 5 years) Intermediate Term (> 5 years) • All liver cancers - melphalan • Additional Drugs • Additional drugs • Medical Device • Proprietary melphalan • Other organs • 3rd party melphalan • Apparatus improvements • Additional Data Gener
Slide 36: High Efficiency (HE) Filter Media Development
High Efficiency (HE) Filter Media Development STATUS: § Melphalan – Achieved consistent in-vitro first pass removal efficiency of 98% or better § Internal development project § Developed trade secret manufacturing process to create new filter medium EXPECTED BENEFITS: § Reduced systemic toxicity for
Slide 37: Gen 2 - HE Hemofiltration Cartridge
Gen 2 - HE Hemofiltration Cartridge Dual Filter Housing with Integrated Pole Mount 37
Slide 38: Clinical Data Development Goals
Clinical Data Development Goals § Generate data to establish Chemosaturation as the Standard Of Care (SOC) for disease control in the liver. § Utilize High Efficiency (HE) Filter § Concomitant therapy to compliment standard of care treatments § Increase safety of procedure § Potential clinical trial
Slide 39: Anticipated Publication Schedule
Anticipated Publication Schedule Phase 3 MEL: § Journal submission: Q4 2011 (tied to NDA resubmission safety data) § Podium Presentation: § ESMO Stockholm, September 2011 § CIRSE Munich, September 2011 Phase 2 NET: § Journal Submission: Q3 2011 § Podium Presentations § ESMO Stockholm, September 2011
Slide 40: Asia, Ex US America's, MEA, Australia Regulatory Approvals and Commercialization Plans
Asia, Ex US America’s, MEA, Australia Regulatory Approvals and Commercialization Plans § Intend to leverage CE Mark to obtain reciprocal regulatory approvals for our Delcath Hepatic CHEMOSAT System § Utilize existing 3rd party melphalan available to physicians § Seek to secure strategic partners and
Slide 41: US Commercialization Strategy
US Commercialization Strategy § Initial focus on leading cancer centers and referring community hospitals § Market to Medical Oncologists via CSO § Direct Strategy to sell to Interventional Radiologists and Surgeons: 12 Sales & Medical Science Liaison territories ultimately expanding to as many as 6
Slide 42: U.S. Reimbursement Strategy
U.S. Reimbursement Strategy Strategy: intend to seek chemosaturation specific codes based upon value proposition relative to other cancer therapies Physician: § While undergoing FDA review, apply for CPT Category III code § Convert the Category III code to Category I following FDA approval Hospital:
Slide 43: 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, 2011 § Debt: None § Shares Out: 43.1 million (49.8 million fully diluted*) Capital Structure Strengthe
Slide 44: In conclusion…
In conclusion… § The last 12 months have seen much progress § We’ve faced challenges and are meeting them § We’re preparing to address a $3 billion European market opportunity § We are initiating efforts to expand clinical data with Gen 2 HE Filter System § We’re committed to building shareholder va