UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): November 18, 2011 (November 15, 2011)
DELCATH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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001-16133
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06-1245881
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(State or Other Jurisdiction
of Incorporation)
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(Commission File Number)
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(IRS Employer
Identification Number)
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810 Seventh Avenue, 35th Floor, New York, New York, 10019
(Address of principal executive offices, including zip code)
(212) 489-2100
(Registrant’s telephone number, including area code)
NONE
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 7.01. Regulation FD Disclosure.
A copy of Delcath Systems, Inc.’s updated investor presentation slides that the Company presented at the Lazard Capital Markets’ Eighth Annual Healthcare Conference on Tuesday, November 15, 2011 and intends to use effective immediately is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference.
The information disclosed under this Item 7.01, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.
Item 9.01. Financial Statements and Exhibits.
The following exhibit is filed herewith:
(d) Exhibits.
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Exhibit No.
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Description
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99.1
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Delcath Systems, Inc. Investor Presentation Slides
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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DELCATH SYSTEMS, INC.
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Dated: November 18, 2011
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By:
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/s/ Peter J. Graham
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Name:
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Peter J. Graham
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Title:
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Executive Vice President, General Counsel
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EXHIBIT INDEX
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Exhibit No.
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Description
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99.1
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Delcath Systems, Inc. Investor Presentation Slides
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Exhibit 99.1
Investor Presentation
(NASDAQ: DCTH)
(NASDAQ: DCTH)
November 2011
2 DELCATH SYSTEMS, INC
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, assumptions and other statements
that are not historical facts. Forward-looking statements are subject to known and unknown risks and
uncertainties and are based on potentially inaccurate assumptions, which could cause actual results to
differ materially from expected results, performance or achievements expressed or implied by
statements made herein. Our actual results could differ materially from those anticipated in forward-
looking statements for many reasons, including, but not limited to; uncertainties relating to the time
required to build inventory and establish commercial operations in Europe, CE Marking for the
Generation Two High Efficiency filter, the timing of our commercial launch in Europe, adoption, use and
resulting sales, if any, for the CHEMOSAT system in the EEA, our ability to successfully commercialize
the chemosaturation system and the potential of the system as a treatment for patients with cancer in
the liver, availability of melphalan in the EEA, acceptability of the Phase III clinical trial data by the FDA,
our ability to address the issues raised in the Refusal to File letter received from the FDA and the timing
of our re-submission of our NDA, re-submission and acceptance of the Company’s NDA by the FDA,
approval of the Company’s NDA for the treatment of metastatic melanoma to the liver, adoption, use and
resulting sales, if any, in the United States, approval of the current or future chemosaturation system for
other indications or the same indication in other foreign markets, actions by the FDA or other foreign
regulatory agencies, our ability to successfully enter into distribution and strategic partnership
agreements in foreign markets and the corresponding revenue associated with such foreign markets,
our ability to secure reimbursement for the chemosaturation system, progress of our research and
development programs and results of future clinical trials, uncertainties regarding our ability to obtain
financial and other resources for any research, development and commercialization activities, overall
economic conditions and other factors described in our filings with the Securities and Exchange
Commission including the section entitled ‘‘Risk Factors’’ in our most recent Annual Report on Form 10-
K and our Reports on Form 10-Q and Form 8-K.
related to future events and future financial performance which include statements about our
expectations, beliefs, plans, objectives, intentions, goals, strategies, assumptions and other statements
that are not historical facts. Forward-looking statements are subject to known and unknown risks and
uncertainties and are based on potentially inaccurate assumptions, which could cause actual results to
differ materially from expected results, performance or achievements expressed or implied by
statements made herein. Our actual results could differ materially from those anticipated in forward-
looking statements for many reasons, including, but not limited to; uncertainties relating to the time
required to build inventory and establish commercial operations in Europe, CE Marking for the
Generation Two High Efficiency filter, the timing of our commercial launch in Europe, adoption, use and
resulting sales, if any, for the CHEMOSAT system in the EEA, our ability to successfully commercialize
the chemosaturation system and the potential of the system as a treatment for patients with cancer in
the liver, availability of melphalan in the EEA, acceptability of the Phase III clinical trial data by the FDA,
our ability to address the issues raised in the Refusal to File letter received from the FDA and the timing
of our re-submission of our NDA, re-submission and acceptance of the Company’s NDA by the FDA,
approval of the Company’s NDA for the treatment of metastatic melanoma to the liver, adoption, use and
resulting sales, if any, in the United States, approval of the current or future chemosaturation system for
other indications or the same indication in other foreign markets, actions by the FDA or other foreign
regulatory agencies, our ability to successfully enter into distribution and strategic partnership
agreements in foreign markets and the corresponding revenue associated with such foreign markets,
our ability to secure reimbursement for the chemosaturation system, progress of our research and
development programs and results of future clinical trials, uncertainties regarding our ability to obtain
financial and other resources for any research, development and commercialization activities, overall
economic conditions and other factors described in our filings with the Securities and Exchange
Commission including the section entitled ‘‘Risk Factors’’ in our most recent Annual Report on Form 10-
K and our Reports on Form 10-Q and Form 8-K.
3 DELCATH SYSTEMS, INC
Company Highlights
• Our goal is making established chemotherapeutic drugs work better in target organs
• Initial focus is high dose chemotherapy for improved disease control in the liver
• Successful and highly statistically significant Phase 3 trial results reported
• Encouraging Phase 2 data in additional tumor types
• On verge of commercial launch in Europe
• Filed for CE Marking for Gen Two High Efficiency Filter
• Positioned to address potential $3.0 billion long term European labeled market
opportunity
opportunity
• Filing applications seeking regulatory approval in multiple foreign markets
• Intend to re-file NDA as soon as possible following January meeting with FDA
• Potential $675 million US labeled market opportunity
• Issued patents and orphan drug designations create competitive barriers
• Deep and experienced management team
Concentrating the Power of Chemotherapy for Disease Control in the Liver
4 DELCATH SYSTEMS, INC
Potential Multi-Billion Dollar Market Opportunity*
Transparent Areas
Represent Potential
Additional Indications
Represent Potential
Additional Indications
13,505**
101,563
355,712
• CE Mark in EU for delivery of melphalan to
the liver permits physician use on a broad
range of liver cancers
the liver permits physician use on a broad
range of liver cancers
• Potential $3 Billion long term EU Market
Opportunity*
Opportunity*
• Leverage CE Mark to gain regulatory
approvals in Asia, America’s (EX US), MEA,
and Australia
approvals in Asia, America’s (EX US), MEA,
and Australia
• Potential $8 Billion Asia/Australia Market
Opportunity*
Opportunity*
• Seeking initial indication for metastatic
melanoma in U.S., a potential $670 million **
market opportunity
melanoma in U.S., a potential $670 million **
market opportunity
• Significant potential label expansion is
possible in U.S. in the future with additional
clinical studies
possible in U.S. in the future with additional
clinical studies
5 DELCATH SYSTEMS, INC
Spectrum of Liver Cancer Treatments
Existing Treatments Involve Significant Limitations
|
Type of Treatment
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Advantages
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Disadvantages
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Systemic
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o Non-invasive
o Repeatable
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– Systemic toxicities
– Limited efficacy in liver
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Regional (e.g., IHP)
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o Therapeutic effect
o Targeted
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– Invasive/limited repeatability
– Multiple treatments are
required |
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Focal
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o Isolated removal of tumor
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– 90% unresectable
– Invasive and/or limited
repeatability |
6 DELCATH SYSTEMS, INC
Open Surgical IHP - Where It All Began
Isolated Hepatic Perfusion: Proof of Concept, but High Morbidity and Non-Repeatable
7 DELCATH SYSTEMS, INC
The Delcath Chemosaturation System
Three Steps of Chemosaturation
1) ISOLATION
2) SATURATION
3) FILTRATION
Advantages of Chemosaturation
• Improved disease control in the
liver
liver
• Treats entire liver
• Allows for ~ 100x effective dose
escalation of drug agents at
tumor site
escalation of drug agents at
tumor site
• Controls systemic toxicities
• Repeatable
• Complements systemic therapy
Minimally Invasive, Repeatable Liver Procedure That Could Complement Systemic Therapy
Note: Image not to scale.
8 DELCATH SYSTEMS, INC
Melphalan Dosing & Background
• Well understood, dose dependant, tumor preferential, alkylating cytotoxic agent that
demonstrates no hepatic toxicity
demonstrates no hepatic toxicity
• Manageable systemic toxicities associated with Neutropenia and Cytopenia
• Drug dosing over 10x higher than FDA-approved dose via systemic IV chemotherapy
• Dose delivered to tumor is approximately 100x higher than that of systemic IV
chemotherapy
chemotherapy
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Type
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Dosing (mg/kg)
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Multiple Myeloma (label)
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0.25
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Chemoembolization
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0.62
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Surgical Isolated Hepatic Perfusion (IHP)
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1.50
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Myeloablation
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2.50-3.50
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Chemosaturation (PHP)
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3.00
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An established Drug For Liver Cancer Therapy
9 DELCATH SYSTEMS, INC
What Chemosaturation Offers
Patients:
o Significant improvement in disease control in the liver compared to
standard of care in patients with unresectable hepatic melanoma mets
standard of care in patients with unresectable hepatic melanoma mets
o Manageable systemic toxicities
o Time, so that primary cancers can continue to be treated
Physicians:
o Novel, targeted liver directed treatment to complement other
cancer therapies
cancer therapies
o Repeatable, percutaneous procedure
o Ability to treat the entire liver, including both visible and micro tumors
o Ability to continue treating patients for extra-hepatic disease
Attractive Clinical and Economic Proposition For Patient and Providers
10 DELCATH SYSTEMS, INC
Interventional
Radiologist
Patient
Primary
Care
Medical
Oncologist
Offers systemic therapy to
treat Cancer
treat Cancer
Oncologist
Offers resection or other focal therapy
to treat cancer in Liver
to treat cancer in Liver
Transferred for
chemosaturation
chemosaturation
Diagnosis
of Cancer
of Cancer
Identification of liver
involvement
involvement
with no improvement from
systemic therapy
systemic therapy
When liver disease is
controlled, patients return to the
Medical Oncologist for
additional systemic therapy
controlled, patients return to the
Medical Oncologist for
additional systemic therapy
11 DELCATH SYSTEMS, INC
Summary of Updated Phase III Results*
• Primary endpoint exceeded, p value = 0.0001, hazard ratio of .35
o Treatment arm shows 5x median hepatic progression free (hPFS) survival compared to control arm
o CS/PHP median hPFS of 8.0 months compared to 1.6 months for BAC
o 86% overall clinical benefit (CR + PR + SD)
• Secondary endpoints support results
o OS Secondary endpoint - No difference in Kaplan-Meier curves due to cross over treatment response (9.8
months compared to 9.9 months)
months compared to 9.9 months)
o CS/PHP median overall PFS of 6.7 months vs 1.6 months for BAC
• OS exploratory cohort analysis favorable
o Median survival of 9.8 months for treatment arm compared to 4.1 months non-crossover BAC patients
o Median survival of 11.4 months for all patients treated with melphalan, including crossover
o 13 treatment patients (5 treatment, 8 crossover) and 2 BAC patients still alive at 6/30/2011
• Safety profile - expected and consistent with currently approved labeling for
melphalan
melphalan
o Treatment related Deaths: 3/40 patients (7.5%) 3/116 procedures (2.6%)
o Neutropenic Sepsis (n=2) 5%, Hepatic Failure (n=1) 2.5% (95% tumor burden)
Trial Outcomes Favorable and Consistent with Special Protocol Assessment
* Presented at 2011 ECCO/ESMO Annual Meeting
12 DELCATH SYSTEMS, INC
Phase 2 NCI Trial - Metastatic Neuroendocrine (mNET) Cohort
Pre-CS
(Baseline)
Post-CS #2
(+4 Months)
Post-CS #1
(+6 Weeks)
Promising Initial Response Rate in Attractive Market
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Phase 2 mNET Tumor Cohort (n=24)*
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Number (n)
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Primary Tumor Histology
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|
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Carcinoid
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4
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Pancreatic Islet Cell
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20
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Response
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|
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Not Evaluable (Toxicity, Incomplete Treatment, Orthotopic Liver
Transplantation) |
4
|
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Progressive Disease
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2
|
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Minor Response / Stable Disease
|
4
|
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Partial Response (30.0% - 99.0% Tumor Reduction)
|
13
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Complete Response (No Evidence of Disease)
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1
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Objective Tumor Response
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14
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Objective Tumor Response Rate
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70%
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Duration (months)
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Median Hepatic PFS
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15.5
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Overall Survival After CS
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30.4
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*Presentation at ECCO/ESMO 2011 annual meeting
13 DELCATH SYSTEMS, INC
Gen Two High Efficiency (HE) Filter
STATUS:
o Melphalan - consistent first pass removal efficiency of 98% or better in both in vitro and pre-
clinical, GLP animal studies
clinical, GLP animal studies
o New trade secret manufacturing process for filter medium
o Accelerated development timeline
o Filed for CE marking for Gen Two HE Filter and expect to receive in Q1 2012
o Potential EU commercial launch in Q1 2012 with Gen Two HE Filter, assuming CE Mark
received
received
o Planned Expanded Access Program (EAP) with use of Gen Two product with HE Filter
EXPECTED BENEFITS:
o Reduced systemic toxicity for improved safety profile
o Concomitant Therapy (complements systemic therapies)
o Increased utility in a wider range of patients
Gen Two HE Filter has the Potential to Enhance Procedure and Market Opportunity
14 DELCATH SYSTEMS, INC
Product Development Pipeline
• Melanoma liver mets
• Proprietary drug-melphalan &
apparatus
apparatus
• All liver cancers - melphalan
• Class III device
• 3rd party melphalan
• Additional data generation in
HCC,mCRC and mNET
HCC,mCRC and mNET
• Additional drugs
• Other organs
• Broaden label
• Other liver cancers - melphalan
• Apparatus improvements
Initial Opportunity
Near Term (< 5 years)
Intermediate Term (> 5 years)
• Primary liver cancer (HCC)
• Drug-melphalan & apparatus
• Proprietary melphalan drug
approval
approval
• Apparatus improvements
• Additional drugs
• Other organs
• Broaden label
• Other liver cancers - melphalan
• Additional drugs
• Other organs
Robust Development Program Planned
• Leverage CE Mark approval
• HCC clinical trial
• 3rd party melphalan
15 DELCATH SYSTEMS, INC
Clinical Data Development Goals
• Generate data to establish Chemosaturation as the Standard Of Care
(SOC) for disease control in the liver.
(SOC) for disease control in the liver.
• Utilize Gen Two High Efficiency (HE) Filter
o Concomitant therapy to complement standard of care treatments
o Increase safety of procedure
• Potential clinical trials to expand data:
o HCC: 1L Phase 2 randomized Chemosaturation vs. Sorafenib;
2L Phase 3 randomized Chemosaturation vs. Best Supportive Care
for Sorafenib failure
for Sorafenib failure
o mCRC: 2L Phase 2 signal seeking/safety Chemosaturation
o US Expanded Access Program (EAP) (for Melanoma) with use of Gen Two product
with HE Filter
with HE Filter
Exciting Opportunities for New Clinical Data
16 DELCATH SYSTEMS, INC
• US - largest opportunity for Melanoma
• China- largest opportunity for HCC
• CRC - largest opportunity worldwide
*TPM Total Potential Market
17 DELCATH SYSTEMS, INC
European Markets
• CE Marking on CHEMOSAT device covers 30 countries in the
European Economic Area (EEA)
European Economic Area (EEA)
• Indication is for “intra-arterial delivery of chemotherapeutic agent
(melphalan hydrochloride) to the liver”
(melphalan hydrochloride) to the liver”
• Hospitals procure melphalan separately from existing sources
• Melphalan for injection approved in 14 countries and
commercially available
commercially available
• Estimate potentially applicable to ~100,000 patients annually
• 6 top countries (DE, UK, FR, IT, SP, NL) represent ~70% of total
patient population
patient population
• Intend to target these 6 countries plus Ireland (“Target
Countries”)
Countries”)
Large European Market Opportunity Concentrated in Target Countries
18 DELCATH SYSTEMS, INC
European Commercialization Plans
Objective: Commercial adoption
Major Assumptions:
• Gen Two HE filter available for commercial launch
• Focus efforts in Target Countries
• 6-8 Initial Training centers
• Initiate test market in 2012 for 6 months to validate assumptions and finalize model
• Full commercialization in 2H 2012
Tactics & Execution:
• Market to medical oncologists via contract organization - Medical Science Liaison (MSL)
• Sell to hospital-based interventional radiologists and surgeons with combination of direct sales and
distributors
distributors
• Establish European patient education & awareness programs (PR, website)
• Leverage existing new technology reimbursement channels, while pursuing permanent procedure
reimbursement via Health Technology Assessment (HTA)
reimbursement via Health Technology Assessment (HTA)
• Clinical trials to generate additional data for HCC and CRC
• Planned Expanded Access Program (EAP) with use of Gen Two product with HE Filter
Strategy and Tactics to Address All Key Constituents
19 DELCATH SYSTEMS, INC
European Marketing Considerations
Reimbursement:
o No centralized EEA device reimbursement body - regional and national systems
o Devices typically reimbursed under DRG as part of a procedure
o Immediate reimbursement plans:
• Utilize existing codes where permitted until permanent reimbursement established (e.g. Italy)
• Apply for funding under new technology programs (e.g. NUB in Germany and HAS in France)
• Other oncology therapies currently reimbursed, despite lacking randomized data
o Retained reimbursement experts to obtain new procedure specific coding and payment
o Developing Health Technology Assessment (HTA)
o Focused on highlighting clinical value proposition and demonstrating cost effectiveness
Melphalan:
o CHEMOSAT system approved in the EEA for the intra-arterial administration of melphalan to the liver
o Physicians will continue to procure melphalan independently and use in their professional opinion
o Clinical experience in EEA and publications support use of melphalan for disease control in the liver
Clinical Data:
o Delcath Phase 3 and Phase 2 data supplements extensive surgical IHP data with melphalan
o Expect to initiate additional studies with Standard of Care (SOC) in 2012 with availability of HE filter in
HCC and metastatic CRC
HCC and metastatic CRC
o Marketing to medical oncologists will be data driven
Required Elements In Place To Support Commercial Launch
20 DELCATH SYSTEMS, INC
European Interim New Technology Reimbursement Programs
Interim New Technology Payment Programs Already Exist in Major European Markets
21 DELCATH SYSTEMS, INC
Market by Disease - EEA Device Only
|
|
Germany
(Direct)
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UK
(Direct)
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France
(Indirect)
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Italy
(Indirect)
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Spain
(Indirect)
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Netherlands
(Direct)
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Total
Potential (patients)
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Potential
Market ($ millions)1,2,3
|
|
|
||||||||
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Total Potential Market #Patients
|
||||||||
|
Ocular Melanoma
|
403
|
296
|
294
|
284
|
197
|
79
|
1,553
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$46.6
|
|
Cutaneous
Melanoma |
2,834
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1,735
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1,314
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1,398
|
628
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662
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8,571
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$257.1
|
|
CRC
|
18,978
|
10,155
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10,490
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13,952
|
7,694
|
3,151
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64,420
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$1,932.6
|
|
HCC (Primary)
|
3,941
|
1,734
|
3,645
|
6,253
|
2,616
|
197
|
18,386
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$551.6
|
|
NET
|
2,168
|
1,624
|
1,645
|
1,579
|
1,185
|
438
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8,639
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$259.2
|
|
TOTAL
|
25,087
|
13,513
|
15,780
|
21,784
|
11,495
|
3,786
|
91,445
|
$3,047.1
|
Europe is Large Potential Market Opportunity for Device Only
1. Assumes 2.5 treatments per patient
2. Assumes ASP of $12K (device only)
3. Assumes mix of direct sales and distributors
22 DELCATH SYSTEMS, INC
U.S. FDA Regulatory Status
• On February 22, 2011, received Refusal to File (RTF) letter from the FDA
§ Manufacturing plant inspection timing
§ Product and sterilization validation
§ Additional statistical analysis clarification
§ Additional safety data
o RTF stated that safety information provided was insufficient to allow FDA to accept our application and
review the overall risk/benefit profile
review the overall risk/benefit profile
o FDA & SPA approved CRF’s did not collect all hospitalization data in the patient records in an
effective manner
effective manner
o Follow-up meeting with FDA held in April 2011 to review proposed plan of action which includes:
o No additional studies or generation of new data requested
• Pre-NDA Submission meeting with FDA scheduled for mid-January 2012
• Continued progress in collecting, entering and monitoring patient safety data from our clinical trial sites
o Data migration to new database
o Created new Case Report Form (CRF)
o Data Entry and monitoring ongoing
Intend to Submit Revised NDA Following January Meeting With FDA
23 DELCATH SYSTEMS, INC
Market by Disease* - USA
|
Liver Metastasis
|
Potential Market
# Patients
|
Potential Market
# Procedures
(Avg 2.5/patient)
|
Potential Market ($MM)
$20K ASP **
|
|
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
|
96,057
|
$1,921.1
|
|
HCC (Primary)
|
12,386
|
30,964
|
$619.3
|
|
NET
|
9,986
|
24,965
|
$499.3
|
|
TOTAL OTHER
(Potential Label Expansion)
|
60,794
|
151,985
|
$3,039.7
|
*TPM Total Potential Market
** Estimated ASP
24 DELCATH SYSTEMS, INC
U.S. 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 60 territories as revenues ramp
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
• Utilize top centers from Phase III trial as Centers of Excellence for training
and support
and support
Direct Sales Model Supplemented With CSO Detailing Program
25 DELCATH SYSTEMS, INC
U.S. Reimbursement Strategy
Strategy: intend to seek chemosaturation specific codes based upon value
proposition relative to other cancer therapies
proposition relative to other cancer therapies
o Physician:
• Applied for for CPT Category III code
• Convert the Category III code to Category I following FDA approval
o Hospital:
• Apply for new ICD-9/10 procedure code to capture full procedure of
hepatic isolation and chemosaturation
hepatic isolation and chemosaturation
• Request new DRG based on costs above those of existing DRGs and
clinical dissimilarity to other hepatic procedures in current DRGs
clinical dissimilarity to other hepatic procedures in current DRGs
Pursuing New Specific Codes For Chemosaturation Procedure
26 DELCATH SYSTEMS, INC
Strategy For Asia, Ex US America’s, MEA and Australia
• Intend to leverage CE Mark to obtain reciprocal regulatory approvals for
our Delcath Hepatic CHEMOSAT System
our Delcath Hepatic CHEMOSAT System
• Utilize existing 3rd party melphalan available to physicians
• Seek to secure strategic partners and specialty distributors
Combination of Direct Sales, Strategic Partnerships & Specialty Distributors
27 DELCATH SYSTEMS, INC
International Regulatory Status Update
• Leveraging the CE Mark for CHEMOSAT
• Completed product notification process for CHEMOSAT system
with the Medicines and Medical Device Safety Authority in New
Zealand
with the Medicines and Medical Device Safety Authority in New
Zealand
• Submitted applications to obtain regulatory approval for
CHEMOSAT in Australia, Singapore and Hong Kong
CHEMOSAT in Australia, Singapore and Hong Kong
• In the future intend to submit applications to obtain regulatory
approval in certain key markets in Asia including Japan, Korea
and Taiwan, as well as Canada, Latin America including Brazil
and Argentina and the Middle East
approval in certain key markets in Asia including Japan, Korea
and Taiwan, as well as Canada, Latin America including Brazil
and Argentina and the Middle East
28 DELCATH SYSTEMS, INC
Market by Disease - Australia/Asia
Initial Target Markets (China, Japan, S. Korea, Taiwan, Australia)
Initial Target Markets (China, Japan, S. Korea, Taiwan, Australia)
1. Assumes 2.5 treatments per patient
2. Assumes ASP of $9K
3. Assumes mix of systems with and without Delcath branded melphalan
4. Assumes sales by distributors
China
(Drug)
S. Korea
(Drug)
Japan
(Device)
Taiwan
(Drug)
Australia
(Device)
Total
Potential
Potential
(patients)
Potential
Market 1,2,3,4
Market 1,2,3,4
Total Potential Market #Patients
HCC (Primary)
197,082
7,486
7,625
4,945
604
217,742
$4,899.2
Other
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
Melanoma
Melanoma
1,760
66
175
31
96
2,128
$47.9
Cutaneous
Melanoma
Melanoma
667
74
238
429
1,996
3,404
$76.6
OTHER TOTAL
292,229
14,980
38,376
8,315
5,057
358,957
$8,201.0
Asia Represents Potential $8.2 Billion Market Opportunity
29 DELCATH SYSTEMS, INC
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 processes
FDA Protection
• Orphan Drug Designation granted for melphalan in the treatment of ocular melanoma,
cutaneous melanoma and metastatic neuroendocrine tumors, as well as for doxorubicin
in the treatment of HCC
cutaneous melanoma and metastatic neuroendocrine tumors, as well as for doxorubicin
in the treatment of HCC
o Provides 7 years of marketing exclusivity post FDA approval
• Additional Orphan Drug applications to be filed for other drugs and indications, including melphalan
for HCC and CRC
for HCC and CRC
Multiple Levels of Protection
30 DELCATH SYSTEMS, INC
Deep and Experienced Management Team
Significant Combination Product Approval and Commercialization Experience
|
Executive
|
Title
|
Prior Affiliation(s)
|
Years of
Experience |
|
Eamonn Hobbs
|
President and CEO
|
AngioDynamics, E-Z-EM
|
30
|
|
Graham Miao, Ph.D
|
EVP & CFO
|
Dun & Bradstreet, Pagoda Pharma,
Schering-Plough, Pharmacia |
21
|
|
David McDonald
|
EVP Business Development
|
AngioDynamics, RBC Capital
Markets |
28
|
|
Krishna Kandarpa, M.D.,
Ph.D. |
CMO and EVP, R&D
|
Harvard, MIT, Cornell, UMass
|
31
|
|
Agustin Gago
|
EVP, Global Sales & Marketing
|
AngioDynamics, E-Z-EM
|
29
|
|
Peter Graham, J.D.
|
EVP & General Counsel
|
Bracco, E-Z-EM
|
16
|
|
John Purpura
|
EVP, Regulatory Affairs & Quality
Assurance |
E-Z-EM, Sanofi-Aventis
|
27
|
|
Harold Mapes
|
EVP, Global Operations
|
AngioDynamics, Mallinkrodt
|
25
|
|
Bill Appling
|
SVP Operations & Medical Device
R&D |
AngioDynamics
|
25
|
|
Dan Johnston, Ph.D.
|
VP, Pharma R&D
|
Pfizer, Wyeth
|
10
|
FINANCIALS
32 DELCATH SYSTEMS, INC
Financial Summary
Financial & Operating Overview
• Follow On Offerings: Raised ~ $94 million since November 2009
• Burn Rate: $3.4 million average per month Q3 2011
• Cash: $44.7 million at September 30, 2011
• Debt: None
• Shares Out: ~48 million (~55 million fully diluted*)
• Institutional Ownership: ~23% at September 30, 2011
• Market Capitalization: ~$160 million as of September 30, 2011
• Avg. Daily Volume (3 months) ~580,000
Balance Sheet Strengthened Significantly in Past Two Years To Support Growth Activities
As of September 30th, 2011 fully diluted includes an additional 4.2 million options at $5.04, 2.5 million warrants at $3.51, and 210,422 unvested restricted shares.
33 DELCATH SYSTEMS, INC
Company Highlights
• Our goal is making established chemotherapeutic drugs work better in target organs
• Initial focus is high dose chemotherapy for improved disease control in the liver
• Successful and highly statistically significant Phase 3 trial results reported
• Encouraging Phase 2 data in additional tumor types
• On verge of commercial launch in Europe
• Filed for CE Marking for Gen Two High Efficiency Filter
• Positioned to address potential $3.0 billion long term European labeled market
opportunity
opportunity
• Filing applications seeking regulatory approval in multiple foreign markets
• Intend to re-file NDA as soon as possible following January meeting with FDA
• Potential $675 million US labeled market opportunity
• Issued patents and orphan drug designations create competitive barriers
• Deep and experienced management team
Concentrating the Power of Chemotherapy for Disease Control in the Liver
34 DELCATH SYSTEMS, INC
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 the Treatment of Unresectable Cancers Confined to the Liver." The Oncologist 5
(2000): 416-24.
Without Tumor Necrosis Factor for the Treatment of Unresectable Cancers Confined to the Liver." The Oncologist 5
(2000): 416-24.
Blake, Simon P., Karen Weisinger, Michael B. Atkins, and Vassilios Raptopoulos. "Liver Metastases from Melanoma:
Detection with Multiphasic Contrast Enhanced CT." Radiology 213 (1999): 92-96. Print
Detection with Multiphasic Contrast Enhanced CT." Radiology 213 (1999): 92-96. Print
Ferlay J, Shin HR, Bray F, Forman D, Mathers C and Parkin DM.
GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10 [Internet].
Lyon, France: International Agency for Research on Cancer; 2010. Available from: http://globocan.iarc.fr
GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10 [Internet].
Lyon, France: International Agency for Research on Cancer; 2010. Available from: http://globocan.iarc.fr
Nawaz Khan, Ali, Sumaira MacDonald, Ajay Pankhania and David Sherlock. "Liver, Metastases: [Print] - EMedicine
Radiology." Liver, Metastases. EMedicine - Medical Reference, 10 Feb. 2009. Web.
<http://emedicine.medscape.com/article/369936-print>.
Radiology." Liver, Metastases. EMedicine - Medical Reference, 10 Feb. 2009. Web.
<http://emedicine.medscape.com/article/369936-print>.
Neuroendocrine Tumors. Practice Guidelines in Oncology- v.2.2009. National Comprehensive Cancer Network
(NCCN). 2009.
(NCCN). 2009.
Pawlik, Timothy M., Daria Zorzi, Eddie K. Abdalla, Bryan M. Clary, Jeffrey E. Gershenwald, Merrick I. Ross, Thomas A.
Aloia, Steven A. Curley, Luis H. Camacho, Lorenzo Capussotti, Dominique Elias, and Jean-Nicolas Vauthey. "Hepatic
Resection for Metastatic Melanoma: Distinct Patterns of Recurrence and Prognosis for Ocular Versus Cutaneous
Disease." Annals of Surgical Oncology 13.5 (2006): 712-20.
Aloia, Steven A. Curley, Luis H. Camacho, Lorenzo Capussotti, Dominique Elias, and Jean-Nicolas Vauthey. "Hepatic
Resection for Metastatic Melanoma: Distinct Patterns of Recurrence and Prognosis for Ocular Versus Cutaneous
Disease." Annals of Surgical Oncology 13.5 (2006): 712-20.
35 DELCATH SYSTEMS, INC
Appendix II. - Phase 3 Pivotal Trial Details
36 DELCATH SYSTEMS, INC
Phase III Clinical Trial Design
Randomized to CS
92 patients: ocular
or cutaneous melanoma
CS/Melphalan
Treat every 4 weeks x 4 rounds
(responders can receive up to 6 rounds)
Cross-over
Primary Trial Endpoint
• Statistically significant difference in Hepatic Progression
Free Survival (“hPFS”): p < 0.05
Free Survival (“hPFS”): p < 0.05
• Over 80% of Oncologic drugs approved by FDA between
2005 - 2007 on endpoints other than overall survival
2005 - 2007 on endpoints other than overall survival
Modeled hPFS for Trial Success:
7.73 months (CS)
vs.
4 months (BAC)
Secondary Trial Endpoints
• Hepatic response and duration of hepatic response
• Overall response and duration of overall response
• Overall Survival - Diluted by Cross Over
• SAP calls for analysis of various patient cohorts
Pre-CS (Baseline)
Post-CS (22+ Months)
Hepatic Response - Metastatic Melanoma
Fully Powered, 93 Patient, Randomized, Multi-Center NCI Led Study
37 DELCATH SYSTEMS, INC
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 therapies (radiation, chemo, immuno, image guided local)
• 90% Ocular, 10% Cutaneous - No difference in response
• Overall PFS 186 vs. 46 days for BAC
• 34% response rate for CS/PHP compared to 2% for BAC
• 52% stable disease for CS/PHP compared to 27% for BAC
• 86% overall clinical benefit (CR + PR + SD)
Strong Clinical Trial Results
38 DELCATH SYSTEMS, INC
Summary of Phase III Results
• Primary endpoint exceeded, p value = 0.001, hazard ratio of .301
o Treatment arm shows 5x median hepatic progression free (hPFS) survival compared to control
arm
arm
o CS/PHP median hPFS of 245 days compared to 49 days for BAC
o 86% overall clinical benefit (CR + PR + SD)
• Secondary endpoints support results
o OS Secondary endpoint - No difference in Kaplan-Meier curves due to cross over treatment
response (298 days compared to 301 days)
response (298 days compared to 301 days)
• OS cohort analysis favorable
o Median survival of 298 days for treatment arm compared to 124 in non-crossover BAC patients
o 14 treatment patients (6 treatment, 8 crossover) and 3 BAC patients still alive at 12/31/2010
• Safety profile - expected and consistent with currently approved labeling
for melphalan
for melphalan
o Treatment related Deaths: 3/40 patients (7.5%) 3/116 procedures (2.6%)
o Neutropenic Sepsis (n=2) 5%, Hepatic Failure (n=1) 2.5% (95% tumor burden)
Trial Outcomes Favorable and Consistent with Special Protocol Assessment
39 DELCATH SYSTEMS, INC
Phase I/II NCI Trials - Neuroendocrine
Pre-CS
(Baseline)
Post-CS #2
(+4 Months)
Post-CS #1
(+6 Weeks)
Promising Initial Response Rate in Attractive Market
|
Neuroendocrine Tumor Trial Results (n=23)*
|
|
|
|
Number (n)
|
|
Primary Tumor Histology
|
|
|
Carcinoid
|
3
|
|
Pancreatic Islet Cell
|
17
|
|
Response
|
|
|
Not Evaluable (Toxicity, Incomplete Treatment, Orthotopic Liver
Transplantation) |
4
|
|
Progressive Disease
|
1
|
|
Minor Response / Stable Disease
|
3
|
|
Partial Response (30.0% - 99.0% Tumor Reduction)
|
13
|
|
Complete Response (No Evidence of Disease)
|
2
|
|
Objective Tumor Response
|
15
|
|
Objective Tumor Response Rate
|
79%
|
|
|
Duration (months)
|
|
Median Hepatic PFS
|
39
|
|
Overall Survival After CS
|
40
|
*Presentation at American Hepato-Pancreo-Biliary Association 2008 annual meeting
40 DELCATH SYSTEMS, INC
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 expected1 (due to cross over
provision, most patients received PHP/CS treatment)
provision, most patients received PHP/CS treatment)
• OS cohort analysis - all positive trends
a) Median survival of 298 days for treatment arm compared to 124 in non-crossover BAC patients
b) Median survival of 398 days for BAC Cross Over patients vs. 124 non-cross over BAC patients
• OS Secondary endpoint - No difference in Kaplan-Meier curves(due to cross over
treatment response)
treatment response)
• Safety profile as expected - in line with current FDA approved labeling for IV
administration of Melphalan and Phase I CS/PHP study results
administration of Melphalan and Phase I CS/PHP study results
o Treatment related Deaths: 3/40 patients (7.5%) 3/116 procedures (2.6%)
o Neutropenic Sepsis (n=2) 5%, Hepatic Failure (n=1) 2.5% (95% tumor burden)
o Current approved labeling for Melphalan - 3% to 10% mortality rate.
Encouraging Survival Data With Expected Safety Profile
1. Source: Unger et. al. Cancer 2001;91: 1148
* DELCATH SYSTEMS, INC
© 2011 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED